chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTP, HEP, HIBV, OPV
Symptoms: Blood immunoglobulin M normal, Complement factor C3, Dermatitis bullous, Differential white blood cell count normal, Eosinophil count increased
Clinical narrative: This case was retrieved via a search of scientific literature on 22 October 2013. Verbatim from the article: "A 3-month-old healthy female infant presented to the dermatology clinic with a 1 month history of blisters which began on her feet. The blisters developed 3 days after she received her routine 2 month immunizations (oral polio, DPT, HIB, and hepatitis B). The blisters had been increasing in both number and size and had spread to the patient's hands. She had no prior history of skin disorders and no family history of atopy. Physical examination revealed a well-appearing infant girl who was noted to have multiple 0.25 to 1 cm tense bullae on erythematous bases. The lesions were clustered most intensely on the ventral surfaces of the palms and soles, but also were present on the lateral digits and the dorsal hands and feet. Solitary lesions were also noted on her arms and legs. No lesions were noted on the patient's trunk, face, or perineum. Punch biopsies were performed of the lesional and perilesional skin from the dorsal right foot for both standard histologic analysis and for immunofluorescence studies. Laboratory evaluation including a complete blood count with differential was within normal limits, with the exception of a mild peripheral eosinophilia (8%). Hematoxylin and eosin staining clearly demonstrated a subepidermal bullous dermatosis with an intense mixed inflammatory infiltrate containing numerous eosinophils within the dermis. Periodic acid-Schiff stain for fungi was negative. Gram's stain was negative. Direct immunofluorescence of perilesional skin revealed linear staining of IgG along the basement membrane zone. Staining of complement component C3 was also seen in the same distribution. Staining for IgA, IgM, and fibrinogen was negative, and no circulating anti-basement membrane zone antibodies were detected in the patient's serum. The mother's serum was tested and found to be devoid of circulating anti-basement membrane zone antibodies. Neither salt-split skin testing or immunoblot assay was performed. After a potent CYCLOCRT ointment was applied, her blisters resolved completely at 6 weeks with only mild postinflammatory hyperpigmentation and no textural changes. One year after resolution of her lesions the patient has had no further outbreaks and has continued the recommended schedule for routine childhood immunizations." Documents held by sender: none.
Age: 0.2
Sex: F
Vaccine: DTP, HEP, HIBV, OPV
Symptoms: Eosinophilia, Full blood count normal, Fungal test negative, Gram stain negative, Inflammation
Clinical narrative: This case was retrieved via a search of scientific literature on 22 October 2013. Verbatim from the article: "A 3-month-old healthy female infant presented to the dermatology clinic with a 1 month history of blisters which began on her feet. The blisters developed 3 days after she received her routine 2 month immunizations (oral polio, DPT, HIB, and hepatitis B). The blisters had been increasing in both number and size and had spread to the patient's hands. She had no prior history of skin disorders and no family history of atopy. Physical examination revealed a well-appearing infant girl who was noted to have multiple 0.25 to 1 cm tense bullae on erythematous bases. The lesions were clustered most intensely on the ventral surfaces of the palms and soles, but also were present on the lateral digits and the dorsal hands and feet. Solitary lesions were also noted on her arms and legs. No lesions were noted on the patient's trunk, face, or perineum. Punch biopsies were performed of the lesional and perilesional skin from the dorsal right foot for both standard histologic analysis and for immunofluorescence studies. Laboratory evaluation including a complete blood count with differential was within normal limits, with the exception of a mild peripheral eosinophilia (8%). Hematoxylin and eosin staining clearly demonstrated a subepidermal bullous dermatosis with an intense mixed inflammatory infiltrate containing numerous eosinophils within the dermis. Periodic acid-Schiff stain for fungi was negative. Gram's stain was negative. Direct immunofluorescence of perilesional skin revealed linear staining of IgG along the basement membrane zone. Staining of complement component C3 was also seen in the same distribution. Staining for IgA, IgM, and fibrinogen was negative, and no circulating anti-basement membrane zone antibodies were detected in the patient's serum. The mother's serum was tested and found to be devoid of circulating anti-basement membrane zone antibodies. Neither salt-split skin testing or immunoblot assay was performed. After a potent CYCLOCRT ointment was applied, her blisters resolved completely at 6 weeks with only mild postinflammatory hyperpigmentation and no textural changes. One year after resolution of her lesions the patient has had no further outbreaks and has continued the recommended schedule for routine childhood immunizations." Documents held by sender: none.
Age: 0.2
Sex: F
Vaccine: DTP, HEP, HIBV, OPV
Symptoms: Periodic acid Schiff stain, Skin hyperpigmentation, Skin lesion
Clinical narrative: This case was retrieved via a search of scientific literature on 22 October 2013. Verbatim from the article: "A 3-month-old healthy female infant presented to the dermatology clinic with a 1 month history of blisters which began on her feet. The blisters developed 3 days after she received her routine 2 month immunizations (oral polio, DPT, HIB, and hepatitis B). The blisters had been increasing in both number and size and had spread to the patient's hands. She had no prior history of skin disorders and no family history of atopy. Physical examination revealed a well-appearing infant girl who was noted to have multiple 0.25 to 1 cm tense bullae on erythematous bases. The lesions were clustered most intensely on the ventral surfaces of the palms and soles, but also were present on the lateral digits and the dorsal hands and feet. Solitary lesions were also noted on her arms and legs. No lesions were noted on the patient's trunk, face, or perineum. Punch biopsies were performed of the lesional and perilesional skin from the dorsal right foot for both standard histologic analysis and for immunofluorescence studies. Laboratory evaluation including a complete blood count with differential was within normal limits, with the exception of a mild peripheral eosinophilia (8%). Hematoxylin and eosin staining clearly demonstrated a subepidermal bullous dermatosis with an intense mixed inflammatory infiltrate containing numerous eosinophils within the dermis. Periodic acid-Schiff stain for fungi was negative. Gram's stain was negative. Direct immunofluorescence of perilesional skin revealed linear staining of IgG along the basement membrane zone. Staining of complement component C3 was also seen in the same distribution. Staining for IgA, IgM, and fibrinogen was negative, and no circulating anti-basement membrane zone antibodies were detected in the patient's serum. The mother's serum was tested and found to be devoid of circulating anti-basement membrane zone antibodies. Neither salt-split skin testing or immunoblot assay was performed. After a potent CYCLOCRT ointment was applied, her blisters resolved completely at 6 weeks with only mild postinflammatory hyperpigmentation and no textural changes. One year after resolution of her lesions the patient has had no further outbreaks and has continued the recommended schedule for routine childhood immunizations." Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Vaccine positive rechallenge
Clinical narrative: Initial case was received from a consumer and nurse on 06 December 2013. This female patient (date of birth and age not reported) whose medical history and concomitant medication was not reported had received FLUZONE (batch number, route, dose and anatomical site of administration not reported) on an unspecified date in 2012. The patient had received previous 2 doses of FLUZONE. It was reported that on an unspecified date, patient has had "systemic reaction to FLUZONE each of the past 3 years, getting a little worse each year". The patient declined to provide further information. Last vaccine given in 2012. No laboratory details and corrective treatment was reported. The outcome of the event was unknown. The list of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Syncope
Clinical narrative: Case number PHEH2013US024411, is an initial spontaneous report received from the physician on 20 Nov 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13012) intramuscularly on 16 Nov 2013. On the same day after vaccination, he fainted and fell down. It was reported that he was not injured by fall. The event outcome was unknown. The seriousness and causality were not reported.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood creatine phosphokinase normal, C-reactive protein normal, Immediate post-injection reaction
Clinical narrative: The patient received AFLURIA (Lot # T59406) in her left upper arm on the morning of 10/2/14 (both the patient and the vaccinator were standing). She was in her normal state of health at the time. The patient is left hand dominant. The patient immediately noted "that something felt different" in that the vaccination site "hurt more than normal". She noted a "stinging/burning" pain (6/10) in her left upper arm while waiting in the clinic during the 15 minute period of observation. The patient took 800mg MOTRIN in later in the day without improvement. Over the next 72 hours the patient noted intermittent "soreness" (6/10) of her left upper and left shoulder. This pain increased with writing, driving and was worse in the am and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM or weakness of her left upper extremity. The patient was seen on 10/7/14 by her PCM for a history (over 10 month) of right shoulder pain with radiculopathy. An MRI of the cervical spine (done 1/13/14) should: multilevel degenerative disc disease, worse at C5/C6 with mild/moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with Gabapentin tid, neck pillow and PT. At that time the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On 11/12/14 the patient was seen by her PCM for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM (the patient stated that she had pain and difficulty with lifting her arm above her head; washing her hair and internal rotation--hooking her bra). The patient denies a history of trauma to her left shoulder or neck. Labs were drawn for CRP, CK (both normal) and ESR (slightly elevated at 28). The patient was prescribed LIDODERM patches which did improve the pain. Physical therapy was ordered at this appointment but was not started until 1/9/15. Prior to her first PT appointment the patient had noted improvement in her ROM (she was able to reach above her head). At the time of her appointment the patient reports much improvement (pain 0-1/10 and that she can drive and wash/comb her hair without left arm/shoulder pain; she is experiencing minimal discomfort with writing and that she is able to hook/unhook her bra with some discomfort).
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Intervertebral disc degeneration, Nuclear magnetic resonance imaging spinal abnormal, Red blood cell sedimentation rate increased
Clinical narrative: The patient received AFLURIA (Lot # T59406) in her left upper arm on the morning of 10/2/14 (both the patient and the vaccinator were standing). She was in her normal state of health at the time. The patient is left hand dominant. The patient immediately noted "that something felt different" in that the vaccination site "hurt more than normal". She noted a "stinging/burning" pain (6/10) in her left upper arm while waiting in the clinic during the 15 minute period of observation. The patient took 800mg MOTRIN in later in the day without improvement. Over the next 72 hours the patient noted intermittent "soreness" (6/10) of her left upper and left shoulder. This pain increased with writing, driving and was worse in the am and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM or weakness of her left upper extremity. The patient was seen on 10/7/14 by her PCM for a history (over 10 month) of right shoulder pain with radiculopathy. An MRI of the cervical spine (done 1/13/14) should: multilevel degenerative disc disease, worse at C5/C6 with mild/moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with Gabapentin tid, neck pillow and PT. At that time the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On 11/12/14 the patient was seen by her PCM for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM (the patient stated that she had pain and difficulty with lifting her arm above her head; washing her hair and internal rotation--hooking her bra). The patient denies a history of trauma to her left shoulder or neck. Labs were drawn for CRP, CK (both normal) and ESR (slightly elevated at 28). The patient was prescribed LIDODERM patches which did improve the pain. Physical therapy was ordered at this appointment but was not started until 1/9/15. Prior to her first PT appointment the patient had noted improvement in her ROM (she was able to reach above her head). At the time of her appointment the patient reports much improvement (pain 0-1/10 and that she can drive and wash/comb her hair without left arm/shoulder pain; she is experiencing minimal discomfort with writing and that she is able to hook/unhook her bra with some discomfort).
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood creatine phosphokinase normal, C-reactive protein normal, Discomfort
Clinical narrative: The patient received AFLURIA (Lot # T59406) in her left upper arm on the morning of 10/2/14 (both the patient and the vaccinator were standing). She was in her normal state of health at the time. The patient is left hand dominant. The patient immediately noted "that something felt different" in that the vaccination site "hurt more than normal". She noted a "stinging/burning" pain (6/10) in her left upper arm while waiting in the clinic during the 15 minute period of observation. The patient took 800mg MOTRIN in later in the day without improvement. Over the next 72 hours the patient noted intermittent "soreness" (6/10) of her left upper and left shoulder. This pain increased with writing, driving and was worse in the am and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM or weakness of her left upper extremity. The patient was seen on 10/7/14 by her PCM for a history (over 10 month) of right shoulder pain with radiculopathy. An MRI of the cervical spine (done 1/13/14) should: multilevel degenerative disc disease, worse at C5/C6 with mild/moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with Gabapentin tid, neck pillow and PT. At that time the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On 11/12/14 the patient was seen by her PCM for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM (the patient stated that she had pain and difficulty with lifting her arm above her head; washing her hair and internal rotation--hooking her bra). The patient denies a history of trauma to her left shoulder or neck. Labs were drawn for CRP, CK (both normal) and ESR (slightly elevated at 28). The patient was prescribed LIDODERM patches which did improve the pain. Physical therapy was ordered at this appointment but was not started until 1/9/15. Prior to her first PT appointment the patient had noted improvement in her ROM (she was able to reach above her head). At the time of her appointment the patient reports much improvement (pain 0-1/10 and that she can drive and wash/comb her hair without left arm/shoulder pain; she is experiencing minimal discomfort with writing and that she is able to hook/unhook her bra with some discomfort).
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: The patient received AFLURIA (Lot # T59406) in her left upper arm on the morning of 10/2/14 (both the patient and the vaccinator were standing). She was in her normal state of health at the time. The patient is left hand dominant. The patient immediately noted "that something felt different" in that the vaccination site "hurt more than normal". She noted a "stinging/burning" pain (6/10) in her left upper arm while waiting in the clinic during the 15 minute period of observation. The patient took 800mg MOTRIN in later in the day without improvement. Over the next 72 hours the patient noted intermittent "soreness" (6/10) of her left upper and left shoulder. This pain increased with writing, driving and was worse in the am and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM or weakness of her left upper extremity. The patient was seen on 10/7/14 by her PCM for a history (over 10 month) of right shoulder pain with radiculopathy. An MRI of the cervical spine (done 1/13/14) should: multilevel degenerative disc disease, worse at C5/C6 with mild/moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with Gabapentin tid, neck pillow and PT. At that time the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On 11/12/14 the patient was seen by her PCM for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM (the patient stated that she had pain and difficulty with lifting her arm above her head; washing her hair and internal rotation--hooking her bra). The patient denies a history of trauma to her left shoulder or neck. Labs were drawn for CRP, CK (both normal) and ESR (slightly elevated at 28). The patient was prescribed LIDODERM patches which did improve the pain. Physical therapy was ordered at this appointment but was not started until 1/9/15. Prior to her first PT appointment the patient had noted improvement in her ROM (she was able to reach above her head). At the time of her appointment the patient reports much improvement (pain 0-1/10 and that she can drive and wash/comb her hair without left arm/shoulder pain; she is experiencing minimal discomfort with writing and that she is able to hook/unhook her bra with some discomfort).
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Radiculopathy, Red blood cell sedimentation rate increased, Vaccination site pain
Clinical narrative: The patient received AFLURIA (Lot # T59406) in her left upper arm on the morning of 10/2/14 (both the patient and the vaccinator were standing). She was in her normal state of health at the time. The patient is left hand dominant. The patient immediately noted "that something felt different" in that the vaccination site "hurt more than normal". She noted a "stinging/burning" pain (6/10) in her left upper arm while waiting in the clinic during the 15 minute period of observation. The patient took 800mg MOTRIN in later in the day without improvement. Over the next 72 hours the patient noted intermittent "soreness" (6/10) of her left upper and left shoulder. This pain increased with writing, driving and was worse in the am and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM or weakness of her left upper extremity. The patient was seen on 10/7/14 by her PCM for a history (over 10 month) of right shoulder pain with radiculopathy. An MRI of the cervical spine (done 1/13/14) should: multilevel degenerative disc disease, worse at C5/C6 with mild/moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with Gabapentin tid, neck pillow and PT. At that time the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On 11/12/14 the patient was seen by her PCM for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM (the patient stated that she had pain and difficulty with lifting her arm above her head; washing her hair and internal rotation--hooking her bra). The patient denies a history of trauma to her left shoulder or neck. Labs were drawn for CRP, CK (both normal) and ESR (slightly elevated at 28). The patient was prescribed LIDODERM patches which did improve the pain. Physical therapy was ordered at this appointment but was not started until 1/9/15. Prior to her first PT appointment the patient had noted improvement in her ROM (she was able to reach above her head). At the time of her appointment the patient reports much improvement (pain 0-1/10 and that she can drive and wash/comb her hair without left arm/shoulder pain; she is experiencing minimal discomfort with writing and that she is able to hook/unhook her bra with some discomfort).
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. A 72-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number, dose, dose number, not reported) in the left arm on 20 Oct 2014. The patient had a medical history of allergy to codeine, leg restlessness, insomnia. It was reported that on 21 Oct 2014, the patient developed pain at injection site and he had difficulty raising left arm. The patient had been taking ALEVE as corrective treatment. Lab details were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Bone disorder, Muscle disorder, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. A 72-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number, dose, dose number, not reported) in the left arm on 20 Oct 2014. The patient had a medical history of allergy to codeine, leg restlessness, insomnia. It was reported that on 21 Oct 2014, the patient developed pain at injection site and he had difficulty raising left arm. The patient had been taking ALEVE as corrective treatment. Lab details were not reported. The outcome of the event was unknown. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Initial report received from healthcare professional on 21 Nov 2014. A 72-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number, dose, dose number, not reported) in the left arm on 20 Oct 2014. The patient had a medical history of allergy to codeine, leg restlessness, insomnia. It was reported that on 21 Oct 2014, the patient developed pain at injection site and he had difficulty raising left arm. The patient had been taking ALEVE as corrective treatment. Lab details were not reported. The outcome of the event was unknown. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Initial report received from a healthcare professional on 17 November 2014. A number of four patients (age and gender not reported), whose concomitant medication were not reported, had received intramuscularly a dose of FLUZONE, (batch number: UI189AA) (site of vaccination not reported), on an unspecified date in Oct-2014. On an unspecified date in Oct-2014, patient experienced muscle pain, pain when they lift up the arm where the injection was administered and soreness at injection site. Illness at time of vaccination and pre-existing physician diagnosed allergies were not provided. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Flu vaccine given intradermal on 1/26/15: 1/27/15 = about 50 mm x 50 mm erythema with slight edema to (L) deltoid c/o #2-3/no tenderness on palpation: Tx= TYLENOL 325-650 mg po wtih 8hs PRN for pain. Warm compress on site x 15 mts. Application, TID.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient states his arm hurts where the shot was given. States it feels like he just got the shot but it has been 2 months.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Mucous membrane disorder, Respiratory tract congestion, Somnolence
Clinical narrative: 3 1/2 hrs after vax, pt developed congestion, difficulty breathing, purulent mucous membranes, face swollen, coughing - took antihistamine - sx began to subside approximately 3am - groggy following day.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: 3 1/2 hrs after vax, pt developed congestion, difficulty breathing, purulent mucous membranes, face swollen, coughing - took antihistamine - sx began to subside approximately 3am - groggy following day.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Pain immediately after vaccination at the site then developed soreness, redness, hot to touch, and a small blister approx 1 inch from inj. site - developed over following 24 hrs after vax. Began to improve after that.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Adhesiolysis, Biopsy lymph gland abnormal, Blood cholesterol increased, Blood homocysteine normal, Blood thyroid stimulating hormone normal
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, High density lipoprotein normal, Lipids, Lipoma
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Local swelling, Lymphadenopathy, Lymphangitis, Mass, Metabolic function test normal
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oedema, Pain, Pathology test, Pyrexia, Seroma
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vitamin D
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Axillary mass, Biopsy, Blood cholesterol increased, Blood homocysteine normal, Blood thyroid stimulating hormone normal
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Glycosylated haemoglobin normal, High density lipoprotein increased, Lipoma, Local swelling
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymphadenopathy, Lymphangitis, Mass excision, Metabolic function test, Oedema
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pathology test, Pyrexia, Seroma, Vitamin D
Clinical narrative: The patient is a 45 year old male with a history of HTN, OSA and hypercholesterolemia. The patient reports he receives all his vaccines in his left arm and he experienced significant local swelling, pain and lymphadenopathy localized to his axilla and systemic symptoms of fever within 1-2 days of vaccine receipt 06 OCT 2011. He reports the fever, resolved after 1-2 days but the edema continued and he developed a mass over the next several months. He had no local site reaction over his deltoid, upper arm or elbow or arthralgias. He had no exanthem, pruritus, shortness of breath, chest pain, nausea, airway or vascular compromise. He stated he initially assumed the axillary symptoms would resolve, and waited 6 or month months, but he eventually pursued evaluation and which resulted in mass excision from his axilla. Pathology demonstrated a lipoma and 1 lymph node with otherwise normal pathology. He had two subsequent episodes of recurrent seroma at the excision site and also required adhesion release. He also developed lymphangitis requiring treatment with a compression sleeve for approximately 6 months.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Myoclonus, Syncope
Clinical narrative: Syncopal episode with myoclonic activity x2. First 15 seconds after 2nd shot given, lasting 10 seconds. Second 5 minutes later, lasting 10 seconds.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Periarthritis
Clinical narrative: I got the flu shot on 10/1/14 in my upper left arm. 2 hours later I started with severe pain, which hot worse. I tried everyrhing, nothing helped. I went to the dr. and was told, that I have a "frozen shoulder." I still can not lift my arm and have pain.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Dizziness, Fall, Nausea
Clinical narrative: Pt grew light-headed, fell/lowered himself to the floor. Complains of dizziness and nausea, no vomiting. Drank approx 4-6 oz of water, recovered, walked out of the office under his own power.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain, Pain in extremity, Trismus
Clinical narrative: No pain after injection. Later in evening left shoulder achy. Saturday morning - left side stiff, achy up neck to the ear and down left arm to the middle finger. Later Saturday right side of jaw locked up (hx TMJ). Patient took ALEVE and rested. Symptoms decreasing over next few days. Mild achy on Wednesday 1/21/15.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: On Friday, symptoms began with weak knees, then parathesis of right foot which progressed to his hands. By Tuesday, the patient could barely walk. He came to emergency department with progressive weakness. He was admitted to the hospital and treated for Guillain Barre Syndrome.
Age: 22.0
Sex: M
Vaccine: JEV1
Symptoms: Erythema, Urticaria
Clinical narrative: The patient developed small hives/red spots throughout his torso and arms.
Age: 52.0
Sex: M
Vaccine: DTAP
Symptoms: Depressed level of consciousness, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Felt like I was going to pass out. Tingling and numbness around my tongue, and traveling up my neck to me head and sinuses.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram abnormal, Epilepsy, Faecal incontinence
Clinical narrative: Previously did not have headaches or any disease conditions, no head injuries. After receiving 1st two doses (08/11/2011, 11/23/2010) of vaccine, she had severe headaches, physician ordered Motrin. Third dose was 03/24/2011.  1st witnessed seizure was 12/10/2011. Evidence of hidden soiled underwear in her room were found prior to this date, which suggest she had been having seizures prior to the 1st witnessed seizure.  Diagnosed with primary generalized seizure disorder now taking Keppra.  Had Stevens-Johnson reaction to taking Topamax. Her last witnessed seizure was 08/09/2012.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nuclear magnetic resonance imaging, Stevens-Johnson syndrome
Clinical narrative: Previously did not have headaches or any disease conditions, no head injuries. After receiving 1st two doses (08/11/2011, 11/23/2010) of vaccine, she had severe headaches, physician ordered Motrin. Third dose was 03/24/2011.  1st witnessed seizure was 12/10/2011. Evidence of hidden soiled underwear in her room were found prior to this date, which suggest she had been having seizures prior to the 1st witnessed seizure.  Diagnosed with primary generalized seizure disorder now taking Keppra.  Had Stevens-Johnson reaction to taking Topamax. Her last witnessed seizure was 08/09/2012.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Synocpal Episode.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: 2 syncopal episodes immediately after receiving Gardasil.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Mobility decreased, Pain, Pyrexia, Swelling
Clinical narrative: PAIN, SWELLING, FEVER, LETHARGIC, GUARDING ARM, UNABLE TO MOVE ARM.
Age: 60.0
Sex: F
Vaccine: FLU3, HEPA, TDAP, TYP
Symptoms: Angioedema, Eye pruritus, Lip swelling, Migraine, Pruritus
Clinical narrative: Patient took dose or oral typhoid. After using this had some itching of medial right eye.  Prior to this had not noticed any problems.  Then used Zomig as pt awoke this am with migraine headache (has tolerated for several years).  Began to feel itchy around left lip, then began to swell. This began around after having coffee and toast. Pt had used vaccine 1/2 hour before breakfast.   Sense of lip swlling; puffiness.  Flu vaccine given 5 days ago; Hep A vaccine (2nd dose) 5 days ago. DX: Angioedema -  new onset angioedema after using oral typhoid vaccine this morning.
Age: 0.19
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Emotional distress, Screaming, Vomiting
Clinical narrative: high-pitched, nonstop screaming for 3 hours, could not be comforted  vomited
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local swelling, Rash erythematous, Skin warm
Clinical narrative: Pt had reaction (local swelling and erythema) about 6 hours after receiving the flu shot and pneumovax over the left arm. Left arm had indurated, warm, erythematous plaque 17 X 15.5 cm texas shaped rash.  Feeling ok now with minimal pain. She is monitoring the redness as well. No loss of function either. Patient given diphenhydramine prn for itching, swelling and pain.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Asocial behaviour, Decreased eye contact, Self injurious behaviour, Tongue disorder
Clinical narrative: Duration 12 days: Loss of eye contact. Tongue out of mouth to side constantly unless sleeping or eating. Smacking self in head. Hard to engage where previously was interactive.
Age: 0.59
Sex: M
Vaccine: DTAP
Symptoms: Asocial behaviour, Decreased eye contact, Self injurious behaviour, Tongue disorder
Clinical narrative: Duration 12 days: Loss of eye contact. Tongue out of mouth to side constantly unless sleeping or eating. Smacking self in head. Hard to engage where previously was interactive.
Age: 50.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Delirium, Feeling abnormal, Feeling hot, Mobility decreased
Clinical narrative: Patient states the day following the vaccine administration he started to feel "off" during the day.  That evening he developed chills.  During the night he believes he had a high fever, woke up lying on his floor and states he had difficulty getting up.  He doesn't know how he got on the floor.  He did not take his temperature but says he felt very warm.  He was nauseated and his arm was very sore.  He states he was "delirious".  The following morning he felt a little better, and as the day progressed he eventually felt more like himself.
Age: 50.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient states the day following the vaccine administration he started to feel "off" during the day.  That evening he developed chills.  During the night he believes he had a high fever, woke up lying on his floor and states he had difficulty getting up.  He doesn't know how he got on the floor.  He did not take his temperature but says he felt very warm.  He was nauseated and his arm was very sore.  He states he was "delirious".  The following morning he felt a little better, and as the day progressed he eventually felt more like himself.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: STATES FLU VACCINE GIVEN 11/7/14. ON 11/8/14 HAD TENDERNESS IN LEFT ARM ABOVE INJECTION SITE RADIATING UP INTO LEFT SHOULDER. AS OF 1/27/15 STATES TENDERNESS AND PAIN CONTINUES AND WORSENS WITH LIFTING LEFT ARM AND LAYING IN BED ON LEFT SIDE. ALSO COMPLAINS OF "SLIGHT DECREASE IN RANGE OF MOTION IN LEFT ARM". NO TREATMENT, HAS TAKEN OVER THE COUNTER ADVIL.
Age: 1.24
Sex: M
Vaccine: DTAPIPVHIB, PNC, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Welt-like red mark by injection site (right leg) 10 days after vaccination. Second smaller red mark on day 11.
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Burning sensation, Rash erythematous, Skin hyperpigmentation
Clinical narrative: Mom noted a red bumpy rash on the abdomen the day after vaccines administered. One day after that area was very red and hyperpigmented, burn-like rash.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Gait disturbance, Influenza like illness, Peroneal nerve palsy
Clinical narrative: LEFT FOOT DROP, SLAPPING GAIT. STARTED FLU LIKE SYYMPTOMS  ON 12/17/14. TREATED WITH TAMIFLU.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Burning sensation, Electromyogram, Gait disturbance, Influenza like illness
Clinical narrative: LEFT FOOT DROP, SLAPPING GAIT. STARTED FLU LIKE SYYMPTOMS  ON 12/17/14. TREATED WITH TAMIFLU.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Peroneal nerve palsy
Clinical narrative: LEFT FOOT DROP, SLAPPING GAIT. STARTED FLU LIKE SYYMPTOMS  ON 12/17/14. TREATED WITH TAMIFLU.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regards an unspecified number of patients of unknown age and gender. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot number and expiration date were not reported) and GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was filled. Additional information has been requested.