chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Dermatitis, Discomfort, Headache, Induration
Clinical narrative: 64-year-old female who reports she received zoster vaccine 7 days ago (lot number L006382) and developed a dermatitis to her injection site periphery, elbow, neck, back, and waistband area. The patient reported pruritis, and the dermatitis was characterized by popular lesions, no erythema, pustules or vesicles. She states she also had a large induration at her elbow. She states they first appeared on Monday, 16 November 2015, which was 3 days after vaccine receipt (13 Nov). The lesions did improved overall as of 20 Nov 2015. Also the patient noted the induration decreased in size and there was a decrease in severity of discomfort. The patient took TYLENOL per her usual medication routine. She denied immediate reaction, urticarial, oral facial tongue or throat swelling, shortness of breath, wheezing, conjunctivitis, rhinorrhea. She denied systemic reaction for fever chills, malaise, cough or arthralgias or myalgias. She sated she had headaches intermittently and general aches and pains consistent with her baseline arthritis.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dermatitis, Pain, Papule, Pruritus, Skin lesion
Clinical narrative: 64-year-old female who reports she received zoster vaccine 7 days ago (lot number L006382) and developed a dermatitis to her injection site periphery, elbow, neck, back, and waistband area. The patient reported pruritis, and the dermatitis was characterized by popular lesions, no erythema, pustules or vesicles. She states she also had a large induration at her elbow. She states they first appeared on Monday, 16 November 2015, which was 3 days after vaccine receipt (13 Nov). The lesions did improved overall as of 20 Nov 2015. Also the patient noted the induration decreased in size and there was a decrease in severity of discomfort. The patient took TYLENOL per her usual medication routine. She denied immediate reaction, urticarial, oral facial tongue or throat swelling, shortness of breath, wheezing, conjunctivitis, rhinorrhea. She denied systemic reaction for fever chills, malaise, cough or arthralgias or myalgias. She sated she had headaches intermittently and general aches and pains consistent with her baseline arthritis.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: 10/8/15 (L) leg shingles. VZV PCR (+) from lesion. Treated with acyclovir.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Polymerase chain reaction positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Zoster with rash along (R) leg on 5/28/15. Treated with acyclovir.
Sex: F
Vaccine: HPV9
Symptoms: Influenza
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and route were unknown). On an unknown date after receiving GARDASIL 9, the patient developed the "flu" an unspecified time. The pharmacist stated that the unspecified patient had not received any additional doses of GARDASIL 9 yet. The outcome of the event was unknown. Additional information has been requested,
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Serum ferritin decreased
Clinical narrative: This spontaneous report has been received from a healthcare worker and a consumer (the patient's mother) concerning an 18 year old female patient. None concurrent conditions, pertinent medical history and drug reactions/allergies were reported. The patient was not pregnant. On 12-FEB-2015, the patient was vaccinated with the first dose of GARDASIL, (Lot # K009902, exp. date unspecified). On 30-JUN-2015, the patient received the second dose of GARDASIL, (Lot # K011138, exp. date unspecified), 0.5 ml, intramuscular injection, as recommended by the physician. There was no concomitant medication reported. In approximately November 2015 (reported as "about a month ago"), the patient had a ferritin level drawn at her school for an unspecified reason which result was "low" (unspecified level), the patient sought medical attention. There was no significant disability or incapacity, hospitalization or prolonged, nor life threatening. At the reporting time, the outcome of the patient's ferritin low was reported as not recovered. The causal assessment of the patient's ferritin low to GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 23-NOV-2015 the patient was vaccinated with an improperly stored dose of MMR II (Lot # K024036, expiration date 26-NOV-2015) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. 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: This spontaneous report was received from a certified medical assistant referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of oral ROTATEQ, (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports 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 was received from certified medical assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 30-NOV-2015 the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (Lot # 1014427, expiration date 09-MAR-2018) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Blood test, Electroencephalogram, Seizure, Ultrasound scan
Clinical narrative: Seizures, hospitalization.
Age: 0.36
Sex: F
Vaccine: DTAPIPV, HIBV, PPV, RVX
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Fever, projectile vomiting.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Respiratory viral panel, Rhinorrhoea, Wheezing
Clinical narrative: Runny nose, Cough that progressed to wheezing. Received Flumist on Nov 10,2015 and then started to have symptoms within 24hrs with runny nose & cough. Wheezing started on Nov 13, 2015-Requiring Albuterol treatment. Patient recovered with treatment and close follow-up.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain, Swelling face, Vomiting
Clinical narrative: Body aches, Vomiting x3, Malaise, swelling of face.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Alopecia, Asthenia, Chest pain, Dizziness
Clinical narrative: Patient collapsed at cheerleading. She collapsed again four days later. She passed out at our home two days later. She was admitted to hospital and has subsequently been diagnosed with POTS syndrome. She has episodes of extreme weakness, fatigue, dizziness, digestive problems, body pains and numbness, low blood pressure, high heart rate, irregular heart beat, chest pains, shortness of breath, migraines, and hair loss. She is currently seeing a neurologist and a cardiologist. She takes Florinef, Elavil, and Lexapro to help with her symptoms. She has episodes approximately every 2 weeks even with medication. These episodes leave her unable to function and she misses school frequently. Her school schedule will be abbreviated beginning in January.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspepsia, Dyspnoea, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Patient collapsed at cheerleading. She collapsed again four days later. She passed out at our home two days later. She was admitted to hospital and has subsequently been diagnosed with POTS syndrome. She has episodes of extreme weakness, fatigue, dizziness, digestive problems, body pains and numbness, low blood pressure, high heart rate, irregular heart beat, chest pains, shortness of breath, migraines, and hair loss. She is currently seeing a neurologist and a cardiologist. She takes Florinef, Elavil, and Lexapro to help with her symptoms. She has episodes approximately every 2 weeks even with medication. These episodes leave her unable to function and she misses school frequently. Her school schedule will be abbreviated beginning in January.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Gastrointestinal disorder, Heart rate increased, Heart rate irregular, Hypoaesthesia
Clinical narrative: Patient collapsed at cheerleading. She collapsed again four days later. She passed out at our home two days later. She was admitted to hospital and has subsequently been diagnosed with POTS syndrome. She has episodes of extreme weakness, fatigue, dizziness, digestive problems, body pains and numbness, low blood pressure, high heart rate, irregular heart beat, chest pains, shortness of breath, migraines, and hair loss. She is currently seeing a neurologist and a cardiologist. She takes Florinef, Elavil, and Lexapro to help with her symptoms. She has episodes approximately every 2 weeks even with medication. These episodes leave her unable to function and she misses school frequently. Her school schedule will be abbreviated beginning in January.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Hypotension, Laboratory test, Loss of consciousness, Migraine, Pain
Clinical narrative: Patient collapsed at cheerleading. She collapsed again four days later. She passed out at our home two days later. She was admitted to hospital and has subsequently been diagnosed with POTS syndrome. She has episodes of extreme weakness, fatigue, dizziness, digestive problems, body pains and numbness, low blood pressure, high heart rate, irregular heart beat, chest pains, shortness of breath, migraines, and hair loss. She is currently seeing a neurologist and a cardiologist. She takes Florinef, Elavil, and Lexapro to help with her symptoms. She has episodes approximately every 2 weeks even with medication. These episodes leave her unable to function and she misses school frequently. Her school schedule will be abbreviated beginning in January.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Patient collapsed at cheerleading. She collapsed again four days later. She passed out at our home two days later. She was admitted to hospital and has subsequently been diagnosed with POTS syndrome. She has episodes of extreme weakness, fatigue, dizziness, digestive problems, body pains and numbness, low blood pressure, high heart rate, irregular heart beat, chest pains, shortness of breath, migraines, and hair loss. She is currently seeing a neurologist and a cardiologist. She takes Florinef, Elavil, and Lexapro to help with her symptoms. She has episodes approximately every 2 weeks even with medication. These episodes leave her unable to function and she misses school frequently. Her school schedule will be abbreviated beginning in January.
Sex: F
Vaccine: FLUX
Symptoms: Cardiac failure, Death
Clinical narrative: Case number PHHY2015US158435 is an initial spontaneous report received from a consumer (patient's daughter) on 23 Nov 2015. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, she passed away from heart failure. The reporter stated that she did not think having the influenza vaccine over the years was related to the event. No further information was provided.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left upper arm pain, increasing in severity to the point I was unable to lift the arm above my head. Used Tylenol, Ibuprofen, Prednisone.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Eye pain, Fatigue, Headache
Clinical narrative: Woken up by chills, headache and eye pain, very achy back, exhausted feeling.  Temp 103.8.  Took 600 mg Advil and ice chips and juice.  Temp down to 102.8. Next day (Sun) temp of 102.2 - 102.8 all day, with 600 mg Advil every 6 hours.  Monday fever of 100.5 - 101.8 all day.  Tuesday (today) fever of 99.5 - 100.5 all day.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Woken up by chills, headache and eye pain, very achy back, exhausted feeling.  Temp 103.8.  Took 600 mg Advil and ice chips and juice.  Temp down to 102.8. Next day (Sun) temp of 102.2 - 102.8 all day, with 600 mg Advil every 6 hours.  Monday fever of 100.5 - 101.8 all day.  Tuesday (today) fever of 99.5 - 100.5 all day.
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: Customer got shingles shot on 12/3/15. The site of injection was swollen and red 2 days after injection and by the 3rd day the swollen went down.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Infection, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hard circle at site of injection. Warm to touch. Pt has slight fever and headache. Pt seen family Dr today (12/7/15) who said it is infected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Red, hard circle at site of injection. Warm to touch. Pt has slight fever and headache. Pt seen family Dr today (12/7/15) who said it is infected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified patient of unknown age. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX from one of the following two lot numbers and expiration dates as the pharmacist did not know which lot number and expiration date was administered to this unspecified patient (lot# L020482; expiry date: 02-SEP-2016, lot# L029485; expiry date: 06-NOV-2016). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 20-AUG-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot# was reported as J013315, expiry date 18-OCT-2015, dose, route and dose number were unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 30-NOV-2015 the patient was inadvertently administered an expired dose of VAQTA (lot # L001627, expiry date: 11-NOV-2015) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. Additional information has been requested.
Age: 1.37
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Full blood count, Rash
Clinical narrative: Rash.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 21-NOV-2015, the patient was inadvertently vaccinated with expired PNEUMOVAX 23, expiry date 30-AUG-2015, (lot#, dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. Additional information is not expected as the reporter did not wish further contact.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis psoriasiform
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old male patient. The patient had no drug allergies/reactions. On 23-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose not reported) subcutaneously. Concomitant therapy included cholesterol and blood pressure medications. The pharmacist reported that "within three months" of the administration of ZOSTAVAX (on an unspecified date in 2015) the patient developed what was diagnosed by an unspecified physician as a "psoriasis-like rash". The patient was currently being treated with an unspecified "topical steroid" (manufacturer unspecified). At time of this reporting, the patient had not recovered. The causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient states her Lt. arm began hurting the day she received her flu shot. No redness, swelling or fever reported. Able to use her arm. Pain extends to middle of uppper arm and occasionally to base of neck. Still painful today which is 5 weeks later. Has not been seen by a MD but did call their office.
Age: 76.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling
Clinical narrative: Itching -  Redness - Swelling.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Pt states pain, numbness and inability to move arm as he did before vaccination.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was seen in office. While here it was suggested that patient get PREVNAR. Patient agreed, but forgot he had this in 12/19/14. Also CMA did not check documentation.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dystonia, Heart rate increased, Hypertension, Loss of consciousness
Clinical narrative: To urgent care with c/o sx palpitations, fast and pounding heartbeat. C/O dizziness and like was going to pass out. Had c/o tingling in hands and face. C/O sx onset 20 min. after flu vaccine, felt lightheaded and BP high. Pt took Clonidine-metoprolol with resolution of sx. In ED only BP increased. ED MD Dx: Dystonic Drug Rx - flu vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Paraesthesia
Clinical narrative: To urgent care with c/o sx palpitations, fast and pounding heartbeat. C/O dizziness and like was going to pass out. Had c/o tingling in hands and face. C/O sx onset 20 min. after flu vaccine, felt lightheaded and BP high. Pt took Clonidine-metoprolol with resolution of sx. In ED only BP increased. ED MD Dx: Dystonic Drug Rx - flu vaccine.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness, Seizure, Urinary incontinence
Clinical narrative: I gave the MCV MENACTRA vaccine first in the right deltoid and then the HPV GARDASIL 9 in the right deltoid. Patient stated she was ok I then put syringes and needles in the sharps container and then took my gloves off and threw them away, I asked patient if she felt ok she stated yes then I stated that we were going to keep her for a few minutes to monitor her this is when she began to pass out and began leaning to her left side. Patient was still on the exam table I grabbed her so that she would not fall off and laid her down. I began trying to get her to respond when she began to start mild convulsions, I opened door with one hand still on  my patient and asked the employee to assist me because she was right outside the door. Patient was still having mild convulsions and had a loss of urine. I went to grab PAC-C and a pulse oximetry to do vitals. Blood pressure was taken by employee and it was stable at 120/80 and oxygen stats were stable in the 98%. By this time patient had already stopped with convulsions and was talking to PA-C who was next to her trying to calm her down, patient was very shaken up and scared. Patient recovered well and was taken home by her mother. Patient will follow up in one week with PA-C.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Fine motor skill dysfunction, Hypoaesthesia
Clinical narrative: Started with numbness in fingers on both hands.
Age: 62.0
Sex: F
Vaccine: FLUR3
Symptoms: Pharyngeal oedema, Swelling face, Swollen tongue
Clinical narrative: Face, Throat and tongue started swelling. Went to ER to be treated.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Painful arm and knee next day, then radiated to ankle for about three days then disappeared.  Then patient reports feeling sick like flu, tired, for a week.  Then about a week later her arm started hurting again.  She called us at the pharmacy today.
Sex: U
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain
Clinical narrative: Nausea, body aches and chills for 24 hrs, no fever did not present for evaluation.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness from site of injection all the way to the elbow. It was notived 1 day after vacccine, but 2 days after, the swelling and redness started to reduce.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Haemorrhage, Pain, Skin discolouration
Clinical narrative: Bled/black and blue/painful.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional concerning an unknown number of patients of unknown age and gender. In November 2015, the patients received improperly stored GARDASIL 9 lot # L014415, expiration date: 25-JUL-2016 (dose and route were not reported). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: Patient called states "I have a swollen lymph node under my left arm. Been here for two days. No pain or fever" will take med if pain or fever occurs. To go to ER or contact private physician if symptoms worsen.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Rash macular
Clinical narrative: Pain in (L) shoulder, ROM of (L) arm. The injection site is a little red, but not very warm. There is edema. There are macular lesions down the length of the arm and up the neck.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Injection site swelling, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a male patient who received FLUARIX. Co-suspect products included FLULAVAL. In November 2015, the patient received FLUARIX and FLULAVAL. In 2015, less than a week after receiving FLUARIX and FLULAVAL, the patient experienced injection site pain and injection site swelling. In November 2015, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolving and the outcome of the wrong injection technique was unknown. The reporter considered the injection site pain and injection site swelling to be related to FLUARIX and FLULAVAL. Additional details were provided as follows: This case was previously reported to a manufacturer. This case was reported by a pharmacist, who herself was a mother of the patient. The reporter stated that about a week ago, in November 2015, the patient received either FLUARIX or FLULAVAL vaccine at a public health clinic. The patient experienced extreme pain and swelling in his arm (injection site). In the reporter's opinion, it was very abnormal in the way the vaccine was administered verses the way she would administer it. The vaccine was administered lower than what she would have administered and was not given in the deltoid region, which led to wrong injection technique. The reporter suggested that the pain and swelling was caused by FLUARIX and FLULAVAL vaccine. The reporter also took the picture of the patient's arm. The details regarding lot number, expiration date, if any other vaccines were administered on the same day or 4 weeks prior exact date of vaccination, name and date of birth of the patient, which arm the vaccine was administered and the date on which the swelling and pain started were unknown. The sales representative thought the swelling and pain has resolved because the vaccine was given about a week ago.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 45-year-old male patient who received FLUARIX QUADRIVALENT (batch number C75ES, expiry date 30th June 2016). Concurrent medical conditions included gout. Concomitant products included allopurinol. On 11th November 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 11th November 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. This case was reported by the patient himself. The patient experienced difficulty in sleep because of the pain in right shoulder. The patient was seen by an urgent care center for injection site pain. The patient had planned to follow up with his physician on an unknown date.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. In approximately 2015, the patients were vaccinated with improperly stored doses VARIVAX (Merck) lot # K011804, expiration date 21-AUG-2016 (route of administration was not reported) since a previous temperature excursion on 19-MAY-2015. No adverse effects were reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Metal poisoning, Optic ischaemic neuropathy, Optic neuritis, Seizure, Vaccination complication
Clinical narrative: Suffered from ischemic optic neuropathy/optic neuritis - having seizure disorders - heavy metal poisoning due to influenza vaccine.
Age: 6.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Child w/large area of erythema over (L) deltoid consistent w/local reaction to immunization (DTaP). IPV site -  not red.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: Generalized allergic reaction - shortness of breath - itching, redness at site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Peripheral swelling, Tenderness
Clinical narrative: Redness, swelling, painful to touch, swelling up into neck and down arm (R).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Discomfort, Pain, Tendonitis
Clinical narrative: Flu shot given 10/1 upper deltoid - discomfort and residual pain the bicep - seen by MD 11/6 Rx ice and antiinflammatories 4 day - still uncomfortable.  2 mos later with some residual weakness - Dx as tendinitis.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Pain, Pain in extremity, Rash
Clinical narrative: Pt c/o of pain in (L) arm w/movement/activity 11/25-11/29 developed rash which progressed over 2 days. Pt was seen at care center and Dx w/shingles rash. Rash progressed and (L) hand painful. Rx Acyclovir 400mg TID x 7 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Flu vac administered 11/25/15 (Lt) deltoid pt noted pruritic rash at bra wire line 11/27/15 spread to torso, axilla, abd and inner thighs.
Age: 14.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Afternoon of shot he was dizzy and lightheaded, cold sweats, felt yucky all over, headache. Slept over 14 hours, that night. Woke up yucky again. Felt itchy all over. 5 inch itchy rash around shot site.
Age: 14.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Injection site reaction, Pruritus generalised, Rash pruritic
Clinical narrative: Afternoon of shot he was dizzy and lightheaded, cold sweats, felt yucky all over, headache. Slept over 14 hours, that night. Woke up yucky again. Felt itchy all over. 5 inch itchy rash around shot site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness at the injection site. Covered most of the back of her arm. Happened in about 24 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chromaturia, Decreased appetite, Fatigue, Headache
Clinical narrative: Slept the month of July away; extreme fatigue. really bad headache, a few days my urine turned brown, my daughter said I smelled sickly sweet, my whole body ached, exp. my joints in shoulders, arms, wrists, knees, ankles and feet no appetite, nausea, the fatigue still haunts me on side of mouth and below lip blistery, stinging achy rash that oozed and swelled.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Lip blister, Musculoskeletal pain, Nausea, Oral mucosal blistering
Clinical narrative: Slept the month of July away; extreme fatigue. really bad headache, a few days my urine turned brown, my daughter said I smelled sickly sweet, my whole body ached, exp. my joints in shoulders, arms, wrists, knees, ankles and feet no appetite, nausea, the fatigue still haunts me on side of mouth and below lip blistery, stinging achy rash that oozed and swelled.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash, Swelling
Clinical narrative: Slept the month of July away; extreme fatigue. really bad headache, a few days my urine turned brown, my daughter said I smelled sickly sweet, my whole body ached, exp. my joints in shoulders, arms, wrists, knees, ankles and feet no appetite, nausea, the fatigue still haunts me on side of mouth and below lip blistery, stinging achy rash that oozed and swelled.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives and itching 11-12 hours post injection. BENADRYL x 1 dose, 6 hours post BENADRYL rash and itching, BENADRYL repeated.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injected limb mobility decreased, Pain in extremity, Tremor
Clinical narrative: Left arm turned red, became very sore to the point it was difficult to move. Patient got the chills and could not stop shaking. A warm bath did not make him feel better so they went to ER.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Hot and swelling - shoulder to elbow with pain. 3+ days fever (101 degrees to 102 degrees)/chills. Bad headache; itching neck, face, under arm, and facial swelling. Vomited - 1x next day after shot. Fatigued, dizzy, weak following 3rd day. Used Ibuprofen B.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Hot and swelling - shoulder to elbow with pain. 3+ days fever (101 degrees to 102 degrees)/chills. Bad headache; itching neck, face, under arm, and facial swelling. Vomited - 1x next day after shot. Fatigued, dizzy, weak following 3rd day. Used Ibuprofen B.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: Hot and swelling - shoulder to elbow with pain. 3+ days fever (101 degrees to 102 degrees)/chills. Bad headache; itching neck, face, under arm, and facial swelling. Vomited - 1x next day after shot. Fatigued, dizzy, weak following 3rd day. Used Ibuprofen B.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Heart rate increased, Tachycardia
Clinical narrative: Severe fast heart beat (tachycardia; several) weakness; about 3:30 to 4 pm. 911 was called I talked to them after few minutes; by that time I felt little better and I refused paramedic to come in.
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Blood test, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Chest X-ray abnormal, Electrocardiogram, Fatigue, Insomnia
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity, Pulmonary oedema, Pyrexia
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Asthenia, Electrocardiogram, Fatigue, Insomnia, Mobility decreased
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 86.0
Sex: M
Vaccine: UNK, FLU3, FLU3
Symptoms: Pain in extremity, Pulmonary oedema, Pyrexia, X-ray
Clinical narrative: Developed severe pain in the left arm, which radiated to the shoulder and neck. Ran fever intermittently for weeks. Had EKG and X-ray five days after getting injection. Diagnosed with early pneumonia - took doxycycline and went back to Dr. for a second X-ray. Weak and exhausted still!
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Asthenia, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: The day after the injection, I woke in a state of extreme exhaustion and weakness. I have been barely able to function and almost a month later, I am still very tired and weak and staying at home, also have swollen glands that are painful under my ear lobe.
Age: 44.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching around the injection site.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe shoulder and arm pain.  Pain has continued in the shoulder and arm since the day of the vaccine.  Not as severe as the first week but continuous.
Age: 8.0
Sex: M
Vaccine: FLUN4, IPV, MMRV, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Raised area of erythema and warmth.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Peripheral swelling
Clinical narrative: Cough - dizzy, swollen arm.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Myalgia, Pain in extremity
Clinical narrative: Pt came in 9 days after receiving the shot. He claimed that 1-2 days after receiving it he had severe pain in both hips and one leg. He described it as both a muscle pain and bone pain. I told him to go see his Dr about it.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Tendon pain
Clinical narrative: I experienced extreme joint pain, muscle and tendon pain in my hips, back, shoulders and neck for 19 days. Unresponsive to pain medication or anti inflammatory meds. Addendum Dec 1st - continued headaches and fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Crying, Heart rate increased, Helplessness, Pyrexia
Clinical narrative: Fever of 103 approximately 6 hours after vaccine. Experienced fast heartbeat, weakness and felt helpless and was crying - very unusual for me. Symptoms lasted for approx. 2 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed chickenpox (varicella) despite having been previously vaccinated.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-DEC-2015, the patient received an expired VARIVAX (Merck) (lot # J013905, expiration date: 30-OCT-2015), dose and route were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to 16 patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (lot# L008054, expiry date: 30-NOV-2016) (strength and dose unspecified). No concomitant medications were reported. No adverse effect were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling - lg amount, redness, warm to touch. Ice and ibuprofen.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of an unknown gender and age. No information regarding the patients' concurrent conditions and medical was provided. On unknown dates (reported as multiple unspecified dates), multiple patients were vaccinated with improperly stored doses of ROTATEQ lot # K014826, expiration date: 28-MAY-2016 (dose and route of administration were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Alopecia, Amenorrhoea, Asthenia, Blood test normal
Clinical narrative: This spontaneous report was received from a physician regarding a female patient of unknown age. No medical history and concurrent conditions were reported. On 04-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (dose and frequency were unknown). On 13-JAN-2015, the patient was vaccinated with second dose of GARDASIL. On an unspecified date in 2015 after vaccination with the second dose of GARDASIL, the patient experienced occasional headaches and abdominal pain. On 23-MAY-2015, the patient was presented with viral gastritis. On 26-MAY-2015, the patient was vaccinated with the third dose of GARDASIL. After vaccinated with the third dose, the patient reported increased in the occasional headaches and abdominal pain. The patient's mother stated that "all hell broke loose" after the third dose. The patient's mother also reported that the patient's abdominal pain become so severe that she spent a lot of time in the fetal position to ease the pain and the headaches became dehabilitating. The patient was taken to several physicians included a neurologist, gastroenterologist, and a pediatric surgeon. The physician noted that the patient had many diagnostic tests completed including abdominal ultrasound, blood work and MRI of the brain and all were reported to be within normal limits. On an unspecified date in 2015, the patient had undergone abdominal CT scan which showed constipation. The patient began a gluten free diet (date unspecified), although her celiac test was negative on 08-JUN-2015. This diet improved the abdominal symptoms although if the patient does intake a food product with gluten, the abdominal pain was back and the patient has brain fog. On an unspecified date in 2015, the patient visited the pediatric neurologist and was diagnosed with occipital neuralgia. Treatment provided to the patient for occipital neuralgia included TOPAMAX. The patient was under the care of the homeopathic physician who diagnosed the patient "leaky gut syndrome". On an unspecified date in 2015, the patient's gynecologist diagnosed the patient with amenorrhea, however, the gynecologist suggested that this was secondary due to stress. The physician also noted the patient's hair was thinning as well. Additionally the physician also mentioned that the only other related occurrence during this time frame- was a bout of viral gastritis diagnosed on 23-MAY-2015. The outcome of all the events was reported as not recovered. The relatedness of all the events with GARDASIL was not reported. No product quality complaint was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abdomen abnormal, Constipation, Feeling abnormal, Gastritis viral, Gastrointestinal disorder
Clinical narrative: This spontaneous report was received from a physician regarding a female patient of unknown age. No medical history and concurrent conditions were reported. On 04-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (dose and frequency were unknown). On 13-JAN-2015, the patient was vaccinated with second dose of GARDASIL. On an unspecified date in 2015 after vaccination with the second dose of GARDASIL, the patient experienced occasional headaches and abdominal pain. On 23-MAY-2015, the patient was presented with viral gastritis. On 26-MAY-2015, the patient was vaccinated with the third dose of GARDASIL. After vaccinated with the third dose, the patient reported increased in the occasional headaches and abdominal pain. The patient's mother stated that "all hell broke loose" after the third dose. The patient's mother also reported that the patient's abdominal pain become so severe that she spent a lot of time in the fetal position to ease the pain and the headaches became dehabilitating. The patient was taken to several physicians included a neurologist, gastroenterologist, and a pediatric surgeon. The physician noted that the patient had many diagnostic tests completed including abdominal ultrasound, blood work and MRI of the brain and all were reported to be within normal limits. On an unspecified date in 2015, the patient had undergone abdominal CT scan which showed constipation. The patient began a gluten free diet (date unspecified), although her celiac test was negative on 08-JUN-2015. This diet improved the abdominal symptoms although if the patient does intake a food product with gluten, the abdominal pain was back and the patient has brain fog. On an unspecified date in 2015, the patient visited the pediatric neurologist and was diagnosed with occipital neuralgia. Treatment provided to the patient for occipital neuralgia included TOPAMAX. The patient was under the care of the homeopathic physician who diagnosed the patient "leaky gut syndrome". On an unspecified date in 2015, the patient's gynecologist diagnosed the patient with amenorrhea, however, the gynecologist suggested that this was secondary due to stress. The physician also noted the patient's hair was thinning as well. Additionally the physician also mentioned that the only other related occurrence during this time frame- was a bout of viral gastritis diagnosed on 23-MAY-2015. The outcome of all the events was reported as not recovered. The relatedness of all the events with GARDASIL was not reported. No product quality complaint was reported. Additional information has been requested.