chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Cerebral artery embolism, Cerebrovascular accident, Dysarthria, Facial paresis, Hemiparesis
Clinical narrative: transient cerebral ischemia (stroke); ischemic strokes; transient cerebral ischemia (stroke)/right thalamic stroke; multiple cerebral thromboembolism; Information has been received regarding a case in litigation concerning the patient of unknown age and gender. In or around 14-OCT-2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered left-sided weakness, left facial weakness and dysarthria and was diagnosed with transient cerebral ischemia (stroke). To date, patient has suffered approximately four more strokes to include diagnoses of right thalamic stroke, ischemic strokes and multiple cerebral thromboembolism. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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 vaccination, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was reported as related.   Upon internal review, the events of transient cerebral ischemia (stroke), right thalamic stroke, ischemic strokes and multiple cerebral thromboembolism were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Ischaemic stroke, Transient ischaemic attack
Clinical narrative: transient cerebral ischemia (stroke); ischemic strokes; transient cerebral ischemia (stroke)/right thalamic stroke; multiple cerebral thromboembolism; Information has been received regarding a case in litigation concerning the patient of unknown age and gender. In or around 14-OCT-2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered left-sided weakness, left facial weakness and dysarthria and was diagnosed with transient cerebral ischemia (stroke). To date, patient has suffered approximately four more strokes to include diagnoses of right thalamic stroke, ischemic strokes and multiple cerebral thromboembolism. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient 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 vaccination, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was reported as related.   Upon internal review, the events of transient cerebral ischemia (stroke), right thalamic stroke, ischemic strokes and multiple cerebral thromboembolism were determined to be medically significant.
Sex: M
Vaccine: TYP
Symptoms: Blood blister
Clinical narrative: SMALL BLOOD BLISTER; This spontaneous case report was received from a caregiver (PVX2019-114) on 11-Jan-2019. The report describes a male consumer who developed small blood blister 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 Wednesday (09-Jan-2019) and today morning he had a small blood blister, but it's flat, right where his bottom lip and his skin meet. The consumer did not experience any other adverse effects such as swelling lethargy, he was not tired and totally fine. However, when he came home from work today, he noticed a second blister.  The action taken with Vivotif with respect to the event small blood blister was unknown.  The clinical outcome of the event small blood blister was unknown.  Company's Comment: In this case, a male consumer developed small blood blister 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 event "small blood blister" with Vivotif could not be assessed.; Sender's Comments: Company's Comment: In this case,a male consumer developed small blood blister 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 event "small blood blister" with Vivotif could not be assessed.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-235) on 24-Jan-2019. The report describes a male consumer who "took unrefrigerated Vivotif". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer finished entire course of Vivotif but the doses were unrefrigerated. He took his first dose on 17-Jan-2019.  The action taken with Vivotif with respect to the event "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the event "took unrefrigerated Vivotif" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 4; A spontaneous case report was received from a consumer on 28-Jan-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201901-000066 (PVX2019-258; wife) and PVX201901-000067 (PVX2019-259, husband) were created and cross-linked in the database.  This case report described a female consumer who "took third dose on day 4". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003239) for typhoid fever prophylaxis.  It was reported that the consumer took two doses in a row. The doses were taken on 23-Jan-2019, 25-Jan-2019, and 26-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 4" was not applicable.  The clinical outcome of the event "took third dose on day 4" was unknown.  Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000067:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 4; A spontaneous case report was received from a caregiver on 28-Jan-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201901-000066 (PVX2019-258; wife) and PVX201901-000067 (PVX2019-259, husband) were created and cross-linked in the database.  This case report described a male consumer who "took third dose on day 4". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003239) for typhoid fever prophylaxis.  It was reported that the consumer took two doses in a row. The doses were taken on 23-Jan-2019, 25-Jan-2019, and 26-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose on day 4" was not applicable.  The clinical outcome of the event "took third dose on day 4" was unknown.  Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 4" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000066:
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK TWO DOSES OF VIVOTIF WITH FOOD; This spontaneous case report was received from a caregiver (PVX2019-267) on 29-Jan-2019. The report describes a male consumer who "took two doses of Vivotif with food". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the second and third dose with breakfast. He completed the full course of Vivotif.   The action taken with Vivotif with respect to the event "took two doses of Vivotif with food" was not applicable.  The clinical outcome of the event "took two doses of Vivotif with food" was unknown.  Company's Comment: The causality of the event "took two doses of Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses of Vivotif with food" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error, Product storage error
Clinical narrative: TOOK DOSES WITH FOOD; TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-275) on 29-Jan-2019. The report describes a female consumer who "took doses with food" and "took unrefrigerated Vivotif". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  It was reported that the consumer left Vivotif unrefrigerated for 12 hours before taking Vivotif and she completed the Vivotif course. She also took it with food.  The action taken with Vivotif with respect to the events "took doses with food" and "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the events "took doses with food" and "took unrefrigerated Vivotif" was unknown.  Company's Comment: The causality of the event "took doses with food" and "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses with food" and "took unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH FOOD; This spontaneous case report was received from a consumer (PVX2019-266) on 29-Jan-2019. The report describes a female consumer who "took Vivotif with food". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer completed the course of Vivotif. She believed that she snacked and may have consumed food before waiting the two hours after taking Vivotif.  The action taken with Vivotif with respect to the event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-300) on 31-Jan-2019. The report describes an adult male consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 23-Jan-2019 and the last dose on 29-Jan-2019. All the doses were unrefrigerated.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE THIRD AND FOURTH DOSE; This spontaneous case report was received from a nurse (PVX2019-297) on 31-Jan-2019. The report describes an 18-year-old female consumer who "missed to take third and fourth 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 dose of Vivotif on 25-Jan-2019 and the second dose on 27-Jan-2019. She did not take any further dose which due on 29-Jan-2019 and 31-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "missed to take third and fourth dose" was not applicable.  The clinical outcome of the event "missed to take third and fourth dose" was unknown.  Company's Comment: The causality of the event "missed to take third and fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third and fourth dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a consumer (PVX2019-304) on 01-Feb-2019. The report describes a 61-year-old adult female consumer who "took two doses in a row". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prevention.  It was reported that the consumer took the two doses of Vivotif in a row. The doses were taken on 30-Jan-2019 and 31-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVEL; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-312) on 04-Feb-2019. The report describes a 54-year-old adult female consumer who "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel". The consumer was receiving Vivotif (lot number: 3003240 and expiry date: Nov 2019) for travel.  It was reported that the consumer took the first dose of Vivotif on 03-Feb-2019, which was unrefrigerated for 5 days. The consumer also stated that she will be arriving on 14-Feb-2019.  The action taken with Vivotif with respect to the events "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel" was not applicable.  The clinical outcome of the events "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel"" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete Vivotif doses one week prior to travel"" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED A DOSE; This spontaneous case report was received from a nurse (PVX2019-313) on 04-Feb-2019. The report describes a 21-year-old adult male consumer who "missed a dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 01-Feb-2019 and missed to take the second dose which was due on 03-Feb-2019.   The action taken with Vivotif with respect to the event "missed a dose" was not applicable.  The clinical outcome of the event "missed a dose" was unknown.  Company's Comment: The causality of the event "missed a dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-325) on 05-Feb-2019. The report describes a 49-year-old adult female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003240; expiry date: Nov 2019) for typhoid prevention.  It was reported that the consumer picked up Vivotif about one week ago and did not refrigerate it. She took an unrefrigerated dose on Sunday (03-Feb-2019).  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE ON DAY 4; This spontaneous case report was received from a consumer (PVX2019-341) on 07-Feb-2019. The report describes a 33-year-old adult female consumer who "took second dose on day 4". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis  It was reported that the consumer took her second dose of Vivotif on day 4. The doses were taken on 04-Feb-2019 and 07-Feb-2019, respectively.   The action taken with Vivotif with respect to the event "took second dose on day 4" was not applicable.  The clinical outcome of the event "took second dose on day 4" was unknown.  Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable; Sender's Comments: Company's Comment: The causality of the event "took second dose on day 4" was considered as not applicable
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF RIGHT AFTER DINNER; This spontaneous case report was received from a consumer (PVX2019-342) on 07-Feb-2019. The report describes a female consumer who "took Vivotif after dinner". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis for trip.  It was reported that the consumer took the first dose of Vivotif right after dinner instead of on an empty stomach.  The action taken with Vivotif with respect to the event "took Vivotif after dinner" was not applicable.  The clinical outcome of the event "took Vivotif after dinner" was unknown.  Company's Comment: The causality of the event "took Vivotif after dinner" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif after dinner" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE; This spontaneous case report was received from a pharmacist (PVX2019-361) on 08-Feb-2019. The report describes a female consumer who "missed the second dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif on 05-Feb-2019 but she missed to take the second dose which was due on 07-Feb-2019.  The action taken with Vivotif with respect to the event "missed the second dose" was not applicable.  The clinical outcome of the event "missed the second dose" was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK THREE DOSES WITH FOOD; This spontaneous case report was received from a pharmacist (PVX2019-362) on 08-Feb-2019. The report describes a 72-year-old elderly male consumer who "took three doses with food". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took three doses of Vivotif with food.  The action taken with Vivotif with respect to the event "took three doses with food" was not applicable.  The clinical outcome of the event "took three doses with food" was unknown.  Company's Comment: The causality of the event "took three doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses with food" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Contraindication to vaccination
Clinical narrative: TOOK VIVOTIF WHILE ON AUGMENTIN; This spontaneous case report was received from a pharmacist (PVX2019-365) on 08-Feb-2019. The report describes a female consumer who "took Vivotif while on Augmentin". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis and Augmentin (amoxicillin and clavulanic; one daily) for an unknown indication.  It was reported that the consumer started Augmentin 21 days ago, taking it every day until today (start date: 18-Jan-2019 and end date- 08-Feb-2019). She started Vivotif 8 days ago and completed the course (start date: 31-Jan-2019 and end date- 06-Feb-2019).  The action taken with Vivotif and Augmentin with respect to the event "took Vivotif while on Augmentin" was not applicable.  The clinical outcome of the event "took Vivotif while on Augmentin" was unknown.  Company's Comment: The causality of the event "took Vivotif while on Augmentin" was considered as not applicable. ; Sender's Comments: Company's Comment : The causality of the event "took Vivotif while on Augmentin" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: DID NOT COMPLETE HIS DOSES ONE WEEK PRIOR TO TRAVEL; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a caregiver (PVX2019-421) on 13-Feb-2019. The report describes a 15-year-old adolescent male consumer who "took an unrefrigerated dose" and "did not complete his doses one week prior to travel". The consumer was receiving oral Vivotif capsule (one dose every other day) (lot number: 3003239 and expiry date: Oct 2019) for typhoid prophylaxis  It was reported that the caregiver left Vivotif unrefrigerated since 24-Jan-2019 and her son took his first dose on 13-Feb-2019. He would be leaving for a mission trip on 23-Feb-2019.  The action taken with Vivotif with respect to the events "took an unrefrigerated dose" and "did not complete his doses one week prior to travel" was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete his doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete his doses one week prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: HIVES ON HIS BACK, TORSO, AND ARMS; This spontaneous case report was received from a nurse (PVX2019-588) on 06-Mar-2019. The report described a 59-year-old male consumer who had hives on his back, torso, and arms following the intake of oral Vivotif for typhoid fever prophylaxis.  The consumer's past medication included Hepatitis A vaccine (only 1 dose) which was taken on 01-Mar-2019.  The consumer's concomitant medication included ibuprofen, Tylenol (paracetamol), Flonase (fluticasone propionate) as needed for unknown indication. He also took medications for blood pressure.   The consumer was allergic to ciprofloxacin and penicillin as a kid. He used to have hives from ciprofloxacin.   It was reported that the consumer took the first dose of Vivotif on 02-Mar-2019. On 04-Mar-2019, he experienced hives on his back, torso, and arms. He did not take the additional doses.  The consumer took one dose of Benadryl (diphenhydramine) for the treatment of hives on 04-Mar-2019 and the hives started to get better. Then on 05-Mar-2019, the hives came back a little bit, but now they were recovering and going away.  He did not expose to any atypical or new environment. He did not have any new food, chemical, or medication exposure. He also did not change his laundry detergent or soap.  The action taken with Vivotif with respect to the event hives on his back, torso, and arms was dosage discontinued.  The clinical outcome of the event hives on his back, torso, and arms was resolving.  The reported causality with respect to the event hives on his back, torso, and arms was possible.  Company's Comment: In this case, it was reported that a 59-year-old male consumer who had hives on his back, torso, and arms following the intake of oral Vivotiff. There seems to be a temporal association between the intake of Vivotif and the event. Hence, the causality of the event with Vivotif was assessed as possible. Additionally, co-administration of Hepatitis A vaccine (only 1 dose) on 01-Mar-2019 also provides a plausible explanation for the reported events.; Sender's Comments: Company's Comment: In this case, it was reported that a 59-year-old male consumer who had hives on his back, torso, and arms following the intake of oral Vivotiff. There seems to be a temporal association between the intake of Vivotif and the event. Hence, the causality of the event with Vivotif was assessed as possible. Additionally, co-administration of Hepatitis A vaccine (only 1 dose) on 01-Mar-2019 also provides a plausible explanation for the reported events.
Sex: F
Vaccine: TYP
Symptoms: Dry skin, Eye swelling, Hypersensitivity, Pruritus, Rash macular
Clinical narrative: PUFFY FACE/ SWOLLEN FACE; SWOLLEN EYE; DRY BLOTCHES; HIVES-LIKE RASH; This spontaneous case report was received from a nurse (PVX2019-583) on 05-Mar-2019. It described a female consumer who experienced puffy face/ swollen face, swollen eye, dry blotches and hives-like rash following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. She also used an unknown face wash.   The consumer's concomitant medication included Cyred (desogestrel and ethinyl estradiol) for an unknown indication.   It was reported that the consumer took the first two dose of Vivotif on 28-Feb-2019 and 02-Mar-2019, respectively. On 01-Mar-2019, she used a facewash (nurse did not know the name). On 02-Mar-2019, she experienced the following events; puffy/ swollen face, dry blotches, hives like rash, swollen eye. These symptoms occurred just on her face, neck and one of the eye. She took the third dose on 04-Mar-2019.  She took Benadryl (diphenhydramine) a couple of time for itching on 04-Mar-2019.  The action taken with Vivotif with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was dosage maintained.  The action taken with face wash with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was unknown.  The clinical outcome of the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was not resolved.  The reporter's causality of Vivotif with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was possible.  Company's Comment: In this case, it was reported that a female consumer who experienced puffy face/ swollen face, swollen eye, dry blotches and hives-like rash following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. The events appear to be due to a hypersensitivity reaction to Vivotif. Also, hypersensitivity reaction is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Swelling face, Urticaria
Clinical narrative: PUFFY FACE/ SWOLLEN FACE; SWOLLEN EYE; DRY BLOTCHES; HIVES-LIKE RASH; This spontaneous case report was received from a nurse (PVX2019-583) on 05-Mar-2019. It described a female consumer who experienced puffy face/ swollen face, swollen eye, dry blotches and hives-like rash following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. She also used an unknown face wash.   The consumer's concomitant medication included Cyred (desogestrel and ethinyl estradiol) for an unknown indication.   It was reported that the consumer took the first two dose of Vivotif on 28-Feb-2019 and 02-Mar-2019, respectively. On 01-Mar-2019, she used a facewash (nurse did not know the name). On 02-Mar-2019, she experienced the following events; puffy/ swollen face, dry blotches, hives like rash, swollen eye. These symptoms occurred just on her face, neck and one of the eye. She took the third dose on 04-Mar-2019.  She took Benadryl (diphenhydramine) a couple of time for itching on 04-Mar-2019.  The action taken with Vivotif with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was dosage maintained.  The action taken with face wash with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was unknown.  The clinical outcome of the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was not resolved.  The reporter's causality of Vivotif with respect to the events puffy face/ swollen face, swollen eye, dry blotches and hives-like rash was possible.  Company's Comment: In this case, it was reported that a female consumer who experienced puffy face/ swollen face, swollen eye, dry blotches and hives-like rash following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. The events appear to be due to a hypersensitivity reaction to Vivotif. Also, hypersensitivity reaction is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: U
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous case was received from a pharmacist on 10-Jun-2019. It describes a consumer who developed hives, after the administration of Vivotif for an unknown indication.  Case report: The consumer got hives after taking Vivotif. The consumer took 2 doses so far.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer developed hives, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, hives 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 developed hives, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, hives is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: RASH ON BOTH LEGS AND ARMS; This spontaneous case report (PVX2019-1835) was received from a pharmacist on 16-Jul-2019. It describes a female consumer who developed rash on both legs and arms (PT: Rash generalized), after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three doses of Vivotif on 11-Jul-2019, 13-Jul-2019, and 15-Jul-2019, respectively. On 13-Jul-2019, after taking the second dose she developed rash. The rash was on both legs and both arms. She took antihistamine as treatment and the rash went away. Again on 15-Jul-2019, after taking the third dose she developed rash and took an antihistamine dose again. She had no atypical exposure to any food, chemicals, and medications prior to the rash.  The reporter was not certain about the rash history of the consumer, but the consumer completed the course of Vivotif in 2005 and 2010 and there were no adverse reactions experienced from Vivotif both the time.  The consumer's had environmental allergies, for which she was takes Flonase (fluticasone).  Action taken with Vivotif was vaccine discontinued.  The consumer had recovered from the event on 15-Jul-2019.  Company's Comment: In this case, it was reported that the consumer had rash on both legs and arms after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash on both legs and arms after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: U
Vaccine: TYP
Symptoms: Rash pruritic
Clinical narrative: INCREASINGLY WORSE DIFFUSE PRURITIC RASH WITH EACH DOSE OF ORAL TYPHOID; This spontaneous case report was received from a nurse on 14-Aug-2019. It described a 35-year-old consumer who experienced "increasingly worse diffuse pruritic rash with each dose of oral Typhoid" (PT: Rash pruritic), during therapy with oral Vivotif for an unknown indication.  Case report: The consumer had experienced increasingly worse diffuse pruritic rash with each dose of oral Typhoid. Hence, the consumer took only three doses of Vivotif and held the fourth dose.  Action taken with Vivotif was vaccine discontinued.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer experienced "increasingly worse diffuse pruritic rash with each dose of oral Typhoid". 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. Also, rash is labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "increasingly worse diffuse pruritic rash with each dose of oral Typhoid" . 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. Also, rash is labelled as per CCDS.
Sex: M
Vaccine: FLU3
Symptoms: Fat tissue increased
Clinical narrative: fatty tissue built up in deltoid area; Initial information received on 21-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a male patient age unknown who experienced fatty tissue built up in deltoid area (fat tissue increased), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  In April 2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in the deltoid nos for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fatty tissue built up in deltoid area (fat tissue increased) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratories details reported.  Final diagnosis was fat tissue increased.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported as unknown for fat tissue increased.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4, IPV, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Frozen vaccines from excursion were administered to the patients, no AE; Initial information received on 22-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves approximately 26 patients of an unknown demographics who were received frozen vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot: UT6657MA Expiry date: 30-Jun-2020), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Lot: U6522AA, U6560BA, expiry date not reported) and IPV (VERO) [IPOL] (Lot: P1F491M,  Expiry date not reported) via unknown route in an unknown administration site on an unknown date for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Product storage error temperature too low.   It was reported that nurse from clinic reported that temperature excursions for Menactra, Fluzone Quadrivalent 0.5 ml single dose and IPOL. Two of the IPOL were opened. Temperature excisions occurred on 29-Jan-2020 when refrigerator reached a temperature of 46.2 F for one hour because of malfunction . Due to an emergency in the clinic the vaccines had to be transported to another facility. Temp reached 24.9 F for a total of 35 minutes during transport to the other facility. Reason for excursion was due to temperature instability with transport cooler. Nurse stated that she was told the vaccines were okay to use but they are not. They have administered these vaccines that were frozen.  It was also reported that vaccines that have reached a temperature< 32F not suitable for use.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: UNK
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: Positive for the flu; Positive for the flu; This is a spontaneous case, reported by other health professional (nurse) to agency and initially received on 17-Apr-2020, concerning a female patient with unknown age.   The patient had no medical history.  The patient had no concomitant medications.  On an unspecified date in Nov-2019, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiration date: not reported] for prevention of flu.  On an unspecified date in Feb-2020, rapid flu test was performed and the patient was positive for the flu (explicitly coded as 'vaccination failure'). The patient did not receive any treatment.  On an unspecified date in 2020, the outcome of the event 'flu' was resolved.  At the time of this report, the outcome of the event 'vaccination failure' was not reported.  The events of 'flu' and 'vaccination failure' were assessed as serious due to criteria of medically significance, per company.  The reported did not provide causality assessment.  The reported did not give permission to be contacted for further information.  Company comment: The patient was administered INN Flu Vaccine Seasonal on an unspecified date in Nov-2019. The patient tested positive for influenza, on an unspecified date in Feb-2020. The patient was tested positive in time frame of 21 days and up to 180 days post vaccination (coded as vaccination failure). Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.; Sender's Comments: The patient was administered INN Flu Vaccine Seasonal on an unspecified date in Nov-2019. The patient tested positive for influenza, on an unspecified date in Feb-2020. The patient was tested positive in time frame of 21 days and up to 180 days post vaccination (coded as vaccination failure). Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: antibody test  negative; This spontaneous report was received from a registered nurse and male patient "in 60's years of age" who is also a physician, . Infoamtaion regarding the patient's medical history, concurrent conditions and cocnomitant medications was not provided.  On 11-NON-2019, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 10/1.0 mcrg/ml (dose, route, lot # and expiration date were not provided) for prophylaxis. Nurse reported that the patient was tested non immune and not reactive for antibody testing(hepatitis b surface antibody negative ) on an unknown date after was administered hepatitis b vaccine (recombinant)(RECOMBIVAX HB) ;no clarifying information provided.   The outcome of hepatitis b surface antibody negative was unknown.    Causality assessment was not provided.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Donor experienced  burning and swelling around site that evening. at about 6;00pm
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Decreased appetite, Erythema, Headache, Malaise
Clinical narrative: Localized arm pain, redness, swelling, warmth, area of 4 by 6 inches.  Fever to 100.5 F, headache, severe body aches, nausea, severe abdominal pain, malaise, anorexia.  Symptoms lasted through 4th day after received injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Localized arm pain, redness, swelling, warmth, area of 4 by 6 inches.  Fever to 100.5 F, headache, severe body aches, nausea, severe abdominal pain, malaise, anorexia.  Symptoms lasted through 4th day after received injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Localized arm pain, redness, swelling, warmth, area of 4 by 6 inches.  Fever to 100.5 F, headache, severe body aches, nausea, severe abdominal pain, malaise, anorexia.  Symptoms lasted through 4th day after received injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Nausea, Pain
Clinical narrative: On February 18, 2020 the patient received Shingrix in the right deltoid. The patient experienced body aches, chills, nausea and limited mobility for 2 days post-vaccination. Unknown treatment regimen or whether patient sought medical attention for adverse reactions. On February 21, the patient was feeling better though the body aches had not resolved. Pharmacy received a request for further documentation from GSK regarding this ADE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fall, Headache
Clinical narrative: The patient reported dizziness, upset stomach and headache after immunization. The pt also fell down after getting dizzy. The pt denied hitting her head. Pt asked her PCP and was informed that she can take 2 Tylenol.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: When patient woke up this morning, grandmother noticed large erythematous area from injection site up to neck. No swelling or splotching. Not raised. Pruritic and warm to touch. No other symptoms. Advised by PCP to take over-the-counter Benadryl and continue to monitor.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Skin warm
Clinical narrative: When patient woke up this morning, grandmother noticed large erythematous area from injection site up to neck. No swelling or splotching. Not raised. Pruritic and warm to touch. No other symptoms. Advised by PCP to take over-the-counter Benadryl and continue to monitor.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Injection site rash, Pyrexia
Clinical narrative: Low grade fever starting on 4/22/2020,  rash started on right thigh evening of 4/23/2020, seen at office 4/24/2020 diagnosed with Erythema multiforme. Treated with oral Zyrtec and steroids.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Bacterial test, Injection site erythema, Injection site vesicles, Viral test
Clinical narrative: per Patient's Mom:  4/22 child's right arm/vaccine area, redness appeared, later that afternoon (around 1pm) tiny blisters began to appear.  4/23 blisters worsened. Mom called our office to inform, made an appt for patient to be seen at 1:40pm. Patient seen by doctor.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect immunization given. No adverse events noted.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: fever of 100.5, injection site arm swollen to about the size of a softball, hard when pressed, warm to touch, no coloration
Age: 35.0
Sex: M
Vaccine: HPV9
Symptoms: Wrong patient received product
Clinical narrative: Gardisil is not indicated for administration to patients beyond age26 unless it is determined to be necessary in shared decision making process with MD and patient. Patient was advised of rationale for immunization and consented to receive it. However, it had not been ordered to be administered by the provider seeing the patient. It was administered to patient in error, was meant for a patient with a very similar name.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Redness around injection site, soreness in entire arm, body aches and fatigue.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Heart rate increased, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Tired about 7 hours after vaccine, minimal pain in injection site. 2am- fever Next day- high fever, high heart rate. Currently 2nd day after administered and seen again by healthcare professional) high fever, high heart rate, lovalized reaction to injection site- major swelling, moderate pain, muscle spasms.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Tired about 7 hours after vaccine, minimal pain in injection site. 2am- fever Next day- high fever, high heart rate. Currently 2nd day after administered and seen again by healthcare professional) high fever, high heart rate, lovalized reaction to injection site- major swelling, moderate pain, muscle spasms.