chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a consumer to a 67 year old female patient. The patient's concurrent condition included arthropathy. The patient's concomitant therapies included citalopram, omeprazole, and valacyclovir hydrochloride. The patient's medical history was not reported. The patient's historical drugs included codeine. On 23-APR-2019, the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, frequency, and route of administration were not reported; lot # R033342 and expiration date 03-AUG-2020) to prevent pneumonia. On 24-APR-2019 (reported as the next day), the patient was sick to her stomach and experiencing severe arm pain. She had a fever of 103.7. The patient vomited nonstop for 2 days. Her arm was swelled around the injection site, and she had a raised rash. She sought medical attention, hence, went to urgent care where she saw 3 physicians, who gave her cream (unspecified) for the rash and medicine for nausea. She did also see a dermatologist who told her there must have been a bad toxin (product contamination microbial) that got into the vaccine that caused her reaction. She had a large scab on the injection site that was black, the tissue there was dead and was still healing. She said her doctor told her she would have a large scar when it was completely healed. The patient's daughter took pictures of her arm.  The patient reporter she has never had a reaction to a shot before this. The outcome of nausea, injection site necrosis, rash papular, vaccination site swelling, vomiting, pyrexia, pain in extremity, abdominal discomfort and injection site scab was reported as not recovered. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review, the injection site necrosis was determined to be medically significant. Lot number was reported in the source document but the expiration date was not. But, when entering the lot number in the system automatically auto-populated the expiration date.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer concerning a currently 71 year old not married female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.    On 10-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient experienced herpes zoster. The patient received an unspecified treatment.   The outcome of herpes zoster was unknown.     The reporter considered that the event resulted from Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 18-APR-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) (lot # R008206 and expiration date 16-SEP-2019) (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for a time frame 1 hour 15 minutes and -14 °C to -10°C for a time frame 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA010082: US-009507513-1905USA010085: US-009507513-1905USA006081: US-009507513-1905USA010081: US-009507513-1905USA010092:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of  PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 01-MAY-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) lot # R008206 and expiration date 19-SEP-2019 (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for a time frame of 1 hour 15 minutes and -14 °C to -10°C for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA010082: US-009507513-1905USA010085: US-009507513-1905USA010080: US-009507513-1905USA006081: US-009507513-1905USA010092:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of  PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 11-APR-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) (lot # R008206 and expiration date 16-SEP-2019) (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA006081: US-009507513-1905USA010085: US-009507513-1905USA010080: US-009507513-1905USA010081: US-009507513-1905USA010092:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 11-APR-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) (lot # R008206 and expiration date 16-SEP-2019) (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA006081: US-009507513-1905USA010084: US-009507513-1905USA010082: US-009507513-1905USA010085: US-009507513-1905USA010080: US-009507513-1905USA010092: US-009507513-1905USA010081:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 12-APR-2019, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027993 and expiration date 01-OCT-2020)  (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA006081: US-009507513-1905USA010082: US-009507513-1905USA010080: US-009507513-1905USA010081: US-009507513-1905USA010092: US-009507513-1905USA010085:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.    On 02-MAY-2019, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027993 and expiration date 01-OCT-2020)  (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK)for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.  This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA006081: US-009507513-1905USA010080: US-009507513-1905USA010081: US-009507513-1905USA010092: US-009507513-1905USA010082:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of VARIVAX was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.   On 11-APR-2019, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027993 and expiration date 01-OCT-2020)  (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010085: US-009507513-1905USA010082: US-009507513-1905USA010081: US-009507513-1905USA010080: US-009507513-1905USA010084: US-009507513-1905USA006081:
Sex: F
Vaccine: HPV9
Symptoms: Pain, Peripheral swelling, Rash
Clinical narrative: The patient developed pain and being sore after receiving the first dose of GARDASIL 9; The patient developed swelling, after receiving the fisrt dose; After the second dose, the patient's arm "swelled up to twice it's size."; The patient's arm "swelled up again"; She developed a rash; This spontaneous report was received from a pharmacist, via a company representative, referring to a 12 year old non-pregnant female patient. The patient's medical history included reaction to previous exposure to any vaccine (reported as "sensitive to vaccines"). No information was provided regarding the patient's concurrent conditions or concomitant medications.     On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prevention of human papillomavirus (HPV) (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, after receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient developed pain, swelling, and being sore; then, on an unknown date, 2 months after the first dose, the patient was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), after the second dose, the patient's arm "swelled up to twice it's size" (peripheral swelling). Subsequently, the patient recovered and on an unspecified date, 3 weeks later, the patient's arm "swelled up again" (peripheral swelling) and she developed a rash. It was unknown if the patient received any treatment for the events, or if laboratory diagnostic studies were performed.  At the reporting time, the outcome of swelling, pain, rash, and the 2 episodes of peripheral swelling was reported as resolved. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient received her first dose of Gardasil 9 at age 11 and the second dose at age 16; No adverse effect reported; This spontaneous report was received from a pharmacist referring to a 16-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.   On an unknown date (also reported as at 11 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, indication, anatomical site, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV) infection.      On an unspecified date (also reported as at 16 years old), the patient was possibly vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, frequency, indication, anatomical site, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV) infection (Inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: patient had an unspecified reaction after being administered a dose of GARDASIL 9; This spontaneous report was received from a physician via a company representative and refers to a male patient currently 17 years old. There was no information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided.  On 20-AUG-2018, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# N020353 with expiration date on 28-APR-2020, exact dose frequency and route of administration were not provided).   On an unknown date, reported as after being administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient experienced an unspecified reaction. The outcome of the event was unknown. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was not reported.  Lot number was reported in the source document, but the expiration date was not. But, when entering the lot number in MARRS the system automatically auto-populated the expiration date.  This is one of several reports received form the same reporter.; Sender's Comments:  US-009507513-1905USA011106: US-009507513-1905USA011668:
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Swelling face
Clinical narrative: development of facial swelling; rash; This spontaneous report was received from a health professional (Nurse practitioner) refers to a 10-year-old female patient. The patient's concurrent conditions and medical history were not provided. Concomitant medications included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA).   On an unknown date in 2016 (reported as 3 years ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via intramuscular route for prophylaxis (Lot # and expiry date unspecified).             On an unknown date in 2016 (reported as 3 years ago), after the first dose of vaccine the patient experienced facial swelling and later a rash (not specified).  As per nurse practitioner, this was first time to hear of this reaction and there was no treatment given to patient at the time of first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).    The patient was in the office for unspecified reason recently and nurse practitioner stated patient' s mother refused second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in immunization series as patient experienced a reaction after first dose. No cancer adverse event. The patient did not die. No significant disability and hospitalization. No Life-threatening events. No overdose. No PQC involved. No further information provided.     Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued. The outcome of swelling face and rash was resolved.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; an unspecified 16 year old "vaccine naive" patient was administered a dose of PROQUAD; This spontaneous report was received from a pharmacist refers to a 16 year old patient of unknown gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in May 2019 (reported as "earlier this week"), the "vaccine naïve" patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (strength, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). The outcome of the events was unknown. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; The patient recieved one expired dose of VAQTA; This spontaneous report was received from an office manager, regarding 17 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 03-APR-2019, the patient was vaccinated with one expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5, intramuscular, lot number R010368, expiration date 25-MAR-2019, for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012081:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; The patient recieved one expired dose of VAQTA; This spontaneous report was received from an office manager, regarding a 12 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 24-MAY-2019, the patient was vaccinated with one expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5, intramuscular, lot number R010368, expiration date 25-MAR-2019, for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA011920:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: bunch of adverse event; This case was reported by a pharmacist via other manufacturer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix 50 mcg/mg. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced bunch of adverse event to Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: itching; This case was reported by a physician via sales rep and described the occurrence of injection site itching in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient complained that site reaction of itching that took almost 3 weeks to dissipate.  The reporter contacted Agency and the patient spoke to them to get additional information on 2nd dose of Shingrix and whether site reaction would be any different. The reporter did not agree to follow up with GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Diziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic fatigue.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a history of chronic fatigue. The patient also mentioned dizziness.
Sex: F
Vaccine: VARZOS
Symptoms: Purpura
Clinical narrative: purpura on forearms; This case was reported by a consumer via other manufacturer and described the occurrence of purpura in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced purpura. On an unknown date, the outcome of the purpura was unknown.   It was unknown if the reporter considered the purpura to be related to Shingrix.  Additional details were provided as follows: The patient reportedly experienced purpura on forearms.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Borrelia test negative, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Rheumatism; Leg pain; Knee pain; Stiffness; This case was reported by a consumer via call center representative and described the occurrence of rheumatism in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGLES SHOT (received the other shingles shot at 50 years of age).   In April 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced rheumatism, leg pain, knee pain and stiffness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the rheumatism, leg pain, knee pain and stiffness were not recovered/not resolved.   It was unknown if the reporter considered the rheumatism, leg pain, knee pain and stiffness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. About a month ago of reporting date, the patient received the shingles shot and at the time of reporting, the patient experienced leg knee pain and stiffness. The patient did not think about the shot, when rheumatism was seen. The patient wanted to know if these events were caused due to shingles shot and if these would go away in time. The physician recommended high dose Tylenol. The blood tests were negative. No lyme.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Rheumatic disorder
Clinical narrative: Rheumatism; Leg pain; Knee pain; Stiffness; This case was reported by a consumer via call center representative and described the occurrence of rheumatism in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGLES SHOT (received the other shingles shot at 50 years of age).   In April 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced rheumatism, leg pain, knee pain and stiffness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the rheumatism, leg pain, knee pain and stiffness were not recovered/not resolved.   It was unknown if the reporter considered the rheumatism, leg pain, knee pain and stiffness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. About a month ago of reporting date, the patient received the shingles shot and at the time of reporting, the patient experienced leg knee pain and stiffness. The patient did not think about the shot, when rheumatism was seen. The patient wanted to know if these events were caused due to shingles shot and if these would go away in time. The physician recommended high dose Tylenol. The blood tests were negative. No lyme.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: fever; chills; slight nausea; ache; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills, nausea, pain and headache. On an unknown date, the outcome of the fever, chills, nausea, pain and headache were unknown.   It was unknown if the reporter considered the fever, chills, nausea, pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix within a 5 month time frame. The patient experienced fever, chills, slight nausea, and ache and asked for what to take for headache.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Middle insomnia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: fever; muscle pain; upset stomach; This case was reported by a consumer via sales rep and described the occurrence of fever in a 55-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th May 2019, the patient received Shingles vaccine. In May 2019, less than a day after receiving Shingles vaccine, the patient experienced fever, muscle pain and upset stomach. On an unknown date, the outcome of the fever, muscle pain and upset stomach were unknown.   It was unknown if the reporter considered the fever, muscle pain and upset stomach to be related to Shingles vaccine.  Additional details were reported as follows: The patient was a service connected veteran. The age at vaccination was not reported. The patient got the shingles shot the day before reporting and woke up in the middle of the night with bad muscle pain and felt like had a fever. The patient expected arm to be painful but the pain in muscles was tough and was asking was it normal. The patient had an upset stomach as well.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Swelling
Clinical narrative: swelling; chills; This case was reported by a consumer via sales rep and described the occurrence of swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on an unknown date, refer case US2019AMR087873).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced swelling and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling and chills were unknown.   It was unknown if the reporter considered the swelling and chills to be related to Shingrix.  Additional details were reported as follows: The case was reported by the retired vaccine representative. The age at vaccination was not reported, however it could be 65 or 66 years. The reporter did not know the lot number the second shot was about one month before the date of reporting date. The patient after the 2nd shot of Shingrix had smaller swelling and chills about 12 hours later. The reporter did not agree to follow up with GlaxoSmithKline.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: child received ActHIB subcutaneously/no AE; Upon internal review on 04-DEC-2018, a significant amendment was performed on 23-May-2019 to update the case from non-case to valid case as per local reference document.  Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient (possibly 1 year, gender unknown) who received vaccine HIB (PRP/T) VACCINE [Act-HIB] lot number not reported via subcutaneous route in the arm NOS on 30-Nov-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant:Possibly live vaccines.  It was a case of actual medication error due to inappropriate route of vaccination.  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Addendum: significant correction was performed on 23-May-2019 to update the case from non-case to valid case as per local reference document.  Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: a child less than 35m age, received two doses of Fluzone Quadrivalent 0.25ml,; Upon second medical examination of the case during internal review, a significant correction was performed on 22-May-2019 to classify the case from non-valid to valid.  Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse.  This case involves les than 35 months old patient who received 0.25 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] twice.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site, 1 other doses were administered on unknown dates for suspect INFLUENZA QUADRIVAL A-B VACCINE.  It was of actual medication error due to extra dose administered.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.58
Sex: U
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: a possible untoward reaction to a flu vaccine; Based on information received on 23-May-2019, the report previously considered as non-case became valid due to specific adverse reaction.  Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone and aaitional information was received on 23-May-2019.  This case involves a 7 months old patient (gender not reported) who experienced a possible untoward reaction to a flu vaccine, while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose and dose in series not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious a possible untoward reaction to a flu vaccine (adverse reaction) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was a possible untoward reaction to a flu vaccine.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for a possible untoward reaction to a flu vaccine.  Information on batch number requested.  Documents held by the sender: none.
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: There was a temperature excursion for Adacel and the range got down to 27 C, 2 vials were administered to 2 patients before it was known there was a temperature excursion/ no AE; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 54 years old male patient who was vaccinated with a 0.5ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5602AA via unknown route in the left deltoid on 08-May-2019 which had temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  case details: It was reported that there was a temperature excursion for Adacel and the range got down to 27 C. Caller said she is not sure how long the refrigerator was out. Caller stated 2 vials were administered to 2 patients before she knew there was a temperature excursion. Adacel injection that had been frozen in a prior temperature excursion where the temperature reached 27 F making the doses not suitable for use.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: administered an overdose of IPOL, at the school gave 3 times as much the dose for IPOL vaccination; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a male patient of an unknown age who received 3 times as much the dose of vaccine IPV (VERO) [IPOL] lot PIA24 via intramuscular route in unknown administration site on 16-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of overdose.  Caller reported that PA administered an overdose of IPOL. The PA thought she had drawn up 0.05ml, and then realized she had actually given 3 times that amount.  Final diagnosis was administered an overdose of ipol, at the school gave 3 times as much the dose for ipol vaccination.  It was unknown if any adverse event occurred.  Documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave Daptacel to a 15 mo old which was expired yesterday/ No side effects reported; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone.  This case involves a 15 months old male patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) on an unknown date.  On 17-May-2019, the patient received a fourth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5202AA and expiry date: 16-May-2019) in the left thigh.  It was a case of actual medication error due to expired vaccine used.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: the vaccine expired on yesterday and the nurse administered the vaccine (Daptacel) to a patient by mistake; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a patient of an unknown demographics who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expiration date: 16-May-2019, batch number, dose, dose in series, route and site of administration were not reported) on 17-May-2019 (reported as today).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient administered a Daptacel vaccine on 17-May-2019, with expiration date  16-May-2019; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a 19 months old female patient who was vaccinated with an expired 0.5 ml fourth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5202AA and expiry date: 16-May-2019) via intramuscular route in the right thigh on 17-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
Sex: F
Vaccine: MNQ, UNK
Symptoms: Neurological symptom
Clinical narrative: severe neurological adverse reactions; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a company representative.  This case involves female patient (age not reported) who experienced severe neurological adverse reactions, while she received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date (1 year ago), the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGOCOCCAL VACCINE B (not produced by Sanofi Pasteur) lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed severe neurological adverse reactions (nervous system disorder) unknown latency, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGOCOCCAL VACCINE B.  Other relevant tests not reported.   Final diagnosis was severe neurological adverse reactions.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for severe neurological adverse reactions.  Information on the batch number was requested.  List of documents held by sender: none.