chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Patient called pharmacy and described red irritation.  She spoke to pharmacist on duty who reassured her it was a possible injection site reaction and should dissipate with time.  On Wednesday 3/4/15, the patient returned to the pharmacy and presented with a red and irregular irritation at the injection site and surrounding areas.  The patient did not complain of pain but the area felt hot to the touch and the patient indicated that the irritation was increasing in size.  I recommended that the patient seek medical attention.  After some hesitation she agreed.  It is unknown if this was an allergic reaction to the vaccine or possible infection post administration.  The physician gave the patient an antibiotic injection and prescriptions for an oral antibiotic along with a corticosteroid.  Patient is to follow up with physician and indicated she would return to pharmacy with any other relevant information.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown dates since 16-FEB-2015, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ orally (dose and lot number were not were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Pt woke up with redness, warmth and raised across back area-took BENADRYL-Pt. called to be checked today 3-10-15. Left arm has raised wheal 1/2 x 1/2 and 5 1/2 x 3"-Right arm has 1/2 x 1/2-wheal and 6" x 3" - erythema-Both warm to touch.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 4-year-old patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced hospitalization (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the hospitalization was unknown. It was unknown if the reporter considered the hospitalization to be related to KINRIX. Additional information: The reporter was the mother of the patient. She declined demographics and then she disconnected the call. No further details could be obtained.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Guillain Barre Syndrome. Treated with IVIG.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event, adult vaccine given to 17 yr old.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Flushing, Hypertension, Pyrexia, Rash
Clinical narrative: Pt developed a large lump upper left arm, progressing to rash on her neck, torso, and facial flushing; no difficulty swallowing or changes in breathing.  She returned to the clinic on 3/5/15, where she received Depo Medrol, prednisone oral, Pepcid, and Alavert.  She worsened on Friday evening, and went to the ED, with a fever of 100.4, and HTN 200's/high 100's.  She received adrenaline.  She continued to have symptoms over the weekend, although lessening.  She has returned to work, and continues to improve.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: Warm to touch, redness noted, generalized body aches, swelling at site.
Age: 1.39
Sex: F
Vaccine: HEPA, MMR, PER, TDAP
Symptoms: Rash erythematous, Skin warm, Swelling
Clinical narrative: Bright red rash, raised up, very hot to touch, swollen. Took her to the emergency room and they started her on antibiotics.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Sudden onset fever 102.5, Sore throat.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Injection site irritation, Injection site rash, Injection site warmth, Insomnia
Clinical narrative: Recipient stated that she experienced nausea and tightening and cramping in the abdominal area and inability to sleep.  The following morning the recipient awoken and had a 10 cm rash with warmth and irritation at injections site.  Worsened as day progressed.  3:00 PM rash was 30 cm.  Sent to urgent care.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Nausea
Clinical narrative: Recipient stated that she experienced nausea and tightening and cramping in the abdominal area and inability to sleep.  The following morning the recipient awoken and had a 10 cm rash with warmth and irritation at injections site.  Worsened as day progressed.  3:00 PM rash was 30 cm.  Sent to urgent care.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Activities of daily living impaired, Feeling abnormal, Hypersensitivity, Injection site erythema, Injection site reaction
Clinical narrative: Recipient stated that she experienced nausea and tightening and cramping in the abdominal area and inability to sleep.  The following morning the recipient awoken and had a 10 cm rash with warmth and irritation at injections site.  Worsened as day progressed.  3:00 PM rash was 30 cm.  Sent to urgent care.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Recipient stated that she experienced nausea and tightening and cramping in the abdominal area and inability to sleep.  The following morning the recipient awoken and had a 10 cm rash with warmth and irritation at injections site.  Worsened as day progressed.  3:00 PM rash was 30 cm.  Sent to urgent care.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injection site pain
Clinical narrative: Patient experienced pain at site of injection ~4-6 times per day whereby she must massage area with force to alleviate pain.  She has had a few times where she has lost strength in her left arm and dropped a laundry basket at home.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Fatigue, Febrile convulsion, Generalised tonic-clonic seizure
Clinical narrative: 2 febrile seizures (generalized tonic-clonic, short). Temp of 39.6C around 12:00PM. First seizure at 3:00PM. Second seizure at 6:00pm. According to ED note, patient was very tired after second seizure, prompting father to take him to Emergency Department.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Rash all over body.  During vaccine Dr warned me that it is not uncommon to have a reaction to the MMR shot.  I just thought I would report rash so the percentage is accurate.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema
Clinical narrative: Erythema from mid thigh to knee.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Bradyphrenia, Chills, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Felt really tired, arm pain. Then shooting pain all over body to knee caps. Had chills, felt foggy. Sweating and said he was burning up. Headache and felt he was thinking slowly. Could not track thoughts well.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Hyperhidrosis, Pain, Pain in extremity, Thinking abnormal
Clinical narrative: Felt really tired, arm pain. Then shooting pain all over body to knee caps. Had chills, felt foggy. Sweating and said he was burning up. Headache and felt he was thinking slowly. Could not track thoughts well.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Confusional state, Delirium, Disorientation, Mental status changes
Clinical narrative: Mental status changed: pt became confused, disorientated and developed delirium symptoms that required hospitalization.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Condition aggravated, Diplegia, Guillain-Barre syndrome, Laboratory test
Clinical narrative: G-B Type Syndrome. Acute onset with bilateral paralysis of lower extremities as well as neurogenic bladder.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Neurogenic bladder
Clinical narrative: G-B Type Syndrome. Acute onset with bilateral paralysis of lower extremities as well as neurogenic bladder.
Age: 27.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Insomnia, Nausea
Clinical narrative: Nausea and extreme abdominal discomfort lasted 2-3 days. This caused eating to be quite painful and sleeping was also difficult.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain upper, Injection site bruising, Injection site mass, Injection site swelling
Clinical narrative: Large swollen bruised lump at injection site, stomach pain next day.
Sex: U
Vaccine: HEP
Symptoms: Clinically isolated syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received Hepatitis B vaccine. On an unknown date, 180 days after receiving Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 180 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: UNK
Symptoms: Clinically isolated syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HBV-IPV vaccine. On an unknown date, 180 days after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HBV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 180 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple sclerosis in a unk subject who received Hepatitis B vaccine. On an unknown date, 180 days after receiving Hepatitis B vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. It was unknown if the investigator considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of multiple sclerosis in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 180 days after receiving the vaccine, the subject developed new onset multiple sclerosis. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results of human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple sclerosis in a unk subject who received Hepatitis B vaccine. On an unknown date, 90 days after receiving Hepatitis B vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. It was unknown if the investigator considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of multiple sclerosis in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 90 days after receiving the vaccine, the subject developed new onset multiple sclerosis. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, a short-term increase in risk after vaccination of any type was observed, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article.
Sex: U
Vaccine: UNK
Symptoms: Clinically isolated syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HPV-IPV vaccine. On an unknown date, 42 days after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HBV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 42 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinating diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinating diseases up to 3 years after vaccination. The results of human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinating diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinating diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: UNK
Symptoms: Clinically isolated syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HBV-IPV vaccine. On an unknown date, 90 days after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HBV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 90 days after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: UNK
Symptoms: Clinically isolated syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HBV-IPV vaccine. On an unknown date, 1 year after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HPV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 1 year after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: HEP
Symptoms: Clinically isolated syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received Hepatitis B vaccine. On an unknown date, 1 year after receiving Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 1 year after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Sex: U
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple sclerosis in a unk subject who received Hepatitis B vaccine. On an unknown date, 1 year after receiving Hepatitis B vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. It was unknown if the investigator considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of multiple sclerosis in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either ENGERIX B (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or RECOMBIVAX HB (Merck Sharp and Dohme Corp; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 1 year after receiving the vaccine, the subject developed new onset multiple sclerosis. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Upper and lower extremity weakness and numbness with difficulty ambulating over 3 days. Diagnosis of Guillain Barre Syndrome made. Treated with IVIG.
Age: 61.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Lumbar puncture normal, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Upper and lower extremity weakness and numbness with difficulty ambulating over 3 days. Diagnosis of Guillain Barre Syndrome made. Treated with IVIG.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Mobility decreased, Pain
Clinical narrative: Patient experienced soreness after injection, pain continued with limited use of arm. Dr diagnosed inflammation of bursa in shoulder.
Age: 0.85
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count normal, Irritability, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: 3/10/15 screaming uncontrollably for 3 hours, fussy, low grade fever, maculopapular rash on trunk and face.
Age: 0.85
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: 3/10/15 screaming uncontrollably for 3 hours, fussy, low grade fever, maculopapular rash on trunk and face.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Patient had one mucousy bloody stool one week after rotavirus vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant referring to 4 unspecified patients of unknown age. On an unknown date, the patients were vaccinated wit doses of improperly stored ROTATEQ (orally, dose and lot number not provided) which were exposed to 34 F for a total 237 hours. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, strength and dosage unspecified) orally, which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with ROTATEQ (strength, dose, lot# were not reported) oral which were stored improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased
Clinical narrative: This spontaneous report as received from a register nurse refers to a 17 year old female patient without known drug allergies. On 13-FEB-2015, the patient was vaccinated with third dose of GARDASIL 0.5 ml, intramuscular (lot number was not reported). There was no concomitant medications. The nurse stated that the patient in 2015 was complaining of severe shoulder pain. The pain radiates from the arm in which the patient received the GARDASIL injection up to the shoulder. The patient was seen by unspecified physician's office on 03-MAR-2015 and upon examination determinate that the patient s passive range of motion was normal however her active range of motion was painful. The patient's arm was not red and did not had sign of infection. The outcome of the events were reported as not recovered. The events did not require intervention to prevent serious criteria, did not produce significant disability or incapacity, did not require hospitalization and it was not life threatening for the patient. No product quality complain was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a register nurse refers to a 17 year old female patient without known drug allergies. On 13-FEB-2015, the patient was vaccinated with third dose of GARDASIL 0.5 ml, intramuscular (lot number was not reported). There was no concomitant medications. The nurse stated that the patient in 2015 was complaining of severe shoulder pain. The pain radiates from the arm in which the patient received the GARDASIL injection up to the shoulder. The patient was seen by unspecified physician's office on 03-MAR-2015 and upon examination determinate that the patient s passive range of motion was normal however her active range of motion was painful. The patient's arm was not red and did not had sign of infection. The outcome of the events were reported as not recovered. The events did not require intervention to prevent serious criteria, did not produce significant disability or incapacity, did not require hospitalization and it was not life threatening for the patient. No product quality complain was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with GARDASIL (strength, dose, lot# were not reported) intramuscular which were stored improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients (gender and age not reported). On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot# and dose were not reported). No adverse effects were reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to his or her 10 years old son. In approximately 2006, when the patient was 1 to 2 years old, he was vaccinated with VARIVAX (Merck) (lot number, dose, and route were unknown). On 25-FEB-2015 the patient was diagnosed by his pediatrician with shingles. The outcome of shingles was unknown. The causality between shingles and VARIVAX (Merck) was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patiens were vaccinated with improperly stored doses of GARDASIL (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored of RECOMBIVAX HB (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. Since 17-FEB-2015, the patients were vaccinated with VAQTA (strength, dose, lot# were not reported) intramuscular which were improperly. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Information has been received from a male physician and a nurse concerning physician's 70 year old female wife with diabetes. On an unspecified date in 2008 (reported as "7 years ago"), the patient received her first dose of PNEUMOVAX 23. On 28-JAN-2015 the patient was vaccinated with her second dose of PNEUMOVAX 23 (strength: 25/0.5 (unit not provided) dose, route not reported, lot# K005957/ expiration date: 08-MAR-2015) for routine vaccination. The nurse reported that since 28-JAN-2015, the patient experienced pain, redness, swollenness, and tenderness throughout her whole arm and patient's arm was "twice the size of her husband". The physician stated he would rate his wife's injection site reaction with PNEUMOVAX 23 as severe. He also reported that his wife's arm was tender up to her shoulder and down to her elbow and was "swollen to double its normal size". The physician was requested lot check for this lot of PNEUMOVAX 23. ADVIL and ice were given as treatment for the events. The patient had seen the physician for medical attention. There was no lab diagnostic studies performed. The outcome of all the adverse events was reported as not recovered. This report was one of the two reports received from the same reporter (MARRS# 1502USA000317). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of (VAQTA) (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Left arm swollen, hot and painful now after pneumococcal vaccine yesterday. Swelling and heat goes to scapula and ear lobe. She has used TYLENOL and symptoms are worsening. pain is 7/10 now as injection site. She denies wheezing. Patient will go to ER now at this nurse's recommendation. No provider in clinic. 05/09/2013 call placed back to patient now. She never went to ER. She states she had a fever and then it left over night. Slight rash remains at injection site. There are 2 linear rashes 1 inch a part and fading. Patient states she took TYLENOL and stayed home. Patient called triage nurse last evening through her HMO and they recommended ice and to stay home from work and to continue to take TYLENOL. She is just watching the rash per now as directed by HMO nurse.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Left arm swollen, hot and painful now after pneumococcal vaccine yesterday. Swelling and heat goes to scapula and ear lobe. She has used TYLENOL and symptoms are worsening. pain is 7/10 now as injection site. She denies wheezing. Patient will go to ER now at this nurse's recommendation. No provider in clinic. 05/09/2013 call placed back to patient now. She never went to ER. She states she had a fever and then it left over night. Slight rash remains at injection site. There are 2 linear rashes 1 inch a part and fading. Patient states she took TYLENOL and stayed home. Patient called triage nurse last evening through her HMO and they recommended ice and to stay home from work and to continue to take TYLENOL. She is just watching the rash per now as directed by HMO nurse.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On a unspecified date, the patients received a batch of improperly stored GARDASIL (dose, strength, route and lot# were not reported). No adverse effects reported. This case was one of the three reports received from the same reporter. (Other two products were captured in cases 1503USA003160 and case 1502USA005910). Additional information has been requested.