chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital; Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital; Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest); Severe fatigue with significant interference with activity; Severe muscle pain significantly interfering with activity; Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 degree F); Moderate malaise/feeling sick present with some interference with activity; Joint pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 03Jan2024, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Joint pain with some interference with activity"; PYREXIA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate fever (101.3 to 102 degree F)"; VACCINATION SITE PAIN (medically significant) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site swelling"; MALAISE (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (medically significant) with onset 03Jan2024, outcome "unknown", described as "Severe fatigue with significant interference with activity"; MYALGIA (medically significant) with onset 03Jan2024, outcome "unknown", described as "Severe muscle pain significantly interfering with activity"; NAUSEA (medically significant), VOMITING (medically significant) all with onset 03Jan2024, outcome "unknown" and all described as "Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital". The patient underwent the following laboratory tests and procedures: Body temperature: Moderate fever (101.3 to 102 °F).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital; Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital; Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest); Severe fatigue with significant interference with activity; Severe muscle pain significantly interfering with activity; Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 degree F); Moderate malaise/feeling sick present with some interference with activity; Joint pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 03Jan2024, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Joint pain with some interference with activity"; PYREXIA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate fever (101.3 to 102 degree F)"; VACCINATION SITE PAIN (medically significant) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site swelling"; MALAISE (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (medically significant) with onset 03Jan2024, outcome "unknown", described as "Severe fatigue with significant interference with activity"; MYALGIA (medically significant) with onset 03Jan2024, outcome "unknown", described as "Severe muscle pain significantly interfering with activity"; NAUSEA (medically significant), VOMITING (medically significant) all with onset 03Jan2024, outcome "unknown" and all described as "Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital". The patient underwent the following laboratory tests and procedures: Body temperature: Moderate fever (101.3 to 102 °F).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loosing her sense of smell and taste; loosing her sense of smell and taste; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), outcome "not recovered" and all described as "loosing her sense of smell and taste".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400006272 same reporter, same drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Recently I came down with COVID for the 3rd time though I have gotten all boosters; Recently I came down with COVID for the 3rd time though I have gotten all boosters; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose number unknown (Booster), manufacturer unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Recently I came down with COVID for the 3rd time though I have gotten all boosters". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid. Clinical course: Recently patient came down with COVID for the 3rd time though patient had gotten all boosters, patient went and purchased Paxlovid (hopefully it worked).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: heart failure: Diagnosed after chest pains from Covid injection; This is a spontaneous report received from a Consumer or other non HCP.  A 58-year-old female patient received BNT162b2 (COMIRNATY), on 02Dec2021 at 12:00 as dose 4 (booster), single (Lot number: FJ1620) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: Jan2010 (ongoing); "Mantle cell lymphoma", start date: 02May2019 (ongoing); "Venous insufficiency", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer/biontech COVID-19 vaccine (Dose 1, Time: 12:00, Left Arm; Intramuscular;Batch/Lot number: EP7534), administration date: 25Mar2021, for COVID-19 immunisation; pfizer/biontech COVID-19 vaccine (Dose 2, Time: 12:15, Left Arm; Intramuscular; Batch/Lot number: ER8735), administration date: 14Apr2021, for COVID-19 immunisation; pfizer/biontech COVID-19 vaccine (Dose 3, Time: 10:45; Left Arm; Intramuscular; Batch/Lot number: 32030BD), administration date: 04Nov2021, for COVID-19 immunisation, reaction(s): "heart failure", "shortness of breath/could hardly breathe", "severe chest pains", "palpitations", "made her sick", "dizziness". The following information was reported: CARDIAC FAILURE (medically significant) with onset Jun2022, outcome "not recovered", described as "heart failure: Diagnosed after chest pains from Covid injection". Therapeutic measures were taken as a result of cardiac failure with Farxiga.
Age: 38.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: medical assistant administered 0.05ml IPOL instead of 0.05ml of a PPD vaccine for a skin test with no reported adverse event; Initial information received on 11-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 38 years old male patient who stated medical assistant administered 0.05ml IPV (VERO) [IMOVAX POLIO] ipol instead of 0.05ml of a TUBERCULIN TEST [TUBERSOL] ppd vaccine for a skin test with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection (with an unknown dosage, strength, expiry date, batch number) for TB Skin test. The information on batch number was requested. On 11-Jan-2024, the patient received a dose of 0.05 ml of suspect IPV (VERO) Suspension for injectionlot W1A101M ,Expiry date : 02-OCT-2025, strength was unknown) via subcutaneous route in unknown administration site for Prophylactic vaccination (Immunization) and medical assistant administered 0.05ml ipol instead of 0.05ml of a ppd vaccine for a skin test with no reported adverse event (wrong product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles symptoms 1 week later.
Age: 96.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: My mother received two injections of the RSV vaccine on two separate dates in November and December, both in 2023.  After her second RSV vaccine injection in December, I noticed that she had already been given the vaccine the month before.  I became concerned and went back to the pharmacy to speak with the pharmacist who said there are no adverse effects from the second dosage.  The pharmacist informed me that the insurance approved and paid for the vaccine at the time it was administered and the pharmacy has no way of knowing if patient had received the same vaccine the month before.  Patient received both vaccine at the same location.  Patient has not exhibited any adverse reaction or effect from the second vaccine.  Patient never complained of headaches or nausea or other symptoms and has been in a good mood.  Patient has been seen by her nurse practitioner twice since the second vaccine and is in good health.  Patient's blood pressure today was 120/61.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; Information has been received from regulatory authority on 15-JAN-2023 referring to a 70-74 (age group: elderly) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Total 1 dose was vaccinated.  On an unknown date in 2009, the patient experienced pneumococcal infection. On an unknown date in 2009, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event pneumococcal infection was not known.    The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had it on side of head up to top and behind right eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had it on side of head up to top and behind right eye). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JAN-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had shingles on the side of head up to the top and behind right eye. The patient stated that he/she was very lucky to only get a minor version as the patient had shingles shot that goodness. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: patient developed shingles; did not return for 2nd dose; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: patient developed shingles) and incomplete course of vaccination (Verbatim: did not return for 2nd dose). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JAN-2024 Healthcare professional reported that the patient received 1st dose of Shingrix and developed shingles. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Shingrix shot and had vertigo; This non-serious case was reported by a consumer via call center representative and described the occurrence of vertigo in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vertigo (Verbatim: Shingrix shot and had vertigo). The outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.     It was unknown if the company considered the vertigo to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JAN-2024 The patient got the Shingrix vaccine and had vertigo and had to go to the physician. No additional details regarding adverse event outside of what was left on afterhours VM box. The reporter stated that please consult with consumer regarding any additional details. The reporter requested to consent the follow up.
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: just the adjuvant portion of the vaccine was administered; Just the adjuvant portion of the vaccine was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PK74B, expiry date 22-FEB-2025) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: just the adjuvant portion of the vaccine was administered) and inappropriate dose of vaccine administered (Verbatim: Just the adjuvant portion of the vaccine was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024. The reporter reported that her pharmacy sent a dose of Arexvy to a nursing home and just the adjuvant portion of the vaccine was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email in healthcare professional (HCP) details.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Frequent bowel movements, Heart rate
Clinical narrative: Elevated heart rate; Full body aches; No appetite; Sleepy; pretty pooped out; He had High Temperature 101 F; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Elevated heart rate), PAIN (Full body aches), DECREASED APPETITE (No appetite), SOMNOLENCE (Sleepy) and FREQUENT BOWEL MOVEMENTS (pretty pooped out) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031632) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Dec-2023, the patient experienced HEART RATE INCREASED (Elevated heart rate), PAIN (Full body aches), DECREASED APPETITE (No appetite), SOMNOLENCE (Sleepy), FREQUENT BOWEL MOVEMENTS (pretty pooped out), PYREXIA (He had High Temperature 101 F) and FATIGUE (fatigue). In December 2023, HEART RATE INCREASED (Elevated heart rate), PAIN (Full body aches), DECREASED APPETITE (No appetite), SOMNOLENCE (Sleepy), FREQUENT BOWEL MOVEMENTS (pretty pooped out), PYREXIA (He had High Temperature 101 F) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2023, Body temperature: High Temperature 101 F. On 01-Dec-2023, Heart rate: Elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had previously received 5 doses of Moderna COVID-19 vaccines as followed; 1st shot; First Primary monovalent dose received on 17-Mar-2021 with LOT no. 046A21A, 2nd shot; second primary monovalent dose received on 14-Apr-2021 with LOT no. 026B21A, 3rd shot; first monovalent booster dose received on 13-Apr-2022 with LOT no. 042J21A, 4th shot; first bivalent booster dose received on 22-Oct-2022 with LOT no. 049B22A, 5th shot; second bivalent booster dose received on 10-May-2023 with LOT no. 065822A. Expiry date was unknown for all reported doses.  No concomitant medication was reported.  After receiving dose 6, later that night on 01-Dec-2023, patient became real sick. It lasted 36 to 48 hours. Patient stated that he drank water and rest a lot. He did not see his HCP and did not take medications. All symptoms went away, and he recovered 100 percent on his own.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2024: Live Significant Follow-Up information received: Reporter details, patient details, suspect product details, event details added and narrative updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Pyrexia, Somnolence
Clinical narrative: Elevated heart rate; Full body aches; No appetite; Sleepy; pretty pooped out; He had High Temperature 101 F; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Elevated heart rate), PAIN (Full body aches), DECREASED APPETITE (No appetite), SOMNOLENCE (Sleepy) and FREQUENT BOWEL MOVEMENTS (pretty pooped out) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031632) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Dec-2023, the patient experienced HEART RATE INCREASED (Elevated heart rate), PAIN (Full body aches), DECREASED APPETITE (No appetite), SOMNOLENCE (Sleepy), FREQUENT BOWEL MOVEMENTS (pretty pooped out), PYREXIA (He had High Temperature 101 F) and FATIGUE (fatigue). In December 2023, HEART RATE INCREASED (Elevated heart rate), PAIN (Full body aches), DECREASED APPETITE (No appetite), SOMNOLENCE (Sleepy), FREQUENT BOWEL MOVEMENTS (pretty pooped out), PYREXIA (He had High Temperature 101 F) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2023, Body temperature: High Temperature 101 F. On 01-Dec-2023, Heart rate: Elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had previously received 5 doses of Moderna COVID-19 vaccines as followed; 1st shot; First Primary monovalent dose received on 17-Mar-2021 with LOT no. 046A21A, 2nd shot; second primary monovalent dose received on 14-Apr-2021 with LOT no. 026B21A, 3rd shot; first monovalent booster dose received on 13-Apr-2022 with LOT no. 042J21A, 4th shot; first bivalent booster dose received on 22-Oct-2022 with LOT no. 049B22A, 5th shot; second bivalent booster dose received on 10-May-2023 with LOT no. 065822A. Expiry date was unknown for all reported doses.  No concomitant medication was reported.  After receiving dose 6, later that night on 01-Dec-2023, patient became real sick. It lasted 36 to 48 hours. Patient stated that he drank water and rest a lot. He did not see his HCP and did not take medications. All symptoms went away, and he recovered 100 percent on his own.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2024: Live Significant Follow-Up information received: Reporter details, patient details, suspect product details, event details added and narrative updated.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Regulatory Agency 12-JAN-2024.   This spontaneous report has been downloaded from Regulatory Authority and referring to an Elderly (age: 70-74 years old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated 1 time of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).   On an unknown date in 2009, the patient experienced streptococcus pneumoniae pneumonia, and serotyping was not available. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and suspect vaccine was unknown.   Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; Information has been received from Agency 12-JAN-2024.   This spontaneous report has been downloaded from Surveillance System and referring to an Adult (age: 35-39 years old) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated 1 time of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).   On an unknown date in 2009, the patient experienced pneumococcal bacteraemia and serotyping was not applicable. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and suspect vaccine was unknown.   Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test
Clinical narrative: Pneumococcal infection; Information has been received from Agency on 15-JAN-2023 referring to a 55-59 (age group: Adult) female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Total 4 vaccines were given.  On an unknown date in 2022, the patient experienced pneumococcal infection. On an unknown date in 2022, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event pneumococcal infection was not known.    The causal relationship between pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: RVX
Symptoms: Cough, Fatigue, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: running nose; sneezing; sore throat; lingering cough; extreme fatigue; This non-serious case was reported by a consumer and described the occurrence of runny nose in a 67-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included atorvastatin calcium trihydrate (Atorvastatin), lisinopril, alprazolam, insulin lispro, insulin lispro protamine suspension (Humalog Mix50) and insulin lispro, insulin lispro protamine suspension (Humalog Mix25).   On 07-JAN-2024, the patient received RSV vaccine. On 08-JAN-2024, 1 days after receiving RSV vaccine, the patient experienced runny nose (Verbatim: running nose), sneezing (Verbatim: sneezing), sore throat (Verbatim: sore throat), cough (Verbatim: lingering cough) and fatigue (Verbatim: extreme fatigue). On 15-JAN-2024, the outcome of the runny nose, sneezing, sore throat, cough and fatigue were resolved (duration 7 days).   It was unknown if the reporter considered the runny nose, sneezing, sore throat, cough and fatigue to be related to RSV vaccine.     It was unknown if the company considered the runny nose, sneezing, sore throat, cough and fatigue to be related to RSV vaccine.   Additional Information: GSK receipt date: 15-JAN-2024 The patient self-reported this case. This report was submitted via the online direct entry reporting system.  The patient received RSV vaccine in the evening and woke up next morning with running nose, sneezing, sore throat, coughing, extreme fatigue, but no noticeable fever 97.6 (normal for him). The symptoms were treated. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: LOT OF BAD STUFF AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in 2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced lot of bad stuff after receiving vaccine (Dose number in series 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lot of bad stuff after receiving vaccine was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Aphasia, COVID-19, Cardiac stress test abnormal, Catheterisation cardiac abnormal
Clinical narrative: Admit date: 1/2/2024  Discharge date: 01/12/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: 01/12/2024  Brief Summary of Hospital Stay: As per H&P Patient is a 65 YO year old female with past medical history of rheumatoid arthritis, hypertension, Cor pulmonale presenting to Hospital with complaint of coughing shortness for breath.  Patient is alert but oriented to herself only.  She does not know the place and time. Per chart review, patient came to emergency department for shortness of breath and cough.  Patient does not know why she is in the hospital. Patient reports a little burning when urinating.  She denied chest pain, sob, abdominal pain, fever, chill, nausea vomiting.  Patient seems to have word-finding difficulty.    Patient was found to have elevated D-dimer, CTA chest negative for PE Patient was found to have elevated troponin, concern for NSTEMI.  Emergency department consulted cardiologist, recommend to start aspirin and heparin drip.   Code Status discussed with patient, patient elected FULL  Hospital Course: Cardiology was consulted. TTE reported newly reduced EF, concern for possible Takotsubo vs schemic. Repeat limited echo reported apical thrombus. Heparin gtt was started. Patient underwent stress test for ischemic eval, which reported evidence of induced myocardial ischemia involving the inferior wall segment. EF 39%. LHC was performed on 1/10/24 which reported non obstructive CAD. Heparin was transitioned to xarelto. No further cardiac workup is needed. Troponin elevation attributed to concomitant COVID infection.  Upon exam this morning, patient feeling overall better. Denies chest pain. Patient was medically optimized. Vital signs were stable for discharge.  Discharged to Home
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery disease, Cough, Dyspnoea, Dysuria, Echocardiogram
Clinical narrative: Admit date: 1/2/2024  Discharge date: 01/12/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: 01/12/2024  Brief Summary of Hospital Stay: As per H&P Patient is a 65 YO year old female with past medical history of rheumatoid arthritis, hypertension, Cor pulmonale presenting to Hospital with complaint of coughing shortness for breath.  Patient is alert but oriented to herself only.  She does not know the place and time. Per chart review, patient came to emergency department for shortness of breath and cough.  Patient does not know why she is in the hospital. Patient reports a little burning when urinating.  She denied chest pain, sob, abdominal pain, fever, chill, nausea vomiting.  Patient seems to have word-finding difficulty.    Patient was found to have elevated D-dimer, CTA chest negative for PE Patient was found to have elevated troponin, concern for NSTEMI.  Emergency department consulted cardiologist, recommend to start aspirin and heparin drip.   Code Status discussed with patient, patient elected FULL  Hospital Course: Cardiology was consulted. TTE reported newly reduced EF, concern for possible Takotsubo vs schemic. Repeat limited echo reported apical thrombus. Heparin gtt was started. Patient underwent stress test for ischemic eval, which reported evidence of induced myocardial ischemia involving the inferior wall segment. EF 39%. LHC was performed on 1/10/24 which reported non obstructive CAD. Heparin was transitioned to xarelto. No further cardiac workup is needed. Troponin elevation attributed to concomitant COVID infection.  Upon exam this morning, patient feeling overall better. Denies chest pain. Patient was medically optimized. Vital signs were stable for discharge.  Discharged to Home
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Fibrin D dimer increased, Intracardiac thrombus, Myocardial ischaemia
Clinical narrative: Admit date: 1/2/2024  Discharge date: 01/12/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: 01/12/2024  Brief Summary of Hospital Stay: As per H&P Patient is a 65 YO year old female with past medical history of rheumatoid arthritis, hypertension, Cor pulmonale presenting to Hospital with complaint of coughing shortness for breath.  Patient is alert but oriented to herself only.  She does not know the place and time. Per chart review, patient came to emergency department for shortness of breath and cough.  Patient does not know why she is in the hospital. Patient reports a little burning when urinating.  She denied chest pain, sob, abdominal pain, fever, chill, nausea vomiting.  Patient seems to have word-finding difficulty.    Patient was found to have elevated D-dimer, CTA chest negative for PE Patient was found to have elevated troponin, concern for NSTEMI.  Emergency department consulted cardiologist, recommend to start aspirin and heparin drip.   Code Status discussed with patient, patient elected FULL  Hospital Course: Cardiology was consulted. TTE reported newly reduced EF, concern for possible Takotsubo vs schemic. Repeat limited echo reported apical thrombus. Heparin gtt was started. Patient underwent stress test for ischemic eval, which reported evidence of induced myocardial ischemia involving the inferior wall segment. EF 39%. LHC was performed on 1/10/24 which reported non obstructive CAD. Heparin was transitioned to xarelto. No further cardiac workup is needed. Troponin elevation attributed to concomitant COVID infection.  Upon exam this morning, patient feeling overall better. Denies chest pain. Patient was medically optimized. Vital signs were stable for discharge.  Discharged to Home
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Admit date: 1/2/2024  Discharge date: 01/12/2024  Admitting Physician: MD   Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: 01/12/2024  Brief Summary of Hospital Stay: As per H&P Patient is a 65 YO year old female with past medical history of rheumatoid arthritis, hypertension, Cor pulmonale presenting to Hospital with complaint of coughing shortness for breath.  Patient is alert but oriented to herself only.  She does not know the place and time. Per chart review, patient came to emergency department for shortness of breath and cough.  Patient does not know why she is in the hospital. Patient reports a little burning when urinating.  She denied chest pain, sob, abdominal pain, fever, chill, nausea vomiting.  Patient seems to have word-finding difficulty.    Patient was found to have elevated D-dimer, CTA chest negative for PE Patient was found to have elevated troponin, concern for NSTEMI.  Emergency department consulted cardiologist, recommend to start aspirin and heparin drip.   Code Status discussed with patient, patient elected FULL  Hospital Course: Cardiology was consulted. TTE reported newly reduced EF, concern for possible Takotsubo vs schemic. Repeat limited echo reported apical thrombus. Heparin gtt was started. Patient underwent stress test for ischemic eval, which reported evidence of induced myocardial ischemia involving the inferior wall segment. EF 39%. LHC was performed on 1/10/24 which reported non obstructive CAD. Heparin was transitioned to xarelto. No further cardiac workup is needed. Troponin elevation attributed to concomitant COVID infection.  Upon exam this morning, patient feeling overall better. Denies chest pain. Patient was medically optimized. Vital signs were stable for discharge.  Discharged to Home
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Back pain, Bone pain, Decreased appetite, Fatigue
Clinical narrative: Numbness tingling in hands about 30 minutes Low back pain lower abdominal pain Tibial pain frontal sinus pain rib pain fatigue anorexia
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Musculoskeletal chest pain, Paraesthesia, Sinus pain
Clinical narrative: Numbness tingling in hands about 30 minutes Low back pain lower abdominal pain Tibial pain frontal sinus pain rib pain fatigue anorexia
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Axillary mass, Chest X-ray, Chills, Computerised tomogram thorax, Diarrhoea
Clinical narrative: Unable to swallow; left upper arm lump at injection site/lump under armpit, lump under arm; left arm - painful, limited mobility; diarrhea; headaches, nausea, fatigue; chills; body aches; dizziness. As of today's date 1-12-2024: Still difficulty swallowing/left arm painful.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Dysphagia, Fatigue, Headache, Injection site mass
Clinical narrative: Unable to swallow; left upper arm lump at injection site/lump under armpit, lump under arm; left arm - painful, limited mobility; diarrhea; headaches, nausea, fatigue; chills; body aches; dizziness. As of today's date 1-12-2024: Still difficulty swallowing/left arm painful.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Limb mass, Mobility decreased, Nausea, Oesophagogastroduodenoscopy, Pain
Clinical narrative: Unable to swallow; left upper arm lump at injection site/lump under armpit, lump under arm; left arm - painful, limited mobility; diarrhea; headaches, nausea, fatigue; chills; body aches; dizziness. As of today's date 1-12-2024: Still difficulty swallowing/left arm painful.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Unable to swallow; left upper arm lump at injection site/lump under armpit, lump under arm; left arm - painful, limited mobility; diarrhea; headaches, nausea, fatigue; chills; body aches; dizziness. As of today's date 1-12-2024: Still difficulty swallowing/left arm painful.
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Side effect to Arexvy...day after vaccine given coughing began..still coughing 3 days later...no problems before vaccine was administrate.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Immobile, Injection site rash, Pain, Rash
Clinical narrative: Patient received both Fluzone HD 2023-24 PFS and Pneumovax 2023 on the same day and in the same deltoid. This caused the patient to go seek medical attention for rash down the entire are, immobility of carpals and phalanges, swelling and pain. A Cortisone shot, and Cefdinir 300mg was giving to ease reactions/symptoms. Two days after the event redness and rash of the arm had resolved to the upper arm and shoulder.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Patient received both Fluzone HD 2023-24 PFS and Pneumovax 2023 on the same day and in the same deltoid. This caused the patient to go seek medical attention for rash down the entire are, immobility of carpals and phalanges, swelling and pain. A Cortisone shot, and Cefdinir 300mg was giving to ease reactions/symptoms. Two days after the event redness and rash of the arm had resolved to the upper arm and shoulder.
Sex: M
Vaccine: COVID19
Symptoms: Device failure, Device malfunction, Needle issue
Clinical narrative: When giving COVID booster (spikevax ndc: 8077102-01) pharmacist went to depress the plunger to administer the vaccine and the plunger would not move. Pharmacist did note some resistance to expelling the air prior to administration but not to the point she found it alarming. Pharmacist attempted to give the vaccine a second time only to find the same issue. After fiddling with the vaccine pharmacist ruled the vaccine (lot 3030701 exp 4/24) to be compromised and patient elected to get the vaccine another day. After further scrutiny it looks like the failure was in the BD eclipse needle, lot 1217268 exp 7/31/26 as in comparison to another needle appeared to have a slight band near the end of the needle, possible indicating a manufacturing error or blockage.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from {HA} on 12-JAN-2024.  This spontaneous report was received from public data set 2009 to 2022 (data current as at 29-JUN-2023) about invasive pneumococcal disease (streptococcus pneumoniae) of Regulatory Authority and referred to an elderly (65-69 years old) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated 1 dose (time) of pneumococcal 23v polysaccharide vaccine (manufacture unknown) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown date in 2019, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal). On an unknown date in 2019, streptococcus pneumoniae serotyping showed not available.   At the time of reporting, the outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the event and suspect vaccine was not provided.  Upon internal review, the event pneumonia pneumococcal was determined as medically significant.
Sex: M
Vaccine: PNC, PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from regulatory authority On 12-JAN-24 (for last significant version).  This spontaneous report was referring to a male child patient (age: 2-4). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. On unknown dates, the patient was vaccinated with 2  doses of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for prophylaxis (formulation, strength, indication, dose, route of administration, lot#, and expiration date were not reported)  On an unknown date in 2009, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2009, Streptococcus pneumoniae serotyping showed Not Available. At the time of reporting, the outcome of the event Streptococcus pneumoniae pneumonia was not known. The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) regarding streptococcus pneumoniae pneumonia was reported as Not Applicable.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from regulatory authority On 12-JAN-24 (for last significant version).  This spontaneous report was referring to a female elder patient (age: 80-84). The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported  On an unknown date, the patient started therapy with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, ot #, expiry date, and route of administration were not provided).  On an unknown date in 2009, the patient experienced Streptococcus pneumoniae pneumonia. On an unknown date in 2009, Streptococcus pneumoniae serotyping showed Not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was not known. The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23)  regarding Streptococcus pneumoniae pneumonia was reported as Not Applicable.   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.