chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: After the first booster, he was itching just on his back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262; Anatomical location: left arm), administration date: 02Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EM9810; Anatomical location: left arm), administration date: 21Feb2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "After the first booster, he was itching just on his back". Therapeutic measures were taken as a result of pruritus.  Additional information: After the first booster, he was itching just on his back and was given gaba and the itching phased off towards end of year. Lot:  is what is written on the card. Hard to read the writing. All of his vaccines were Pfizer vaccines, and they were all given in his left arm at the (withheld). Did not receive any other vaccines that same day. The patient saw  the allergist the first time it happened with the first booster. Allergist said no, its not an allergic reaction and prescribed the gaba at first. Allergist thought it was a neurological issue.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416811 same patient, same event different dose (dose 2);US-PFIZER INC-202201387218 same patient, same event different dose (second booster);US-PFIZER INC-202201387232 same patient, same event different dose (LOE);US-PFIZER INC-202201387233 same reporter, different patient, different event;
Sex: F
Vaccine: COVID19-2, UNK, COVID19
Symptoms: Fatigue
Clinical narrative: the second booster shot made her arm a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the second booster shot made her arm a little sore".  Additional information: Patient had been on Ibrance since 2018 (unspecified date). Patient stated the second booster shot made her arm a little sore.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200128173 same patient.different suspect product and AE;
Sex: F
Vaccine: COVID19-2, UNK, COVID19
Symptoms: Pain in extremity
Clinical narrative: the second booster shot made her arm a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster; unknown manufacturer), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the second booster shot made her arm a little sore".  Additional information: Patient had been on Ibrance since 2018 (unspecified date). Patient stated the second booster shot made her arm a little sore.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200128173 same patient.different suspect product and AE;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: Transient ischaemic attack
Clinical narrative: Dr. believes it was a mini stroke, ordering an MRI.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis
Clinical narrative: severe arthritis; arthralgia; This spontaneous report was received from a consumer and refers to a female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered subcutaneously for prophylaxis (strength, dose, lot #, expiry date, anatomical site injection and route of administration were not provided).  On an unknown date, the patient experienced severe arthritis, and arthralgia. At the time of reporting, the outcome of the events unknown.    The causal relationship between arthralgia, arthritis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; this was an adult patient; This spontaneous report was received from a medical assistant and refers to an adult, postpartum and delivered 6 weeks ago, patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W028561, expiration date: 06-MAR-2024, (strength, exact dose, dose number, and route of administration were not provided) for prophylaxis; and sterile diluent, solution for injection/infusion, lot# W018605, expiration date: 25-OCT-2024, (strength, dose, route of administration, and indication were not provided) (product administered to patient of inappropriate age). No additional AE details available (no adverse event).
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 7-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W018825, expiration date: 14-JUN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W018825, expiration date: 14-JUN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided); pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided); and hepatitis a vaccine inact (HAVRIX) lot #94H52, expiration date: 30-NOV-2023, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838: US-009507513-2212USA003061:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Patient was administered improperly stored GARDASIL 9; This spontaneous report was received from a Certified Medical Assistant, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-SEP-2022, the patient was administered an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U028825, expiration date: 02-NOV-2023, for prophylaxis (route and anatomical location were not provided). No additional adverse event was reported.  According to the reporter, the excursion occurred on 19-SEP-2022 at 31.8°F for 19 minutes, and there were no previous temperature excursions.
Sex: F
Vaccine: MMR
Symptoms: Biopsy skin abnormal, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, CD4 lymphocytes
Clinical narrative: palisaded neutrophilic granulomatosis dermatitis; Foreign body granuloma of skin and subcutaneous tissue; rubella virus granulomatosis disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included multiple sclerosis.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as seven years after vaccination), the patient experienced papules that grew to larger pink to violaceous plaque involving the left arm which was diagnosed initially as granulomatous dermatitis and was treated with hydroxychloroquine without benefit. After twenty years from the onset of the event, an skin biopsy was collected and histopathology results showed Palisaded and foreign body granulomatous dermatitis with concern for follicular rupture, infection, or consideration of palisaded neutrophilic granulomatous dermatitis, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 754 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 2251.2 mm3, CD3 CD4 T cells count: 895.2 mm3, CD3 CD8 T cells count: 1382.8 mm3 (elevated; reversed CD4:CD8 ratio), Activated T Cells HLA-DR CD4: 9.86%, Activated T Cells HLA-DR CD8: 40.6% (elevated), CD19 B cells count: 52.97 mm3 (low), CD56 CD16 NK cells count: 658.1 mm3, T-Cell mitogen proliferation: 103%, Rubella IgG titer: 1171 IU/ml, Rubella neutralization titer: 5120 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease ( Palisaded neutrophilic granulomatous dermatitis,  granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Cell marker, Chest X-ray abnormal, Foreign body reaction, Granuloma, Granuloma skin
Clinical narrative: palisaded neutrophilic granulomatosis dermatitis; Foreign body granuloma of skin and subcutaneous tissue; rubella virus granulomatosis disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included multiple sclerosis.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as seven years after vaccination), the patient experienced papules that grew to larger pink to violaceous plaque involving the left arm which was diagnosed initially as granulomatous dermatitis and was treated with hydroxychloroquine without benefit. After twenty years from the onset of the event, an skin biopsy was collected and histopathology results showed Palisaded and foreign body granulomatous dermatitis with concern for follicular rupture, infection, or consideration of palisaded neutrophilic granulomatous dermatitis, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 754 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 2251.2 mm3, CD3 CD4 T cells count: 895.2 mm3, CD3 CD8 T cells count: 1382.8 mm3 (elevated; reversed CD4:CD8 ratio), Activated T Cells HLA-DR CD4: 9.86%, Activated T Cells HLA-DR CD8: 40.6% (elevated), CD19 B cells count: 52.97 mm3 (low), CD56 CD16 NK cells count: 658.1 mm3, T-Cell mitogen proliferation: 103%, Rubella IgG titer: 1171 IU/ml, Rubella neutralization titer: 5120 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease ( Palisaded neutrophilic granulomatous dermatitis,  granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Granulomatous dermatitis, HLA marker study, Histology, Laboratory test, Mitogen stimulation test
Clinical narrative: palisaded neutrophilic granulomatosis dermatitis; Foreign body granuloma of skin and subcutaneous tissue; rubella virus granulomatosis disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included multiple sclerosis.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as seven years after vaccination), the patient experienced papules that grew to larger pink to violaceous plaque involving the left arm which was diagnosed initially as granulomatous dermatitis and was treated with hydroxychloroquine without benefit. After twenty years from the onset of the event, an skin biopsy was collected and histopathology results showed Palisaded and foreign body granulomatous dermatitis with concern for follicular rupture, infection, or consideration of palisaded neutrophilic granulomatous dermatitis, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 754 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 2251.2 mm3, CD3 CD4 T cells count: 895.2 mm3, CD3 CD8 T cells count: 1382.8 mm3 (elevated; reversed CD4:CD8 ratio), Activated T Cells HLA-DR CD4: 9.86%, Activated T Cells HLA-DR CD8: 40.6% (elevated), CD19 B cells count: 52.97 mm3 (low), CD56 CD16 NK cells count: 658.1 mm3, T-Cell mitogen proliferation: 103%, Rubella IgG titer: 1171 IU/ml, Rubella neutralization titer: 5120 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease ( Palisaded neutrophilic granulomatous dermatitis,  granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Nasopharyngeal swab, Natural killer cell count, Palisaded neutrophilic granulomatous dermatitis, Papule, Rubella
Clinical narrative: palisaded neutrophilic granulomatosis dermatitis; Foreign body granuloma of skin and subcutaneous tissue; rubella virus granulomatosis disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included multiple sclerosis.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as seven years after vaccination), the patient experienced papules that grew to larger pink to violaceous plaque involving the left arm which was diagnosed initially as granulomatous dermatitis and was treated with hydroxychloroquine without benefit. After twenty years from the onset of the event, an skin biopsy was collected and histopathology results showed Palisaded and foreign body granulomatous dermatitis with concern for follicular rupture, infection, or consideration of palisaded neutrophilic granulomatous dermatitis, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 754 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 2251.2 mm3, CD3 CD4 T cells count: 895.2 mm3, CD3 CD8 T cells count: 1382.8 mm3 (elevated; reversed CD4:CD8 ratio), Activated T Cells HLA-DR CD4: 9.86%, Activated T Cells HLA-DR CD8: 40.6% (elevated), CD19 B cells count: 52.97 mm3 (low), CD56 CD16 NK cells count: 658.1 mm3, T-Cell mitogen proliferation: 103%, Rubella IgG titer: 1171 IU/ml, Rubella neutralization titer: 5120 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease ( Palisaded neutrophilic granulomatous dermatitis,  granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody test, Rubivirus test positive, Skin plaque, T-lymphocyte count
Clinical narrative: palisaded neutrophilic granulomatosis dermatitis; Foreign body granuloma of skin and subcutaneous tissue; rubella virus granulomatosis disease; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 45-year-old female patient. The patient's concurrent conditions included multiple sclerosis.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as seven years after vaccination), the patient experienced papules that grew to larger pink to violaceous plaque involving the left arm which was diagnosed initially as granulomatous dermatitis and was treated with hydroxychloroquine without benefit. After twenty years from the onset of the event, an skin biopsy was collected and histopathology results showed Palisaded and foreign body granulomatous dermatitis with concern for follicular rupture, infection, or consideration of palisaded neutrophilic granulomatous dermatitis, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 754 mg/dL, blood immunoglobulin A: 129 mg/dL, Blood immunoglobulin M: 52 mg/dL, CD3 T cells count: 2251.2 mm3, CD3 CD4 T cells count: 895.2 mm3, CD3 CD8 T cells count: 1382.8 mm3 (elevated; reversed CD4:CD8 ratio), Activated T Cells HLA-DR CD4: 9.86%, Activated T Cells HLA-DR CD8: 40.6% (elevated), CD19 B cells count: 52.97 mm3 (low), CD56 CD16 NK cells count: 658.1 mm3, T-Cell mitogen proliferation: 103%, Rubella IgG titer: 1171 IU/ml, Rubella neutralization titer: 5120 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease ( Palisaded neutrophilic granulomatous dermatitis,  granuloma skin and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Biopsy skin abnormal, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, CD4 lymphocytes
Clinical narrative: palisaded granulomatous dermatitis; rubella virus granulomatosis disease; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 55-year-old female patient. The patient's concurrent conditions included hypertension and hyperlimidia.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as thirteen years after vaccination), the patient experienced papules and nodules that coalesce into larger plaque with focal pustules localized to the left arm which was diagnosed initially as granulomatous dermatitis and was treated with surgical excision, intralesional triamcinolone and hydroxychloroquine. After ten years from the onset of the event, an skin biopsy was collected and histopathology results showed palisaded granulomatous dermatitis concerning for rheumatoid nodule or infection, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 462 mg/dL (low), blood immunoglobulin A: 36 mg/dL (low), Blood immunoglobulin M: 32 mg/dL (low), CD3 T cells count: 957 mm3, CD3 CD4 T cells count: 883 mm3, CD3 CD8 T cells count: 71 mm3 (low), CD19 B cells count: 255 mm3, CD56 CD16 NK cells count: 230 mm3, Rubella IgG titer: 1623 IU/ml, Rubella neutralization titer: 10240 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (Granulomatous dermatitis and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Cell marker, Chest X-ray abnormal, Granuloma, Granulomatous dermatitis, Histology
Clinical narrative: palisaded granulomatous dermatitis; rubella virus granulomatosis disease; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 55-year-old female patient. The patient's concurrent conditions included hypertension and hyperlimidia.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as thirteen years after vaccination), the patient experienced papules and nodules that coalesce into larger plaque with focal pustules localized to the left arm which was diagnosed initially as granulomatous dermatitis and was treated with surgical excision, intralesional triamcinolone and hydroxychloroquine. After ten years from the onset of the event, an skin biopsy was collected and histopathology results showed palisaded granulomatous dermatitis concerning for rheumatoid nodule or infection, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 462 mg/dL (low), blood immunoglobulin A: 36 mg/dL (low), Blood immunoglobulin M: 32 mg/dL (low), CD3 T cells count: 957 mm3, CD3 CD4 T cells count: 883 mm3, CD3 CD8 T cells count: 71 mm3 (low), CD19 B cells count: 255 mm3, CD56 CD16 NK cells count: 230 mm3, Rubella IgG titer: 1623 IU/ml, Rubella neutralization titer: 10240 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (Granulomatous dermatitis and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Laboratory test, Lesion excision, Nasopharyngeal swab, Natural killer cell count, Nodule
Clinical narrative: palisaded granulomatous dermatitis; rubella virus granulomatosis disease; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 55-year-old female patient. The patient's concurrent conditions included hypertension and hyperlimidia.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as thirteen years after vaccination), the patient experienced papules and nodules that coalesce into larger plaque with focal pustules localized to the left arm which was diagnosed initially as granulomatous dermatitis and was treated with surgical excision, intralesional triamcinolone and hydroxychloroquine. After ten years from the onset of the event, an skin biopsy was collected and histopathology results showed palisaded granulomatous dermatitis concerning for rheumatoid nodule or infection, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 462 mg/dL (low), blood immunoglobulin A: 36 mg/dL (low), Blood immunoglobulin M: 32 mg/dL (low), CD3 T cells count: 957 mm3, CD3 CD4 T cells count: 883 mm3, CD3 CD8 T cells count: 71 mm3 (low), CD19 B cells count: 255 mm3, CD56 CD16 NK cells count: 230 mm3, Rubella IgG titer: 1623 IU/ml, Rubella neutralization titer: 10240 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (Granulomatous dermatitis and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Palisaded neutrophilic granulomatous dermatitis, Papule, Rubella, Rubella antibody test, Rubivirus test positive
Clinical narrative: palisaded granulomatous dermatitis; rubella virus granulomatosis disease; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 55-year-old female patient. The patient's concurrent conditions included hypertension and hyperlimidia.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as thirteen years after vaccination), the patient experienced papules and nodules that coalesce into larger plaque with focal pustules localized to the left arm which was diagnosed initially as granulomatous dermatitis and was treated with surgical excision, intralesional triamcinolone and hydroxychloroquine. After ten years from the onset of the event, an skin biopsy was collected and histopathology results showed palisaded granulomatous dermatitis concerning for rheumatoid nodule or infection, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 462 mg/dL (low), blood immunoglobulin A: 36 mg/dL (low), Blood immunoglobulin M: 32 mg/dL (low), CD3 T cells count: 957 mm3, CD3 CD4 T cells count: 883 mm3, CD3 CD8 T cells count: 71 mm3 (low), CD19 B cells count: 255 mm3, CD56 CD16 NK cells count: 230 mm3, Rubella IgG titer: 1623 IU/ml, Rubella neutralization titer: 10240 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (Granulomatous dermatitis and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Sex: F
Vaccine: MMR
Symptoms: Skin plaque, T-lymphocyte count
Clinical narrative: palisaded granulomatous dermatitis; rubella virus granulomatosis disease; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning a 55-year-old female patient. The patient's concurrent conditions included hypertension and hyperlimidia.  On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and boosters of the vaccine for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided).  On an unknown date (reported as thirteen years after vaccination), the patient experienced papules and nodules that coalesce into larger plaque with focal pustules localized to the left arm which was diagnosed initially as granulomatous dermatitis and was treated with surgical excision, intralesional triamcinolone and hydroxychloroquine. After ten years from the onset of the event, an skin biopsy was collected and histopathology results showed palisaded granulomatous dermatitis concerning for rheumatoid nodule or infection, serum tests for rubella virus were performed with the following results: Blood immunoglobulin G: 462 mg/dL (low), blood immunoglobulin A: 36 mg/dL (low), Blood immunoglobulin M: 32 mg/dL (low), CD3 T cells count: 957 mm3, CD3 CD4 T cells count: 883 mm3, CD3 CD8 T cells count: 71 mm3 (low), CD19 B cells count: 255 mm3, CD56 CD16 NK cells count: 230 mm3, Rubella IgG titer: 1623 IU/ml, Rubella neutralization titer: 10240 (units not provided); additionally, a chest radiography was performed and produce normal results excluding obvious intrathoracic granulomatous diseases and nasopharyngeal swab was negative.; which concluded with a diagnose of rubella virus granulomatosis disease (Granulomatous dermatitis and rubivirus test positive).  At the reporting time, the outcome of the events was unknown.  The authors considered that the repeated antigenic exposure with the suspect vaccine booster, may have serves as a triggering for the reported event.  This is one of three reports from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2212USA000040:
Age: 10.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE.; Agency reporting a 10 year old patient received her 2nd dose of GARDASIL 9 too early. The patient received her 1st dose on 20OCT2022 and she received her 2nd dose on 26DEC2022. No additional clarifying statements or details were provided. No additional; This spontaneous report as received from a n unspecified reported mentioned as agency, also reported as Office Manager) refers to a 10 year old patient, gender unspecifed There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 02-OCT-2022 the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)prefilled syringe, dose: 0.5 milliliter,  lot # 1775827, expiration date: 27-JUN-2024 for prophylaxis (route of administration, and anatomical location were not reported).    The patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)prefilled syringe, dose: 0.5 milliliter,  lot # 1775827, expiration date: 27-JUN-2024 for prophylaxis (route of administration, and anatomical location were not reported),  too early on 26-DEC-2022 (Inappropriate schedule of product administration). No additional adverse event. No PQC was reported.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: RN called for vaccine stability evaluation after TE on 12/23/22 and reported that 1 dose of  VARIVAX  was administered on 12/27/22. No additional AEs, no PQCs reported.; RN called for vaccine stability evaluation after TE on 12/23/22 and reported that 1 dose of  VARIVAX  was administered on 12/27/22. No additional AEs, no PQCs reported.; This spontaneous report was received from a healthcare professional referring to a 15-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-DEC-2022, a dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion (TE) (temperature and time not reported). On 27-DEC-2022, the patient was vaccinated with the improperly stored dose varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U010399 and expiration date: 01-APR-2023) subcutaneous injection, 0.5 mL/once as prophylaxis (strength and route of administration were not provided) (Product storage error). No additional adverse events (AEs) were reported.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Vomiting
Clinical narrative: Vomited up dose 3 of Vivotif within 30 minutes; Resumed taking dose 3 on day 6 and dose 4 on day 8; A spontaneous report was received from a nurse on 28NOV2022. It described a child (unknown age and gender) who "vomited up dose 3 of Vivotif within 30 minutes" (PT: Vomiting) and "resumed taking dose 3 on day 6 and dose 4 on day 8" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first three doses of Vivotif as scheduled on day 1, 3 and 5, however vomited up the third dose within 30 minutes due to norovirus. Reportedly, the third dose which was intact; was recovered by the patient's mother and was refrigerated. Furthermore, it was reported that the patient resumed taking the third dose on day 6 with no problems and the fourth dose on day 8. The patient had recovered from the event "vomited up dose 3 of Vivotif within 30 minutes" at the time of this report, whereas the outcome of the event "resumed taking dose 3 on day 6 and dose 4 on day 8" was not applicable.  Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer vomited up dose 3 of Vivotif within 30 minutes (vomiting) and resumed taking dose 3 on day 6 and dose 4 on day 8 (inappropriate schedule of product administration). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer vomited up dose 3 of Vivotif within 30 minutes (vomiting) and resumed taking dose 3 on day 6 and dose 4 on day 8 (inappropriate schedule of product administration). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: UNK
Symptoms: Vaccination site pain
Clinical narrative: Arm is still hurting/ persistent pain on the arm since more than two weeks; A spontaneous report was received from the patient on 01DEC2022.  It described a 35-year-old female patient (height: 67 inches/170.18 cm, weight: 152 pounds/68.95 kg) whose "arm is still hurting/ persistent pain on the arm since more than two weeks (vaccination site pain) following the administration of BioThrax (anthrax vaccine adsorbed) (lot number: unknown) for immunisation. It was reported that the patient received BioThrax on 07NOV2022 following which her arm was paining. Reportedly, the patient still has had persistent pain in the arm, for more than two weeks now (as per report). Additionally, it was reported that the patient received no treatment for the reported event. The patient had not recovered from the reported event, at the time of this report.  Action taken with BioThrax with respect to the reported event was not applicable.  The patient had no medical history and her surgical history included gall bladder surgery (removal) and tonsils surgery (removal).  The patient's concomitant medications included Synthroid (levothyroxine sodium) for thyroid, Effexor (venlafaxine hydrochloride) for anxiety and depression, Lessina (ethinylestradiol, levonorgestrel) as a birth control, Xyrem (oxybate sodium) and Ritalin (methylphenidate hydrochloride) for narcolepsy.  No additional information was reported.  Company comment: It was reported that a consumer received BioThrax for immunization and her arm is still hurting/in persistent pain on the arm for more than two weeks (vaccination site pain). Considering the case information, the role of BioThrax cannot be ruled out and the causality of vaccination site pain is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer received BioThrax for immunization and her arm is still hurting/in persistent pain on the arm for more than two weeks (vaccination site pain). Considering the case information, the role of BioThrax cannot be ruled out and the causality of vaccination site pain is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: Upset stomach; Nausea; Vomitings; A spontaneous report was received from a nurse on 02DEC2022. It described a 17-years-old male patient (patient 1) who had "nausea" (PT: Nausea), "vomitings" (PT: Vomiting) and "upset stomach" (PT: Abdominal discomfort) following administration of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient received Vivotif on an unknown date and following the two doses of Vivotif he had nausea, vomiting, and an upset stomach. The outcome of the reported events was unknown, at the time of this report.  Action taken with Vivotif with respect to the reported event was unknown.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000313 (patient 1) and 22000314 (patient 2) were created and cross linked in the database.  Company comment: A 17-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A 17-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: Upset stomach; Nausea; Vomitings; A spontaneous report was received from a nurse on 02DEC2022. It described a 14-years-old male patient (patient 2) who had "nausea" (PT: Nausea), "vomitings" (PT: Vomiting) and "upset stomach" (PT: Abdominal discomfort) following administration of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown), for immunisation. It was reported that the patient received Vivotif on an unknown date and following the two doses of Vivotif he had nausea, vomiting, and an upset stomach. The outcome of the reported events was unknown, at the time of this report.  Action taken with Vivotif with respect to the reported event was unknown.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000313 (patient 1) and 22000314 (patient 2) were created and cross-linked in the database.  Company comment: A 14-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A 14-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.