chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Arthralgia, Blood thyroid stimulating hormone normal, Borrelia test negative, Full blood count normal, Haemoglobin normal
Clinical narrative: MYALGIA; ARTHRALGIA; RASH ON LEGS AND ARMS; A spontaneous case report was received from another healthcare professional on 07-Jun-2019 for two consumers.  Based on the information obtained from the reporter, two individual case safety reports PVX201906-000466 (first consumer) and PVX201906-000467 (second consumer) were created and cross-linked in the database.  This case describes a female consumer (weight: 91 kg and height: 167 cm) who developed rash on arms and legs, myalgia, and arthralgia, after taking Vivotif for unknown indication.  Case report: The consumer took three doses of Vivotif on 30-May-2019, 1-Jun-2019, and 03-Jun-2019, respectively. On an unknown date, she had rash on arms and legs, myalgia, and arthralgia.   She took Benadryl (diphenhydramine) for rash on arms and legs and ibuprofen for myalgia and arthralgia.  The consumer's medical history included obesity, anxiety, and allergic rhinitis.  Concomitant medication included oral Zyrtec (cetirizine; 10 mg once in a day), Zoloft (sertraline; 100 mg once in a day), Topamax (50 mg; once in a day).  Laboratory test included complete blood count (CBC), thyroid stimulating hormone (TSH), Lyme ab test, and comprehensive metabolic panel (CMP) test. All the test was conducted on 05-Jun-2019 and the results were found to be normal. The hemoglobin was found to be 11.2 and she had anemia.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events.  Company's Comment: In this case, it was reported that the consumer developed rash on arms and legs, myalgia, and arthralgia after taking Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, rash, myalgia, and arthralgia 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 developed rash on arms and legs, myalgia, and arthralgia after taking Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, rash, myalgia, and arthralgia is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201906-000466:
Sex: U
Vaccine: TYP
Symptoms: Metabolic function test normal, Myalgia, Rash
Clinical narrative: MYALGIA; ARTHRALGIA; RASH ON LEGS AND ARMS; A spontaneous case report was received from another healthcare professional on 07-Jun-2019 for two consumers.  Based on the information obtained from the reporter, two individual case safety reports PVX201906-000466 (first consumer) and PVX201906-000467 (second consumer) were created and cross-linked in the database.  This case describes a female consumer (weight: 91 kg and height: 167 cm) who developed rash on arms and legs, myalgia, and arthralgia, after taking Vivotif for unknown indication.  Case report: The consumer took three doses of Vivotif on 30-May-2019, 1-Jun-2019, and 03-Jun-2019, respectively. On an unknown date, she had rash on arms and legs, myalgia, and arthralgia.   She took Benadryl (diphenhydramine) for rash on arms and legs and ibuprofen for myalgia and arthralgia.  The consumer's medical history included obesity, anxiety, and allergic rhinitis.  Concomitant medication included oral Zyrtec (cetirizine; 10 mg once in a day), Zoloft (sertraline; 100 mg once in a day), Topamax (50 mg; once in a day).  Laboratory test included complete blood count (CBC), thyroid stimulating hormone (TSH), Lyme ab test, and comprehensive metabolic panel (CMP) test. All the test was conducted on 05-Jun-2019 and the results were found to be normal. The hemoglobin was found to be 11.2 and she had anemia.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events.  Company's Comment: In this case, it was reported that the consumer developed rash on arms and legs, myalgia, and arthralgia after taking Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, rash, myalgia, and arthralgia 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 developed rash on arms and legs, myalgia, and arthralgia after taking Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, rash, myalgia, and arthralgia is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201906-000466:
Sex: F
Vaccine: TYP
Symptoms: Headache
Clinical narrative: DULL HEADACHE; This spontaneous case (PVX2019-1631) was received from a consumer on 24-Jun-2019. It describes a 64-year-old female consumer who had dull headache, after the administration of oral Vivotif (one dose every other day; lot number: 3003279 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 21-Jun-2019. On the same day, she experienced dull headache. On 23-Jun-2019, she took the second dose. She continued taking Vivotif as her nurse stated that headache was a possible side effect and recommended to continue taking Vivotif. The consumer also stated that she had been under lot of stress and did not want to blame Vivotif for the headaches.  She took Tylenol (paracetamol) for headache.  Action taken with Vivotif was dosage maintained.  The consumer had recovered from the event.  Company's Comment: In this case, it was reported that the consumer had a 64-year-old female consumer had dull headache, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache are 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 a 64-year-old female consumer had dull headache, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: DID NOT COMPLETE VIVOTIF ONE WEEK PRIOR TO TRAVEL; This spontaneous case report was received from a pharmacist (PVX2019-034) on 04-Jan-2019 and a follow-up was received on 07-Jan-2019. The report describes a male consumer who "did not complete Vivotif one week prior to travel". The consumer was receiving oral Vivotif (one dose every other day; lot no: 3003240) for typhoid fever prophylaxis.  It was reported that the consumer took the doses of Vivotif on 03-Jan-2019, 05-Jan-2019, 07-Jan-2019 and would take the last dose on 09-Jan-2019. He was travelling right away.  The action taken with Vivotif with respect to the event "did not complete Vivotif one week prior to travel" was not applicable.  The clinical outcome of the event "did not complete Vivotif one week prior to travel" was unknown.  Company's Comment: The causality of the event "did not complete Vivotif one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete Vivotif one week prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-042) on 04-Jan-2019. The report describes a 49-year-old male consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif capsule (lot number: 3003238) for an unknown indication.  It was reported that the consumer took the first dose of Vivotif that was unrefrigerated for 24 hours.  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 an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: ATE CHOCOLATE 45 MINUTES BEFORE TAKING VIVOTIF; This spontaneous case report was received from a consumer (PVX2019-051) on 07-Jan-2019. The report describes an 18-year-old male consumer who "ate chocolate 45 minutes before taking Vivotif". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer ate a little piece of chocolate 45 minutes before taking a dose of Vivotif on 05-Jan-2018. The last dose was on 07-Jan-2018.  The action taken with Vivotif with respect to the event "ate chocolate 45 minutes before taking Vivotif" was not applicable.  The clinical outcome of the event "ate chocolate 45 minutes before taking Vivotif" was unknown.  Company's Comment: The causality of the event "ate chocolate 45 minutes before taking Vivotif" was considered as not applicable; Sender's Comments: Company's Comment: The causality of the event "ate chocolate 45 minutes before taking Vivotif" was considered as not applicable
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND DOSE ON DAY 4; This spontaneous case report was received from a pharmacist (PVX2019-055) on 07-Jan-2019. The report describes a consumer who "took second dose on day 4". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif on 04-Jan-2019 and the second dose on 07-Jan-2019 instead of 06-Jan-2019.  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: M
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 (PVX2019-071) on 08-Jan-2019. The report describes a 67-year-old elderly male consumer who "took two doses in a row". The consumer was receiving oral Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took the first two doses of Vivotif on 07-Jan-2019 and 08-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: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a nurse on 10-Jan-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX2019-089 (PVX201901-000027; husband) and PVX2019-090 (PVX201901-000028, wife) were created and cross-linked in the database.  This case report describes an adult male consumer who "took Vivotif with food". The consumer was receiving Vivotif for unknown indication.  It was reported that the consumer took the three out of four doses of Vivotif with food.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was 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. US-PaxVax Berna GmbH-PVX201901-000028:
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a nurse on 10-Jan-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX2019-089 (PVX201901-000027; husband) and PVX2019-090 (PVX201901-000028, wife) were created and cross-linked in the database.  This case report describes an adult female consumer who "took Vivotif with food". The consumer was receiving Vivotif for unknown indication.  It was reported that the consumer took the three of the four doses of Vivotif with food.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was 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. US-PaxVax Berna GmbH-PVX201901-000027:
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK VIVOTIF WITH FOOD; A spontaneous case report was received from a pharmacist on 10-Jan-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX2019-091 (PVX201901-000029; female) and PVX2019-092 (PVX201901-000030, male) were created and cross-linked in the database.  This case report describes an adult male consumer who "took Vivotif with food". The consumer was receiving Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took the three doses of Vivotif with food. The doses were taken on 03-Jan-2019, 05-Jan-2019, and 07-Jan-2019, respectively.  The action taken with Vivotif with respect to event "took Vivotif with food" was not applicable.  The clinical outcome of the event "took Vivotif with food" was 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. US-PaxVax Berna GmbH-PVX201901-000029:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-122) on 14-Jan-2019. The report describes a female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer brought Vivotif home and took one dose. Then the vaccine was left on the counter for a week. She realized it had to be refrigerated when she took her last dose. She took all the doses according to schedule.   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: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product storage error
Clinical narrative: MISSED SECOND DOSE OF VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-115) on 14-Jan-2019. The report describes a male consumer who "missed second dose of Vivotif". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003207 and expiry date: Feb 2019) for a typhoid fever prophylaxis.   It was reported that the consumer took his first on Friday and was supposed to take his next dose on Sunday (yesterday). However, his refrigerator failed and Vivotif went out of range for 6 hours. He did not take the dose on Sunday, thus missing the second dose.  The action taken with Vivotif with respect to the event "missed second dose of Vivotif" was not applicable.  The clinical outcome of the event "missed second dose of Vivotif" was unknown.  Company's Comment: The causality of the event "missed second dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed second dose of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: TOOK THREE DOSES OF EXPIRED VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-149) on 16-Jan-2019. The report describes a 41-year-old adult male consumer who "took three doses of expired Vivotif". The consumer was receiving Vivotif (lot number: 3003202 and expire date: Nov 2018) for an unknown indication.  It was reported that the consumer took three expired doses of Vivotif.   The action taken with Vivotif with respect to the event "took three doses of expired Vivotif" was not applicable.  The clinical outcome of the event "took three doses of expired Vivotif" was unknown.  Company's Comment: The causality of the event "took three doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses of expired Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from an other healthcare professional (PVX2019-144) on 16-Jan-2019. The report describes a 65-year-old elderly female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif (lot number: 3003214) for an unknown indication.   It was reported that the consumer picked up Vivotif on 08-Jan-2019 and never refrigerate them. She took the unrefrigerated doses on 09-Jan-2019, 11-Jan-2019, and 13-Jan-2019 respectively.  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: M
Vaccine: TYP
Symptoms: Product residue present
Clinical narrative: PASSED  CAPSULE IN STOOL; This spontaneous case report was received from an other healthcare professional (PVX2019-374) on 08-Feb-2018. The report describes a 34-year-old adult male consumer who "passed capsule in stool". The consumer was receiving Vivotif capsule (lot number: 3003215 and expiry date: 29-Apr-2019) for an unknown indication.  It was reported that the consumer was taking Vivotif. He passed a whole capsule when he went to the restroom.  The action taken with Vivotif with respect to the event "passed capsule in stool" was not applicable.  The clinical outcome of the event "passed capsule in stool" was unknown.  Company's Comment: In this case a 34-year-old adult male consumer "passed capsule in stool" following intake of Vivotif. The causality of the event "passed capsule in stool" was considered as not applicable.; Sender's Comments: Company's Comment: In this case a 34-year-old adult male consumer "passed capsule in stool" following intake of Vivotif. The causality of the event "passed capsule in stool" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Decreased appetite, Incomplete course of vaccination, Nausea
Clinical narrative: DID NOT TAKE FOURTH DOSE OF VIVOTIF; DECREASED APPETITE; NAUSEA; STOMACH CRAMPS AND PAIN; This spontaneous case report was received from a nurse (PVX2019-419) on 13-Feb-2019. The report describes a 17-year-old female consumer who had nausea, stomach cramps and pain, and decreased appetite following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. The consumer "did not take fourth dose of Vivotif".  The consumer had a history of epilepsy, asthma, irregular menstrual cycle and had a knee surgery in past. The consumer was allergic to viscous lidocaine.  The consumer's concomitant medication included oral Singulair (montelukast; 10 mg per day) for asthma and oral Lessina (levonorgestrel; 20 mg) for irregular menstrual cycle.  It was reported that the consumer took the three doses of Vivotif on 17-Jan-2019, 19-Jan-2019, and 21-Jan-2019, respectively. On 17-Jan-2019, after the intake of dose the consumer experienced GI (gastrointestinal) side effects including nausea, stomach cramps and pain, and decreased appetite which got worse with each dose. The consumer did not have any atypical exposure to food, medications or environmental exposures. The consumer also stated that she discontinued Vivotif after completing the three doses of Vivotif.  The action taken with Vivotif with respect to the events nausea, stomach cramps and pain, and decreased appetite was dosage maintained while with respect to the event "did not take fourth dose of Vivotif" was not applicable.  The clinical outcome of the events nausea, stomach cramps and pain, and decreased appetite was resolved while with respect to the event "did not take fourth dose of Vivotif" was unknown.  The reporter's causality with respect to the events nausea, stomach cramps and pain, and decreased appetite was related.  Company's Comment: In this case, it was reported that a 17-year-old female consumer had nausea, stomach cramps and pain, and decreased appetite following the intake of oral Vivoti . There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, stomach cramps and pain, and decreased appetite are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take fourth dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a 17-year-old female consumer had nausea, stomach cramps and pain, and decreased appetite following the intake of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, stomach cramps and pain, and decreased appetite are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "did not take fourth dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Headache, Neck pain
Clinical narrative: HEADACHE; This spontaneous case report was received from a consumer (PVX2019-665) on 15-Mar-2019. It described a 68-year-old elderly female consumer who had headache following the intake of Vivotif for travel.  The consumer occasionally has headache from caffeine.   It was reported that the consumer took the first dose of Vivotif on 20-Feb-2019 and the last dose on 26-Feb-2019. On 21-Feb-2019, she experienced headache which persists for the whole day in an irregular manner. She had a headache on the left side of her head and it was worse in evenings and nights when she had to sleep. She stated that the pain would move around the top, side, back and bottom of the neck. She further stated that it had not completely gone away, but she was getting better.  The consumer's treatment medications included ibuprofen, Tylenol (paracetamol), and Aspirin (acetylsalicylic acid) which she was taking alternatively for headache.  The action taken with Vivotif with respect to the event headache was dosage maintained.  The clinical outcome of the event headache was resolving.  Company's Comment: In this case, it was reported that a 68-year-old elderly female consumer who had headache following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache 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 a 68-year-old elderly female consumer who had headache following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, headache is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Nausea, Pain in extremity
Clinical narrative: LEG PAIN; LEGS FELT REALLY HEAVY LIKE NUMB; NAUSEA; HEADACHE; RASH; This spontaneous case (PVX2019-779) was received from non-healthcare professional on 01-Apr-2019. It describes a 52-year-old female consumer who experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the last dose of Vivotif on 26-Mar-2019 and on the same day, she experienced nausea, headaches, rash, leg pain and numbness. She felt better on 01-Apr-2019 from the events. The rash did not spread, but her legs felt heavy like numb over the weekend.  Action taken with Vivotif was unknown.  The consumer had not recovered from the events "leg pain" and "legs felt really heavy like numb". However, she was recovering with the event's "nausea", "headache", and "rash".  Company's Comment: In this case, it was reported that the consumer experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, limited information precludes further assessment of case. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, limited information precludes further assessment of case.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: LEG PAIN; LEGS FELT REALLY HEAVY LIKE NUMB; NAUSEA; HEADACHE; RASH; This spontaneous case (PVX2019-779) was received from non-healthcare professional on 01-Apr-2019. It describes a 52-year-old female consumer who experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the last dose of Vivotif on 26-Mar-2019 and on the same day, she experienced nausea, headaches, rash, leg pain and numbness. She felt better on 01-Apr-2019 from the events. The rash did not spread, but her legs felt heavy like numb over the weekend.  Action taken with Vivotif was unknown.  The consumer had not recovered from the events "leg pain" and "legs felt really heavy like numb". However, she was recovering with the event's "nausea", "headache", and "rash".  Company's Comment: In this case, it was reported that the consumer experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, limited information precludes further assessment of case. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "nausea", "headache", "rash", "leg pain" and her "legs felt really heavy like numb", while being on oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. However, limited information precludes further assessment of case.
Sex: F
Vaccine: TYP
Symptoms: Arthralgia, Diarrhoea, Fatigue, Muscle spasms, Pyrexia
Clinical narrative: ARTHRALGIA; FATIGUE; DIARRHEA; CRAMPS; FEVER; HIVES; This spontaneous case (PVX2019-1381) was received from a nurse on 30-May-2019. It describes a 49-year-old adult female consumer who experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif (one capsule every other day; lot no: 3003240) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-May-2019. On 25-May-2019, she had diarrhea, cramps, fever, arthralgia, fatigue, and hives. She reported that the hives were spread on her lower body part (either the consumer's legs or stomach). She did not have any respiratory symptoms along with the hives.   Treatment of the events included Tylenol (acetaminophen; 500 mg) (as needed) for fever and pain as needed.  The consumer's medical history included asthma, mild reflux and insulin resistance. She was allergic to Cipro and ibuprofen.   Concomitant medication included Zantac (ranitidine) for mild reflux, Claritin (loratadine) for seasonal allergies, Metformin for insulin resistance, and an oral contraceptive. The past medication included she received yellow fever vaccine on 10-Apr-2019 for yellow fever prophylaxis and experienced mild arm discomfort, several loose bowel movements (BMs) and some mild abdominal cramping on the same day. She also received an old injectable typhoid injection in 1991 and had a red arm and fever from it.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events diarrhea, cramps, fever, and hives on 28-May-2019 while the clinical outcome of the events arthralgia and fatigue was unknown.  Company's Comment: In this case, it was reported that the consumer had experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. 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 experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: ARTHRALGIA; FATIGUE; DIARRHEA; CRAMPS; FEVER; HIVES; This spontaneous case (PVX2019-1381) was received from a nurse on 30-May-2019. It describes a 49-year-old adult female consumer who experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif (one capsule every other day; lot no: 3003240) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-May-2019. On 25-May-2019, she had diarrhea, cramps, fever, arthralgia, fatigue, and hives. She reported that the hives were spread on her lower body part (either the consumer's legs or stomach). She did not have any respiratory symptoms along with the hives.   Treatment of the events included Tylenol (acetaminophen; 500 mg) (as needed) for fever and pain as needed.  The consumer's medical history included asthma, mild reflux and insulin resistance. She was allergic to Cipro and ibuprofen.   Concomitant medication included Zantac (ranitidine) for mild reflux, Claritin (loratadine) for seasonal allergies, Metformin for insulin resistance, and an oral contraceptive. The past medication included she received yellow fever vaccine on 10-Apr-2019 for yellow fever prophylaxis and experienced mild arm discomfort, several loose bowel movements (BMs) and some mild abdominal cramping on the same day. She also received an old injectable typhoid injection in 1991 and had a red arm and fever from it.  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events diarrhea, cramps, fever, and hives on 28-May-2019 while the clinical outcome of the events arthralgia and fatigue was unknown.  Company's Comment: In this case, it was reported that the consumer had experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. 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 experienced diarrhea, cramps, fever, arthralgia, fatigue, and hives, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous case (PVX2019-1418) was received from a physician on 03-Jun-2019. It describes an 8-year-old male child consumer who had fever and headache, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 01-Jun-2019. On 02-Jun-2019, he had headache and fever (103 degree Fahrenheit to 104 degree Fahrenheit). He took oral ibuprofen (200 mg) for treatment and his physician assumed that he took 3 doses of it. He reported that he had no other symptoms and not had any similar reaction to other vaccines in the past.   The consumer did not take any other medications.  The consumer was allergic to peanut.  Action taken with Vivotif was unknown.  The consumer had not recovered from the events fever and headache.  Company's Comment: In this case, it was reported that the consumer had fever and headache after the intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, fever and headache are 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 fever and headache after the intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, fever and headache are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: LOST 4 LBS; BAD DIARRHEA; This spontaneous case report (PVX2019-2074) was received from a consumer on 12-Aug-2019. It described a 66-year-old elderly male consumer who had bad diarrhea (PT: Diarrhoea) and lost 4 lbs (PT: Weight decreased), after the administration of Vivotif (lot number: 3003277) for vaccination for trip.  Case report: The consumer took two doses of Vivotif a month ago for a trip. He stated that he had a little bit of diarrhea after the first dose, but it was severe after the second dose. The consumer stopped taking Vivotif because of diarrhea and lost up to 4 Ibs of weight. He stated he did not receive any treatments for it and have not spoken to a physician. However, he had received the typhoid injectable vaccine afterward.  Moreover, he had no relevant past medical history and he never had anything like it. He stated he was not on other medications.  Action taken with Vivotif was vaccine discontinued.  The consumer had been recovering from the reported events.  Company's Comment: In this case, it was reported that the consumer had bad diarrhea and lost 4 lbs after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, diarrhea is labelled as per CCDS.; Sender's Comments: In this case, it was reported that the consumer had bad diarrhea and lost 4 lbs after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, diarrhea is labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Fatigue, Gastrointestinal disorder, Gastrointestinal pain, Lethargy
Clinical narrative: SEVERE LETHARGY/ KNOCKED HER OUT; TIREDNESS THROUGHOUT THE DAY; MILD GASTROINTESTINAL (GI) SIDE EFFECTS SUCH AS CRAMPING; TUMMY UPSET; This case (PVX2019-2187) was received from a pharmacist on 27-Aug-2019. It described a 36-year-old adult female consumer who reported "severe lethargy/ knocked her out" (PT: Lethargy), "mild gastrointestinal (GI) side effects such as cramping" (PT: Abdominal pain upper), "tummy upset" (PT: Abdominal discomfort), "tiredness throughout the day" (PT: Fatigue), during therapy of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took Vivotif doses on 23-Aug-2019, 25-Aug-2019, and 27-Aug-2019, respectively. She reported that after taking each dose it "knocked her out". She had severe lethargy in the morning. She experienced mild GI side effects such as cramping, after taking each dose. Also, she had tiredness throughout the day, for which she consumed caffeine. It was reported that her tummy was getting upset. She denied any other reactions such as swelling or rash. She took oral Pepto Bismol (bismuth subsalicylate) for stomach cramping.   Past medication included Hepatitis A and B vaccines, which were taken on 22-Aug-2019 for Hepatitis A and B prophylaxis, respectively. She also took oral typhoid in the past. She did not have any medical conditions or allergies.  Concomitant medication included oral Lutera (levonorgestrel; once a day) for birth control.  Action taken with Vivotif with respect to the reported events was dosage maintained.  The consumer was recovered from the events of "mild gastrointestinal (GI) side effects such as cramping" and "tummy upset", while the consumer was recovering from the events "tiredness throughout the day" and "severe lethargy/ knocked her out ".  Company's Comment: In this case, it was reported that the consumer experienced "severe lethargy/ knocked her out", "mild gastrointestinal (GI) side effects such as cramping", "tummy upset" , "tiredness throughout the day" during therapy of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. 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 experienced "severe lethargy/ knocked her out", "mild gastrointestinal (GI) side effects such as cramping", "tummy upset" , "tiredness throughout the day" during therapy of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Dehydration, Dizziness
Clinical narrative: DEHYDRATION DUE TO COLON CLEANSING; SWEATY; WEAK; LIGHTHEADED; STOMACH IN PAIN AND UNCOMFORTABLE; This spontaneous case report (PVX2019-2896) was received from a consumer on 22-Nov-2019. Additional information was received on 27-Nov-2019. It described a female consumer who developed dehydration due to colon cleansing (PT: Dehydration), felt sweaty (PT: Hyperhidrosis), weak (PT: Asthenia), lightheaded (PT: Dizziness), stomach in pain and uncomfortable (PT: Abdominal pain upper), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took last dose of Vivotif on 19-Nov-2019 in the morning. On the same day, in the afternoon she had a scheduled colon cleansing/colon hydrotherapy for cleaning her colon. She reported that during and after the hydrotherapy she started feeling sick with the symptoms of weak, sweaty, lightheaded, and stomach in pain and uncomfortable. She also reported that all the symptoms were possibly due to hydrotherapy and she developed dehydration due to the colon cleansing, as she did not experience any side effects after taking first three doses.  Action taken with Vivotif with respect to the reported events was not applicable.  The consumer had recovered from the reported events on 19-Nov-2019.  Company's Comment: In this case, it was reported that the consumer developed dehydration due to colon cleansing, felt sweaty, weak, lightheaded, stomach in pain and uncomfortable after intake of Vivotif. The consumer got a colon cleanse. There seems to be a temporal association between the intake of the vaccine and the events. Also, the causal role of vaccine cannot be ruled out. 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 developed dehydration due to colon cleansing, felt sweaty, weak, lightheaded, stomach in pain and uncomfortable after intake of Vivotif. The consumer got a colon cleanse. There seems to be a temporal association between the intake of the vaccine and the events. Also, the causal role of vaccine cannot be ruled out. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Hyperhidrosis, Malaise
Clinical narrative: DEHYDRATION DUE TO COLON CLEANSING; SWEATY; WEAK; LIGHTHEADED; STOMACH IN PAIN AND UNCOMFORTABLE; This spontaneous case report (PVX2019-2896) was received from a consumer on 22-Nov-2019. Additional information was received on 27-Nov-2019. It described a female consumer who developed dehydration due to colon cleansing (PT: Dehydration), felt sweaty (PT: Hyperhidrosis), weak (PT: Asthenia), lightheaded (PT: Dizziness), stomach in pain and uncomfortable (PT: Abdominal pain upper), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took last dose of Vivotif on 19-Nov-2019 in the morning. On the same day, in the afternoon she had a scheduled colon cleansing/colon hydrotherapy for cleaning her colon. She reported that during and after the hydrotherapy she started feeling sick with the symptoms of weak, sweaty, lightheaded, and stomach in pain and uncomfortable. She also reported that all the symptoms were possibly due to hydrotherapy and she developed dehydration due to the colon cleansing, as she did not experience any side effects after taking first three doses.  Action taken with Vivotif with respect to the reported events was not applicable.  The consumer had recovered from the reported events on 19-Nov-2019.  Company's Comment: In this case, it was reported that the consumer developed dehydration due to colon cleansing, felt sweaty, weak, lightheaded, stomach in pain and uncomfortable after intake of Vivotif. The consumer got a colon cleanse. There seems to be a temporal association between the intake of the vaccine and the events. Also, the causal role of vaccine cannot be ruled out. 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 developed dehydration due to colon cleansing, felt sweaty, weak, lightheaded, stomach in pain and uncomfortable after intake of Vivotif. The consumer got a colon cleanse. There seems to be a temporal association between the intake of the vaccine and the events. Also, the causal role of vaccine cannot be ruled out. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: adverse reaction to Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th March 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it was captured as adult as per vaccine indication. The patient received Shingrix and experienced an unspecified adverse reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Neuralgia, Post herpetic neuralgia, Pruritus
Clinical narrative: Post herpetic neuralgia; itchiness; neurological pain; residual discomfort; develop herpes zoster which was a severe case; This case was reported by a consumer and described the occurrence of herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th January 2020, less than 6 months after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the patient experienced pruritus, nerve pain and general discomfort. The patient was treated with gabapentin. On an unknown date, the outcome of the herpes zoster, pruritus, nerve pain and general discomfort were not recovered/not resolved.   It was unknown if the reporter considered the herpes zoster, pruritus, nerve pain and general discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's wife. The patient received the 1st dose and was due for 2nd dose on about 12th January 2020. On that day, he began to develop herpes zoster which was severe case. Till the day of reporting, he was suffering from neurological pain and itching.  It affected his chest, back and upper arm. The reporter asked for suggestion regarding 2nd dose and what to do about the residual discomfort. The patient was on Gabapentin. This case was linked with US2020AMR039709, reported by same reporter.   Follow up information received from consumer on 16th April 2020: On 13th January 2020, the patient had herpez zoster. Less than 6 months, the patient experienced from post herpetic neuralgia. The reporter stated that, till the time of reporting, the post herpetic neuralgia was not recovered. The reporter gave consent to contact physician (or other licensed medical practitioner) who was most familiar with the reported event.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: musce aches; Feeling tired; slight headache; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced myalgia, tiredness and headache. On an unknown date, the outcome of the myalgia, tiredness and headache were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the afternoon on the day before reporting. After vaccination the patient felt tired, muscle aches and slight headache. The patient asked how long did the side effects last.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Feeling tired; Feeling achy; This case was reported by a consumer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2020, the patient received the 1st dose of Shingrix. On 21st March 2020, 1 days after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were unknown.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's wife. The patient felt tired and achy after waking.  The reporter enquired how long do the side effects last normally.