chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Exposure during pregnancy, Pyrexia, Vomiting
Clinical narrative: This is a prospective pregnancy case. This 37-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 13th July 2015. Concurrent medical conditions included thyroid disorder. Concomitant products included SYNTHROID and Prenatal Vitamins. The subject's last menstrual period was on 7th December 2014 and estimated date of delivery was 12th September 2015. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On 13th July 2015, 12 hrs after receiving BOOSTRIX, the subject developed fever (Non-serious). Additional event(s) included dehydration on 14th July 2015, vomiting on 14th July 2015 and vaccine exposure during pregnancy. The outcome of fever was recovered/resolved. The outcome(s) of the additional event(s) included dehydration (recovered/resolved), vomiting (recovered/resolved) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. Additional details were provided as follows: The patient received Tdap vaccine and unable to verify the brand name for Tdap. The reported batch number is (C4506AC or O4506AC), but this was not able to verify the Tdap vaccine as a GlaxoSmithKline vaccine. On 13th July 2015 (around 10 or 11 PM), 12 hours after receiving BOOSTRIX the patient experienced fever (a little over 100 degrees F). On 14th July 2015, 1 day after vaccination the patient experienced vomiting and dehydration. The patient was fine by end of the following day. The patient visited to her obstetrician due to fever and vomiting and the obstetrician stated that the patient was also dehydrated.
Sex: M
Vaccine: HEPAB
Symptoms: Condition aggravated, Inappropriate schedule of drug administration, Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus aggravated in a male patient who received TWINRIX adult (batch number 797K7, expiry date 29th April 2017). Co-suspect products included TWINRIX adult. Concurrent medical conditions included tinnitus. On 1st July 2015, the patient received the 1st dose of TWINRIX adult. On an unknown date, the patient received the 2nd dose of TWINRIX adult. In August 2015, not applicable after receiving TWINRIX adult and an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced tinnitus aggravated. On an unknown date, the outcome of the tinnitus aggravated and drug dose administration interval too long were unknown. It was unknown if the reporter considered the tinnitus aggravated to be related to TWINRIX adult. Additional details were provided as follows: The patient also received other vaccines on the same day but did not specify which vaccines. The patient was late for 2nd dose of TWINRIX adult and he was wondering how long he can wait for 2nd dose to receive, and still have it would be effective. The patient was also inquiring if there were any reports of tinnitus with TWINRIX. At the same time, the patient was emphasizing that he was not saying that TWINRIX caused tinnitus because he was already having tinnitus. The patient stated that, may be TWINRIX aggravated the tinnitus and may be not. The patient was extremely sensitive to offer any further information so no further information available. The reporter's call was transferred to MI.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. Approximately in 2015, an unspecified number of patients were vaccinated with an unspecified doses in series of LIQUID PEDVAXHIB lot number L009649, expiration date 29-NOV-2017 (dose and route of administration were not reported). The vaccine was improperly stored between 26-AUG-2015 and 01-SEP-2015. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. Since 08-JUL-2015, the patients were vaccinated with unknown doses of (Oka/Merck) VARIVAX (route was not reported, lot # L004650, expiry date: 11-FEB-2015), which were exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 01-AUG-2015, patients were vaccinated with VAQTA (dose, frequency and route of administration were not provided), lot # K019560, expiration date 02-JUN-2017; lot # L002717, expiration date 02-JUN-2017 and lot # K012457, expiration date 04-JUN-2017. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 01-AUG-2015, patients were vaccinated with ROTATEQ, (dose, frequency and route of administration were not provided), lot # K011948, expiration date 07-JUN-2016; lot # K020181, expiration date 24-JUN-2016 and lot # K024700, expiration date 30-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. Since 02-JUL-2015, unspecified patients were vaccinated with improperly stored (may have been exposed to temperatures outside of the recommended range) PROQUAD (Merck) (Lots # K023861, exp date 25-MAY-2016; L009208, exp date 31-OCT-2016; L005293, exp date 17-AUG-2016) (dose, route, frequency and strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reporter (MARRS # 1509USA003624). Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health care worker refers to a 18 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015, the patient was inadvertently given the adult formulation of VAQTA (route of administration, dose, lot number and expiration date were not reported). There was no adverse effects reported. There was no product quality complaints reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant were not reported. Approximately in 2015, an unspecified number of patients was vaccinated with GARDASIL lot number K010215, expiration date 05-MAY-2017 (dose and route of administration were not reported). The is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 24-AUG-2015, the patient was vaccinated with ZOSTAVAX of lot # L000461, expiry date: 08-MAR-2016 (dose and route were not reported). Other suspect therapy included Influenza virus vaccine (manufacturer unknown) which was also administered on 24-AUG-2015. Concomitant medications were not reported. On an unspecified date in AUG-2015 (also reported as approximately one week after vaccination) the patient was diagnosed with bronchitis and the patient was treated with an unspecified antibiotic. The outcome of bronchitis was reported as recovering. Causality assessment was not provided. Addditional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored (Oka/Merck) VARIVAX. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency and route of administration were not provided), lot # K007263, expiration date 09-JUN-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. Since 08-JUL-2015, the patients were vaccinated with unknown doses of PROQUAD (Merck) (route was not reported, lot # L007228, expiry date: 03-SEP-2015), which were exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Eye pain, Headache, Migraine, Pain of skin
Clinical narrative: Pt c/o constant migraines 2-3 days after receiving his 1st dose of Anthrax. Pain is dull across the eyes and temples/top of scalp. Daily occurrence.
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Palm size mild edema, erythema and pain to right upper arm surrounding the PREVNAR injection site. Patient was started on doxycycline 100mg BID x 5 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. Since 07-FEB-2015, unspecified patients were vaccinated with improperly stored (may have been exposed to temperatures outside of the recommended range) VARIVAX (Merck) (Lots # K008824, exp date 19-FEB-2016; K020760 exp date 31-OCT-2016; K15994, exp date 23-SEP-2016; L001327 exp date 13-JAN-2017) (dose, route, frequency and strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reported(MARRS #1508USA003624). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. Approximately in 2015, an unspecified number of patients were vaccinated with an unspecified doses in series of RECOMBIVAX HB lot number J007943, expiration date 05-FEB-2016 (dose and route of administration were not reported). The vaccine was improperly stored between 26-AUG-2015 and 01-SEP-2015. There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. Since 08-JUL-2015, the patients were vaccinated with unknown doses of ZOSTAVAX (route was not reported, lot# K006438, expiry date: 05-AUG-2015), which were exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, TTOX
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. In July 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported). Concomitant therapies included a dose of tetanus toxoid vaccine (manufacturer unknown) administered the same day. On an unknown date in 2015, reported as "an unspecified time after being administered both vaccines", the patient experienced hives. The outcome of urticaria and the relatedness between the hives and the PNEUMOVAX 23 were unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (CMA) referring to a patient of unknown gender and unknown age. On 20-AUG-2015, one dose of improperly stored (Oka/Merck) VARIVAX injection (lot  K010438, expiration date 22-JUL-2016) 0.5 ml in temperature excursion was administered to the patient subcutaneously. This VARIVAX (Oka/Merck) was patient's second dose but the date for patient's very first dose was not provided. No adverse effects were reported. The CMA also inquired the temperature stability. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency and route of administration were not provided), lot # L021361, expiration date 30-MAR-2017. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No pertinent medical history and concurrent conditions of the patient were reported. On 07-SEP-2015, the unspecified patient was vaccinated with ZOSTAVAX vial (Lo021609 and expiry date: 10-SEP-2016) (dose, site and route of administration not reported). On 08-SEP-2015, the patient woke up in the morning and noticed a "golf ball sized" swelling and injection site reaction. The patient was advised to ice the area. No laboratory details were provided. The patient sought for the medical attention and called the pharmacist. The outcome of injection site swelling and injection site erythema was unknown. The causality of the events was not reported. No product quality complaint (PQC) was filed. No further information was available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency and route of administration were not provided), lot # L021361, expiration date 30-MAR-2017. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever that wouldn't respond to TYLENOL or MOTRIN. Mom reported temp 103 degrees F axillary. 101 degrees F tympanic in office today. PA saw patient, re-assured parent that pt. seemed well. Reviewed concerning signs and symptoms. Continue alternating TYLENOL and MOTRIN as directed.
Age: 1.85
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Rash, Rash papular
Clinical narrative: Papulovesicular rash developed at injection site and antecubital area of same arm 2 days after Hep A #2 administered. Topical hydrocortisone and oral BENADRYL provided. Rash spread to trunk/face 6 days after injection, prednisone x 5 days provided.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: None observed at time of administration. Pt 8 wks pregnant at time of shot.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Contusion, Petechiae, Platelet count decreased
Clinical narrative: 8-30-15 -> mom noticed bruising. 9-3-15 to ER for petechiae, plts 4,000. 9-6-15 -> plts 1,000. Placed on high dose steroids. 9-8-15 plts 9,000. Followed by Hematology at hospital. Appts for repeat blood work.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 04-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (lot # L006386 and expiry date: 25-FEB-2017) injection of dose 0.5 milliliter (ml) once, subcutaneous. No concomitant medications were reported. No adverse events were experienced by the patient. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, warm to touch, swollen, itchy. Symptoms worsened on 09/10/15. Thigh checked 9/10/15, redness spreading, injection site harder to touch. Warm to touch, No fever.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 01-AUG-2015, patients were vaccinated with M-M-R II, (dose, frequency and route of administration were not provided), lot # K021151, expiration date 02-NOV-2016; lot # K022285, expiration date 12-NOV-2016; lot # K024038, expiration date 26-NOV-2016 and lot # reported as L001336, expiration date 13-JAN-2017. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored PROQUAD (Merck) lot# L014401, expiration date 23-OCT-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Back pain, Cyst, Depression, Dysthymic disorder
Clinical narrative: The following timeline starts a year prior to patient receiving the third dose of the GARDASIL Vaccine. This part pertains to headaches, tingling in hands, face and head, and fatigue. 1/29/12 started VYVANSE for ADHD. 7/20/12 received the first GARDASIL vaccine. 9/21/12 received the second GARDASIL vaccine. 1/23/13 PROAIR HFA prescribed. 1/23/13 Azithromycin prescribed. 1/23/13 Received the third GARDASIL vaccine. 2/14/13 Patient stopped taking VYVANSE about a month ago dur to the side effects and she didn't feel it was helping. Headaches started, tingling and fatigue. 2/15/13 started amphetamine for ADHD. Discontinued due to headaches, tingling and fatigue. 3/8/13 started methylphenidate for ADHD. Discontinued due to headaches, tingling and fatigue. 3/30/13 Diagnosed with Dysthymia Disorder. Still having headaches, tingling and fatigue. 11/22/13 started Bupropion for depression. Stopped after 2 months. Still having headaches, tingling and fatigue. 1/7/14 started seeing a new therapist. Started Neuro Biologic Advanced Neurotransmitter Support for ADHD. April of 2014 and an IEP was put in place at school to help with grades and stress. 9/9/14 Referred to institute and had MRI. Was told to take 200 mg of B2 to prevent headaches. Headaches continued and was told to increase to 400 mg of B2. Still having headaches-stopped B2. 10/14/14 seen another Dr. and was told to take Magnesium to prevent headaches. Still having headaches-stopped Magnesium. Tried peppermint oil to prevent headaches. Headaches continued-stopped using peppermint oil. 2/4/15 Started NEUROCORE to help with stress and anxiety. 3/14/15 Started chiropractor for neck and back pain. This timeline is for immune issue 4/24/14 Dermatologist prescribed doxycyc mono for staph infection. Condition worsened. 5/1/4 Dermatologist prescribed Levofloxacin. Condition worsened. 5/13/14 Infectious disease dr prescribed smz/tmp ds and mupirocin. Condition continued. 7/7/14 Infectious disease dr prescribed smz/tmp ds again. Condition continued. 10/8/14 Dermatologist prescribed ACTICLATE. 12/26/14 dermatologist diagnosed cyst to be surgically removed. 1/19/15 Plastic surgeon recommends surgically removing cyst.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Neck pain, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: The following timeline starts a year prior to patient receiving the third dose of the GARDASIL Vaccine. This part pertains to headaches, tingling in hands, face and head, and fatigue. 1/29/12 started VYVANSE for ADHD. 7/20/12 received the first GARDASIL vaccine. 9/21/12 received the second GARDASIL vaccine. 1/23/13 PROAIR HFA prescribed. 1/23/13 Azithromycin prescribed. 1/23/13 Received the third GARDASIL vaccine. 2/14/13 Patient stopped taking VYVANSE about a month ago dur to the side effects and she didn't feel it was helping. Headaches started, tingling and fatigue. 2/15/13 started amphetamine for ADHD. Discontinued due to headaches, tingling and fatigue. 3/8/13 started methylphenidate for ADHD. Discontinued due to headaches, tingling and fatigue. 3/30/13 Diagnosed with Dysthymia Disorder. Still having headaches, tingling and fatigue. 11/22/13 started Bupropion for depression. Stopped after 2 months. Still having headaches, tingling and fatigue. 1/7/14 started seeing a new therapist. Started Neuro Biologic Advanced Neurotransmitter Support for ADHD. April of 2014 and an IEP was put in place at school to help with grades and stress. 9/9/14 Referred to institute and had MRI. Was told to take 200 mg of B2 to prevent headaches. Headaches continued and was told to increase to 400 mg of B2. Still having headaches-stopped B2. 10/14/14 seen another Dr. and was told to take Magnesium to prevent headaches. Still having headaches-stopped Magnesium. Tried peppermint oil to prevent headaches. Headaches continued-stopped using peppermint oil. 2/4/15 Started NEUROCORE to help with stress and anxiety. 3/14/15 Started chiropractor for neck and back pain. This timeline is for immune issue 4/24/14 Dermatologist prescribed doxycyc mono for staph infection. Condition worsened. 5/1/4 Dermatologist prescribed Levofloxacin. Condition worsened. 5/13/14 Infectious disease dr prescribed smz/tmp ds and mupirocin. Condition continued. 7/7/14 Infectious disease dr prescribed smz/tmp ds again. Condition continued. 10/8/14 Dermatologist prescribed ACTICLATE. 12/26/14 dermatologist diagnosed cyst to be surgically removed. 1/19/15 Plastic surgeon recommends surgically removing cyst.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Stress
Clinical narrative: The following timeline starts a year prior to patient receiving the third dose of the GARDASIL Vaccine. This part pertains to headaches, tingling in hands, face and head, and fatigue. 1/29/12 started VYVANSE for ADHD. 7/20/12 received the first GARDASIL vaccine. 9/21/12 received the second GARDASIL vaccine. 1/23/13 PROAIR HFA prescribed. 1/23/13 Azithromycin prescribed. 1/23/13 Received the third GARDASIL vaccine. 2/14/13 Patient stopped taking VYVANSE about a month ago dur to the side effects and she didn't feel it was helping. Headaches started, tingling and fatigue. 2/15/13 started amphetamine for ADHD. Discontinued due to headaches, tingling and fatigue. 3/8/13 started methylphenidate for ADHD. Discontinued due to headaches, tingling and fatigue. 3/30/13 Diagnosed with Dysthymia Disorder. Still having headaches, tingling and fatigue. 11/22/13 started Bupropion for depression. Stopped after 2 months. Still having headaches, tingling and fatigue. 1/7/14 started seeing a new therapist. Started Neuro Biologic Advanced Neurotransmitter Support for ADHD. April of 2014 and an IEP was put in place at school to help with grades and stress. 9/9/14 Referred to institute and had MRI. Was told to take 200 mg of B2 to prevent headaches. Headaches continued and was told to increase to 400 mg of B2. Still having headaches-stopped B2. 10/14/14 seen another Dr. and was told to take Magnesium to prevent headaches. Still having headaches-stopped Magnesium. Tried peppermint oil to prevent headaches. Headaches continued-stopped using peppermint oil. 2/4/15 Started NEUROCORE to help with stress and anxiety. 3/14/15 Started chiropractor for neck and back pain. This timeline is for immune issue 4/24/14 Dermatologist prescribed doxycyc mono for staph infection. Condition worsened. 5/1/4 Dermatologist prescribed Levofloxacin. Condition worsened. 5/13/14 Infectious disease dr prescribed smz/tmp ds and mupirocin. Condition continued. 7/7/14 Infectious disease dr prescribed smz/tmp ds again. Condition continued. 10/8/14 Dermatologist prescribed ACTICLATE. 12/26/14 dermatologist diagnosed cyst to be surgically removed. 1/19/15 Plastic surgeon recommends surgically removing cyst.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a patient of unknown demographics. Concurrent conditions and pertinent medical history were unknown. On an unknown date the patient was vaccinated with GARDASIL (dosing details unknown). It was reported that the patient fainted after receiving GARDASIL. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician to an unspecified number of unspecified patients of unknown age and gender. The patient's pertinent medical histories and drug reactions/allergies were not reported. Since 29-JUN-2015, the patients were administered an unspecified number of doses of M-M-R II, (Oka/Merck) PROQUAD and (Oka/Merck) VARIVAX (all doses, lot#, expiration date and route were not reported, which   were reconstituted with improperly stored expired sterile diluent (Merck sterile diluent) (lot # K012002 with expiration date 21-JUN-2017; lot # K016443, with expiration date 12-JUL-2017; lot # K018026 with expiration date 17-AUG-201 and lot # K024557 with expiration date 10-OCT-2017. No adverse effect was reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site joint pain, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 42 year old female patient. The patient had no drug reaction/allergies. On 26-AUG-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# was reported as I022262 with expired date 05-NOV-2016, intramuscular, dose was unknown) for vaccination. No concomitant therapy was reported. During the same evening, the patient experienced injection site swelling, tenderness, joint pain and chest pain. The patient did not seek any medical attention. No treatment was given and no lab tests were performed. On 27-AUG-2015, the patient, who also worked at the same pharmacy where the vaccine was administered, stated that the events "injection site swelling, tenderness, joint pain and chest pain" were resolving. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from the patient's father, referring to his 14 month old son. No patient's medical history, concurrent conditions and drug reactions or allergies were present at the time of the report. On 31-AUG-2015, the patient was vaccinated subcutaneously with a dose of MMR II (dose, lot # and expiration date were not reported) for measles, mumps and rubella prophylaxis. On the same date, on 31-AUG-2015 a few hours after receiving the vaccine, the patient had red spots on his back between his shoulder blades and on his lower neck. The patient was treated with BENADRYL the same evening and recovered on unspecified date in 2015. No concomitant therapies were reported. No laboratory diagnostic studies were performed. The father's patient sought unspecified medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 67 year old male patient. The patient did not report any medical history nor drug allergy. On 29-AUG-2015, the patient was vaccinated subcutaneously in his left deltoid with a dose of ZOSTAVAX lot # L012477, expiration date: 10-JUL-2016 (strength, dose and frequency was not reported). The patient did not report any concomitant medication at that time. On 01-SEP-2015, the patient began to experience left shoulder and neck pain. The reporter stated that the patient called the pharmacy for guidance on 02-SEP-2015 as the pain still persisted, however no treatment was given. No further information was provided. At the time of the report, the outcome of left shoulder and neck pain was reported as not recovered. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered  Nurse refers to a 19 year old patient of unknown gender. The patient's concurrent conditions and pertinent medica history were not reported. On 16-AUG-2010, the patient was vaccinated with the first dose of VAQTA, (Lot #, exp. date, strength and dose were nor provided). On 17-JUL-2015, the patient was administered the second doe of VAQTA, (Lot #, exp. date , strength and dose were not provided). The reporting nurse stated that the second dose was a pediatric dose rather than the indicated adult dose. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 08-SEP-2015, the patient was inadvertently administered a dose of (Oka/Merck) VARIVAX (route, lot number and expiration date were not provided) and a dose of (Oka/Merck) PROQUAD (route, lot number and expiration date were not provided) was administered to the patient so there was an overdose. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 64 year old female patient. No concurrent or historical condition was reported. On an unspecified date in October 2011, the patient received an initial dose of PNEUMOVAX 23, lot number, expiration date, dose, route, frequency and anatomical location were not reported. On 10-JAN-2012 the patient received a second dose of PNEUMOVAX 23, lot number, expiration date, dose, route, frequency and anatomical location were not reported. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an unknown age female patient concerning on herself. The patient's concurrent conditions and medical history were not reported. On an unknown date, approximately in 2008, reporter as "7 seven years ago", the patient was vaccinated with the first dose of GARDASIL, injection, (route of administration, anatomical location, lot number and expiration date were not provided). She did not completed the series for unspecified reasons. On an unknown date, approximately in July 2015m reporter as "two months ago", the patient was vaccinated with the second dose of GARDASIL, injection, (route of administration, anatomical location, lot number and expiration date were not provided). The reporter stated that she would follow up with her physician for her third and final dose of the series. There were not adverse events reported. There was not a product quality issue involved. Additional information is not expected since the reporter details are not available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. In August 2015, the patients were vaccinated with RECOMBIVAX HB lot # J013394, expiration date 25-AUG-2016 and lot number L001456, expiration date 22-OCT-2016 (routes were not provided). Concomitant therapy information was not provided. In August 2015, there was an incorrect product storage as unspecified doses of improperly stored RECOMBIVAX HB were administered to unspecified patients. No adverse events were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Secondary transmission
Clinical narrative: This spontaneous report was received from a health professional concerning an adult male patient of approximately 30 years of age. It was reported that the patient had no risk factors other than the patient had never had chickenpox. Approximately in 2013, reported as two years earlier, the patient experienced a varicella-like rash, after his young child had recently been vaccinated with VARIVAX  (dose, frequency, route, lot No. were not reported). No Product Quality Issue was reported. At the time of this report, the outcome of varicella-like rash was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 08-SEP-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # J013450 Expiration date: 24-JAN-2015) (dose, route and anatomical location of administration were not reported). No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. On unspecified dates, the patient presented allergies to BACTRIM, CECLOR, VICODIN, penicillin (MARRS case # 1509USA005344), ULTRAM, codeine and rauwolfia. No pertinent medical history was reported. On 16-JUL-2015 the patient was vaccinated with ZOSTAVAX, subcutaneous, 0.65 ml, once, lot # L015416, expiration date 01-AUG-2016. Concomitant therapies included albuterol (manufacturer unknown), COMBIVENT, CARTIA, levothyroxine (manufacturer unknown), lovastatin, metformin, montelukast (manufacturer unknown), omeprazole (manufacturer unknown), ranitidine and warfarin. On an unspecified date, in 2015, after vaccination, the patient developed shingles. On 02-SEP-2015 the patient was seen by a healthcare provider and was prescribed with unspecified corticosteroid for treatment. No laboratory diagnostics studies were performed. At the time of reporting, the outcome of shingles was reported as not recovered. The reporter did not assess the relationship between ZOSTAVAX and shingles. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and allergies were not reported. On unknown dates, the unspecified patients were vaccinated with (Merck) PROQUAD, (lot # L017140 with expiration date: 13-NOV-2016), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. Other suspect and concomitant therapies were not reported. No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On an unknown dates, the unspecified patients were vaccinated with dose of (Oka/Merck) VARIVAX, (lot # K005426 with expiration date: 15-APR-2016; and lot# reported as J011407 with expiration date: 13-NOV-2015 00), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. Other suspect and concomitant therapies were not reported. No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2016, the patients were administered doses of PNEUMOVAX 23 lot number K006681, expiration date 21-OCT-2015 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2016, the patient were administered doses of GARDASIL 9 lot numbers: K26242, expiration date 28-JAN-2017; K026247, expiration date 29-JAN-2017; L007560, expiration date 15-JUN-2017 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2015, the patents were administered doses of GARDASIL lot numbers:  K007828, expiration date 02-MAR-2017; K010215, expiration date 05-MAY-2017; K010574, expiration date 08-APR-2017; K011562, expiration date 08-APR-2017; H021861, expiration date 09-OCT-2015 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. Since 26-JUL-2016, the patients were administered doses of oral, ROTATEQ lot numbers: K001716, expiration date 24-NOV-2016; K009753, expiration date 28-APR-2016; and lot number reported as K008144, expiration date 12-FEB-2016 (dose, strength and frequency were not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Started to have swelling and redness in the pm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Haematoma, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient had no pertinent medical history or drug reactions/allergies. On 29-JAN-2015 the patient was vaccinated with one dose of ZOSTAVAX, (dose: 1 injection), subcutaneously in her arm (lot # and expiration date were not reported). No concomitant therapy was given. The next day, on 30-JAN-2015, the patient woke up and experienced pain in the arm the vaccine was administered. Her arm was "sore and purple". The pain subsided but two weeks later the pain reappeared and had been progressively worse. The patient still experienced pain. The patient had sought physician treatment, taking unspecified medication and physical therapy, but still had the symptoms. The patient had a magnetic resonance imaging (MRI) and would receive the results very soon. The outcome of the events was reported as not recovered. Additional information is not expected as there was no consent from the reporter to let us contact her doctor.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site haematoma, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient had no pertinent medical history or drug reactions/allergies. On 29-JAN-2015 the patient was vaccinated with one dose of ZOSTAVAX, (dose: 1 injection), subcutaneously in her arm (lot # and expiration date were not reported). No concomitant therapy was given. The next day, on 30-JAN-2015, the patient woke up and experienced pain in the arm the vaccine was administered. Her arm was "sore and purple". The pain subsided but two weeks later the pain reappeared and had been progressively worse. The patient still experienced pain. The patient had sought physician treatment, taking unspecified medication and physical therapy, but still had the symptoms. The patient had a magnetic resonance imaging (MRI) and would receive the results very soon. The outcome of the events was reported as not recovered. Additional information is not expected as there was no consent from the reporter to let us contact her doctor.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Skin discolouration
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient had no pertinent medical history or drug reactions/allergies. On 29-JAN-2015 the patient was vaccinated with one dose of ZOSTAVAX, (dose: 1 injection), subcutaneously in her arm (lot # and expiration date were not reported). No concomitant therapy was given. The next day, on 30-JAN-2015, the patient woke up and experienced pain in the arm the vaccine was administered. Her arm was "sore and purple". The pain subsided but two weeks later the pain reappeared and had been progressively worse. The patient still experienced pain. The patient had sought physician treatment, taking unspecified medication and physical therapy, but still had the symptoms. The patient had a magnetic resonance imaging (MRI) and would receive the results very soon. The outcome of the events was reported as not recovered. Additional information is not expected as there was no consent from the reporter to let us contact her doctor.