chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pallor, Posture abnormal, Retching, Seizure, Syncope
Clinical narrative: 25 yo F new hire in our outpatient clinic.  Minutes  s/p MMR and varicella injection LVN administering reports patient slouched back in chair and head went back in spastic movements (10-20 sec) then patient leaned forward, pale and clammy, able to talk, breath, RR 30, Pulse 50s/60s.  LVN called for help. Unable to get BP due to distance from wall equipment. Clinic NP (me)  walk in and witnessed similar episode repeat of head back/spastic movements, then patient sat forward, was pale, c/o nausea and numb hands., Had dry heaves. EMS called/arrived within 5 min. No known Hx of cardiac hx, seizures, DM, Pregnancy, recent illness. Stated no hx of vaccine reactions or issues with injections or blooddraws.  EMS stated EKG normal. Patient left via Gurney with EMS. Reportedly declined going to hospital via ambulance and was driven by roommate in private car to ED.   Assessment includes s/p seizure episode vs. Cardiogenic syncopal episode/vasovagal.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pain, Pain in extremity, Skin mass, X-ray limb
Clinical narrative: subcutaneous lump, redness and pain started 3 days after vaccine was given, pain still present 4.5 weeks after vaccine was given, and child reports pain in arm with movement (not in shoulder joint), subcutaneous mass measures 1.5 cm and mom reported this has increased in size since the initial lump appeared 3 days after the vaccine.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Child has a case of mild chicken pox
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea
Clinical narrative: employee report on 04/19/2020 . Headache right sided and nausea on 4/16/2020 9pm lasting 1-2 hours. & another episode of nausea and headache right sided the day after the vaccine 04/17/2020 around 2pm.Employee reports " I rested and took Tylenol extra strength.  All symptoms had resolved when reported on 04/19/2020 to nurse at 3pm .
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Administration site swelling, Injection site erythema
Clinical narrative: redness and swelling at site administered- improve on own
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: He had the shingles shot on 08april2020 had fever,and body aches that night. The following day he was nauseous, chills, fever, sweating and head ache. these sympoms lasted  until sat. He is doing fine today.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: He had the shingles shot on 08april2020 had fever,and body aches that night. The following day he was nauseous, chills, fever, sweating and head ache. these sympoms lasted  until sat. He is doing fine today.
Age: 27.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, TYP, TYP
Symptoms: Abdominal discomfort, Adverse food reaction, Allergy test positive, Antibody test positive, Antinuclear antibody
Clinical narrative: In 2015, I started having gastrointestinal issues, diagnosed as GERD, out of nowhere. Symptoms included intense burning in the stomach, diarrhea, and rapid weight loss and fatigue. For the next five years, I continued to worsen, symptoms got worse to include nausea with every meal. I had a food sensitivity panel done in 2016 which showed polyreactivity to foods. In 2019, I was diagnosed with autoimmune disease. I have labs and genetic testing to show this. I currently am polyreactive to almost all foods, critically low vitamin levels resulting in malnutrition, dysbiosis, extreme fatigue.
Age: 27.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, TYP, TYP
Symptoms: Autoimmune disorder, Bacterial test, C-reactive protein, Complement factor C3, Complement factor C4
Clinical narrative: In 2015, I started having gastrointestinal issues, diagnosed as GERD, out of nowhere. Symptoms included intense burning in the stomach, diarrhea, and rapid weight loss and fatigue. For the next five years, I continued to worsen, symptoms got worse to include nausea with every meal. I had a food sensitivity panel done in 2016 which showed polyreactivity to foods. In 2019, I was diagnosed with autoimmune disease. I have labs and genetic testing to show this. I currently am polyreactive to almost all foods, critically low vitamin levels resulting in malnutrition, dysbiosis, extreme fatigue.
Age: 27.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, TYP, TYP
Symptoms: Cytogenetic analysis, Diarrhoea, Dysbiosis, Dyspepsia, Fatigue
Clinical narrative: In 2015, I started having gastrointestinal issues, diagnosed as GERD, out of nowhere. Symptoms included intense burning in the stomach, diarrhea, and rapid weight loss and fatigue. For the next five years, I continued to worsen, symptoms got worse to include nausea with every meal. I had a food sensitivity panel done in 2016 which showed polyreactivity to foods. In 2019, I was diagnosed with autoimmune disease. I have labs and genetic testing to show this. I currently am polyreactive to almost all foods, critically low vitamin levels resulting in malnutrition, dysbiosis, extreme fatigue.
Age: 27.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, TYP, TYP
Symptoms: Gastrooesophageal reflux disease, Laboratory test abnormal, Malnutrition, Metabolic function test, Nausea
Clinical narrative: In 2015, I started having gastrointestinal issues, diagnosed as GERD, out of nowhere. Symptoms included intense burning in the stomach, diarrhea, and rapid weight loss and fatigue. For the next five years, I continued to worsen, symptoms got worse to include nausea with every meal. I had a food sensitivity panel done in 2016 which showed polyreactivity to foods. In 2019, I was diagnosed with autoimmune disease. I have labs and genetic testing to show this. I currently am polyreactive to almost all foods, critically low vitamin levels resulting in malnutrition, dysbiosis, extreme fatigue.
Age: 27.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, TYP, TYP
Symptoms: Stool analysis abnormal, Weight decreased
Clinical narrative: In 2015, I started having gastrointestinal issues, diagnosed as GERD, out of nowhere. Symptoms included intense burning in the stomach, diarrhea, and rapid weight loss and fatigue. For the next five years, I continued to worsen, symptoms got worse to include nausea with every meal. I had a food sensitivity panel done in 2016 which showed polyreactivity to foods. In 2019, I was diagnosed with autoimmune disease. I have labs and genetic testing to show this. I currently am polyreactive to almost all foods, critically low vitamin levels resulting in malnutrition, dysbiosis, extreme fatigue.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Injection site swelling, Local reaction
Clinical narrative: Severe inflammation. Stayed a localized reaction, but stayed for days. I have pictures of left thigh 3 days after injection...while it is still extremely swollen. It started to fade on day 4 and was mostly back to normal by day 5. I didn't quite know what to put under vaccine (item 17), but this is what was on his medical record: influenza vaccine quad (FLUZONE/FLUARIX) (6 months and older)(PF) I do not know if this was the result of the vaccine itself or the person administering it (my husband was present during the immunization), but I would like to avoid a reaction like this in the future. Please contact me for pictures if interested/able.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: patient called pharmacy 04/20/2020 wanting to know when she received her Tetanus shot.  She was having ongoing pain in right shoulder and upper arm swelling and thought it might be due to the shot she received back in November 2019.  She said her primary care physician told her to call the pharmacy.  She has not been evaluated by a medical professional at this time.  Patient does not want to go to physician office due to current covid-19 pandemic.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: redness, swelling hot on the injection site PAIN
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Loss of personal independence in daily activities, Pain, Vaccine positive rechallenge
Clinical narrative: Felt like I had the flu for 2 days. Tired & achey. Couldn't get anything done. Both times of shots. Lost 4 days of productive time. 1st shot - 9-5-19 2nd shot 2-28-20
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Computerised tomogram head, Electroencephalogram, Laboratory test, Rash
Clinical narrative: Rash on Left flank. frequent seizures starting one week after vaccination. Joint pain starting 2 days after vaccination.
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Seizure
Clinical narrative: Rash on Left flank. frequent seizures starting one week after vaccination. Joint pain starting 2 days after vaccination.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: HIVES ON THE ABDOMEN AND EXTREMITIES (ARM) PATIENT WAS GIVEN DIPHENHYDRAMINE 8ML (1520)
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Haematoma, Syncope
Clinical narrative: Syncope after vaccinations, unwitnessed. Pt sustained 3x3cm hematoma to (R) frontal. Vital signs stable. Follow up scheduled.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Pruritus, Urticaria
Clinical narrative: ErythemaMultiform, UrticariaPruritus & ERYTHEMA; PRURITUS
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Pain, Swelling
Clinical narrative: & pain, swelling, "rock hard"
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dysstasia, Electromyogram, Fall, Hypersensitivity, Loss of control of legs
Clinical narrative: Leg muscles very weak and painful. Walking is difficult but not impossible. Very difficult rising from a chair. Fell 4 times (no injuries). Both hands swollen and painful which might be from rotator cuff tears. Have been to 5 doctors over several months with many tests. The clinic should have all my records
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Leg muscles very weak and painful. Walking is difficult but not impossible. Very difficult rising from a chair. Fell 4 times (no injuries). Both hands swollen and painful which might be from rotator cuff tears. Have been to 5 doctors over several months with many tests. The clinic should have all my records
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Gait disturbance, Laboratory test, Muscular weakness, Myalgia
Clinical narrative: Leg muscles very weak and painful. Walking is difficult but not impossible. Very difficult rising from a chair. Fell 4 times (no injuries). Both hands swollen and painful which might be from rotator cuff tears. Have been to 5 doctors over several months with many tests. The clinic should have all my records
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Leg muscles very weak and painful. Walking is difficult but not impossible. Very difficult rising from a chair. Fell 4 times (no injuries). Both hands swollen and painful which might be from rotator cuff tears. Have been to 5 doctors over several months with many tests. The clinic should have all my records
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: body aches, occasional chills, slight tension headache and lethargy lasting 8 days from time of vaccination. symptoms self resolved without further intervention. reported by patient to Dr.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Lethargy, Pain, Tension headache
Clinical narrative: body aches, occasional chills, slight tension headache and lethargy lasting 8 days from time of vaccination. symptoms self resolved without further intervention. reported by patient to Dr.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Drug effective for unapproved indication, Therapeutic response unexpected
Clinical narrative: drug use for unapproved indication; wart resolution following HPV vaccination; Literature Report:   Information has been received from the authors in a published literature article, refers to a 9 year old female patient with with a 4-month history of two 2-3 mm warts (verruca vulgaris) on the right 1st and 5th fingers. The patient's medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot#, expiration date, and indication were not provided) for prophylaxis. Within one month of the second vaccination, the warts completely regressed with no recurrence noted 9 months after clearance and the patient's hands showed complete clearance (drug effective for unapproved indication).   The authors stated that several reports showed significant reduction or complete clearance of persistent warts with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) vaccine.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: titer levels were too low; This spontaneous report has been received from a pharmacist referring to a 16 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.         On an unknown date, the patient had hepatitis B titers done and the titer levels did not meet criteria and were too low (hepatitis b surface antibody negative). At the reporting time, the outcome of hepatitis b surface antibody negative was unknown. The causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). The patient's pertinent medical history and drug reactions or allergies were not provided.   On 09-APR-2020, unspecified doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), lot # S031703 with expiration date 06-APR-2021 underwent a temperature excursion from 5.4 to 8.3 °F during 45 minutes as recorded by the digital data logger. Also the unspecified doses underwent previous temperature excursions on an unspecified dates.  On 10-APR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031703, expiration date 06-APR-2020, for prophylaxis (strength, dose, frequency and anatomical location were not provided). No adverse effects were reported.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report was received from a pharmacist (PVX2019-572) on 04-Mar-2019. The report described an adult female consumer who "did not take Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer did not take Vivotif according to the schedule. The doses were taken on 25-Feb-2019, 27-Feb-2019, 02-Mar-2019, and 03-Mar-2019, respectively. Also, she was leaving to an endemic area on coming Friday.  The action taken with Vivotif with respect to the event "did not take Vivotif according to schedule" was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK ALL THE DOSES ON CONSECUTIVE DAYS; This case (PVX2019-2200) was received from a consumer on 28-Aug-2019. It described a male consumer who "took all the doses on consecutive days" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took all the doses of Vivotif on consecutive days, last week. He stated that he would be travelling on 11-Oct-2019.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of reported events was unknown.  Company's Comment: The causality of the event "took all the doses on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all the doses on consecutive days" was considered as not applicable.
Sex: F
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 female 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-PVX201901-000030:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: TOOK TWO DOSES IN A ROW; TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a caregiver (PVX2019-318) on 04-Feb-2019. The report describes a male consumer who "took two doses in a row" and "took unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took two doses in a row. The doses were taken as 18-Jan-2019, 19-Jan-2019, 21-Jan-2019, and 23-Jan-2019. The caregiver also stated that her son might have left Vivotif unrefrigerated for more than 24 hours after he completed his first dose of Vivotif.  The action taken with Vivotif with respect to the events "took two doses in a row" and "took unrefrigerated doses" was not applicable.  The clinical outcome of the events "took two doses in a row" and "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two doses in a row" and "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" and "took unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED TO TAKE THIRD CAPSULE ON TIME; This spontaneous case report was received from a consumer (PVX2019-327) on 05-Feb-2019. The report describes a male consumer who "missed to take third capsule on time". The consumer was receiving Vivotif capsule for an unknown indication.  It was reported that the consumer missed to take the third capsule according to schedule and took it a day later. The doses were taken on 28-Jan-2019, 30-Jan-2019, and 02-Feb-2019 respectively.  The action taken with Vivotif with respect to the event "missed to take third capsule on time" was not applicable.  The clinical outcome of the event "missed to take third capsule on time" was unknown.  Company's Comment: The causality of the event "missed to take third capsule on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third capsule on time" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK THE FIRST DOSE OF VIVOTIF IMMEDIATELY AFTER EATING; A spontaneous case report was received from a caregiver on 19-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000134 (PVX2019-457; husband) and PVX201902-000135 (PVX2019-458, daughter) were created and cross-linked in the database.  The report describes a 46-year-old male consumer who "took the first dose of Vivotif immediately after eating". 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 immediately after eating on 19-Feb-2019.  The action taken with Vivotif with respect to the event "took the first dose of Vivotif immediately after eating" was not applicable.  The clinical outcome of the event "took the first dose of Vivotif immediately after eating" was unknown.  Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000135:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a pharmacist (PVX2019-447) on 18-Feb-2019.The report describes a 39-year-old female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003241 and expiry date: Nov 2019) for typhoid fever prophylaxis.   It was reported that the consumer took the first unrefrigerated dose of Vivotif on 14-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 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: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE ON DAY 7; This spontaneous case report was received from a pharmacist (PVX2019-487) on 22-Feb-2019. The report described a female consumer who "took third dose on day 7". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the third dose of Vivotif on day 7. The doses were taken on day 1, day 3, and day 7 respectively.  The action taken with Vivotif with respect to the event "took third dose on day 7" was not applicable.  The clinical outcome of the event "took third dose on day 7" was unknown.  Company's Comment: The causality of the event "took third dose on day 7" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 7" 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 (PVX2019-562) on 04-Mar-2019. It describes a 20-year-old adult female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one capsule on every other day; lot number: 3003240) for typhoid prophylaxis.  It was reported that the consumer took the first dose of Vivotif on 03-Mar-2019 that was left unrefrigerated for 48 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: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TWO TWO DOSES IN A ROW; This spontaneous case report was received from a nurse (PVX2019-593) on 06-Mar-2019. It describes a female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer accidentally took two doses of Vivotif in a row.  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 storage error
Clinical narrative: TOOK UNREFRIGERATED COURSE OF VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-596) on 07-Mar-2019. It described a 35-year-old adult male consumer who "took unrefrigerated course of Vivotif". The consumer was receiving oral Vivotif (one capsule every other day; lot number: 3003241) for typhoid prophylaxis.  It was reported that the consumer did not refrigerate Vivotif after it was picked up on 16-Feb-2019 and complete course between 18-Feb-2019 to 24-Feb-2019.  The action taken with Vivotif with respect to the event "took unrefrigerated course of Vivotif" was not applicable.  The clinical outcome of the event "took unrefrigerated course of Vivotif" was unknown.  Company's Comment: The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO DOSES OF UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1516) was received from a consumer on 11-Jun-2019. It describes a 53-year-old adult female consumer who "took two doses unrefrigerated Vivotif ". The consumer was receiving oral Vivotif (one capsule every other day) (lot number: 3003272) for typhoid prophylaxis.  Case report: The consumer left Vivotif doses at room temperature (80 to 90-degree Fahrenheit). Then, she took two doses on 09-Jun-2019 and 11-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses unrefrigerated Vivotif " was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses unrefrigerated Vivotif " was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: WILL NOT BE  ABLE TO COMPLETE COURSE BEFORE TRAVEL; TOOK UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1517) was received from a consumer on 11-Jun-2019. It describes a 25-year-old adult male consumer who "took unrefrigerated Vivotif" and "will not be able to complete course before travel". He was receiving oral Vivotif (one capsule every other day) (lot no: 3003272) for typhoid prophylaxis.   Case report: The consumer left Vivotif doses outside the refrigerator, then after 6 to 7 hour, he took the first dose on 07-Jun-2019, which was good to use but then he took the second dose on 09-Jun-2019, which was unrefrigerated for 30 hours at 75 degree Fahrenheit. Also, he had a planned trip for one month on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" and "will not be able to complete course before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" and "will not be able to complete course before travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: TOOK EXPIRED COURSE OF VIVOTIF; This spontaneous case (PVX2019-1518) was received from a consumer on 11-Jun-2019. It describes a female consumer who "took expired course of Vivotif", while being on oral Vivotif (one capsule every other day) (expiry date: Apr 2019) for typhoid prophylaxis.   Case report: The consumer took expired doses of Vivotif. The first dose was taken on 04-Jun-2019 and the last dose was on 10-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took expired course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took expired course of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK THREE UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1520) was received from a pharmacist on 12-Jun-2019. It describes a female consumer who "took three unrefrigerated doses", while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif which were kept at room temperature since 07-May-2019. She took the first dose on 07-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event  "took three unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP, UNK
Symptoms: Contraindication to vaccination
Clinical narrative: TOOK MACROBID 48 HOUR BEFORE STARTING VIVOTIF; This spontaneous case (PVX2019-1529) was received from a consumer on 12-Jun-2019. It describes a 21-year-old female consumer who "took Macrobid 48 hour before starting Vivotif". The consumer was receiving Vivotif capsule for an unknown indication and Macrobid (nitrofurantoin) for urinary tract infection (UTI) prevention.  Case report: The consumer took Macrobid 48 hour before taking the first dose of Vivotif. She completed full course of Vivotif.  Action taken with Vivotif and Macrobid was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Macrobid 48 hour before starting Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Macrobid 48 hour before starting Vivotif" was considered as not applicable.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE DOSES ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1537) was received from a consumer on 10-Jun-2019. It describes a consumer who "did not take doses according to schedule". The consumer was receiving oral Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 01-Jun-2019, 04-Jun-2019, 07-Jun-2019, and 09-Jun-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take doses according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take doses according to schedule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES OF VIVOTIF ON THE SAME DAY; This spontaneous case was received from a nurse on 13-Jun-2019. It describes an 18-year-old male consumer who "took two doses of Vivotif on the same day". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif on the same day.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses of Vivotif on the same day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses of Vivotif on the same day" 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 (PVX2019-1540) was received from a caregiver on 13-Jun-2019. It describes a 14-year-old adolescent male consumer who "took two doses in a row", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 12-Jun-2019 and 13-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event 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: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1536) was received from a nurse on 13-Jun-2019. It describes a 21-year-old adult female consumer who "took two doses in a row", while being on Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 07-Jun-2019, 09-Jun-2019, 11-Jun-2019, and 12-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event 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: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 14-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes a 13-year-old adolescent female consumer who "missed the second dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 11-Jun-2019 and missed her second dose, which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event 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. US-PaxVax Berna GmbH-PVX201906-000497:
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED THE FOURTH DOSE; A spontaneous case report was received from a consumer on 14-Jun-2019 for four consumer.  Based on the information obtained from the consumer, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes an 11-year-old child male consumer who "missed the fourth dose", while being on Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 07-Jun-2019 and missed his fourth dose which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000497:
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED THE FOURTH DOSE; A spontaneous case report was received from a caregiver on 14-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes a 9-year-old child female consumer who "missed the fourth dose", while being on Vivotif for an unknown indication.  Case report: The consumer took first dose of Vivotif on 07-Jun-2019 and missed her fourth dose which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the fourth dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000497:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 14-year-old adolescent male consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003277) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and missed to take the second dose, which was due on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event 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. US-PaxVax Berna GmbH-PVX201906-000506: US-PaxVax Berna GmbH-PVX201906-000507: US-PaxVax Berna GmbH-PVX201906-000508:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 10-year-old female child consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003275) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and missed to take the second dose, which was due on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event 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. US-PaxVax Berna GmbH-PVX201906-000505:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 13-year-old adolescent male consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003277) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and missed to take the second dose which was due on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event 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. US-PaxVax Berna GmbH-PVX201906-000505:
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF EVERY DAY INSTEAD OF EVERY OTHER DAY; This spontaneous case (PVX2019-1578) report was received from a pharmacist on 18-Jun-2019. It describes a consumer who "took Vivotif every day instead of every other day". The consumer was receiving Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took Vivotif doses every day instead of every other day.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif every day instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif every day instead of every other day" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: MISSED TO TAKE THIRD AND FOURTH DOSE ON SCHEDULE; A spontaneous case report was received from a nurse on 19-Jun-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201906-000516 (PVX2019-1598; husband) and PVX201906-000517 (PVX2019-1599, wife) were created and cross-linked in the database.  This case describes a 57-year-old adult female consumer who "missed to take third and fourth dose on schedule", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first two dose of Vivotif on 03-Jun-2019 and 05-Jun-2019. Then, she went to a non-endemic zone trip from 07-Jun-2019 to 17-Jun-2019. Hence, did not take remaining two doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.   Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000516:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1596) report was received from a caregiver on 19-Jun-2019. It describes a 21-year-old adult female consumer who "took full unrefrigerated course of Vivotif". She was receiving Vivotif for an unknown indication.  Case report: The consumer took full course of Vivotif on unknown dates, but never refrigerated it.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took full unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took full unrefrigerated course of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product administration error, Product storage error
Clinical narrative: TOOK FOUR UNREFRIGERATED DOSES OF VIVOTIF; TOOK VIVOTIF RIGHT AFTER EATING; This spontaneous case report (PVX2019-1607) was received from a caregiver on 20-Jun-2019. It describes a male consumer who "took four unrefrigerated doses of Vivotif" and also he "took Vivotif right after eating". He was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took all four unrefrigerated doses of Vivotif. He also took Vivotif right after eating. He had a planned trip.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" and also he "took Vivotif right after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" and also he "took Vivotif right after eating" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK FOUR UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case (PVX2019-1634) was received from a caregiver on 24-Jun-2019. It describes a female consumer who "took four unrefrigerated doses of Vivotif". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took all unrefrigerated doses of Vivotif. She took the last dose on 23-Jun-2019. She stated that she would be leaving for an endemic area on 05-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP, UNK
Symptoms: Contraindication to vaccination
Clinical narrative: STARTED ANTIBIOTICS THE DAY AFTER THE FIRST DOSE OF VIVOTIF; This spontaneous case (PVX2019-1655) was received from a caregiver on 25-Jun-2019. It describes a female consumer who "started antibiotics the day after the first dose of Vivotif". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis and oral amoxicillin (500 mg capsule; three times a day) for dental procedure.  Case report: The consumer took a dose of Vivotif and a day after, she started taking amoxicillin for a planned dental procedure.  Action taken with Vivotif and amoxicillin was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "started antibiotics the day after the first dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "started antibiotics the day after the first dose of Vivotif" was considered as not applicable.