chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient's drug reactions/allergies included anaphylaxis and codeine allergy. On 03-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot number reported J001003, expiration date April 2014) 0.65 ml once only, subcutaneous in the right deltoid. Concomitant therapies included PRILOSEC, amitriptyline hydrochloride (manufacturer unknown), CRESTOR and sertraline hydrochloride. On 04-JUN-2013, the patient noticed "a red spot which was warm to touch and about the size of a half dollar" on her right deltoid area which was the vaccine site. On the same date, the patient was seen by her physician on for the injection reaction, and was told by her physician "that it was normal to have this type of reaction after the administration of a vaccine." 05-JUN-2013, the patient returned to the pharmacy to make this pharmacist aware of the injection site reaction. She also informed this pharmacist that her unspecified physician ordered topical cortisone cream and TYLENOL to be used as needed for the injection site reaction. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient received the first dose of GARDASIL (route, dose and lot number not provided), in April of 2008, the second dose of GARDASIL (route, dose and lot number not provided) in June of 2008 (exact dates unspecified) and was in the office on 10-JUN-2013 to receive the third dose of GARDASIL (route, dose and lot number not provided). No adverse event was reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician regarding a male patient of unknown age with no pertinent medical history reported. Approximately on 01-JUN-2013 (reported as "about 10 days ago") the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) 0.65 ml, subcutaneous, once) for prevention. No other suspect therapies or concomitant medications were reported. Approximately on 01-JUN-2013 (reported as "about 10 days ago") the patient presented with "shingle-like" symptoms after receiving ZOSTAVAX. The outcome for "shingle-like" symptoms was unknown at the time of the report. No treatment information was reported. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Erythema, Pain in extremity, Phlebitis, Rash
Clinical narrative: This spontaneous report as received from registered nurse and a pharmacist concerning a 22 year old female patient with penicillin allergy (PCN), current smoker and pertussis vaccine allergy, occupation unknown. None illness were reported at the time of vaccination. The patient's medical history included delivery of the baby (new mom). On 13-MAR-2013 21:45 PM the patient was vaccinated with PNEUMOVAX 23 dose, in the left thigh (lot # reported as H026843 exp date unknown) after being given an epidural and after delivery of the baby. The pharmacist reported that subsequently the vaccination in approximately 13-MAR-2013 the patients developed swelling and phlebitis. It was noted that in March 2013 AT 5:24 am, the patient also have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23 and also have needed to come back to the emergency room for unspecified treatment. The registered nurse reported that on 16-MAR-2013 the patient experienced swelling (also reported as subsequently vaccination), had a rash, red and warm to touch, that required an emergency room or doctor visit. The patient was discharged to home and not narcotic pain medications orally or topically were given. The outcome of swelling, having a rash, red and warm to touch was reported recovered. The outcome of phlebitis and severe pain in their legs and not been able to walk was unknown. This is one of several reports from the same reporter. Lot number H026843 is an invalid lot number for pneumococcal vaccine, polyvalent. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report as received from registered nurse and a pharmacist concerning a 22 year old female patient with penicillin allergy (PCN), current smoker and pertussis vaccine allergy, occupation unknown. None illness were reported at the time of vaccination. The patient's medical history included delivery of the baby (new mom). On 13-MAR-2013 21:45 PM the patient was vaccinated with PNEUMOVAX 23 dose, in the left thigh (lot # reported as H026843 exp date unknown) after being given an epidural and after delivery of the baby. The pharmacist reported that subsequently the vaccination in approximately 13-MAR-2013 the patients developed swelling and phlebitis. It was noted that in March 2013 AT 5:24 am, the patient also have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23 and also have needed to come back to the emergency room for unspecified treatment. The registered nurse reported that on 16-MAR-2013 the patient experienced swelling (also reported as subsequently vaccination), had a rash, red and warm to touch, that required an emergency room or doctor visit. The patient was discharged to home and not narcotic pain medications orally or topically were given. The outcome of swelling, having a rash, red and warm to touch was reported recovered. The outcome of phlebitis and severe pain in their legs and not been able to walk was unknown. This is one of several reports from the same reporter. Lot number H026843 is an invalid lot number for pneumococcal vaccine, polyvalent. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with history of herpes outbreaks and penicillin allergy. On 17-APR-2013 the patient was vaccinated with ZOSTAVAX, (subcutaneous, concentration and lot number unknown). Concomitant therapies included VALTREX and SYNTHROID. In approximately May 2013 (reported as a couple of days ago) the patient experienced rash on an unspecified part of her body. The patient sought for medical attention, called the pharmacist to see if she can take VALTREX again. The pharmacist reported that the patient has "an ongoing issue with herpes and has been getting prescriptions of VALTREX for a while now". No treatment was given. The outcome of rash on an unspecified part of her body and an ongoing issue with herpes was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Breath sounds abnormal, Erythema, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with VARIVAX (Merck) (lot# H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the right thigh, strength not specified) and M-M-R II (lot # not reported) (in the left thigh, strength and total daily dose not reported). It was reported that "three to four days later", on approximately 28-APR-2013, the child developed red dots on her torso that were not itchy, lasting one to two days before fading, no fever, mildly fussy, fighting sleep. On 03-MAY-2013, she developed redness and swelling on her right thigh with raised bumps. She was examined on 06-MAY-2013, but no treatment was prescribed. The outcome of mildly fussy, fighting sleep and redness and swelling on her right thigh with raised bumps was unknown. This is one of several reports received from the same source. The patient's twin sister experienced almost identical symptoms (related ID: 1306USA006730). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Productive cough, Rash
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with VARIVAX (Merck) (lot# H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the right thigh, strength not specified) and M-M-R II (lot # not reported) (in the left thigh, strength and total daily dose not reported). It was reported that "three to four days later", on approximately 28-APR-2013, the child developed red dots on her torso that were not itchy, lasting one to two days before fading, no fever, mildly fussy, fighting sleep. On 03-MAY-2013, she developed redness and swelling on her right thigh with raised bumps. She was examined on 06-MAY-2013, but no treatment was prescribed. The outcome of mildly fussy, fighting sleep and redness and swelling on her right thigh with raised bumps was unknown. This is one of several reports received from the same source. The patient's twin sister experienced almost identical symptoms (related ID: 1306USA006730). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Insomnia, Irritability
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with VARIVAX (Merck) (lot# H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the right thigh, strength not specified) and M-M-R II (lot # not reported) (in the left thigh, strength and total daily dose not reported). It was reported that "three to four days later", on approximately 28-APR-2013, the child developed red dots on her torso that were not itchy, lasting one to two days before fading, no fever, mildly fussy, fighting sleep. On 03-MAY-2013, she developed redness and swelling on her right thigh with raised bumps. She was examined on 06-MAY-2013, but no treatment was prescribed. The outcome of mildly fussy, fighting sleep and redness and swelling on her right thigh with raised bumps was unknown. This is one of several reports received from the same source. The patient's twin sister experienced almost identical symptoms (related ID: 1306USA006730). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with VARIVAX (Merck) (lot# H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the right thigh, strength not specified) and M-M-R II (lot # not reported) (in the left thigh, strength and total daily dose not reported). It was reported that "three to four days later", on approximately 28-APR-2013, the child developed red dots on her torso that were not itchy, lasting one to two days before fading, no fever, mildly fussy, fighting sleep. On 03-MAY-2013, she developed redness and swelling on her right thigh with raised bumps. She was examined on 06-MAY-2013, but no treatment was prescribed. The outcome of mildly fussy, fighting sleep and redness and swelling on her right thigh with raised bumps was unknown. This is one of several reports received from the same source. The patient's twin sister experienced almost identical symptoms (related ID: 1306USA006730). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Irritability, Rash
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with (merck) VARIVAX (lot # H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the left thigh, strength not specified) and M-M-R II (lot # not reported) (in the right thigh, strength and total daily dose not reported). It was reported that this patient experienced almost identical symptoms (with her twin sister (related ID: 1306USA004508), except that the spots developed on the left thigh in which the (merck) VARIVAX was administered. The identical symptoms included: red dots on her torso that were not itchy, mildly fussy, fighting sleep and redness and swelling on her vaccinated thigh with raised bumps. It was unspecified whether the patient sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been with.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with (merck) VARIVAX (lot # H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the left thigh, strength not specified) and M-M-R II (lot # not reported) (in the right thigh, strength and total daily dose not reported). It was reported that this patient experienced almost identical symptoms (with her twin sister (related ID: 1306USA004508), except that the spots developed on the left thigh in which the (merck) VARIVAX was administered. The identical symptoms included: red dots on her torso that were not itchy, mildly fussy, fighting sleep and redness and swelling on her vaccinated thigh with raised bumps. It was unspecified whether the patient sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been with.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Irritability, Sleep disorder
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old female patient. On 25-APR-2013 the patient was vaccinated with (merck) VARIVAX (lot # H018457, expiry date 05-OCT-2017) (1350 U, 0.5 ml, subcutaneous in the left thigh, strength not specified) and M-M-R II (lot # not reported) (in the right thigh, strength and total daily dose not reported). It was reported that this patient experienced almost identical symptoms (with her twin sister (related ID: 1306USA004508), except that the spots developed on the left thigh in which the (merck) VARIVAX was administered. The identical symptoms included: red dots on her torso that were not itchy, mildly fussy, fighting sleep and redness and swelling on her vaccinated thigh with raised bumps. It was unspecified whether the patient sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been with.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Chest discomfort, Chest pain, Nausea
Clinical narrative: Nausea started soon after vaccination and has persisted for 3d.  On day 3 after vaccine also developed chest tightness and intermittent pain.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Nausea, Oedema peripheral
Clinical narrative: Headache, nausea, fever onset next day and spiked to 102, upset stomach, diarrhea two days later, swelling and soreness in both arms.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache, nausea, fever onset next day and spiked to 102, upset stomach, diarrhea two days later, swelling and soreness in both arms.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Fluid retention, Pruritus
Clinical narrative: Fluid build up/knotting in bicep. Itching and discomfort. Still present as of 06/15/2013.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: Onset of shingles on arm where vaccine was given. Numbness in arm and hand.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain, Arthralgia, Back pain, Chills, Headache
Clinical narrative: Fever 101.2, child complained of headache and joint pain specifically ankles and knees, and back pain.  Also complained of abdominal pain, and vomit.  In addition he had chills and the start of a runny nose. This exact same thing happened when this injection was given to my other child.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Fever 101.2, child complained of headache and joint pain specifically ankles and knees, and back pain.  Also complained of abdominal pain, and vomit.  In addition he had chills and the start of a runny nose. This exact same thing happened when this injection was given to my other child.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient had tingling pain in left arm starting day after vaccine was administered. Pain was very painful for two weeks. Pain is less severe but continues to present time. Pain is relieved by Ibuprofen or TYLENOL.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 05-JUN-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 672608/1715AA, expiration date 02-FEB-2013 and route not reported). The pharmacist stated that the patient administered an expired ZOSTAVAX to himself/herself. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult patient of unknown age and gender. On 03-JUN-2013 the patient was vaccinated with a pediatric dose (0.5 milliliter (ml)) RECOMBIVAX HB (lot#, expiration date not reported) intramuscularly (strength : 5 micrograms/0.5 ml). This was the first dose of RECOMBIVAX HB administered to this patient. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 02-MAY-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # 1200AA, expiration date 14-APR-2013) 0.5 ml, intramuscular (therapy route unspecified). The Registered Nurse reported that a patient was administered an expired dose of PNEUMOVAX 23. The Registered Nurse was unsure if any more patients were administered the expired dose of PNEUMOVAX 23 but was aware of one unspecified patient. No adverse effect reported. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Cerebral palsy, Computerised tomogram, Electroencephalogram, Irritability, Lethargy
Clinical narrative: During the week following the vaccines, patient was lethargic and irritable.  Within the week, he also began twitching during diaper changes.  The twitching started in his legs and gradually moved to his entire body.  We took him back to his family doctor who told us that he was fine & this reaction was normal. We ended up taking him to the emergency room two weeks later because we thought he was having seizures.  He was diagnosed with cerebral palsy.  Prior to his vaccinations, patient was a fully functioning, normally developing infant.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging
Clinical narrative: During the week following the vaccines, patient was lethargic and irritable.  Within the week, he also began twitching during diaper changes.  The twitching started in his legs and gradually moved to his entire body.  We took him back to his family doctor who told us that he was fine & this reaction was normal. We ended up taking him to the emergency room two weeks later because we thought he was having seizures.  He was diagnosed with cerebral palsy.  Prior to his vaccinations, patient was a fully functioning, normally developing infant.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Employee received Hep-B #3 6/12/2013, donor returned to center 6/14/2013 and has swelling, warm to touch at injection site of wheal.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling hot, Hypoaesthesia
Clinical narrative: Weakness, feeling of warm in hands and legs, numbness in feet.
Age: 0.17
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an approximately 8 week old patient of unknown gender. On 18-MAR-2013, the patient was vaccinated with a dose of MMR II (lot number and expiry date reported as H015829 and August 2014 respectively, dose unspecified), subcutaneously instead of a polio vaccine (manufacturer unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age, unknown gender. On 07-JUN-2013 the patient was vaccinated with an expired VARIVAX (Merck) (lot # 670700/0817AA, expiry date 02-JUN-2013, strength, dose, frequency, route and site unspecified). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood test, Headache, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Patient is a 14-year-old left-handed young gentleman who presents now for evaluation of "headaches every day." He has a personal history of motion sickness. There is no family history of headache. In June of 2011, he had a minor concussion, from which he recovered completely. He recalls mild intermittent headaches of no significant consequence. In the last week of January, he was given the GARDASIL immunization. During the first week of February, he developed "this headache that never went away." He describes a bilateral temporal or occipital sharp pain at a level of 9/10 initially, although in retrospect he re-grades this at a level 6/10. Occasionally this has "spikes of pain" that may a reach a level 9, but these are relatively brief. The headache does not change much with activity, and he is actually able to run through many of these days. There is no prodrome, aura or postdrome. He has had no significant nausea, vomiting, photophobia or osmophobia. Occasionally there is some phonophobia. Over the course of the first couple of weeks with these headaches, he had transient fevers and fatigue, but no persistent symptoms have been noted. Emergency department treatments at hospital were unhelpful, as was a hospitalization. Trials of natural supplements, amitriptyline, MAXALT, IMITREX, and steroids were also generally ineffective. At most, "some of the medications just took a slight edge off the headache." He has had no neurological complications. IMPRESSION; POST-IMMUNIZATION HEADACHE SYNDROME The features are quite typical of a newly daily persistent headache syndrome. This syndrome may occur spontaneously, but sometimes is seen in the context of a viral infection or immunization. Given the timing, I have discuseed the options with the patient and his mother, and also the differential diagnosis, which includes chronic migraine or chronic tension-type headache. The lack of response to any medication options seems to indicated an NDPH-related phenomenon, and when following immunization, such symptoms may last 6 to 24 months. This prognosis was also reviewed with the patient and his mother. Numerous natural/lifestyle measures for headache stabilization were discussed and reviewed in handout form. No daily medication is typically helpful in this setting, but the amitriptyline may help with mood and sleep control while the daily headache is being managed. We discussed strict regulation of sleep, meals, exercise hydration and school attendance. Absolutely no restrictions on activity were placed. Headache education and instructions were provided to the patient and his mother, and follow up was left here on an open amitriptyline.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Face and mouth X-ray, Fatigue, Headache, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: Patient is a 14-year-old left-handed young gentleman who presents now for evaluation of "headaches every day." He has a personal history of motion sickness. There is no family history of headache. In June of 2011, he had a minor concussion, from which he recovered completely. He recalls mild intermittent headaches of no significant consequence. In the last week of January, he was given the GARDASIL immunization. During the first week of February, he developed "this headache that never went away." He describes a bilateral temporal or occipital sharp pain at a level of 9/10 initially, although in retrospect he re-grades this at a level 6/10. Occasionally this has "spikes of pain" that may a reach a level 9, but these are relatively brief. The headache does not change much with activity, and he is actually able to run through many of these days. There is no prodrome, aura or postdrome. He has had no significant nausea, vomiting, photophobia or osmophobia. Occasionally there is some phonophobia. Over the course of the first couple of weeks with these headaches, he had transient fevers and fatigue, but no persistent symptoms have been noted. Emergency department treatments at hospital were unhelpful, as was a hospitalization. Trials of natural supplements, amitriptyline, MAXALT, IMITREX, and steroids were also generally ineffective. At most, "some of the medications just took a slight edge off the headache." He has had no neurological complications. IMPRESSION; POST-IMMUNIZATION HEADACHE SYNDROME The features are quite typical of a newly daily persistent headache syndrome. This syndrome may occur spontaneously, but sometimes is seen in the context of a viral infection or immunization. Given the timing, I have discuseed the options with the patient and his mother, and also the differential diagnosis, which includes chronic migraine or chronic tension-type headache. The lack of response to any medication options seems to indicated an NDPH-related phenomenon, and when following immunization, such symptoms may last 6 to 24 months. This prognosis was also reviewed with the patient and his mother. Numerous natural/lifestyle measures for headache stabilization were discussed and reviewed in handout form. No daily medication is typically helpful in this setting, but the amitriptyline may help with mood and sleep control while the daily headache is being managed. We discussed strict regulation of sleep, meals, exercise hydration and school attendance. Absolutely no restrictions on activity were placed. Headache education and instructions were provided to the patient and his mother, and follow up was left here on an open amitriptyline.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Phonophobia, Pyrexia, Tension headache
Clinical narrative: Patient is a 14-year-old left-handed young gentleman who presents now for evaluation of "headaches every day." He has a personal history of motion sickness. There is no family history of headache. In June of 2011, he had a minor concussion, from which he recovered completely. He recalls mild intermittent headaches of no significant consequence. In the last week of January, he was given the GARDASIL immunization. During the first week of February, he developed "this headache that never went away." He describes a bilateral temporal or occipital sharp pain at a level of 9/10 initially, although in retrospect he re-grades this at a level 6/10. Occasionally this has "spikes of pain" that may a reach a level 9, but these are relatively brief. The headache does not change much with activity, and he is actually able to run through many of these days. There is no prodrome, aura or postdrome. He has had no significant nausea, vomiting, photophobia or osmophobia. Occasionally there is some phonophobia. Over the course of the first couple of weeks with these headaches, he had transient fevers and fatigue, but no persistent symptoms have been noted. Emergency department treatments at hospital were unhelpful, as was a hospitalization. Trials of natural supplements, amitriptyline, MAXALT, IMITREX, and steroids were also generally ineffective. At most, "some of the medications just took a slight edge off the headache." He has had no neurological complications. IMPRESSION; POST-IMMUNIZATION HEADACHE SYNDROME The features are quite typical of a newly daily persistent headache syndrome. This syndrome may occur spontaneously, but sometimes is seen in the context of a viral infection or immunization. Given the timing, I have discuseed the options with the patient and his mother, and also the differential diagnosis, which includes chronic migraine or chronic tension-type headache. The lack of response to any medication options seems to indicated an NDPH-related phenomenon, and when following immunization, such symptoms may last 6 to 24 months. This prognosis was also reviewed with the patient and his mother. Numerous natural/lifestyle measures for headache stabilization were discussed and reviewed in handout form. No daily medication is typically helpful in this setting, but the amitriptyline may help with mood and sleep control while the daily headache is being managed. We discussed strict regulation of sleep, meals, exercise hydration and school attendance. Absolutely no restrictions on activity were placed. Headache education and instructions were provided to the patient and his mother, and follow up was left here on an open amitriptyline.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Drooling, Erythema, Injection site erythema, Irritability, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old patient. On 20-MAY-2013 the patient was vaccinated with (merck) VARIVAX (lot # H018782, expiry date 15-OCT-2014) (1350 U, 0.5 ml, subcutaneous in the left thigh, strength not specified) and M-M-R II (lot # not reported) (in the right thigh, strength and total daily dose not reported). It was reported that an unspecified hepatitis A vaccine (manufacturer unknown) (lot # not reported) was also administered in an unspecified site intramuscularly on 20-MAY-2013. This patient developed a fever of 102.2F on 28-MAY-2013, which lasted two days. The patient was examined by a physician on 30-MAY-2013, who observed a red spot on the left thigh and a red spot on the face. The physician prescribed TYLENOL and ADVIL. The outcome of a red spot on the left thigh and a red spot on the face was unknown. This is one of several reports received from the same source.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 12 month old patient. On 20-MAY-2013 the patient was vaccinated with (merck) VARIVAX (lot # H018782, expiry date 15-OCT-2014) (1350 U, 0.5 ml, subcutaneous in the left thigh, strength not specified) and M-M-R II (lot # not reported) (in the right thigh, strength and total daily dose not reported). It was reported that an unspecified hepatitis A vaccine (manufacturer unknown) (lot # not reported) was also administered in an unspecified site intramuscularly on 20-MAY-2013. This patient developed a fever of 102.2F on 28-MAY-2013, which lasted two days. The patient was examined by a physician on 30-MAY-2013, who observed a red spot on the left thigh and a red spot on the face. The physician prescribed TYLENOL and ADVIL. The outcome of a red spot on the left thigh and a red spot on the face was unknown. This is one of several reports received from the same source.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from an 84 year old female patient regarding herself. There were no preexisting medical conditions or allergies or birth defects. On 09-DEC-2008, at 11:00 am, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) which was very expensive for the patient at a private doctor office or hospital or hospital with the private funds. There was no illness at the time of vaccination. On 13-APR-2013, the patient experienced shingles, a very severe case and the patient was totally incapacitated for more than a month (disability) and the pain was worse. The patient had taken an anti-viral medication (unspecified) and a shot of something else (unspecified). The patient was told to take a tranquilizer but the patient was already on one (unspecified). Nothing was helping the patient. Rash was going away after 4 weeks but the pain was worse. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Disability, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from an 84 year old female patient regarding herself. There were no preexisting medical conditions or allergies or birth defects. On 09-DEC-2008, at 11:00 am, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) which was very expensive for the patient at a private doctor office or hospital or hospital with the private funds. There was no illness at the time of vaccination. On 13-APR-2013, the patient experienced shingles, a very severe case and the patient was totally incapacitated for more than a month (disability) and the pain was worse. The patient had taken an anti-viral medication (unspecified) and a shot of something else (unspecified). The patient was told to take a tranquilizer but the patient was already on one (unspecified). Nothing was helping the patient. Rash was going away after 4 weeks but the pain was worse. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Polymerase chain reaction
Clinical narrative: Patient was diagnosed with shingles that was found to be caused by the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Patient was diagnosed with shingles that was found to be caused by the vaccine.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Insomnia, Neck pain
Clinical narrative: Pain in elbow joints, *severe* pain in neck, inability to sleep: pain is worse when lying down. Administered Advil (4).
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: This study case was received from the investigator in a trial on 17 January 2013. A 20-year old (age stated on ECG report) male subject had received the following vaccinations on 23 February 2012: ACAM2000 (lot number, right arm and route not reported); anthrax vaccine (Manufacture name, lot number not reported); and Typhoid vaccine (Manufacture name and lot number not reported). At study visit 2 on 28 February 2012 the subject reported he had experienced the same night following the vaccinations on 23 February 2012 mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue. The symptoms worsened over 12 hours but the subject did not seek medical evaluation. The symptoms resolved completely the following day on 24 February 2012. An electrocardiogram on 28 February 2012 was normal and a rapid Troponin was completed as well; however the result was not available as the vial broke during processing. The subject was referred for follow-up care. Assessment: low suspicion myopericarditis. Relevant medical history included occasional chest pain (onset in 1999) and night palpitations (onset date unknown). The subject was reported as recovered on 24 February 2012. According to the Investigator, the events of mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue was considered important events and possibly related. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Myopericarditis, Nausea, Night sweats, Troponin
Clinical narrative: This study case was received from the investigator in a trial on 17 January 2013. A 20-year old (age stated on ECG report) male subject had received the following vaccinations on 23 February 2012: ACAM2000 (lot number, right arm and route not reported); anthrax vaccine (Manufacture name, lot number not reported); and Typhoid vaccine (Manufacture name and lot number not reported). At study visit 2 on 28 February 2012 the subject reported he had experienced the same night following the vaccinations on 23 February 2012 mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue. The symptoms worsened over 12 hours but the subject did not seek medical evaluation. The symptoms resolved completely the following day on 24 February 2012. An electrocardiogram on 28 February 2012 was normal and a rapid Troponin was completed as well; however the result was not available as the vial broke during processing. The subject was referred for follow-up care. Assessment: low suspicion myopericarditis. Relevant medical history included occasional chest pain (onset in 1999) and night palpitations (onset date unknown). The subject was reported as recovered on 24 February 2012. According to the Investigator, the events of mild shortness of breath, worsening headache, lightheadedness, night sweats, nausea and general fatigue was considered important events and possibly related. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: This study case was received from the investigator in a trial on 17 January 2013. A male subject (date of birth not reported) with not reported relevant medical history had received the following vaccination on 06 March 2012: ACAM2000 (lot number, left arm and route not reported). On 12 March 2012 (study visit 2 of the study) the subject reported that on 10 March 2012 which was 4 days following vaccination, he experienced mild onset of palpitations, chest discomfort/pressure, fainting, shortness of breath, headaches, rash on hand and generalized muscle weakness/numbness. He was evaluated in the emergency room with proposed diagnosis of anxiety. Investigator assessment: low suspicion of myopericarditis. The subject was reported as recovered on 11 March 2012. According to the investigator, the events mild onset of palpitations, chest discomfort/pressure, fainting, shortness of breath, headaches, rash on hand and generalized muscle weakness/numbness were considered important events and possibly related. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Muscular weakness, Myopericarditis, Palpitations, Rash, Syncope
Clinical narrative: This study case was received from the investigator in a trial on 17 January 2013. A male subject (date of birth not reported) with not reported relevant medical history had received the following vaccination on 06 March 2012: ACAM2000 (lot number, left arm and route not reported). On 12 March 2012 (study visit 2 of the study) the subject reported that on 10 March 2012 which was 4 days following vaccination, he experienced mild onset of palpitations, chest discomfort/pressure, fainting, shortness of breath, headaches, rash on hand and generalized muscle weakness/numbness. He was evaluated in the emergency room with proposed diagnosis of anxiety. Investigator assessment: low suspicion of myopericarditis. The subject was reported as recovered on 11 March 2012. According to the investigator, the events mild onset of palpitations, chest discomfort/pressure, fainting, shortness of breath, headaches, rash on hand and generalized muscle weakness/numbness were considered important events and possibly related. Documents held by sender: None.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Intussusception, Large intestine perforation, Surgery
Clinical narrative: 4/13/13 surgery for colonic perforation after intussusception.
Age: 54.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: It began in my legs - on both sides at the same time - my legs became sort of jelly like - my knees would suddenly buckle underneath me (I first noticed it when I was on the treadmill - my legs buckled under me and felt progressively weak....this continued and then began to move up my body...fortunately, the weakness as it moved up through my body over the course of the next few days or weeks (I no longer recall) was mild. However, it was pronounced enough to make my doctor realize what was happening and guess that perhaps the H1N1 vaccine had been the cause.  However, when he questioned the authorities, they denied any connection and said there had been no other cases reported. However, this year, when I went to get a flu vaccine, I was told by the clinic that because I had had Guillain Barre, I was not permitted to get a flu vaccine this year.
Age: 46.0
Sex: M
Vaccine: MMRV
Symptoms: Feeling abnormal, Pyrexia, Rash
Clinical narrative: Developed rash, low grade fever, generally just feeling bad.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Corneal lesion, Deafness, Dizziness, Dyspnoea
Clinical narrative: Bad pain everywhere, dizziness, blurred vision, ringing in ears, deafness, difficulty breathing, hair/eyelash loss, eye lesions, sleep apnea, difficulty walking.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Madarosis, Pain, Sleep apnoea syndrome, Tinnitus
Clinical narrative: Bad pain everywhere, dizziness, blurred vision, ringing in ears, deafness, difficulty breathing, hair/eyelash loss, eye lesions, sleep apnea, difficulty walking.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Bad pain everywhere, dizziness, blurred vision, ringing in ears, deafness, difficulty breathing, hair/eyelash loss, eye lesions, sleep apnea, difficulty walking.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Developed ITP, platelets dropped to as low as 5,000. Have had to receive IVIG. No known cure.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Computerised tomogram head normal, Dysarthria, Fatigue, Headache, Malaise
Clinical narrative: On 15 June started to develop headache and malaise.  On 16 June went to ER for 8/10 headache, vomiting, malaise, myalgias, fatigue, and slurred speech; head CT normal.  Was treated with toradol, Fioricet and phenergan.  On 17 June, headache improving to 4/10 with meds.  NO evidence of encephalitis.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Myalgia, Vomiting
Clinical narrative: On 15 June started to develop headache and malaise.  On 16 June went to ER for 8/10 headache, vomiting, malaise, myalgias, fatigue, and slurred speech; head CT normal.  Was treated with toradol, Fioricet and phenergan.  On 17 June, headache improving to 4/10 with meds.  NO evidence of encephalitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 x 3" warm, indurated area (L) deltoid and 6 x 7" red, warm indurated area (R) upper arm. Tx - recheck if fever, increased pain or decreased use of arm. Advised should improve without tx over next 2-4 d.
Age: 1.05
Sex: F
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: 2 cm x 1 cm firm, red, warm area (Lt) thigh (+) fever (T 100.7); area increased in size on 6/13/13.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after injection the site became red, swollen, hot and very tender to the touch. Received DLA (dexamethasone) and antihistamines.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, RV1
Symptoms: Blood glucose normal, Dyskinesia, Electroencephalogram normal, Gaze palsy
Clinical narrative: Several episodes over few days, afebrile, VSS 1-2 seconds both eyes rolled up, patient appears to hold his arms and legs still then resumes all movement of extremities the episodes witnessed by mom, 6 h and MD = lasted about 2 weeks.
Age: 1.12
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Amino acid level, Ataxia, Blood folate, Cerebellar ataxia, Clumsiness
Clinical narrative: 5/28/13: 12-month vaccines --> MMR to right thigh. 5/29/13: Phone call reporting "red bump" to right thigh. 6/05/13: Office visit for rash, clumsiness --> sterile abscess, right thigh --> 1 cm area of petechiae to sternum, o/w no rash --> uncertain ataxia with gait weak, right side. 6/07/13: Follow-up office visit --> rash, (+) ataxic gait --> admission hospital Dx "Acute cerebellar ataxia."
Age: 1.12
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Cytomegalovirus test, Epstein-Barr virus test, Hemiparesis, Herpes simplex serology negative, Injection site abscess sterile
Clinical narrative: 5/28/13: 12-month vaccines --> MMR to right thigh. 5/29/13: Phone call reporting "red bump" to right thigh. 6/05/13: Office visit for rash, clumsiness --> sterile abscess, right thigh --> 1 cm area of petechiae to sternum, o/w no rash --> uncertain ataxia with gait weak, right side. 6/07/13: Follow-up office visit --> rash, (+) ataxic gait --> admission hospital Dx "Acute cerebellar ataxia."
Age: 1.12
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling, Mycoplasma test, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: 5/28/13: 12-month vaccines --> MMR to right thigh. 5/29/13: Phone call reporting "red bump" to right thigh. 6/05/13: Office visit for rash, clumsiness --> sterile abscess, right thigh --> 1 cm area of petechiae to sternum, o/w no rash --> uncertain ataxia with gait weak, right side. 6/07/13: Follow-up office visit --> rash, (+) ataxic gait --> admission hospital Dx "Acute cerebellar ataxia."
Age: 1.12
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Organic acid analysis, Petechiae, Rash, Urine homocystine, Vitamin B12
Clinical narrative: 5/28/13: 12-month vaccines --> MMR to right thigh. 5/29/13: Phone call reporting "red bump" to right thigh. 6/05/13: Office visit for rash, clumsiness --> sterile abscess, right thigh --> 1 cm area of petechiae to sternum, o/w no rash --> uncertain ataxia with gait weak, right side. 6/07/13: Follow-up office visit --> rash, (+) ataxic gait --> admission hospital Dx "Acute cerebellar ataxia."
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, left deltoid swelling with redness, left deltoid warm to touch.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, nodule formation in (L) arm, deltoid area. Warm and painful to touch.