chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 10-AUG-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K025006; expiration date 22-JUL-2017) dose and route of administration were not reported). Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 61 year old female patient. On 26-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). On 26-AUG-2015, the patient experienced herpes zoster. The patient sought medical attention via seeing nurse practitioner. The nurse practitioner reported that the patient experienced prodromal symptoms, prior to receiving ZOSTAVAX. The outcome of the herpes zoster was unknown. Relatedness between the herpes zoster and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 1.62
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 month old male patient with asthma, irritable bowel syndrome, allergy to latex and drug reaction/ allergy to BIACIN and AUGMENTIN. On 23-JAN-1998, the patient was vaccinated with MMR II (dose, lot number and expiration date were unspecified). Concomitant therapies included SINGULAIR, fluticasone propionate, ADVAR and albuterol sulfate (manufacturer unknown). On 23-JAN-1998, reported as "shortly afterwards", the patient experienced injection site reaction of swelling and redness. Patient recovered in an unspecified time frame. Nurse states that the physician's office was notified of this reaction but no additional medical treatment was provided. No diagnostic tests have been performed. Relatedness between the event and MMR II was not reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, MEN, DTAP, MNQ
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2015US082848 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 567240) received on 15 Jun 2015. This report refers to a 2-month-old male patient. Medical history was not reported. Concomitant medication included ZANTAC. He was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in his right leg and DTAP (batch number: unknown) in his left leg on 24 Feb 2015. On 25 Feb 2015 he had high fever of 103.7 for which he took TYLENOL 2.5 mg. He also had large swollen lump leg on leg. He visited hospital (emergency room) for fever reduction. The final outcome of the events was recovered. The events were reported as non-serious. Causality was not reported.
Age: 0.2
Sex: M
Vaccine: DTAP, MEN, DTAP, MNQ
Symptoms: Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2015US082848 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 567240) received on 15 Jun 2015. This report refers to a 2-month-old male patient. Medical history was not reported. Concomitant medication included ZANTAC. He was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in his right leg and DTAP (batch number: unknown) in his left leg on 24 Feb 2015. On 25 Feb 2015 he had high fever of 103.7 for which he took TYLENOL 2.5 mg. He also had large swollen lump leg on leg. He visited hospital (emergency room) for fever reduction. The final outcome of the events was recovered. The events were reported as non-serious. Causality was not reported.
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2015US072275, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568023) website on 15 June 2015. This report refers to a 12 years old male patient. His concurrent condition included asthma. Concomitant medications were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown), HPV (manufacturer and batch number unknown) and TDAP (manufacturer and batch number unknown) on 02 Mar 2015. On 03 Mar 2015, the patient experienced redness and swelling localized to upper right arm only. Case was assessed as non-serious. Outcome and causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, DTAP, MNQ
Symptoms: Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US072874 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System  (VAERS ID 568860) received on 15 Jun 2015. This report refers to a 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) and DTAP (batch number: unknown) on 09 Mar 2015. On 10 Mar 2015 she had fever, was tired, had overall feeling of not feeling well and headache. The final outcome of the events was recovered. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Abdominal pain upper, Fatigue, Full blood count normal, Lethargy, Mononucleosis heterophile test negative
Clinical narrative: Case number PHHY2015US072938 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 569864) received on 15 Jun 2015. This report refers to a 11-year-old female patient. Medical history included allergy to amoxicillin and bee stings. Concomitant medication included over the counter chewable vitamin. She was vaccinated with meningococcal vaccine (manufacturer and batch report: unknown) and GARDASIL (other manufacturer, batch number: unknown) on 11 Mar 2015. On 12 Mar 2015 she had fever greater than 102 for two days then it has been low grade ever since. She was very lethargic, fatigued, muscle weakness and stomach pain. She was still symptomatic and it has been 5 days. Following the events she visited the emergency room. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Case number PHHY2015US072938 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 569864) received on 15 Jun 2015. This report refers to a 11-year-old female patient. Medical history included allergy to amoxicillin and bee stings. Concomitant medication included over the counter chewable vitamin. She was vaccinated with meningococcal vaccine (manufacturer and batch report: unknown) and GARDASIL (other manufacturer, batch number: unknown) on 11 Mar 2015. On 12 Mar 2015 she had fever greater than 102 for two days then it has been low grade ever since. She was very lethargic, fatigued, muscle weakness and stomach pain. She was still symptomatic and it has been 5 days. Following the events she visited the emergency room. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Abdominal pain upper, Fatigue, Lethargy, Muscular weakness, Pyrexia
Clinical narrative: Case number PHHY2015US072938 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 569864) received on 15 Jun 2015. This report refers to a 11-year-old female patient. Medical history included allergy to amoxicillin and bee stings. Concomitant medication included over the counter chewable vitamin. She was vaccinated with meningococcal vaccine (manufacturer and batch report: unknown) and GARDASIL (other manufacturer, batch number: unknown) on 11 Mar 2015. On 12 Mar 2015 she had fever greater than 102 for two days then it has been low grade ever since. She was very lethargic, fatigued, muscle weakness and stomach pain. She was still symptomatic and it has been 5 days. Following the events she visited the emergency room. The final outcome of the events was not recovered. The events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: MEN, VARCEL, MNQ, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHHY2015US080793 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 570370) received on 15 Jun 2015. This report refers to a 16-year-old female patient. On 17 Mar 2015, she was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) along with varicella zoster vaccine (other manufacturer, batch number: not reported). On 18 Mar 2015, her area of injection became very hard, it was stinging, burning, itching, hot, turned red, it swelled quite a bit and was painful to the touch. She also had fatigue. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: MEN, VARCEL, MNQ, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US080793 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 570370) received on 15 Jun 2015. This report refers to a 16-year-old female patient. On 17 Mar 2015, she was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) along with varicella zoster vaccine (other manufacturer, batch number: not reported). On 18 Mar 2015, her area of injection became very hard, it was stinging, burning, itching, hot, turned red, it swelled quite a bit and was painful to the touch. She also had fatigue. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Migraine, Myalgia, Nausea, Neck pain
Clinical narrative: Case number PHHY2015US085592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 570802) website on 07 Jul 2015. This report refers to a 20-year-old female patient. Current conditions were none. The patient had slight allergy to latex. Concomitant medication included birth control patch. The patient was vaccinated with BEXSERO (batch number: not reported) intramuscularly into the left arm on 20 Mar 2015. On the same day after vaccination at 11:00 PM, the patient experienced migraine headache, lightheadedness, nausea and vomiting. On 21 Mar 2015 in the morning, the patient experienced sore muscles, diarrhea and neck pain. The final outcome of the events was complete recovery. Seriousness and causality was not reported.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US085592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 570802) website on 07 Jul 2015. This report refers to a 20-year-old female patient. Current conditions were none. The patient had slight allergy to latex. Concomitant medication included birth control patch. The patient was vaccinated with BEXSERO (batch number: not reported) intramuscularly into the left arm on 20 Mar 2015. On the same day after vaccination at 11:00 PM, the patient experienced migraine headache, lightheadedness, nausea and vomiting. On 21 Mar 2015 in the morning, the patient experienced sore muscles, diarrhea and neck pain. The final outcome of the events was complete recovery. Seriousness and causality was not reported.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Diarrhoea, Dizziness, Migraine, Myalgia, Nausea
Clinical narrative: Case number PHHY2015US085592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 570802) website on 07 Jul 2015. This report refers to a 20-year-old female patient. Current conditions were none. The patient had slight allergy to latex. Concomitant medication included birth control patch. The patient was vaccinated with BEXSERO (batch number: not reported) intramuscularly into the left arm on 20 Mar 2015. On the same day after vaccination at 11:00 PM, the patient experienced migraine headache, lightheadedness, nausea and vomiting. On 21 Mar 2015 in the morning, the patient experienced sore muscles, diarrhea and neck pain. The final outcome of the events was complete recovery. Seriousness and causality was not reported.
Age: 20.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Neck pain, Vomiting
Clinical narrative: Case number PHHY2015US085592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 570802) website on 07 Jul 2015. This report refers to a 20-year-old female patient. Current conditions were none. The patient had slight allergy to latex. Concomitant medication included birth control patch. The patient was vaccinated with BEXSERO (batch number: not reported) intramuscularly into the left arm on 20 Mar 2015. On the same day after vaccination at 11:00 PM, the patient experienced migraine headache, lightheadedness, nausea and vomiting. On 21 Mar 2015 in the morning, the patient experienced sore muscles, diarrhea and neck pain. The final outcome of the events was complete recovery. Seriousness and causality was not reported.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL, MEN, VARCEL
Symptoms: Dizziness, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site urticaria
Clinical narrative: Case number PHHY2015US080330 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 571561) received on 15 Jun 2015. This report refers to a 12-year-old male patient. Medical history included asthma. This polymedicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) and varicella vaccine (manufacturer and batch number: unknown) in his right arm on 25 Mar 2015. On 26 Mar 2015 he had a large red, raised welt at the shot site which was 2 and 1/2 inch by 2 inch and felt hot to touch. He was dizzy and his arm felt numb. The final outcome of the events was condition unchanged. The seriousness and causality was not reported.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL, MEN, VARCEL
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Case number PHHY2015US080330 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 571561) received on 15 Jun 2015. This report refers to a 12-year-old male patient. Medical history included asthma. This polymedicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) and varicella vaccine (manufacturer and batch number: unknown) in his right arm on 25 Mar 2015. On 26 Mar 2015 he had a large red, raised welt at the shot site which was 2 and 1/2 inch by 2 inch and felt hot to touch. He was dizzy and his arm felt numb. The final outcome of the events was condition unchanged. The seriousness and causality was not reported.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL, MEN, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2015US080330 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 571561) received on 15 Jun 2015. This report refers to a 12-year-old male patient. Medical history included asthma. This polymedicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) and varicella vaccine (manufacturer and batch number: unknown) in his right arm on 25 Mar 2015. On 26 Mar 2015 he had a large red, raised welt at the shot site which was 2 and 1/2 inch by 2 inch and felt hot to touch. He was dizzy and his arm felt numb. The final outcome of the events was condition unchanged. The seriousness and causality was not reported.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Back pain, Electrocardiogram normal, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US075139 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 571750) received on 15 Jun 2015. This report refers to a 16-year-old female patient. Medical history included asthma. This poly medicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) on 27 Mar 2015. On the same date immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back. She also felt nauseous all evening and had tingling in her fingers on both hands. Following the events she visited the emergency room. The final outcome of the events was reported as not recovered. The events were reported as non-serious. Causality was not reported.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Nausea, Paraesthesia
Clinical narrative: Case number PHHY2015US075139 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 571750) received on 15 Jun 2015. This report refers to a 16-year-old female patient. Medical history included asthma. This poly medicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) on 27 Mar 2015. On the same date immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back. She also felt nauseous all evening and had tingling in her fingers on both hands. Following the events she visited the emergency room. The final outcome of the events was reported as not recovered. The events were reported as non-serious. Causality was not reported.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Back pain, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Nausea
Clinical narrative: Case number PHHY2015US075139 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 571750) received on 15 Jun 2015. This report refers to a 16-year-old female patient. Medical history included asthma. This poly medicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) on 27 Mar 2015. On the same date immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back. She also felt nauseous all evening and had tingling in her fingers on both hands. Following the events she visited the emergency room. The final outcome of the events was reported as not recovered. The events were reported as non-serious. Causality was not reported.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2015US075139 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 571750) received on 15 Jun 2015. This report refers to a 16-year-old female patient. Medical history included asthma. This poly medicated patient was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) on 27 Mar 2015. On the same date immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back. She also felt nauseous all evening and had tingling in her fingers on both hands. Following the events she visited the emergency room. The final outcome of the events was reported as not recovered. The events were reported as non-serious. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP, HPVX, MNQ, TDAP
Symptoms: Pruritus, Rash erythematous, Tenderness
Clinical narrative: Case number PHHY2015US076197, is an initial spontaneous report received from the Vaccine Adverse Events Reporting System (VAERS reference number: 572539) on 15 Jun 2015. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported) on 03 Mar 2015. She was also vaccinated with HPV (other manufacturer, batch number: not reported) and TDAP (other manufacturer, batch number: not reported) on 03 Mar 2015. On 02 Apr 2015, she experienced itching under arm then bumps on top of left arm and down the left side which was painful to touch. Bumps were red with little white heads. The outcome of the events was reported as condition unchanged. The health authority reported that events were non-serious and causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN, TDAP, HPVX, MNQ, TDAP
Symptoms: Pain, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US076197, is an initial spontaneous report received from the Vaccine Adverse Events Reporting System (VAERS reference number: 572539) on 15 Jun 2015. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported) on 03 Mar 2015. She was also vaccinated with HPV (other manufacturer, batch number: not reported) and TDAP (other manufacturer, batch number: not reported) on 03 Mar 2015. On 02 Apr 2015, she experienced itching under arm then bumps on top of left arm and down the left side which was painful to touch. Bumps were red with little white heads. The outcome of the events was reported as condition unchanged. The health authority reported that events were non-serious and causality of the events was not reported.
Age: 20.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pain of skin, Pyrexia
Clinical narrative: Case number PHHY2015US075156, is an initial spontaneous report received the vaccine adverse events reporting system (VAERS reference number: 572692) on 15 Jun 2015. This report refers to a 20 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported) in to the left arm on 01 Apr 2015. Same day after vaccination, he experienced fever, sore muscle, nausea and swollen lymph nodes. His skin hurts to touch. The outcome of the events was reported as condition unchanged. The events were reported as non-serious and causality of the events was not reported.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lip swelling, Poor quality sleep
Clinical narrative: This spontaneous report was received from a physician, concerning a 14 year old male patient. At the time of this report, the patient had none pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 10-JUN-2015, the patient was vaccinated with his first dose of GARDASIL, lot # K006960, 0.5 ml, intramuscular (anatomical location and expiration date were unspecified). On an unspecified date in 2015, after vaccination, the patient experienced lip swelling. Then, the patient visited the reporting physician and was assessed. No treatment was given for the lip swelling and none laboratory diagnostic studies were performed. The outcome of lip swelling was reported as recovered/resolved 2 days after the onset of the event, on an unknown date in 2015. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lip swelling
Clinical narrative: This spontaneous report was received from a physician, concerning a 14 year old male patient. At the time of this report, the patient had none pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 10-JUN-2015, the patient was vaccinated with his first dose of GARDASIL, lot # K006960, 0.5 ml, intramuscular (anatomical location and expiration date were unspecified). On an unspecified date in 2015, after vaccination, the patient experienced lip swelling. Then, the patient visited the reporting physician and was assessed. No treatment was given for the lip swelling and none laboratory diagnostic studies were performed. The outcome of lip swelling was reported as recovered/resolved 2 days after the onset of the event, on an unknown date in 2015. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Diarrhoea, Dizziness, Fatigue, Vomiting
Clinical narrative: Reported by mother:  at 8:00 pm her child begin vomiting and had diarrhea until aprox 4:00am on 8/26/2015. On 8/26/2015 became febrile with a reported temperature of 103 degrees F at 7:00pm.  Took to ER at 9:00pm on 8/26/15.  Resolved by 8/27/15.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Reported by mother:  at 8:00 pm her child begin vomiting and had diarrhea until aprox 4:00am on 8/26/2015. On 8/26/2015 became febrile with a reported temperature of 103 degrees F at 7:00pm.  Took to ER at 9:00pm on 8/26/15.  Resolved by 8/27/15.
Sex: U
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: L.A.D. about 1 wk. after MMR in (L) thigh.
Sex: U
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: L.A.D. about 1 wk. after MMR in (L) thigh.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Body temperature increased, Chills, Myalgia, Rash
Clinical narrative: Slight temperature up to 100.4 began within a couple hours of shots and lasted until approx. a week and a half later; chills began a week later and lasted about a day; severe muscle/joint pains, particularly in the hips, began a week later and lasted a few days, chickenpox rash began a week later and lasted approx. 5 days.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Slight temperature up to 100.4 began within a couple hours of shots and lasted until approx. a week and a half later; chills began a week later and lasted about a day; severe muscle/joint pains, particularly in the hips, began a week later and lasted a few days, chickenpox rash began a week later and lasted approx. 5 days.
Age: 38.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Middle insomnia, Nausea
Clinical narrative: Woke up in middle of night 8/26 with stomach pain and nausea.  Headache later in the day. 8/28 and 8/29 Moderate Diarrhea.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradycardia, Computerised tomogram, Confusional state, Dizziness, Electrocardiogram
Clinical narrative: 102 degree fever, nausea, vomiting, headache, dizziness, confusion, bradycardia, herpatic encephalitis.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Electroencephalogram, Headache, Lumbar puncture, Meningoencephalitis herpetic, Nausea
Clinical narrative: 102 degree fever, nausea, vomiting, headache, dizziness, confusion, bradycardia, herpatic encephalitis.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Vomiting
Clinical narrative: 102 degree fever, nausea, vomiting, headache, dizziness, confusion, bradycardia, herpatic encephalitis.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a consumer as part of a marketing research program refers to her/his friend, an approximately 74 year old male patient with decreased immune responsiveness. The patient's medical history included a melanoma tumor recently removed. On an unknown date, in approximately 2013, the patient was vaccinated with the first dose of ZOSTAVAX, injection (route of administration, anatomical location, lot number and expiration date were not reported). There were not concomitant medications provided. On an unspecified date, in 2013, the patient experienced shingles soon after getting the vaccine. The patient received a doctor's evaluation. The patient was incapacitated because of shingles (on his waist) and the rash took so long to fade. The outcome of shingles was reported as recovering/resolving since 4 or 6 months ago. The reporter considered shingles to be related to ZOSTAVAX. The reporter considered shingles to be an other medically significant event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Adverse event, Decreased appetite, Fatigue, Headache
Clinical narrative: Information has been received from a consumer referring to her 14 year old daughter no pertinent medical history. The patient was allergic to mushrooms and coconuts. The patient was not pregnant. The patient was vaccinated with all three doses of GARDASIL or GARDASIL 9 (not confirmed the vaccine by the reporter) (both lot number, expiration date, dose and route were unknown) in July 2014, October 2014 and January 2015 respectively. There were no concomitant medications. On an unknown date the patient had stomach pain, headache, fatigue and a loss of appetite after receiving the vaccine. The reporter also reported that on an unknown date the patient spent a week in a hospital due to unspecified event. The outcome of the events was reported as not recovered/not resolved. The causality between the events and GARDASIL or GARDASIL 9 were unknown. Additional information is not expected because the reporter did not consent to contact the physician.
Age: 69.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: Pt presented to MC ECC on 31 AUG with rash which he states appeared on 29 AUG.  Patient has erythematous macules on torso and extremities with itching. He does not have any vesicular lesions.  Presumed to be an adverse reaction to one of the vaccines he received. Patient was treated with Benadryl and topical hydrocortisone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: My daughter began complaining of left leg pain while playing outside on the swing set. We thought she hurt it possible from a fall, but as she was complaining and we began to look, her left thigh was extremely swollen compared to the right and the mid thigh (site of vaccination) was very red, raised, and warm to the touch.  We tried icing the area, but as time passed she complained of more pain and starting limping and wanting my husband and I to carry her so she did not have to bear weight on the left leg.  The next morning, 08/30/2015 she immediatley began complaining of pain and I noticed the redness had spread and the entire thigh and knee were swollen by at least 150%.  She continued to limp and I took her an after hours doctor at 8:00 PM to have it evaluated. We drew markings around the reddened area and I was advised to use warm compresses instead of ice. As of 9/01/2015, she began walking normally again and the redness and swelling had decreased some, but the site of injection was still red, feels hard, and warm to the touch.  As of today, 09/02/2015, the redness and swelling has decreased a little more, but the injection site is still hard, red and slightly warm to the touch. She is only complaining of pain directly at the injection site now instead of complaining of the whole leg. We are continuing to use a warm compress which does make the site feel softer temporarily.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site warmth
Clinical narrative: My daughter began complaining of left leg pain while playing outside on the swing set. We thought she hurt it possible from a fall, but as she was complaining and we began to look, her left thigh was extremely swollen compared to the right and the mid thigh (site of vaccination) was very red, raised, and warm to the touch.  We tried icing the area, but as time passed she complained of more pain and starting limping and wanting my husband and I to carry her so she did not have to bear weight on the left leg.  The next morning, 08/30/2015 she immediatley began complaining of pain and I noticed the redness had spread and the entire thigh and knee were swollen by at least 150%.  She continued to limp and I took her an after hours doctor at 8:00 PM to have it evaluated. We drew markings around the reddened area and I was advised to use warm compresses instead of ice. As of 9/01/2015, she began walking normally again and the redness and swelling had decreased some, but the site of injection was still red, feels hard, and warm to the touch.  As of today, 09/02/2015, the redness and swelling has decreased a little more, but the injection site is still hard, red and slightly warm to the touch. She is only complaining of pain directly at the injection site now instead of complaining of the whole leg. We are continuing to use a warm compress which does make the site feel softer temporarily.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, nausea, couldn't keep fluids down. Subsided after 3 hours with rest.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Intussusception
Clinical narrative: Abdominal pain, intussusception.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Chills, Constipation, Decreased appetite
Clinical narrative: Weakness, intense headache, dizziness, light headed-ness, stomach pains, constipation, loss of appetite, nausea, chills, extreme exhaustion.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Weakness, intense headache, dizziness, light headed-ness, stomach pains, constipation, loss of appetite, nausea, chills, extreme exhaustion.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Haemoglobin normal, Hyperhidrosis, Pallor, Seizure, Skin discolouration
Clinical narrative: Patient fainted within 2 minutes of VARIVAX vaccine being given. She then appeared to have seizure activity. She shook for 1-2 minutes. Very pale and appeared to have a green hue to skin. O2 sat 92% Pulse 40. Pt sweating profusely. Transferred to hosp ER.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope, Urine analysis normal
Clinical narrative: Patient fainted within 2 minutes of VARIVAX vaccine being given. She then appeared to have seizure activity. She shook for 1-2 minutes. Very pale and appeared to have a green hue to skin. O2 sat 92% Pulse 40. Pt sweating profusely. Transferred to hosp ER.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site vesicles
Clinical narrative: Took out dressing at night. Next day found blister at injection site. Contacted pharmacist and doctor.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a healthcare worker referring to her husband, a male patient of unknown age, via a company representative. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown), (dose, anatomical location, route, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient had an unspecified adverse reaction to PCV (manufacturer unknown), the patient was hospitalized on an unspecified date for an unspecified period. At the time of the report, the outcome of the adverse reaction to PCV (manufacturer unknown) was unknown. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Diarrhea, vomit, low grade fever and rapid breathing.
Age: 0.74
Sex: M
Vaccine: FLU3
Symptoms: Food allergy, Hypersensitivity, Pyrexia, Rhinorrhoea
Clinical narrative: Started with a runny nose then turned into a 103+ fever.  Called our pediatrician's after care nurse line on 9/25/2011.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Developmental delay, Diarrhoea
Clinical narrative: Rash that developed all over the body which worsened each day for about 10 days.  Along with very high fever (104), vomit, poop explosions.  Then slowly over the course of a couple of months my son lost his babbling, eye contact and stopped developing.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Language disorder, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Rash that developed all over the body which worsened each day for about 10 days.  Along with very high fever (104), vomit, poop explosions.  Then slowly over the course of a couple of months my son lost his babbling, eye contact and stopped developing.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Autism spectrum disorder, Bronchitis, Cough, Developmental delay, Diarrhoea
Clinical narrative: started with runny nose, then cough then high fever. The doctor's office noted on 1/21 URI symptoms then on 1/23 we brought my son in for wheezing which he then was prescribed medication for bronchitis.  My son's over health would get worse with each vaccine as well as his development slowed down after this vaccine and the MMR stopped his development all together.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Insomnia, Pyrexia, Rhinorrhoea, Speech disorder developmental, Upper respiratory tract infection
Clinical narrative: started with runny nose, then cough then high fever. The doctor's office noted on 1/21 URI symptoms then on 1/23 we brought my son in for wheezing which he then was prescribed medication for bronchitis.  My son's over health would get worse with each vaccine as well as his development slowed down after this vaccine and the MMR stopped his development all together.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Wheezing
Clinical narrative: started with runny nose, then cough then high fever. The doctor's office noted on 1/21 URI symptoms then on 1/23 we brought my son in for wheezing which he then was prescribed medication for bronchitis.  My son's over health would get worse with each vaccine as well as his development slowed down after this vaccine and the MMR stopped his development all together.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain, Swelling, Tenderness
Clinical narrative: Following influenza vaccine received yesterday, I had mild tenderness and redness for a few hours following. when I woke up this morning around 0600, I noticed moderate pain without touching, redness and swelling. My provider at the medical group measured the size of the induration at 7cm by 5cm with mild erythema.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Palpitations
Clinical narrative: After receiving vaccination the patient waited in waiting area until given the okay to leave. At the front cash registers the patient report heart palpitations and dizziness and was told to sat down. Pharmacist was called up to handle. Patient appeared pale and stated their heart was racing. After some water and sitting for about 15 minutes the patient appeared better and stated she felt better besides some heartburn that she normally experiences. Heart palpitations and racing went away but the patient said she didn't feel normal, possibly dehydrated and anxious due to the event.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Solid red Rash all over. The rash burns and itches.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Pruritus, Skin warm, Swelling
Clinical narrative: Skin hot to touch; itching, redness, headache, and swelling.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Nuclear magnetic resonance imaging, VIIth nerve paralysis, Vertigo
Clinical narrative: FACIAL PALSY, HEADACHE, VERTIGO.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Patient felt arm soreness and pain, noticed redness. Also felt body aches.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Dyspnoea, Skin reaction, Skin warm, Urticaria
Clinical narrative: Pt received the zoster vaccine last week and reports a 3.5" in diameter skin reaction (raised, hot wheal) that also caused her to have SOB and pt had to increase her neb txs. Pt also reports having to take 20mg prednisone x 2 days (uses prn severe asthma sx) to "calm the reaction. Reports the prednisone helped improve her SOB sx and her skin reaction.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: PATIENT DEVELOPED A RASH ON HER HEAD AND THE REST OF HER BODY 2 DAYS AFTER VACCINE.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Peripheral swelling
Clinical narrative: Patient had swelling in lower arm starting 2 days after administration.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Urticaria
Clinical narrative: I noticed a few hives on his lower leg (both right and left).  At first there were just 6, and they were flat and red.  My husband and I both studied them, and they were completely smooth, within the next 3 hours he developed a total of 11 hives, and they turned into raised angry looking welts.  I called the doctor and was instructed to put hydrocortisone cream on hives and administer Benadryl. It took 3 days for the hives to go away with this course of action.  I even called the doctor back again because it was taking so long, but was advised to continue as told.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Heart rate decreased, Skin discolouration
Clinical narrative: Mother stated while trying to have a bowel movement had a episode of heart rate dropping and turning purple. Took him to Hospital and was seen by Dr after waiting 2 hours in lobby and experiencing 2 additional episodes' of turning purple.
Age: 32.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Confusional state, Muscular weakness, Urticaria, Vertigo
Clinical narrative: Hives on both sides of face, vertigo, muscle weakness, confusion.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: PT did not have a reaction she recieved incorrect vaccination.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Gastroenteritis viral, Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2015US013862 is an initial spontaneous report from a healthcare professional received on 15 Jul 2015. This report refers to a 17-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with BEXSERO (batch number: unknown) in his left arm on 14 Jul 2015. On the same date while returning to his home after the vaccination, he had to pull over and throw up. He has since thrown up/vomited multiple times, has nausea, diarrhea, and a fever of 102 degrees. It was reported that he basically had symptoms of a really bad stomach flu. He was told to go to urgent care where he received anti-nausea medication and was sent home after observation. The outcome, seriousness and causality assessment of the events was not reported. Seriousness of really bad stomach flu was upgraded based on available information in the source document.
Age: 6.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US011954, is an initial spontaneous report received from a pharmacist on 18 Jun 2015. This report refers to a 6 year old female patient. Historical conditions was not reported. She was vaccinated with BEXSERO (batch number: not reported) intramuscularly on 12 Jun 2015. No adverse event was reported following this maladministration.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US012012, is an initial spontaneous report from a medical assistant received on 22 Jun 2015. This report refers to a 17 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with BEXSERO (batch number: 146101A) at a dose of 0.5 ml intramuscularly on 15 Jun 2015. It was reported that the patient received BEXSERO that reached up to 49F for 4 hours on 10 Jun 2015. No adverse event was reported.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US012028, is an initial spontaneous report from a medical assistant received on 22 Jun 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with BEXSERO (batch number: 146101A) at a dose of 0.5 ml intramuscularly on 15 Jun 2015. It was reported that the patient received BEXSERO that reached up to 49F for 4 hours on 10 Jun 2015. No adverse event was reported.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pyrexia, Swelling face
Clinical narrative: The day after vaccination, patient started experiencing nausea,"high fever"(exact temp unknown-did not have thermometer.) Three days later pt started having bsd headaches off and on. Today patient's face is swollen.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever, chills, arm got red, swollen and warm in a radius that exteded to 6 inches below the injections site.  Started to resolve on 9/1/15.
Age: 28.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Pain, Rash, Skin warm
Clinical narrative: INJECTION SITE/ARM HAS RASH, REDNESS, PAIN AND WARM TO TOUCH. TREATED WITH IBUPROFEN AND BENADRYL.
Age: 0.94
Sex: F
Vaccine: HEP, HIBV, IPV, PNC13
Symptoms: Diarrhoea, Expired product administered
Clinical narrative: Child was administered an expired vaccine.  Hep B, child developed severe diarrhea that burned her diaper area.  Treating with neosporin, aquaphor and oatmeal baths.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Nausea, Oral discomfort, Paraesthesia oral
Clinical narrative: Tingling/burning at the roof of her mouth a few hours after the vaccination.  Later the tingling also went to her tongue.  Tingling went away after a few hours.  However, stomach upset, nausea came on later that evening.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Rash morbilliform
Clinical narrative: Systemic morbilliform to the; head, neck, torso (front and back), and all four limbs.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Confusional state, Dyskinesia, Endotracheal intubation, Mechanical ventilation, Mental status changes
Clinical narrative: Garbled speech, mouth twisted to left, excessive salivation, confusion, altered mental status requiring intubation and mechanical ventilation.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Salivary hypersecretion, Speech disorder
Clinical narrative: Garbled speech, mouth twisted to left, excessive salivation, confusion, altered mental status requiring intubation and mechanical ventilation.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Raised red whelps on right arm with itching. Mother rushed patient to ER. Raised red whelps on torso by time they got to ER. Child placed on Benadryl and Prednisone and improved. Went to school next day and whelps improved per mother.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: FAINTING, SWEATING AND PALE IN COLOR.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Lip swelling, Swelling face
Clinical narrative: Pt. reported swelling to the face and lips.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Fever, lymphadenopathy, rash.
Age: 43.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, fever, general body aches and pain.