chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
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 H015859, exp 26-JUN-2015) on 23-NOV-2012 (also reported as 23-NOV-2013), 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. Vaccine adverse event report was received from the Physician. Patient's demographics were updated. Illness at time of vaccination was reported as none. On 22-AUG-2012 at 04:24am, the received the second dose of MENACTRA (lot number 44349AA) intramuscular in her left arm. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Headache, Hypoaesthesia, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old male patient with high blood pressure. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (strength, dose unknown, lot # H019038, Expiration date: not provided; subcutaneous). Concomitant therapies included amlodipine. On 24-MAR-2013, 4 days after onset of therapy the patient developed Bell's Palsy. He had no feeling on the right side of his face, he cannot shut his right eye, and is having trouble drinking and eating due to the paralysis on the right of his face. The patient sought medical attention as on 28-MAR-2013 he went to the emergency room at the hospital. He was given famciclovir and prednisone as treatment for the AE. The patient states he is not recovering and still has all the symptoms at the time of reporting. No reporter causality provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paraesthesia, Tinnitus, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old male patient with high blood pressure. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (strength, dose unknown, lot # H019038, Expiration date: not provided; subcutaneous). Concomitant therapies included amlodipine. On 24-MAR-2013, 4 days after onset of therapy the patient developed Bell's Palsy. He had no feeling on the right side of his face, he cannot shut his right eye, and is having trouble drinking and eating due to the paralysis on the right of his face. The patient sought medical attention as on 28-MAR-2013 he went to the emergency room at the hospital. He was given famciclovir and prednisone as treatment for the AE. The patient states he is not recovering and still has all the symptoms at the time of reporting. No reporter causality provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Eyelid function disorder, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old male patient with high blood pressure. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (strength, dose unknown, lot # H019038, Expiration date: not provided; subcutaneous). Concomitant therapies included amlodipine. On 24-MAR-2013, 4 days after onset of therapy the patient developed Bell's Palsy. He had no feeling on the right side of his face, he cannot shut his right eye, and is having trouble drinking and eating due to the paralysis on the right of his face. The patient sought medical attention as on 28-MAR-2013 he went to the emergency room at the hospital. He was given famciclovir and prednisone as treatment for the AE. The patient states he is not recovering and still has all the symptoms at the time of reporting. No reporter causality provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eyelid function disorder, Headache, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old male patient with high blood pressure. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (strength, dose unknown, lot # H019038, Expiration date: not provided; subcutaneous). Concomitant therapies included amlodipine. On 24-MAR-2013, 4 days after onset of therapy the patient developed Bell's Palsy. He had no feeling on the right side of his face, he cannot shut his right eye, and is having trouble drinking and eating due to the paralysis on the right of his face. The patient sought medical attention as on 28-MAR-2013 he went to the emergency room at the hospital. He was given famciclovir and prednisone as treatment for the AE. The patient states he is not recovering and still has all the symptoms at the time of reporting. No reporter causality provided. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Nausea
Clinical narrative: Malaise, arthralgia, myalgia, rigors, nausea.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Tiredness, extremely weak, dizziness, extreme chills, shivers, pain at injection site. This last until 04/04 when I started experiencing rashes from the left side of my shoulder to across my chest. Insomnia 04/05--AM.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Rash
Clinical narrative: Tiredness, extremely weak, dizziness, extreme chills, shivers, pain at injection site. This last until 04/04 when I started experiencing rashes from the left side of my shoulder to across my chest. Insomnia 04/05--AM.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a 69 year old female patient. On an unknown date (reported as years ago), the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date (reported as so many years ago), the patient experienced redness, swelling that was itchy at the injection site after receiving the vaccination. It was unspecified if the patient had sought any medical attention or any lab tests were performed. The patient was treated with a steroid, prednisone steroid pack (reported as PRED PACK). The patient had recovered from all the events on an unknown date. The relatedness for all the events was unknown for PNEUMOVAX 23 (manufacturer unknown). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Full blood count, Incorrect dose administered, Muscle twitching, Urine analysis
Clinical narrative: This spontaneous report was received from a consumer concerning her approximately 15 year old daughter with no pertinent medical history. Current condition of the patient included sulfa allergy. On an unknown date in April 2012 (about a year ago), the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in 2012, the patient was vaccinated with dose 2 of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On an unknown date, the patient was vaccinated with dose 3 of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 28-MAR-2013, the patient was inadvertently vaccinated with dose 4 of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. Concomitant therapy included PRILOSEC. Approximately on 21-MAR-2013 (a week before the fourth dose), the patient experienced abdominal pain. However, after the fourth dose of GARDASIL, the medication had intensified the effect and had caused the patient to double over with pain. The patient was in so much pain that she had to go to an emergency room of an unspecified hospital. Since an unknown date, the patient was also experiencing involuntary twitching. The patient sought medical attention (went to an emergency room). The patient was treated with DEMEROL and with TYLENOL. On an unknown date, complete blood count (CBC) and urine tests were performed and the result was unknown. The patient had not recovered from the abdominal pain and involuntary twitching at the time of reporting. The relatedness for abdominal pain and involuntary twitching was unknown for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated intramuscular with 0.5 ml PNEUMOVAX23 lot # H014653, expiration date: 19-APR-2014. The anatomical location was not reported. On an unknown date the patient experienced fever. The outcome of fever was reported as recovered/resolved. This case was linked to cases 1303USA005018, 1304USA002367 and 1304USA002385 based on the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). ZOSTAVAX was exposed to temperature up to 24F for 67 days (1608 hours) and it was determined not viable. Improperly stored ZOSTAVAX had been administered to the patient. No adverse effects reported. This is one of several reports received from the same source (same reporter link: 1304USA002220 and 1304USA002221). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: No therapeutic response, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to an adult female patient of unknown age. On an unknown date, the adult patient was vaccinated with a 2 doses of MMR II (lot number, expiry date and route was not reported) when she was a child. On an unknown date, the patient had low rubella titers. Treatment was not provided. The outcome of low rubella titers was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 60-year-old female patient. Current condition included allergy to NEOSPORIN ear drops. Patient had experienced rash with NEOSPORIN ear drops in the past. On 20-MAR-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX, (lot# H022153, expiration date 18-MAR-2013) subcutaneously. Concomitant therapies included SYNTHROID and estrogens (unspecified), progesterone. On 22-MAR-2013, two days after vaccination with ZOSTAVAX, the patient experienced rash in on the forearm of the vaccinated arm and was vesicular. He reported that it was itchy but he stated he did not believe it to be varicella-like. The patient had not seen her physician nor had she taken any treatment for the rash. The outcome of the event was unknown. Medical attention was not sought for the events. Causalty was not reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a mother refers to her 15 year old son (who is also the patient). On an unknown date in JUN-2012, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in AUG-2012, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). The patient was yet to receive the third dose of the vaccine and it was well beyond the time frame for dosing listed in the Pl and no side effects was reported. This is one of the two assistant received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 26-MAR-2013 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# 0406AE, expiration date 25-MAR-2013, route not reported). No adverse event. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a mother refers to her 13 year old son (who is also the patient). On an unknown date in JUN-2012, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in AUG-2012, the patient was vaccinated with secod dose of GARDASIL, (lot number, expiry date and route was not reported). The patient was yet to receive the third dose of the vaccine and it was well beyond the time frame for dosing listed in the Pl and no side effects was reported. This is one of the two reports received from the same reporter. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Paraesthesia, Paraesthesia oral, Syncope
Clinical narrative: This spontaneous report as received from an office manager (healthcare worker) refers to a 12 year old male patient with allergic to KEFLIX and no pertinent medical history. On 05-AUG-2009 the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. On 27-MAR-2013 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot # H010649, EXP date 20-FEB-2015) intramuscularly. There was no concomitant therapy. On 05-AUG-2009 the patient experienced fainted after administration of his first dose of GARDASIL. The patient recovered without requiring medical treatment on an unspecified day. On later of 27-MAR-2013 the patient felt tingling in his arms, legs and tongue and he fainted. He was evaluated in an emergency room and was treated with prednisone and BENADRYL. The patient was seen in the office on 28-MAR-2013 and was found to be fully recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23, .5 ml, intramuscular. Anatomical location, lot number and expiration were not reported. On an unknown date the patient experienced injection site pain. The patient was afebrile. No treatment was provided. The outcome of injection site pain is unknown. The reporter did not provide the relatedness of injection site pain for PNEUMOVAX 23. This case was linked to cases 1303USA005018, 1304USA002367 and 1304USA002378, based on the same reporter. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a consumer refers to the reporter's 1 year old grand-daughter with no pertinent medical history or drug reactions/allergies. On 16-MAR-2013, "10 days ago", the patient was vaccinated with a M-M-R II. There was no concomitant therapy. On an unknown date the patient developed "swollen lymph nodes in the groin" after she was administered M-M-R II. The patient was evaluated by her unspecified physician and was prescribed amoxicillin. The outcome of swollen lymph nodes in the groin was reported as not recovered/not resolved. Additional information is not expected.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pain, Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 month old female patient with no medical history. On approximately 15-MAR-2013 the patient was vaccinated with (Merck) VARIVAX. Other suspect therapies included M-M-R II and hepatitis a vaccine (manufacturer unspecified). Concomitant therapies included PREVNAR. In March 20123, couple of days after vaccination, the patient developed a fever, achiness and runny nose. On approximately 22-MAR-2013, approximately 1 week after vaccination, the patient developed a measles like rash. On 24-MAR-2013, the patient was taken to an unspecified urgent care facility for medical attention. The outcome of runny nose, fever, measles like rash and achiness is unknown. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician, via a field representative, refers to a 2 year old female patient. On 19-MAR-2013 the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneous (dose number is unknown). No other co-suspects or concomitant medications were reported. Approximately a week later (assumed 26-MAR-2013) the patient developed a large, 2 inch  in diameter, red, hard welt on her leg at the site of injection. A call was made to the physician. The outcome of developed a large, 2 inch in diameter, red, hard welt on her leg at the site of injection was reported as not recovered/not resolved. The relatedness for developed a large, 2 inch in diameter, red, hard welt on her leg at the site of injection is unknown for (Merck) VARIVAX. The reporter cannot be contacted. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a patient of unknown age and gender. No medical history was reported. On 03-APR-2013, the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot # 670875/0631AA, expiry: 21-JAN-2013) that had expired. Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician refers to a 61 year old male patient. The patients medical history included bacterial meningitis 20 years ago. The patient had no drug allergies or reactions. on 13-MAR-2013, the patient was vaccinated with a dose of 0.65ml ZOSTAVAX, (lot number, expiry date was not reported, route was subcutaneous) in the left arm. Concomitant medications were not reported. On 25-MAR-2013, the patient developed pain, tingling and weakness of his left arm after receiving ZOSTAVAX. The outcome of the event was reported as recovering. The patient sought medical attention (phone call to physician). Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: On 4-3-13 mother brought her son age 1 yr into Health Dept for immunizations. Nurse administered a KINRIX instead of a Hib vaccine.
Age: 1.78
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt leg swollen and red, warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pustule, Injection site swelling
Clinical narrative: Erythema, swelling, small pustules approximately 3 cm x 4 cm diameter at (R) deltoid area.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction, Vaccination complication
Clinical narrative: Localized reaction to DTaP vaccine.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-FEB-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular, lot number H014283. On 15-FEB-2013 the patient experienced feeling achy, fever of 102.7 and pain at injection site. The patient was seen in the ER and was discharged the same day. Treatment information was not reported. On 16-FEB-2013, 3 days after onset of therapy the patient experienced left leg cellulitis (hospitalization). Treatment included intravenous clindamycin. The outcome of left leg cellulitis, fever, pain at injection site and achy is unknown. The relatedness for achy, pain at injection site, fever and cellulitis of the left leg was not reported for PNEUMOVAX23. This case was linked to cases 1303USA005018, 1304USA002378 and 1304USA002385, based on same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (no demographic details were provided). The patient's medical history was unknown. On an unspecified date (calculated as March 2013), the patient received a dose of ZOSTAVAX. No dosing information was provided. The expiration date of ZOSTAVAX was reported as 06-MAR-2013 and the lot number as 0169AE. No concomitant medications were reported. The reporter stated that the patient that the administered dose of ZOSTAVAX was expired. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 18 month shots were given to a 12 month old.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on upper torso and neck on 4-3-13. BENADRYL given, good effect noted by mother.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction on right thigh where PROQUAD was given. No evidence of infection. 3 in. in diameter. Red, swollen, hot to touch.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypertension, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: HTN in AM 191/106. Swelling, hard and pain and hot at injection site. No redness. Pressure in head, went to ER.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: HTN in AM 191/106. Swelling, hard and pain and hot at injection site. No redness. Pressure in head, went to ER.
Age: 1.05
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose normal, Caesarean section, Exposure during pregnancy, Live birth
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to GARDASIL was at 33 week(s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given birth to female infant weighing 6 lb 2 oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscular on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result:0Rh +); glucose test on 15-AUG-2012 (108 negative);maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012) (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012 (NL). The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days of gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via c-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine positive, Rhesus antibodies positive, Streptococcus test negative, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to GARDASIL was at 33 week(s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given birth to female infant weighing 6 lb 2 oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscular on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result:0Rh +); glucose test on 15-AUG-2012 (108 negative);maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012) (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012 (NL). The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days of gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via c-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood glucose normal, Blood group O, Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to GARDASIL was at 33 week(s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given birth to female infant weighing 6 lb 2 oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscular on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result:0Rh +); glucose test on 15-AUG-2012 (108 negative);maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012) (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012 (NL). The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days of gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via c-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine, Streptococcus test negative, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) on 19-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was pregnant before getting the vaccine. Initial exposure to GARDASIL was at 33 week(s) gestation. The patient's LMP was on approximately 01-FEB-2012 and EDD was on approximately 07-NOV-2012. The patient was exposed to GARDASIL during trimester 3. The outcome of the patient was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse concerning a 33 year-old female patient with a history of 1 previous pregnancies and 2 live births. Previously, the patient had given birth to female infant weighing 6 lb 2 oz on 29-SEP-2009 via C-section (38th week). Other relevant history was described as none known. The patient was not smoking and not using alcohol or drugs. The patient was inadvertently vaccinated with a dose of GARDASIL (lot number not reported) intramuscular on 19-SEP-2012. Concomitant medications included: generic prenatal vitamins (unspecified) and DIFLUCAN. The patient had been pregnant (LMP 02-FEB-2012, previously reported 01-FEB-2012) before vaccination. Method of confirmation: urine/serum pregnancy test (no details specified). Other lab test included: blood grouping on 31-MAY-2012 (result:0Rh +); glucose test on 15-AUG-2012 (108 negative);maternal serum alpha fetoprotein test (MSAFP) on 11-JUN-2012) (negative); B-streptococcal test on 14-OCT-2012 (negative) and ultrasound 01-OCT-2012 (NL). The patient gave birth to a male infant on 03-NOV-2012 via c-section, at 38 weeks and 4 days of gestation. There was no complication during delivery, the patient was not admitted to a hospital (or her stay was not prolonged). The baby was reported to be normal, with no congenital anomalies, weighing 6lb 8oz, length 19 inches. Apgar score was 8 after 1 minute and 9 after 5 minutes. No neonatal problems were reported. Causality for live birth via c-section was not reported. Upon internal review, the patient's live birth via C-section was determined to be another medically significant event. Additional information is not expected.