chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 05-JAN-2015, the patient was vaccinated with an expired dose of M-M-R II subcutaneous, 0.5 ml, lot number H012142, expiry date 29-JUN-2014. No adverse effect reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Dyskinesia, Screaming, Skin warm, Sleep terror, Tremor
Clinical narrative: Had vaccines during day on 1/8/15. Later that evening he felt warm and had episode of screaming, shaking arms over head and jerking. Did not respond to parents for 10 minutes. By time they were at ER was back to normal. Sounds like night terror, doubt febrile seizure, reported because of time relationship to immunization.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Had vaccines during day on 1/8/15. Later that evening he felt warm and had episode of screaming, shaking arms over head and jerking. Did not respond to parents for 10 minutes. By time they were at ER was back to normal. Sounds like night terror, doubt febrile seizure, reported because of time relationship to immunization.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Vomiting
Clinical narrative: Rash/vomiting
Age: 1.29
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Varicella post vaccine
Clinical narrative: Injection given on - 1-7-15. Chicken pox lesion with red line started 1/15/15.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Erythema, Skin discolouration, Skin warm
Clinical narrative: Pt was seen 8 days after receiving shot. Next day of receiving vaccine patient developed increase redness, chills and temp. Dark central purple area a little bigger but the enlarging redness has decreased in past 4 days. Felt a little damp to area (R arm). (R) arm with 3x2 cm oblong darkened, bruised patch with mild surrounding 3 cm of erythema, warm to touch. No fluctuance or discharge.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythematous, confluent, swelling around and adjacent to injection site.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Mass, Pain, Skin warm
Clinical narrative: 1-day post vaccine pt. presented w/ 2.5" large, red, swollen mass that was warm to the touch and painful. Sent pt to MD for f/u.
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 16 September 2013. A patient (demographical details was not reported) had received a dose of FLUZONE HD (lot number: U4715AA, dose number, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an adverse reaction (details were not specified). Laboratory details and corrective medications were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Middle insomnia, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 16 September 2013. A patient (demographical details was not reported) had received a dose of FLUZONE HD (lot number: U4715AA, dose number, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an adverse reaction (details were not specified). Laboratory details and corrective medications were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Flatulence, Haematochezia
Clinical narrative: Initial report received from a consumer on 21 September 2013. A 70-year-old female patient, who had no medical history and concomitant medications, had received a dose of FLUZONE HD (Batch number was not reported) intramuscularly in left deltoid on 17 September 2013. The patient also received an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, Batch number, anatomical site of vaccination was not reported) on 08 September 2013. On 17 September 2013, the patient felt feverish, had itching on face, felt tired and weak, had chills and was shaking, small amount of redness on the left deltoid and was sore. On an unspecified date 2 days after vaccination, patient had gas, passed two BM's (Bowel movements) which were normal, but when she cleaned herself there was light pink to red coloring on the tissue. Patient had no constipation. This symptom continued for two days. By 21 September 2013, the patient had normal BM. The patient was advised to undergo colonoscopy by physician. Laboratory investigations were unknown. Corrective treatments were not provided. At the time of this report, the patient had not recovered from the events. Documents held by sender were none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Pruritus, Pyrexia, Tremor
Clinical narrative: Initial report received from a consumer on 21 September 2013. A 70-year-old female patient, who had no medical history and concomitant medications, had received a dose of FLUZONE HD (Batch number was not reported) intramuscularly in left deltoid on 17 September 2013. The patient also received an intramuscular dose of PNEUMOVAX (Manufacturer: Merck, Batch number, anatomical site of vaccination was not reported) on 08 September 2013. On 17 September 2013, the patient felt feverish, had itching on face, felt tired and weak, had chills and was shaking, small amount of redness on the left deltoid and was sore. On an unspecified date 2 days after vaccination, patient had gas, passed two BM's (Bowel movements) which were normal, but when she cleaned herself there was light pink to red coloring on the tissue. Patient had no constipation. This symptom continued for two days. By 21 September 2013, the patient had normal BM. The patient was advised to undergo colonoscopy by physician. Laboratory investigations were unknown. Corrective treatments were not provided. At the time of this report, the patient had not recovered from the events. Documents held by sender were none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Fatigue, Pain of skin
Clinical narrative: The below narrative includes initial report received from a healthcare professional on 23 September 2013 plus subsequent follow up: A 72-year-old female patient had received an intramuscular dose of FLUZONE HD (lot number: U4761AA, dose number was not reported) in the left deltoid on 20 September 2013. The patient had allergy to amoxicillin and patient had no illness at the time of vaccination. On 21 September 2013, the patient experienced chills, fatigue and claimed skin hurt all over. On 22 September 2013, symptoms were resolving but still felt fatigue with activities of daily living. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. Additional information received on 22-Nov-2013: Case updated with events outcome.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling, Vasodilatation
Clinical narrative: Initial report received fro a healthcare professional on 20 September 2013. A 74-year-old female patient had received a dose of FLUZONE HD (batch number: U4713AA) intramuscularly in the right deltoid on 20 September 2013. The subject had a history of cancer and had no illness at the time of vaccination. On 20 September 2013, immediately after vaccination the patient's right deltoid injection site area began to swell to the size of a golf ball, maybe a little smaller. The patient's veins in the right hand became pronounced and swollen. No other symptoms occurred. No laboratory investigations were performed. Treatment medications were not reported. At the time of this report, the patient was not recovered. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Initial report received from a pharmacist on 07-Oct-2013: The patient had received FLUZONE HD vaccine (lot number U4764AA and expiration date unknown) IM on left deltoid on 04-Oct-2013. On 04-Oct-2013, the patient reported redness, soreness and itching at the injection site. Patient's medical history includes allergies to sulfa drugs. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 26 September 2013. A 71-year-old female patient whose illness at the time of vaccination,medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD vaccine (lot number: U4717AA, dose number was not reported) in the left deltoid on 24 September 2013. On 24 September 2013 soon after vaccination, the patient had sore arm, 10 hours after vaccination, the patient had fever of 102 (unit not provided) and cramps in thigh. It was reported that the cramps were not minor and not located in her arm but they occurred in the anterior portion of her thigh (quadriceps). Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: Initial report received from a healthcare professional on 11 November 2013. A 52-year-old female patient, whose medical history and concomitant medication were not reported, had received 3 dose of FLUZONE vaccine (batch number- H888AB) in left upper arm route of administration and dose was not reported on 21 August 2013. On 02 November 2013, 10 weeks after vaccination the patient developed bump, and which become hot. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient was not recovered, Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Muscle atrophy, Muscle fatigue, Muscle spasms, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal discomfort, Actinic keratosis, Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Albumin globulin ratio
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Albumin urine present, Alpha 1 globulin normal, Alpha 1 microglobulin decreased, Alpha 2 globulin normal, Amyotrophic lateral sclerosis
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Angiotensin converting enzyme, Anti-neuronal antibody negative, Anti-thyroid antibody negative, Anti-thyroid antibody positive, Antineutrophil cytoplasmic antibody negative
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Antinuclear antibody, Antinuclear antibody negative, Antiphospholipid antibodies negative, Anxiety, Arthralgia
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthropathy, Aspartate aminotransferase increased, Aspartate aminotransferase normal, Asthma, Autoimmune neuropathy
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Babesiosis, Basophil count decreased, Basophil percentage, Beta 2 microglobulin urine decreased, Beta globulin normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Beta-2 glycoprotein antibody, Biopsy muscle abnormal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatine phosphokinase increased, Blood creatinine normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood folate normal, Blood glucose decreased, Blood glucose normal, Blood lactic acid increased, Blood potassium normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood pyruvic acid normal, Blood sodium normal, Blood test abnormal, Blood thyroid stimulating hormone normal, Blood triglycerides increased
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood urea nitrogen/creatinine ratio, Blood urea normal, Blood urine absent, Borrelia test negative, C-reactive protein normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Carbon dioxide normal, Cardiac stress test, Cardiolipin antibody negative, Carnitine palmitoyltransferase deficiency, Chromaturia
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chronic fatigue syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Coagulation factor VIII level increased, Condition aggravated, Congenital cerebrovascular anomaly
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Constipation, Dysgraphia, Dyskinesia, Dyspnoea, Electromyogram abnormal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eosinophil count decreased, Eosinophil count normal, Eosinophil percentage, Erectile dysfunction, Exercise tolerance decreased
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Factor XI deficiency, Fatigue, Full blood count normal, Gait disturbance, Gastric disorder
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gastrooesophageal reflux disease, Globulin urine present, Globulins increased, Glomerular filtration rate, Glucose urine absent
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin normal, Granulocyte percentage, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Haematocrit normal, Haemoglobin normal, High density lipoprotein normal, Hypoaesthesia, Hyporeflexia
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Immunology test, Immunology test abnormal, Insomnia, International normalised ratio normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Intervertebral disc disorder, Joint stiffness, Laboratory test normal, Liver function test abnormal, Low density lipoprotein normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lyme disease, Lymphocyte count normal, Lymphocyte percentage, Malignant melanoma in situ, Mean cell haemoglobin concentration normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Metabolic function test normal, Micturition urgency, Monocyte count normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Monocyte percentage, Motor neurone disease, Muscle atrophy, Muscle contractions involuntary, Muscle fatigue
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Muscle twitching, Muscular weakness, Musculoskeletal chest pain, Musculoskeletal discomfort
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Myoglobinuria, Myositis, Neck pain, Neuropathy peripheral
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Neutrophil count normal, Neutrophil percentage, Nitrite urine absent, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Obesity, Oesophagogastroduodenoscopy, Pain in extremity, Pharyngeal disorder, Platelet count normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pollakiuria, Polyneuropathy, Progressive muscular atrophy, Protein total normal, Protein urine absent
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Prothrombin time prolonged, Pulmonary function test normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Red cell distribution width normal, Rheumatoid factor negative, Rhinitis, Rhinitis allergic, Sensory loss
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sigmoidoscopy, Sleep apnoea syndrome, Specific gravity urine normal, Spinal muscular atrophy, Spirometry normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Thrombin time normal, Thyroid neoplasm, Tinnitus, Tyrosine kinase mutation assay, Urine bilirubin decreased
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine electrophoresis normal, Urine ketone body absent, Urobilinogen urine increased, Very low density lipoprotein increased, Vitamin B12 normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Vitamin K increased, Von Willebrand's factor activity increased, White blood cell count decreased, White blood cells urine negative, pH urine normal
Clinical narrative: Initial report received from a healthcare professional on 14 May 2014. A 57-year-old male patient had received a dose of FLUZONE (batch number UH486AA, dose number and route of vaccination not reported) in left deltoid on 18 November 2011. The patient's illness at the time of vaccination was not reported and had no known allergies. On 18 November 2011, same day after vaccination, the patient presented fever, joint pain, muscle fatigue, muscle spasms and muscle atrophy. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Case number PHHY2014US015149, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515673) website on 03 Feb 2014. This report refers to a 66-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly in the left arm on 24 Nov 2013. On 26 Nov 2013, sh experienced muscle pain throughout the arm, which lasted for 3 days. She was treated with ALEVE and naproxen. The final outcome of the event was reported as complete recovery. The seriousness and causality of the event were not reported. No additional information was available.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Crying, Injection site erythema, Irritability
Clinical narrative: About an hour after my daughter received her hepatitis A vaccine, she's been very fussy and crying off and on and now it's been 14 hours of the off and on fussiness/crying. Injection site was red for a few hours and now at 14 hours after the shot the site is no longer red. I may be taking her back to her pediatricians office in the morning for a check.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This spontaneous medically confirmed report (initial receipt 16-Jan-2015) concerns a 57-year-old female patient. On an unspecified date, the patient received an influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced 'a life threatening reaction' possibly within the last one or two years. The outcome was unknown. Reporter's comments: It was not known if the influenza vaccine was AFLURIA.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This medically confirmed report (initial receipt 16-Jan-2015) concerns a patient. On an unspecified date, years ago, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not specified). On an unspecified date, the patient developed a Guillain-barre-like reaction. Outcome was not reported.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Nasal congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: 1) Low-grade fever (101 deg F) for a few hours - Treated with Tylenol 2) Sudden onset of thick, yellow/green nasal and chest congestion starting at 8PM 8/29/14 and lasted for 3-4 days - Treated with Amoxicillin. 3) Excessive fussiness from around 8PM 8/29/14 to 10AM 8/30/14. 4) Excessive sleepiness from 8/30/14 to 9/1/14. 5) Weak Appetite from 8/29/14 to 8/31/14.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: 1) Low-grade fever (101 deg F) for a few hours - Treated with Tylenol 2) Sudden onset of thick, yellow/green nasal and chest congestion starting at 8PM 8/29/14 and lasted for 3-4 days - Treated with Amoxicillin. 3) Excessive fussiness from around 8PM 8/29/14 to 10AM 8/30/14. 4) Excessive sleepiness from 8/30/14 to 9/1/14. 5) Weak Appetite from 8/29/14 to 8/31/14.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV, PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Right leg swelling, increased pain, welts.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Skin rash appearing on front of neck, no treatment; rash spread to face and back of neck during following week.  Completed course of oral vaccination on 1/10/2015.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom called and reported that around eight she noticed that areas was very red and swollen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Mom called the clinic on 1/13/2015 and reported that child developed redness, swelling and was hot to touch. Was told to give Benadryl and use ice pack we offerd an appt. She did not show to appt. I called mom and she repoted that everything resolved after giving Benadryl.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: Overall itching and slight Asthma for about an hour.  Followed shortly after by swelling and redness around injection point at the inside base of bicep.  As of this report redness and swelling continue to expand and very painful to touch.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling abnormal
Clinical narrative: Noticed red patch 3" x 2" on underarm during day, but had been feeling bad since early morning.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Erythema, Inflammation, Upper respiratory tract infection
Clinical narrative: MILD INFLAMMATION AND REDNESS IN SHOULDER AND ARM. SOME BRUISING REMAINS.  PATIENT CLAIMS SHE GOT AN UPPER RESPIRATORY INFECTION, ALTHOUGH RELATIONSHIP TO VACCINE IS UNLIKELY.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site nerve damage, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a non-clinical-study-program, from a contactable consumer who reported for herself. An 83-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single dose in the arm, in Nov2014. The patient medical history and concomitant medications were not reported. Clinical course was as follows: patient reported that in Nov2014 she had a shot of PREVNAR 13 vaccine in her arm and her arm hurt and it was sore in the muscle area from shoulder down to her elbow. She mentioned that especially when she wanted to lift it up it was very sore in the muscle area up to her shoulder. Patient reported that since the injection, it was very sore in the muscle and it was hard to lift her arm. She also mentioned that it was very painful during night in Nov2014. She did not have any rash or redness in the area. According to the patient, the injection apparently hit a nerve and caused the arm pain which lasted for a couple of days. She had gone to a doctor and that was what he thought that had happened. Outcome of events was recovered on unspecified date in Nov2014. Follow-up (01Dec2014): New information reported from the same contactable consumer includes: reaction details, recovery date and outcome. Follow-up (12Jan2015): New information reported from the same contactable consumer includes: reaction data (event injection hit a nerve was added), doctor opinion.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blood test normal, Confusional state, Decreased appetite, Electrocardiogram normal
Clinical narrative: This is a spontaneous report from a contactable consumer that reporter for his father and from the contactable wife's consumer. A 87 years old male patient received PREVNAR 13, intramuscular at 0.5ml single dose on 19Dec2014 around noon. The patient had history of pneumonia four times before and was being prepared for cataract surgery and had history of bypass 10-15 years ago and a surgery for skin cancer. At 7:00 that night, he said he was tired and didn't feel good so went to bed. At 10:00 PM, he got up to go to the bathroom and he stumbled to the door frame. He said he didn't have any power in his legs and he hard of hearing after the fall. At 3:00 AM on 20Dec2014 he had gotten up again and missed the bathroom door and fell down 3 steps to the landing. The wife noticed there was some confusion. At 7:30 AM the wife took him to the ER. He was there for 5-6 hours and they checked everything-blood tests, urine, EKGs and they also give him IV fluids. So then he went home as they couldn't find anything wrong. The rest of the day he pretty much slept away. Early on morning on 21Dec2014 he woke and got himself downstairs. Around 5:00 he just slumped to the floor. He did not have strength to help himself up and the wife couldn't get him up. The wife suggested he roll over to his stomach and maybe using arms and knees he could get up. He couldn't even roll over or didn't understand. About 6:30 an ambulance took him to the ER again. He again slept most of the day and didn't want to eat. The rest of the week, he napped a lot. Concomitant medications included COUMADIN, ZESTRIL, TOPROL, LIPITOR; CARDIZEM; Warfarin; aspirin 81 mg; multivitamin; Vitamin D and Fish Oil, all ongoing. The patient did not received any treatment for the events. Outcome for the events weakness, exhausted, hard of hearing and tired was reported as not recovered while the patient recovered from confusional state, fall, the outcome of the events somnolence, decreased appetite and feeling abnormal was unknown. Follow up (13Jan2015) Additional information reported from the contactable wife's consumer includes details on the clinical course of the patient. Lab data and events added.