chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Renal disorder, Sinus headache, Swelling, Swelling face
Clinical narrative: I have already sent the information that you have asked for concerning my flu shot. I don't understand why I have received another form requesting the same information in more detail. I have already had over a dozen trips to my doctor or his Physician Assistant because of the affects of the flu shot. I have suffered severe facial swelling, blurred vision, kidney problems, severe headaches, nausea, and myriad of typical flu symptoms. I took the shot at 3:30 PM. Within 30 minutes of taking the shot I had a bad headache. By 7:30 PM I had a sore throat and sinus pain and swelling. My eyelids and facial tissue also began swelling to the point that I could barely open my eyes. At approximately 8:00 PM, my husband took me to the Emergency Room. I visited my Optometrist. He examined my eyes and read through the data sheets of the flu serum, provided by pharmacy. Dr suggested that the potential cause of the problem, is the mercury based preservative. The same preservative had been used previously in contact lens materials and had caused allergic reactions in some patients. It is no longer used in contact lens solutions. This was my first ever flu shot. The only reason that I took the shot was because it was suggested that it would protect my sister when I went to visit her. My sister is suffering from 4th stage cancer and her immune system is compromised. I will never recommend getting a flu shot to anyone after the ongoing heath problems I have suffered since January 2014.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred
Clinical narrative: I have already sent the information that you have asked for concerning my flu shot. I don't understand why I have received another form requesting the same information in more detail. I have already had over a dozen trips to my doctor or his Physician Assistant because of the affects of the flu shot. I have suffered severe facial swelling, blurred vision, kidney problems, severe headaches, nausea, and myriad of typical flu symptoms. I took the shot at 3:30 PM. Within 30 minutes of taking the shot I had a bad headache. By 7:30 PM I had a sore throat and sinus pain and swelling. My eyelids and facial tissue also began swelling to the point that I could barely open my eyes. At approximately 8:00 PM, my husband took me to the Emergency Room. I visited my Optometrist. He examined my eyes and read through the data sheets of the flu serum, provided by pharmacy. Dr suggested that the potential cause of the problem, is the mercury based preservative. The same preservative had been used previously in contact lens materials and had caused allergic reactions in some patients. It is no longer used in contact lens solutions. This was my first ever flu shot. The only reason that I took the shot was because it was suggested that it would protect my sister when I went to visit her. My sister is suffering from 4th stage cancer and her immune system is compromised. I will never recommend getting a flu shot to anyone after the ongoing heath problems I have suffered since January 2014.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Contusion, Drug administered at inappropriate site, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2014US071132 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 527840) on 09 Jun 2014 with a follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014. This spontaneous report refers to a 61 year old male patient. His current conditions included chronic obstructive pulmonary disease and concomitant medications were not reported. On 07 Dec 2013, he was vaccinated with FLUVIRIN (batch number: 1310101, expiry date: 31 May 2014) high and in the back of his left arm. On 08 Dec 2013, he had immense bruising in his upper arm with excruciating shoulder pain. His shoulder joint was inflamed with a partial tear to rotator cuff. The patient visited the emergency room on an unspecified date and underwent MRI and X-ray of shoulder (results not provided). The outcome of the events was condition unchanged. The events were reported as non serious but were reassessed as serious upon internal review and the causality of the events was not reported. Upon follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014, it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1310101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Non-significant follow-up information received from Quality Assurance Department (reference number: 305534) on 12 Jun 2014: Updated QA reference number only. Follow up information received from the quality assurance department on 24 Jun 2014: Batch summary and expiry date updated.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rotator cuff syndrome, X-ray limb
Clinical narrative: Case number PHHY2014US071132 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 527840) on 09 Jun 2014 with a follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014. This spontaneous report refers to a 61 year old male patient. His current conditions included chronic obstructive pulmonary disease and concomitant medications were not reported. On 07 Dec 2013, he was vaccinated with FLUVIRIN (batch number: 1310101, expiry date: 31 May 2014) high and in the back of his left arm. On 08 Dec 2013, he had immense bruising in his upper arm with excruciating shoulder pain. His shoulder joint was inflamed with a partial tear to rotator cuff. The patient visited the emergency room on an unspecified date and underwent MRI and X-ray of shoulder (results not provided). The outcome of the events was condition unchanged. The events were reported as non serious but were reassessed as serious upon internal review and the causality of the events was not reported. Upon follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014, it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1310101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Non-significant follow-up information received from Quality Assurance Department (reference number: 305534) on 12 Jun 2014: Updated QA reference number only. Follow up information received from the quality assurance department on 24 Jun 2014: Batch summary and expiry date updated.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Contusion, Musculoskeletal pain, Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: Case number PHHY2014US071132 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 527840) on 09 Jun 2014 with a follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014. This spontaneous report refers to a 61 year old male patient. His current conditions included chronic obstructive pulmonary disease and concomitant medications were not reported. On 07 Dec 2013, he was vaccinated with FLUVIRIN (batch number: 1310101, expiry date: 31 May 2014) high and in the back of his left arm. On 08 Dec 2013, he had immense bruising in his upper arm with excruciating shoulder pain. His shoulder joint was inflamed with a partial tear to rotator cuff. The patient visited the emergency room on an unspecified date and underwent MRI and X-ray of shoulder (results not provided). The outcome of the events was condition unchanged. The events were reported as non serious but were reassessed as serious upon internal review and the causality of the events was not reported. Upon follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014, it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1310101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Non-significant follow-up information received from Quality Assurance Department (reference number: 305534) on 12 Jun 2014: Updated QA reference number only. Follow up information received from the quality assurance department on 24 Jun 2014: Batch summary and expiry date updated.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray limb
Clinical narrative: Case number PHHY2014US071132 is an initial spontaneous report received from vaccine adverse event reporting system web site (VAERS reference number: 527840) on 09 Jun 2014 with a follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014. This spontaneous report refers to a 61 year old male patient. His current conditions included chronic obstructive pulmonary disease and concomitant medications were not reported. On 07 Dec 2013, he was vaccinated with FLUVIRIN (batch number: 1310101, expiry date: 31 May 2014) high and in the back of his left arm. On 08 Dec 2013, he had immense bruising in his upper arm with excruciating shoulder pain. His shoulder joint was inflamed with a partial tear to rotator cuff. The patient visited the emergency room on an unspecified date and underwent MRI and X-ray of shoulder (results not provided). The outcome of the events was condition unchanged. The events were reported as non serious but were reassessed as serious upon internal review and the causality of the events was not reported. Upon follow up information received from the quality assurance department (QA reference number: 305534) on 24 Jun 2014, it was reported that based on the document review, it was concluded that FLUVIRIN batch number 1310101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Non-significant follow-up information received from Quality Assurance Department (reference number: 305534) on 12 Jun 2014: Updated QA reference number only. Follow up information received from the quality assurance department on 24 Jun 2014: Batch summary and expiry date updated.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, 6VAX-F, PNC13, RVX
Symptoms: Apnoea, Endotracheal intubation, Resuscitation, Unresponsive to stimuli
Clinical narrative: He vomited and blocked airway, turned blue, I (parent) had to perform CPR until paramedics got there and then was life flighted to the closest hospital. He had to get a breathing tube and a hospital stay for 3 weeks and a day and almost did not make it. We have since come home with oxygen and a feeding tube to his intestines that goes continuously.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, 6VAX-F, PNC13, RVX
Symptoms: Cyanosis, Endotracheal intubation, Gastrointestinal tube insertion, Obstructive airways disorder, Resuscitation
Clinical narrative: He vomited and blocked airway, turned blue, I (parent) had to perform CPR until paramedics got there and then was life flighted to the closest hospital. He had to get a breathing tube and a hospital stay for 3 weeks and a day and almost did not make it. We have since come home with oxygen and a feeding tube to his intestines that goes continuously.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, 6VAX-F, PNC13, RVX
Symptoms: Vomiting
Clinical narrative: He vomited and blocked airway, turned blue, I (parent) had to perform CPR until paramedics got there and then was life flighted to the closest hospital. He had to get a breathing tube and a hospital stay for 3 weeks and a day and almost did not make it. We have since come home with oxygen and a feeding tube to his intestines that goes continuously.
Age: 1.02
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea
Clinical narrative: Chronic Diarrhea. Every diaper is diarrhea. Every single day for 3 weeks now.
Age: 46.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Severe swelling, burning, redness, and pain.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: Started with Stomach Ache, nausea and diarrhea, today about 5:00 AM she vomit (one time). I am a physician and her father, I gave her a metoclopramide 10 mg and right now she is feeling a little improvement.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B surface antibody positive, Vertical infection transmission
Clinical narrative: This case was reported in a literature article and described the occurrence of hepatitis B in a 9-month-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Subject's mother was HBV mono-infected and positive for hepatitis B surface antigen (HBsAg) with HBV DNA levels greater or equal to 6 log copies/mL. She was negative for hepatitis C antibody and HIV infection. Subject's mother was treated as part of a study to reduce perinatal hepatitis B transmission with tenofovir disoproxil fumarate (TDF) 300 mg orally for only 17 days due to non-compliance with prenatal care. She was lost to follow-up until 35 weeks gestation, where at that time TDF was started. She delivered between 2009 and 2012 at 37 weeks and 5 days gestation via spontaneous vaginal delivery and breast-fed during her hospital stay. Subject's birth weight was 3,419 kg and Apgar scores of 8 at 1 and 9 at 5 minutes. On an unspecified date, within 12 h of birth, the subject received unspecified dose of Hepatitis B vaccine (unknown route, injection site and batch number) and hepatitis B immunoglobulin (HBIG). At the age of 9 or 12 months, between 9 and 12 months after vaccination with Hepatitis B vaccine and HBIG, the subject was tested positive for hepatitis B surface antigen due to vertical infection transmission. The subject was referred to a pediatric gastroenterologist for management. At the time of reporting the outcome of the event was unspecified. Author's conclusion: this is the second published case series to date on the use of TDF prophylaxis in HBV mono-infected, highly viremic mothers. This series suggests that the use of TDF in the third trimester reduces maternal HBV DNA levels and is well tolerated by pregnant women. Initiation of TDF in the third trimester in highly viremic women to reduce vertical transmission should be considered. Follow-up received on 25 June 2014: This case was upgraded to serious due to Hepatitis B infection. The author assumed that the subject completed the vaccination series but he had no access to the records. The subject was not symptomatic when the gastroenterologist saw him 3 months after the Hepatitis B diagnosis.
Age: 73.0
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 medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site pain, Injury, Musculoskeletal pain, Nodule, Sensory loss
Clinical narrative: This medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Tenderness
Clinical narrative: This medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
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 medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Sensory loss
Clinical narrative: This medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
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 medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
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 medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
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 medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 73.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX, FLUX
Symptoms: Axillary nerve injury, Muscular weakness, Musculoskeletal pain
Clinical narrative: This medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, 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 five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. 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 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two 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. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six 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 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site reaction, Local swelling, Pain in extremity
Clinical narrative: Localized shingles outbreak in Left arm where vaccine was administered.  Left arm swelling, redness and pain.
Age: 37.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a 37 year old male patient. No information on medical history, concurrent conditions or concomitant drugs was provided. On 19-JUN-2014 the patient was intramuscularly vaccinated with a dose of GARDASIL, 0.5ml, dose number, site of injection, lot# and expiration date not reported. The patient was 37 years old at the time of vaccination. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of RECOMIVAX HB that were exposed to temperatures out of range on 02-JUN2014 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effect has been observed or reported. The outcome of the event was unknown. NO PQC reported. The case has been linked with the cases (same reporter link) # 1406USA011663, 1406USA012409 and 1406USA012415. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of PNEUMOVAX23 that were exposed to temperatures out of range on 02-JUN-2014 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effect has been observed or reported. The outcome of the event was unknown. No PQC reported. The case has been linked with the cases (same reporter link) #1406USA012405, 1406USA012409 and 1406USA012415. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of VAQTA, that were exposed to temperatures out of range on 02-JUN-204 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effects has been observed or reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases (same reported link) # 1406USA012405, 1406USA011663, and 1406USA012415. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. It was reported that doses of ROTATEQ that were exposed to temperatures out of range on 02-JUN-2014 were administered to an unspecified number of unspecified patients on unspecified dates (approximately in June 2014). No other concomitant therapies reported. The temperature excursion was supported. No adverse effect has been observed or reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases (same reporter link) # 1406USA012405, 1406USA12409 and 1406USA011663.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Dizziness, Fall, Head injury, Pallor
Clinical narrative: Client left vaccine room stating she felt fine and then heard her down the hall stating, "I am going to have a seizure and heard a thud" Found on back, oreintated x3 and alert, states hit back of head on concrete floor, no concussion symptoms. Did not want treatment but then when correctional officiers were walking her back to cell she become woozy and came to nurse office where she laid on exam table and ice to back of head. Was very pale, appeared to be syncope.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Client left vaccine room stating she felt fine and then heard her down the hall stating, "I am going to have a seizure and heard a thud" Found on back, oreintated x3 and alert, states hit back of head on concrete floor, no concussion symptoms. Did not want treatment but then when correctional officiers were walking her back to cell she become woozy and came to nurse office where she laid on exam table and ice to back of head. Was very pale, appeared to be syncope.
Sex: U
Vaccine: MMRV
Symptoms: Encephalitis, Encephalopathy, Injury
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age (child) and gender. The nurse received this information from other patient's parent who heard about reported event. On an unknown date, the patient was vaccinated with an unspecified dose of PROQUAD (Merck) (dose, frequency, route, lot number and exp. date were not reported). On an unknown date, the patient was severely injured and the nurse believed that the injuries were similar to an encephalitis or an encephalopathy that this child developed after receiving PROQUAD (Merck). The nurse reported that the child's parents "went to court and won" and that compensation had already been granted. The outcome of encephalitis, encephalopathy and severely injury was unknown. The relatedness between reported events and PROQUAD (Merck) was not reported. Upon internal review, encephalitis and encephalopathy were considered to be medically significant. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Rash
Clinical narrative: 4-5 days for aches and flu like symptoms before severe rash developed from center of chest around left side to back center. Dr Rx NEURONTIN and VALTREX.