chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: F
Vaccine: YF
Symptoms: Immunisation, Incorrect dose administered, Injection site extravasation, No adverse event
Clinical narrative: patient was administered a dose of yellow fever at a travel clinic and part of the liquid came out so the provider administered another complete dose/ no adverse event; Based on information previously received on 04-Feb-2020, the following information product coding changed to yellow fever vaccine (UNK MFR) from YF-VAX and Stamaril has been amended.  Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 23 months old female patient who received a dose of YELLOW FEVER VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination, on an unknown date and it was reported that liquid came out so they administered another dose of the vaccine (incorrect dose administered).  Medical history, medical treatment, vaccination and family history were not provided.   It was actual medication error due to incorrect dose administered. It was reported that when a person took the granddaughter to a travel clinic to get the yellow fever vaccine and the provider stated some of the liquid came out so they administered another dose of the vaccine. Physician is concerned that the toddler has more than the recommended vaccine in her system and wants to know what to watch for. She would like a call back with recommendations. Caller doesn't know if it is YF-VAX or Stamaril.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Based on information previously received on 04-Feb-2020, the following information product coding changed to yellow fever vaccine (UNK MFR) from YF-VAX and Stamaril has been amended.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: right arm pain that progressively getting worst with throbbing & stabbing pain in her shoulder; female patient was 27 weeks & 4 days pregnant who received a dose of adacel; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA036161, 2020SA036186 and 2020SA036199 (same reporter).  This case involves a 30-year-old female patient who was pregnant and developed right arm pain that progressively getting worst with throbbing & stabbing pain in her shoulder (pain in extremity), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The gestation period was 27 weeks & 4 days.  The date of last menstrual period estimated due date, information regarding previous medical pregnancy and medical history were not reported.  On 28-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6602AA and expiration date 25-Feb-2022) via an unknown route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious right arm pain that progressively getting worst with throbbing & stabbing pain in her shoulder (pain in extremity), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Also this was a case of vaccine exposure during pregnancy as pregnant patient received a dose of Adacel vaccine.  Details of laboratory data were not reported.  Final diagnosis was pain in extremity and vaccine exposure during pregnancy.  It was not reported if the patient received any corrective treatment.  The event outcome of the event was not reported at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: reporting having administered a dose of ActHIB and then realizing the diluent portion was expired/ no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from the nurse.  This case involves a 47 year old female patient who was vaccinated with an 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number of Act-HIB: UI955AA and expiry date: 08Jun2020 and of box: U6111AA and expiry date: 24Jan2020, frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination on 06-Feb-2020. The diluent was expired (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It is a case of actual medication error due to expired product administered. It was reported that the patient was administered a dose of Act-HIB and then realizing the diluent portion was expired due to the diluent having a different expiration and their vaccines are input by a state run program that has placed the expiration date of the Act-HIB portion in the system and not the diluent.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive And Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA032577, 2020SA038344, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038348, 2020SA038349, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038350 and 2020SA038352.  This case involves a four months old female patient who 0.5 ml dose of  IPV (VERO) [IPOL] (lot PIF541M, exp date: 07-DEC-2020) via unknown route in the right thigh for prophylactic vaccination on 15-Jan-2020.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; HIB VACCINE (HIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA038344, 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038348, 2020SA038349, 2020SA038345, 2020SA038343, 2020SA038347, 2020SA038350, 2020SA038352 and 2020SA038344.  This case involves a four months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] (lot number PIF541M and expiry date 07-Dec-2020) via unknown route in the left thigh for Prophylactic vaccination on 15-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised (product storage error).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA038346, 2020SA032577, 2020SA038343, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038348, 2020SA038344, 2020SA038302, 2020SA038347, 2020SA038349, 2020SA038350, 2020SA038352 and 2020SA038343.  This case involves a 15 months old male patient who 0.5 ml dose of IPV (VERO) [IPOL] (lot number PIF541M expiry date 07-Dec-2020) via unknown route in the right thigh for Prophylactic vaccination on 15-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038350 and 2020SA038352.  This case involves a two months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] lot PIF541M (Expiry date 07-Dec-2020) (lot PIF541M) via intramuscular route in an unknown administration site for Prophylactic vaccination on 16-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: efrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information was received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038343, 2020SA038344, 2020SA038346, 2020SA038348, 2020SA038350, 2020SA038352, 2020SA038351 and 2020SA038345.  This case involves a four months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] (lot PIF541M, expiry date 07-Dec-2020) via an unknown route in the left thigh for prophylactic vaccination on 18-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), HIB VACCINE CONJ (TET TOX) (ACT-HIB); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13),HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised (product storage error).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given expired Daptacel to patient by mistake, No AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18 months old male patient who was vaccinated with an expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (fourth dose in series, lot number: C5367AA and expiry date: 30-Jan-2020) via intramuscular route in the thigh NOS on 11-Feb-2020.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel given after the expiration date, No AE; Initial information received on 11-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves15 month male patient who was vaccinated with expired 0.5 ml first dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5366AA and 07-Feb-2020) via intramuscular route in the left thigh on 10-Feb-2020 for prophylactic vaccination. It was a 4th in series dose but as a 1st Daptacel dose.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HIB VACCINE CONJ (TET TOX) (ACT-HIB).  It was actual medication error due to expired vaccine used.  No adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Occupational exposure to product, Product physical issue
Clinical narrative: she started to draw it up she noticed the "bottom of the vial was completely gone" and the medicine went all over her, no AE; bottom of the vial was completely gone, vail was cracked on the bottom, no AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case involves a female patient (age not reported) who was exposed to DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ208ABA) while preparing product for administration via unknown route in unknown administration site for prophylactic vaccination on an unknown date (occupational exposure to product and product physical issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was a case of occupational exposure while preparing product for administration and cracked product  It was reported that when she started to draw vaccine up she noticed the "bottom of the vial was completely gone" and the medicine went all over her. She removed another vial from the carton and started to withdraw the medication and noticed it was cracked on the bottom. Incident happened prior to use.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: a area size of a "baseball" that is red, swollen and painful/injection site swelling; a area size of a "baseball" that is red, swollen and painfull/injection site swelling; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient who experienced area size of a "baseball" that is red, swollen and painful/injection site swelling (vaccination site reaction and inflammation), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided.  On 07-Feb-2020, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6220AA and expiry date: 13-May-2020] via an unknown route at an unknown administration site.  On an unknown date, the patient developed a non-serious area size of a "baseball" that is red, swollen and painful/injection site swelling (vaccination site reaction and inflammation), (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of laboratory data not reported.  Final diagnoses were vaccination site reaction and inflammation.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown as it was not reported for vaccination site reaction and inflammation.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Sore arm with moderate pain.  Feel tired, have muscle and maybe joint pain, a bad headache, and a touch of nausea.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm with moderate pain.  Feel tired, have muscle and maybe joint pain, a bad headache, and a touch of nausea.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: moderate amount of redness and swelling at site area: started 02/17/2020 started 02/18/2020: fever and chills, sweats, body/muscle aches, nausea, increased redness and swelling to site 02/19/2020: same symptoms as 02/18/2020
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: moderate amount of redness and swelling at site area: started 02/17/2020 started 02/18/2020: fever and chills, sweats, body/muscle aches, nausea, increased redness and swelling to site 02/19/2020: same symptoms as 02/18/2020
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: blisters, rash, fever, upper/lower extremities, chest, genitals x 2 weeks
Sex: F
Vaccine: HPV9
Symptoms: Neoplasm malignant, Positron emission tomogram abnormal
Clinical narrative: signs of "neoplasm cancer"; This spontaneous report was received from a 44-year-old female patient who was reporting on herself. She had no pertinent medical history, drug reactions or allergies and concomitant therapies. In December 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) injection, intramuscularly (lot # and expiration date were not reported) for prophylaxis, as recommended by her obstetrics and gynecology physician (OGBYN).  On 30-DEC-2019 , she developed "neoplasm cancer", however did not seek medical attention. On 06-FEB-2020, the patient visited her physician who performed a positron emission tomography (PET) scan which indicated signs of "neoplasm cancer". The outcome of the event was was reported as not recovered. Relatedness between the event and the suspect vaccine was not provided. Upon internal review, the event of neoplasm cancer was considered to be medically significant.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: hot at the administration site; redness at the administration site; hot, redness and itching at the administration site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AN44, expiry date 24th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ( batch number MP42R,, expiry date 19th September 2021)).   On 10th February 2020, the patient received the 2nd dose of Shingrix. On 10th February 2020, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows:  The patient experienced injection site warmth, injection site erythema and injection site itching after receiving 2nd dose of Shingrix. Adverse reactions began on the day of vaccination and still continued. The reporter stated the patient did not experienced adverse reactions after the 1st dose of Shingrix. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injected limb mobility decreased, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Patient woke up early 2/19/2020 due to symptoms: headache, pain to right arm, body felt very warm, unable to lift right arm and very tender to touch.  Patient had received Men B vaccine the day before, 2/18/2020.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Influenza like illness, Pain, Pyrexia
Clinical narrative: High fever, shivers, dizziness, aches and pains, flu-like, all night.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Alopecia, Angiogram, Biopsy bone marrow, C-reactive protein increased, Computerised tomogram
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Heart rate abnormal, Housebound, Impaired gastric emptying, Magnetic resonance imaging
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Postural orthostatic tachycardia syndrome, Pyrexia, Red blood cell sedimentation rate increased, Syncope
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Angiogram, Autoimmune disorder, Biopsy bone marrow, Bone scan, C-reactive protein increased
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Gastrointestinal disorder, Heart rate abnormal, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Magnetic resonance imaging, Postural orthostatic tachycardia syndrome, Pyrexia, Red blood cell sedimentation rate increased, Syncope
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Ultrasound abdomen
Clinical narrative: My daughter received the HPV vaccine on 7/31/2019. On 9/21/2019, my daughter started a fever which ended up lasting 21 days, was hospitalized for 5 nights, had elevated sed rate and CRP for 3 months, tested for a variety of infectious diseases, had an MRA/MRI, CT, bone marrow biopsy, etc.  Currently, she has been diagnosed with POTS secondary to the undiagnosed event that precipitated her auto-immune response. She is on homebound, faints frequently due to the heart rate changes, severe fatigue, hair loss, and nausea/vomiting (likely due to gastroparesis secondary to POTS).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Inadvertently administered Men B when client should have received HPV
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Erythema multiforme, Rash
Clinical narrative: Erythema multiforme minor.  Rash involving the hands that started yesterday and then spread all over.  Course of her symptoms over time is worsening.  Skin sensations associated with rash: non-pruritic, painless.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Jan 2019 I completed the shots shingrix and today went to doctor and have shingles; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  In January 2019, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In January 2019, the patient received dose of Shingrix and experienced Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Myalgia
Clinical narrative: Chills; Pain in muscles; Upset digestive system; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, myalgia and gastrointestinal upset. On an unknown date, the outcome of the chills, myalgia and gastrointestinal upset were not recovered/not resolved.   It was unknown if the reporter considered the chills, myalgia and gastrointestinal upset to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experienced chills, pain in muscles and upset digestive system. The reporter was wondering about how long the side effects last.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: local redness; local swelling; This case was reported by a physician via call center representative and described the occurrence of localized erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were recovered/resolved.   It was unknown if the reporter considered the localized erythema and local swelling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced local redness and swelling that lasted for 24 hours. Reporter consented to follow up. This case is link with case US2020024284, reported by same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: soreness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in April 2019 and experienced soreness at site of injection, refer case US2020025196).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced soreness at site of injection. The patient stated that it was a dull, sore like pain that he notices from time to time when using his left arm and also sometimes bothers him when trying to sleep on it. The patient did not consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in April 2019 and experienced soreness at site of injection, refer case US2020025196).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain. The patient was treated with ibuprofen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced soreness at site of injection. The patient stated that it was a dull, sore like pain that he notices from time to time when using his left arm and also sometimes bothers him when trying to sleep on it. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Induration, Peripheral swelling, Pyrexia, Rash
Clinical narrative: bad headache; had 101.4 fever; had a large spot in my arm swelling up hard; arm hardness; spot on arm; This case was reported by a other health professional via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fever, swelling arm, induration and rash. On an unknown date, the outcome of the headache, fever, swelling arm, induration and rash were unknown.   It was unknown if the reporter considered the headache, fever, swelling arm, induration and rash to be related to Shingrix.  Additional details were provided as follows The age at vaccination not provided. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received Shingrix vacccine and experienced a large spot on arm swelled up hard and swelling below it,101.4 degree F fever and bad headache      Lab Comments: On an unknown date lab test was performed
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Biopsy eyelid, Skin ulcer
Clinical narrative: developed a problem with my autoimmune system / Shingrex vac. could have contributed to this problem; ulcer on the inside of my lower lid; This case was reported by a consumer and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and skin ulcer. On an unknown date, the outcome of the autoimmune disorder and skin ulcer were unknown.   It was unknown if the reporter considered the autoimmune disorder and skin ulcer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient had the Shingrix vaccination and developed an ulcer on the inside of patients lower lid.  The opthomologist had done a biopsy but not yet received the results. The patient thinks that though developed a problem  with patients autoimmune system. The patient asked a question that it possible that the Shingrix vaccine could had contributed to this problem
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Mobility decreased, Pain
Clinical narrative: flu like symptoms; achy; feverish; headache; chills; decreased mobility; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever, headache, chills and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, pain, fever, headache, chills and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever, headache, chills and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  The reporter was patients wife. The patient experienced flu like symptoms, achy, feverish, headache , chills and just decreased mobility after receiving Shingrix in high up on the deltoid muscle. The stayed in chair most of the day. The reporter reported that about 36 to 72 hours later the issues resolved. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; achy; feverish; headache; chills; decreased mobility; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever, headache, chills and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, pain, fever, headache, chills and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever, headache, chills and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  The reporter was patients wife. The patient experienced flu like symptoms, achy, feverish, headache , chills and just decreased mobility after receiving Shingrix in high up on the deltoid muscle. The stayed in chair most of the day. The reporter reported that about 36 to 72 hours later the issues resolved. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: started having muscle stiffness; started having muscle spasms; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th December 2019, the patient received Boostrix. On 30th December 2019, immediately after receiving Boostrix, the patient experienced muscle stiffness and muscle spasm. On an unknown date, the outcome of the muscle stiffness and muscle spasm were not recovered/not resolved.   It was unknown if the reporter considered the muscle stiffness and muscle spasm to be related to Boostrix.  Additional details were provided as follows: Adverse event being filed with voicemail information only.  The age at the vaccination was not reported. The patient received Boostrix Vaccine for tetanus and shortly after started having muscle stiffness and muscle spasms and have been suffering ever since. The reporter consented to follow up. No additional details were provided at the time of the call.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 1st dose of Shingrix. On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced nausea and fever. On an unknown date, the outcome of the nausea and fever were recovered/resolved.   It was unknown if the reporter considered the nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient 2 days after receiving dose of Shingrix experienced nausea and fever which had resolved. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix. In November 2019, 3 weeks after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   The reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. About 3 weeks after vaccination, the patient experienced itching. This case is linked to case US2020AMR023925 reported for the same patient for 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: severe side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced severe side effects from the vaccine but did not provide any further details. The reporter did not consent to follow up. The patient refused for any demographic information.