chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.11
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Oropharyngeal pain, Viral infection
Clinical narrative: Pt seen 2/5/13 by me, having been to ER previous night, dx with viral infx in ER. In office T 102.1, very uncomfortable with neck tilted to (L), multiple enlarged tender (L) post ax LN, sl enlg (R) post ax LN. Normal neck flexion, but child irritable. Diffuse somewhat lacy M-Prash sib had had a sore throat. Patient did not have red throat but (+) throat culture.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, MMR, VARZOS
Symptoms: Crying, Wrong drug administered
Clinical narrative: Received ZOSTAVAX vaccine accidentally instead of VARIVAX. Noted error on 2/21/13. T = 100.4 on 2/21/13. "Cries at the drop of a hat!" (since vaccines per mom).
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash
Clinical narrative: Rash B/L thigh the same day as vaccinated. Tx: BENADRYL & given EPI-PEN junior for emergency.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient. In 2010, the patient was vaccinated in her thigh with the first dose of GARDASIL (injection) (lot#, dose and route not reported). On an unknown date, the patient experienced pain in her leg. She developed paresthesia, numbness and pain in the thigh. On an unknown date, the patient was vaccinated in the opposite arm with a second dose of GARDASIL (injection) (lot#, dose and route not reported). On an unknown date, the patient experienced persistent arm pain. She saw a chiropractor, neurologist and physical medicine physician. The treatment was tramadol hydrochloride and physcial therapy. On approximately 2012, the patient had a blood work (results not reported). At the time of the report the patient had not recovered from the events. The relatedness of the events with GARDASIL was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, CSF white blood cell count increased, Confusional state
Clinical narrative: 11/6/12 - sharp pain behind (R) ear radiating to anterior neck, shoulder, (R) arm, headache; maculopapular rash (R) scapula. 11/8/12 - to Emergency Room for above symptoms. 11/15/12 - new onset confusion, dry mouth, rash & symptoms as above (11/6/12). 11/16/12 - admitted from ED with zoster-induced non-injection site zoster with questionable neuro involvement. Lumbar puncture done; tx with acyclovir.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Herpes zoster, Musculoskeletal pain, Neck pain
Clinical narrative: 11/6/12 - sharp pain behind (R) ear radiating to anterior neck, shoulder, (R) arm, headache; maculopapular rash (R) scapula. 11/8/12 - to Emergency Room for above symptoms. 11/15/12 - new onset confusion, dry mouth, rash & symptoms as above (11/6/12). 11/16/12 - admitted from ED with zoster-induced non-injection site zoster with questionable neuro involvement. Lumbar puncture done; tx with acyclovir.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Pain in extremity, Polymerase chain reaction, Rash maculo-papular, Red blood cells CSF positive
Clinical narrative: 11/6/12 - sharp pain behind (R) ear radiating to anterior neck, shoulder, (R) arm, headache; maculopapular rash (R) scapula. 11/8/12 - to Emergency Room for above symptoms. 11/15/12 - new onset confusion, dry mouth, rash & symptoms as above (11/6/12). 11/16/12 - admitted from ED with zoster-induced non-injection site zoster with questionable neuro involvement. Lumbar puncture done; tx with acyclovir.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test negative
Clinical narrative: 11/6/12 - sharp pain behind (R) ear radiating to anterior neck, shoulder, (R) arm, headache; maculopapular rash (R) scapula. 11/8/12 - to Emergency Room for above symptoms. 11/15/12 - new onset confusion, dry mouth, rash & symptoms as above (11/6/12). 11/16/12 - admitted from ED with zoster-induced non-injection site zoster with questionable neuro involvement. Lumbar puncture done; tx with acyclovir.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 51 year old male patient regarding himself. The patient had no drug allergies. On 11-JAN-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included LIPITOR. On 14-FEB-2013, the patient developed shingles and was diagnosed by the physician. The patient stated that he did have a sinus infection around the time of vaccination but was not medicated. The patient stated that the shingles was getting worse. Laboratory diagnostics were not performed. Treatment rendered for the event was famciclovir and zovira. The outcome of developed shingles was unknown. The patient sought medical attention. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 51 year old male patient regarding himself. The patient had no drug allergies. On 11-JAN-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included LIPITOR. On 14-FEB-2013, the patient developed shingles and was diagnosed by the physician. The patient stated that he did have a sinus infection around the time of vaccination but was not medicated. The patient stated that the shingles was getting worse. Laboratory diagnostics were not performed. Treatment rendered for the event was famciclovir and zovira. The outcome of developed shingles was unknown. The patient sought medical attention. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia
Clinical narrative: Pt has had a sore arm since her shot on 1/15/13.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt has had a sore arm since her shot on 1/15/13.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Herpes zoster multi-dermatomal, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 20 month old female patient with allergy to ZITHROMAX and no pertinent medical history. On 20-JUN-2012 the patient was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot # 671083/0826AA, exp. date: 02-JUN-2013). Concomitant therapies included copper (unspecified), ferrous fumarate, folic acid, vitamins (unspecified), POLY-VI-SOL with Iron tablets. On 12-FEB-2013 the patient developed upper respiratory infection and shingles after receiving VARIVAX (Merck). The patient developed congestion, fever, and drainage so AUGMENTIN was prescribed. The patient also presented with rash on top of both buttocks and some spread down the left leg. Rash consisted of "maculopapular papules with unilateral dermatomal distribution". Treatment with ZOVIRAX ointment, AUGMENTIN and oral acyclovir were given for the events. Viral culture was performed but no result provided. The patient was seen by physician. The outcome of the events was reported as not recovered. The relatedness for the events with the therapy was unknown. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Upper respiratory tract congestion, Upper respiratory tract infection, Viral test
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 20 month old female patient with allergy to ZITHROMAX and no pertinent medical history. On 20-JUN-2012 the patient was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot # 671083/0826AA, exp. date: 02-JUN-2013). Concomitant therapies included copper (unspecified), ferrous fumarate, folic acid, vitamins (unspecified), POLY-VI-SOL with Iron tablets. On 12-FEB-2013 the patient developed upper respiratory infection and shingles after receiving VARIVAX (Merck). The patient developed congestion, fever, and drainage so AUGMENTIN was prescribed. The patient also presented with rash on top of both buttocks and some spread down the left leg. Rash consisted of "maculopapular papules with unilateral dermatomal distribution". Treatment with ZOVIRAX ointment, AUGMENTIN and oral acyclovir were given for the events. Viral culture was performed but no result provided. The patient was seen by physician. The outcome of the events was reported as not recovered. The relatedness for the events with the therapy was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Ear pain, Headache, Laboratory test abnormal, Lumbar puncture
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Nervous system disorder, Rhinitis perennial, Rhinoscopy, Sinusitis, Tendonitis
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Ear pain, Headache, Lumbar puncture, Nervous system disorder
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rhinitis perennial, Rhinoscopy, Sinusitis, Tendonitis, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain upper, Alopecia, Anaemia, Back pain, Blood test
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Cognitive disorder, Computerised tomogram, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Feeling abnormal, Headache, Insomnia, Joint swelling, Lumbar puncture
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain, Paranasal sinus hypersecretion, Temperature intolerance, Tendonitis
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Tilt table test, Vertigo, Vestibular function test
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. She past complained of allergic rhinitis, exercise induced asthma. The patient had seasonal allergies and rhinitis. On 22-AUG-2012 the patient was vaccinated with her first dose of GARDASIL (lot number 0518AE exp date 21-NOV-2014) in her right arm. That day she also received MENACTRA her left arm. The physician reported that the patient's mother had stated, that soon after the first dose, the patient began experiencing headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity. After the second dose of GARDASIL (lot number reported as H015859, exp 26-JUN-2013) on 23-NOV-2012, the symptoms intensified. The patient was seen by an unspecified ear, nose and throat specialist and was diagnosed with perennial rhinitis and sinusitis, based on rhinoscopy. She was given several rounds of unspecified antibiotics, with no relief. She was seen by a gastroenterologist who did not make a definitive diagnosis. The mother stated that "last week" she was seen at a neurologist's office to have a spinal tap performed to "find the root of her neurological problems". The reporter physician had stated that she had not received any reports from these specialists, information was only from the patient's mother's report. The outcome of headaches, ear aches, tendonitis and stomach pain at mild to moderate intensity and neurological problems was unknown. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The reporter reported that the patient received GARDASIL (lot# was not reported) on 22-FEB-2012 and 25-FEB-2013.No adverse effect reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 19-FEB-2013 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # H018015; expired date: 14-OCT-2013) (dose and route unspecified). The vaccine was stored in refrigeration under 46 degrees Fahrenheit from 07-FEB-2013 to 27-FEB-2013. The outcome of the event was unknown. No adverse effect reported. This is one of three reports from the same reporter. The MARR# of the other two reports are 1303USA000093 and 1303USA000094. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an 80 year old female patient with no known allergies. Current condition of the patient included hypertension. On 19-FEB-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H01547 and 08-JUN-2014 respectively, route unspecified). No concomitant medications were reported. On 19-FEB-2013, the patient experienced redness, swelling and possible cellulitis at the injection site after being administered with PNEUMOVAX23. On 22-FEB-2013, the patient sought medical attention (visited the office). The physician prescribed an unspecified antibiotic and to apply ice to the injection site to bring down the swelling. It was unspecified if any lab tests were performed. The outcome of redness, swelling and possible cellulitis at the injection site was unknown. The relatedness for redness, swelling and possible cellulitis at the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning two patients of unknown age and gender. The patients who were intended to received ZOSTAVAX were inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously due to human error on an unknown date in August 2012. No concomitant medications were reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Tendonitis
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients of unknown ages. The patients were vaccinated with a dose of AFLURIA (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unspecified date, the patients experienced injection site pain. The pharmacist stated that the pain went away approximately 1 and a half days after administration of the vaccine. The relatedness for injection site pain was unknown for AFLURIA. Follow-up information has been received from the registered pharmacist concerning one female patient in her 40's who in October 2012 was vaccinated with a dose of AFLURIA (Lot # not reported) and a dose of PNEUMOVAX23 (Lot # not reported). The patient developed tendonitis after vaccination in approximately October 2012 and recovered 3 weeks later. The relatedness for tendonitis was unknown for AFLURIA and PNEUMOVAX23. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 16-JUL-2012 the patient was vaccinated with the first dose of GARDASIL(lot# unknown) 0.5 ml, intramuscular. On 12-NOV-2012 and 16-JAN-2013 the patient received the second dose and the third dose of 0.5 ml GARDASIL(lot#unknown). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. There was no PQC involved. It was unknown if the patient had sought medical attention. The action taken and outcome were unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Somnolence
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. On 31-OCT-2012 the patient was vaccinated with the first 0.5 ml dose  of GARDASIL for prevention of HPV. On approximately 18-JAN-2013 (about two weeks before adverse event onset), the patient was vaccinated with the second 0.5 ml dose of GARDASIL. On 01-FEB-2013, the patient experienced being tired and sleeping all the time. The patient did not seek medical attention, but treated by herself with herbal supplements. After taking supplements, the patient's adverse events improved. At the time of report, the patient was recovering from tired and sleeping all the time. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-FEB-2013 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # H018015; expired date: 14-OCT-2013) (dose and route unspecified). The vaccine was stored in refrigeration under 45 degrees Fahrenheit from 07-FEB-2013 to 27-FEB-2013. The outcome of the event was unknown. No adverse effect reported. This is one of three reports from the same reporter. The MARRS# of the other two reports are 1303USA000094 and 1302USA013682. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age (gender unspecified). On 03-AUG-2012, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). On 26-FEB-2013, the patient asked about the 3rd dose of GARDASIL which was late. The patient was not experiencing any known symptoms. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 25-FEB-2013 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # H018015; expired date: 14-OCT-2013) (dose and route unspecified). The vaccine was stored in refrigeration under 46 degrees Fahrenheit from 07-FEB-2013 to 27-FEB-2013. The outcome of the event was unknown. No adverse effect reported. This is one of the three reports from the same reporter. The MARRS# of the other two reports are 1303USA000093 and 1302USA013682. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified patient of unknown age. The reporter stated on 14-JAN-2013 the unspecified patient might have been inadvertently administered TUBERCULIN PPD (manufacture: sanofi-Pasteur) instead of PNEUMOVAX23 but she was not sure. She stated that a blood sample was drawn to determine if the unspecified patient had pneumococcal titer levels that would an immune response that would be normal if there was a possibility that PNEUMOVAX23 was administered. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. Approximately on an unknown date in 2009 (reported as about 5 years ago), the patient was vaccinated with first and the second dose of GARDASIL, (lot number, expiry date and route was not reported0. Concomitant medications were not reported. The patient was in the office to receive the third dose of GARDASIL, on 27-FEB-2013. No adverse event was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Varicella
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient experienced itchy rash 5 to 10 days after vaccination which was diagnosed as chicken pox. The outcome of the reported event was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a 67 year old female patient. On 20-FEB-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date reported as H01574 and 08-JUN-2014 respectively, route unspecified). No concomitant medications were reported. On an unknown date in February 2013, the patient experienced swelling, redness and tenderness at the injection site. On an unknown date, the patient sought medical attention (called the physician office). The physician did not see the patient. The physician prescribed ice and BENADRYL over the phone to alleviate the symptoms of the patient. It was unspecified if any lab tests were performed. The outcome of swelling, redness and tenderness at the injection site was unknown. The relatedness for swelling, redness and tenderness at the injection site was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient who was intended to receive ZOSTAVAX was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously due to human error on an unknown date in February 2013. No concomitant medications were reported. No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Oral administration complication, Regurgitation
Clinical narrative: This spontaneous report as received from a physician referred to a patient of unknown age and gender. Physician stated that patient today (27-FEB-2013) received the first dose in the ROTATEQ series (oral, lot#, dose/frequency were unspecified), but regurgitated some of the dose. No adverse effects noted. It was unspecified whether patient had sought medical attention nor not. The outcome of "regurgitated some of the dose" was unknown. The relationship was not provided.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). The pharmacist reported that the patient would now like to receive the third dose of GARDASIL, 11 months after the second dose was administered. No adverse symptoms were reported. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a consumer refers her son, a 15 year old male patient. On 20-JAN-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular for prophylaxis, the patient is foreign but he received the vaccine in another country. The reporter informed that the vaccine which was administered to the patient was stored under incorrectly temperature (not under refrigeration). Additional information is not expected, because the reporter refused to provide more details.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G decreased, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a 32 year old female patient. The patient had no pertinent medical history. On 28-NOV-2012 the patient was vaccinated with her first dose of VARIVAX (Merck) (lot number unknown) and on 02-JAN-2013 with her second dose. The patient used no concomitant medication. On 12-FEB-2013 a varicella/Zoster IgG titer was performed and the result was 0.81 Zoster IgG, where what was considered within normal limits from the lab after two doses would be 1.1 IgG or greater. No adverse effects reported. The outcome and relatedness of the event was not provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash maculo-papular, Swelling
Clinical narrative: 1 day after receiving vaccine pt developed rash on face, head, & scalp. Itching, swelling fine maculopapular & torso.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. On 05-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided), 0.65 ml, subcutaneous. Concomitant therapies included tuberculin purified protein derivative administered on 05-FEB-2013. The patient brought information that stated these treatments should not be given together. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a female physician of unknown age. On an unknown date in 2013, a few days ago, the patient was vaccinated with ZOSTAVAX (route, dose, and lot # were unknown). The morning after Vaccination, the patient experienced pain across her body, down to her legs and in her joints. There was not treatment given for the event. The outcome of event was reported as recovered/resolved. The patient did not sought medical attention. The relatedness for pain across her body, down to her legs in her joints was not reported for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a female registered nurse who is the patient via company representative refers of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose and lot number were not provided). On an unknown date, the patient administered the vaccination to herself, and had an injection site reaction. Nurse described the reactions as a hard silver dollar sized area of redness and swelling at the injection site. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness
Clinical narrative: C/o dizziness, comes in waves that started around noon today. I was advised by my doctor to wait it out & if necess. go to the Health Department. Denies rash or nausea. Instructed to go to an ER if worse.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Tremor
Clinical narrative: Mother reported child had high fever and a short shaking episode. Child was taken to emergency department for evaluation.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath. Tightness in the chest pt. was given BENADRYL capsule.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Last PNEUMOVAX 4/25/2012 (less than a year prior) - no adverse effect noted.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Prolonged pain & subjective weakness in arm where vaccine administered.
Age: 1.2
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash pruritic
Clinical narrative: Patient was seen in office 02/25/13 for low-grade fever, decreased appetite, and rash that was mildly pruritic. Rash was classic for varicella in immunized patients.
Age: 19.0
Sex: M
Vaccine: FLUX, TYP
Symptoms: Arthralgia, Pain
Clinical narrative: Severe joint pain in the shoulder of the injection site. Sharp burning and deep pain similar to a torn muscle. Pain is still severe and has actually become worse since onset.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Syncope
Clinical narrative: Flu shot administered at 4:40 PM in treatment room. Patient did not appear to have adverse physical or mental reaction. He walked to the front desk (approx 25 ft) took out his wallet, paid a fee for his flu injection, and then fell backwards, appearing to faint. This was witnessed by a staff member. Roused quickly, checked by paramedics, dismissed to go home.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose increased, Urticaria
Clinical narrative: Hives all over back.  Over the past months it has gotten worse and he cannot have a day without antihistamine.  It has also raised his glucose levels due to the stress of the hives.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Headache, Ophthalmological examination normal
Clinical narrative: Recurring partial vision loss (top 1/3 field of vision loss) in left eye lasting about 5 minutes and then recur an hour or more later.   Preceded by a headache the night before, but none at time of incident.  Sought diagnosis by visiting opthalmologist who proceeded with a retinal evaluation.  No retinal damage whatsoever (no tear, no detachment, no clots).  ??? Migraine-type vision loss even without migraine symptoms (had mediocre headache, not magnitude of migraine).  Never had migraines.  Symptoms of vision loss disappeared after 4 days and normal eye function.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Dermatitis diaper, Diarrhoea, Skin ulcer, Stool analysis normal
Clinical narrative: Diarrhea occurring 10 times a day and has lasted for 2 months now and is still continuing. Have tried solid foods to constipate her and a liquid zinc compound that hasn't helped. The diarrhea lead to a horrible diaper rash with open sores that took a month to heal.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus
Clinical narrative: 3" x 1½" oval, red, itchy swelling.  Firm/hard feeling to inflamed area.  Extends down arm from injection sight.  No symptoms until suddenly itchy and inflammation discovered at that time. Still ongoing 1st March 2013.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus, Swelling
Clinical narrative: 3" x 1½" oval, red, itchy swelling.  Firm/hard feeling to inflamed area.  Extends down arm from injection sight.  No symptoms until suddenly itchy and inflammation discovered at that time. Still ongoing 1st March 2013.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister
Clinical narrative: Blisters on hands and soles of feet.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: HIVES SINCE 2/14/2013.
Age: 49.0
Sex: F
Vaccine: DTAP, HEP, HEPA, PPV
Symptoms: Chills, Granulocyte count, Injection site pain, Injection site swelling, Lymphocyte count increased
Clinical narrative: Chills, soreness at injection site Rt arm, ill feeling. Took Ibuprofen 60 mg. During day of 2-28-2013 more soreness, chills. that eveing and into 3-1 early am - fever up to 101, increased soreness, swelling around injection site and nodule in right arm pit.
Age: 49.0
Sex: F
Vaccine: DTAP, HEP, HEPA, PPV
Symptoms: Malaise, Nodule, Pyrexia, White blood cell count increased
Clinical narrative: Chills, soreness at injection site Rt arm, ill feeling. Took Ibuprofen 60 mg. During day of 2-28-2013 more soreness, chills. that eveing and into 3-1 early am - fever up to 101, increased soreness, swelling around injection site and nodule in right arm pit.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Local reaction
Clinical narrative: Within 5 minutes of vaccination injection patient started to have a local reaction (redness and pseudopod) at the MMR and varicella injection site.  Pt was immediately assessed by Pediatric provider and was given 2.5ml oral Benadryl.  Pt's mother was instructed observe for further reactions and if needed go to local emergency room.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Computerised tomogram, Electroencephalogram, Laboratory test, Narcolepsy, Sleep study
Clinical narrative: Patient received the Flu Mist vaccine on October, 3, 2012 at school. The County Health Department was the vaccine administrator for her. Two months after she had received the Flu Mist, she was diagnosed with narcolepsy. She had a CT scan, EEG, and a sleep study done by Dr. Dr. was the one who discovered what was causing patient's symptoms. Also, her pediatrician's office ran tests to find out what was wrong with her.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Blood test normal, Decreased appetite, Fatigue, Helicobacter test negative
Clinical narrative: 02/04/2013 began complaining of upper abdominal pain/tightness and nausea only after eating. These symptoms continued daily for about 7-10 days. The abdominal pain and nausea then became constant and worse after consuming any amount of food and constant fatigue set in.  On 02/18/2013 doctor was visited and blood was drawn; all tests were negative. Zantac 75 was prescribed, taken daily, with no help. Nausea, fatigue, and abdominal pain persisted with fatigue increasing over time.  On 02/27/2013 doctor was visited again with further tests ordered. Doctor recommended Omeprazole and Claritin (for observed post-nasal drip).  As of 03/01/2013 there has been no change with continued fatigue, nausea, and upper abdominal pain/tightness. Patient is always "tired", has little appetite but does consume food at meal time although small quantities; always feels worse after eating.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle tightness, Nausea
Clinical narrative: 02/04/2013 began complaining of upper abdominal pain/tightness and nausea only after eating. These symptoms continued daily for about 7-10 days. The abdominal pain and nausea then became constant and worse after consuming any amount of food and constant fatigue set in.  On 02/18/2013 doctor was visited and blood was drawn; all tests were negative. Zantac 75 was prescribed, taken daily, with no help. Nausea, fatigue, and abdominal pain persisted with fatigue increasing over time.  On 02/27/2013 doctor was visited again with further tests ordered. Doctor recommended Omeprazole and Claritin (for observed post-nasal drip).  As of 03/01/2013 there has been no change with continued fatigue, nausea, and upper abdominal pain/tightness. Patient is always "tired", has little appetite but does consume food at meal time although small quantities; always feels worse after eating.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness, Flushing, Heart rate increased, Myalgia, Presyncope
Clinical narrative: Increased heart rate, dizziness, low-grade fever, near fainting spell, flush cheeks, muscle pain (arm, shoulder and back), and loss of ability to focus (went home from work).  Significantly elevated tinnitus symptoms as well.