chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Oropharyngeal pain
Clinical narrative: This case was received on 16 June 2014 via a third party query tool search on the VAERS database, under reference number 526138. A 24 year-old male patient with a history of a sulfa allergy had received on 07 March 2014, an intradermal left arm injection of ACAM2000 (lot number VV00403A) and 10 days later was found to have left arm swelling at site of smallpox vaccination, new pustular acne-like lesions that spread to the upper chest, back and right shoulder, felt fatigued with sore throat and swollen cervical lymph nodes for 24 hours. The patient was seen in the emergency room. Treatment included ADVIL prn. Current illnesses was arm soreness at site of typhoid and anthrax vaccine given two days prior (manufacturers, lot numbers, routes and sites of administration not reported). Other medications were reported as none. Lab data and prior vaccinations were not reported. No further information was available at the time of the report. Outcome was recovered. Although the lot number for ACAM2000 was reported as VV00403A. To date, the only ACAM2000 lot number released from bulk lot VV04003 was VV04003A. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Ocular hyperaemia, Rash vesicular
Clinical narrative: This spontaneous report was received from a Registered Pharmacist concerning approximately a 71 year old female patient. The patient current condition included asthma. The patient had no drug reactions and allergies. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, lot number J014811, expiry date, 21-FEB-2015, single dose, subcutaneously (other details unspecified). Concomitant therapies included SINGULAIR, SYMBICORT and ZYRTEC. On 19-JUN-2014, 3 days after onset of therapy the patient experienced shingles. It was reported by the pharmacist that, the patient developed an itchy rash across her forehead, lesions on the left side of her forehead, and redness of her left eye on 19-JUN-2014. The patient was evaluated by her unspecified physician and was diagnosed with shingles. The patient was prescribed an unspecified antiviral medication. No product quality complaint (PQC) was filed. No lab diagnostics were performed. The patient sought medical attention by the office visit to physician. However, no intervention initiated to prevent serious criteria as there was no seriousness criteria reported. The action taken was assessed as not applicable. The outcome of shingles was reported as not recovered. The causality was not specified in the report. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ocular hyperaemia, Rash, Rash pruritic, Skin lesion
Clinical narrative: This spontaneous report was received from a Registered Pharmacist concerning approximately a 71 year old female patient. The patient current condition included asthma. The patient had no drug reactions and allergies. On 17-JUN-2014, the patient was vaccinated with ZOSTAVAX, lot number J014811, expiry date, 21-FEB-2015, single dose, subcutaneously (other details unspecified). Concomitant therapies included SINGULAIR, SYMBICORT and ZYRTEC. On 19-JUN-2014, 3 days after onset of therapy the patient experienced shingles. It was reported by the pharmacist that, the patient developed an itchy rash across her forehead, lesions on the left side of her forehead, and redness of her left eye on 19-JUN-2014. The patient was evaluated by her unspecified physician and was diagnosed with shingles. The patient was prescribed an unspecified antiviral medication. No product quality complaint (PQC) was filed. No lab diagnostics were performed. The patient sought medical attention by the office visit to physician. However, no intervention initiated to prevent serious criteria as there was no seriousness criteria reported. The action taken was assessed as not applicable. The outcome of shingles was reported as not recovered. The causality was not specified in the report. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 52 year old male patient with asthma, Crohn's disease, anemia, osteopenia, malabsorption syndrome, vitamin D insufficiency, chronic obstructive pulmonary disease (COPD), gastroesophageal reflux disease (GERD), nocturia, emphysema and smoking. On 12-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013345, expiration date 11-JAN-2015, 1 single shot, intramuscular for prevention of pneumococcal disease. Concomitant therapies included SYMBICORT, SINGULAIR, ACTONEAL and PROAIR (dosages/frequencies/manufacturers unknown). The nurse reported that on 13-JUN-2014 the left arm of the patient (demographics unknown) became swollen from the shoulder to the elbow after receiving PNEUMOVAX 23. BENADRYL (dosage/frequency/manufacturer unknown) was given as the treatment for the event. No lab diagnostics studies were performed. The patient had sought medical attention. At the time of the report, outcome of the event was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Asthenia, Axillary nerve injury, Blood pressure increased, Injected limb mobility decreased, Injection site atrophy
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain, Injury, Musculoskeletal pain, Nodule, Sensory loss
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Tenderness
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Joint range of motion decreased, Reflex test normal
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Sensory loss
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Axillary nerve injury, Blood pressure increased, Immediate post-injection reaction, Injected limb mobility decreased, Injection site atrophy
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site nodule, Injection site pain, Joint range of motion decreased, Reflex test normal, Sensory loss
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site nodule, Injection site pain, Joint range of motion decreased, Muscular weakness, Reflex test normal
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Axillary nerve injury, Muscular weakness, Musculoskeletal pain
Clinical narrative: This case was retrieved via a search of scientific literature on 23 June 2014. Verbatim from the article: "A 73-year-old right-handed man presented for evaluation of left shoulder pain and abduction weakness. He had not seen a physician for the past 15 years and he never had any regular screenings performed, but he received annual flu shots. He reported that he received a flu shot about 8 weeks earlier at a drive-through flu shot clinic offered by a hospital. He reported that directly after the injection and for weeks afterwards he experienced severe local pain at the injection site and felt like he had a "knot" in his shoulder. He never developed a rash at the injection site, but about 5 weeks after the injection, he was not able to abduct his left arm. There was no other specific trauma or other history of recent injections to his shoulder. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. He also reported no preceding infectious illness, recent travels, or contact with sick people. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion, which was slightly tender to palpation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle, and he was unable to abduct his left arm. The patient had active range of motion of the first 10 degrees of shoulder abduction, but could not abduct beyond that. He scored a 2 on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis, and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. On the basis of the patient's medical history, physical examination, and reported injection site, the diagnosis of injection-induced traumatic axillary nerve injury was made. The patient declined to undergo further diagnostic testing, including nerve conduction studies and magnetic resonance imaging, because he was not an insurance beneficiary. Therefore, he was treated symptomatically with analgesics and occupational therapy, including passive and active range of motion exercises. At 1-month follow-up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy, and pain. At 6 weeks after initiation of occupational therapy, the therapist reported greatly improved flexion; he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4-, indicating good function (75%)." Documents held by sender: none.
Age: 1.56
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: Vomiting, diarrhea, rash.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Autoimmune haemolytic anaemia, Hypercoagulation, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: 16June2014: Rash on upper torso of 5 days duration. 18June2014: Varicella zoster PCP. Positive (Result 19Jun14). 18June2014: Thrombophilia and findings consistent with Autoimmune Homolytic Anemia with suppressed marrow response.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Patient in for well child check, given 4 vaccines as ordered, parent in agreement. Parent and child leave facility go to birthday party and baby has some frosting and starts vomiting, that when mom notices rash on trunk and face. Return to clinic.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient developed (5) vesicles on (L) arm and (L) back that appear to be varicella. No systemic reaction.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Muscle spasms, Premature labour
Clinical narrative: I started having cramping and bleeding around 9:00 AM on May 27th 2014.  Diagnosis is that I was having a miscarriage.  I started labor and then was given some pain medication to take until a DNC was performed on May 29th 2014.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Ultrasound antenatal screen, Uterine dilation and curettage
Clinical narrative: I started having cramping and bleeding around 9:00 AM on May 27th 2014.  Diagnosis is that I was having a miscarriage.  I started labor and then was given some pain medication to take until a DNC was performed on May 29th 2014.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Child felt to have contacted chickenpox 1 week after receiving varicella vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The nurse reported that on an unknown date these unspecified patients received improperly stored PROQUAD (Merck) (lot#, dose, route, indication not reported) exposed to -9C for an undetermined timeframe. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a child patient of unknown age and gender. On an unknown date the child patient was inadvertently administered a dose of ZOSTAVAX (lot#, dose, route, indication not reported) instead of VARIVAX (Merck). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose, route, indication not reported). Concomitant therapy was not reported. On an unspecified date the patient's left arm became swollen from the shoulder to the elbow after receiving PNEUMOVAX 23. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Rash erythematous
Clinical narrative: Patient was given PENTACEL, Hepatitis B and PROQUAD injections on 6/16/2014 at 2:15 pm. Within 5 minutes following administration of these vaccines, patient developed a patch of red rash to his forehead. The red rash appeared to be increasing on his forehead. BENADRYL .2 ml(50 mg/ml) given.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Moderate swelling erythema, warmth at right arm.
Age: 13.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Numbness at site of injection (right deltoid) down to right wrist.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: Chills on 5/29/14, followed by "throat closing" and swollen lymph nodes in left supraclavicular region from 5/30/14 through 6/2/14 -- tender lymph node palpated by me.  Reports Tmax 99.2 with accompanying rash.  Prior tetanus history 2002 was Td.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Chills on 5/29/14, followed by "throat closing" and swollen lymph nodes in left supraclavicular region from 5/30/14 through 6/2/14 -- tender lymph node palpated by me.  Reports Tmax 99.2 with accompanying rash.  Prior tetanus history 2002 was Td.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Within 8 hours, rash started on legs (left), spread onto diaper region and then up trunk on to face. Resolved within 48 hours.
Age: 10.0
Sex: M
Vaccine: PNC13
Symptoms: Band neutrophil count increased, Blood urea decreased, Diarrhoea, Grunting, Haematochezia
Clinical narrative: Grunting with respirations, respiratory rate 44, heart rate 138, one bloody stool. CBC, CMP, UA and x-ray reported below. Patient showed clinical improvement by 5:50pm. Reported labs the next morning were normal and lungs sounded clear. That day (22nd) the patient had multiple loose stools without abdominal tenderness or distension, and he was given PEDIALYTE. Complete recovery in 24 hours with no intervention.
Age: 10.0
Sex: M
Vaccine: PNC13
Symptoms: Specific gravity urine increased, Urine ketone body present, White blood cell count increased, X-ray abnormal
Clinical narrative: Grunting with respirations, respiratory rate 44, heart rate 138, one bloody stool. CBC, CMP, UA and x-ray reported below. Patient showed clinical improvement by 5:50pm. Reported labs the next morning were normal and lungs sounded clear. That day (22nd) the patient had multiple loose stools without abdominal tenderness or distension, and he was given PEDIALYTE. Complete recovery in 24 hours with no intervention.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Patient became unconscious and had 2 seizures post receiving the MCV, Hep A and Varicella. Was transferred to the Hosp. via ambulance then on to another Hosp. 6-9-14 Mom via hospital took child to another hospital but was released at 4 AM. Neurologist said it was from having a Varicella at 4 y/o then one on 6/3/14. However child did not have Varicella at 4 y/o. Mom requesting cardiology referral from PCP as child's father had a similar issue at a young age.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy at 9am, day of vaccination with swelling, redness and warmth, some decreased mobility of deltoid (right) muscle due to amount of swelling. Got steroid shot 6/27/14. Doing better now.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Back injury, Rash, Rash macular
Clinical narrative: This spontaneous report as received from an 80 year old male patient with high blood pressure and back problems refers to himself. The patient had no drug reactions/allergies. The patient stated that when he was a child, after receiving vaccinations like Whooping Cough, he developed scar tissue at the site of injection. On an unspecified date of 2011 (reported as "almost 3 years ago") the patient was vaccinated at a local pharmacy (specific contact information unspecified) with ZOSTAVAX (lot #, dose, route and frequency were not provided). Other suspect therapies included hydrocodone (manufacturer unspecified). Concomitant therapies included ALEVE, TYELNOL, PEPCID and high blood pressure medicine (unspecified). Patient also stated that for the last few years about every 6 months he receives a steroid shot directly in his lower back due to back problems and that he was currently receiving this medication when he received ZOSTAVAX. On an unspecified date of 2014 (reported as "almost 2 years later this past spring") the patient developed a non-itchy, red, blotchy rash that looked like pimples on the back of his upper arm and between his legs. The patient also reported that right before the rash developed he hurt his back and needed to be placed on unspecified muscle relaxers and hydrocodone. No lab diagnostics studies were performed. The patient didn't seek for medical attention. No treatment was given for the adverse events. The rash resolved soon after on its own. The patient reported he only developed the rash once he was on these additional medications and stated he believed he developed the rash due to the hydrocodone. Causality assessment between ZOSTAVAX and the adverse events was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender with vaccine prophylaxis. Patient's medical history and previous drug reaction was not reported. On 23-JUN-2014 the patient was vaccinated with VARIVAX (merck) 0.5 ml with lot number J006962 and expiry date 05-JUN-2015 subcutaneously and M-M-R II (dose unit unknown) with lot number K000255 and expiry date 05-JUN-2015. No concomitant medications were administered. On 26-JUN-2014 3 days later, the patient had inadvertently received another doses of M-M-R II (lot # and exp unspecified) and VARIVAX (merck) (lot# expiry date unspecified). No adverse effect was reported. The outcome of inadvertently received another dose of MMR II (lot and exp unspecified) and VARIVAX (lot# exp unspecified) 3 days later on 06/26/2014 and no adverse effect was unknown. No additional information provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practitioner nurse (LPN) refers to a 16 year old female patient with DILAUDID allergy. None of pertinent medical history was reported. On 22-MAY-2014 the pregnant patient was vaccinated with a dose of GARDASIL lot # J013324, expiry date 12-FEB-2016, 0.5 ml, intramuscular. Concomitant therapies included prenatal vitamins. The patient was currently almost two months pregnant. The patient's conception date was "about 29-APR-2014". The Last Menstrual Period (LMP) was approximately on 15-APR-2014 and Estimated Due Date (EDD) was 20-JAN-2015. No adverse effect reported. Patient did not seek medical attention and no treatment was given. None of lab diagnostics studies performed. The outcome of a event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient reported tenderness, slight inflammation, redness and warmth at site of injection the following morning at 10am. She took BENADRYL later.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a 59-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2013 the subject received a dose of FLUARIX (.5 ml, unknown details, right arm). In October 2013, less then one day after vaccination with FLUARIX, the subject experienced injection site pain. At the time of reporting the event was unresolved. Per the nurse, the subject received "the injection about 4 weeks ago and the pain is still unresolved." Per the nurse, "on a scale of 1 to 10, it [the pain] is about 5." The healthcare professional considered the event was probably related to vaccination with FLUARIX 2013-14.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Lung disorder, Myalgia
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of back pain near shoulder in a 78-year-old male subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Concurrent medications included ZESTRIL and Aspirin. On 23 September 2013 at 13:30 the subject received a dose of Influenza vaccine unspecified (unknown details, right arm). On 24 September 2013, 1 day after vaccination with Influenza vaccine unspecified, the subject experienced back pain near shoulder (described as "back pain in right shoulder") and muscle pain. The subject sought medical attention with his physician about back pain in right shoulder after receiving vaccination, where he was told that it was most likely muscle pain. The subject "took ADVIL tablets for the pain but it did not go away." On 29 October 2013, 36 days after vaccination with influenza vaccine unspecified, the subject experienced pulmonary hypoinflation (described as "hypoinflated lung"). The subject sought medical attention on 29 October 2013 and was told he "had a hypoinflated lung." The physician prescribed him SINGULAIR which he started on 30 October 2013. At the time of reporting the events were unresolved.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Initial report was received on 23 June 2014 from a health care professional. A 59 year-old female patient had received on an unspecified date ADACEL, lot number U4875AA (route and site of administration not reported) and unspecified amount of time later after administration, experienced cellulitis. No further information was provided at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: Initial report was received on 23 June 2014 from a consumer, who is also the patient. A 74 year-old male patient with no reported past medical history had received on 11 January 2013 an intramuscular injection of ADACEL (lot number and site of administration not reported) and later the same day, experience an increased heart rate. The patient stated he was previously on a diet program when he was taking a diet pill and during the checkup they found the heart rate increased. The reporter stated, the heart rate was as high as 181. The patient was seen by a physician and diagnosed with atrial fibrillation. Outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: Initial report received on 17 June 2014 from an investigator participating in a trial. A 24-year-old male subject, with no relevant medical history, had received an injection of ACAM2000 on 03 May 2011 (lot number, route and site of administration were not reported). On 09 June 2014, he presented with elevated troponin with a mild severity. No cardiac symptoms have been identified. He had a normal ECG. Troponin test was repeated 2 days later and yielded same results. No further information is expected to follow. No corrective treatment was received. At the time of the report, the patient was not recovered. The investigator reported that a cardiac etiology is unlikely, but subject was referred appropriately. Relationship was assessed as remote. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Redness to back of arm evening of day given shot. Called Saturday to say site red, swollen, very warm about 4+ inches around injection site - injection dark red and a line from site. No fever. Sent to ER. Admitted on 6/29.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, White blood cell count increased
Clinical narrative: Redness to back of arm evening of day given shot. Called Saturday to say site red, swollen, very warm about 4+ inches around injection site - injection dark red and a line from site. No fever. Sent to ER. Admitted on 6/29.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Adverse reaction, Cellulitis, Musculoskeletal stiffness, Pain
Clinical narrative: Redness to back of arm evening of day given shot. Called Saturday to say site red, swollen, very warm about 4+ inches around injection site - injection dark red and a line from site. No fever. Sent to ER. Admitted on 6/29.