chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a female patient of unknown age with no drug reactions or allergies. On an unknown date, about the time when the vaccine was first released to the market, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On unknown dates, the patient experienced 5 or 6 episodes of shingles (about 1 episode every year) that involved a recurring bump on the lower back of the patient and viral activity around the eye of the patient. It was reported that the patient was having one of these shingles episodes at the time of reporting (reported as currently, on 08-OCT-2013) (start date unspecified). VZVIP packet was faxed to pharmacist. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. The outcome of 5 or 6 episodes of shingles (about 1 episode every year) that involves a recurring bump on the patient's lower back and viral activity around the patient's eye was unknown. The patient was not recovered from the event as the patient was having one of these shingles episodes at the time of reporting. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines had been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 08-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Musculoskeletal stiffness
Clinical narrative: Pt. said she experienced upper chest pain shortly after getting the vaccine. Her physician said she was experiencing an internalized reaction to shingles. She later experience stiff muscles - legs and thighs and fingers. Visible outbreak occurred 3 yrs later.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Culture stool, Haematochezia, Occult blood positive
Clinical narrative: Fussiness.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Irritability, Occult blood positive
Clinical narrative: Fussiness.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The spontaneous report as received from a healthcare worker refers to a 33 year old female patient. On 18-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (injection, lot # H021941, exp date as 11-JUL-2014, 0.5 ml/one shot, route as injection). On 18-SEP-2013, two hours after receiving the vaccine, the patient experienced redness at the injection site and was eventually diagnosed with cellulitis. Patient had sought medical attention via going to a "medical facility". Treatment of KEFLEX was taking for an unspecified amount of time. The outcome of "redness at the injection site was eventually diagnosed with cellulitis" was reported as recoving/resolving. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: The spontaneous report as received from a healthcare worker refers to a 33 year old female patient. On 18-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (injection, lot # H021941, exp date as 11-JUL-2014, 0.5 ml/one shot, route as injection). On 18-SEP-2013, two hours after receiving the vaccine, the patient experienced redness at the injection site and was eventually diagnosed with cellulitis. Patient had sought medical attention via going to a "medical facility". Treatment of KEFLEX was taking for an unspecified amount of time. The outcome of "redness at the injection site was eventually diagnosed with cellulitis" was reported as recoving/resolving. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Syncope
Clinical narrative: This spontaneous consumer report (initial receipt 10-Oct-2013) concerns a 61-year-old female patient. Her concomitant medications included simvastatin, levocetirizine, calcium and ibandronic acid. On 08-Oct-2013, the patient received AFLURIA injection (batch number: R55407 (invalid CSL batch number) at a dose of 0.5 ml. On 08-Oct-2013, the patient had a reaction about 5 minutes after the injection. The patient felt ringing in her ears, lightheadedness, like she was going to pass out. Her husband walked her to the chair as she could barely walk. The patient stated that she blacked out. She learned that while she was blacked out, her eyes were rolling back in her head and her tongue was hanging out. When the pharmacist saw her face and tongue swollen, she stuck the patient's leg with an EPI-PEN, which caused the patient to wake up. The patient was sweating as well. The patient was taken to the emergency room and released in a few hours. She underwent laboratory tests which included EKG (electrocardiogram), blood work and heart monitor. At the hospital, she had rapid heartbeat and blood pressure of 200, which was apparently due to the epinephrine autoinjector. Since then, the patient had no symptoms. Outcome was reported as recovered.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Cardiac monitoring, Dizziness, Electrocardiogram, Gait disturbance
Clinical narrative: This spontaneous consumer report (initial receipt 10-Oct-2013) concerns a 61-year-old female patient. Her concomitant medications included simvastatin, levocetirizine, calcium and ibandronic acid. On 08-Oct-2013, the patient received AFLURIA injection (batch number: R55407 (invalid CSL batch number) at a dose of 0.5 ml. On 08-Oct-2013, the patient had a reaction about 5 minutes after the injection. The patient felt ringing in her ears, lightheadedness, like she was going to pass out. Her husband walked her to the chair as she could barely walk. The patient stated that she blacked out. She learned that while she was blacked out, her eyes were rolling back in her head and her tongue was hanging out. When the pharmacist saw her face and tongue swollen, she stuck the patient's leg with an EPI-PEN, which caused the patient to wake up. The patient was sweating as well. The patient was taken to the emergency room and released in a few hours. She underwent laboratory tests which included EKG (electrocardiogram), blood work and heart monitor. At the hospital, she had rapid heartbeat and blood pressure of 200, which was apparently due to the epinephrine autoinjector. Since then, the patient had no symptoms. Outcome was reported as recovered.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gaze palsy, Heart rate increased, Hyperhidrosis, Loss of consciousness, Swelling face
Clinical narrative: This spontaneous consumer report (initial receipt 10-Oct-2013) concerns a 61-year-old female patient. Her concomitant medications included simvastatin, levocetirizine, calcium and ibandronic acid. On 08-Oct-2013, the patient received AFLURIA injection (batch number: R55407 (invalid CSL batch number) at a dose of 0.5 ml. On 08-Oct-2013, the patient had a reaction about 5 minutes after the injection. The patient felt ringing in her ears, lightheadedness, like she was going to pass out. Her husband walked her to the chair as she could barely walk. The patient stated that she blacked out. She learned that while she was blacked out, her eyes were rolling back in her head and her tongue was hanging out. When the pharmacist saw her face and tongue swollen, she stuck the patient's leg with an EPI-PEN, which caused the patient to wake up. The patient was sweating as well. The patient was taken to the emergency room and released in a few hours. She underwent laboratory tests which included EKG (electrocardiogram), blood work and heart monitor. At the hospital, she had rapid heartbeat and blood pressure of 200, which was apparently due to the epinephrine autoinjector. Since then, the patient had no symptoms. Outcome was reported as recovered.
Age: 61.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Tinnitus
Clinical narrative: This spontaneous consumer report (initial receipt 10-Oct-2013) concerns a 61-year-old female patient. Her concomitant medications included simvastatin, levocetirizine, calcium and ibandronic acid. On 08-Oct-2013, the patient received AFLURIA injection (batch number: R55407 (invalid CSL batch number) at a dose of 0.5 ml. On 08-Oct-2013, the patient had a reaction about 5 minutes after the injection. The patient felt ringing in her ears, lightheadedness, like she was going to pass out. Her husband walked her to the chair as she could barely walk. The patient stated that she blacked out. She learned that while she was blacked out, her eyes were rolling back in her head and her tongue was hanging out. When the pharmacist saw her face and tongue swollen, she stuck the patient's leg with an EPI-PEN, which caused the patient to wake up. The patient was sweating as well. The patient was taken to the emergency room and released in a few hours. She underwent laboratory tests which included EKG (electrocardiogram), blood work and heart monitor. At the hospital, she had rapid heartbeat and blood pressure of 200, which was apparently due to the epinephrine autoinjector. Since then, the patient had no symptoms. Outcome was reported as recovered.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: Pain/Swelling/Erythema/Tenderness (5cm x 6cm) around area of injection. Cephalexin prescribed, pt advised to use ibuprofen, cold compress. Later (24 hours) returned to clinic, received IM abx.
Age: 39.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain/Swelling/Erythema/Tenderness (5cm x 6cm) around area of injection. Cephalexin prescribed, pt advised to use ibuprofen, cold compress. Later (24 hours) returned to clinic, received IM abx.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Fatigue, Hyperhidrosis, Injection site bruising, Injection site erythema
Clinical narrative: (R) arm red and sore - large red blotches on Rt arm. Rt thumb pain and unable to move - will see a orthopedic doctor.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: (R) arm red and sore - large red blotches on Rt arm. Rt thumb pain and unable to move - will see a orthopedic doctor.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Rash macular
Clinical narrative: (R) arm red and sore - large red blotches on Rt arm. Rt thumb pain and unable to move - will see a orthopedic doctor.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Site of injection (R arm) - extremely red and sore unable to lift arm -lasted 2-3 days.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Site of injection (R arm) - extremely red and sore unable to lift arm -lasted 2-3 days.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Site of injection (R arm) - extremely red and sore unable to lift arm -lasted 2-3 days.
Age: 19.0
Sex: F
Vaccine: FLUN4
Symptoms: Lymphadenopathy
Clinical narrative: A report has been received from a Health Professional concerning a 19 year old, Female subject, who had been receiving nasal FLUMIST. FLUMIST started on 14-AUG-2013. The patient experienced enlarged lymph node left armpit which started on 16-AUG-2013. At the time of reporting, the event of enlarged lymph node left armpit was improving. The report was considered to be non-serious by company physician.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Headache in forehead area, by 10:00 PM chills, shaking, lightheaded; alternating with low-grade fever 99.7 symptoms subsided after 4 hours; October 23, 2013 7:00 AM tired, muscle and joint aches with no chills or body shakes; slept 4 hours awoke about 3:00 PM slightly tired no headache.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Headache in forehead area, by 10:00 PM chills, shaking, lightheaded; alternating with low-grade fever 99.7 symptoms subsided after 4 hours; October 23, 2013 7:00 AM tired, muscle and joint aches with no chills or body shakes; slept 4 hours awoke about 3:00 PM slightly tired no headache.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Anxiety, Borrelia test negative, Computerised tomogram normal, Mental status changes, Obsessive-compulsive disorder
Clinical narrative: SUDDEN onset of OCD symptoms, sudden onset of anxiety and sudden change in mental state. Diagnosed with PANDAS.  Tested for strep & Lyme. both negative. CT scan, normal.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Streptococcus test negative
Clinical narrative: SUDDEN onset of OCD symptoms, sudden onset of anxiety and sudden change in mental state. Diagnosed with PANDAS.  Tested for strep & Lyme. both negative. CT scan, normal.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Fatigue, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Sudden numbness in entire right side of body from underneath breast through to my toes. I have been diagnosed with partial transverse myelitis and my symptoms have never gotten better.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Weight bearing difficulty
Clinical narrative: Sudden numbness in entire right side of body from underneath breast through to my toes. I have been diagnosed with partial transverse myelitis and my symptoms have never gotten better.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Inflammation, Mobility decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Severe shoulder pain-frozen shoulder. Unable to move shoulder, feels like dislocation/ extremely inflamed.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Patient was asked all screening questions and verified appropriate for receiving vaccine. A few minutes after vaccine administered, patient complains of chest pain and difficulty breathing. Initially administered Benadryl and water. Patient still complained of difficulty breathing, and thought he would lose consciousness. Admistered Epipen and called 911.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to his wife, a 29 year old female patient. On 10-OCT-2013 the patient was preparing a dose of ZOSTAVAX (lot#, expiration date, dose, route, indication not reported) to administer to a patient, and accidently "pricked herself with the syringe". There was no concomitant medication, pertinent medical history or drug reactions/allergies. The patient became pregnant with LMP of 25-FEB-2013 ("7.5 months pregnant on reporting") and EDD of 02-DEC-2013. The patient had already contact gynaecology and obstetrics (OB/GYN). There was no treatment given for the event. No lab diagnostics studies performed. The pregnancy outcome was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Lip swelling, Nausea, Throat tightness
Clinical narrative: 4 hrs after injection developed swollen lips, nausea. Did not go to the ER. Went home and by 7p eyes were swollen shut and some tightening of throat. To ER given IV BENADRYL and steroids.
Age: 0.45
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 10/18/13 Pt was given Flu vaccine. Child was not 6 mos of age yet.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccine have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 08-AUG-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml/one, subcutaneous). The pharmacist reported that, following administration with ZOSTAVAX, the patient developed "a mark on her arm that had not gone away with time". This mark on the patient's arm had now been present for over one month. The patient visited the pharmacy on an unspecified date, and spoke to the pharmacist, but the patient did not seek additional medical attention. No treatment and lab diagnostics studies performed. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 63 year old male patient with diabetes and neuropathy right leg. On 01-OCT-2013 the patient was vaccinated with ZOSTAVAX. On 07-OCT-2013, seven days after receiving ZOSTAVAX the patient experienced severe pain and a dermatological rash. Patient presented to the medical office on 16-OCT-2013, in which the physician assistant noted the patient had experienced a "burning herpetic pain in a dermatomal distribution radiating from back to front, left side mid thoracic region three inches above the umbilicus'. Physician assistant also reported there were no signs of any vesicular pustules, but possibly a rash "under the skin". Physician assistant also reproted that the patient was quite uncomfortable from pain and had prescribed him an unspecified pain medication. No lab diagnostics studies performed. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: BCG, MMR, TDAP, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous pregnancy report as received from a 34 year old female consumer with no drug reactions/allergies refers to herself. On 13-SEP-2013 the patient was vaccinated with a dose of M-M-R II, injection, (dose and route unspecified). Other suspect vaccines administered on the same day included an unspecified varicella vaccine (manufacturer unknown), an unspecified tuberculosis vaccine (manufacturer unknown) (dose and route unknown). Concomitant medication included TDAP (manufacturer unknown). The patient then became pregnant on an unspecified date "within 3 months" following the vaccination date. The LMP was on 10-SEP-2013 and EDD was on 17-JUN-2014. The pregnancy outcome was pending. No lab diagnostics studies performed. The patient sought medical attention via spoke with an unspecified physician. No treatment was given. No adverse experience was reported other than becoming pregnancy. The patient also reported that, according to an unspecified physician, sometimes exposure to unspecified vaccinations during pregnancy was "good for the (unborn) babies' immune systems". Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Night sweats, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 year old female patient with no pertinent medical history and no drug reactions or allergies. On 19-SEP-2013 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number 672547/1745AA, expiration date 13-SEP-2014). The nurse reported that within 12 hours of receiving the first dose of GARDASIL, in September 2013, the patient developed a rash on both arms and stomach with night sweats. The patient sought medical attention - contacted office. A treatment was given for adverse event - BENADRYL and unspecified cortisone cream. No lab diagnostics studies were performed. The night sweats were reported for the first night following the vaccination with the GARDASIL (date unspecified), but then resolved. The rash on both arms and stomach was described as getting better, but was still present during an office visit on 23-SEP-2013. Relatedness between vaccination with GARDASIL and rash on both arms and stomach with night sweats was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Dry eye, Fatigue
Clinical narrative: Felt lump and heaviness in throat. No resp. distress. Followed by dry cough. S/S improved by 3:00 pm, As 3:00 had increased fatigue and dry, eyes w/ blurry vision, f/b headache and chills and generalized joint pain and fatigue. Fever 101.3 at 5:30 - 6:00/p. Has cont'd fatigue and headache.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia, Sensation of foreign body, Sensation of heaviness, Vision blurred
Clinical narrative: Felt lump and heaviness in throat. No resp. distress. Followed by dry cough. S/S improved by 3:00 pm, As 3:00 had increased fatigue and dry, eyes w/ blurry vision, f/b headache and chills and generalized joint pain and fatigue. Fever 101.3 at 5:30 - 6:00/p. Has cont'd fatigue and headache.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local swelling, Pruritus
Clinical narrative: This spontaneous report was received from an approximately 60 year old female patient who is also a company representative regarding herself. Current conditions of the patient included seasonal allergies. There were not pertinent medical histories. On 04-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) on outer aspect of upper left arm at the pharmacy. Concomitant therapies included SYNTHROID, MUCINEX D, vitamins (unspecified) (reported as multivitamin), omega-3 marine triglycerides (reported as fish oil)(manufacturer unknown), glucosamine (manufacturer unknown) and chondroitin (manufacturer unknown). On 06-OCT-2013, the patient experienced the outer aspect of upper, left arm was warm, red and raise. Approximately on an unknown date in October 2013, the affected area on upper, left arm then became bigger, left arm started to swell and patient became itchy on other unspecified parts of her body. The patient sought medical attention at physician office on 07-OCT-2013. The patient was prescribed with the an unspecified dose of KEFLIN for 10 days which was begun on 07-OCT-2013 and BENADRYL (50 milligrams, as needed). No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.53
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Rash
Clinical narrative: Rash on thighs.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report has been received from a pharmacist concerning to a 68 year old female patient. None pertinent medical history and none drug reactions/allergies. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX, lot 3 J004267, expiration date 12-JUL-2014, subcutaneous, (dose not reported). On 12-OCT-2013, the patient experienced silver dollar size rash around injection site which was painful, swollen, warm to touch and tender. The patient sought medical attention by a pharmacy visit and was given hydrocortisone (manufacturer unknown) and hot and cold compress as a treatment for the adverse events. None laboratory diagnostics were performed. At the time of the report, the outcome of the adverse events was recovering. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient, who on 30SEP2013 was vaccinated with AFLURIA and the PNEUMOVAX. The lot # for PNEUMOVAX was H014561 with an expiration date of 21MAR2014. The patient experienced an adverse reaction. It is unknown at this time which vaccine the patient had the reaction to. The reporter stated Novartis was the manufacturer for PNEUMOVAX involved in the incident, but the lot # provided is a valid Merck lot # for PNEUMOVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient has no pertinent medical history. The patient had no drug allergies. On 13-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # J004270, expiration date 12-JUL-2014, reported as 12-JUN-2014) (subcutaneous, 0.65 ml). Concomitant medications were reported as none. On 14-OCT-2013, the patient developed red, swollen lump at the injection site after receiving the dose of ZOSTAVAX. The patient sought for medical attention by seeing the pharmacist. Cold compress and ibuprofen were given as treatment. Lab diagnostics studies performed were reported as none. The outcome of red, swollen lump at the injection site was reported as not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 77 year old female patient with allergy to penicillin, ciprofloxacin and flagyl. On 11-OCT-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J004257, expiry: 12-JUL-2014) subcutaneously. On 12-OCT-2013, the patient experienced headaches, body aches and symptoms at the injection site such as warm to touch, swelling, redness "about silver dollar size" and itchiness. Laboratory diagnostics studies performed were none. Patient sought medical attention. The patient went in to the pharmacy on 15-OCT-2013 and informed the pharmacist. No treatment was given. The outcome of headaches, body aches and symptoms at the injection site such as warm to touch, swelling, redness "about silver dollar size" and itchiness were reported as recovering. This is 1 of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 77 year old female patient with allergy to penicillin, ciprofloxacin and flagyl. On 11-OCT-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J004257, expiry: 12-JUL-2014) subcutaneously. On 12-OCT-2013, the patient experienced headaches, body aches and symptoms at the injection site such as warm to touch, swelling, redness "about silver dollar size" and itchiness. Laboratory diagnostics studies performed were none. Patient sought medical attention. The patient went in to the pharmacy on 15-OCT-2013 and informed the pharmacist. No treatment was given. The outcome of headaches, body aches and symptoms at the injection site such as warm to touch, swelling, redness "about silver dollar size" and itchiness were reported as recovering. This is 1 of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Induration, Injected limb mobility decreased, Injection site pain
Clinical narrative: Within 3 hrs of PNEUMOVAX immunization given 10/10/13 pt had pain develop in her arm where shot was given and it was hard to move. Applied heat. No fever but before bed felt chilled. Next day she noted arm had swelled moderately and redness noted circumferentially around her arm in a band approx 4 cm around, warm to touch and indurated/tender. No other rashes.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Skin warm, Tenderness
Clinical narrative: Within 3 hrs of PNEUMOVAX immunization given 10/10/13 pt had pain develop in her arm where shot was given and it was hard to move. Applied heat. No fever but before bed felt chilled. Next day she noted arm had swelled moderately and redness noted circumferentially around her arm in a band approx 4 cm around, warm to touch and indurated/tender. No other rashes.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician assistant via company representative refers to a couple of patients of unknown age. On an unknown date, a couple of patients were vaccinated with a doses of GARDASIL (doses, routes, lot numbers not reported). On an unknown date, a couple of patients experienced increased severity of pain at the injection site with each subsequent dose of GARDASIL. The outcome of increased severity of pain at the injection site was unknown. A couple of patients sought medical attention via office visit. The relatedness between the adverse event and GARDASIL was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a male patient with type II diabetes and cirrhosis of the liver refers to himself. On 12-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, indication not reported, subcutaneously). Concomitant medication included unspecified diabetes medication. There were not drug reactions/allergies. The patient had a rash before he received ZOSTAVAX and after he received the shot the rash became worse in 2013. There was no treatment given for the event. No lab diagnostics studies performed. The patient sought medical attention via saw an unspecified physician. The outcome of the event was reported as not recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age. On 23-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, site and route of administration not reported). On an unknown date in September 2013 the patient experienced injection site pain, redness and itching. The injection site was also hard to the touch. No treatment given for events. It was reported that therapy with ZOSTAVAX was not discontinued. The outcome of events was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and events was not reported. The patient did not contact her primary healthcare provider but was advised by the pharmacist to keep an eye on it and to contact her primary healthcare provider. Additional information has been requested.
Age: 1.96
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Incomplete course of vaccination
Clinical narrative: Has had only one VARIVAX.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to 2 female patients of unknown ages. On unknown dates the patients were vaccinated with PNEUMOVAX23 (lot # not reported) (total daily dose not reported). It was reported that the 2 patients came back to the pharmacy on separate days with red throbbing reactions at their PNEUNOVAX23 injection sites. Both patients were vaccinated from the same lot # and expiration date. The outcome was unknown. It was also reported that the administering pharmacist contacted the other 7 patients who had also been vaccinated from this lot # and expiration date and no other reactions were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and warm to the touch. Shot given Oct. 15, 2013.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. rec'd AFLURIA and PNEUMOVAX on 10/23/13 both in left arm. Late that evening, area became tender and swollen, spreading to underarm the next day.
Age: 0.44
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Body temperature increased, Dyspnoea, Moaning, Respiratory arrest, Slow response to stimuli
Clinical narrative: Patient received vaccines in the office sometime between 7:30 - 8:30 am. About 3pm there was a note in ER records expecting patients arm and in ER via EMS. Baby was in swing and mom heard him moan, she turned to look at him he vomited once, was short of breath, gasped before and after and stopped breathing for less than 5 secs, she called EMS, on her arrival baby had a temp of 99, in ER temp was 38.9. ER notes describes him as barely interactive on arrival, he was discharged home after that visit, same day.
Age: 0.44
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient received vaccines in the office sometime between 7:30 - 8:30 am. About 3pm there was a note in ER records expecting patients arm and in ER via EMS. Baby was in swing and mom heard him moan, she turned to look at him he vomited once, was short of breath, gasped before and after and stopped breathing for less than 5 secs, she called EMS, on her arrival baby had a temp of 99, in ER temp was 38.9. ER notes describes him as barely interactive on arrival, he was discharged home after that visit, same day.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Joint stiffness, Myalgia, Pain, Sleep disorder
Clinical narrative: For two weeks and counting: muscle ache-severe; joint stiffness/aches; loss of weight; no energy; lots of unusual sleep.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Weight decreased
Clinical narrative: For two weeks and counting: muscle ache-severe; joint stiffness/aches; loss of weight; no energy; lots of unusual sleep.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: The morning after receiving FLUMIST pt. woke up with whelps on arms, itching. The next day spread to trunk, genital area, legs. Seen in ED. Prescribed ZYRTEC, BENADRYL, prednisone.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Paraesthesia, Swelling face
Clinical narrative: Patient received vaccine at approximately 9:50am, reaction started around 10:20 am while pt was teaching, coverage for class arrived and pt went to clinic at 11:05, but nurses were gone. Pt sent to ER due to tingling in (R) hand/arm, redness in both arms, swelling to face, eyes, given Prednisone in ER and a Rx for prednisone and an EPIPEN.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old female patient. On 07-OCT-2013 the patient was given a dose of expired ROTATEQ oral (dose and indication were not provided) (lot number reported as: H010696; exp date: 06-OCT-2013). This was the child's third dose of ROTATEQ in series. No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Injection given on 10/18/13. Received call from Pt on 10/22 reports: 10/19/13 - Stiff neck thought slept wrong; 10/21/13 - Limited movement to L arm; 10/22/13 - Increase moving arm - still some stiffness. No redness or swelling at site.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No adverse effects. A flu clinic was held at school. Mom indicated that she preferred patient be given "Live intranasal vaccine only." Mom also indicated patient has asthma on the top of form.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called pharmacy at 6:07 pm. She said she just wanted to know she had an adverse rxn. The injection site became itchy and started to swell about 1 hour later. After the has it became more itchy and swollen. When she called I told patient to take BENADRYL and hold cold cloth to site. Will give follow up call 10/24/13 in A.M. Called patient again at 10:47 AM, swelling has gone down considerable but still a little warm, Patient said she will be fine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient said 3-4 hours after the flu shot that she got dizzy. She went to the hospital by ambulance. She said they did not determine a cause but she thinks it was the flu shot.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Scab
Clinical narrative: Broke out in a rash on hands and stomach. Rash area scabbed over. Treated with CLARITIN and Hydrocortisone.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Injection site cellulitis - warm, tender to touch, fever to 102 symptoms started 30 hrs after injection and have been progressive since onset. Tx: KEFLEX 500mg 3x/day for 10 days. Dx: at 930AM on 10/24/13.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain, Injection site vesicles
Clinical narrative: Large blister/edema/pain to injection site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site received antibiotics and steroids and pain relievers.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: Red, hot and mild, erythematous in injection area. Erythremia was from bicep into medial bicep and covers whole bicep itself. Mild tenderness.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Had about 3 hours of slight itchy feeling. Then was fine.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms, fever, chills muscle ache about 6 hrs after vaccination and lasted about 12 hrs.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Acute respiratory failure, Chest discomfort, Respiratory distress, Wheezing
Clinical narrative: Flu vax given at 5 pm on 9-25. Wheezing and chest fullness occurred around 6:15 pm. Severe respiratory distress to acute respiratory failure at 3 am on 9-26-13.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 59.0
Sex: F
Vaccine: HIBV, MEN, PPV
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Extreme pain in arm of vaccine - lasted 2 weeks - moist heat - ice - Tylenol every 3 hrs.
Age: 1.87
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Had fever on 10-19-13 in AM. Swelling to left thigh. Increased thigh circumference. Itchy.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Patient called and said after 4 hours, of getting her flu shot (FLUZONE HD) she has localized swelling and redness. Asked pt to call her doctor and take BENADRYL meanwhile. Pt's all vitals were normal per patient.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Middle insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: (L) arm pain into (L) shoulder, upper back and left side of neck. Was a little sore last night before bed, pain woke me up during the night and has continued to increase. Have been taking MOTRIN and using topical muscle cream without relief. Also intermittent vertigo.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Vertigo
Clinical narrative: (L) arm pain into (L) shoulder, upper back and left side of neck. Was a little sore last night before bed, pain woke me up during the night and has continued to increase. Have been taking MOTRIN and using topical muscle cream without relief. Also intermittent vertigo.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pruritus, Vomiting
Clinical narrative: 2 hours after injection got nauseated, vomiting, and itching. Next day came into pharmacy, pharmacist called her primary physician and said to tell her to take BENADRYL.
Age: 1.97
Sex: U
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Febrile convulsion, Haematocrit normal, Haemoglobin normal, White blood cell count normal
Clinical narrative: Febrile seizure.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: I got a rash (large spots) only on the arm where shot was administered. It disappeared two weeks after shot was administered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient was vaccinated on 10/2/13. Reports tingling/numbness in arm (left) that received vaccination on 10/17/13. Unknown if patient followed up with physician re: adverse reaction. (Was recommended for her to do so.).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a female patient of unknown age. Medical history and drug allergies/reactions were not reported. On 11-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J005719 exp date 13-AUG-2014 (dose and route not reported). Concomitant medication were not reported. On 11-OCT-2013, about 1/2 hour after receiving ZOSTAVAX at the injection site under the skin there was a big, red "blob", the size of a plum. The patient sought for medical attention (phone call to pharmacy). No treatment was given for the event. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort
Clinical narrative: Tightness in chest / lungs at approx 1800 10/23/13. Injection given approx 1300 10/23/13. Hx = asthma until 27 yo = (as child). Keep inhaler for emergencies = took 2 puffs inhaler / albuterol = symptoms decreased.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Myalgia, Rash
Clinical narrative: Rash, Headache, Myalgia.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site rash, Insomnia, Local swelling
Clinical narrative: Arm became red w/ rash around site. Arm became swollen and red. Glands under (R) arm became enlarged. Pt reports she could not sleep that night. Pt. used BENADRYL with successful recovery.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Arm became red w/ rash around site. Arm became swollen and red. Glands under (R) arm became enlarged. Pt reports she could not sleep that night. Pt. used BENADRYL with successful recovery.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Deafness neurosensory, Ear congestion, Tinnitus
Clinical narrative: Received immunizations. Approximately 23 hours later developed congestion/feeling blocked in her right ear. There is a consistent "swishing" noise also in the right ear. Denies any local reaction or other symptoms. Called private provider who is unable to see her. Going to a specialist. As of 10/16/13 (R) ear sensorineural hearing loss. Now resolved. Per physician specialist.
Age: 35.0
Sex: F
Vaccine: IPV, MNQ, TYP, YF
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Reported by pt. 10/03/13 YF site 5 cm x 7 cm red, raised patch (R) arm resolved - 10 days. Bruise remains 4/10 pain if touched. 10/17/13 men site: 3 cm x 5 cm red, raised patch pruritic (L) arm verified.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Pain to (L) shoulder with movement and up (L) neck. Began 09/23/13, have taken Ibuprofen and rest.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Pt presented asking about large (red/swollen) inflamed area on same arm as Zostavax was given and same area pt stated was going to see doctor at urgent care at advise of PharmD on duty at pharmacy. Shot given and 2 different antibiotics were given to pt for arm reaction on 10/13/13. Shot for Zostavax given on 10/10/13.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Pt. felt tightness in throat, able to speak fine. No distress noted. BP 120/76. 1 pm Pt. received 25 mg. BENADRYL P.O.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Papule, Rash, Varicella
Clinical narrative: Pt developed red, sore area at injection site pt also developed rash on legs. Went to physician and was told she had a mild case of chicken pox. She had papules consistent with chicken pox.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal
Clinical narrative: Feels loopy BP 160/90 12:10 pm 150/90 12:15 150/90 1225 150/90 12:30 150/88 1240 150/88 1245 P 76. Dr called. BENADRYL 25mg given per Dr request.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Injection site pain, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Fever, Vomiting, Abd pain, Arm pain. TX: Rest, Motrin, hydration.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthenia, Chills, Cold sweat, Feeling abnormal, Pain
Clinical narrative: Pt c/o subjective fever, chills, cold sweats, feeling like her "body felt bludgeoned", generalized pain, weakness.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt c/o subjective fever, chills, cold sweats, feeling like her "body felt bludgeoned", generalized pain, weakness.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction
Clinical narrative: A SECOND AFTER VACCINE ADMINISTRATION PATIENT HAS STREAKS OF RED TO BILATERAL INNER ARM AREA. DENIES ITCHING, SHORTNESS OF BREATH, DENIES FEELING FLUSHED OR ITCHING. PATIENT MONITORED FOR 15MINS, STREAKS APPEAR THE SAME AS 15MINS BEFORE, NO DISTRESS NOTED. DCOTOR SPOKE TO PATIENT AND ZYRTEC PO ORDERED.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Few minutes after vaccination during observation peroid, patient began feeling lighheaded and that she might faint.  Patient did not lose conciousness and was laid supine on the floor, within 30 seconds patient stated all symptoms resolved. She remained in the area for another 15 minutes without subsequent symptoms. She left with a friend and was instructed to see her PCP for follow-up if needed.