chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients (demographics unknown). On unspecified dates since 29-JUN-2015, the patiens were vaccinated with doses of improperly stored PEDVAXHIB (dose, route and lot# not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 07-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On 14-JUL-2015, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB 0.5 ml once intramuscular (Lot # L002867 and expiry date 04-NOV-2017, lot # K025002 with expiry date of 20-JUL-2017, lot # L002866 with expiry date of 10-NOV-2017 and lot # K015464 with expiry date of 09-JUL-2017). Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were not reported. On 14-JUL-2015 and 15-JUL-2015, the patients were vaccinated with improperly stored GARDASIL 9 (unknown strength, dose and route) Lot # K026246, with expiry date of 28-JAN-2017 and lot # L006547 with expiry date of 04-MAR-2017. Concomitant medications were not reported. No adverse effects were reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Pruritus
Clinical narrative: This spontaneous report was received from a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 11-JUL-2015 (reported as 3 days ago), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported). There was no concomitant medication reported. On an unspecified date in July 2015, after the vaccination, the patient experienced fatigue, headache, pruritus, swelling, erythema and influenza like illness. At the reporting time, the outcome of erythema, headache, influenza like illness, fatigue, pruritus and swelling was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a patient of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 11-JUL-2015 (reported as 3 days ago), the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, strength and route of administration were not reported). There was no concomitant medication reported. On an unspecified date in July 2015, after the vaccination, the patient experienced fatigue, headache, pruritus, swelling, erythema and influenza like illness. At the reporting time, the outcome of erythema, headache, influenza like illness, fatigue, pruritus and swelling was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Erythema nodosum
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2015 the patient was vaccinated with GARDASIL 9 (unknown strength and dose) intramuscularly. Concomitant medications were not reported. On 27-JUN-2015, the patient had an adverse event after receiving the GARDASIL 9 and was diagnosed with erythema nodosum 11 days after receiving the initial GARDASIL 9 injection. The patient sought medical attention and visited physician's office and received MOTRIN as treatment in response to the event. The outcome of erythema nodosum was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with GARDASIL lot # K006960 (expiration date, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range for 12 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all follow ups requested to complete the case were received.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Somnolence
Clinical narrative: This initial spontaneous report was received from a medical assistant who called on behalf of the patient's mother, referring to a 12 year old male patient. There was no pertinent medical history or drug allergies/drug reactions. On 08-JUL-2015 the patient was vaccinated with the first dose of GARDASIL intramuscular (0.5ml, once, lot # K007828, expiration date 03/02/2017). There was no concomitant medication. Immediately after received GARDASIL, the patient experienced severe headache, dizziness and sleepiness. The patient sought medical attention by calling the physician, and for the headache, treatment was given with ADVIL. There were no laboratory diagnostic tests performed. At the time of the report, the outcome of severe headache, dizziness and sleepiness was reported as not recovered. The causality for the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. In August 2014, the patient was vaccinated with a first dose of GARDASIL (dose, route, lot# and expiration date were not provided. Then on 21-JUL-2015, the patient received a dose of GARDASIL 9, which was considered to be an inappropriate schedule of drug administration. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 year old male patient with asthma. On 07-JAN-2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. On 22-SEP-2014, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscular. On 14-JUL-2014, the patient was vaccinated with the third dose of GARDASIL (lot number K010574, expiration date 05-APR-2017), 0.5 ml, intramuscular in the arm. Concomitant therapies included SINGULAIR and albuterol sulfate (manufacturer unknown). On an unspecified date in July 2015 the patient experienced redness and injection site swelling. On 16-JUL-2015, the patient sought medical attention (not specified). The reporter stated that the patient had full range of motion in the affected arm and that he was not experiencing any pain. At the reporting time, the outcome of erythema, injection site swelling and injection site reaction was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 27-MAR-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of age and gender unknown. No concurrent or historical condition was reported. On 07-JUL-2015 the patient was vaccinated with improperly stored dose of RECOMBIVAX HB dose, route, frequency, Lot number and anatomical location were unknown and on the same date the patient also was vaccinated with an improperly stored dose of ROTATEQ; unknown route, frequency, lot number and anatomical location. No adverse event was reported. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 07-JUL-2015 the patient was vaccinated with an improperly stored dose of VAQTA, dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 01-JUL-2015 the patient was vaccinated with improperly stored dose of VAQTA, dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 01-JUL-2015 the patient was vaccinated with an improperly stored GARDASIL dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site pain, Middle insomnia, Mobility decreased, Muscular weakness
Clinical narrative: I could not lift my arm the following day. Severe deep burning pain around armpit accompanied by some tingling in my hand as well as moderate to severe weakness of my arm (Left). Also pain at upper shoulder site where injection was given. Pain has subsided some but continues. I most ROM back but not all. Starting PT on August 3, 2015. Pain sometimes unbearable at night. and wakes me out of my sleep. Requires narcotic pain meds as OTC were not effective.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paraesthesia
Clinical narrative: I could not lift my arm the following day. Severe deep burning pain around armpit accompanied by some tingling in my hand as well as moderate to severe weakness of my arm (Left). Also pain at upper shoulder site where injection was given. Pain has subsided some but continues. I most ROM back but not all. Starting PT on August 3, 2015. Pain sometimes unbearable at night. and wakes me out of my sleep. Requires narcotic pain meds as OTC were not effective.
Age: 44.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient with fever, pain in arm where pneumococcal vaccine injection was administered subcutaneously.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Heart rate increased, Peripheral swelling, Rash, Swelling face
Clinical narrative: Patient had a rash the following day but more severe symptoms started 48 hours later. Her face, arms, and feet started to swell, she had a rapid heartbeat, and trouble breathing. Took some Benadryl with no relief. Went to the ER. Was prescribed prednisone. Patient has had a similar reaction with her progesterone injection (same symptoms and required an ER visit).
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Swelling, redness and warm to touch on vaccinated arm. Low grade fever.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypoacusis, Loss of consciousness
Clinical narrative: LIGHTHEADENESS, DIZZINESS, DECREASE IN HEARING, LOC ABOUT 2-5 MINUTES, UNSURE EXACT AMOUNT OF TIME. STATED SHE ATE, DRANK FLUIDS, WENT TO SLEEP A COUPLE HOURS AND WOKE UP WITHOUT SYMPTOMS.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever to 103, headache, myalgias, local redness and pain at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Angioedema, Dyspnoea, Rash pruritic
Clinical narrative: Angioedema with SOB and pruritic rash.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Exposure during pregnancy, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Arm soreness same day. Next day, had no range of motion without having excruciating pain- unable to hold child, do my hair, put on a bra, shake hands, etc. I had two children WITHOUT pain medication and this was the worse!
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood test, Catheterisation cardiac, Insomnia, Joint range of motion decreased
Clinical narrative: Pain in shoulder, weakness in arms and legs, unable to sleep, loss of mobility in arm and shoulder (cannot put on coat or brush hair without help).
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal pain, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Pain in shoulder, weakness in arms and legs, unable to sleep, loss of mobility in arm and shoulder (cannot put on coat or brush hair without help).
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Pain in shoulder, weakness in arms and legs, unable to sleep, loss of mobility in arm and shoulder (cannot put on coat or brush hair without help).
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Burning sensation, Headache, Nausea, Pain, Paraesthesia
Clinical narrative: Skin eruptions, pain body and headaches, burning, itching, tingling, nausea.
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Skin eruptions, pain body and headaches, burning, itching, tingling, nausea.
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Headache, Herpes zoster, Neuralgia, Pain, Paraesthesia
Clinical narrative: Skin eruptions, pain body and headaches, burning, itching, tingling, nausea.
Age: 64.0
Sex: F
Vaccine: TTOX, TTOX, VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Skin eruptions, pain body and headaches, burning, itching, tingling, nausea.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 08-JUL-2015, the patient was vaccinated with an expired dose of GARDASIL (lot # H020901, expiry date 05-JUL-2015) 0.5 ml, intramuscularly. No adverse effects were reported. The outcome of expired product administered was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 60 year old female patient. The patient's concurrent conditions included high cholesterol, high blood pressure and hypothyroidism. On 29-JUN-2015, the patient was vaccinated with ZOSTAVAX (lot # L000450, expiration date: 09-MAR-2016) subcutaneously (dose and strength not reported). Concomitant therapies included atenolol, losartan potassium (+) hydrochlorothiazide and SYNTHROID. On an unspecified date after vaccination, the patient developed a small, red, warm, itchy area at the site of ZOSTAVAX injection. The patient also developed mild muscle pain around the site of injection. The patient sought medical attention - visited pharmacist. Lab tests were reported as none. The patient was recovering. There were no product quality complaints (PQC) involved. The reporter's causality for the events was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report refers to a patient  of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL 9 (lot # L001312, expiry date: 24-FEB-2017) (dosing details unknown). On an unknown date the patient experienced unspecified adverse event. The outcome of the event was unknown . Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored GARDASIL (dose, route and dose number were unspecified), lot# was reported as K002432/exp 08-JUN-2016, K010574/exp 08-APR-2017, K011562/exp 08-APR-2017, K009482 exp/ 06-MAR-2017. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Electrocardiogram normal, Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an 18 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, route of administration, anatomical location and lot# was not reported). Concomitant medications were unspecified by reporter. On an unknown date, after receiving vaccination, the patient collapsed. The physician's office called ambulance and the patient was taken to the hospital. Although, at the time the patient boarded from the ambulance, the doctor said the patient seemed to be fine, the patient was taken to the hospital to check his electrocardiogram (EKG), and blood tests. All tests turned out fine. The next day patient had follow up check up visit with the physician and the patient seems fine. The causal relationship between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored PEDVAXHIB (dose, route and dose number were unspecified), lot# was reported as J001082/exp 08-MAY-2016, lot# was reported as J006415/exp 24-FEB-2016, lot# K026533/exp 07-AUG-2017, lot# K025002/exp 20-JUL-2017, lot# K011078/exp 31-MAR-2017. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose, route and dose number were unspecified), lot# was reported as K001986/exp 09-JUN-2016, lot#K004483/exp 16-AUG-2016, lot# was reported as L007720/exp 08-JUN-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored VAQTA (dose, route and dose number were unspecified), lot# was reported as L017757/exp 08-APR-2018, lot#J010653/exp 02-AUG-2015, lot#J012963/exp 21-SEP-2015, lot#K009506/exp 22-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date the patients were vaccinated with doses of improperly stored ROTATEQ (oral, dose and dose number were unspecified, lot# K011947/exp 07-JUN-2016, lot# L002048/exp 09-JUL-2016, lot# was reported as K023527/exp 22-JUN-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous consumer report (initial receipt- 29-Sep-2014) concerns 65-year-old female patient. The patient had a medical history of seasonal allergies. Her concomitant condition included sensitivity to LEVAQUIN. On 31-Oct-2007, the patient received unspecified flu vaccine (manufacturer and batch number not reported), subcutaneous ZOSTAVAX at 0.65 ml dose once and unspecified "pneumonia" vaccine. On 02-Nov-2007, the patient developed hives "the width of human hand" all over the body. The patient stated that this was recurrence since 2007. The patient would be seeing the dermatologist in a few days. The patient was treated with doxepin hydrochloride at 25 mg. Outcome was reported as not yet recovered.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHEH2013US024141 is an initial spontaneous report received from a pharmacist on 15 NOV 2013. This report refers to an adult female patient. She was vaccinated  with FLUCELVAX (batch number: 009021A) intramuscularly on 13 NOV 2013. Next morning she woke up with numbness in her arm down to  her fingers. Numbness was still ongoing at the time of reporting. No further information about seriousness and causality was provided.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Alopecia, Alopecia areata, Anti-thyroid antibody negative, Antinuclear antibody negative, Blood glucose normal
Clinical narrative: This medically confirmed health authority (initial receipt 537914) concerns 52 year-old male patient. The patient had medical history of mild reactive airway disease (RAD), intermittent asthma (x12 years), actinic keratosis, suspected glaucoma (in 2011, the patient was unclear with the exact nature of this ocular condition which was followed annually), herpes zoster ophthalmicus (17-OCT-2011) involving lesions on left side of his face, eyelid and left side of his scalp, chicken pox (when he was three months old), male pattern baldness (stated that his hair were thinning) and benign lipoma right shoulder (in SEP-2011). The patient's concomitant medication included salbutamol. On 24-MAY-2013, the patient received an influenza vaccination (TIV) (manufacturer or batch number not reported) as a condition of employment. On an unspecified date, about 10 days after vaccination, the patient developed fatigue which lasted for about 2 weeks refer to 2014045254). On 13-SEP-2013, the patient received intramuscular AFLURIA (batch number 08649211A) in the right arm. ON an unspecified date, about 10 days after vaccination, the patient experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The patient denied experiencing fever, chills, nausea, vomiting, headache or arthralgias. On 31-DEC-2013 (Dec/Jan time frame)the patient developed a "bald spot" at the back of his head. On 24-FEB-2014, th patient visited the dermatologist. The examination received 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with   alopecia areata. The patient declined treatment. As of 14-JUL-2014, the patient has not experienced any additional autoimmune illness. The area of the hair loss had expanded slightly. On 19-MAR-2014, the patient underwent laboratory tests for T4 free, thyroid stimulating hormone, thyroid AB, complete blood count and lipid panel, which were all within normal limit. The comprehensive metabolic panel (CMP) was also within normal limit except for glucose which was 100H and antinuclear antibody (ANA) tat was negative. The outcome was reported as unknown.  Reporter's comments: The health authority assessed the case as non-serious. The authority reported symptoms were "anti-thyroid antibody negative", "blood thyroid stimulating hormone normal", "fatigue", "lipid normal", "metabolic function test normal" and "thyroxine free normal".
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Blood thyroid stimulating hormone normal, Fatigue, Full blood count normal, Lipids normal, Metabolic function test normal
Clinical narrative: This medically confirmed health authority (initial receipt 537914) concerns 52 year-old male patient. The patient had medical history of mild reactive airway disease (RAD), intermittent asthma (x12 years), actinic keratosis, suspected glaucoma (in 2011, the patient was unclear with the exact nature of this ocular condition which was followed annually), herpes zoster ophthalmicus (17-OCT-2011) involving lesions on left side of his face, eyelid and left side of his scalp, chicken pox (when he was three months old), male pattern baldness (stated that his hair were thinning) and benign lipoma right shoulder (in SEP-2011). The patient's concomitant medication included salbutamol. On 24-MAY-2013, the patient received an influenza vaccination (TIV) (manufacturer or batch number not reported) as a condition of employment. On an unspecified date, about 10 days after vaccination, the patient developed fatigue which lasted for about 2 weeks refer to 2014045254). On 13-SEP-2013, the patient received intramuscular AFLURIA (batch number 08649211A) in the right arm. ON an unspecified date, about 10 days after vaccination, the patient experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The patient denied experiencing fever, chills, nausea, vomiting, headache or arthralgias. On 31-DEC-2013 (Dec/Jan time frame)the patient developed a "bald spot" at the back of his head. On 24-FEB-2014, th patient visited the dermatologist. The examination received 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with   alopecia areata. The patient declined treatment. As of 14-JUL-2014, the patient has not experienced any additional autoimmune illness. The area of the hair loss had expanded slightly. On 19-MAR-2014, the patient underwent laboratory tests for T4 free, thyroid stimulating hormone, thyroid AB, complete blood count and lipid panel, which were all within normal limit. The comprehensive metabolic panel (CMP) was also within normal limit except for glucose which was 100H and antinuclear antibody (ANA) tat was negative. The outcome was reported as unknown.  Reporter's comments: The health authority assessed the case as non-serious. The authority reported symptoms were "anti-thyroid antibody negative", "blood thyroid stimulating hormone normal", "fatigue", "lipid normal", "metabolic function test normal" and "thyroxine free normal".
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Thyroxine free normal
Clinical narrative: This medically confirmed health authority (initial receipt 537914) concerns 52 year-old male patient. The patient had medical history of mild reactive airway disease (RAD), intermittent asthma (x12 years), actinic keratosis, suspected glaucoma (in 2011, the patient was unclear with the exact nature of this ocular condition which was followed annually), herpes zoster ophthalmicus (17-OCT-2011) involving lesions on left side of his face, eyelid and left side of his scalp, chicken pox (when he was three months old), male pattern baldness (stated that his hair were thinning) and benign lipoma right shoulder (in SEP-2011). The patient's concomitant medication included salbutamol. On 24-MAY-2013, the patient received an influenza vaccination (TIV) (manufacturer or batch number not reported) as a condition of employment. On an unspecified date, about 10 days after vaccination, the patient developed fatigue which lasted for about 2 weeks refer to 2014045254). On 13-SEP-2013, the patient received intramuscular AFLURIA (batch number 08649211A) in the right arm. ON an unspecified date, about 10 days after vaccination, the patient experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The patient denied experiencing fever, chills, nausea, vomiting, headache or arthralgias. On 31-DEC-2013 (Dec/Jan time frame)the patient developed a "bald spot" at the back of his head. On 24-FEB-2014, th patient visited the dermatologist. The examination received 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with   alopecia areata. The patient declined treatment. As of 14-JUL-2014, the patient has not experienced any additional autoimmune illness. The area of the hair loss had expanded slightly. On 19-MAR-2014, the patient underwent laboratory tests for T4 free, thyroid stimulating hormone, thyroid AB, complete blood count and lipid panel, which were all within normal limit. The comprehensive metabolic panel (CMP) was also within normal limit except for glucose which was 100H and antinuclear antibody (ANA) tat was negative. The outcome was reported as unknown.  Reporter's comments: The health authority assessed the case as non-serious. The authority reported symptoms were "anti-thyroid antibody negative", "blood thyroid stimulating hormone normal", "fatigue", "lipid normal", "metabolic function test normal" and "thyroxine free normal".
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 15-Sep-2014) concerns a 50-year-old male patient. The patient had no previous allergies and had medical history of hypertension, hyperlipidemia and chronic lower back pain. On 07-Oct-2013, the patient received AFLURIA (batch number R52607) via unknown route in the right arm. The same day, the patient also received PNEUMOVAX  (batch number J007060) via unknown route in the left arm. On 08-Oct-2013, the patient experienced nausea, vomiting, fever, chills and redness on the left arm (15 cm x 15 cm). The outcome was reported as recovered.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Sep-2014) concerns a 50-year-old female patient. On 02-Oct-2013, the patient received intramuscular AFLURIA (batch number: R54307) in the right arm. On 05-Oct-2013, the patient was sore for a couple of days. The same day, she woke up in the morning and could not move her arm. The area of flu shot on her shoulder was warm, swollen and red. The diagnosis was based on physical examination in the occupational health. The outcome was reported as recovered.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Tachycardia
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Sep-2014) concerns a 42-year-old female patient. On 06-Sep-2013, the patient received AFLURIA (batch number: R52607) via unknown route in the left arm. On 18-Sep-2013, the patient experienced dizziness and tachycardia. The outcome was reported as recovered.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 30 year-old female patient who had a current condition of viral illness with cough and wheeze. Her past medical history included exercise induced asthma and allergies to azithromycin. On 15-Sep-2014, the patient received intramuscular AFLURIA, (batch number "T597107") in the left arm and intramuscular PNEUMOVAX, (batch number H022280) in the right arm. On 17-Sep-2014, the patient experienced severe pain in the right arm, redness and tender to touch. She also had fever. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious and reported that the patient presented to the Emergency Room.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 47 year old female patient who had a medical history of a breast mass and DJD (Degenerative Joint Disease). The patient had no current illness at the time of vaccination. On the 12-SEP-2014, the subject received AFLURIA (batch number 09649221A) via an unknown route, site: "AR". The patient also received PNEUMOVAX (batch number K004487) via an unknown route, site: "AR". On the 13-SEP-2014, the patient developed a large, painful lump at the injection site the size of an orange, raised, warm, very painful. There was also a small red area also located above the large area. The patient went to the Emergency Room. Outcome was not recovered.  Reporter comments: The regulator reported the case as non-serious.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Induration, Peripheral swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 45 year old male patient. On an unspecified date, the patient received AFLURIA (batch number: T59907) via the intramuscular route in the left arm. The patient also received PNEUMOVAX (batch number K010016) via the intramuscular route in the left arm and ADACEL (batch number C4695AA) via the intramuscular route in the right arm. On an unspecified date, the arm was immediately hard, red and swollen. The patient had no other issues.  The patient went home. The patient took diphenhydramine. The arm swelled from shoulder to elbow. The patient went to the ER (Emergency Room) and was given steroid treatment. The patient was OK and the swelling was down. Outcome was recovered. Reporter's comments: The regulator reported the case as non-serious. The regulator reported the terms "immediate post-injection" and "local swelling".
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt- 19-Sep-2014) concerns a female patient. The patient had a medical history of suppressed immune system and colitis. She had drug reaction/allergies to amoxicillin, sulfa, metronidazole, infliximab and azathioprine. On an unspecified date in 2008, the patient received Flu shot, (manufacturer and batch number not provided) in the opposite arm. She concomitantly received PNEUMOVAX 23, (batch number: 1161X). On an unspecified date in 2008, on the second day after vaccination, the patient experienced body aches, 102 degree temperature, fatigue and general Flu like symptoms that lasted for about a day. Her arm was sore for two days. The outcome was recovered.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 30 year-old male patient who had no current illness and no medical history. On 19-SEP-2014, the patient received AFLURIA injection (batch number not reported). On 19-SEP-2014, the patient experienced a sudden onset of aches, fever and chills at indicated time which resulted in sleepiness. The patient also had a moderate to high amount of fatigue and some loss of appetite. Treatment included ibuprofen to control the fever and body aches. The symptoms subsided on Sunday (21-SEP-2014) evening. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 30 year-old male patient who had no current illness and no medical history. On 19-SEP-2014, the patient received AFLURIA injection (batch number not reported). On 19-SEP-2014, the patient experienced a sudden onset of aches, fever and chills at indicated time which resulted in sleepiness. The patient also had a moderate to high amount of fatigue and some loss of appetite. Treatment included ibuprofen to control the fever and body aches. The symptoms subsided on Sunday (21-SEP-2014) evening. The outcome was recovered. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 24 year old female patient with unknown current illness at the time of vaccination. On 28-SEP-2014, the patient received AFLURIA injection (batch number "TS1708") in the left arm. ON 28-SEP-2014, within two hours of vaccination, the patient experienced all over uneasy/unwell feeling. Her  temperature was 101.4 degrees and she had 1 and 1/2" red, warm spot at area of injection which was itchy really bad. She also had tingling and numbness down her arm of injection. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 24 year old female patient with unknown current illness at the time of vaccination. On 28-SEP-2014, the patient received AFLURIA injection (batch number "TS1708") in the left arm. ON 28-SEP-2014, within two hours of vaccination, the patient experienced all over uneasy/unwell feeling. Her  temperature was 101.4 degrees and she had 1 and 1/2" red, warm spot at area of injection which was itchy really bad. She also had tingling and numbness down her arm of injection. The outcome was reported as unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pain, Irritability
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 58 year-old female patient who had no current medical illness. She had a medical history of "penicillin" and serum sickness reaction. Concomitant medications included levothyroxine and imipramine. On 28-SEP-2014, the patient received intramuscular AFLURIA injection (batch number T50207) in the left arm. On 28-SEP-2014, the patient experienced irritability, large (golf ball) lump at injection site, red and painful. She also had slight nausea, aching all over and quite fatigued for 5 days. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 58 year-old female patient who had no current medical illness. She had a medical history of "penicillin" and serum sickness reaction. Concomitant medications included levothyroxine and imipramine. On 28-SEP-2014, the patient received intramuscular AFLURIA injection (batch number T50207) in the left arm. On 28-SEP-2014, the patient experienced irritability, large (golf ball) lump at injection site, red and painful. She also had slight nausea, aching all over and quite fatigued for 5 days. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgraphia, Hypoaesthesia, Injection site reaction, Muscle contractions involuntary, Paraesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 37 year-old male patient who had no known current illness at the time of vaccination and had dominant left arm. On 30-SEP-2014, the patient received intramuscular AFLURIA injection (batch number "TS1708") in the left arm (deltoid). On 06-OCT-2014, the patient started experiencing intermittent fasciculation of left deltoid muscle, numbness and tingling down his left arm and left hand, and noted that his hand writing worsened. The outcome was not reported. Reporter comments: The regulatory assessed the case as non-serious and reported the term of "injection site reaction".
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 63 year-old female patient who had a current illness of "pain", she had no known medical history. On 06-OCT-2014, the patient received AFLURIA injection (batch number not provided) in the left arm. On 06-OCT-2014, the patient experienced extreme deltoid muscle pain in front and rear deltoid muscle of injected left arm after painful injection. It was unknown if there was permanent injury at the time of reporting. The patient had limited arm mobility, pain in deltoid, no trapezium, front and back of neck, and tingling of arm to fingers identified to date. There was also constant pain and interrupted sleep. The outcome was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 33 year-old female patient who had no current illness. She had a medical history bipolar2, postpartum depression, asthma, gastroesophageal reflux disease (GERD), allergic rhinitis and insomnia. Concomitant medications included es omeprazole, fluoxetine, zolpidem, quetiapine, fluticasone propionate and lorazepam. On 03-SEP-2014, the patient received intramuscular AFLURIA injection (batch number 09649211A) in the left arm. On 03-SEP-2014, the patient experienced pain in the left arm shooting down arm, tingling, and shoulder pain which did not resolve as of 09-OCT-2014. Although the patient had no current acute illness, she requested thyroid workup for fatigue, hair loss and weight gain. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented to the Emergency Room, and reported the term of "pain".
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Alopecia, Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 33 year-old female patient who had no current illness. She had a medical history bipolar2, postpartum depression, asthma, gastroesophageal reflux disease (GERD), allergic rhinitis and insomnia. Concomitant medications included es omeprazole, fluoxetine, zolpidem, quetiapine, fluticasone propionate and lorazepam. On 03-SEP-2014, the patient received intramuscular AFLURIA injection (batch number 09649211A) in the left arm. On 03-SEP-2014, the patient experienced pain in the left arm shooting down arm, tingling, and shoulder pain which did not resolve as of 09-OCT-2014. Although the patient had no current acute illness, she requested thyroid workup for fatigue, hair loss and weight gain. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented to the Emergency Room, and reported the term of "pain".
Age: 33.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Paraesthesia, Weight increased
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-DEC-2014) concerns a 33 year-old female patient who had no current illness. She had a medical history bipolar2, postpartum depression, asthma, gastroesophageal reflux disease (GERD), allergic rhinitis and insomnia. Concomitant medications included es omeprazole, fluoxetine, zolpidem, quetiapine, fluticasone propionate and lorazepam. On 03-SEP-2014, the patient received intramuscular AFLURIA injection (batch number 09649211A) in the left arm. On 03-SEP-2014, the patient experienced pain in the left arm shooting down arm, tingling, and shoulder pain which did not resolve as of 09-OCT-2014. Although the patient had no current acute illness, she requested thyroid workup for fatigue, hair loss and weight gain. The outcome was not recovered. Reporter's comments: The regulatory authority assessed the case as non-serious, reported that the patient presented to the Emergency Room, and reported the term of "pain".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Lethargy, Local reaction
Clinical narrative: This medically confirmed health authority report (initial receipt 02-DEC-2014) concerns a 53 year-old female patient who had no known current illness at the time of vaccination. Her medical history included  unknown liver problems. Concomitant medications included propranolol, lactulose, omeprazole, spironolactone and furosemide. On 06-OCt-2014, the patient received intramuscular AFLURIA injection (batch number T51508) in the left arm (deltoid). On 07-OCT-2014, the patient developed a large about 2.5 inch erythematous and pruritic localized reaction around injection site. No notice of bruising. It lasted for 3 days and was getting better. She also reported being lethargic but no other reaction or side effects were not4ed. The outcome was recovered. Reporter Comments: The regulatory assessed the case as non-serious.