chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.92
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 27-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.42
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 18-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unspecified age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant therapies reported. On 03-JAN-2017, the patient was vaccinated with one dose of PROQUAD lot number: M004893 with expiration date: 26-JUL-2017 (dose and route of administration were not provided), for prophylaxis. The administered dose had been improperly stored at a temperature of 5°F to 14°F for one hour (digital data logger) without any previous temperature excursion. No adverse effects were reported.  There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring to herself, who had immunodeficiency. The patient's medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 for prophylaxis (strength, dose, route of administration, lot number and expiration date were not provided). The patient stated that "when she received the PNEUMOVAX23, she got pneumonia. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of pneumonia, and the causal relationship between the event and the PNEUMOVAX23, were unknown. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 09-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot# L039095, expiry date 08-JAN-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dermatitis contact, Eczema, Pyrexia, Rash
Clinical narrative: With fever, Skin rash which initially was told to be nothing to worry about and then as contact dermatitis and later declared as eczema(chronic). Hydrocortisone 2.5% prescribed. And it keeps coming back after every few days.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Guillain-Barre syndrome, Muscular weakness, Oral mucosal blistering, Pyrexia
Clinical narrative: The symptoms gradually came on over a six-day period from the time I received the vaccination. Had a fever and a red rash. Weakness in lower part of my body. Foot, legs, thighs and knees, had extreme pain in my joints, the crippling effects slowly moved up my body and rash followed, blisters in mouth, horrible skin infection testicle, grown.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Skin infection, Testicular disorder
Clinical narrative: The symptoms gradually came on over a six-day period from the time I received the vaccination. Had a fever and a red rash. Weakness in lower part of my body. Foot, legs, thighs and knees, had extreme pain in my joints, the crippling effects slowly moved up my body and rash followed, blisters in mouth, horrible skin infection testicle, grown.
Age: 4.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Eczema, Insomnia, Pruritus, Rash generalised
Clinical narrative: Several breakouts all over his body. From the last vaccination, he had one rash and this time, he had several breakouts all over his body. Doc prescribed same medicine Hydrocortisone 2.5% . He declared its eczema and it had no relation with vaccination. Kindly understand until vaccination, my kid never had any skin problem, and now he is declared to have eczema, which goes and comes back. He scratches. What if he scratches, it might entertain his blood line. Should I wait for a day to come. All this happened because of multiple vaccines which doc totally ignores. Where can I go. I have been to the doc at least six time because of it. Sleepless nights.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Nausea, headache low grade fever.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHEH2016US025362, is an initial spontaneous report received from a pharmacist on 27 Sep 2016. This report refers to a 39 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901) at a dose of 0.5 ml intramuscular on 12 Sep 2016 at 4:15 PM (16:15). On 13 Sep 2016, the pharmacist stated that the arm of patient where she received FLUVIRIN was hurting. It hurt her specially when she lifted, stretched or carried things. The patient has tried ibuprofen but it did not work. Her arm also hurt when she sleeps on it. Upon follow up, the patient stated, arm pain after vaccination for a week. She could not lift things or lay on it. It did not lead to swelling but just an arm pain. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (significant disability). The causality of the events was not reported. Follow up report received from a pharmacist on 01 Nov 2016: Updated suspect drug time and reporter comments.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Epilepsy, Mental disorder, Neurological symptom, Seizure
Clinical narrative: This spontaneous report as received from a physician, via company representative, referring to a 20 year old female patient. The patient's medical history included chronic regional pain syndrome. The patient's drug reactions/allergies and concomitant medications were not reported. On 24-AUG-2012, the patient was vaccinated with the first dose GARDASIL for prophylaxis (dose, route, lot # and expiration date were not reported). It was reported that on the same date the patient was concomitantly vaccinated with meningococcal vaccine (unspecified). On an unknown date, the patient experienced seizures, epilepsy and an unspecified type of psychological and neurological symptoms. At the time of reporting the outcome of the events was unknown. A product quality complaint was not involved. The causality assessment between the events and GARDASIL was not provided. Upon internal review, seizures and epilepsy were determined to be medically significant events. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with one improperly stored dose of PROQUAD for prophylaxis (lot number M037011 with expiration date of 21-FEB-2018) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse symptoms were reported. The dose of the vaccine experienced a temperature excursion of greater than -10 Celsius degrees (°C) but less than 8°C  for 25 hours and 48 minutes. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. In 2016 between 22-NOV-2016 and 14-DEC-2016, the patient was vaccinated with a dose of improperly store PEDVAXHIB, lot number M025194, expiration date 22-MAR-2019, (dose, route and anatomical location were not reported) for prophylaxis. The PEDVAXHIB was exposed to 34.8 Fahrenheit for 35 days and data logger was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA005346: US-009507513-1701USA005345.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. In 2016 between 22-NOV-2016 and 14-DEC-2016, the patient was vaccinated with a dose of improperly store PEDVAXHIB, lot number M025194, expiration date 22-MAR-2019, (dose, route and anatomical location were not reported) for prophylaxis. The PEDVAXHIB was exposed to 34.8 Fahrenheit for 35 days and data logger was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA005346: US-009507513-1701USA004799.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. In 2016 between 22-NOV-2016 and 14-DEC-2016, the patient was vaccinated with a dose of improperly store PEDVAXHIB, lot number M025194, expiration date 22-MAR-2019, (dose, route and anatomical location were not reported) for prophylaxis. The PEDVAXHIB was exposed to 34.8 Fahrenheit for 35 days and data logger was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA004799: US-009507513-1701USA005345.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHEH2015US024447 is an initial spontaneous report received from a medical assistant on 19 Nov 2015. This report refers to a 64 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517701) intramuscularly on 21 Oct 2015. On 22 Oct 2015, the day after receiving vaccine, the patient experienced an all-over body rash. The outcome of the event was complete recovery on 22 Oct 2015. the seriousness of the event was not reported, but the event was upgraded as medically significant based on the information available in the source document. The causality of the event was not reported.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Case number PHEH2016US027535, is an initial spontaneous report received from a consumer on 21 Oct 2016. This is also a quality complaint report (QA reference number: 1017591). This report refers to a 50 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620501, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 05 Oct 2016. On the same day after vaccination, within 12 hours, the patient began to suffer numbness in face. He visited his physician and was diagnosed with Bell's palsy, which was attributed to the flu vaccine. The outcome of the event numbness in the face was reported as condition improving and for the event Bell's palsy it was not reported. The seriousness of the event numbness in face was reported as non serious by the consumer and for the event Bell's palsy it was not reported. The causality of the events was not reported. Seriousness of the event facial paralysis was upgraded to serious as per the Novartis Important Medical Event list. Non significant follow up report received from Quality Assurance department (QA reference number: 1017591) on 01 Nov 2016: QA reference number (1017591) added.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Hypoaesthesia oral, Pruritus, Rash erythematous, Throat tightness
Clinical narrative: Case number PHEH2015US023166, is an initial spontaneous report received from a nurse on 06 Nov 2015. This report refers to an adult female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date in Dec 2012 at 12:00 PM. On the same day shortly after vaccination (minute after vaccination), the patient had an allergic responses to FLUVIRIN. The patient experienced itching, numbness around the mouth and she felt like her throat was closing. The patient did not experience urticaria. The patient was treated with BENADRYL and the symptoms resolved the same day, before the patient left the clinic. It was stated that, the patient received FLUVIRIN again in 2014 and 2015 at an allergists office with no difficulty and allergic reaction did not occur again. Upon follow up, it was stated that the patient experienced itchy palms and red rash on an unknown date. Reporter did not think that the patient had any other allergies. The outcome of the events hypersensitivity, throat tightness, hypoaesthesia oral and pruritus was reported as complete recovery (resolved) on an unknown date in 2012 and complete recovery on an unknown date for other events. Seriousness of the events hypersensitivity, throat tightness, hypoaesthesia oral and pruritus was reported as non serious and not reported for other events. The causality of the events was not reported. The seriousness assessment of the events was upgraded to medically significant based on information available in the source document. Following an internal review was done on 25 Nov 2015 for the information received on 06 Nov 2015: Seriousness of the event throat tightness was upgraded to medically significant. Follow up report received from a nurse on 01 Dec 2015: Added events (allergic response and numbness around the mouth) and outcome of events. Follow up report received from a nurse on 28 Dec 2015: Added events cold sores and red rash and updated patient details (date of birth) and suspect drug information (dose and time of dose). Follow up report received from a nurse on 20 Jan 2016: Deleted the event cold sores (oral herpes) as the patient did not experience this event.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Face oedema, Pruritus, Swelling
Clinical narrative: Case number PHEH2015US024487, is an initial spontaneous report received from a health care professional on 20 Nov 2015. This report refers to a 46 year old female patient. Past medical history was not reported. Current conditions included wheezing, allergies, migraine preventative, migraine, headache, edema, back pain, pain, seasonal allergies, seasonal rhinitis, nausea and vomiting. Her vaccination history included administration of FLUVIRIN (batch number: not reported) last year on 24 Sep 2014, which was well tolerated. Her concomitant medications included ADIPEX-P, Albuterol HFA, ALLEGRA, ALLEGRA-D, DEPAKOTE, EZFE, FIORICET, FROVA, LASIX, Hydrocodone/Acetaminophen, Ibuprofen (manufacturer unknown), NASACORT, PHENERGAN, K-DUR extended-release, RELPAX, Vitamin B6 and ZOFRAN. She was vaccinated with FLUVIRIN (batch number: 157402) 0.5 ml intramuscularly in left arm on 16 Nov 2015. On 17 Nov 2015, she experienced facial edema, angioedema and itchy skin. She was given dexamethasone injection and MEDROL dosepak. She returned to office fully swollen on 20 Nov 2015. She was given an unspecified steroid which was stronger and another dexamethasone injection. The outcome of the events was reported as complete recovery on 27 Nov 2015. The seriousness of the events was reported as non serious by the physician, but the event angioedema was upgraded as medically significant based on Novartis Important Medical Events list and events facial edema and itchy skin were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. Follow up report received from physician on 15 Dec 2015: Updated date of historical vaccination, concomitant medications, current conditions (wheezing, allergies, migraine preventative, migraine, headache, edema, back pain, pain, seasonal allergies, allergic rhinitis, nausea and vomiting), recent vaccination information (dose and vaccination site) and event information (seriousness and outcome of the events).
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Rash, Rash erythematous
Clinical narrative: Burning sensation on legs, red dot rash on legs and abdomen.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dysstasia, Muscular weakness
Clinical narrative: Weak lower extremities. Unable to stand up or walk independently. Acute for about 24 hours and has since receded, but still extremely weak muscles in legs.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Altered state of consciousness, Cough, Productive cough, Retching
Clinical narrative: Severe cough and clear phlegm and gagging and cough lasts for minutes and at times I feel like I will pass out from lack of oxygen. Gag spit out clear mucus not green or yellow just clear.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: My arm hurt at the injection site for longer than normal.  A couple months later, it began to feel like I was carrying a newspaper under my armpit all the time.  My arm experienced limited movement, like wearing a shirt that is too small.  The pain came back and went away several times over the next year.  never dibilitating, but noticable.  The last couple months the pain has been more persistant and grown in intensity, and the swelling under my arm has increased.  I visited my doctor once, not really associating the symptoms with the flu shot at that time.  But I came across information that others had experienced similar effects.  I have another appointment with my doctor next week.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Mobility decreased, Swelling
Clinical narrative: My arm hurt at the injection site for longer than normal.  A couple months later, it began to feel like I was carrying a newspaper under my armpit all the time.  My arm experienced limited movement, like wearing a shirt that is too small.  The pain came back and went away several times over the next year.  never dibilitating, but noticable.  The last couple months the pain has been more persistant and grown in intensity, and the swelling under my arm has increased.  I visited my doctor once, not really associating the symptoms with the flu shot at that time.  But I came across information that others had experienced similar effects.  I have another appointment with my doctor next week.
Age: 10.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Abdominal pain upper, Ear discomfort, Fall, Loss of consciousness, Nausea
Clinical narrative: Minutes after receiving vaccine, my daughter was walking out of the office with me and passed out. She was standing next to me one minute and on the ground the next. Unconscious for about 10-15 seconds then woke up sick to her stomach and threw up. After this, she stayed seated for a few minutes and drank some apple juice. About 5 min later, she was able to stand and walk. She complained of 'stuffy ears' and stomach ache most of the day.
Age: 10.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Vomiting
Clinical narrative: Minutes after receiving vaccine, my daughter was walking out of the office with me and passed out. She was standing next to me one minute and on the ground the next. Unconscious for about 10-15 seconds then woke up sick to her stomach and threw up. After this, she stayed seated for a few minutes and drank some apple juice. About 5 min later, she was able to stand and walk. She complained of 'stuffy ears' and stomach ache most of the day.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: Mom States "It was more red today on his leg so I took him to care now today at eleven thirty." "They said I should let you know."
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Erythema, Headache, Paraesthesia, Pruritus
Clinical narrative: Pt complain of dizziness p 10 mins of giving Anthrax Vaccine 0.5ml LD IM. Put pt in the room and lay in the bed propped both above chest. PT complain that tingling On left arm and pounding in both side of head. Called Dr and attended to pt immediately. VS BP 150 PP 76 RR 18 and Dr assist pt to observe for further adverse reactions. VS obtained again p 15 Mins BP 140/90 PP 60 RR 16 this time complain of itching on the back, neck and scalp with redness and puffiness on the face. Dr ordered BENADRYL 12.5 Mg/5ml 20 ml Given Stat. Orally then observe pt for further adverse reactions. VS obtained again p 10 mins BP 148/104 PP 60 RR 16. after 15 mins pt said that the puffiness and redness in the face is gone. No tingling sensation on arm and No more itching on neck back and scalp. 0945 Pt able to walk uses Bathroom for urination. Remind again of safety in case further adverse reaction.Team 1 reminded of pt condition and all orders carried out. Will notify code team for further of pt condition.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling face
Clinical narrative: Pt complain of dizziness p 10 mins of giving Anthrax Vaccine 0.5ml LD IM. Put pt in the room and lay in the bed propped both above chest. PT complain that tingling On left arm and pounding in both side of head. Called Dr and attended to pt immediately. VS BP 150 PP 76 RR 18 and Dr assist pt to observe for further adverse reactions. VS obtained again p 15 Mins BP 140/90 PP 60 RR 16 this time complain of itching on the back, neck and scalp with redness and puffiness on the face. Dr ordered BENADRYL 12.5 Mg/5ml 20 ml Given Stat. Orally then observe pt for further adverse reactions. VS obtained again p 10 mins BP 148/104 PP 60 RR 16. after 15 mins pt said that the puffiness and redness in the face is gone. No tingling sensation on arm and No more itching on neck back and scalp. 0945 Pt able to walk uses Bathroom for urination. Remind again of safety in case further adverse reaction.Team 1 reminded of pt condition and all orders carried out. Will notify code team for further of pt condition.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: The injection site started to swell aprox. 2 hours after injection.  The next day the patient reported a fever of 102 degrees and nausea. Patient received treatment by physician for the nausea.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Administration site nodule, Erythema, Haemoptysis, Lip swelling, Oral mucosal blistering
Clinical narrative: PATIENT STARTED GETTING A LARGE RED BUMP SHORTLY AFTER ADMINISTRATION. ON 1/12/17 SHE WOKE UP WITH SWOLLEN LIPS, BLISTERS IN HER MOUTH, A RASH ON HER CHEST, AND SHE COUGHED UP BLOOD. THE KNOT AT THE ADMINISTRATION SITE WAS STILL PRESENT. RASH WAS SPREADING OVER ENTIRE BODY BY THE TIME SHE REACHED THE ER. ACCORDING TO HER HUSBAND THEY GAVE HER A SHOT OF STEROIDS AND CALLED IN AN RX FOR PREDNISONE TABLETS. HE STATED THAT THE ER DOCTOR FELT IT WAS A REACTION TO THE VACCINE.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash generalised, Swelling, Vaccination complication
Clinical narrative: PATIENT STARTED GETTING A LARGE RED BUMP SHORTLY AFTER ADMINISTRATION. ON 1/12/17 SHE WOKE UP WITH SWOLLEN LIPS, BLISTERS IN HER MOUTH, A RASH ON HER CHEST, AND SHE COUGHED UP BLOOD. THE KNOT AT THE ADMINISTRATION SITE WAS STILL PRESENT. RASH WAS SPREADING OVER ENTIRE BODY BY THE TIME SHE REACHED THE ER. ACCORDING TO HER HUSBAND THEY GAVE HER A SHOT OF STEROIDS AND CALLED IN AN RX FOR PREDNISONE TABLETS. HE STATED THAT THE ER DOCTOR FELT IT WAS A REACTION TO THE VACCINE.
Age: 11.0
Sex: M
Vaccine: FLU4, MEN, TDAP
Symptoms: Electroencephalogram abnormal, Posture abnormal, Tremor, Vomiting
Clinical narrative: Within a few minutes of receiving vaccine, patient slumped to right with eyes open and head shook for a few second and then was alert and vomited x 1. Hadn't had any breakfast so gave juice and crackers and felt better. No postictal state noted.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-NOV-2016, the patient was vaccinated with a pediatric dose of VAQTA with a lot number M017982 and expiration date of 13-SEP-2017 (strength, dose and route of administration were not provided) for prophylaxis. No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE. Ice applied and swelling deminished after 10 minutes.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Nervousness
Clinical narrative: 2 large red welps on left deltoid that are sore and warm to the touch where she received her PREVNAR 13 vaccine. She also felt a little shaky. Provider advised patient to take Benadryl OTC and if she has no improvement to start Augmentin Rx on Saturday 1/14/16. Instructed to go to the nearest emergency room should SOB develop.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: 2 large red welps on left deltoid that are sore and warm to the touch where she received her PREVNAR 13 vaccine. She also felt a little shaky. Provider advised patient to take Benadryl OTC and if she has no improvement to start Augmentin Rx on Saturday 1/14/16. Instructed to go to the nearest emergency room should SOB develop.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Faeces discoloured, Haematochezia, Milk allergy, Mucous stools, Pyrexia
Clinical narrative: My son got his 2 month vaccines yesterday in the exception of the Hep B vaccine. All of his stools are now green, with mucous and streaks of blood in them. He has had a fever since the vaccine 100.3F. I'm a breastfeeding mom and only introduced formula to his diet less than 2 weeks ago. He has formula (Instant Similac Advance) only once or twice a day (2-8ounces/day). I've only had Almond milk this week and so it's highly unlikely my little one has a milk allergy as the doctor suggested when I returned to report the reaction today.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: Within a few hours arm turned purple from shoulder to elbow and was swollen.  Seen at a Urgent Care; had high fever and received Benadryl.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient had raised, red rash at both injection sites.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site nodule
Clinical narrative: Protruding knot coming from injection site about 1/4 - 1/2 inch from skin *second patient this year/same fluzone quad brand.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Discomfort, Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Area of redness 11cm x 9.5cm noted today. Increased induration 4cm X 3cm. Complained of intermittent discomfort and itching. Hard and warm to touch. Normal ROM.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Eye swelling, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine was administered to my son into his deltoid muscle of left shoulder on Friday 11/18/2016.  He seemed fine on that Friday, however kept mentioning his shot location.  On Saturday 11/19/2016 mid-morning I bumped his shoulder and he complained about it hurting.  After looking and touching his shoulder it was red, hot, extremely swollen and tight. My husband and I called the nurses line  and they recommended he be brought into the ER.  I (due to some medical training as a chiropractor) chose to give him (based on recommendation from nurse and doctor) Benadryl and monitor him due to him not being in any immediate distress with breathing or lethargy.  Throughout that night patient cried his arm hurt and I gave him more Benadryl according to manufacture recommendations.  By next morning the swelling in his left arm had now expanded to his elbow.  We continued to administer Benadryl according to manufacture recommendations and made an appointment with his primary care physician for the next day. Monday morning when patient woke up, his left eye and face were swollen.  I took him the doctor where he was examined and prescribed and liquid steroid and referred to the infectious disease specialist.  The infectious disease doctor advised the arm swelling was likely due to a cell mediated response, however his face and eye involvement was more likely due to an allergic response to the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Swelling face, Type IV hypersensitivity reaction
Clinical narrative: Vaccine was administered to my son into his deltoid muscle of left shoulder on Friday 11/18/2016.  He seemed fine on that Friday, however kept mentioning his shot location.  On Saturday 11/19/2016 mid-morning I bumped his shoulder and he complained about it hurting.  After looking and touching his shoulder it was red, hot, extremely swollen and tight. My husband and I called the nurses line  and they recommended he be brought into the ER.  I (due to some medical training as a chiropractor) chose to give him (based on recommendation from nurse and doctor) Benadryl and monitor him due to him not being in any immediate distress with breathing or lethargy.  Throughout that night patient cried his arm hurt and I gave him more Benadryl according to manufacture recommendations.  By next morning the swelling in his left arm had now expanded to his elbow.  We continued to administer Benadryl according to manufacture recommendations and made an appointment with his primary care physician for the next day. Monday morning when patient woke up, his left eye and face were swollen.  I took him the doctor where he was examined and prescribed and liquid steroid and referred to the infectious disease specialist.  The infectious disease doctor advised the arm swelling was likely due to a cell mediated response, however his face and eye involvement was more likely due to an allergic response to the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Itching and redness.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Blood immunoglobulin E increased, C-reactive protein increased, Full blood count normal, Metabolic function test normal, Peripheral swelling
Clinical narrative: Acute swelling is legs IgE reaction0.02ml and 48 hour delay hypersensitivity was positive.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate increased, Type IV hypersensitivity reaction
Clinical narrative: Acute swelling is legs IgE reaction0.02ml and 48 hour delay hypersensitivity was positive.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal X-ray, Abdominal pain upper, C-reactive protein, Chills, Diarrhoea
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Eye pain, Feeling hot, Influenza virus test, Malaise, Mononucleosis heterophile test
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Paraesthesia, Ultrasound abdomen, Ultrasound pelvis, Urine analysis
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Viral test, Vision blurred, Vomiting
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling hot, Influenza virus test, Malaise, Mononucleosis heterophile test, Nausea
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Paraesthesia, Ultrasound abdomen, Ultrasound pelvis, Urine analysis, Viral test
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: 12/28/16 vomiting and diarrhea (once & done); 12/28/16 2:00 PM general ill feeling all day (nausea and stomach pain); 12/29/16 vomiting again (2 hours); chills, and then feeling hot; most of day; 12/31/16 tingling in hands and feet(off and on for about 10 days); Eyes hurting and blurry vision(off and on and is still occuring).
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Case number PHEH2015US024870 is an initial spontaneous report received from a consumer on 23 Nov 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) multi dose vial intramuscularly on an unknown date. It was reported that on an unknown date the patient was hospitalized and he was diagnosed with Guillain Barre syndrome. The patient was in the intensive care unit (ICU) at the time of reporting. The outcome of the event was unknown. The doctors believed that the event might have been caused by the flu shot. No further information was provided.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Case number PHEH2015US025690, is an initial spontaneous report received from a consumer via pharmaceutical company on 02 Dec 2015. This report refers to a patient of an unknown age and gender. Medical history was not reported. Concomitant medication was not reported. The patient received influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced flu. Final outcome, seriousness and causality were not reported.