chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Tingling throat; Sore throat that felt swollen; Sore throat; This spontaneous report was received from a male patient of unknown age, who was reporting on himself. His medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not provided.  On 09-MAR-2020 (also reported as on an unknown recent date; conflicting information), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (dose, anatomical location, lot #, and expiration date were not provided).  Later, on an unspecified date in March 2020 (reported as one day and a half later), the patient developed tingling in throat (pharyngeal paraesthesia) which progressed to a sore throat (oropharyngeal pain) that felt swollen (pharyngeal swelling). The patient did not seek medical attention and did not receive any treatment for the events.  By the time of the report, the patient had not recovered from any of the events.  The reporter's causality assessment between pharyngeal paraesthesia, oropharyngeal pain, and pharyngeal swelling was not provided.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; Received an expired dose of VARIVAX; This spontaneous report has been received from a nurse practitioner, concerning a 14 month old female patient.      The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 18-MAR-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, and anatomical location not reported) (lot # N027619 has been verified to be valid, expiration date not reported, but upon internal validation established as 04-OCT-2019) for prophylaxis. No additional adverse effect reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Injection site pain; induration and hardness upon palpation; This spontaneous report has been received from a nurse prescriber referring to a 17 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      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) lot # R000303 with expiration date of 29-AUG-2020, (strength, frequency, route, and anatomical location were not provided) for prophylaxis.      On an unknown date, the patient developed injection site pain and induration and hardness upon palpation, which lasted for one month. At the reporting time, outcome of injection site pain and induration was reported as resolved. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R000303; expirationdate: 29-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction
Clinical narrative: heart attack; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified day in approximately January 2018, the pt was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for the prevention of shingles. On 30-MAR-2018 (also reported as shortly after receiving the vaccine), the pt suffered a fatal heart attack as a direct and proximate result of the zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the pt suffered painful injuries, damages, and wrongful death. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury and wrongful death. It was reported that the pt incurred and would continue to incur medical expenses and other economic harm as a direct result of use of zoster vaccine live (ZOSTAVAX). The causal relationship between the event was reported as related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: heart attack
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: herpes zoster/rash on the left side, mid-back that was very painful; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 05-SEP-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the pt suffered a rash on the left side, mid-back that was very painful, and the pt was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccination, the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX)), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of herpes zoster was reported as not resolved. The causal relationship of the event was reported as related to zoster vaccine live (ZOSTAVAX). The reporter considered herpes zoster to be a disabling event.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies.     On 04-MAR-2020,  the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (strength, dose and vaccination scheme were not reported; lot number 1660112, expiration date 18-OCT-2020), as prophylaxis (product storage error).  The vaccine involved was stored in a highest temperature above 47 degrees Fahrenheit (°F) (52.1°F) for 15 minutes. There was a previous temperature excursion above 47 degrees Fahrenheit (°F) (55 °F) for 21 minutes, as recorded by a data logger. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies.     On 06-MAR-2020,  the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) by oral route, lot #1660112, expiration date 18-OCT-2020 for prophylaxis (dosage schedule were not reported) following a temperature excursion (product storage error).  The vaccine involved was stored in a highest temperature above 47 degrees Fahrenheit (°F) (52.1°F) for 15 minutes and above 47 degrees Fahrenheit (°F) (55 °F) for 21 minutes, as recorded by a data logger. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Hemiparesis
Clinical narrative: A week later, the patient was hospitalized again and diagnosed with acute, recurrent, cerebral artery cerebrovascular accident; Patient was hospitalized and diagnosed with acute left hemispheric cerebrovascular accident; This initial spontaneous report was received from a lawyer on 27-MAR-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medication were not reported. On or around 19-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered slurred speech and right sided weakness. The patient was hospitalized and diagnosed with acute left hemispheric cerebrovascular accident. A week later, the patient was hospitalized again and diagnosed with acute, recurrent, cerebral artery cerebrovascular accident. As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. He suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. He sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.  Upon internal review, cerebrovascular accident was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Pruritus
Clinical narrative: left sided flank pain and itching, patient was diagnosed with shingles; This initial spontaneous report was received from a lawyer on 27-MAR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medication were not reported. On or around 28-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered severe left sided flank pain and itching. Then, she was diagnosed with shingles (herpes zoster). As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. He suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. He sustained severe, serious, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.  The reporter considered shingles as disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Facial paralysis, Herpes zoster, Hypoaesthesia, Oral pain
Clinical narrative: Bell's Palsy, herpes zoster, mouth sore and left facial numbness; Bell's Palsy, herpes zoster, mouth sore and left facial numbness; Bell's Palsy, herpes zoster, mouth sore and left facial numbness; Bell's Palsy, herpes zoster, mouth sore and left facial numbness; This initial spontaneous report was received from a lawyer on 27-MAR-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medication were not reported. On or around 15-SEP-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered severe acute left sided numbness as well as his mouth developing pus pockets and his left eyelid drooping. The patient was diagnosed with Bell's palsy, herpes zoster, mouth sore and left facial numbness. As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. He suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. He sustained severe, serious, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.  The reporter considered the adverse events as disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Oral pustule
Clinical narrative: Bell's Palsy, herpes zoster, mouth sore and left facial numbness; Bell's Palsy, herpes zoster, mouth sore and left facial numbness; Bell's Palsy, herpes zoster, mouth sore and left facial numbness; Bell's Palsy, herpes zoster, mouth sore and left facial numbness; This initial spontaneous report was received from a lawyer on 27-MAR-2020, regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medication were not reported. On or around 15-SEP-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered severe acute left sided numbness as well as his mouth developing pus pockets and his left eyelid drooping. The patient was diagnosed with Bell's palsy, herpes zoster, mouth sore and left facial numbness. As a direct and proximate result of vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. He suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. He sustained severe, serious, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. He suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.  The reporter considered the adverse events as disabling.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: BAD STOMACH CRAMPS; This spontaneous case report was received from a consumer (PVX2019-324) on 05-Feb-2019. The report describes a 34-year-old female consumer who experienced bad stomach cramps following the intake of Vivotif for an unknown indication.  The consumer's concurrent medical condition includes hypothyroid.  The consumer's concomitant medication included Vitamin B12 (cobalamin), Vitamin B2 (riboflavin), Vitamin D (ergocalciferol), magnesium oxide, and other medication for hypothyroid.  It was reported that the consumer took the first dose of Vivotif on Saturday (02-Feb-2019) and started having stomach cramps 14 to 15 hours later for the rest of the day. She took second dose on 04-Feb-2019. She did not have diarrhea but felt like she had to go to the bathroom every 20 to 30 minutes. She was not exposed to any atypical food or chemicals and had no relevant medical conditions.   The action taken with Vivotif with respect to the event bad stomach cramps was unknown.  The clinical outcome of the event bad stomach cramps was unknown.  Company's Comment: in this case, a 34-year-old female consumer who had bad stomach cramps following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: in this case, a 34-year-old female consumer who had bad stomach cramps following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: MISSED THE THIRD DOSE; VOMITED THE SECOND DOSE OF VIVOTIF; This spontaneous case report was received from a caregiver (PVX2019-505) on 25-Feb-2019. The report describes a female consumer who "vomited the second dose of Vivotif" and "missed the third dose". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer took the first two doses of Vivotif on 20-Feb-2019 and 22-Feb-2019, respectively. On 23-Feb-2019, she vomited and saw the pill in her vomit. She did not vomit afterwards. She did not take any more doses afterwards and planning to take vaccine shots.  The caregiver also stated that her daughter was not ill. She did not believe that vomiting was due to the Vivotif as the consumer also vomited a week before she started Vivotif.  The action taken with Vivotif with respect to the event "vomited the second dose of Vivotif" was dosage discontinued while with respect to the event "missed the third dose" was not applicable.  The clinical outcome of the event "vomited the second dose of Vivotif" was resolved while with respect to the event "missed the third dose" was unknown.  Company's Comment: In this case, it was reported that the consumer "vomited the second dose of Vivotif" and "missed the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer "vomited the second dose of Vivotif" and "missed the third dose". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Haematochezia
Clinical narrative: BLOODY STOOL; This spontaneous case report was received from a nurse (PVX2019-523) on 26-Feb-2019. The report described a male consumer who had an episode of bloody stool following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif on 25-Feb-2019 and had an episode of bloody stool in the night.   The action taken with Vivotif with respect to the event bloody stool was unknown.  The clinical outcome of the event bloody stool was unknown.  Company's Comment: In this case, the consumer experienced the event "bloody stool" following the intake of oral Vivotif. Although, the events were reported with reasonable time relationship to intake of the vaccine, there is limited information regarding the medical history, concomitant medications and events in this case. Therefore, the causality of the events with Vivotif could not be assessed.  A follow up was received on 07-Mar-2019 with an update on the history, dosing dates, causality, and outcome.  Start date of the dose was updated to 26-Feb-2019. She took the other doses on 28-Feb-2019, 02-Mar-2019, and 04-Mar-2019, respectively. He had a history of hemorrhoid from last 10 years but there was no recent hemorrhoid. He had no surgical history and he did not take any concomitant and treatment medications.  The action taken with Vivotif with respect to the event bloody stool was dosage maintained  The clinical outcome of the event bloody stool was resolved.  Company's Comment: In this case, it was reported that a male consumer had an episode of bloody stool following the intake of first dose of Vivotif. The consumer took the four doses of Vivotif on every other day. The event subsided on its own without any treatment There seems to be a temporal association between the intake of the vaccine and the event. However, history of hemorrhoid for last 10 years provides a plausible explanation for the event. Hence, the causality of the event bloody stool is assessed as unlikely with Vivotif vaccine.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer had an episode of bloody stool following the intake of first dose of Vivotif. The consumer took the four doses of Vivotif on every other day. The event subsided on its own without any treatment. There seems to be a temporal association between the intake of the vaccine and the event. However, history of hemorrhoid for last 10 years provides a plausible explanation for the event. Hence, the causality of the event bloody stool is assessed as unlikely with Vivotif vaccine.
Sex: F
Vaccine: TYP
Symptoms: Extra dose administered, Nausea
Clinical narrative: NAUSEOUS; TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a pharmacist (PVX2019-541) on 28-Feb-2019. The report describes a female consumer who felt nauseous following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. The consumer also "took two doses in a row".  It was reported that the consumer took Vivotif doses as an inappropriate way. The doses were taken on day 1, 3, 5, and 6. She took the fourth dose today (28-Feb-2019) after which she was very nauseous. She took Emetrol (phosphorated carbohydrate) to treat nausea.  The action taken with Vivotif with respect to the events nauseous and "took two doses in a row" was not applicable.  The clinical outcome of the events nauseous and "took two doses in a row" was unknown.  Company's Comment: In this case, it was reported that a female consumer experienced "nausea" following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took two doses in a row" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer experienced "nausea" following the intake of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Vomiting
Clinical narrative: DID NOT COMPLETE VIVOTIF COURSE ONE WEEK PRIOR TO TRAVEL TO AFRICA; THREW UP; This spontaneous case report was received from a pharmacist (PVX2019-613) on 11-Mar-2019. It described a 25-year-old female consumer who threw up following the intake of Vivotif capsule for travelling. The consumer also "did not complete Vivotif course one week prior to travel to country".  It was reported that the consumer took the first dose of Vivotif on 08-Mar-2019 and within 15 minutes, she threw up the capsule. She had a planned travel to country on 15-Mar-2019.  The action taken with Vivotif with respect to the event threw up was unknown while with respect to the event "did not complete Vivotif course one week prior to travel to country" was not applicable.  The clinical outcome of the event threw up was resolved while outcome of the event "did not complete Vivotif course one week prior to travel to country" was unknown.  Company's Comment: In this case, it was reported that a 25-year-old female consumer who threw up following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "did not complete Vivotif course one week prior to travel to country" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 25-year-old female consumer who threw up following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, threw up (PT: Nausea) is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "did not complete Vivotif course one week prior to travel to country" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: THREW UP THE THIRD DOSE; This spontaneous case report was received from a pharmacist (PVX2019-553) on 28-Feb-2019. The report describes a 54-year-old female consumer who "threw up the third dose". The consumer was receiving Vivotif capsule for an unknown indication.  It was reported that the consumer took the third dose of Vivotif on 28-Feb-2019, and threw it up after 1 hour. She saw the capsule in her vomit.  The action taken with Vivotif with respect to the event "threw up the third dose" was unknown.  The clinical outcome of the event "threw up the third dose" was unknown.  Company's Comment: In this case, a 54-year-old female consumer "threw up the third dose" following administration of third dose of Vivotif .There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif was assessed as possible. The event is known to occur with Vivotif and is labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, a 54-year-old female consumer "threw up the third dose" following administration of third dose of Vivotif .There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif was assessed as possible. The event is known to occur with Vivotif and is labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH PAIN; This spontaneous case report was received from a nurse on 08-Mar-2019. It described a female consumer who had stomach pain following the intake of Vivotif for an unknown indication.  It was reported that the consumer had stomach pain after taking the second, third, and fourth dose of Vivotif.  The action taken with Vivotif with respect to the event stomach pain was dosage maintained.  The clinical outcome of the event stomach pain was unknown.  Company's Comment: In this case, it was reported that a female consumer had stomach pain following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer had stomach pain following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible
Sex: M
Vaccine: TYP
Symptoms: Nausea, Product storage error, Pyrexia
Clinical narrative: NAUSEA; FEVER; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a caregiver (PVX2019-661) on 15-Mar-2019. It described a 6-year-old male consumer who experienced nausea and fever following the intake of oral Vivotif (lot number: 3003238) for typhoid fever prophylaxis. The consumer also "took an unrefrigerated dose".  It was reported that the consumer took an unrefrigerated dose of Vivotif on 13-Mar-2019. He experienced nausea at school on 14-Mar-2019. He also had fever (slightly high temperature). By the time he reached home, the caregiver checked his temperature but he had no fever. Both events were resolved on 14-Mar-2019  The action taken with Vivotif with respect to the events nausea and fever was unknown while with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the events nausea and fever was resolved while with respect to the event "took an unrefrigerated dose" was unknown.  Company's Comment: In this case, it was reported that a 6-year-old male consumer had nausea and fever after intake of Vivotif. The consumer also "took an unrefrigerated dose". There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated dose" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a 6-year-old male consumer had nausea and fever after intake of Vivotif. The consumer also "took an unrefrigerated dose". There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: VOMITED AFTER LAST DOSE OF VIVOTIF; This spontaneous case (PVX2019-1492) was received from a pharmacist on 10-Jun-2019. It describes a female consumer who "vomited after last dose of Vivotif". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the last dose of Vivotif on Friday. On Saturday, in the middle of the night, she threw up. However, she did not vomit any more afterwards. Also, she did not take any treatment for it.  The consumer's medical history included bipolar disorder.  The consumer did not take any concomitant medication.  Action taken with Vivotif was not applicable.  The consumer had recovered from the event.  Company's Comment: In this case, it was reported that the consumer vomited after last dose of Vivotif. There seems to be a temporal association between the intake of vaccine and the event. Also, vomiting is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer vomited after last dose of Vivotif. There seems to be a temporal association between the intake of vaccine and the event. Also, vomiting is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: THREW UP; This spontaneous case (PVX2019-1538) was received from a pharmacist on 13-Jun-2019. It describes an 18-year-old male consumer who threw up, after the administration of Vivotif for an unknown indication.  Case report: The consumer threw up 15 minutes after taking the final dose of Vivotif.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer  threw up after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  threw up after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: THROWING UP; TOOK VIVOTIF WITH DINNER; This spontaneous case (PVX2019-1539) was received from a consumer on 13-Jun-2019. It describes a 22-year-old adult female consumer who was "throwing up", after the intake of Vivotif (lot number: 3003275) for an unknown indication. She "took Vivotif with dinner".  Case report: The consumer took the first dose of Vivotif on 09-Jun-2019 with dinner around 9 pm. Then, around 5 or 5:30 am, she violently threw up for 5 hours. It was reported that she had a normal dinner and she was fine after taking the second dose.  Action taken with Vivotif with respect to the event "throwing up" was dosage maintained while with respect to the event "took Vivotif with dinner" was not applicable.  The consumer had recovered from the event "throwing up", while the clinical outcome of the event "took Vivotif with dinner" was unknown.  Company's Comment: In this case, it was reported that female consumer was "throwing up" after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took Vivotif with dinner" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that female consumer was "throwing up" after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took Vivotif with dinner" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Dysphagia
Clinical narrative: DIFFICULTY IN SWALLOWING; TOOK VIVOTIF WITH TWO DRIED APRICOTS; This spontaneous case (PVX2019-1550) was received from a nurse on 14-Jun-2019. It describes a 71-year-old elderly female consumer who had difficulty in swallowing, while being on Vivotif capsule for an unknown indication. She also "took Vivotif with two dried apricots".   Case report: The consumer took the first dose of Vivotif with two dried apricots as she had difficulty in swallowing the pill. She thought that difficulty in swallowing was due to gastroesophageal reflux disease (GERD)  The consumer's medical concurrent conditions included GERD and allergies.  Concomitant medication included Allegra (fexofenadine) and Claritin (loratadine) tablets as needed for allergies.  Action taken with Vivotif with respect to the event difficulty in swallowing was unknown while with respect to the event "took it with two dried apricots" was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a 71-year-old elderly female consumer had difficulty in swallowing while being on Vivotif. Considering the medical history of gastroesophageal reflux disease, the causality of the event is assessed as unlikely with Vivotif. The causality of the event "took it with two dried apricots" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 71-year-old elderly female consumer had difficulty in swallowing while being on Vivotif. Considering the medical history of gastroesophageal reflux disease, the causality of the event is assessed as unlikely with vivotif . The causality of the event "took it with two dried apricots" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: VOMITED THE ENTIRE UNDISSOLVED VIVOTIF; This spontaneous case (PVX2019-1577) report was received from a nurse on 17-Jun-2019. It describes an 18-year-old adult female consumer who "vomited the entire undissolved Vivotif". The consumer was receiving Vivotif and Prozac for unknown indications.  Case report: The consumer was taking Prozac (fluoxetine). She also took the first dose of Vivotif on 12-Jun-2019. She vomited the entire undissolved medication on the same day.   A follow-up was received on 18-Jun-2019, stated that vomiting persisted even after stopping Vivotif.   Action taken with Vivotif and Prozac was dosage discontinued.  The consumer had not recovered from the event.  The reporter considered the event unrelated to Vivotif while it was related to Prozac.  Company's Comment: In this case, it was reported that the consumer "vomited the entire undissolved Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer "vomited the entire undissolved Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Flatulence, Headache, Nausea
Clinical narrative: GAS; NAUSEA; HEADACHE; ABDOMINAL ACHE/ DISCOMFORT; ADMINISTRATION OF VIVOTIF DOSE WITH LIQUID KEFIR; This spontaneous case report (PVX2019-1576) was received from a consumer on 18-Jun-2019. It describes a 73-year-old elderly female consumer who had nausea, headache, abdominal ache/ discomfort, and gas, after the "administration of Vivotif with liquid kefir" (one capsule every other day orally) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif with liquid kefir on 17-Jun-2019. On the same day, she developed nausea, headache, and abdominal ache. The symptoms worsened during the day. Later, she had a lot of gas.   She took two doses of oral Gas-X (simethicone), one in the late afternoon and another in the evening. She also took one dose of Pepto (bismuth subsalicylate) in the evening for the treatment of side effects on 17-Jun-2019.  She had gluten sensitivity for the past 10 years.  She did not take any concomitant medication.  Action taken with Vivotif with respect to the events nausea, headache, abdominal ache/ discomfort, and gas was unknown while with respect to the event "administration of Vivotif dose with liquid kefir" was not applicable.  The consumer had been recovering from the events nausea, headache, and abdominal ache/ discomfort, while with the event gas was recovered, and the clinical outcome of the event "administration of Vivotif dose with liquid kefir" was unknown.  Company's Comment: In this case, it was reported that the consumer had nausea, headache, abdominal ache/ discomfort, and gas, after the "administration of Vivotif with liquid kefir". There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, headache, abdominal ache/ discomfort, and gas are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "administration of Vivotif dose with liquid kefir" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had nausea, headache, abdominal ache/ discomfort, and gas, after the "administration of Vivotif with liquid kefir". There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, headache, abdominal ache/ discomfort, and gas are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "administration of Vivotif dose with liquid kefir" was considered as not applicable.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Tinnitus
Clinical narrative: soreness injection site; I have disturbing ringing in the ears; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and ringing in ears. On an unknown date, the outcome of the injection site pain and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and ringing in ears to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site and disturbing ringing in the ears.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Flushing, Headache, Injection site pain, Nausea
Clinical narrative: I have soreness at the injection site; I do feel mildly feverish; with a headache; slightly flushed; mildly nauseous; light-headed; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, headache, flushing, nausea and light headedness. On an unknown date, the outcome of the injection site pain, fever, headache, flushing, nausea and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, headache, flushing, nausea and light headedness to be related to Shingrix.  Additional details were provided as follows: The patient felt slightly flushed, mildly nauseous, light-headed, mildly feverish with a headache and had soreness at the injection site.  The patient was curious about the duration of the symptoms since the patient was supposed to travel on Wednesday.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I have soreness at the injection site; I do feel mildly feverish; with a headache; slightly flushed; mildly nauseous; light-headed; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, headache, flushing, nausea and light headedness. On an unknown date, the outcome of the injection site pain, fever, headache, flushing, nausea and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, headache, flushing, nausea and light headedness to be related to Shingrix.  Additional details were provided as follows: The patient felt slightly flushed, mildly nauseous, light-headed, mildly feverish with a headache and had soreness at the injection site.  The patient was curious about the duration of the symptoms since the patient was supposed to travel on Wednesday.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blister, Chills, Diarrhoea, Headache
Clinical narrative: had some of the side effects headache; had some of the side effects fever; had some of the side effects shivering; neck ache the night of the shot.; next day my stomach was upset; Slight diarrhea; I noticed a couple bumps / one of my right arm one of my left arm and one on my back below my neck; I noticed a couple bumps that itch; small blister / one was like three little blisters; I must have scratched so they were scabs; shingles; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles. On an unknown date, the outcome of the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles were unknown.   It was unknown if the reporter considered the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had headache, fever, shivering and neck ache the night of the shot. The patient also had  upset stomach, diarrhea, couple bumps that itch to little on right arm and left arm and one on back and below neck, small blister scratched so they were scabs. The patient asked is it possible aving a mild chicken pox like outbreak from the shot or these just belittle shingles and asked is this contagious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neck pain, Pyrexia, Rash pruritic, Rash vesicular
Clinical narrative: had some of the side effects headache; had some of the side effects fever; had some of the side effects shivering; neck ache the night of the shot.; next day my stomach was upset; Slight diarrhea; I noticed a couple bumps / one of my right arm one of my left arm and one on my back below my neck; I noticed a couple bumps that itch; small blister / one was like three little blisters; I must have scratched so they were scabs; shingles; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles. On an unknown date, the outcome of the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles were unknown.   It was unknown if the reporter considered the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had headache, fever, shivering and neck ache the night of the shot. The patient also had  upset stomach, diarrhea, couple bumps that itch to little on right arm and left arm and one on back and below neck, small blister scratched so they were scabs. The patient asked is it possible aving a mild chicken pox like outbreak from the shot or these just belittle shingles and asked is this contagious.