chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Product contamination, Quality of life decreased, Sensory disturbance, Victim of crime
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Blood test, Bone pain, Brain neoplasm, Discomfort
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dyspnoea, Gait disturbance, Herpes zoster, Injection site bruising, Injection site pain
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site vesicles, Insomnia, Laboratory test, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Myalgia, Myosclerosis, Pain, Pain in extremity
Clinical narrative: My left arm went into excruciating, long agonizing and slow torture within the muscles (deep wound; blisters appeared on my muscles (left arm)) (triceps and biceps). Blisters appeared on my arm muscles. All of my muscles are stiffening, painful, throbbing, sharp in my biceps (left arm). No Treatments!!! Just humiliations. My legs, calves became painful, stiffening and debilitating within. Deep wound. Dr. referred me to the Pulmonary Department to see Dr. and Doctor looked as if he kept getting messages through his hospital computer. He requested that I take the pneumococcal #13 vaccination. He left the isolated room (Sept 4, 2016) to go get a nurse, who took around 30 minutes to appear and he never came back. The nurse came alone. The nurses' demeanor was cold and she acted strange. She had a large needle. She told me that I would have to be extremely still because it will take a while for the medicine to get into me (left arm). She loaded my arm with something very bad. The same night, I felt a blockage, agonizing, slow, painful attack of that vaccination in my left arm. A couple of days later blisters appeared on my biceps/triceps. My arm (left) went into a spasm convulsion which made it impossible for me to sleep. It felt like peanut and a little oil. She unloaded the full tank into my arm. She did not inject the needle in my mid to upper shoulder. She injected my lower left arm. She intentionally hurt me. The pains were agonizing, excruciating and whatever she injected into my lower shoulder took 6 months to move an inch. It was slow and agonizing. That vaccination attacks my skeletal muscular system - my nerve muscles and bone aches 90% of the time. Today, the pain of the injection has complicated my life. I believe the vaccination needle was laced with a debilitating agent, a biological agent, some form of chemical agent or possibly nerve agent. The medicine has traveled throughout my body causing aching and throbbing pains and bone aches. I struggle to walk at times. The hospital administration threatened to do some very, very bad me for reporting the center to television station and judicial system. Dr. intentionally transferred after hearing the effects of the vaccination. Offering pain pills isn't considered to be a treatment. Pain pills are to cover up a condition - not to treat it. Dr. intentionally left the scene of the crime the same month 9-2016; I am stuck living with a deep wound and a new disease. Dr. did a test for nerve damage and when she saw no answer, she claim (to my face) that she was quitting her job. Hospital may have falsified dates.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Flushing, Injection site pain, Palpitations, Pyrexia
Clinical narrative: Patient states he received the SHINGRIX vaccine in the morning and 8 hours later he became dizzy, developed a fever of 102, heart racing, states he is feeling better today, just feels "flush", temp 99, his arm at injection site is sore.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 102.5 after immunizations.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives, SOB.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain, Pain in extremity, Swelling
Clinical narrative: Patient had throbbing, and pain in the left arm starting the day of the vaccination. About a day afterwards patient noticed limited range of motion in the left arm (limited abduction) along with the other symptoms. Patient began massaging the arm and also did shoulder exercises(abduction/adduction, full rotation movements), with no improvement in symptoms. Patient denies any fever entire time, noted minimal swelling, and no redness or warmth from the area. However, initial symptoms have not abated (it is now about a month and half post-vaccination). Patient will be following up with his orthopedic surgeon soon.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Discomfort, Pain, Pain in extremity, X-ray limb
Clinical narrative: Patient had throbbing, and pain in the left arm starting the day of the vaccination. About a day afterwards patient noticed limited range of motion in the left arm (limited abduction) along with the other symptoms. Patient began massaging the arm and also did shoulder exercises(abduction/adduction, full rotation movements), with no improvement in symptoms. Patient denies any fever entire time, noted minimal swelling, and no redness or warmth from the area. However, initial symptoms have not abated (it is now about a month and half post-vaccination). Patient will be following up with his orthopedic surgeon soon.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient had throbbing, and pain in the left arm starting the day of the vaccination. About a day afterwards patient noticed limited range of motion in the left arm (limited abduction) along with the other symptoms. Patient began massaging the arm and also did shoulder exercises(abduction/adduction, full rotation movements), with no improvement in symptoms. Patient denies any fever entire time, noted minimal swelling, and no redness or warmth from the area. However, initial symptoms have not abated (it is now about a month and half post-vaccination). Patient will be following up with his orthopedic surgeon soon.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: Patient had throbbing, and pain in the left arm starting the day of the vaccination. About a day afterwards patient noticed limited range of motion in the left arm (limited abduction) along with the other symptoms. Patient began massaging the arm and also did shoulder exercises(abduction/adduction, full rotation movements), with no improvement in symptoms. Patient denies any fever entire time, noted minimal swelling, and no redness or warmth from the area. However, initial symptoms have not abated (it is now about a month and half post-vaccination). Patient will be following up with his orthopedic surgeon soon.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Vomiting
Clinical narrative: Nine hours of off/on vomiting, severe case of the chills, severe joint pain/back pain; by about 4:00 AM on June 7, I was finally through the worst of it. Looking back on my situation, I should have gone to the ER.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a company representative, who was reporting on his mother-in-law, a 71-year-old female patient. The patient's concurrent condition included fibromyalgia and arthritis. Her drug reaction and allergies were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX for prevention (dose, route of administration, anatomical location, lot# and expiration date were not reported). Other suspect therapies included sterile diluent (STERILE DILUENT) (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant therapies were not provided. On an unknown date, also reported as "beginning on an unspecified date and received on 08-MAY-2018; discrepancy", the patient developed discomfort, itching, rash on the right chest cavity, and no pain. The patient sought medical attention and on 8-MAY-2018 was diagnosed with shingles. On an unspecified date, the patient received something to help with the symptoms (details were not reported). Product quality complaint was not reported. The outcome of the event was reported as not recovered. Causality assessment was not provided.
Age: 26.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 year old patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 injection, for prophylaxis (dose, lot number and expiration date were not reported). No adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Hypertension, Leukocytosis
Clinical narrative: This literature market report has been received from authors of a published article. This report referred to a male patient of unknown age. The patient was born to healthy parents who was diagnosed at age 5 years with autoimmune lymphoproliferative syndrome (ALPS) with refractory immune thrombocytopenic purpura (ITP), anemia, neutropenia, and splenomegaly. The patient was splenectomized at age 7 years and subsequently received corticosteroids, mycophenolate-late mofetil (MMF), intravenous immunoglobulin, eltrombopag, and rituximab for refractory ITP. The platelet counts normalized after MMF and immunoglobulin treatment, suggesting an autoimmune etiology, though the patient did not have elevated autoantibodies (extractable nuclear antigens, deoxyribonucleic acids (DNA), ribonucleoprotein, antinuclear antibodies, anticardiolipin, and antithyroid). The patient had episodic aseptic meningitis, with lumbar punctures revealing reactive lymphocytosis in the cerebrospinal fluid consisting of 85% T cells in a 6:1 CD4+ to CD8+ ratio. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient had a systemic reaction to pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) with leukocytosis and hypertension. The outcome of leukocytosis and hypertension was unknown. The reporter considered leukocytosis and hypertension to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dizziness, Herpes zoster, Pain, Scar
Clinical narrative: Information has been received on 04-JUN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about October 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient experienced feeling of dizziness and feeling lightheaded and developed painful blisters on her neck. Thereafter, the patient presented to her primary care physician and was diagnosed with shingles, which lead to severe scarring throughout her body. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. It is claimed the patient sustained pain and suffering for severe and permanent personal injuries. Severe scarring throughout her body, dizziness and feeling lightheaded and persistent strain of herpes zoster/shingles were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 12-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 20-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001552: US-009507513-1806USA001551: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1710USA003103: US-009507513-1806USA001547: US-009507513-1806USA001549: US-009507513-1806USA001550: US-009507513-1806USA001561:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 12-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001552: US-009507513-1806USA001551: US-009507513-1806USA001550: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1710USA003103:
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided) and a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 12-JAN-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot # and expiration date were not provided) and a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 20-JAN-2018, the patient was re-vaccinated with a dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001551; US-009507513-1806USA001547; US-009507513-1806USA001548; US-009507513-1806USA001549; US-009507513-1806USA001550; US-009507513-1806USA001560; US-009507513-1806USA001559; US-009507513-1806USA001558; US-009507513-1806USA001557; US-009507513-1806USA001556; US-009507513-1806USA001555; US-009507513-1806USA001554; US-009507513-1806USA001553; US-009507513-1806USA001552; US-009507513-1710USA003103.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 12-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 08-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Sex: U
Vaccine: HPV9
Symptoms: Immunisation, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). On 02-JAN-2018, the patient was re-vaccinated with a dose of GARDASIL 9 (dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 12-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Age: 20.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from the office manager on 21 May 2018. This case involves 20 years old patient (Gender was not reported) who was vaccinated with first and second dose of MENACTRA (batch number, expiry date, route and site of administration were not reported for both dose) on 03 Aug 2017 and 16 May 2018. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to extra dose administered. It was unknown whether patient had adverse event related to vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: Question-Caller is an office manager calling to ask if there are any safety concerns with a patient who received the first MENACTRA vaccine on 8/3/2017 and a 2nd MENACTRA vaccine on 5/16/2018. No other information provided. Special Handling - Response - Verified demographics. Response per standards. Case copied to USPV.  ppd-ddm/kc/21May2018.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Confusional state, Feeling abnormal
Clinical narrative: Initial unsolicited report was received from a Nurse on 22-May-2018. This case involves a 54-year-old female patient who was vaccinated once with 0.5 ml dose of ADACEL (batch number: U5771AA, expiry date, dose in series, and site of administration were not reported) via intramuscular route on 26-Apr-2018. Patient's medical history and concomitant medication were not reported. On an unknown date, few days after the vaccine, patient began having some confusion, a foggy head and feeling like she was having difficulty finding her words. No other deficits noted. Lab tests and corrective treatment were not reported. Outcome of the events was not recovered. List of documents held by sender: none.
Age: 1.92
Sex: F
Vaccine: MENB, MNQ
Symptoms: Laboratory test normal, Syncope
Clinical narrative: Initial unsolicited report received from nurse on 24 May 2018. This case involves female patient (age not reported) who was vaccinated with a dose of MENACTRA in arm on an unspecified date and vaccinated with TRUMENBA in the deltoid on May 2004 (Batch number, expiration date, dose, route was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. Patient had no underlying conditions. On an unspecified date, following the vaccination, the patient fainted and was taken to the emergency room. The lab results were normal-no issues. Corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle spasms, Myalgia, Neck pain, Pain
Clinical narrative: On 6/4/18 patients partner presented to pharmacy saying that patient has been experiencing left shoulder pain since the shingles vaccine was given. She stated that the pharmacist must have given the injection too high on 4/23/18. Patient was going to orthopedic dr the next day. On 6/5/18 Dr diagnosed pt with pain in left shoulder; mass of joint of left shoulder; myofacial muscle pain. She stated she did not have significant pain after the shot but had a spasm later that evening that caused pain and move into her neck. She has had persistent pain and spasm since. She has left shoulder pain post shingles vaccine. Symptoms are consistent with myofascial pain syndrome and spasm but she does have a palpable lesion over the left deltoid which could be an abscess. Dr recommended MRI to rule out rotator cuff tear and mass. Dr prescribed ROBAXIN 500 mg 3 times a day as well as over the counter analgesics and heat.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, X-ray limb normal
Clinical narrative: On 6/4/18 patients partner presented to pharmacy saying that patient has been experiencing left shoulder pain since the shingles vaccine was given. She stated that the pharmacist must have given the injection too high on 4/23/18. Patient was going to orthopedic dr the next day. On 6/5/18 Dr diagnosed pt with pain in left shoulder; mass of joint of left shoulder; myofacial muscle pain. She stated she did not have significant pain after the shot but had a spasm later that evening that caused pain and move into her neck. She has had persistent pain and spasm since. She has left shoulder pain post shingles vaccine. Symptoms are consistent with myofascial pain syndrome and spasm but she does have a palpable lesion over the left deltoid which could be an abscess. Dr recommended MRI to rule out rotator cuff tear and mass. Dr prescribed ROBAXIN 500 mg 3 times a day as well as over the counter analgesics and heat.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Left arm, swollen and warm to the touch, treated with Doxycline HCL 100mg Take 1 capsule(s) twice a day by oral route with meals not MILK.#20 for 10 days. Patient reported event today during a nurse visit.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Pain in jaw, Pyrexia, Vaccination complication
Clinical narrative: Patient had a fever of 101 that evening following the vaccine, jaw and chest pain. She drove herself to the hospital due to this, worried of a possible heart attack. She is fairly fit and plays a good bit of tennis, but does doe this out in the heat. The ER advised her the reaction was due to the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer and described the occurrence of erythematous rash in a adult patient who received SHINGRIX. On 26th May 2018, the patient received SHINGRIX. On 27th May 2018, 1 days after receiving SHINGRIX, the patient experienced erythematous rash and itchy rash. On an unknown date, the outcome of the erythematous rash and itchy rash were unknown. It was unknown if the reporter considered the erythematous rash and itchy rash to be related to SHINGRIX. Additional details were provide as follows: The age at vaccination was not reported. On 26th May 2018 (Saturday), the patient received SHINGRIX. On 27th May 2018 Sunday, the patient experienced a pre-shingle kind of rash on the left ankle. On 28th May 2018 (Monday), the patient had a new one on rash on the left ankle, they were both bright red and itchy. The patient enquired that if this was normal adverse event after receiving the SHINGRIX vaccine. The patient will call physician on 29th May 2018, when the holiday would be over.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Blurred vision.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Swelling of arm from elbow to shoulder, hot to touch, sore x 4 days.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Neck pain, Pain in extremity, Vaccination complication
Clinical narrative: Patient contact today 6/7/2018 in pharmacy - patient stated she had a "bad" reaction after the vaccinations last month. She described having pain on the left side of her neck (anterior cervical lymph node area) extending up to her ear. It was "very painful," sharp at times and otherwise continuously "very achy." She thinks it may have been slightly swollen and doesn't remember if it was tender or warm to touch. She doesn't remember having any other side effects besides sore arms. It lasted for 3 days after the shots and she was ready to go to the doctor when it subsided. She is "fine" now.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Gait disturbance, Injection site erythema
Clinical narrative: Redness in the upper arm (deltoid region), sore. It is hot. The redness is spreading superior from the site of injection. On 6-6-18, customer reports that ringing in ears, feeling fogginess, extreme fatigue and week; staggered when walking.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm, Tinnitus
Clinical narrative: Redness in the upper arm (deltoid region), sore. It is hot. The redness is spreading superior from the site of injection. On 6-6-18, customer reports that ringing in ears, feeling fogginess, extreme fatigue and week; staggered when walking.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Chills, Diarrhoea, Headache
Clinical narrative: Employee states at 23:30 on 6/5/18 the day of the vaccination he became nauseated, vomited and had diarrhea. Reports he was chilling during the night. On 6/6/18 employee stayed home from work because he was still nauseated and had no energy. Today 6/7/18 employee came to Employee Health services reporting the symptoms from the past 2 days. Reports he has no energy today and his hands are achy. Reports he has eaten some yogurt and granola. T99.7 while in the clinic. Reports he has a history of migraines and he had a head ache yesterday but employee isn't sure whether it was a migraine or part of adverse reaction.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired work ability, Nausea, Pain in extremity, Vomiting
Clinical narrative: Employee states at 23:30 on 6/5/18 the day of the vaccination he became nauseated, vomited and had diarrhea. Reports he was chilling during the night. On 6/6/18 employee stayed home from work because he was still nauseated and had no energy. Today 6/7/18 employee came to Employee Health services reporting the symptoms from the past 2 days. Reports he has no energy today and his hands are achy. Reports he has eaten some yogurt and granola. T99.7 while in the clinic. Reports he has a history of migraines and he had a head ache yesterday but employee isn't sure whether it was a migraine or part of adverse reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: KINRIX give about 9:45 on 6/5/18 then morning of 6/6/18 parents noted a little erythema on right deltoid (where shot was given). By late afternoon the area was larger warm and somewhat tender. I saw him at9 am on 6/7/18. Mom says it seemed a little less tender but about the same size. It was about 2"x2" warm erythematous and mildly tender. Child happy. Tx suggested cold compress and Tylenol or Motrin.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Amnesia, Angiogram normal, Aphasia, Arteriogram, Asthenia
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Blood lactic acid increased, Body temperature increased, CSF white blood cell count increased, Chills, Computerised tomogram head normal
Clinical narrative: Received the Hepatitis A, SHINGRIX and PNEUMOVAX all at the same time in the left deltoid at 9:30 AM on 5/3/18. In the evening on 5/3/2018 there was redness, swelling, warmth and pain in the left arm at the injection site. On 5/4/2018 symptoms included fatigue, oral temperature of 100.8 and increased pain, warmth, redness and swelling extending from the left deltoid area to the middle of the left forearm. Left arm was sensitive to touch. Symptoms continued on 5/7/18 and my skin was also sensitive to touch from left arm extending across my back over to right arm. On 5/9/18 symptoms: increased fatigue, chills, and just wanted to sleep. Increased sensitivity of skin of my arms and back to touch and to the fabric of my shirt and mild confusion. On 5/10/18 at 8:00am, I had chills, skin sensitivity, increased confusion/decreased mental status, unable to stand up and tremors. 911 was called and when the firemen were helping me down the stairs, I had a tonic/clonic seizure lasting 3-4 minutes. I was transported to the Emergency room for testing then later that afternoon admitted to the telemetry floor. My temperature was 39.8 degrees Celsius. I was given IV antibiotics/antiviral medication, DILANTIN and IV fluids. I was unconscious from 5/10/18 through 5/11/18. On 5/12/18, I started responding to questions but had significant memory loss. I was discharged home from the Hospital on 5/13/2018 with a diagnosis of viral encephalitis to take oral Valacyclovir three times a day until 6/3/18, and a diagnosis of new onset seizure related to the infection. As of 6/3/18, I still have some memory loss and difficulty recalling certain words, weight loss and my strength and appetite are not back to normal.