chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: FLUX, IPV, VARCEL
Symptoms: Atypical pneumonia, Product administered to patient of inappropriate age, Pyrexia, Varicella post vaccine
Clinical narrative: Patient (9 month old) received influenza vaccination; Chicken pox; High fevers; Walking pneumonia; Information has been downloaded from Agency (US-CHIRONMA-PHHY2013US116848).  This spontaneous report was received from an other health professional referring to a 9 months old female patient. The patient's concurrent condition and medical history were not reported. The patient's concomitant therapy included acetaminophen (TYLENOL).  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacture unknown) (1 dosage form; strength, dose detail, route, lot # and expiration date were unknown) for immunization. On 27-DEC-2012, the patient was vaccinated with influenza virus vaccine (unspecified) (1 dosage form; strength, dose detail, route, lot # and expiration date were unknown) for immunization (product administered to patient of inappropriate age). On the same date, the patient was vaccinated with polio vaccine (unspecified) (1 dosage form; strength, dose detail, route, lot # and expiration date were unknown) for immunization.  On 29-DEC-2012, the patient experienced chicken pox, high fevers and walking pneumonia. The outcome of the events chicken pox, high fevers and walking pneumonia was not recovered. The reporter considered the causality assessments between the events chicken pox, high fevers, walking pneumonia and influenza virus vaccine (unspecified) were suspected related. The causality assessments between the events chicken pox, high fevers, walking pneumonia and polio vaccine (unspecified) and varicella virus vaccine live (oka/merck) (manufacture unknown) were unknown.  The reporter considered all the events to be medically significant.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Ophthalmic herpes zoster, Oral herpes
Clinical narrative: Fever blisters in nostrils; Shingles in the eye; Swollen bar at injection site; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2013US140261).  Information has been received from a healthcare professional referring to a 60 years old female patient. The patient's medical history was not provided. The patient's concurrent condition included drug allergy. The patient's concomitant therapies included amlodipine (+) estrogens (+) conjugated (+) medroxyprogesterone acetate (PREMPRO), levothyroxine sodium, duloxetine hydrochloride (CYMBALTA) and sertraline hydrochloride.     On 13-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form, lot # J003796 and expiration date 28-JUN-2014; strength was unknown) subcutaneously for immunisation. On the same day, the patient was also vaccinated with influenza virus sag 3v vaccine inactivated (FLUVIRIN) (1 dosage form (DF), lot # 1307601 and expiration date 31-MAR-2014; strength was unknown) intramuscularly for immunisation.   On 26-SEP-2013, the patient experienced fever blisters in nostrils, shingles in the eye and swollen bar at injection site. The outcome of the events was reported as recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was not provided. The causality between the events of fever blisters in nostrils, shingles in the eye and influenza virus sag 3v vaccine inactivated (FLUVIRIN) was assessed as suspected by the reporter. The causality between swollen bar at injection site and influenza virus sag 3v vaccine inactivated (FLUVIRIN) was not provided.  The events of fever blisters in nostrils, shingles in the eye and swollen bar at injection site was considered to be medically significant by the reporter.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA008650:
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Skin ulcer
Clinical narrative: Blisters; Rash lead to weeping; Rash on scalp, right ear, right side of neck, chest, back/ Rash lead to very painful sores; Shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US001716).  Information has been received from an other healthcare professional referring to a 60 years old male patient. The patient's medical history and concurrent condition was not provided. The patient's concomitant medication included escitalopram oxalate (LEXAPRO), pravastatin, minerals (unspecified) (+) vitamins (unspecified) (CENTRUM), ubiquinones (unspecified) and selenium (unspecified).     On 01-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form; strength, lot # and expiration date were unknown) intramuscularly for immunisation. On the same day, the patient was also vaccinated with influenza virus vaccine (unspecified) (1 dosage form (DF); strength, lot # and expiration date were unknown) intramuscularly for immunisation.  On 08-OCT-2014, 7 days after onset of therapy, the patient experienced blisters, rash lead to weeping, rash on scalp, right ear, right side of neck, chest, back/ rash lead to very painful sores and shingles. The outcome of all the events was unknown. The causality between all the events and vaccinated with zoster vaccine live (ZOSTAVAX) was not provided. The causality between all the events and influenza virus vaccine (unspecified) was assessed as suspected by the reporter.  The events of blisters, rash lead to weeping, rash on scalp, right ear, right side of neck, chest, back/ rash lead to very painful sores and shingles were considered to be medically significant by the reporter.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Skin weeping
Clinical narrative: Blisters; Rash lead to weeping; Rash on scalp, right ear, right side of neck, chest, back/ Rash lead to very painful sores; Shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US001716).  Information has been received from an other healthcare professional referring to a 60 years old male patient. The patient's medical history and concurrent condition was not provided. The patient's concomitant medication included escitalopram oxalate (LEXAPRO), pravastatin, minerals (unspecified) (+) vitamins (unspecified) (CENTRUM), ubiquinones (unspecified) and selenium (unspecified).     On 01-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form; strength, lot # and expiration date were unknown) intramuscularly for immunisation. On the same day, the patient was also vaccinated with influenza virus vaccine (unspecified) (1 dosage form (DF); strength, lot # and expiration date were unknown) intramuscularly for immunisation.  On 08-OCT-2014, 7 days after onset of therapy, the patient experienced blisters, rash lead to weeping, rash on scalp, right ear, right side of neck, chest, back/ rash lead to very painful sores and shingles. The outcome of all the events was unknown. The causality between all the events and vaccinated with zoster vaccine live (ZOSTAVAX) was not provided. The causality between all the events and influenza virus vaccine (unspecified) was assessed as suspected by the reporter.  The events of blisters, rash lead to weeping, rash on scalp, right ear, right side of neck, chest, back/ rash lead to very painful sores and shingles were considered to be medically significant by the reporter.
Sex: U
Vaccine: PNC13
Symptoms: Mass, Skin warm, Swelling
Clinical narrative: Had a lump for a week that was hot and swollen; Had a lump for a week that was hot and swollen; Had a lump for a week that was hot and swollen; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender started received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient had a lump for a week that was hot and swollen. Outcome of the events was unknown.  Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Severe rash all over the body; This is a spontaneous report from a contactable nurse. A 12-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The nurse reported that they were about to administer meningococcal vaccine b (MENB) vaccine and an HPV vaccine to the patient and a warning for the administration of vaccines flared the medical record due to a previous reaction to the administration of pneumococcal 13-val conj vac (dipht crm197 protein). The nurse reported that the patient developed a reaction to pneumococcal 13-val conj vac (dipht crm197 protein) as a severe rash all over the body on an unspecified date but not diagnosed as an anaphylactic reaction, and this reaction was experienced only once. The nurse requested the information about the possible cross reactivity between the vaccine pneumococcal 13-val conj vac (dipht crm197 protein) and meningococcal vaccine b vaccine or HPV vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Contusion, Cough, Erythema, Extensive swelling of vaccinated limb
Clinical narrative: Cough; THIN RHINNORHEA; "SHAKING" PERIOD POST FALLING ASLEEP; RED BUMPS ON BACK WHICH HAVE BEEN SPREADING, SOME ARE CRUSTING OVER; LEFT DELTOID BECOMING HOT TO TOUCH, SWOLLEN, REDDENED AND TENDER; Cellulitis; Allergic reaction; SWOLLEN FROM ELBOW UP INTO AXILLA; SWOLLEN FROM ELBOW UP INTO AXILLA; BRUISED LOOKING; Information has been downloaded from regulatory authority (US-SP-2011-03710).  This spontaneous report was received from a healthcare professional concerning a 4-year-old male patient. The patient's concurrent conditions gastrooesophageal reflux disease (GERD), asthma, seasonal allergy, developmental delay, Specific allergy (drug), shaking, tonsillectomy, adenoidectomy, tympanostomy tube insertion, allergic rhinitis, chronic sinusitis, otitis media, contact dermatitis, urticaria and allergy to nuts; his concomitant medications included esomeprazole magnesium (NEXIUM), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), albuterol sulfate (manufacturer unknown), albuterol sulfate (PROAIR) and beclomethasone dipropionate (QVAR). The patient's medical history and previous drugs reactions were not reported.   On 15-JUN-2011, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous, lot #13212 for prophylactic vaccination (strength, dose, dose schedule, anatomical site of injection and expiration date were not reported) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (DAPTACEL), lot # C3473A, by intramuscular route, for prophylactic vaccination (strength, dose, anatomical site of injection and expiration date were not reported).   On the same day, the patient experienced cellulitis, allergic reaction (hypersensitivity), swollen from elbow up into axila (extensive swelling of vaccinated limb and lymphadenopathy), left deltoid becoming hot to touch, swollen, reddened and tender (vaccination site inflammation). On 27-JUN-2011, the patient experienced red bumps on back which have been spreading, some were crusting over (varicella). On an unknown date the patient experienced cough, bruised looking (contusion), shaking period post falling asleep (tremor) and thin rhinorrhea (rhinorrhea).     On 27-JUN-2011, the patient recovered from the events of cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion and vaccination site inflammation. The outcome of tremor, rhinorrhoea, cough and varicella was reported as resolved.    The causality assessment between the suspect vaccines and all the aforementioned events was not reported.       The events of the cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion, vaccination site inflammation, tremor, rhinorrhea, cough and varicella were considered to be medically significant.   Lot number 13212  is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  2011-03709:
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Hypersensitivity, Lymphadenopathy, Rash erythematous, Rhinorrhoea, Scab
Clinical narrative: Cough; THIN RHINNORHEA; "SHAKING" PERIOD POST FALLING ASLEEP; RED BUMPS ON BACK WHICH HAVE BEEN SPREADING, SOME ARE CRUSTING OVER; LEFT DELTOID BECOMING HOT TO TOUCH, SWOLLEN, REDDENED AND TENDER; Cellulitis; Allergic reaction; SWOLLEN FROM ELBOW UP INTO AXILLA; SWOLLEN FROM ELBOW UP INTO AXILLA; BRUISED LOOKING; Information has been downloaded from regulatory authority (US-SP-2011-03710).  This spontaneous report was received from a healthcare professional concerning a 4-year-old male patient. The patient's concurrent conditions gastrooesophageal reflux disease (GERD), asthma, seasonal allergy, developmental delay, Specific allergy (drug), shaking, tonsillectomy, adenoidectomy, tympanostomy tube insertion, allergic rhinitis, chronic sinusitis, otitis media, contact dermatitis, urticaria and allergy to nuts; his concomitant medications included esomeprazole magnesium (NEXIUM), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), albuterol sulfate (manufacturer unknown), albuterol sulfate (PROAIR) and beclomethasone dipropionate (QVAR). The patient's medical history and previous drugs reactions were not reported.   On 15-JUN-2011, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous, lot #13212 for prophylactic vaccination (strength, dose, dose schedule, anatomical site of injection and expiration date were not reported) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (DAPTACEL), lot # C3473A, by intramuscular route, for prophylactic vaccination (strength, dose, anatomical site of injection and expiration date were not reported).   On the same day, the patient experienced cellulitis, allergic reaction (hypersensitivity), swollen from elbow up into axila (extensive swelling of vaccinated limb and lymphadenopathy), left deltoid becoming hot to touch, swollen, reddened and tender (vaccination site inflammation). On 27-JUN-2011, the patient experienced red bumps on back which have been spreading, some were crusting over (varicella). On an unknown date the patient experienced cough, bruised looking (contusion), shaking period post falling asleep (tremor) and thin rhinorrhea (rhinorrhea).     On 27-JUN-2011, the patient recovered from the events of cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion and vaccination site inflammation. The outcome of tremor, rhinorrhoea, cough and varicella was reported as resolved.    The causality assessment between the suspect vaccines and all the aforementioned events was not reported.       The events of the cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion, vaccination site inflammation, tremor, rhinorrhea, cough and varicella were considered to be medically significant.   Lot number 13212  is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  2011-03709:
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Skin warm, Swelling, Tenderness, Tremor, Vaccination site inflammation
Clinical narrative: Cough; THIN RHINNORHEA; "SHAKING" PERIOD POST FALLING ASLEEP; RED BUMPS ON BACK WHICH HAVE BEEN SPREADING, SOME ARE CRUSTING OVER; LEFT DELTOID BECOMING HOT TO TOUCH, SWOLLEN, REDDENED AND TENDER; Cellulitis; Allergic reaction; SWOLLEN FROM ELBOW UP INTO AXILLA; SWOLLEN FROM ELBOW UP INTO AXILLA; BRUISED LOOKING; Information has been downloaded from regulatory authority (US-SP-2011-03710).  This spontaneous report was received from a healthcare professional concerning a 4-year-old male patient. The patient's concurrent conditions gastrooesophageal reflux disease (GERD), asthma, seasonal allergy, developmental delay, Specific allergy (drug), shaking, tonsillectomy, adenoidectomy, tympanostomy tube insertion, allergic rhinitis, chronic sinusitis, otitis media, contact dermatitis, urticaria and allergy to nuts; his concomitant medications included esomeprazole magnesium (NEXIUM), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), albuterol sulfate (manufacturer unknown), albuterol sulfate (PROAIR) and beclomethasone dipropionate (QVAR). The patient's medical history and previous drugs reactions were not reported.   On 15-JUN-2011, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous, lot #13212 for prophylactic vaccination (strength, dose, dose schedule, anatomical site of injection and expiration date were not reported) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (DAPTACEL), lot # C3473A, by intramuscular route, for prophylactic vaccination (strength, dose, anatomical site of injection and expiration date were not reported).   On the same day, the patient experienced cellulitis, allergic reaction (hypersensitivity), swollen from elbow up into axila (extensive swelling of vaccinated limb and lymphadenopathy), left deltoid becoming hot to touch, swollen, reddened and tender (vaccination site inflammation). On 27-JUN-2011, the patient experienced red bumps on back which have been spreading, some were crusting over (varicella). On an unknown date the patient experienced cough, bruised looking (contusion), shaking period post falling asleep (tremor) and thin rhinorrhea (rhinorrhea).     On 27-JUN-2011, the patient recovered from the events of cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion and vaccination site inflammation. The outcome of tremor, rhinorrhoea, cough and varicella was reported as resolved.    The causality assessment between the suspect vaccines and all the aforementioned events was not reported.       The events of the cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion, vaccination site inflammation, tremor, rhinorrhea, cough and varicella were considered to be medically significant.   Lot number 13212  is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  2011-03709:
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Cough; THIN RHINNORHEA; "SHAKING" PERIOD POST FALLING ASLEEP; RED BUMPS ON BACK WHICH HAVE BEEN SPREADING, SOME ARE CRUSTING OVER; LEFT DELTOID BECOMING HOT TO TOUCH, SWOLLEN, REDDENED AND TENDER; Cellulitis; Allergic reaction; SWOLLEN FROM ELBOW UP INTO AXILLA; SWOLLEN FROM ELBOW UP INTO AXILLA; BRUISED LOOKING; Information has been downloaded from regulatory authority (US-SP-2011-03710).  This spontaneous report was received from a healthcare professional concerning a 4-year-old male patient. The patient's concurrent conditions gastrooesophageal reflux disease (GERD), asthma, seasonal allergy, developmental delay, Specific allergy (drug), shaking, tonsillectomy, adenoidectomy, tympanostomy tube insertion, allergic rhinitis, chronic sinusitis, otitis media, contact dermatitis, urticaria and allergy to nuts; his concomitant medications included esomeprazole magnesium (NEXIUM), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), albuterol sulfate (manufacturer unknown), albuterol sulfate (PROAIR) and beclomethasone dipropionate (QVAR). The patient's medical history and previous drugs reactions were not reported.   On 15-JUN-2011, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), by subcutaneous, lot #13212 for prophylactic vaccination (strength, dose, dose schedule, anatomical site of injection and expiration date were not reported) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (DAPTACEL), lot # C3473A, by intramuscular route, for prophylactic vaccination (strength, dose, anatomical site of injection and expiration date were not reported).   On the same day, the patient experienced cellulitis, allergic reaction (hypersensitivity), swollen from elbow up into axila (extensive swelling of vaccinated limb and lymphadenopathy), left deltoid becoming hot to touch, swollen, reddened and tender (vaccination site inflammation). On 27-JUN-2011, the patient experienced red bumps on back which have been spreading, some were crusting over (varicella). On an unknown date the patient experienced cough, bruised looking (contusion), shaking period post falling asleep (tremor) and thin rhinorrhea (rhinorrhea).     On 27-JUN-2011, the patient recovered from the events of cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion and vaccination site inflammation. The outcome of tremor, rhinorrhoea, cough and varicella was reported as resolved.    The causality assessment between the suspect vaccines and all the aforementioned events was not reported.       The events of the cellulitis, hypersensitivity, extensive swelling of vaccinated limb, lymphadenopathy, contusion, vaccination site inflammation, tremor, rhinorrhea, cough and varicella were considered to be medically significant.   Lot number 13212  is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  2011-03709:
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Autism spectrum disorder, Developmental regression, Injection site swelling, Speech disorder developmental
Clinical narrative: At the time of this. There was no signs by the time we got home his leg was puffy swollen and red by in the morning he was having a ton of issues as far as starting to regress in language and being more verbal I'm starting to act out in the sons of not being able to get what he needs to get across in November 19 he was diagnosed with autism
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Cerebral haemorrhage, Contusion, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: With one one day showed extreme  bruising and petechiae all over body  Developed ITP, platelet count dropped to 2,000  Suffered a brain bleed 4 days after symptoms started, and started having seizures
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: With one one day showed extreme  bruising and petechiae all over body  Developed ITP, platelet count dropped to 2,000  Suffered a brain bleed 4 days after symptoms started, and started having seizures
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: headache, body aches, fever, nausea, fatigue from 7am July 7, to 10am July 8
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever on 6/24 and 6/25, then developed a measles like rash on her legs on the 26th. The rash was very faint on the morning of the 27th, and gone by that evening.
Age: 0.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, VARCEL
Symptoms: Agitation, Crying, Decreased appetite, Dermatitis, Diarrhoea
Clinical narrative: rash; right eye seeps as if infected; allergic reaction; agitation; diarrhea; insomnia; lymphadenopathy; chickenpox; unspecified disability; legs sore; loss of appetite; cries of pain; Information has been downloaded from regulatory authority (HQ2900705JUL2001)  This spontaneous report was received from a healthcare professional referring to a 7-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.   On 20-NOV-2000, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form daily (qd) by subcutaneous route); and also with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) injection (1 dosage form daily by intramuscular route); poliovirus vaccine inactivated (unspecified) (1 dosage form daily); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid injection (1 dosage form daily by intramuscular route); and hib conj vaccine (crm197) injection (1 dosage form daily by intramuscular route). All suspect vaccines indicated for immunization.  Strength, dose, anatomical location, lot #, and expiration date were not reported for all vaccines.  On 20-NOV-2000, the patient experienced legs sore (pain in extremity), cries of pain (crying), and loss of appetite (decreased appetite).  On an unknown date, the patient experienced unspecified disability (disability), chickenpox (varicella), lymphadenopathy, insomnia, diarrhoea, agitation,  allergic reaction (hypersensitivity), right eye seeps as if infected (eye infection), and rash (dermatitis).      The outcome of disability, varicella, lymphadenopathy, insomnia, diarrhoea, agitation, hypersensitivity, eye infection, dermatitis, crying, decreased appetite, and pain in extremity was unknown.  The causal relationship between the events and suspect vaccines were not reported.  According to the agency, all events were considered serious due to the disability.
Age: 0.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, VARCEL
Symptoms: Eye discharge, Eye infection, Hypersensitivity, Injection site pain, Insomnia
Clinical narrative: rash; right eye seeps as if infected; allergic reaction; agitation; diarrhea; insomnia; lymphadenopathy; chickenpox; unspecified disability; legs sore; loss of appetite; cries of pain; Information has been downloaded from regulatory authority (HQ2900705JUL2001)  This spontaneous report was received from a healthcare professional referring to a 7-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.   On 20-NOV-2000, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form daily (qd) by subcutaneous route); and also with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) injection (1 dosage form daily by intramuscular route); poliovirus vaccine inactivated (unspecified) (1 dosage form daily); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid injection (1 dosage form daily by intramuscular route); and hib conj vaccine (crm197) injection (1 dosage form daily by intramuscular route). All suspect vaccines indicated for immunization.  Strength, dose, anatomical location, lot #, and expiration date were not reported for all vaccines.  On 20-NOV-2000, the patient experienced legs sore (pain in extremity), cries of pain (crying), and loss of appetite (decreased appetite).  On an unknown date, the patient experienced unspecified disability (disability), chickenpox (varicella), lymphadenopathy, insomnia, diarrhoea, agitation,  allergic reaction (hypersensitivity), right eye seeps as if infected (eye infection), and rash (dermatitis).      The outcome of disability, varicella, lymphadenopathy, insomnia, diarrhoea, agitation, hypersensitivity, eye infection, dermatitis, crying, decreased appetite, and pain in extremity was unknown.  The causal relationship between the events and suspect vaccines were not reported.  According to the agency, all events were considered serious due to the disability.
Age: 0.58
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, VARCEL
Symptoms: Lymphadenopathy, Rash, Varicella post vaccine
Clinical narrative: rash; right eye seeps as if infected; allergic reaction; agitation; diarrhea; insomnia; lymphadenopathy; chickenpox; unspecified disability; legs sore; loss of appetite; cries of pain; Information has been downloaded from regulatory authority (HQ2900705JUL2001)  This spontaneous report was received from a healthcare professional referring to a 7-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.   On 20-NOV-2000, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form daily (qd) by subcutaneous route); and also with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) injection (1 dosage form daily by intramuscular route); poliovirus vaccine inactivated (unspecified) (1 dosage form daily); diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid injection (1 dosage form daily by intramuscular route); and hib conj vaccine (crm197) injection (1 dosage form daily by intramuscular route). All suspect vaccines indicated for immunization.  Strength, dose, anatomical location, lot #, and expiration date were not reported for all vaccines.  On 20-NOV-2000, the patient experienced legs sore (pain in extremity), cries of pain (crying), and loss of appetite (decreased appetite).  On an unknown date, the patient experienced unspecified disability (disability), chickenpox (varicella), lymphadenopathy, insomnia, diarrhoea, agitation,  allergic reaction (hypersensitivity), right eye seeps as if infected (eye infection), and rash (dermatitis).      The outcome of disability, varicella, lymphadenopathy, insomnia, diarrhoea, agitation, hypersensitivity, eye infection, dermatitis, crying, decreased appetite, and pain in extremity was unknown.  The causal relationship between the events and suspect vaccines were not reported.  According to the agency, all events were considered serious due to the disability.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 18-APR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Shortly after receiving zoster vaccine live (ZOSTAVAX) inoculation, pt suffered and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered as not recovered. The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the event was considered as disabling.
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillan-Barre syndrome; This spontaneous report was received from an office manager via a company representative and refers to a female patient of unknown age (an office manager's friend's daughter). The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (lot number and expiry date were not reported) for prophylaxis.  On an unknown date, after a dose of the vaccine, the patient experienced Guillain-Barre syndrome. The current status of the patient and the outcome of the event were unknown.  The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of Guillain-Barre syndrome was determined to be medically significant.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported; The Physician reports that the patient received GARDASIL 9 at age 15 years, the second dose in the HPV vaccination series on 7/7/2020.; This spontaneous report was received from a physician referring to a 15 years old patient of unknown gender. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.      On 04-JUN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, lot# and expiration date were not provided) intramuscularly for prophylaxis. On 07-JUL-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S010729, expiration date 02-DEC-2021; dose detail and strength were not provided) (inappropriate schedule of product administration). No additional adverse effect were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 5 unspecified patients experienced syncope/3 of the unspecified patients were male; This spontaneous report was received from a physician via a company representative and refers to 3 male patients, at the age range of 11 to 16 years old. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of vaccination, lot# and expiration date were not provided) for prophylaxis. After administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patients experienced syncope.  The outcome of the event was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as dose not changed. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003881:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medication were not provided. On or about 22-DEC-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX), (lot#, dose and route unknown), as prescribed and/or administered by a pharmacist at a Pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a health care provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown. Causality was assessed as related.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Shingles-like rash spread over the arm, torso and on the lower chest; Rash looked like vesicular lesions with no particular dermatome; Look like shingles; Information has been downloaded from Agency (US-CHIRONMA-PHHY2016US105128).  Information has been received from a consumer referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 dosage form (DF); strength, route, lot # and expiration date were unknown) for immunisation. On an unknown date, the patient was vaccinated with influenza virus vaccine (unspecified) (1 DF; strength, lot # and expiration date were unknown) intramuscularly for immunisation.      On an unknown date, the patient experienced shingles-like rash spread over the arm, torso and on the lower chest, rash looked like vesicular lesions with no particular dermatome and look like shingles. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was not provided. The causality between all events and influenza virus vaccine (unspecified) was assessed as suspected by the reporter.  The events of shingles-like rash spread over the arm, torso and on the lower chest, rash looked like vesicular lesions with no particular dermatome and look like shingles were considered to be medically significant by the reporter.
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: Unilateral painful rash; Herpes zoster; Itchy; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2016US164467).  This spontaneous report has been received from a healthcare professional, referring to a 4 years old female patient. The patient's history condition and concomitant medication were not provided.  On 18-NOV-2008, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) and influenza virus vaccine (unspecified), both for immunisation. The dose for both vaccines was 1 dosage form. The route, strength, lot number and expiration date for both vaccines were unknown.  On 16-APR-2016 (the patient vaccinated in 2008 and was 4 years old in 2016, which was an inconsistency), the patient experienced unilateral painful rash, herpes zoster and itchy. The outcome of the events was reported as recovered. The causality assessment between varicella virus vaccine live (oka/merck) (manufacturer unknown) and the events was unknown. The causality assessment between influenza virus vaccine (unspecified) and the events was reported as suspected.  The agency considered the events to be serious for the following reason: medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia, Pain, Swelling
Clinical narrative: pain / constant ache, increased pain with movement; swelling; majority of the redness (increased temperature at dosing site); increased temperature at dosing site / area still has a slightly elevated temperature; muscle pain; This case was reported by a consumer and described the occurrence of pain upon movement in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site warmth and muscle pain. On an unknown date, the patient experienced pain upon movement, swelling and injection site erythema. On an unknown date, the outcome of the pain upon movement, swelling, injection site erythema and muscle pain were unknown and the outcome of the injection site warmth was not recovered/not resolved.   It was unknown if the reporter considered the pain upon movement, swelling, injection site erythema, injection site warmth and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked side effects of Shingrix how long does the pain/swelling last after receiving the first shot. The patient was at 1 week and half after 1st dose of Shingrix, and while the majority of the redness (increased temperature at dosing site) had gone, the area still had a slightly elevated temperature compared to surrounding muscle, and there continues to be muscle pain, constant ache, increased pain with movement and/or touching.
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: pain / constant ache, increased pain with movement; swelling; majority of the redness (increased temperature at dosing site); increased temperature at dosing site / area still has a slightly elevated temperature; muscle pain; This case was reported by a consumer and described the occurrence of pain upon movement in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site warmth and muscle pain. On an unknown date, the patient experienced pain upon movement, swelling and injection site erythema. On an unknown date, the outcome of the pain upon movement, swelling, injection site erythema and muscle pain were unknown and the outcome of the injection site warmth was not recovered/not resolved.   It was unknown if the reporter considered the pain upon movement, swelling, injection site erythema, injection site warmth and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked side effects of Shingrix how long does the pain/swelling last after receiving the first shot. The patient was at 1 week and half after 1st dose of Shingrix, and while the majority of the redness (increased temperature at dosing site) had gone, the area still had a slightly elevated temperature compared to surrounding muscle, and there continues to be muscle pain, constant ache, increased pain with movement and/or touching.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injected limb mobility decreased, Injection site bruising, Lymphadenopathy, Pyrexia
Clinical narrative: Bruising at the injection site; Swollen, unspecified lymph nodes; Bruising underneath the arm; fever; could not lift arm for 1 week; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site bruising, enlargement of lymph nodes, bruising of arm and fever. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the injection site bruising, enlargement of lymph nodes, bruising of arm and fever were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site bruising, enlargement of lymph nodes, bruising of arm and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix about 3 months ago at a different pharmacy and had experienced bruising at the injection site of the arm, and underneath the arm. The patient noted swollen, unspecified lymph nodes.  The patient also reported fever.   No other details were known about the patient, as there was no pharmacy profile. The reporter did not consent to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Nonspecific reaction, Pallor, Peripheral coldness, Skin discolouration
Clinical narrative: severe systemic reaction; pale and blue hands; pale hands; cold hands; shacking hands; Severe chills; This case was reported by a physician via call center representative and described the occurrence of nonspecific reaction in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Bexsero. On 30th June 2020, 2 hrs 30 min after receiving Bexsero, the patient experienced nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills. On an unknown date, the outcome of the nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills were unknown.   It was unknown if the reporter considered the nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and after 2 and a half hours patient started with severe chills, shacking, both her hands were cold, pale and blue and reported a severe systemic reaction.  No hives, no swelling no anaphylactic reaction involved. Not complete DOB was reported.  No further details were provided.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: severe systemic reaction; pale and blue hands; pale hands; cold hands; shacking hands; Severe chills; This case was reported by a physician via call center representative and described the occurrence of nonspecific reaction in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Bexsero. On 30th June 2020, 2 hrs 30 min after receiving Bexsero, the patient experienced nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills. On an unknown date, the outcome of the nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills were unknown.   It was unknown if the reporter considered the nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and after 2 and a half hours patient started with severe chills, shacking, both her hands were cold, pale and blue and reported a severe systemic reaction.  No hives, no swelling no anaphylactic reaction involved. Not complete DOB was reported.  No further details were provided.