chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: TYP
Symptoms: Thyroid function test normal, Vomiting, Weight decreased, X-ray gastrointestinal tract abnormal
Clinical narrative: This spontaneous case (PVX2019-929) was received from a caregiver on 18-Apr-2019. It describes a female consumer who lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF for typhoid prophylaxis. Case report: The consumer started VIVOTIF on 19-Mar-2019, and since then she had been vomiting almost daily, along with constant stomach pain and occasional headache. She lost about 10-pound weight as she did not want to eat. As per the reporter, vomiting VIVOTIF was either bile or stomach acid and was either green or yellow. At the time of the report her weight remained the same and she had not lost any additional weight. In addition, it was reported that in late February or early March, before VIVOTIF administration, the consumer attended an environmental camp where she, along with multiple other children became sick. She had vomiting and fever, but no diarrhea. The health department indicated that the children had contracted norovirus. As she was recovering from norovirus, the caregiver held VIVOTIF course and stored it in the refrigerator. After she recovered from the norovirus and everything returned to normal, she started VIVOTIF administration on 19-Mar-2019. Laboratory test included stool samples, H pylori testing, bowel blockage testing, full blood panel, thyroid test, and pancreatitis test. All of the tests were normal. However, according to the bowel X-ray, she had constipation. The reporter additionally mentioned that the consumer had not complained of constipation, however she had "battled with it in the past, a really long time ago". The consumer's past medication included Zantac (ranitidine) for possible reflux, but it had not helped. Action taken with VIVOTIF for the events was unknown. The consumer had not recovered from the events lost 10-pound weight , vomiting, stomach pain, and occasional headache. However, the outcome of the events constipation and loss of appetite was unknown.; Sender's Comments: Company Comment:  In this case, it was reported that an 11-year-old female consumer lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache, after the administration of VIVOTIF. The case has been considered serious as the consumer had significant weight loss.The causality of the events "lost 10-pound weight, had constipation, experienced loss of appetite, vomiting, stomach pain, and occasional headache" is assessed as possible as the events were reported with reasonable time relationship to intake of the vaccine.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; the patient was inadcertently administered a dose of MMR II, that was expired; Information was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-APR-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) (rHA) (dose and route were not reported, lot# N02469, expiration date 07-APR-2019) for prophylaxis, that was expired. No adverse effect reported.
Sex: M
Vaccine: PPV
Symptoms: Blister, Blister rupture
Clinical narrative: had 2 fluid filled blisters, 1 inch away from the injection site; one of the blisters had already popped; Information has been received from a pharmacist referring to a male patient of unknown age. The patient did not have any drug reactions/allergies. Medical history included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in 2018 (reported as a year ago). Information about concomitant medication was unknown.    On 12-APR-2019 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (intramuscular; strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis (reported as "received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) a year ago"). On 13-APR-2019, the patient returned to the pharmacy and had 2 fluid filled blisters, 1 inch away from the injection site. The pharmacist reported that "one of the blisters had already popped" and the patient did not receive any treatment. The outcome of the events was reported as recovering. The causality was not provided.
Sex: M
Vaccine: MMR
Symptoms: Movement disorder
Clinical narrative: difficulty with movement; This spontaneous report was received from a consumer (also a social worker) regarding her son a 4-year-old male patient. Patient had no drug allergies or reactions. Concomitant therapies included sterile diluent. Currently patient had a genetic condition Ataxia telangiectasia which was diagnosed when he was 2 and half years old (it was mentioned that condition was not due to vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)).  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 (route of administration, anatomical location, lot # and expiration date were not reported) as scheduled immunization (as it was recommended by patient's physician). On an unknown date patient experienced difficulty with movement (movement disorder). Patient refused to answer that was treatment given for adverse event or not. The outcome of movement disorder was reported as not recovered. Causality assessment was not provided.
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: the patient was negative for immunity to varicella; the patient was negative for immunity to measles, mumps, but positive for immunity to rubella; This spontaneous report as received from a nurse referring to his son, a 27-year-old male patient, via a filed employee. The patient's pertinent medical history and concomitant medical history were not reported.   On unknown dates, the patient was administered a serious of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date were not reported) and varicella virus vaccine live (OKA/Merck) (VARIVAX) (strength, dose, frequency, route, lot # and expiration date were not reported) on time, as a child for prophylaxis.   On an unknown date, the patient had bloodwork drawn to check titers for school requirement on an unspecified date which showed he was negative for immunity to measles, mumps and varicella, but positive for immunity to rubella. Present status for the events was unknown.  The causal relationship between the events and suspected vaccines were not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse events; Patient was administrated an expired dose of Varivax; Patient was administrated an expired dose of Varivax; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs or allergies were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).       On 23-APR-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) reported lot number N012486 with expiry date 20-APR-2019 (strength, dose, route and frequency were not reported) for prophylaxis.  No adverse effects were reported.  No product quality complaint was filed.  Lot number N012486 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 20-APR-2019, but upon internal validation established as 24-APR-2019.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Acute disseminated encephalomyelitis, Acute haemorrhagic leukoencephalitis, Cerebrovascular accident, Chemotherapy, Developmental regression
Clinical narrative: Information has been received from an unknown reporter via a company representative referring to a 16 years old female patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported. On 30-APR-2013, 03-JUL-2013 and 15-NOV-2013, the patient received her first, second and third dose of GARDASIL respectively, (lot number reported as 055AE, J00417 and 010AE; dose, route of administration and expiration date were unknown) for prophylaxis. In October 2018, the patient experienced stiff neck, sore throat and wasn't feeling good. The patient concurrently had mononucleosis. Lab or diagnostic studies showed that the patient's white blood cell count was normal, but she had elevated liver function test (LFT). In November 2018, the patient was admitted to the hospital and stayed for 5-months (Hospitalization End Date estimated in March 2019). The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) /pulse-infections hemorrhagic leuko-encephalitis. The patient received chemotherapy and alternative medicine. The patient also had a stroke (start date unspecified). The patient's doctor said that the 17 years old he once knew was now developmentally like a 4-year-old. The outcome of the events was unknown. The causality assessment between the events and GARDASIL was unknown. Upon internal review, acute disseminated encephalomyelitis, acute hemorrhagic leukoencephalitis and stroke were determined to medically significant.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Infectious mononucleosis, Liver function test increased, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Information has been received from an unknown reporter via a company representative referring to a 16 years old female patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported. On 30-APR-2013, 03-JUL-2013 and 15-NOV-2013, the patient received her first, second and third dose of GARDASIL respectively, (lot number reported as 055AE, J00417 and 010AE; dose, route of administration and expiration date were unknown) for prophylaxis. In October 2018, the patient experienced stiff neck, sore throat and wasn't feeling good. The patient concurrently had mononucleosis. Lab or diagnostic studies showed that the patient's white blood cell count was normal, but she had elevated liver function test (LFT). In November 2018, the patient was admitted to the hospital and stayed for 5-months (Hospitalization End Date estimated in March 2019). The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) /pulse-infections hemorrhagic leuko-encephalitis. The patient received chemotherapy and alternative medicine. The patient also had a stroke (start date unspecified). The patient's doctor said that the 17 years old he once knew was now developmentally like a 4-year-old. The outcome of the events was unknown. The causality assessment between the events and GARDASIL was unknown. Upon internal review, acute disseminated encephalomyelitis, acute hemorrhagic leukoencephalitis and stroke were determined to medically significant.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Regressive behaviour, White blood cell count normal
Clinical narrative: Information has been received from an unknown reporter via a company representative referring to a 16 years old female patient. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not reported. On 30-APR-2013, 03-JUL-2013 and 15-NOV-2013, the patient received her first, second and third dose of GARDASIL respectively, (lot number reported as 055AE, J00417 and 010AE; dose, route of administration and expiration date were unknown) for prophylaxis. In October 2018, the patient experienced stiff neck, sore throat and wasn't feeling good. The patient concurrently had mononucleosis. Lab or diagnostic studies showed that the patient's white blood cell count was normal, but she had elevated liver function test (LFT). In November 2018, the patient was admitted to the hospital and stayed for 5-months (Hospitalization End Date estimated in March 2019). The patient was diagnosed with acute disseminated encephalomyelitis (ADEM) /pulse-infections hemorrhagic leuko-encephalitis. The patient received chemotherapy and alternative medicine. The patient also had a stroke (start date unspecified). The patient's doctor said that the 17 years old he once knew was now developmentally like a 4-year-old. The outcome of the events was unknown. The causality assessment between the events and GARDASIL was unknown. Upon internal review, acute disseminated encephalomyelitis, acute hemorrhagic leukoencephalitis and stroke were determined to medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 15-OCT-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA009929: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 23-OCT-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA009929: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 13-DEC-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA009929: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 06-MAR-2019, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA009929: US-009507513-1904USA012654: US-009507513-1904USA012653: US-009507513-1904USA012655: US-009507513-1904USA012652:
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: This case was reported in a literature article and described the occurrence of rheumatoid arthritis in a adult female subject who received Flu seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included palindromic rheumatism. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed rheumatoid arthritis. Serious criteria included GSK medically significant. The outcome of rheumatoid arthritis was unknown. The investigator considered that there was a reasonable possibility that the rheumatoid arthritis may have been caused by Flu seasonal TIV Dresden. Additional information provided This case was reported in a literature article and described the occurrence of rheumatoid arthritis (RA) in a middle-aged female who was vaccinated with unspecified inactivated trivalent influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of study in which vaccine side-effects related studies were discussed. The patient was healthy. The patient was treated for palindromic rheumatism. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received unspecified inactivated trivalent influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. It was reported that the patient received standard dose of vaccine. On an unspecified date, an unknown period after vaccination, the patient developed RA. Treatment was unknown. The outcome of the event was not provided. The author stated, "The vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart. This might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena. The incidence of autoimmune reactions to influenza vaccines is currently unknown, but it can no longer be assumed that a coincidental (i.e., un-related) association exists between immunization and the onset of RA and systemic lupus erythematosus (SLE)." The author concluded, "Although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, we might be able to find the at-risk groups and lower the incidence. Similar to analyzing HLA-B*5801 status in the high-risk population before prescribing allopurinol for gout, we might be running special panels for those at-risk communities before vaccinating." This is 1 of the 3 valid cases reported in this literature article.
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: This case was reported in a literature article and described the occurrence of rheumatoid arthritis in a adult female subject who received Flu seasonal TIV Dresden for prophylaxis. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed rheumatoid arthritis. Serious criteria included GSK medically significant. The outcome of rheumatoid arthritis was unknown. The investigator considered that there was a reasonable possibility that the rheumatoid arthritis may have been caused by Flu seasonal TIV Dresden. Additional information updated This case was reported in a literature article and described the occurrence of rheumatoid arthritis (RA) in a middle-aged female who was vaccinated with unspecified inactivated trivalent influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of study in which vaccine side-effects related studies were discussed. The patient was healthy. No information on patient's family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified inactivated trivalent influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. It was reported that the patient received standard dose of vaccine. On an unspecified date, an unknown period after vaccination, the patient developed RA. Treatment was unknown. The outcome of the event was not provided. The author stated, "The vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart. This might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena. The incidence of autoimmune reactions to influenza vaccines is currently unknown, but it can no longer be assumed that a coincidental (i.e., un-related) association exists between immunization and the onset of RA and systemic lupus erythematosus (SLE)." The author concluded, "Although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, we might be able to find the at-risk groups and lower the incidence. Similar to analyzing HLA-B*5801 status in the high-risk population before prescribing allopurinol for gout, we might be running special panels for those at-risk communities before vaccinating." This is 1 of the 3 valid cases reported in this literature article.
Sex: F
Vaccine: FLUX
Symptoms: Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a adult female subject who received Flu vaccine unspecified for prophylaxis. On an unknown date, unknown after receiving Flu vaccine unspecified, the subject developed systemic lupus erythematosus. Serious criteria included GSK medically significant. The outcome of systemic lupus erythematosus was unknown. The investigator considered that there was a reasonable possibility that the systemic lupus erythematosus may have been caused by Flu vaccine unspecified. Additional information provided. This case was reported in a literature article and described the occurrence of systemic lupus erythematosus (SLE) in a young female in late 20s who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of study in which vaccine side-effects related studies were discussed. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed SLE. It was initially manifested with lupus neuritis presenting as classical fortification spectra permeated by the diversity of different colors. Treatment was unknown. The outcome of the event was not provided. The author stated, "The vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart. This might direct towards slightly altered pathologic mechanisms directed at vaccine-related phenomena. The incidence of autoimmune reactions to influenza vaccines is currently unknown, but it can no longer be assumed that a coincidental (i.e., unrelated) association exists between immunization and the onset of RA and systemic lupus erythematosus (SLE)". The author concluded, "Although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, we might be able to find the at-risk groups and lower the incidence. Similar to analyzing HLA-B*5801 status in the high-risk population before prescribing allopurinol for gout, we might be running special panels for those at-risk communities before vaccinating". This is 1 of the 3 valid cases reported in this literature article.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 22nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd April 2019, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), injection site pain (serious criteria clinically significant/intervention required), injection site swelling (serious criteria clinically significant/intervention required), myalgia (serious criteria clinically significant/intervention required) and fatigue (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On 23rd April 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling, myalgia and fatigue were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, injection site pain, injection site swelling, myalgia and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The patient experienced fever, chills, injection site pain, injection site swelling, myalgia and fatigue after receiving 1st dose of SHINGRIX. The patient was treated with tylenol for fever and chills. This case is linked to case US2019073191, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 22nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd April 2019, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria clinically significant/intervention required), chills (serious criteria clinically significant/intervention required), injection site pain (serious criteria clinically significant/intervention required), injection site swelling (serious criteria clinically significant/intervention required), myalgia (serious criteria clinically significant/intervention required) and fatigue (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol). On 23rd April 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling, myalgia and fatigue were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, injection site pain, injection site swelling, myalgia and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The patient experienced fever, chills, injection site pain, injection site swelling, myalgia and fatigue after receiving 1st dose of SHINGRIX. The patient was treated with tylenol for fever and chills. This case is linked to case US2019073191, reported by same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dry skin, Gingival pain, Injection site pain, Pemphigus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pemphigus vulgaris in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced pemphigus vulgaris (serious criteria GSK medically significant), injection site pain, itchy upper limbs, dry skin and rash. In October 2018, the patient experienced soreness gum. The patient was treated with AQUAPHOR and prednisone. On an unknown date, the outcome of the pemphigus vulgaris was not recovered/not resolved and the outcome of the injection site pain and itchy upper limbs were recovered/resolved and the outcome of the soreness gum, dry skin and rash were unknown. It was unknown if the reporter considered the pemphigus vulgaris, injection site pain, itchy upper limbs, soreness gum, dry skin and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left deltoid. The patient experienced itching down her left arm and soreness at the injection site which lasted about a week. In September 2018, the patient went to the doctor for spots on her skin and her physician mentioned that the patient had dry skin and prescribed AQUAPHOR for her skin. In mid October 2018, the patient started to develop sore gums and at first she disregarded it because she thought that she brushed her teeth too vigorously. The patient reported that then she developed a handful of spots under her left breast, 10 spots on her back and right upper shoulder. The patient's physician biopsied a spot on her back and found Pemphigus Vulgaris. The patient did not remember when this first biopsy occurred. On 9th January 2019, the patient had second biopsy of her midsection and it also came back Pemphigus Vulgaris. In January 2019, the physician prescribed Prednisone on a tapered dose for over a month and again she was taking 5 mg daily at the time of reporting. The patient reported that at the time of reporting, she was having a flare up again and was returning to the dermatologist on the day of reporting. The patient did not consent to follow up. The reporting did not wish to give physician information before speaking with her physician. Lab Comments: On an unknown date, the Biopsy was performed.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pemphigus vulgaris in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced pemphigus vulgaris (serious criteria GSK medically significant), injection site pain, itchy upper limbs, dry skin and rash. In October 2018, the patient experienced soreness gum. The patient was treated with AQUAPHOR and prednisone. On an unknown date, the outcome of the pemphigus vulgaris was not recovered/not resolved and the outcome of the injection site pain and itchy upper limbs were recovered/resolved and the outcome of the soreness gum, dry skin and rash were unknown. It was unknown if the reporter considered the pemphigus vulgaris, injection site pain, itchy upper limbs, soreness gum, dry skin and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left deltoid. The patient experienced itching down her left arm and soreness at the injection site which lasted about a week. In September 2018, the patient went to the doctor for spots on her skin and her physician mentioned that the patient had dry skin and prescribed AQUAPHOR for her skin. In mid October 2018, the patient started to develop sore gums and at first she disregarded it because she thought that she brushed her teeth too vigorously. The patient reported that then she developed a handful of spots under her left breast, 10 spots on her back and right upper shoulder. The patient's physician biopsied a spot on her back and found Pemphigus Vulgaris. The patient did not remember when this first biopsy occurred. On 9th January 2019, the patient had second biopsy of her midsection and it also came back Pemphigus Vulgaris. In January 2019, the physician prescribed Prednisone on a tapered dose for over a month and again she was taking 5 mg daily at the time of reporting. The patient reported that at the time of reporting, she was having a flare up again and was returning to the dermatologist on the day of reporting. The patient did not consent to follow up. The reporting did not wish to give physician information before speaking with her physician. Lab Comments: On an unknown date, the Biopsy was performed.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: her son was given Ipol vaccines,his second and third doses were 2 weeks apart; her son was given Ipol vaccines,his second and third doses were 2 weeks apart; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional by phone.  This case was cross-referenced with case 2019SA118227 (same reporter).  This case involves a 10 years old male patient who was vaccinated with a second and third doses of IPV (VERO) [IPOL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-Oct-2018 and 25-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to extra dose administered and inappropriate schedule of vaccine administration.  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: U
Vaccine: DTAPIPV, FLU4
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a physician (pediatric allergist).  This case involves a patient of unknown demographics who experienced allergic reaction, while he/she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unspecified date of Mar-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: C5248AA and expiry date: 21-Aug-2019) via unknown route in unknown administration site.   On an unspecified date of Mar-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (expiry date: 30-Jun-2018) lot number not reported via unknown route in unknown administration site.   On an unknown date, following the vaccination the patient experienced non-serious allergic reaction (hypersensitivity).  Other relevant tests not reported.  Final diagnosis was allergic reaction.  It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for allergic reaction.  List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine, Product intolerance
Clinical narrative: Allergy to tetanus toxoid; tetanus toxoid intolerance; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a healthcare professional by e-mail via other company (Pfizer) (Manufacturer report number: 2019054353).  This case involves a patient of an unknown demographics who reported allergy to tetanus toxoid and tetanus toxoid intolerance, while he/she received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On an unknown date, the patient developed a non-serious allergy to tetanus toxoid (allergy to vaccine) and tetanus toxoid intolerance (product intolerance), following the administration of TETANUS TOXOID.  No lab data was reported.  Final diagnosis was tetanus toxoid intolerance and allergy to tetanus toxoid.   It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.  Documents held by the sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: high fever; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves adult patient of unknown demographics who experienced high fever, while received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On an unknown date, the patient developed a non-serious high fever (pyrexia) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that the patient almost went to hospital.  No Lab data was reported.  Final diagnosis was high fever.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for high fever.  Documents held by the sender: none.