chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Case number PHHY2013US135181 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500004) website on 25 Nov 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 02 Nov 2010. Since 06 Nov 2010, she started experiencing numbness and weakness in bilateral upper and lower extremities and also had loss of control of half of face. These symptoms worsened progressively. She went to the emergency room due to these events and underwent MRI (nuclear magnetic resonance imaging), EMG (electromyogram) and spinal tap and she was finally diagnosed with Guillain-Barre Syndrome. She received treatment with intravenous immunoglobulin (IVIG) during hospital stay. Outcome of the events as recovered (as of 14 Aug 2013). Causality was not reported for these events.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2013US135181 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500004) website on 25 Nov 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 02 Nov 2010. Since 06 Nov 2010, she started experiencing numbness and weakness in bilateral upper and lower extremities and also had loss of control of half of face. These symptoms worsened progressively. She went to the emergency room due to these events and underwent MRI (nuclear magnetic resonance imaging), EMG (electromyogram) and spinal tap and she was finally diagnosed with Guillain-Barre Syndrome. She received treatment with intravenous immunoglobulin (IVIG) during hospital stay. Outcome of the events as recovered (as of 14 Aug 2013). Causality was not reported for these events.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Dysarthria, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Case number PHHY2013US135227 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 500479) website on 25 Nov 2013. This report refers to a 36-year-old female patient. Her medical history included uterine fibroids. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 01 Dec 2010. On 01 Jan 2011, she experienced loss of balance, tingling in hands and feet and slurred speech which resulted in emergency visit. She was diagnosed with Guillain-Barre Syndrome, confirmed by MRI (nuclear magnetic resonance imaging), neurological test and spinal tap (lumbar puncture). She was hospitalized for one week and received physical therapy, speech therapy and occupational therapy and intravenous immunoglobulin (IVIG) treatment. She still had occasional tingling in hands. Outcome of the events was reported as not recovered as of 19 Aug 2013. No causality was reported for the events.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Case number PHHY2013US135227 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 500479) website on 25 Nov 2013. This report refers to a 36-year-old female patient. Her medical history included uterine fibroids. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 01 Dec 2010. On 01 Jan 2011, she experienced loss of balance, tingling in hands and feet and slurred speech which resulted in emergency visit. She was diagnosed with Guillain-Barre Syndrome, confirmed by MRI (nuclear magnetic resonance imaging), neurological test and spinal tap (lumbar puncture). She was hospitalized for one week and received physical therapy, speech therapy and occupational therapy and intravenous immunoglobulin (IVIG) treatment. She still had occasional tingling in hands. Outcome of the events was reported as not recovered as of 19 Aug 2013. No causality was reported for the events.
Age: 53.0
Sex: U
Vaccine: FLUX
Symptoms: Balance disorder, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Neck pain
Clinical narrative: Case number PHHY2013US135476 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 25 Nov 2013. This report refers to a 53-year-old patient of an unknown gender. The medical history of the patient included Penicillin allergy and concomitant medication included fenofibrate and diazepam. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 18 Dec 2012. On 04 Mar 2013, the patient was diagnosed with Guillain-Barre Syndrome, and paralysis. The patient went to emergency room and received immunoglobulin treatment for these events. Stamina was recovered in about two months with this therapy, but lower neck pain and balance disorder was still unrecovered. Patient had constant pain in feet, could not walk as well and had balance off. Outcome of the events was reported as not recovered. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events.
Age: 53.0
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Case number PHHY2013US135476 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 25 Nov 2013. This report refers to a 53-year-old patient of an unknown gender. The medical history of the patient included Penicillin allergy and concomitant medication included fenofibrate and diazepam. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 18 Dec 2012. On 04 Mar 2013, the patient was diagnosed with Guillain-Barre Syndrome, and paralysis. The patient went to emergency room and received immunoglobulin treatment for these events. Stamina was recovered in about two months with this therapy, but lower neck pain and balance disorder was still unrecovered. Patient had constant pain in feet, could not walk as well and had balance off. Outcome of the events was reported as not recovered. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US135682 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502672) website on 25 Nov 2013. This report refers to a 78-year-old female patient. Her medical history included hypertension, diabetes mellitus type 2, chronic kidney disease (CKD) stage 3 and polymyalgia rheumatic. Her concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 06 Sep 2013. On 12 Sep 2013, one week after receiving flu vaccine, she presented with Guillain-Barre syndrome to medical center (emergency visit), which was diagnosed by neurology. It was reported that there was no other obvious source of infection. CSF cultures and tests were pending for viral/bacterial infections. Outcome of the event was reported as not recovered as of 16 Sep 2013. Reporter assessed the case as serious (life threatening). No other information was provided.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Agitation, Dyspnoea, Pyrexia, Urticaria
Clinical narrative: Case number PHHY2013US135222 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 504492) web site on 25 Nov 2013. This report refers to a 44-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 26 Sep 2013. On 26 Sep 2013 she had shortness of breath, agitation, fever and hives. The outcome of the events was reported as complete recovery.
Age: 1.5
Sex: M
Vaccine: FLUX
Symptoms: Convulsion, Pyrexia
Clinical narrative: Case number PHHY2013US135339 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 504571) on 25 Nov 2013. This report refers to a 1.6-years-old (18 months) male patient. His medical history included acid reflux and concomitant medications included TYLENOL. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left leg on 28 Sep 2013. On 28 Sep 2013, he ran a fever in the evening. Emergency was called at 10:30 pm and he had a seizure while taking by ambulance to hospital. He was taken to emergency room and was diagnosed with febrile fever due to fever of 103.7 while admission. The outcome was reported as complete recovery.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Pharyngeal oedema
Clinical narrative: Case number PHHY2013US135343 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 504572) on 25 Nov 2013. This report refers to a 66-years-old female patient. Her medical history included allergy to tree grass and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 28 Sep 2013. On 28 Sep 2013, she experienced chills, sore throat, cough, throat swelling and aches. The outcome was reported as complete recovery.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Chills, Fatigue, Nausea, Syncope
Clinical narrative: Case number PHHY2013US135363 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 504581) on 25 Nov 2013. This report refers to an 87-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. 10 minutes after vaccination (event onset date unspecified), she became very nauseated and fainted. When she reached home she went right to bed with chills and became very tired. She had a very bad pain in her chest for 4 hours the next night. The outcome was reported as complete recovery.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial infection, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer and described the occurrence of bacterial infection in a 29-year-old female patient who received BOOSTRIX (batch number 34EB5, expiry date unknown). The patient's past medical history included shingles. On 20th November 2014, the patient received BOOSTRIX. In November 2014, an unknown time after receiving BOOSTRIX, the patient experienced headache. On 21st November 2014, the patient experienced injection site pain, injection site induration, tiredness and injection site swelling. On 22 November 2014, the patient experienced injection site burning and injection site erythema. On 26th November 2014, the patient experienced bacterial infection and skin warm. The patient was treated with BENADRYL (nos) and antibiotics nos, (Drug name unknown). On an unknown date, the outcome of the bacterial infection, injection site pain, injection site burning, injection site induration, tiredness, injection site swelling, injection site erythema, skin warm and headache were not recovered/not resolved. It was unknown if the reporter considered the bacterial infection, injection site pain, injection site burning, injection site induration, tiredness, injection site swelling, injection site erythema, skin warm and headache to be related to BOOSTRIX. Additional information: The consumer reported she really wasn't feeling well after the injection. She is still tired. She stated the infection has spread from injection site to under arm pits, also to lymph nodes. The injection site swollen. there is a red ring around the injection site that has started to spread and become bigger. The lump under arm is about the size of half a dollar under her skin. The pain, swelling, and redness started getting worse on 22 November 2014. By 23 November 2014, these things were unbearable. It was diagnosed as bacterial infection on 26 November 2014. Consumer tried BENADRYL as treatment but it didn't help. She is using an antibiotic. She stated it feel like nerve pain. Consumer has had shingles in past and states it feels like shingles. She described her arms as red and hot which is unresolved. She also has had a headache that is improving. Consumer went to urgent care to be seen. She stated the pharmacist used a sterile needle, alcohol, and gloves when giving injection.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Neuralgia, Skin warm
Clinical narrative: This case was reported by a consumer and described the occurrence of bacterial infection in a 29-year-old female patient who received BOOSTRIX (batch number 34EB5, expiry date unknown). The patient's past medical history included shingles. On 20th November 2014, the patient received BOOSTRIX. In November 2014, an unknown time after receiving BOOSTRIX, the patient experienced headache. On 21st November 2014, the patient experienced injection site pain, injection site induration, tiredness and injection site swelling. On 22 November 2014, the patient experienced injection site burning and injection site erythema. On 26th November 2014, the patient experienced bacterial infection and skin warm. The patient was treated with BENADRYL (nos) and antibiotics nos, (Drug name unknown). On an unknown date, the outcome of the bacterial infection, injection site pain, injection site burning, injection site induration, tiredness, injection site swelling, injection site erythema, skin warm and headache were not recovered/not resolved. It was unknown if the reporter considered the bacterial infection, injection site pain, injection site burning, injection site induration, tiredness, injection site swelling, injection site erythema, skin warm and headache to be related to BOOSTRIX. Additional information: The consumer reported she really wasn't feeling well after the injection. She is still tired. She stated the infection has spread from injection site to under arm pits, also to lymph nodes. The injection site swollen. there is a red ring around the injection site that has started to spread and become bigger. The lump under arm is about the size of half a dollar under her skin. The pain, swelling, and redness started getting worse on 22 November 2014. By 23 November 2014, these things were unbearable. It was diagnosed as bacterial infection on 26 November 2014. Consumer tried BENADRYL as treatment but it didn't help. She is using an antibiotic. She stated it feel like nerve pain. Consumer has had shingles in past and states it feels like shingles. She described her arms as red and hot which is unresolved. She also has had a headache that is improving. Consumer went to urgent care to be seen. She stated the pharmacist used a sterile needle, alcohol, and gloves when giving injection.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abasia, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Feeling hot, Headache, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Musculoskeletal stiffness, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 50.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Pyrexia, Somnolence, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer. A 50 years old female patient received PREVNAR 13, 0.5ml single dose, in her physician's office on 13Jan2015 intramuscular in left arm. After 24 hours of receiving the vaccine on 14Jan2015 the patient experienced woke up with left arm being sore and stiff, lethargic, whole body hurts so much for every movement, joints were hurting, headache, chills, dizziness, fever on and off, so sleepy, feeling very, very hot, injection site to left arm is hot, swollen, red, and throbbing, no energy, lower back pain, the patient can't focus her eyes and she could not walk. No other vaccine was given on 13Jan2-15. The patient previously had received influenza vaccine in Aug or Sep of 2014. Relevant medical history included diabetes diagnosed in July of 2014 and ongoing, high blood pressure in 2012, cholesterol in Mar2014, hiatal hernia diagnosed 20 years ago, anxiety in 2010. The patient experienced an allergic reaction to DIOVAN described as swollen tongue, hoarseness and lost of her voice, and then experienced hives and rash to DONNATAL, cephalexin and CLARITIN all taken in the past on unknown date. Concomitant medications included NESINA 25mg tablets by mouth once a day for diabetes; INVOKANA 300mg tablets by mouth once a day for diabetes; Metformin 500mg tablets by mouth twice a day for diabetes; Spironolactone 25mg tablets by mouth once a day for high blood pressure; Atorvastatin 20mg tablets by mouth once a day cholesterol; BYSTOLIC 2.5mg tablets by mouth once a day for blood pressure; Lansoprazole 30mg capsules by mouth twice a day for hiatal hernia; CYMBALTA 60mg capsules by mouth in the morning and 30mg capsule by mouth in the evening for anxiety. On 10Jan2015 the consumer had blood work done. She stated her CBC, A1C, thyroid panel, vitamin D, kidney function and iron tests all came back normal. All events reported were ongoing.
Age: 36.0
Sex: F
Vaccine: JEV1
Symptoms: Migraine
Clinical narrative: PT c/o Migraine HA started approx, 4 hrs post vaccination.
Age: 5.0
Sex: F
Vaccine: HEP, IPV, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Chills, Condition aggravated, Crying
Clinical narrative: Low energy, muscle weakness, pain, increased stomach pain, high fever 102, no appetite, chills, sleeping all day, glazed eyes, body pain all over, excessive crying. Two days later continuing for a week-Sore throat and runny nose over all feeling sick.
Age: 5.0
Sex: F
Vaccine: HEP, IPV, VARCEL
Symptoms: Decreased appetite, Ear infection, Glassy eyes, Hypersomnia, Malaise
Clinical narrative: Low energy, muscle weakness, pain, increased stomach pain, high fever 102, no appetite, chills, sleeping all day, glazed eyes, body pain all over, excessive crying. Two days later continuing for a week-Sore throat and runny nose over all feeling sick.
Age: 5.0
Sex: F
Vaccine: HEP, IPV, VARCEL
Symptoms: Muscular weakness, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Low energy, muscle weakness, pain, increased stomach pain, high fever 102, no appetite, chills, sleeping all day, glazed eyes, body pain all over, excessive crying. Two days later continuing for a week-Sore throat and runny nose over all feeling sick.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Induration, pain, warmth at site of injection x3 days.  Followed by 3 weeks of tenderness/soreness at the site.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Asthenia, Back pain, Body temperature increased, Decreased appetite
Clinical narrative: Temperature of 104.5 / Severe pain in lower back. Severe sweating.  Swelling of joints. Loss of appetite. No energy. Lower coccyx pain and in hip joints, ear canals and diaphram.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Diaphragmalgia, Ear pain, Hyperhidrosis, Joint swelling
Clinical narrative: Temperature of 104.5 / Severe pain in lower back. Severe sweating.  Swelling of joints. Loss of appetite. No energy. Lower coccyx pain and in hip joints, ear canals and diaphram.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Bursitis, Injection site pain
Clinical narrative: Arm where injection was administered was very painful for about a full week from the time of the injection, but excruciating shoulder pain followed at that same time. Doctor that I saw for the pain in early January says it is probably bursitis.  I have used ice as well as heat. Doctor recommended 600 to 800 mg of Ibuprofen three times daily, but these don't seem to help. I still have agonizing pain daily.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Exaggerated startle response
Clinical narrative: MOTHER DESCRIBES "WEIRD EPISODES" WHERE HE APPEARS SHOCKED OR STARTLED WITH NO APPARENT TRIGGERS. HAD SEVERAL BRIEF EPISODES THOUGHOUT THE DAY LASTING 2-3 SECONDS. PARENTS REPORT THESE EPISODES BEGAN 5 HOURS AFTER IMMUNIZATIONS WERE GIVEN 01/26/2015.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Dizziness, then redness and pain at injecion site, later in the day progressed to severe headache and neck and back pain, spreading to ribs and it hurts to breathe.  I am still having a lot of pain and headache. They gave me the Flu vaccine for age 65 and older.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Neck pain, Pain, Painful respiration
Clinical narrative: Dizziness, then redness and pain at injecion site, later in the day progressed to severe headache and neck and back pain, spreading to ribs and it hurts to breathe.  I am still having a lot of pain and headache. They gave me the Flu vaccine for age 65 and older.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Joint range of motion decreased, Musculoskeletal chest pain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Radiculitis brachial
Clinical narrative: Severe pain left arm which affected ROM for at least 3 months. Pain continued and progressed to include left side rib pain which continues despite left arm pain resolving after approximately 6 months. Dx: Brachial Neuritis with systemic involvement.
Age: 1.56
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Irritability, Rash generalised
Clinical narrative: Rash starting on anterior trunk in chest region and spreading rapidly to entire trunk, anterior and posterior, then neck, then face and proximal arms and legs.  Nonpruritic.  No URI symptoms.  No fever.  Just a little irritable.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Stinging and burning at time of injection.  Red raised large bump around injection site within two hours.  Began to spread to size of my hand, causing pain and itching, with pain from shoulder to wrist causing numbness in fingers within 24 hours.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Stinging and burning at time of injection.  Red raised large bump around injection site within two hours.  Began to spread to size of my hand, causing pain and itching, with pain from shoulder to wrist causing numbness in fingers within 24 hours.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Intussusception 1/21/2015 w/ blood in stool, emesis. (S/P attempted air enema reduction x 6 that was finally reduced on the last attempt). (Done at medical center).
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Epistaxis, Menorrhagia, Pain in extremity
Clinical narrative: Two days after receiving GARDASIL, 8/7/14, shot experienced bilateral thigh pain. Around 2 weeks after shot, experienced nosebleeds at random times. Most recent nosebleed last week. Also have had increased pain and bleeding with menstrual cycles x2. ADVIL for cramps. Used to only get nosebleeds in winter. Has not had them for a long time. Increased pain and bleeding in Sept and October. ADVIL 400 mg did not help. Thigh pain last a few weeks. Not doing any activity this summer. Was not working, no sports. Never both legs at the same time. When it did hurt, would last an hour. Was not limping. Pain usually started when laying down. Could get up and move around when had the pain. Did not wake from sleep. Increased bleeding: Uses pads (regular flow, thins). Usually has to change once a day. Usually only has 2 inch circle of blood. Increased to almost the whole pad and needed to change 2-3 times a day. That same flow lasted for 7 days. August period - had it when had shot. Early Sept and early Oct had cycle. This month was normal cycle. Nosebleeds since shot: Had one last week. At least 3-4 per month since vaccine, until last week.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Was vaccinated for 4 strains of HPV 7 years ago. Was negative for HPV at the time. I am positive for HPV now.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial misuse report received from medical assistant on 13 December 2013. An unknown age and gender had received ACTHIB. (No information was provided regarding the patient). Patient stated that yesterday (12 December 2013) and also in October 2013 took the dose of FLUZONE. She also asked if she could take anything to counteract the over dosage. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102.0 (reported via patient). Left arm pain/shoulder pain. Mild nausea (intermittent).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm sore at injection site, increasing in pain progressively since early November. Has seen MD. No infection. Placed on NSAIDS x 1 week. Physical therapy recommended by MD.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Exposed to herpes labialis 37 years ago. Never had an outbreak. One lesion diagnosed at physical one week prior to injection. Had outbreak of shingles within a few days of vaccine. On antivirals and pain patch. Lesion and shingles on back.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pt felt shot given very high on arm - felt joint shoulder pain for 45 min after injection. Numb and weak by end of day in arm and fingers. Has pain and limited ROM. Ortho MD felt shot may have been given in AC joint. Referred for physical tx.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 days after vaccination, a 3x5 area at site was hot, red and hard. Saw PCP who prescribed prednisone po x 5 days. Antibiotics not required - full recovery.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Within 15-20 minutes after vaccination, tongue and throat felt swollen. No other symptoms. BENADRYL 50 mg IM given and 911 called. Pt. transported to hosp.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Gout, Influenza, Joint swelling, Peripheral swelling, Staphylococcal infection
Clinical narrative: Pt. received 0.5 mL of FLUARIX QUADRIVALENT IM (in right deltoid) on Friday, 12/12/14. He started noticing swelling in his elbow over the weekend. On Monday the 15th, he saw his Dr, who told him he had influenza A. His arm kept swelling steadily, and on 12/25, he went to hospital. From there he was referred to another Medical Center where he was treated for gout (unsuccessfully) and later for a staph infection (successfully).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid became swollen, red and warm in a 2" x 3" area at injection site. Saw her MD and was prescribed a 10 day course of AUGMENTIN. She fully recovered.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Amnesia, Chills, Computerised tomogram, Convulsion, Electroencephalogram
Clinical narrative: I had a headache, aching neck and shoulders, fever and chills for about a month. Then I had a seizure on 06/23/2014 and that resulted in a 5 day hospital stay. I was diagnosed aseptic meningitis. I had several other seizures while in the hospital and then seizures on 7/5/2014, 7/9/2014 and 1/14/2015. I have to take Keppra 1000 mg per say to control the seizures. I have memory loss during the hospital stay and troubles with memory in general now.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lumbar puncture abnormal, Memory impairment, Meningitis aseptic, Musculoskeletal pain
Clinical narrative: I had a headache, aching neck and shoulders, fever and chills for about a month. Then I had a seizure on 06/23/2014 and that resulted in a 5 day hospital stay. I was diagnosed aseptic meningitis. I had several other seizures while in the hospital and then seizures on 7/5/2014, 7/9/2014 and 1/14/2015. I have to take Keppra 1000 mg per say to control the seizures. I have memory loss during the hospital stay and troubles with memory in general now.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: I had a headache, aching neck and shoulders, fever and chills for about a month. Then I had a seizure on 06/23/2014 and that resulted in a 5 day hospital stay. I was diagnosed aseptic meningitis. I had several other seizures while in the hospital and then seizures on 7/5/2014, 7/9/2014 and 1/14/2015. I have to take Keppra 1000 mg per say to control the seizures. I have memory loss during the hospital stay and troubles with memory in general now.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Hypopnoea, Pharyngeal oedema, Rhinorrhoea
Clinical narrative: 2 hours after vaccination, she experienced throat, face and tongue swelling, shallow breathing and discharge from eyes and nose. Also a cough saw PCP next day. Symptoms had ceased. She was prescribed OTC BENADRYL which she chose not to take.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Swollen tongue
Clinical narrative: 2 hours after vaccination, she experienced throat, face and tongue swelling, shallow breathing and discharge from eyes and nose. Also a cough saw PCP next day. Symptoms had ceased. She was prescribed OTC BENADRYL which she chose not to take.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Patient experienced numbness in 3 fingers in her left hand on 1/22/15. Numbness continued to her left hand and stopped at left elbow.  No Medical attention sought by patient. Patient stated today on 1/29/15 numbness is improving and is only located in left hand and finger tips. The numbness comes and goes. She stated work/activity at home may have been a contributing factor.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Cough, Dizziness
Clinical narrative: Shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough, low grade fever first day, high fever 102.7 second day. Went to hospital second day approx. 4:00 PM, had IV drip, medication for fever. Fever finally down at approx. 8:30 PM, then discharged.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Influenza virus test negative, Nausea, Pain, Pyrexia
Clinical narrative: Shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough, low grade fever first day, high fever 102.7 second day. Went to hospital second day approx. 4:00 PM, had IV drip, medication for fever. Fever finally down at approx. 8:30 PM, then discharged.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, Urine analysis normal, Vomiting
Clinical narrative: Shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough, low grade fever first day, high fever 102.7 second day. Went to hospital second day approx. 4:00 PM, had IV drip, medication for fever. Fever finally down at approx. 8:30 PM, then discharged.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Convulsion
Clinical narrative: Pt. had a seizure 30 minutes after receiving a flu vaccine.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Lip disorder, Pruritus generalised
Clinical narrative: Generalized itching, bumps on inside of lips occurred in less than 1 hour after vaccination. Given BENADRYL 50mg IM. EMS transported to hospital.
Age: 19.0
Sex: M
Vaccine: MEN
Symptoms: Rash generalised
Clinical narrative: Rash all over body that subsides with Benadryl.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Severe site reaction with pruritis and baseball-sized erythema.  Intermittent stabbing pain at site lasting over two months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Presented to pharmacy with red swollen arm that was warm to the touch.  Recommended Tylenol and cool compresses and to report back in one day.  01/28/2015 arm was much better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Localised infection
Clinical narrative: Pt. c/o redness and swelling in Right upper arm between injection sights and elbow.  Mom took pt. to Urgent Care on Sunday 01/25/2015. Pt. was seen there and placed on Cephalexin by Urgent Care Physician stating that arm was infected.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Localised infection
Clinical narrative: Pt. c/o redness and swelling in right upper arm between injection sights and elbow.  Mom took pt. to Urgent Care on Sunday 01/25/2015.  Pt. was seen there and placed in Cephalexin by Urgent Care Physician stating that arm was infected.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant male patient who received FLULAVAL (batch number 5ZP94, expiry date June 2015). On an unknown date, the patient received FLULAVAL .25 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: Nurse reports that she administered a FLULAVAL vaccine to a patient who is under the recommended age for FLULAVAL, no other AEs were reported.
Age: 0.9
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received FLUARIX (batch number X9HM3, expiry date 15th June 2015). On an unknown date, the patient received FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant male patient who received FLULAVAL (batch number 5ZP94, expiry date June 2015). On an unknown date, the patient received FLULAVAL .25 ml. On an unknown date, an unknown time after receiving FLULAVAL, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: Nurse reports that she administered a FLULAVAL vaccine to a patient who is under the recommended age for FLULAVAL, no other AEs were reported. This case is one of the 2 cases reported by the same reporter for the same vaccine.