chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypotension, Hypothermia, Injection site oedema, Injection site pain
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Paresis, Polyneuropathy, Presyncope, Raynaud's phenomenon
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal pain, Swelling, Tachycardia, Tonic clonic movements, Tremor
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Underweight
Clinical narrative: Pain, Edema, Right arm (immunization site) strength loss, Reynaud Phenomenon, Joint pain. 15 days later pain on the left side arm, one month after presented pain in the low body section. Generalized strength loss, Disability, Fibromyalgia, paresthesia, paresis, chronic pain, chronic fatigue, arthralgia, myalgia, allodynia, costochondritis, headaches,  insomnia, spinal pain, dizziness, nausea, hypotension, gastroesophageal reflux, gastrointestinal disorder, dysautonomia, tachycardia, distal hypothermia, swelling, hair loss, tremors, facial paresis, Tonic-clonic movements, presyncope, Shaking chills, low weight. Current treated with painkillers, anti-convulsives and steroids.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia, Biopsy artery normal, Blindness, Blood pressure increased, Claudication of jaw muscles
Clinical narrative: 9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Fatigue, Feeling abnormal, Hyperhidrosis, Impaired driving ability
Clinical narrative: 9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Mass excision, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: 9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Night sweats, Nuclear magnetic resonance imaging normal, Occult blood negative, Pain of skin, Platelet count increased
Clinical narrative: 9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary mass, Pyrexia, Temporal arteritis, Thoracotomy, Visual impairment
Clinical narrative: 9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: 9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Repetitive strain injury
Clinical narrative: Flu vaccine AFLURIA lot # 12449211A given 10/29/15. Employee stated on 2/9/16 that she has had pain from upper arm to fingers starting 3 days after shot. No fever, swelling or redness reported. Seen by occupational health - physician treating for work related repetitive motion.
Age: 18.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MMR, TDAP
Symptoms: Axillary pain, Immediate post-injection reaction, Peripheral swelling, Urticaria
Clinical narrative: Immediate armpit soreness lasting 5 days. Hives on face, arms, hands lasting 2 weeks. Hand and finger swelling. lasted 1 week.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US021581, is an initial spontaneous report from a nurse received on 21 Oct 2015. This report refers to a 54 years old female patient. Medical history and concomitant medications were not reported. On 21 Oct 2015 the patient received FLUVIRIN (batch number: 1517401) intramuscularly at a dose of 1 ml in error. The case was assessed as non-serious. No adverse event was reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021582, is an initial spontaneous report from a nurse received on 21 Oct 2015. This report refers to a 38-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1517401) intramuscularly at a dose of 1 ml in error on 21 Oct 2015. The case was assessed as non-serious. No adverse event was reported following the maladministration.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US021297, is an initial spontaneous report received from a pharmacist on 19 Oct 2015. This report refers to a 16 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157801) intramuscularly on 18 Oct 2015. It was reported that, before administration, the FLUVIRIN was out of temperature range at 49 Fahrenheit for 4 hours. No adverse event was reported following this maladministration.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product physical issue
Clinical narrative: Case number PHEH2015US021584, is an initial spontaneous report received from healthcare professional on 21 Oct 2015. This report refers to a 29 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1516401) intramuscularly on 15 Oct 2015. It was reported that during vaccination vial leakage was observed from the point where diaphragm and metal meet. Further there was no harm caused to patient and no medical attention was required. No adverse event was reported following this event.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US021636, is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a 28 year old male patient. Medical history and concomitant medication were not reported. On an unknown date, the patient was intramuscularly vaccinated with FLUVIRIN (batch number: 157601) whose pre filled syringe was out of temperature range (64 degree Fahrenheit) for 1 to 3 hours. No adverse event was reported following this medication error.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021579, is an initial spontaneous report from a nurse received on 21 Oct 2015. This report refers to a 47-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1517401) intramuscularly at a dose of 1 ml in error on 21 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US021583 is an initial spontaneous report received from a nurse on 21 Oct 2015. This report refers to a 24 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated FLUVIRIN (batch number: 1517401) intramuscularly at a dose of 1 ml in error on 21 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Device leakage, No adverse event
Clinical narrative: Case number PHEH2015US021585, is an initial spontaneous report received from healthcare professional and QA department (reference number: 1007902) on 21 Oct 2015. This report refers to a 41 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1516401) intramuscularly on 15 Oct 2015. It was reported that while drawing out vaccine from the vial leakage was observed from the point where diaphragm and metal meet. Further it was also reported that there was no harm caused to patient and no medical attention was required. No adverse event was reported following this event.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020298, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 63 year old male patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. It was reported that the patient was administered with FLUVIRIN vaccine which was stored out of 47 degree Fahrenheit temperature. No adverse event was reported following this maladministration.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021630, is an initial spontaneous report from a health care professional received on 22 Oct 2015. This report refers to a 2 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1516201) intramuscularly on 21 Oct 2015. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US021637, is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a patient of unknown demographics. Medical history and concomitant medication were not reported. On an unknown date, the patient was intramuscularly vaccinated with FLUVIRIN (batch number: not reported) which was out of temperature range for 24 hours. No adverse event was reported following this medication error.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Case number PHEH2015US021003, is an initial spontaneous report received from a consumer on 16 Oct 2015. This report refers to a 37 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 158402) intramuscularly in her buttock on 14 Oct 2015. No adverse event was reported following this maladministration.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US020969, is a combined initial and follow-up spontaneous report from a health care professional received on 16 Oct 2015. This report refers to a 23-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with intramuscular dose of FLUVIRIN (batch number: 1515601) at a dose of 1 ml instead of 0.5 ml on 14 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site warmth
Clinical narrative: Case number PHEH2015US021242, is an initial spontaneous report from a pharmacist received on 19 Oct 2015. This report refers to a 38 years old female patient. Medical history and concomitant medications were not reported. The patient was not allergic to eggs and had FLUVIRIN (batch number: not reported) in the past. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. Post vaccination the patient developed warmth and circle mark at the injection site. The outcome, seriousness and causality of the event were not reported.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021294, is an initial spontaneous report received from a nurse on 19 Oct 2015. This report refers to a 2 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 18 Oct 2015. No adverse event was reported following this maladministration.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Lethargy, Muscular weakness
Clinical narrative: Case number PHEH2015US021639 is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a male patient of an unknown age. Medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1517601) intramuscularly on 22 Oct 2015. On the same day, the patient suddenly developed muscle weakness, extreme fatigue and lethargy. It was reported that these events were consistent for over 12 hours without resolution. Following this the patient visited emergency room where no medication was administered to him. No further information was provided. The final outcome of the events was reported as unknown. Seriousness and causality of the events was reported as unknown.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US021305, is a combined initial and follow up spontaneous report received from a pharmacist on 20 Oct 2015. This report refers to a 59 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly on 16 Oct 2015. It was reported that before vaccination the FLUVIRIN was exposed to 55 and 64 degree Fahrenheit temperature for 3 hours. No adverse event was reported following this maladministration.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020290, is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 59 years old male patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US021423, is an initial spontaneous report received from a healthcare professional on 20 Oct 2015. This report refers to a 52 years old female patient. Historical condition and concomitant medication were not provided. It was reported that FLUVIRIN (batch number: 157602) stored at 48 degree F for 8 hours was administered to the patient intramuscularly on 20 Oct 2015. No adverse event was reported following this maladministration.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Case number PHEH2015US021671 is an initial spontaneous report received from a health care professional on 23 Oct 2015. This report refers to a 67 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 151601) intramuscularly, about 3 inches below deltoid muscle, on an unknown date in Oct 2015. No adverse event was reported following this medication error.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020613 is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 39 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) at a dose of 0.5 ml, intramuscularly on 08 Oct 2015. No adverse event was reported following this medication error.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020166, is an initial spontaneous report received from a healthcare professional on 07 Oct 2015. This report refers to an 85 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 06 Oct 2015. No adverse event was reported following this administration error.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020167, is an initial spontaneous report received from a healthcare professional (medical assistant) on 07 Oct 2015. This report refers to a 71-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 06 Oct 2015. No adverse event was reported following this administration error.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020944, is an initial spontaneous report received from a medical assistant on 14 Oct 2015. This report refers to a 3 year old male patient. Medical history and concomitant medication was not reported. The patient received the FLUVIRIN (batch number: 15733P) intramuscular in error. No adverse event was reported following the maladministration.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020168, is an initial spontaneous report received from a healthcare professional (medical assistant) on 07 Oct 2015. This report refers to a 66-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 06 Oct 2015. No adverse event was reported following this administration error.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020294 is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 60 years old male patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020963, is a combined initial and follow up spontaneous report received from a nurse on 15 Oct 2015 and on 20 Oct 2015, respectively. This report refers to a 49 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1413101) intramuscularly on 13 Oct 2015. No adverse event was reported following this maladministration.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020295, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to 54 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. It was reported that before administration the vaccine was stored out of temperature range at 47 degree Fahrenheit. No adverse event was reported following this maladministration.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020296, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 56 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly on 07 Oct 2015 that was out of temperature range at 47 Fahrenheit. No adverse event was reported following this medication error.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020297, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 28 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly on 07 Oct 2015. Nurse reported that the administered FLUVIRIN vaccine was stored out of temperature range at 47 F. No adverse event was reported following this medication error.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020299, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 44 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly at a dose of 0.5 ml on 07 Oct 2015. It was reported that the patient was administered with FLUVIRIN vaccine which was stored out of 47 Fahrenheit temperature. No adverse event was reported following this maladministration.
Age: 52.0
Sex: M
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020300, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 524 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular at a dose on 07 Oct 2015. It was reported that the patient received FLUVIRIN vaccine that was out of temperature range at 47F before administration. No adverse event was reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US020301 is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 55 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly on 07 Oct 2015. The nurse reported that the patient was administered FLUVIRIN multi dose vial (MDV) that was in out of temperature range at 47 degree Fahrenheit. No adverse events were reported following the maladministration.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US022290 is an initial spontaneous report received from a nurse on 29 Oct 2015. This report refers to a 3 and a half year old male patient. Past medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1515401) multi dose vial (MDV) intramuscularly on 29 Oct 2015. No adverse events were reported following the maladministration.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: Case number PHEH2015US022214, is an initial spontaneous report from a medical assistant received on 28 Oct 2015. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. The patient was administered with FLUVIRIN (batch number: 158403) intramuscular on 28 Oct 2015. After vaccination the vaccine ran back out of the injection site and down the patient arm. No adverse event was reported.
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Facial pain, Influenza like illness, Musculoskeletal pain, Neck pain
Clinical narrative: Case number PHEH2014US022649 is an initial spontaneous report received from a healthcare professional on 07 Nov 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly from a multidose vial on an unknown date. On an unknown date following vaccination, she experienced pain in shoulder, pain in neck, pain in back, pain on the side of face and flu like symptoms on one side of her body. Final outcome was unknown. The seriousness and causality were not reported. No additional details were available.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022656 is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a 02 year old male patient. His medical history and concomitant medication were not reported. On 06 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 1411301) via intramuscular route. No adverse event was reported following this administration error.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US020038, is an initial spontaneous report from a nurse received on 06 Oct 2015. This report refers to a 2-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 158105) intramuscularly on 06 Oct 2015. No adverse event was reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood uric acid normal, Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHEH2015US020110, is an initial spontaneous report received from a consumer (patient) on 07 Oct 2015. This report refers to a 60 years old female patient. Historical condition and concomitant medication were not provided. Her vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) with no problems. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 05 Oct 2015. Later that evening the patient experienced pain in left foot arch; redness in foot, ankles and hands; swelling of ankles, hands and knuckles. Further the patient experienced low grade fever. The patient got his uric acid levels tested at physician's office and those levels did not indicate gout. Final outcome of the events were unknown. The seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2015US020110, is an initial spontaneous report received from a consumer (patient) on 07 Oct 2015. This report refers to a 60 years old female patient. Historical condition and concomitant medication were not provided. Her vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) with no problems. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 05 Oct 2015. Later that evening the patient experienced pain in left foot arch; redness in foot, ankles and hands; swelling of ankles, hands and knuckles. Further the patient experienced low grade fever. The patient got his uric acid levels tested at physician's office and those levels did not indicate gout. Final outcome of the events were unknown. The seriousness and causality of the events were not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020165, is an initial spontaneous report received from a healthcare professional on 07 Oct 2015. This report refers to a 71 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) suspension intramuscularly at a dose of 0.5 ml on 06 Oct 2015. No adverse event was reported following the administration error.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHEH2014US022419 is an initial spontaneous report received from a physician on 06 Nov 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412901) intramuscularly in arm on 01 Oct 2014. It was reported that he was experiencing pain in his arm and shoulder of injection site since he was administered the injection. He had pain only when moving around and not pain at rest. The events outcome was unknown. The seriousness and causality of the event was not reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US022425, is an initial spontaneous report received from a pharmacist on 06 Nov 2014l. This report refers to a 69 year old female patient. Her medical history and concomitant medication was not reported. Pharmacist reported that she was vaccinated with FLUVIRIN (batch number: unknown) twice during the 2014-2015 flu season in error. She received the second dose of FLUVIRIN (batch number: 1413301) on 06 Nov 2014. No adverse event was reported. No further information was provided.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022434, is an initial spontaneous report from a medical assistant received on 06 Nov 2014. This report refers to a 6-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly at a dose of 0.5 ml that was stored at a temperature of 31 F-47 F for two weeks from a multi dose vial on 01 Nov 2014. No adverse event reported.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022442, is an initial spontaneous report from a medical assistant received on 06 Nov 2014. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly at a dose of 0.5 ml that was stored at a temperature of 31 F-47 F for two weeks from a multi dose vial on 01 Nov 2014. No adverse event reported.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022443, is an initial spontaneous report from a medical assistant received on 06 Nov 2014. This report refers to a 9-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly at a dose of 0.5 ml that was stored at a temperature of 31 F-47 F for two weeks from a multi dose vial on 01 Nov 2014. No adverse event reported.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022447, is an initial spontaneous report from a medical assistant received on 06 Nov 2014. This report refers to a 7-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly at a dose of 0.5 ml that was stored at a temperature of 31 F-47 F for two weeks from a multi vial dose on 01 Nov 2014. No adverse event reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US022451 is an initial spontaneous report from the consumer received on 07 Nov 2014. This report refers to a 62-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on 23 Sep 2014. On 07 Nov 2014, she was inadvertently vaccination with FLUVIRIN (batch number: 146501) instead of pneumonia shot. No adverse event reported following these medication errors.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHEH2014US022458, is an initial spontaneous report from a pharmacist received on 05 Nov 2014. This report refers to a 55-year-old female patient. Medical history and concomitant medications were not reported. The patient received two doses of FLUVIRIN (batch number: not available) intramuscularly on the morning of 05 Nov 2014 at the hospital. No adverse event was reported following this medication error.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Case number PHEH2014US022476 is an initial spontaneous report from the consumer received on 06 Nov 2014 and a follow up report from the consumer received on 15 Jan 2015 and with a follow up information received from the pharmacist on 23 Feb 2015. This report refers to a 56-year-old female patient. She had no known drug allergies. She was vaccinated with FLUVIRIN (batch  number: 1206501) at a dose of 0.5 ml intramuscularly in left arm on 12 Oct 2014. On the same date, after vaccination she experienced pain in her shoulder which has later diminished but not completely recovered. The patient was unable to lift her arm more than 180 degrees without experiencing pain. She cannot lift very high without experiencing pain/weakness in left shoulder or complete inability to lift something when arm was in certain position. She cannot sleep on left shoulder without experiencing pain. The outcome of the events reported as complete recovery. The seriousness and causality of the events were not reported. Follow up report from the consumer received on 15 Jan 2015: Added new events (weakness of shoulder and inability to lift arm). Updated dose of FLUVIRIN. Follow up information received from a pharmacist on 23 Feb 2016: Updated batch number of vaccine and date of vaccination, new event (pain in arm) and outcome of the events.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Case number PHEH2014US022524, is an initial spontaneous report received from a pharmacist on 06 Nov 2014. This report refers to a 74 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1410901) intramuscular on 13 Oct 2014. Pharmacist reported that within 4 days of vaccination she experienced muscle stiffness radiating from above injection site and down elbow. Reaction continued a week later and was unsure if reaction persists. Patient works out three times a week including arms. She is an older woman but is in great shape. Final outcome of the event, seriousness and causality assessment was not reported.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US022645 is an initial spontaneous report received from a nurse on 07 Nov 2014. This report refers to a 3 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1412121) from a multi dose vial (MDV) on 07 Nov 2014. No adverse events were reported following the inadvertent administration.
Sex: U
Vaccine: FLU3
Symptoms: Drug administration error, No adverse event
Clinical narrative: Case number PHEH2015US022019, is an initial spontaneous report received from pharmacist on 26 Oct 2015. This report refers to a patient of unknown demographics. Historical condition and concomitant medication were not provided. The patient was vaccinated with a partial dose of FLUVIRIN (batch number: not provided) due to administration error on an unspecified date. It was reported that needle was not fixed tightly, subsequently majority of vaccine dripped out on arm, due to which patient received a partial dose. No further adverse event was reported.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Mobility decreased, Myalgia, Pain
Clinical narrative: I had the PNEUMOVAX 23 shot on January 20th 2016 at around 10L50 -11ish am. On that same day, by 2:00 pm, I could not move my arm, it felt very heavy, and with severe pain. The pain was worse the next day, and continued until Feb 1st 2016 I still have muscle pain, but I will cope with this pain.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US020603, is an initial spontaneous report received from a nurse on 13 Oct 2015. This report refers to a 24 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with an expired dose of FLUVIRIN (batch number: 1412701) intramuscularly at a dose of 0.5 ml on 08 Oct 2015. No adverse event was reported following this maladministration.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US022027, is an initial spontaneous report from a health care professional received on 26 Oct 2015. This report refers to a 3 years and 6 months old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157104) intramuscularly on 22 Oct 2015. No adverse event was reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US022041, is an initial spontaneous report received from healthcare professional on 26 Oct 2015. This report refers to a 53 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly on 26 Oct 2015. It was reported that vaccine was stored at room temperature for 8 hours prior administration. No adverse event was reported following this medication error.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US022025, is an initial spontaneous report received from a health care professional on 27 Oct 2015. This report refers to a 13 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly and FLUZONE (other manufacturer, batch number: not reported) both administered about 12 days apart on 12 Oct 2015 and 26 Oct 2015 respectively. No adverse event was reported following this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US022251, is an initial spontaneous report from a nurse received on 28 Oct 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient received 0.5 ml of FLUVIRIN (batch number: 1516201) via subcutaneous route in error on an unknown date. The case was assessed as non-serious. No adverse event was reported following this maladministration.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Case number PHEH2015US022361, is an initial spontaneous report from a nurse received on 29 Oct 2015. This report refers to a 54 years old female patient. Medical history and concomitant medications were not reported. The patient received 0.5 ml of FLUVIRIN (batch number: 1515101) via subcutaneous route of 21 Oct 2015. On the same day after vaccination the patient experienced injection site reaction. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US022671, is an initial spontaneous report received from a pharmacy student on 02 Nov 2015. This report refers to a male patient of unknown age. Medical history and concomitant medication was not reported. The patient brought the MDV of FLUVIRIN (batch number: 1515401) to home and left it out at room temperature for up to 12-13 hours. The patient later administered the FLUVIRIN on 31 Oct 2015. No adverse event was reported. No further information was provided.