chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with doses of improperly stored GARDASIL (dose, frequency, route and lot# were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.92
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Inflammation, Skin infection
Clinical narrative: 03/27/2015 Skin infection on bilateral arms and inflammation got treated with KEFLEX antibiotic and BACTROBAN oint.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registerd nurse via a field representative referring to a patient of unknown age and gender. No relevant medical history was reported. On 16-MAR-2015 the patient was vaccinated with the first dose of GARDASIL. The second and the third dose were received on 04-JUN-2013 and 03-JAN-2014 respectively. On 16-MAR-2015 the patient was given a fourth dose of GARDASIL in error. Dose, route and lot number of the four doses of GARDASIL were unknown. No adverse effects were noted. Product was confirmed not to be GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Crying, Discomfort, Injection site pain
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients were vaccinated with VARIVAX (Merck) (dose, route and lot# were not reported). On unknown dates these patients experienced injection site pain after receiving VARIVAX (Merck). The reporter stated that injection site pain in the other unspecified patients experienced with M-M-R II was more painful compared to the injection site pain the unspecified patients experienced with VARIVAX (Merck). The reporter also reported that all of these unspecified patients cried after receiving VARIVAX (Merck) because the injections were so "uncomfortable." No treatment was given for these adverse events. No lab diagnostics studies were performed. The outcome of these events was reported as recovered/resolved. The relationship between discomfort and VARIVAX (Merck) was related, the relationship between other events and VARIVAX (Merck) was not reported. This one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Crying, Discomfort, Injection site pain
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown date these patients were vaccinated with M-M-R II (dose, route and lot# were not reported). On unknown dates these patients experienced injection site pain after receiving M-M-R II. The reporter stated that the injection site pain the unspecified patients experienced with M-M-R II was more painful compared to the injection site pain the other unspecified patients experienced with VARIVAX (Merck). the reporter also reported that all these unspecified patients cried after receiving M-M-R II because the injections were so "uncomfortable." No treatment was given for these adverse events. No lab diagnostics studies were performed. The outcome of these events was reported as recovered/resolved. The relationship between discomfort and M-M-R II was related, the relationship between other events and M-M-R II was not reported. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Activities of daily living impaired, Arthritis bacterial, Bone erosion, Bone marrow oedema, C-reactive protein normal
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Gout, Impaired driving ability, Inflammation, Joint injury, Mobility decreased
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Muscle oedema, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Sleep disorder
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Spondylitis, Tenderness, Tendonitis
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Arthritis bacterial, Bone erosion, Bone marrow oedema, C-reactive protein normal, Enthesopathy
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Gout, Humerus fracture, Impaired driving ability, Inflammation, Injected limb mobility decreased
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Injection site injury, Injection site pain, Joint injury, Muscle oedema, Musculoskeletal pain
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Osteitis, Pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Spondyloarthropathy, Tenderness
Clinical narrative: This serious spontaneous literature report (initial receipt 24-Mar-2015) concerns a 55 year-old female patient who denied prior shoulder pain, fever, redness, soft tissue swelling, interval trauma, excessive lifting, pulling or exercising. She previously received Influenza virus vaccine and Tdap vaccine. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). The patient also received Tdap vaccine (batch number not provided). On an unspecified date, less than 24 hours after receiving the influenza vaccine and Tdap vaccine, the patient experienced left shoulder pain which was described as dull/achy, 5 out of 10 (10-point scale with 10 being the worst pain) at rest. The shoulder pain exacerbated with shoulder manipulation, most notably with abduction. She also reported persistent 3-4/10 dull pain at rest, sleep disturbances due to pain, and difficulty with lifting, carrying and driving. Investigations included physical examination which was positive for left deltoid tenderness, restricted adduction, and tenderness upon passive abduction and arm elevation - reflexes, strength and sensation were intact. Serum C-reactive protein was normal. Non-enhanced MRI (Magnetic Resonance Imaging) of the left shoulder demonstrated abnormal osseous oedema in the lateral humeral head and neck, and abnormal soft tissue oedema in the teres minor muscle, including its myotendinous junction and humeral insertion. A three-month follow-up (after an ineffective subacromial corticosteroid injection) non-enhanced MRI demonstrated ongoing inflammatory disease as evidenced by new visualization of an 8-mm humeral head cortical erosion. The patient's pain persisted, but at approximately 6 weeks post-injection, her pain with sleep reduced from 4/10 to 2/10. Her rest pain reduced from 5/10 to 3/10 at approximately 7 weeks but with persistent mild restricted motion on physical exam. At around 6 weeks post vaccination, her symptoms began to improve, albeit minimally. On an unspecified date, it was diagnosed as shoulder injury related to vaccine administration (SIRVA). The humeral greater tuberosity erosion depicted on the follow-up MRI reflected not only sequel of prolonged immune response, but it also strongly suggested direct needle impact - likely secondary to the CDC (Centers for Disease Control and Prevention) recommended needle length. She did not undergo surgical repair. The outcome was recovering. Reporter's comments: The reporter reported that the post-injection findings were attributed to sequel from direct needle impact and reactive change related to the injected material. Differential diagnoses included focal septic arthritis, calcific tendinitis with intraosseous penetration, gout, and seronegative spondyloarthropathic enthesopathy. Her prolonged response was likely due in part to performed antibody existing within her synovial tissue from prior vaccinations.
Sex: U
Vaccine: FLU3
Symptoms: Cardiac stress test, Eyelid ptosis, Foetal exposure during pregnancy, Haemangioma, Laboratory test
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 20-Mar-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero included a prenatal vitamin, calcium, iron for anemia and TUMS for heartburn. She had coffee (1/2 cup once weekly) from 12-Mar-2013 to 01-Sep-2013. The 32-year-old mother had no previous pregnancies and had a first trimester serum test on 04-Jun-2013, alpha-fetoprotein test on 02-Jul-2013, glucose tolerance test on 04-Sep-2013, and ultrasound tests on 11-Jun-2013, 23-Apr-2013 and 30-Jul-2013. The mother's DOC (date of conception) was 26-Mar-2013 and EDC (estimated date of confinement) was 17-Dec-2013. There was no family history of congenital anomaly including Marcus Gunn Syndrome. On the 22-Sep-2013, the patient received the Tdap vaccine (adult) via the mother intrauterine. On the 25-Sep-2013, the patient received the AFLURIA vaccine (batch number R53207) via the mother, intrauterine, 1 shot 1 day. On the 21-Dec-2013, the patient was born at a gestation age of 40.6 and the birth weight was 3.75 kg. The baby was diagnosed with left eye ptosis (jaw winking syndrome) as per the pediatric medical record and was being followed by a pediatric ophthalmologist. The baby was also diagnosed with hemangioma in the left chest under the nipple ranging in size from 2cm - 3x5 cm with 1x1 tail. At 12 months of age the hemangioma was 3cm per pediatric records. Outcome was unknown. Linked to case 2015049895 (mother's case).
Sex: U
Vaccine: FLU3
Symptoms: Marcus Gunn syndrome
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 20-Mar-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero included a prenatal vitamin, calcium, iron for anemia and TUMS for heartburn. She had coffee (1/2 cup once weekly) from 12-Mar-2013 to 01-Sep-2013. The 32-year-old mother had no previous pregnancies and had a first trimester serum test on 04-Jun-2013, alpha-fetoprotein test on 02-Jul-2013, glucose tolerance test on 04-Sep-2013, and ultrasound tests on 11-Jun-2013, 23-Apr-2013 and 30-Jul-2013. The mother's DOC (date of conception) was 26-Mar-2013 and EDC (estimated date of confinement) was 17-Dec-2013. There was no family history of congenital anomaly including Marcus Gunn Syndrome. On the 22-Sep-2013, the patient received the Tdap vaccine (adult) via the mother intrauterine. On the 25-Sep-2013, the patient received the AFLURIA vaccine (batch number R53207) via the mother, intrauterine, 1 shot 1 day. On the 21-Dec-2013, the patient was born at a gestation age of 40.6 and the birth weight was 3.75 kg. The baby was diagnosed with left eye ptosis (jaw winking syndrome) as per the pediatric medical record and was being followed by a pediatric ophthalmologist. The baby was also diagnosed with hemangioma in the left chest under the nipple ranging in size from 2cm - 3x5 cm with 1x1 tail. At 12 months of age the hemangioma was 3cm per pediatric records. Outcome was unknown. Linked to case 2015049895 (mother's case).
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Decreased activity, Gait disturbance, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleep loss in a 40-year-old male patient who received BOOSRIX (batch number 773Y, expiry date 3rd April 2016). On 28th January 2014, the patient received BOOSTRIX (intramuscular) .5 ml. On 30th January 2014, 2 days after receiving BOOSTRIX, the patient experienced  sleep loss and joint pain. On an unknown date, the outcome of the sleep loss and joint pain were not recovered/not resolved. The reporter considered the sleep loss and joint pain to be probably related to BOOSTRIX. Additional information was provided as follow: This case was considered a legal case. This was reported by an insurance company for a worker's comp claim. The company was involving GSK given that these were not labeled side effects.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Weight bearing difficulty
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleep loss in a 40-year-old male patient who received BOOSRIX (batch number 773Y, expiry date 3rd April 2016). On 28th January 2014, the patient received BOOSTRIX (intramuscular) .5 ml. On 30th January 2014, 2 days after receiving BOOSTRIX, the patient experienced  sleep loss and joint pain. On an unknown date, the outcome of the sleep loss and joint pain were not recovered/not resolved. The reporter considered the sleep loss and joint pain to be probably related to BOOSTRIX. Additional information was provided as follow: This case was considered a legal case. This was reported by an insurance company for a worker's comp claim. The company was involving GSK given that these were not labeled side effects.
Age: 40.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sleep loss in a 40-year-old male patient who received BOOSRIX (batch number 773Y, expiry date 3rd April 2016). On 28th January 2014, the patient received BOOSTRIX (intramuscular) .5 ml. On 30th January 2014, 2 days after receiving BOOSTRIX, the patient experienced  sleep loss and joint pain. On an unknown date, the outcome of the sleep loss and joint pain were not recovered/not resolved. The reporter considered the sleep loss and joint pain to be probably related to BOOSTRIX. Additional information was provided as follow: This case was considered a legal case. This was reported by an insurance company for a worker's comp claim. The company was involving GSK given that these were not labeled side effects.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Computerised tomogram kidney normal, Nausea, Neutrophil count increased
Clinical narrative: Case number PHHY2015US017727, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549362) website on 03 Feb 2015, and with a follow up report received from QA department (reference number: 353108) on 20 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353108) on 21 Mar 2015. This report refers to a 35-year-old female patient. Historical conditions and current illness were none. Concomitant medication was none. She was vaccinated with FLUVIRIN (batch number: 145903) into the left arm intramuscularly on 21 Oct 2014. On 22 Oct 2014, the patient experienced severe lower back pain, nausea, emesis, weakness and had decrease urine output. The patient went to the emergency room due to the worsening of the symptoms. The patient was treated with IV fluids and medication (no further details provided). The patient underwent computerized tomogram scan of kidney and it ruled out kidney stones. The patient underwent laboratory test and they revealed the patient had an elevated white blood cells (17.7) and neutrophils (86). The patient's urine was clear and all the values were in the normal limits for urine test. The final outcome of the events was recovered. The events were reported as non-serious. The events 'decrease urine output, nausea and emesis' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145903) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up report received from QA department (reference number: 353108) on 20 Feb 2015. Updated QA number. Follow-up information received from the Quality Assurance Department (reference number: 353108) on 21 Mar 2015: The suspect vaccine recoded from AGRIFLU to FLUVIRIN and updated FLUVIRIN batch review report.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal, Urine output decreased, Vomiting, White blood cell count increased
Clinical narrative: Case number PHHY2015US017727, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549362) website on 03 Feb 2015, and with a follow up report received from QA department (reference number: 353108) on 20 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353108) on 21 Mar 2015. This report refers to a 35-year-old female patient. Historical conditions and current illness were none. Concomitant medication was none. She was vaccinated with FLUVIRIN (batch number: 145903) into the left arm intramuscularly on 21 Oct 2014. On 22 Oct 2014, the patient experienced severe lower back pain, nausea, emesis, weakness and had decrease urine output. The patient went to the emergency room due to the worsening of the symptoms. The patient was treated with IV fluids and medication (no further details provided). The patient underwent computerized tomogram scan of kidney and it ruled out kidney stones. The patient underwent laboratory test and they revealed the patient had an elevated white blood cells (17.7) and neutrophils (86). The patient's urine was clear and all the values were in the normal limits for urine test. The final outcome of the events was recovered. The events were reported as non-serious. The events 'decrease urine output, nausea and emesis' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145903) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up report received from QA department (reference number: 353108) on 20 Feb 2015. Updated QA number. Follow-up information received from the Quality Assurance Department (reference number: 353108) on 21 Mar 2015: The suspect vaccine recoded from AGRIFLU to FLUVIRIN and updated FLUVIRIN batch review report.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: Case number PHHY2015US032613, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554329) website on 16 Mar 2015, with the follow-up information received from Quality Assurance Department on 25 Mar 2015. This report refers to a 57 year old male patient. Medical history included constant clearing of throat. Concomitant medications included PRILOSEC and fluticasone propionate nasal spray. On 30 Oct 2014, he was vaccinated with FLUVIRIN (batch number: unknown) into left arm. On 05 Nov 2014, he developed twitching of right eyebrow and some facial numbness on right side. The outcome of the events was unknown. Events were assessed as non-serious. Causality assessment was not provided. Seriousness assessment of event twitching of right eyebrow and some facial numbness right side was upgraded based on information available in the source documents. Upon follow-up from QA department, it was stated that reported FLUVIRIN batch number: 0117 is not a valid batch number and batch investigation will not be performed. Follow-up information received from Quality Assurance Department on 25 Mar 2015: Updated QA comments (batch investigation will not be performed).
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Muscle mass, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US031891, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 556536) website on 16 Mar 2015, with the follow-up information received from Quality Assurance Department on 23 Mar 2015. This report refers to a 61-years-old female patient. Historical conditions were not reported. Concomitant medication included LIPITOR. The patient was vaccinated with FLUVIRIN (batch number: unknown) into left arm intramuscularly, along with ZOSTAVAX (other manufacturer, batch number: J004266) into right arm subcutaneously on 09 Oct 2013. On the same day after vaccination, the patient developed tender and stiff muscle right after the shot. Within two days, lifting and placing the arm over the head was painful for the patient. Later, the patient had developed a lump in the middle of muscle at three weeks and the patient kneaded it out over one week. The patient had pain while moving the arm for 6 to 7 months before getting better. One year later, the patient arm still hurts at times when lifting the arm and position of arm gets affected when pain occurs. When the arm was used more it hurts more to the patient. The events were reported as serious (permanent disability). The outcome of the events was reported as condition unchanged. The causality of the events was not reported. Upon the follow-up from QA department, it was stated that the reported FLUVIRIN batch number: 1388601 is not a valid batch number and no QA investigation would be performed. Follow-up information received from Quality Assurance Department on 23 Mar 2015: Updated QA comments.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Face injury, Fall, Feeling abnormal, Head injury
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. The patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Lip injury, Loss of consciousness, Muscle rigidity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. The patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.