chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: None adverse reaction or side effects; pneumococcal 23v polysaccharide vaccine (PNEUMOVAX) (16-JAN-2013 and 13-JUL-2017); Information received from a case in litigation (# 1705USA006337) referring to a 69 year old male patient(pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. On 16-JAN-2013 and 13-JUL-2017, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(reported as PNEUMOVAX; dose, route of administration, anatomical location, lot#, expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). The pt did not experience any adverse event or side effects.; Sender's Comments:  US-009507513-1705USA006337: US-009507513-2002USA005475:
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Product storage error; This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 28-JAN-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) with lot # 1621926 and expiration date reported as 28-NOV-2021 for prophylaxis (strength, dose, frequency, route were not reported) (product storage error). No adverse events were reported. The physician reported that the physician received only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9). The outcome of product storage error and no adverse event was unknown.     This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2002USA001552:
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Tachycardia
Clinical narrative: experienced tachycardia; flushing of the neck , face and ears; This case was reported by a nurse via sales rep and described the occurrence of tachycardia in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia and flushing. On an unknown date, the outcome of the tachycardia and flushing were unknown.   The reporter considered the tachycardia and flushing to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced tachycardia and flushing of the neck, face, and ears. The patient mentioned that he has not experienced such a side effect when receiving other vaccinations.  The patient also mentioned that he had a food allergy but could not remember to what food he had an allergic reaction to in his past.  The reaction to the food was a long time ago. The patient believes reaction was to Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Myalgia, Pain, Pyrexia, Viral infection
Clinical narrative: feels viral; night of fever which breaks; painful bouts of muscle pain in my hip and back; but not pain free; Muscular back pain; This case was reported by a consumer and described the occurrence of viral infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced viral infection, fever, muscle pain, pain and muscular back pain. On an unknown date, the outcome of the viral infection and muscular back pain were unknown and the outcome of the fever, muscle pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the viral infection, fever, muscle pain, pain and muscular back pain 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 was selected as adult as per the vaccine indication. Since having the second dose of shingrix the patient had very painful bouts of muscle pain in the hip and back which culminated into a night of fever which broke and the next day was better but not pain free. The patient also felt viral. The patient stated that this has been going on for three weeks. The patient inquired to the pharmacist if he/she had heard of it earlier since the patient had never had this before. The pharmacist laughed and stated it was not related.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: Flu symptoms; Chills; Fever; Aches; Fatigue; This case was reported by a physician via call center representative and described the occurrence of flu symptoms in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced flu symptoms, chills, fever, pain and fatigue. On an unknown date, the outcome of the flu symptoms, chills, fever, pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the flu symptoms, chills, fever, pain and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient experienced flu symptoms, chills, fever, aches and fatigue. The adverse events lasted for 2 days. The reporter consented to follow up. The batch number and expiration date was not provided as the reporter mentioned that the information was at the facility and did not have the details at the moment.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: numbness of left arm; This case was reported by a pharmacist and described the occurrence of numbness of upper extremities in a 51-year-old male patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 3rd February 2020, the patient received Engerix B adult (intramuscular). On 3rd February 2020, 1 hr after receiving Engerix B adult, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was recovering/resolving.   It was unknown if the reporter considered the numbness of upper extremities to be related to Engerix B adult.  Additional information was provided as follows: The patient received Engerix B vaccine in the left deltoid. About 1 hour later, the patient reported numbness of the injected arm all the way from the shoulder to the hand. At the time of reporting, the patient was improving. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: severe headache; temperature of 100 degrees; felt very tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old 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 headache, fever and tiredness. On an unknown date, the outcome of the headache, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the headache, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of the Shingrix vaccine about 2.5 months ago date in her right deltoid, did not know if it was intramuscular. The patient had temperature of 100 degrees and felt very tired, and severe headache for about 3-4 days.  The patient went to her doctor and was tested for influenza which was negative. The follow up consent was granted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: after receiving the second dose of Shingrix experienced shingles; experienced Shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and immune system disorder. Concomitant products included adalimumab (Humira (Adalimumab)).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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 and Shingrix.  Additional details were provided as follows: The patient was reporter's sister. The patient receiving the 2nd dose of Shingrix experienced shingles. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Delirium, Fatigue, Injection site pain, Malaise, Pain
Clinical narrative: delirious; experience body aches; injection site pain; feeling sick; fatigue; This case was reported by a consumer via call center representative and described the occurrence of delirium in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix. On 6th February 2020, 15 min after receiving Shingrix, the patient experienced delirium (serious criteria GSK medically significant), general body pain, injection site pain, malaise and fatigue. On an unknown date, the outcome of the delirium, general body pain, injection site pain, malaise and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the delirium, general body pain, injection site pain, malaise and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. Approximately 15 minutes later, the patient began to experience body aches, fatigue, feeling sick, delirious and injection site pain. At time of reporting, the events were unresolved. The event feeling sick was not elaborated. The reporter did not consent to follow up.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel administered ina 9 year old by a Medical Assistant with the intention of reducing number of injections/no AE; 09-year-old female patient received Quadracel/no AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2020SA034515 (same reporter).  This case involves a 09-year-old female patient (second patient out of twins) who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which was administered by a Medical Assistant with the intention of reducing number of injections (Off label use; Product administered to patient of inappropriate age).  Patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) (no dosing details reported).  On 11-Dec-2019, the patient received a 0.5 ml 4th single dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA (expiry date: 09-Oct-2020) via intramuscular route in the right deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration and off label use.  It was unknown whether adverse event was noted in the patient or not.  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: FLUX
Symptoms: Contusion, Inflammation
Clinical narrative: big bruise the size of a 3 inch circle.; severe inflammatory reaction; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient who experienced big bruise the size of a 3 inch circle. and severe inflammatory reaction, while she received vaccine INFLUENZA VACCINE.  medical history included Macular degeneration in FEB-2019. The patient's past medical treatment included LUCENTIS. The patient's past vaccination(s) and family history were not provided.  Concomitant medications included AFLIBERCEPT (EYLEA).  On 02-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in the arm nos for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious big bruise the size of a 3 inch circle. (contusion) and severe inflammatory reaction (eye inflammation) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was severe inflammatory reaction and big bruise the size of a 3 inch circle..   The patient was treated with PANTOPRAZOLE SODIUM SESQUIHYDRATE (DURAZOL).  The event outcome is reported as Unknown for Bruise and Eye inflammation.  Information on the batch number was requested.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Injection site pain
Clinical narrative: pain in left shoulder; hard time lifting her shoulder; pain in her left deltoid injection site; 28 weeks & 3 days pregnant exposed to Adacel vaccine; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA036161, 2020SA036186 and 2020SA036190.  This case involves a 34 years old female patient who experienced pain in her left deltoid injection site (injection site pain), hard time lifting her shoulder (injected limb mobility decreased) and pain in left shoulder (musculoskeletal pain), 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 events occurred at 28 Weeks of pregnancy.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, vaccination and family history were not provided.  The patient previous pregnancy/ies details not reported.   No concomitants reported.   On 31-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6602AA and expiry date: 25-Feb-2022) via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious pain in her left deltoid injection site (injection site pain), hard time lifting her shoulder (injected limb mobility decreased) and pain in left shoulder (musculoskeletal pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis were injected limb mobility decreased, injection site pain and musculoskeletal pain.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient outcome was reported as unknown for all events.  Pregnancy outcome was unknown at the time of report.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired QUADRACEL vaccine was administered / No AE; Initial information was received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four years old female patient who on 04-Feb-2020 was vaccinated with 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5325BA) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 month, old patient was given Quadracel/no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  It was reported that 15 month old female patient was given  DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]./no AE (product administered to patient of inappropriate age) on 27-Dec-2019 for prophylactic vaccination [lot C5656AA; expiration date : 31-Aug-2021; dose: 0.5 ml; administration site: right thigh and route of administration not reported].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE [HEPATITIS A] and HIB (PRP/T) VACCINE [ACT-HIB]  It was a actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event 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.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel (expiry date: 07Feb2020) was inadvertently administered to a patient on 10Feb2020/ no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 year old (17 months old) female patient who inadvertently received a fourth dose of 0.5mL of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366BA, Expiration date: 07-FEB-2020) via intramuscular route in the left thigh for prophylactic vaccination on 10-Feb-2020 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included a dose of HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no adverse event.  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.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired dose of Daptacel was administered/no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient who received an expired dose (Expired product administered) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) (no dosing details reported).  On 10-Feb-2020, the patient received a 0.5 ml 4th single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5367AA (expiry date: 30-Jan-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  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: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was inadvertently administered/no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a patient of unknown demographics who received an expire dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] inadvertently (Expired product administered).  The patient medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 10-Feb-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5366AA (expiry date: 07-Feb-2020) via unknown route in unknown administration site for prophylactic vaccination.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not.  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.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting; fever of 99.4; 6 month old female patient was receiving the Fluzone HD; 4 month old female patient was receiving the Fluzone HD; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who experienced vomiting (vomiting), fever of 99.4 (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunization; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunization; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (Cong13-V) for Immunization.  On 04-Feb-2020, the patient received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ307AB and expiry date: 29-Jun-2020 via unknown route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious vomiting (vomiting) and fever of 99.4 (pyrexia) (reported as later in the day, unspecified) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  Laboratory data was not reported.  Final diagnosis was vomiting and fever.  It was not reported if the patient received a corrective treatment.  The outcome of the events was Unknown 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 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: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Body temperature increased, Chest X-ray normal, Computerised tomogram thorax normal, Condition aggravated
Clinical narrative: resting heart rate 140 bpm (slowly came down to normal range within 24 hrs by 2/13/20 6AM),  oral temperature 101.2 degrees F (normal 24 hours later), body aches (lasted less than 12 hours), soreness at injection site (continues), redness at injection site (continues)
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram abnormal, Influenza virus test negative, Injection site erythema, Injection site pain, Pain
Clinical narrative: resting heart rate 140 bpm (slowly came down to normal range within 24 hrs by 2/13/20 6AM),  oral temperature 101.2 degrees F (normal 24 hours later), body aches (lasted less than 12 hours), soreness at injection site (continues), redness at injection site (continues)
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Supraventricular extrasystoles, Tachycardia, Urine analysis normal, Ventricular extrasystoles
Clinical narrative: resting heart rate 140 bpm (slowly came down to normal range within 24 hrs by 2/13/20 6AM),  oral temperature 101.2 degrees F (normal 24 hours later), body aches (lasted less than 12 hours), soreness at injection site (continues), redness at injection site (continues)
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Emotional distress, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: The patient was brought in to the clinic by her mother on 2/13/2020, two days after she received her 6 month immunizations. Mom reports that the patient was a little fussy the day of her vaccinations, and this was not unexpected based on her previous experience with her 2 month and 4 month immunizations. However, mom was surprised to find the patient's left thigh swollen and red on 2/12/2020, the day after she received her Pentacel and Hep B in the left thigh. Mom says she could feel hard "knots" under the skin at the injection sites on the left thigh. The right thigh appeared normal. Mom also reported that the patient has had a decrease in urine output. She reports that she typically has 2-3 wet diapers over the course of the morning, but the patient only had 1 wet diaper that morning. She reports that the patient has not had a decrease in appetite/feeding. The patient gets both breast milk and formula, and has had normal feeding behaviors. Overnight, the patient awoke in the middle of the night and was screaming/crying and this is not typical. It was hard for mom to console her but she eventually went back to sleep. The day of her examination, 2/13/2020, mom reports her urine output is still not normal, and the left thigh is looking a little better than the day before.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling, Irritability, Middle insomnia, Screaming, Urine output decreased
Clinical narrative: The patient was brought in to the clinic by her mother on 2/13/2020, two days after she received her 6 month immunizations. Mom reports that the patient was a little fussy the day of her vaccinations, and this was not unexpected based on her previous experience with her 2 month and 4 month immunizations. However, mom was surprised to find the patient's left thigh swollen and red on 2/12/2020, the day after she received her Pentacel and Hep B in the left thigh. Mom says she could feel hard "knots" under the skin at the injection sites on the left thigh. The right thigh appeared normal. Mom also reported that the patient has had a decrease in urine output. She reports that she typically has 2-3 wet diapers over the course of the morning, but the patient only had 1 wet diaper that morning. She reports that the patient has not had a decrease in appetite/feeding. The patient gets both breast milk and formula, and has had normal feeding behaviors. Overnight, the patient awoke in the middle of the night and was screaming/crying and this is not typical. It was hard for mom to console her but she eventually went back to sleep. The day of her examination, 2/13/2020, mom reports her urine output is still not normal, and the left thigh is looking a little better than the day before.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness,  swelling, pain at injection site.  Fever, chills, shaking
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Redness,  swelling, pain at injection site.  Fever, chills, shaking
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: pt reports pain in right upper neck and down the right arm the next day after injection.  Injection site without redness/swelling or pain
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Influenza like illness, Pruritus, Pyrexia, Rash
Clinical narrative: Mother called and stated 3-4 days after receiving vaccines she noticed fever, flu like symptoms and rash. Mother stated that the flu like symptoms have improved and that the generalized rash with itching to body remained and have not improved with the application of creams. advised Mother  to seek medical attention for child at the nearest emergency room or urgent care center. Also provided address and phone number of a local community health center.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Laboratory test, Rash
Clinical narrative: Mother of the minor refers that in the early morning of 2/7/2020, the minor presented rash on the entire body and was taken to the Emergency Room at Hospital
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   In 2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions(for prophylaxis). Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient 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.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: shivering; muscle pain; tiredness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date,received 1st dose).   On 3rd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced shivering, myalgia and tiredness. On an unknown date, the outcome of the shivering, myalgia and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the shivering, myalgia and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  A day before reporteing, the patient received 2nd dose of Shingrix. The reporter wanted to know how long the events were lasted.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Flushing, Headache, Injection site pain
Clinical narrative: pain at injection; Loss of appetite; fatigue; headache; Leg muscle weak; Flushed; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, appetite lost, fatigue, headache, muscle weakness lower limb and flushing. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the appetite lost, fatigue, headache, muscle weakness lower limb and flushing were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, appetite lost, fatigue, headache, muscle weakness lower limb and flushing to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's friend. The age at vaccination was not reported but could be 61 or 62 years. The patient experienced pain at injection site which resolved and also experienced loss of appetite, fatigue, headache, leg muscles weak, flushed. The patient had been seen by primary care nurse practitioner and has been referred to a rheumatologist for consult. This case has been linked with case US2020019997, reported for same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: pain at injection; Loss of appetite; fatigue; headache; Leg muscle weak; Flushed; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced injection site pain, appetite lost, fatigue, headache, muscle weakness lower limb and flushing. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the appetite lost, fatigue, headache, muscle weakness lower limb and flushing were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, appetite lost, fatigue, headache, muscle weakness lower limb and flushing to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's friend. The age at vaccination was not reported but could be 61 or 62 years. The patient experienced pain at injection site which resolved and also experienced loss of appetite, fatigue, headache, leg muscles weak, flushed. The patient had been seen by primary care nurse practitioner and has been referred to a rheumatologist for consult. This case has been linked with case US2020019997, reported for same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Myalgia, Pyrexia, Rash
Clinical narrative: had fever; chills; muscle aches; red blotchy area on her skin; itchy; painful/patchy rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix. On 6th November 2019, 1 days after receiving Shingrix, the patient experienced fever, chills and muscle pain. In November 2019, the patient experienced red blotches, itchy rash and painful rash. On 7th November 2019, the outcome of the fever, chills and muscle pain were recovered/resolved. On an unknown date, the outcome of the red blotches, itchy rash and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, red blotches, itchy rash and painful rash to be related to Shingrix.  Additional details were reported as follows: The patient received dose and experienced had fever, chills and muscle aches next day. About 1 week after the dose she developed a red blotchy area on her skin that was painful and itchy. The area faded after about 4 days, but then reappeared on a different part of her body. She constantly had patches moving around to different parts of her body, always red, blotchy, painful and itchy, since. The patches seem to be getting higher up on her body as time goes on, and they appear on both sides of her body. None of the patches have developed blisters. The patient had seen her Health Care Professional about the patches. Emergency room visit was required. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: had fever; chills; muscle aches; red blotchy area on her skin; itchy; painful/patchy rash; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix. On 6th November 2019, 1 days after receiving Shingrix, the patient experienced fever, chills and muscle pain. In November 2019, the patient experienced red blotches, itchy rash and painful rash. On 7th November 2019, the outcome of the fever, chills and muscle pain were recovered/resolved. On an unknown date, the outcome of the red blotches, itchy rash and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, red blotches, itchy rash and painful rash to be related to Shingrix.  Additional details were reported as follows: The patient received dose and experienced had fever, chills and muscle aches next day. About 1 week after the dose she developed a red blotchy area on her skin that was painful and itchy. The area faded after about 4 days, but then reappeared on a different part of her body. She constantly had patches moving around to different parts of her body, always red, blotchy, painful and itchy, since. The patches seem to be getting higher up on her body as time goes on, and they appear on both sides of her body. None of the patches have developed blisters. The patient had seen her Health Care Professional about the patches. Emergency room visit was required. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: explosive diarrhea; This case was reported by a consumer via call center representative and described the occurrence of explosive diarrhea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received the 1st dose of Shingrix. On 26th November 2019, 5 days after receiving Shingrix, the patient experienced explosive diarrhea. On an unknown date, the outcome of the explosive diarrhea was resolved with sequelae.   It was unknown if the reporter considered the explosive diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported that she experienced explosive diarrhea 5 days after receiving the vaccine. It had occurred several times since vaccination.  The patient did not experienced any other symptoms prior to the diarrhea like stomach pain or cramps. She mentioned several additional onset dates that she could remember but there were other times too when she experienced diarrhea. She experienced diarrhea on 4th, 5th, 25th, 26th, 27th and 28th January 2020. On 9th January 2020, the patient visited her doctor. The reporter consented to follow up
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient experienced shingles a couple of days after receiving the first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 26th February 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were updated as follows: The pharmacist reported that, couple of days after vaccination the patient experienced Shingles. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia, Nasal congestion, Neck pain
Clinical narrative: headache; muscle pain; stuffy nose; "woozy"; sore neck; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache, muscle pain, nasal stuffiness, woozy and neck pain. On an unknown date, the outcome of the headache, muscle pain, nasal stuffiness, woozy and neck pain were unknown.   It was unknown if the reporter considered the headache, muscle pain, nasal stuffiness, woozy and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced headache, muscle pain, stuffy nose, woozy and sore neck. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hemiparesis, Hypoaesthesia
Clinical narrative: Weakness on the left side of the body; Numbness on the left side of the body; This case was reported by a physician via call center representative and described the occurrence of hemiparesis (left) in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hemiparesis (left) (serious criteria GSK medically significant) and body numbness. On an unknown date, the outcome of the hemiparesis (left) and body numbness were recovered/resolved.   It was unknown if the reporter considered the hemiparesis (left) and body numbness 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 was selected as adult as per vaccine indication. The patient received 1st dose of Shingrix and experienced numbness and weakness on the left side of the body which lasted 2 weeks after receiving 1st dose of Shingrix. The physician (reporter) inquired about data on administration of second dose after 6 month window because the patient wants to receive second dose after 6 months. The physician also inquired about clinical data of use of one dose of Shingrix as well. The reporter declined consent for follow up.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: 2 months of severe arthralgias in hands, feet, knees ; no swelling
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: child was given Kinrix instead of Pediarix.  error found through billing on 2/10/2020.  Verification of documentation to ensure it was not a  clerical error. Once paper confirmed on 2/13/2020 . Parent was notified and  parent stated that child had been without any adverse  reactions post vaccine " maybe a fever but I do not think it was bad."  Mom wanted to know if vaccine would count towards  her series and  she  told yes, it would count, but  infant still needed to be given a Hep B since she had not yet recieved the  4 month dose. Mom  made appointment for daughter to get Hep B  on 2/18/2020.  All of this reported to Medical Director .
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Joint injection, Joint range of motion decreased, Loss of personal independence in daily activities, Magnetic resonance imaging, Musculoskeletal pain
Clinical narrative: Approximate 48 hours after receiving the Tdap injection, report of worsening pain, difficulty accomplishing ADL's due to decreased shoulder ROM and pain, and difficulty lifting things with left arm. Sought out treatment by an orthopedic surgeon who RX PO steroids and a sling. Was given a joint injection X 2 Anterior/posterior approach. Since this second injection she feels nearly back to baseline but lacks confidence in dexterity and strength to do procedures. (pulmonologist) Procedures like intubation, bronchoscopies etc.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Weight bearing difficulty, X-ray limb normal
Clinical narrative: Approximate 48 hours after receiving the Tdap injection, report of worsening pain, difficulty accomplishing ADL's due to decreased shoulder ROM and pain, and difficulty lifting things with left arm. Sought out treatment by an orthopedic surgeon who RX PO steroids and a sling. Was given a joint injection X 2 Anterior/posterior approach. Since this second injection she feels nearly back to baseline but lacks confidence in dexterity and strength to do procedures. (pulmonologist) Procedures like intubation, bronchoscopies etc.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, Body Aches, Chills