chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Hypertension, Immediate post-injection reaction, Insomnia, Lung infection
Clinical narrative: 1st series April 18, 2017: immediate fatigue, muscle pain, joint pain, cold sweat, nightmares. 2nd series 6 June 2017: uncontrollable high blood pressure, insomnia, joint pain, fatigue, indigestion, gall stone, lung infection/bronchitis (September 2017: later determined to be vasculitis). 3rd series 28 Nov 2017: fatigue, insomnia, uncontrollable high blood pressure, severe joint pain, inflamed appendix (April 2018: appendectomy); kidney function drop to 15%; diagnosed with Microscopic Polyangitis (MPA) in Jul 2018.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Microscopic polyangiitis, Myalgia, Nightmare, Renal impairment, Vasculitis
Clinical narrative: 1st series April 18, 2017: immediate fatigue, muscle pain, joint pain, cold sweat, nightmares. 2nd series 6 June 2017: uncontrollable high blood pressure, insomnia, joint pain, fatigue, indigestion, gall stone, lung infection/bronchitis (September 2017: later determined to be vasculitis). 3rd series 28 Nov 2017: fatigue, insomnia, uncontrollable high blood pressure, severe joint pain, inflamed appendix (April 2018: appendectomy); kidney function drop to 15%; diagnosed with Microscopic Polyangitis (MPA) in Jul 2018.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: X-ray
Clinical narrative: 1st series April 18, 2017: immediate fatigue, muscle pain, joint pain, cold sweat, nightmares. 2nd series 6 June 2017: uncontrollable high blood pressure, insomnia, joint pain, fatigue, indigestion, gall stone, lung infection/bronchitis (September 2017: later determined to be vasculitis). 3rd series 28 Nov 2017: fatigue, insomnia, uncontrollable high blood pressure, severe joint pain, inflamed appendix (April 2018: appendectomy); kidney function drop to 15%; diagnosed with Microscopic Polyangitis (MPA) in Jul 2018.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain when pronating arm.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Myalgia
Clinical narrative: Low grade temp.; significant joint pain (neck, shoulders, elbows, wrists, knee (rt), hips); muscular pain.  Required ibuprofen 600mg with only partial relief.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Profound itching over entire body without rash, non-productive dry cough, fever spike of 101.1, body aches, chills. Fever x 36 hours, itching x 96 hours, cough continues.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (strength and route were unknown; lot# N034558, expiration date 05-DEC-2019) and properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N031941, expiration date 03-AUG-2020) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine was stored at 14 to -10 Celsius degrees for 15 minutes, -9 to 8 Celsius degrees for 5 hours and 45 minutes and 9 to 25 Celsius degrees for 3 hours. Data logger was involved. The previous temperature excursions were -14 to -10 Celsius degrees for 30 minutes, -9 to 8 Celsius degrees for 25 hours and 9 to 25 Celsius degrees for 17 hours. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1810USA006601:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-MAR-2009, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long-term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-SEP-2014 was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX vaccine  for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-OCT-2012, the patient was inoculated with ZOSTAVAX at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 10-FEB-2015, the patient was treated a physician office for the onset of rash, which was diagnosed as shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On an unspecified date in 2015, the patient was treated for the onset of a vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.  The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. Later in 2013, the patient was treated at a clinic for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure, immune system disorder, and herpes zoster was unknown. The reporter considered vaccination failure, immune system disorder, and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2015, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On an unspecified date in 2015, the patient was treated for the onset of a severe vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On 16-JAN-2014, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date in 2014, the patient contracted a persistent strain of herpes zoster. On or about 02-SEP-2014, the patient was treated for a persistent vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2015 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015 the patient was treated by a physician at a medical clinic for onset of a vesicular rash, which was diagnosed as chronic herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 28-JAN-2014 the patient was inoculated with ZOSTAVAX vaccine at a clinic for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 07-JUL-2015 the patient was treated at a clinic for onset of a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2014 the patient was inoculated with ZOSTAVAX vaccine at a drug store for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016 the patient was treated by a physician at a medical clinic for onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2006, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2010, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (strength and route were unknown; lot# N034558, expiration date 05-DEC-2019) and properly stored Merck Sterile Diluent (lot# N031941, expiration date 03-AUG-2020) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine was stored at 14 to -10 Celsius degrees for 15 minutes, -9 to 8 Celsius degrees for 5 hours and 45 minutes and 9 to 25 Celsius degrees for 3 hours. Data logger was involved. The previous temperature excursions were -14 to -10 Celsius degrees for 30 minutes, -9 to 8 Celsius degrees for 25 hours and 9 to 25 Celsius degrees for 17 hours. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA009201.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions, concomitant medications, medical history and drug reactions was not provided. On 12-OCT-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R007722, expiration date 10-MAR-2020; route was unknown) for prophylaxis (Incorrect product storage). The temperature excursion was at 26 degrees Celsius or warmer for 2 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-DEC-2017 and 08-FEB-2018, the patient was vaccinated with ROTATEQ (strength were unknown) (lot # N004815 and expiration date 07-OCT-2018; lot # N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 20-DEC-2017 and 21-FEB-2018, the patient was vaccinated with ROTATEQ (strength were unknown) (lot # N004815 and expiration date 07-OCT-2018; lot # N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709:US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017 and 12-FEB-2018, the patient was vaccinated with ROTATEQ) (strength were unknown) (lot # N004815 and expiration date 07-OCT-2018; lot # N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017 and 25-APR-2018, the patient was vaccinated with improperly stored ROTATEQ (strength were unknown) (lot # N004815 and expiration date 07-OCT-2018; lot # N024295 and expiration date 24-MAR-2019) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-DEC-2017 and 01-FEB-2018, the patient was vaccinated with improperly stored ROTATEQ (strength were unknown) (lot # M042169 and expiration date 22-JUN-2018; lot # N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for maximize 15 hours. And on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 19-JAN-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017 and 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 20-NOV-2017, the patient was vaccinated with improperly stored ROTATEQ (strength were unknown, lot# M042169 and expiration date 22-JUN-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017 and 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 10 years old female patient who experienced arthus reaction, while she received vaccine FLUZONE QUADRIVALENT. The patients past vaccination(s) included INFLUENZA VACCINE. The patients past medical history, medical treatment(s) and family history were not provided. On 05-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UI982AB and Exp. Date 30-JUN-2019) via intramuscular route in the left arm. On an unknown date, the patient developed a serious arthus reaction (type iii immune complex mediated reaction) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. No information about relevant tests reported. Final diagnosis was arthus reaction. No information about corrective treatment was reported. The event outcome was unknown. List of documents held by sender: none.; Sender's Comments: This case concerns a young patient who presented with Arthus reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is not known. There is, moreover, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 4-year old female patient who experienced cellulitis on left upper arm and abnormal swelling and redness at injection site, while she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 21-Sep-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA via unknown route in the left arm. On an unknown date the patient developed a serious reaction was cellulitis on left upper arm following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious abnormal swelling and redness at injection site following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was also reported that the patient came back on 24-Sep-2018 for TB check but then showed the staff the reaction on the arm. (Other relevant tests included No lab data.) Final diagnosis was abnormal swelling and redness at injection site and cellulitis on left upper arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovering / Resolving for abnormal swelling and redness at injection site and as Recovering / Resolving for reaction was cellulitis on left upper arm. List of documents held by sender: none. Sender's Comments: This case involves a four years old female patient who presented with cellulitis after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient received vaccine on the 11th and on the 12th the vaccine site was erythemic, hard, warm to touch, and tender.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood creatinine increased, Cardiac murmur, Cellulitis, Dyspnoea, Fluid overload
Clinical narrative: Patient developed cellulitis in the evening of 10/4/18, the day of the vaccination, feeling sick, labored breathing, fever, swelling, - went to the doctor the weekend of 10/5/18. Was sent to the ER - low blood pressure of 84/38, high pulse rate >120, admitted at the hospital on Sunday 10/7/18, discharged Tuesday 10/9/18.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Heart rate increased, Hypotension, Malaise, Pyrexia, Renal impairment
Clinical narrative: Patient developed cellulitis in the evening of 10/4/18, the day of the vaccination, feeling sick, labored breathing, fever, swelling, - went to the doctor the weekend of 10/5/18. Was sent to the ER - low blood pressure of 84/38, high pulse rate >120, admitted at the hospital on Sunday 10/7/18, discharged Tuesday 10/9/18.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Patient developed cellulitis in the evening of 10/4/18, the day of the vaccination, feeling sick, labored breathing, fever, swelling, - went to the doctor the weekend of 10/5/18. Was sent to the ER - low blood pressure of 84/38, high pulse rate >120, admitted at the hospital on Sunday 10/7/18, discharged Tuesday 10/9/18.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Fever, chills, nausea, muscle pain all over, fatigue, sinus congestion, difficulty sleeping due to chills. I received the vaccine on a Friday at about 9:00 am and the "adverse events" started that evening at about 8:30 pm, so about 11-12 hours after I received the vaccine. The next day, Saturday, I did not feel well enough to do my normal activities and just sat around all day under a blanket. I started to feel a little better Sunday afternoon when the fever stopped. Mild nausea continued until Tuesday. I would characterize these "adverse events" as surprising since I normally only get mild soreness at site of vaccines. People should probably be warned to expect to feel awful after getting the SHINGRIX vaccine so they can be prepared. Nevertheless, it was well worth it if it keeps me from getting Shingles.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Sinus congestion
Clinical narrative: Fever, chills, nausea, muscle pain all over, fatigue, sinus congestion, difficulty sleeping due to chills. I received the vaccine on a Friday at about 9:00 am and the "adverse events" started that evening at about 8:30 pm, so about 11-12 hours after I received the vaccine. The next day, Saturday, I did not feel well enough to do my normal activities and just sat around all day under a blanket. I started to feel a little better Sunday afternoon when the fever stopped. Mild nausea continued until Tuesday. I would characterize these "adverse events" as surprising since I normally only get mild soreness at site of vaccines. People should probably be warned to expect to feel awful after getting the SHINGRIX vaccine so they can be prepared. Nevertheless, it was well worth it if it keeps me from getting Shingles.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Approximately 3 minutes after receiving the shot I began to see white spots in my eyes, then my face felt numb (cheeks especially). My chest felt tight and my breathing was as if I was running.  The nurses from clinic called 911. EMS checked my vitals and all BP and O2 levels were normal.  The symptoms eventually went away within an hour or so. Later that evening around 5:30PM I began to have muscle aches, headache and had a fever of 101. The next day the symptoms were gone.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Approximately 3 minutes after receiving the shot I began to see white spots in my eyes, then my face felt numb (cheeks especially). My chest felt tight and my breathing was as if I was running.  The nurses from clinic called 911. EMS checked my vitals and all BP and O2 levels were normal.  The symptoms eventually went away within an hour or so. Later that evening around 5:30PM I began to have muscle aches, headache and had a fever of 101. The next day the symptoms were gone.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: On 10/12/18 patient claimed that she felt the syringe hit her bone upon administration of the PNEUMOVAX 23 vaccine into her right arm and that it hurt. I pulled the syringe back slightly to administer the vaccine properly into the muscle but had a difficult time getting it in. On 10/16/18 the patient saw her doctor because it was painful to move her right arm above shoulder level. The doctor prescribed KEFLEX and advised her to take ALEVE over-the-counter.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: He has a rash that appeared on left side of abdomen/chest. Slight fever and swelling.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: 4pm had swelling on top of arm, not around entire deltoid, described by patient as softball size. Also red and warm. No rash. 10/12/18 in morning, still red, swelling greatly decreased, some tenderness. Went to PCP and received rx for cephalexin x10 days. 10/15/18 All symptoms completely resolved per patient.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee reported hives on feet, ankles, legs, hands, and neck today 10/17/18 several hours after receiving flu shot. She took Benedryl last evening with some effect. Reports some hives and itching remain today. Employee takes daily Claritin daily.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Developed periodic pain (no swelling or stiffness) mostly at the injection site and in the left hand. Sometimes the entire left arm would hurt. Episodes typically occurred once or more daily, lasting from one to two hours. Symptoms diminished in intensity after about two weeks, continued at lower level of intensity. As of the writing of this report, symptoms are occasional (2-3 times/week), at 10-20% of original intensity; recovery is not complete. Administering pharmacist was consulted. Pharmacist advised that the vaccine required several weeks to develop the immunity and is active in the body during this time; and suggested that symptoms would last while vaccine is active, then gradually abate.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Headache, Lethargy, Pyrexia, Skin lesion
Clinical narrative: High fever, headache, lethargy, 20 fluid filled lesions.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Started with headache then chills and muscle ache was. Fever of 103. With MOTRIN fever broke and muscle aches better by 9am 10/17/18 but not feeling 100 percent.
Age: 59.0
Sex: F
Vaccine: ADEN_4_7
Symptoms: Dyspnoea, Heart rate increased, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, shortness of breath, rapid heartbeat, fever.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MNQ, VARCEL
Symptoms: Excessive eye blinking, Feeling hot, Hyperhidrosis, Vertigo
Clinical narrative: Student first received 3 vaccines in right arm with no reaction. Student was then given MCV4 in LUD with no observed reaction, and then given HPV in LLD. Student was fine initially and then less than a minute after his eyes were closed and started fluttering. He started to tip over forward. Exam bed was reclined back and student responded to name and stated he felt like the room was spinning and he was hot. Was provided with water and cold cloths applied to forehead as he started sweating. Sister was present at time and Mom was called. VS were BP 114/79, HR 64, Temp 97.5 orally. Student was able to sit up after five minutes and talk noting he did have breakfast and lunch that day. Mom arrived and explained situation to her and she took the student home around 2:05 pm with instructions to monitor through the night and keep hydrated with water.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder pain developed shortly after injection. Pain has continued for almost 3 weeks, limiting movement.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: SYNCOPE X 30-60 SECONDS.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7 yo male p/w mom with concern for reaction to influenza vaccine. Received influenza vaccine in left deltoid yesterday. Mom noticed some redness at site initially yesterday. Pt went swimming as per usual last night. This morning awakened with increased swelling, redness and warmth to upper arm. No pain or fever per report. No previous h/o vaccine reaction. A: Cellulitis of left upper arm; adverse reaction to influenza vaccine P: - diphenhydrAMINE (BENADRYL) 12.5 mg/5 mL liquid; Give 10 mL by mouth three times daily for 2 days then every 6-8 hours as needed.  Dispense: 118 mL; Refill: 0 - cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 7.1 mLs (355 mg per dose) by mouth 2 (two) times daily for 10 days.  Dispense: 142 mL; Refill: 0 - F/u in 2 days.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Aphasia, Computerised tomogram, Hyperhidrosis, Incoherent, Migraine
Clinical narrative: Patient presented to the ED as a stroke alert for aphasia that started 10 minutes prior. Symptoms started 10 min after the patient received her flu shot. She became diaphoretic and was having trouble speaking. Initially, the patient was able to listen and follow commands, but no longer is following as many commands or answering as many questions. A neurologist was consulted to see the patient. Initially, when interviewed, she rambled incoherences. She had significant difficulty naming. Her speech was nonfluent. Slowly over time, the quality of her speech and fluency improved, although remained impaired, even after a CAT scan was completed. An MRI of brain with and without contrast was subsequently performed and was found to be normal. No evidence of acute ischemia or abnormal enhancement. The patient remained in the ED for approximately 3 hours, received IV fluids and close monitoring. The patient's symptoms appeared to have been completely resolved by that time and considering the unremarkable CT and MRI, the team suspected that this is a complex migraine. The patient was sent home from the ED and will be re-evaluated as an outpatient for migraine treatment.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal, Scan with contrast normal, Speech disorder
Clinical narrative: Patient presented to the ED as a stroke alert for aphasia that started 10 minutes prior. Symptoms started 10 min after the patient received her flu shot. She became diaphoretic and was having trouble speaking. Initially, the patient was able to listen and follow commands, but no longer is following as many commands or answering as many questions. A neurologist was consulted to see the patient. Initially, when interviewed, she rambled incoherences. She had significant difficulty naming. Her speech was nonfluent. Slowly over time, the quality of her speech and fluency improved, although remained impaired, even after a CAT scan was completed. An MRI of brain with and without contrast was subsequently performed and was found to be normal. No evidence of acute ischemia or abnormal enhancement. The patient remained in the ED for approximately 3 hours, received IV fluids and close monitoring. The patient's symptoms appeared to have been completely resolved by that time and considering the unremarkable CT and MRI, the team suspected that this is a complex migraine. The patient was sent home from the ED and will be re-evaluated as an outpatient for migraine treatment.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Started at night, woke up at 3am, left arm was in pain. By 8am arm started to swell, continue to swell all day until it reached the size of a billiard ball. It was very warm, hot, and it turned pink.  Tuesday afternoon called the doctor who recommended cold compresses and ADVIL for the pain.   Symptoms continued all day Wednesday and Thursday. Swelling/pain lasted thru Friday. Ice helped the swelling a little but ADVIL did not cut the pain at all. In a pain scale, pain at 8-9 level. Patient could not raise arm or reach for anything. It felt like a frozen shoulder. By Friday, pain started to decrease. Swelling was still there on Saturday but started to reduce. Patient still has some swelling today.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Received the flu vaccine on 10/8/18 and developed left thigh pain after receiving the injection. Pt went to school the next day and after school his left leg was swollen from the knee up, pain worsens with ambulation.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: Very sore upper arm. Could not touch site. Could not straighten, raise or move arm for 48+ hours after injection. Still sore to touch day 7. Very fatigued, no energy for 24 hours. Felt like I was getting sick.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Chills, Contusion, Erythema, Fatigue
Clinical narrative: Influenza Qudrivalent preservative free (unknown brand) was given in left arm - no soreness. Right arm sore to touch and red/bruised like.  Woke the next morning with aches in hip and spread to entire body muscle aches, chills and likely a fever - although never took temperature.  Chills/aches lasted until about 8PM with little to no relief with acetaminophen once mid day and ibuprofen late afternoon.  Evening tired and developed nausea that lasted most of the following day.  All symptoms except soreness resolved on Sunday October 14th.  Soreness gone by Tuesday October 16.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Influenza Qudrivalent preservative free (unknown brand) was given in left arm - no soreness. Right arm sore to touch and red/bruised like.  Woke the next morning with aches in hip and spread to entire body muscle aches, chills and likely a fever - although never took temperature.  Chills/aches lasted until about 8PM with little to no relief with acetaminophen once mid day and ibuprofen late afternoon.  Evening tired and developed nausea that lasted most of the following day.  All symptoms except soreness resolved on Sunday October 14th.  Soreness gone by Tuesday October 16.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: BELOW THE INJECTION SITE THERE IS A 3 INCH RED, WARM CIRCLE, THE AREA IS PAINFUL.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Insomnia, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm has become warm, red, and swollen the size of a baseball and is keeping her up at night. She has required ice packs for several days.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient explained that the day she received the vaccine and for 3 days after that below the site of injection (same areas towards the front of breasts) it was swollen and what she described as "goose eggs." She said it was red, heated, itch and sore. She said she didn't experience any fever but the reaction was uncomfortable. She is much better now and the reaction has subsided. She almost feels fine.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Patient explained that the day she received the vaccine and for 3 days after that below the site of injection (same areas towards the front of breasts) it was swollen and what she described as "goose eggs." She said it was red, heated, itch and sore. She said she didn't experience any fever but the reaction was uncomfortable. She is much better now and the reaction has subsided. She almost feels fine.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, aches lasting for about 12 hours.