chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.8
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route 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 several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 19 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route 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 several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 years old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route 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 several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months 11 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route 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 several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route 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 several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 11 years 6 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route 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 several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Barium enema abnormal, Intussusception
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined; GlaxoSmithKline; unknown; unknown given on 27 February 2014; haemophilus influenzae type b vaccine (non-gsk); Merck; unknown; unknown given on 27 February 2014; pneumococcal vaccines (non-gsk); Wyeth Labs; unknown; unknown given on 27 February 2014. On 27 February 2014, the subject received 1st dose of ROTARIX (oral). On 15 April 2014, 47 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised for 24 hours and the physician considered the event was life threatening and clinically significant (or requiring intervention). On 16 April 2014, the event was resolved. The physician considered the event was probably related to vaccination with ROTARIX. Follow-up information received on 22 August 2014: The subject had no family history of intussusception or bowel abnormalities, no previous intra-abdominal surgery, no congenital intestinal malformation, no intestinal polyps, no Meckels diverticulum, no intestinal vascular malformations, no cystic fibrosis, no Hirschprung disease, no other gastrointestinal malformation and dysfunction nor intussusception. On 16 April 2014 instead of 15 April, 48 days after vaccination with ROTARIX, the subject experienced intussusception (showed by barium enema). The other diagnostic procedures were unknown since the subject was treated at another hospital. The vaccine was discontinued. On 22 April 2014, the event was resolved by liquid contrast/ hydrostatic water/ air enema.
Age: 36.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity, Paraesthesia, Pharyngeal oedema, Red blood cell sedimentation rate normal
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of numbness ina 36-year-old female patient who received ENGERIX B (adult). On an unknown date, the patient received the 1st dose of ENGERIX B (intramuscular). On an unknown date, 12 hrs after receiving ENGERIX B, the patient experienced numbness, tingling, throat swelling and pain in arm. On an unknown date, the outcome of the numbness, tingling, throat swelling and pain in arm were unknown. It was unknown if the reporter considered the numbness, tingling, throat swelling and pain in arm to be related to ENGERIX B adult. Additional details were provided as follows: The reporter stated that, 12 hours after receiving ENGERIX B adult, the patient experienced numbness, pain and tingling bilaterally in arms, specifically below elbows. On an unknown date, less than a week after receiving ENGERIX B adult the patient experienced throat swelling. The patient presented to emergency room (approximately 1 week after vaccination), stating that she was continuing with pin feeling (tingling) from elbows down to numbness in hands. No further information was available.
Age: 36.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Pharyngeal oedema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of numbness ina 36-year-old female patient who received ENGERIX B (adult). On an unknown date, the patient received the 1st dose of ENGERIX B (intramuscular). On an unknown date, 12 hrs after receiving ENGERIX B, the patient experienced numbness, tingling, throat swelling and pain in arm. On an unknown date, the outcome of the numbness, tingling, throat swelling and pain in arm were unknown. It was unknown if the reporter considered the numbness, tingling, throat swelling and pain in arm to be related to ENGERIX B adult. Additional details were provided as follows: The reporter stated that, 12 hours after receiving ENGERIX B adult, the patient experienced numbness, pain and tingling bilaterally in arms, specifically below elbows. On an unknown date, less than a week after receiving ENGERIX B adult the patient experienced throat swelling. The patient presented to emergency room (approximately 1 week after vaccination), stating that she was continuing with pin feeling (tingling) from elbows down to numbness in hands. No further information was available.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Genital rash, Nausea, Penile pain, Penile swelling
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 69 year old male patient with diabetes, hypertension and allergy to ACE inhibitors. The patient's medical history included cardiac stents. On 04-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot# L012478, expiration date 10-JUL-2016, dose, route and site of administration were not reported). Concomitant therapies included amlodipine, aspirin, PLAVIX, CRESTOR, DIOVAN, AMARYL, GLUCOPHAGE, hydrochlorothiazide (manufacturer unknown), ONGLYZA, PROTONIX, VIAGRA and vitamin d (unspecified), potassium supplement (unspecified). On 05-AUG-2015, the patient experienced nausea, dizziness and fever of 104 Fahrenheit (F). On 06-AUG-2015, the fever decreased to 102F after the patient took TYLENOL. On the same day, the patient was seen in the office and reported to the physician that his son had a viral illness to which the patient had been exposed. On 07-AUG-2015, the patient reported that his penis was swollen and was referred to an unspecified urologist. There was no lab diagnostics studies performed. The outcome of the events was reported as not recovered, however the fever of 104F decreased to 102F. The relatednesss between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 69 year old male patient with diabetes, hypertension and allergy to ACE inhibitors. The patient's medical history included cardiac stents. On 04-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot# L012478, expiration date 10-JUL-2016, dose, route and site of administration were not reported). Concomitant therapies included amlodipine, aspirin, PLAVIX, CRESTOR, DIOVAN, AMARYL, GLUCOPHAGE, hydrochlorothiazide (manufacturer unknown), ONGLYZA, PROTONIX, VIAGRA and vitamin d (unspecified), potassium supplement (unspecified). On 05-AUG-2015, the patient experienced nausea, dizziness and fever of 104 Fahrenheit (F). On 06-AUG-2015, the fever decreased to 102F after the patient took TYLENOL. On the same day, the patient was seen in the office and reported to the physician that his son had a viral illness to which the patient had been exposed. On 07-AUG-2015, the patient reported that his penis was swollen and was referred to an unspecified urologist. There was no lab diagnostics studies performed. The outcome of the events was reported as not recovered, however the fever of 104F decreased to 102F. The relatednesss between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Exposure to communicable disease, Nausea, Penile swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 69 year old male patient with diabetes, hypertension and allergy to ACE inhibitors. The patient's medical history included cardiac stents. On 04-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot# L012478, expiration date 10-JUL-2016, dose, route and site of administration were not reported). Concomitant therapies included amlodipine, aspirin, PLAVIX, CRESTOR, DIOVAN, AMARYL, GLUCOPHAGE, hydrochlorothiazide (manufacturer unknown), ONGLYZA, PROTONIX, VIAGRA and vitamin d (unspecified), potassium supplement (unspecified). On 05-AUG-2015, the patient experienced nausea, dizziness and fever of 104 Fahrenheit (F). On 06-AUG-2015, the fever decreased to 102F after the patient took TYLENOL. On the same day, the patient was seen in the office and reported to the physician that his son had a viral illness to which the patient had been exposed. On 07-AUG-2015, the patient reported that his penis was swollen and was referred to an unspecified urologist. There was no lab diagnostics studies performed. The outcome of the events was reported as not recovered, however the fever of 104F decreased to 102F. The relatednesss between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Peripheral swelling, Urticaria
Clinical narrative: The vaccine was administered on Friday. Next day, Saturday, the sire was red inflamed and itching and throbbing. It got worse on Sunday. Monday I went to my dr. Prescribed antibiotic and topical cream. Better as of 8/20, 8.22 still red and itching.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: The vaccine was administered on Friday. Next day, Saturday, the sire was red inflamed and itching and throbbing. It got worse on Sunday. Monday I went to my dr. Prescribed antibiotic and topical cream. Better as of 8/20, 8.22 still red and itching.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Ear pain, Lymph node pain, Neck pain, Oropharyngeal pain
Clinical narrative: Neck pain, sore throat, trouble swallowing.  Glands and earache started next day (Saturday and continues now on Monday, August 31). No treatment, thinking it would go away, however, it has become worse. Severe throat and ear pain.  Will call doctor's office to ask if antibiotic might be appropriate.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV9
Symptoms: Blood thyroid stimulating hormone, Electrocardiogram, Full blood count, Hypoxia, Laboratory test
Clinical narrative: Patient had syncopal event with tonic clonic movements, convulsions, seizure, and in post ictal state had hypoxia to O2 sat of 72% placed on O2 brought up to 99%.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV9
Symptoms: Metabolic function test, Postictal state, Seizure, Syncope, Tonic clonic movements
Clinical narrative: Patient had syncopal event with tonic clonic movements, convulsions, seizure, and in post ictal state had hypoxia to O2 sat of 72% placed on O2 brought up to 99%.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV9
Symptoms: Seizure, Syncope
Clinical narrative: Patient had syncopal event with tonic clonic movements, convulsions, seizure, and in post ictal state had hypoxia to O2 sat of 72% placed on O2 brought up to 99%.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reaction where shot was given 4 inches X 4 inches red, little swelling and hot to the touch. Right Arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Pain, Pyrexia
Clinical narrative: Body aches, pains, fever of 103 Fahrenheit, dizziness, falls.
Sex: U
Vaccine: DTP, FLU3, FLU3
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Naevus flammeus, Vascular malformation
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included unspecified prenatal vitamins, salmeterol/fluticasone, estradiol, progesterone, calcium carbonate, and DTP vaccine. The patient's mother had a medical history of asthma (diagnosed in 1982), pulmonary embolism (diagnosed in 2004), endometriosis and other uterine disorder, heartburn, and secondary infertility requiring salpingectomy (in 2009) in left tube due to hydrosalpinx. (Refer to the mother case: 2015053328). On 02-Oct-2013, the patient received AFLURIA (batch number R54507) from the mother, in-utero. The patient's mother underwent multiple ultrasound scans, multiple non-stress/stress tests, and alpha-fetoprotein test which were all normal during the course of her pregnancy. The first trimester serum screen was done on 10-Sep-2013. The patient was born at the gestational age of 39.6 (patient's weight 3920.0 grams, Apgars at 1 min: 9, Apgar at 5 min: 9). The patient was diagnosed with vascular malformation (port wine stain) 3.6 x 2.7 cm on mid-chin extending to the right cheek (extension onto the cheek in 2.5 cm) with no involvement of V1, unilateral involvement. This was present since birth with no changes (color, size, shape) and no bleeding. At 4 weeks (on 15-Apr-2014), the patient was well. No further evaluation was required but laser treatment was available. The outcome was not reported.
Sex: U
Vaccine: DTP, FLU3, FLU3
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Foetal non-stress test normal, Naevus flammeus, Vascular malformation
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included unspecified prenatal vitamins, salmeterol/fluticasone, estradiol, progesterone, calcium carbonate, and DTP vaccine. The patient's mother had a medical history of asthma (diagnosed in 1982), pulmonary embolism (diagnosed in 2004), endometriosis and other uterine disorder, heartburn, and secondary infertility requiring salpingectomy (in 2009) in left tube due to hydrosalpinx. (Refer to the mother case: 2015053328). On 02-Oct-2013, the patient received AFLURIA (batch number R54507) from the mother, in-utero. The patient's mother underwent multiple ultrasound scans, multiple non-stress/stress tests, and alpha-fetoprotein test which were all normal during the course of her pregnancy. The first trimester serum screen was done on 10-Sep-2013. The patient was born at the gestational age of 39.6 (patient's weight 3920.0 grams, Apgars at 1 min: 9, Apgar at 5 min: 9). The patient was diagnosed with vascular malformation (port wine stain) 3.6 x 2.7 cm on mid-chin extending to the right cheek (extension onto the cheek in 2.5 cm) with no involvement of V1, unilateral involvement. This was present since birth with no changes (color, size, shape) and no bleeding. At 4 weeks (on 15-Apr-2014), the patient was well. No further evaluation was required but laser treatment was available. The outcome was not reported.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hyposmia, Influenza like illness, Malaise, Microsomia, Olfactory test abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 70 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 30/40 which was not suggestive of malingering (<6). The patient was diagnosed with moderate mircrosmia (34th percentile). The PEA (phenyl ethyl alcohol) test scores were -4.25 left, -3.75 right and -3.00 bilateral. The Whole-Mouth test identification test score was 88% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 70 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 30/40 which was not suggestive of malingering (<6). The patient was diagnosed with moderate mircrosmia (34th percentile). The PEA (phenyl ethyl alcohol) test scores were -4.25 left, -3.75 right and -3.00 bilateral. The Whole-Mouth test identification test score was 88% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anosmia, Influenza like illness, Laboratory test, Malaise, Microsomia
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 70 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 30/40 which was not suggestive of malingering (<6). The patient was diagnosed with moderate mircrosmia (34th percentile). The PEA (phenyl ethyl alcohol) test scores were -4.25 left, -3.75 right and -3.00 bilateral. The Whole-Mouth test identification test score was 88% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 70.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Olfactory test abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 70 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 30/40 which was not suggestive of malingering (<6). The patient was diagnosed with moderate mircrosmia (34th percentile). The PEA (phenyl ethyl alcohol) test scores were -4.25 left, -3.75 right and -3.00 bilateral. The Whole-Mouth test identification test score was 88% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: Information has been received from a 80 year old female patient referring to herself. The patient's medical history included heart problem and diabetes. The patient was allergic to DEMEROL. On an unspecified date in 2010 (reported as "5 years ago") the patient was vaccinated with a dose of ZOSTAVAX (strength lot# and route unspecified: in the right arm). Concomitant therapies included oxycodone, morphine sulfate and lidocaine pain patches. On 04-JAN-2015 the patient got the shingles on her right breast, under her breast to her waist, under her arm and 5-6 inches from her shoulder to her waist. The patient sought medical attention and unspecified treatment was given for the event. Blood work was performed on an unspecified date in 2015 (result unspecified). The event was not improved and the outcome of the event was reported as not recovered/not resolved. The event was considered to be serious due to hospitalization or prolonged (detail information not provided). Additional information has been requested.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Chordee, Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 18-Aug-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included prenatal vitamins, cyanocobalamin, fish oil, calcium, cholecalciferol, clomiphene citrate, monoclonal antibodies, prednisone, esomeprazole magnesium, paracetamol, ibuprofen, loratadine, pseudoephedrine hydrochloride, docusate sodium, doxylamine succinate, lorazepam, folic acid and DTP vaccine. The neonate patient's mother had a medical history of rheumatoid/RA (rheumatoid arthritis) (diagnosed in 2001), infertility (received fertility treatment), hip replacement (in 2006), IBS (irritable bowel syndrome, resolved), ulcers from NSAIDS, Thyroid dysfunction - Graves (diagnosed in 2013), fibroids (that were removed in 2014), GI upset, stomach flu, diarrhoea, vomiting, respiratory infection/cold, headache, carpal tunnel, ulcers, and a carrier for CF (cystic fibrosis). The mother's date of conception was 09-Mar-2014 with twin pregnancy. At first ultrasound at 5.7 weeks, 2 sacs were seen, the first sac had a pole and heartbeat and the second sac had no pole or heartbeat. Twin B was spontaneously aborted at 6 weeks of gestation. At follow-up ultrasound on 6.9 weeks there was still heartbeat in the first sac but the second sac hadn't developed any further. (Refer to case 2015053273). The ultrasound scans (performed on 11-May-2014, 07-Sep-2014, 21-Jul-2014, 05-Oct-2014 and 09-Nov-2014), alfa-fetoprotein test (performed on 01-Jul-2014) and non-invasive prenatal tests (performed on 04-May-2014). On 25-Sep-2014, the patient received AFLURIA vaccine, (batch number: T58606) via the mother in utero. The patient was live born at 40.1 week gestation (weight: 2835 grams, Apgar score at 1 min: 9, Apgar score at 5 mins: 9). The patient was born full term and diagnosed with congential chordee which was diagnosed and confirmed by paediatric urology medical records. The outcome was not reported.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Apgar score abnormal, Cerebrovascular accident, Congenital anomaly, Foetal exposure during pregnancy, Gross motor delay
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia, neurological conditions (migraines from 1991 until 2000 which had resolved), headaches, nausea, constipation, heartburn, low iron, and infertility and was pregnant via IVF (In Vitro Fertilisation). The mother's concomitant medications included prenatal vitamins, estradiol, progesterone injection in oil, progesterone vaginal insert, ondansetron for nausea, paracetamol for headaches, docusate for constipation, iron for low iron, diphenhydramine for sleep and ranitidine for heartburn. The patient's mother drank tea and drank wine between 08-Feb-2013 and 27-Feb-2013 and then again between 06-Jun-2013 until 09-Nov-2013. The mother had an ultrasound on the 06-Aug-2013 saw mild ventriculomegaly. On the 14-Aug-2013, the patient's mother had an ultrasound which saw stable mild ventriculomegaly and was also seen on the 22-Aug-2013 during an MRI (Magnetic Resonance Imaging). On the 02-Oct-2013, the patient received the AFLURIA vaccine (batch number 'R55601') via the mother (intra-uterine) 1 shot 1 day. The patient was born at 39.1 weeks with a birth weight of 3990.0 grams, and Apgars of 0 at one and five minutes. On an unspecified date, the baby was diagnosed with neonatal left MCA (middle cerebral artery) stroke per the pediatric neurology medical record. The baby was seen for follow-up on the 10-Dec-2013. As of the 14-Jan-2014, the baby was off seizure medications. Testing had showed that she was 25% behind in gross motor skills. She was recommended physical therapy when child is older. Neurology will continue to follow up. Outcome was unknown. Reporter comments: The reporter stated that the events were a congenital anomaly.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Apgar score normal, Factor VIII deficiency, Foetal exposure during pregnancy, Hooded prepuce
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia and was an hemophilia A carrier. The mother's concomitant medications included prenatal vitamins and iron for borderline anemia. The mother had caffeine (1/2 diet Coke) from 31-Mar-2013 until 24-Dec-2013, wine (1/4 glass of wine, 0.25 serving 1 day) on the 07-Dec-2013, and had a respiratory infection between 22-Jul-2013 until 31-Jul-2013. On the 10-Jun-2013, the mother had a 1st trimester serum screen which showed that the PAPPA (pregnancy-associated plasma protein A) marker was low and on the 07-Aug-2013 had an ultrasound which saw a choroid plexus cyst. All other ultrasounds and tests were normal (see 2015053323). On the 15-Oct-2013, the patient received AFLURIA injection (batch number R53207) via the mother (intrauterine) 1 shot 1 day. On the 01-Nov-2013, the patient received BOOSTRIX (batch number not reported) via the mother (intrauterine) 1 shot 1 day. The patient was born at 38.3 weeks, with a birth weight of 3350g and Apgars of 8 at both 1 minute and 5 minutes. On an unspecified date, the patient was diagnosed with hemophilia A which was confirmed by haematology and paediatric records. The baby was also diagnosed with a hooded foreskin by urology. Outcome was not reported. Reporter comments: The reporter did not consider either of these major malformations but reported the events as congenital anomalies.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Apgar score normal, Congenital anomaly, Factor VIII deficiency, Foetal exposure during pregnancy, Haematology test abnormal
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia and was an hemophilia A carrier. The mother's concomitant medications included prenatal vitamins and iron for borderline anemia. The mother had caffeine (1/2 diet Coke) from 31-Mar-2013 until 24-Dec-2013, wine (1/4 glass of wine, 0.25 serving 1 day) on the 07-Dec-2013, and had a respiratory infection between 22-Jul-2013 until 31-Jul-2013. On the 10-Jun-2013, the mother had a 1st trimester serum screen which showed that the PAPPA (pregnancy-associated plasma protein A) marker was low and on the 07-Aug-2013 had an ultrasound which saw a choroid plexus cyst. All other ultrasounds and tests were normal (see 2015053323). On the 15-Oct-2013, the patient received AFLURIA injection (batch number R53207) via the mother (intrauterine) 1 shot 1 day. On the 01-Nov-2013, the patient received BOOSTRIX (batch number not reported) via the mother (intrauterine) 1 shot 1 day. The patient was born at 38.3 weeks, with a birth weight of 3350g and Apgars of 8 at both 1 minute and 5 minutes. On an unspecified date, the patient was diagnosed with hemophilia A which was confirmed by haematology and paediatric records. The baby was also diagnosed with a hooded foreskin by urology. Outcome was not reported. Reporter comments: The reporter did not consider either of these major malformations but reported the events as congenital anomalies.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hooded prepuce
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia and was an hemophilia A carrier. The mother's concomitant medications included prenatal vitamins and iron for borderline anemia. The mother had caffeine (1/2 diet Coke) from 31-Mar-2013 until 24-Dec-2013, wine (1/4 glass of wine, 0.25 serving 1 day) on the 07-Dec-2013, and had a respiratory infection between 22-Jul-2013 until 31-Jul-2013. On the 10-Jun-2013, the mother had a 1st trimester serum screen which showed that the PAPPA (pregnancy-associated plasma protein A) marker was low and on the 07-Aug-2013 had an ultrasound which saw a choroid plexus cyst. All other ultrasounds and tests were normal (see 2015053323). On the 15-Oct-2013, the patient received AFLURIA injection (batch number R53207) via the mother (intrauterine) 1 shot 1 day. On the 01-Nov-2013, the patient received BOOSTRIX (batch number not reported) via the mother (intrauterine) 1 shot 1 day. The patient was born at 38.3 weeks, with a birth weight of 3350g and Apgars of 8 at both 1 minute and 5 minutes. On an unspecified date, the patient was diagnosed with hemophilia A which was confirmed by haematology and paediatric records. The baby was also diagnosed with a hooded foreskin by urology. Outcome was not reported. Reporter comments: The reporter did not consider either of these major malformations but reported the events as congenital anomalies.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Contusion, Dizziness, Epistaxis, Laceration, Unresponsive to stimuli
Clinical narrative: Patient became light headed and after administration of immunization by MA. Provider entered room to find patient on the floor unresponsive. Was unresponsive for less than 10 seconds. He was immediately oriented x 3. Diffuse bleeding from right nare and 5mm laceration noted to bridge of nose. Contusion present to forehead between eyebrows. Patient remained supine on floor with legs elevated x 10 minutes. He was then able to assist with transfer to exam table but did become light headed. Head of table lowered. No LOC occurred. Ice applied to forehead contusion. Laceration cleansed and Dermabond applied along with steri strip. Diffuse tenderness with palpation of bridge of nose. No tenderness over forehead or eyebrow areas. Bleeding from right nare was controlled with pressure and was minimal. Blood pressure on dismissal 110/60. His wife was called to take him home. He was able to ambulate from clinic without assist. He was observed in clinic for 1 1/2 hours post incident.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Headache, Hepatitis C RNA increased, Influenza like illness, Liver function test normal
Clinical narrative: Initial symptoms Blurred vision, nausea, headaches, weakness, pain in legs. After third dose had severe flu-like symptoms, sleepiness, feeling shaky, ammonia smell
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Nervousness, Pain in extremity, Somnolence, Vision blurred
Clinical narrative: Initial symptoms Blurred vision, nausea, headaches, weakness, pain in legs. After third dose had severe flu-like symptoms, sleepiness, feeling shaky, ammonia smell
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Cyanosis, Deafness, Dizziness
Clinical narrative: SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Dyspnoea, Ear pain, Endoscopy, Fatigue
Clinical narrative: SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Gastric emptying study, Headache, Hyperacusis, Impaired gastric emptying, Lymphadenopathy
Clinical narrative: SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstruation irregular, Musculoskeletal chest pain, Myalgia, Nausea
Clinical narrative: SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral coldness, Petechiae, Photophobia
Clinical narrative: SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Respiratory tract congestion
Clinical narrative: SOB,BACK/RIB/LEG/JOINT/MUSCLE PAIN, NAUSEA, DIZZINESS, RASHES, HEADACHES, LIGHT/SOUND SENSITIVITY, GASTROPARESIS, PETECHIA RASH, HEAVY PAINFUL IRREGULAR MENSTRUAL CYCLES, LYMPHENDOPATHY, COLD PURPLE FEET, CHRONIC CONGESTION, CHRONIC SORE THROATS, CHRONIC EAR PAIN, HEARING LOSS, CHRONIC FATIGUE,
Age: 1.19
Sex: M
Vaccine: DTAP, DTAPIPV, MMR
Symptoms: Abasia, CSF oligoclonal band present, Computerised tomogram head normal, Crying, Decreased eye contact
Clinical narrative: Fever off and on for several weeks following vaccination. fever 6/6/15 103.7. Excessive crying for several days following with lethargy and decreased LOC. Vomiting 6/8/15. 6/9/15 crying for 6 hours straight, back arching, no eye contact. Saw pediatrician and was sent to hospital. 6/10/15- unable to hold head up, walk, or stand. Continued abnormal posturing, back arching, scissoring of legs, excessive screaming/crying, lethargy, no eye contact. 6/12/15- symptoms began improving. 6/15/15- back to baseline.
Age: 1.19
Sex: M
Vaccine: DTAP, DTAPIPV, MMR
Symptoms: Depressed level of consciousness, Dysstasia, Electroencephalogram normal, Encephalitis, Laboratory test normal
Clinical narrative: Fever off and on for several weeks following vaccination. fever 6/6/15 103.7. Excessive crying for several days following with lethargy and decreased LOC. Vomiting 6/8/15. 6/9/15 crying for 6 hours straight, back arching, no eye contact. Saw pediatrician and was sent to hospital. 6/10/15- unable to hold head up, walk, or stand. Continued abnormal posturing, back arching, scissoring of legs, excessive screaming/crying, lethargy, no eye contact. 6/12/15- symptoms began improving. 6/15/15- back to baseline.
Age: 1.19
Sex: M
Vaccine: DTAP, DTAPIPV, MMR
Symptoms: Lethargy, Lumbar puncture normal, Muscle spasticity, Nuclear magnetic resonance imaging normal, Opisthotonus
Clinical narrative: Fever off and on for several weeks following vaccination. fever 6/6/15 103.7. Excessive crying for several days following with lethargy and decreased LOC. Vomiting 6/8/15. 6/9/15 crying for 6 hours straight, back arching, no eye contact. Saw pediatrician and was sent to hospital. 6/10/15- unable to hold head up, walk, or stand. Continued abnormal posturing, back arching, scissoring of legs, excessive screaming/crying, lethargy, no eye contact. 6/12/15- symptoms began improving. 6/15/15- back to baseline.
Age: 1.19
Sex: M
Vaccine: DTAP, DTAPIPV, MMR
Symptoms: Posture abnormal, Pyrexia, Screaming, Ultrasound abdomen normal, Vomiting
Clinical narrative: Fever off and on for several weeks following vaccination. fever 6/6/15 103.7. Excessive crying for several days following with lethargy and decreased LOC. Vomiting 6/8/15. 6/9/15 crying for 6 hours straight, back arching, no eye contact. Saw pediatrician and was sent to hospital. 6/10/15- unable to hold head up, walk, or stand. Continued abnormal posturing, back arching, scissoring of legs, excessive screaming/crying, lethargy, no eye contact. 6/12/15- symptoms began improving. 6/15/15- back to baseline.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Diplopia, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Felt short of breath, dizzy, weak, nauseated, profuse sweating, muscle pain, double vision that continued until 8/24/15. Vomited once on 8/24.  Noticed rash-like area around injection site that was red, swollen and warm to touch on 8/24 that disappeared in 2 hours.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Felt short of breath, dizzy, weak, nauseated, profuse sweating, muscle pain, double vision that continued until 8/24/15. Vomited once on 8/24.  Noticed rash-like area around injection site that was red, swollen and warm to touch on 8/24 that disappeared in 2 hours.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: Felt short of breath, dizzy, weak, nauseated, profuse sweating, muscle pain, double vision that continued until 8/24/15. Vomited once on 8/24.  Noticed rash-like area around injection site that was red, swollen and warm to touch on 8/24 that disappeared in 2 hours.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test normal, Chest pain, Dizziness, Gait disturbance
Clinical narrative: Swollen lymph nods in armpits and neck. Severe headache, body aches, shaking, joint pain, chest pain, difficulty walking, dizziness, fainting. Headache got better after ER visit but came back once meds wore off. She still has all of these symptoms.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lymphadenopathy, Pain, Syncope, Tremor
Clinical narrative: Swollen lymph nods in armpits and neck. Severe headache, body aches, shaking, joint pain, chest pain, difficulty walking, dizziness, fainting. Headache got better after ER visit but came back once meds wore off. She still has all of these symptoms.
Age: 59.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: C/O itching @ site LD 8-28-15, redness & pain started 8-29-15, seen in work clinic 8-31 with 4x4 inch raised red oval area below injection site. Warm to touch, no streaking, pain decreased, temp WNL. No intervention from Pt (ice, Tylenol) seen by Provider given RX for Augmentin to start immediately and to F/U with ER if condition worsens.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red and itchy located on the arm the vaccine was administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Anterior left thigh red and feels hot with swelling; non tender, nonindurated.
Sex: U
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 1 July 2014, the subject received 2nd dose of ROTARIX (oral, batch number not provided). Less than one month after vaccination with ROTARIX, the subject experienced diarrhea. The subject was hospitalised. At the time of reporting, the outcome of the event was unspecified. The event was first suspected to be due to vaccination with ROTARIX but was later considered as unrelated to vaccination with ROTARIX. The healthcare professional reported another case of diarrhea after vaccination with ROTARIX (see case A1083107A).