chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Faeces discoloured, Fall, Gastrooesophageal reflux disease, Head banging
Clinical narrative: The section above is hard to answer because he was given a lot of vaccines in a short amount of time. 5/5/2016: HIB; pneumococcal PCV; Dip, DTap, DT, Td; Poliomyelitis, Hepatitis B. He had many more 2 months later. I had no idea that his health problems were caused by the vaccinations and I completely trusted the doctor, he acted like all of his symptoms were normal. its been years later and I'm just now finding out that I can report his injuries.  He initially had a fever, was lethargic, and was very fussy, he screamed and cried a lot. He soon developed a very severe case of colic, was projectile vomiting, and had acid reflux-this went on for 2 years. the doctor acted like it wasn't a big deal and prescribed a corn based formula and acid reflux medication, he said he would eventually grow out of it but my son was misreable and in a tremendous amount of pain. all he did was scream at the top of his lungs for the first 2 years of his life. he wouldn't keep eye contact, he always had diarrhea and it was a very foul smell, strange texture, and color. When he was old enough to sit up and play he always wanted to play alone, he didn't talk, he often hit his head many times on the floor or objects and ate gravel and dirt. when he was old enough to walk he would constantly fall and hit his head. showed signs of bein autistic
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Head injury, Irritability, Lethargy, Pica, Pyrexia
Clinical narrative: The section above is hard to answer because he was given a lot of vaccines in a short amount of time. 5/5/2016: HIB; pneumococcal PCV; Dip, DTap, DT, Td; Poliomyelitis, Hepatitis B. He had many more 2 months later. I had no idea that his health problems were caused by the vaccinations and I completely trusted the doctor, he acted like all of his symptoms were normal. its been years later and I'm just now finding out that I can report his injuries.  He initially had a fever, was lethargic, and was very fussy, he screamed and cried a lot. He soon developed a very severe case of colic, was projectile vomiting, and had acid reflux-this went on for 2 years. the doctor acted like it wasn't a big deal and prescribed a corn based formula and acid reflux medication, he said he would eventually grow out of it but my son was misreable and in a tremendous amount of pain. all he did was scream at the top of his lungs for the first 2 years of his life. he wouldn't keep eye contact, he always had diarrhea and it was a very foul smell, strange texture, and color. When he was old enough to sit up and play he always wanted to play alone, he didn't talk, he often hit his head many times on the floor or objects and ate gravel and dirt. when he was old enough to walk he would constantly fall and hit his head. showed signs of bein autistic
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Screaming, Speech disorder, Vomiting projectile
Clinical narrative: The section above is hard to answer because he was given a lot of vaccines in a short amount of time. 5/5/2016: HIB; pneumococcal PCV; Dip, DTap, DT, Td; Poliomyelitis, Hepatitis B. He had many more 2 months later. I had no idea that his health problems were caused by the vaccinations and I completely trusted the doctor, he acted like all of his symptoms were normal. its been years later and I'm just now finding out that I can report his injuries.  He initially had a fever, was lethargic, and was very fussy, he screamed and cried a lot. He soon developed a very severe case of colic, was projectile vomiting, and had acid reflux-this went on for 2 years. the doctor acted like it wasn't a big deal and prescribed a corn based formula and acid reflux medication, he said he would eventually grow out of it but my son was misreable and in a tremendous amount of pain. all he did was scream at the top of his lungs for the first 2 years of his life. he wouldn't keep eye contact, he always had diarrhea and it was a very foul smell, strange texture, and color. When he was old enough to sit up and play he always wanted to play alone, he didn't talk, he often hit his head many times on the floor or objects and ate gravel and dirt. when he was old enough to walk he would constantly fall and hit his head. showed signs of bein autistic
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death
Clinical narrative: Was seen in the morning at my office for 2 month check, exam normal.  Gave immunizations at the end of the visit.  Was called by ER at about 1:30 PM that the patient arrived in the ER deceased.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Ear infection, Malaise
Clinical narrative: The above question is hard to answer because there were a lot of vaccinations given and its been a long time since she received them. I do know that she didn't seem well after the vaccinations. she has suffered from stomach pain, chronic ear infections. and was always sick- all of which have stopped since we stopped vaccinating. the pediatrician bullied me into vaccinating her while I suffered from severe postpartum depression. she received all of the vaccination up until 9/2017
Age: 19.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the pediatric dose of Hepatitis A in error, he was 19 years of age so should have received adult dose. Talked to the Department of Health, they said to treat it as an invalid dose and to repeat the dose.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: C-reactive protein, Enthesopathy, Juvenile idiopathic arthritis, Laboratory test, Red blood cell sedimentation rate
Clinical narrative: Juvenile Idiopathic Arthritis, Enthesitis related.
Age: 0.25
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: wrong vaccine (PCV-13 was intended)
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Feeling hot, Hyperaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Just reporting the side effects I had from getting the 2nd injection of the Shingrix vaccine. I woke up at 4am, 12 hours after receiving the vaccine, feeling hot , like I was becoming sick. It took several hours before I was able to get back to sleep for a bit. When I woke, I could barely get out of bed. I felt very fatigued and tired. Once I got up I felt muscle aches , tired, and feverish.  I did eat breakfast, took Ibuprofen 400mg, and rested, then took my temperature and it was 100.5 degrees F about 11am.  I rested most of the day, my right arm was very sore.  By late afternoon, my fever went away. The site on my arm got red. The next day the arm was redder and painful, like a rash about the size of a baseball.  The day after that it was still red and painful, but a bit better. Today, day 3 the rash is about gone, but still is sensitive to the touch and feels somewhat painful. I think it will be okay by tomorrow.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Malaise, Mobility decreased, Pyrexia
Clinical narrative: Just reporting the side effects I had from getting the 2nd injection of the Shingrix vaccine. I woke up at 4am, 12 hours after receiving the vaccine, feeling hot , like I was becoming sick. It took several hours before I was able to get back to sleep for a bit. When I woke, I could barely get out of bed. I felt very fatigued and tired. Once I got up I felt muscle aches , tired, and feverish.  I did eat breakfast, took Ibuprofen 400mg, and rested, then took my temperature and it was 100.5 degrees F about 11am.  I rested most of the day, my right arm was very sore.  By late afternoon, my fever went away. The site on my arm got red. The next day the arm was redder and painful, like a rash about the size of a baseball.  The day after that it was still red and painful, but a bit better. Today, day 3 the rash is about gone, but still is sensitive to the touch and feels somewhat painful. I think it will be okay by tomorrow.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Fatigue, Irritability, Rash
Clinical narrative: Rash, tired, fussiness
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Headache, Inflammation, Pain
Clinical narrative: baseball size inflamation, bright res and sore/painful, headache, lack of energy, rash on upper chest below neck.  Today (April 13) arm is still swollen, red and sore and still have rash.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: baseball size inflamation, bright res and sore/painful, headache, lack of energy, rash on upper chest below neck.  Today (April 13) arm is still swollen, red and sore and still have rash.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was giving this dosage, however this strength is for 4-6 years of age normal pediatric nurse is out on Quarentine due to COVID-19
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever & Rash
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Cellulitis, Erythema
Clinical narrative: Drop in Blood sugars, cellulitis of Left Arm Stop Glipizide, treating with antibiotics cephalexin 500mg every 6 hours, ceftriaxone inj. 1 gram
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme
Clinical narrative: ErythemaMultiform
Age: 86.0
Sex: M
Vaccine: PNC, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: & Swelling; Erythema
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: & Guillain Barre
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Pyrexia
Clinical narrative: Fever & Pain, discomfort
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Rash, Swelling face, Swollen tongue
Clinical narrative: Swollen Lips at first-then swollen tongue-then swollen jaw + rashes on left thigh and right thigh and on upper right arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb discomfort
Clinical narrative: Pt received 2nd dose of Shingrix on 2/15 (Sat) on 2/16/2020 she noted erythema of (L) arm 1-2 Cm below inject site & some mild discomfort. Has been applying ice & Ibuprofen without change. No fever. Seen by MD 2/18 area was marked & advised to continue with ice and not to take any fever reducing medication to ensure she is not having fevers
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: I got the shingles right after shot- & arm pain - really bad could not get my family Dr. to help me with the Shingrix.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Eye pruritus
Clinical narrative: & Itching of eye
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Chills, Nausea, Vomiting
Clinical narrative: Nausea Vomiting & chills, weakness
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: swelling of lt upper extremity - improving rash improving.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient described small vesicles, some the size of a nickel along the trigeminal nerve on her face. This occurred 2 days after vaccine. Her physician prescribed oral and topical anti-viral medication on 4-6-20. Conditions resolved.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: her arm was itchy, painful, tender and red; her arm was itchy, painful, tender and red; her arm was itchy, painful, tender and red; swelling in her left upper arm; This spontaneous report was received from a physician via company and refers to two patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant medications was reported.  On an unknown dates, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S021740, expiration date 25-MAR-2021 (strength, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, both patients had significant swelling in the upper arm after the injection. The outcome of the event was unknown. The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.   Follow up information was received from practice manager on 13-APR-2020 and refers to one of the patients, who was 75 year-old female. On 25-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left upper arm. On the night of 25-SEP-2019, she experienced swelling in her left upper arm. On 26-SEP-2019 (also reported as the next morning), the swelling was worse and her arm was itchy, painful, tender and red. On that day, she went back to see the physician as an emergency visit and was treated with methylprednisolone (MEDROL). The patient was advised to call the physician if her condition worsened. No call was received and a follow-up phone from the physician was placed to the patient 3 weeks later. The patient stated that her upper arm was better after treatment with methylprednisolone (MEDROL) and she was doing better, but not completely better. The outcome of the events was recovering/resolving. Additional information was not expected.  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon receipt of follow-up information it was determined that the case is now valid because the patients' identifiers were received.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2004USA003682:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site papule, Injection site pruritus, Papule
Clinical narrative: Patient came back to the office on 4/9/20 for a rash he was experiencing near the injection site and behind his right ear - see Temporary VAERS e-report #190503 . Treated with hydroxyzine and loratadine. Patient returned today, 4/14/20, with rash (clusters of erythematous papules and some vesicles) on his torso and in his axilla. The rash is both pruritic and burns.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient came back to the office on 4/9/20 for a rash he was experiencing near the injection site and behind his right ear - see Temporary VAERS e-report #190503 . Treated with hydroxyzine and loratadine. Patient returned today, 4/14/20, with rash (clusters of erythematous papules and some vesicles) on his torso and in his axilla. The rash is both pruritic and burns.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Injection site rash, Rash papular, Rash pruritic
Clinical narrative: Patient came back to the office on 4/9/20 for a rash he was experiencing near the injection site and behind his right ear - see Temporary VAERS e-report #190503 . Treated with hydroxyzine and loratadine. Patient returned today, 4/14/20, with rash (clusters of erythematous papules and some vesicles) on his torso and in his axilla. The rash is both pruritic and burns.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; One patient was administered improperly stored PROQUAD; This spontaneous report has been received from a registered nurse referring to a patient with 13 months old of unknown gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.    On 31-MAR-2020 the child was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot # S022917, expiration date 19-JAN-2021) subcutaneous, as prophylaxis (concentration, frequency, dose, route of administration were not reported).  The use of sterile diluent (MERCK STERILE DILUENT) was reported as "properly stored".  It was informed that the temperature excursion was -14.1 celsius degrees in a time frame of 26 minutes, there was no previous temperature excursion and a digital data logger was involved.  No additional adverse event was provided by the reporter.
Sex: F
Vaccine: TYP
Symptoms: Circumstance or information capable of leading to medication error, Dysphagia, Inappropriate schedule of product administration, Oral administration complication
Clinical narrative: WILL NOT BE COMPLETING DOSES ONE WEEK PRIOR TO TRAVEL TO HONDURAS; DIFFICULTY IN SWALLOWING THE CAPSULE; CHEWED THE CAPSULE; This spontaneous case report was received from nurse (PVX2019-693) on 21-Mar-2019. It described a 10-year-old female consumer who had "difficulty in swallowing the capsule" and "chewed the capsule". The consumer was receiving Vivotif capsule for an unknown indication. The consumer "will not be completing doses one week prior to travel".  It was reported that the consumer tried to take the first dose of Vivotif on 19-Mar-2019 but she was not able to swallow the capsule. However, she managed to take the dose by chewing it up. It was additionally reported that she had a planned trip within 1.5 weeks.  The action taken with Vivotif with respect to the events "difficulty in swallowing the capsule", "chewed the capsule", and "will not be completing doses one week prior to travel" was not applicable.  The clinical outcome of the events "difficulty in swallowing the capsule", "chewed the capsule", and "will not be completing doses one week prior to travel" was unknown.  Company's Comment: In this case, it was reported that a 10-year-old child female consumer had "difficulty in swallowing the capsule" and "chewed the capsule" of Vivotif. The causality of the both the events is not related with Vivotif vaccine. The causality of the event "will not be completing doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 10-year-old child female consumer had "difficulty in swallowing the capsule" and "chewed the capsule" of Vivotif. The causality of the both the events is not related with Vivotif vaccine. The causality of the event "will not be completing doses one week prior to travel" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED THE LAST DOSE; This spontaneous case (PVX2019-942) was received from a consumer on 22-Apr-2019. It describes a 24-year-old female consumer who was "missed the last dose". The consumer was receiving Vivotif (lot no: 3003242) for an unknown indication. 3  Case report: The consumer took three doses of Vivotif and then went out of town. She missed the last dose, which was due on 21-Apr-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed the last dose" was unknown.  Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: TOOK FOUR DOSES OF EXPIRED VIVOTIF; This spontaneous case report (PVX2019-1676, PTC-000067) was received from a pharmacist on 27-Jun-2019. It describes a female consumer who "took four doses of expired Vivotif" (expired product administered), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took all the expired doses of Vivotif, two weeks ago. The doses were expired in April.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-2701) was received from a consumer on 30-Oct-2019. It described a 29-year-old female consumer who "took unrefrigerated doses of Vivotif" (PT: Product storage error), while being on Vivotif for typhoid fever.  Case report: The consumer took all doses of Vivotif that was unrefrigerated. She took the last dose on 25-Oct-2019.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company Comment: The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF EVERY DAY INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-2799) was received from a nurse on 13-Nov-2019. It described a male consumer who "took Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took Vivotif every day instead of every other day.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a patient took Vivotif every day instead of every other day of an unknown indication (Inappropriate schedule of product administration). The causality of the event is assessed as not related.; Sender's Comments: It was reported that a patient took Vivotif every day instead of every other day of an unknown indication (Inappropriate schedule of product administration). The causality of the event is assessed as not related.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT SKIP A DAY BETWEEN SECOND AND THIRD DOSE; This spontaneous case report (PVX2019-2801) was received from a nurse on 13-Nov-2019. It described a male consumer who "did not skip a day between second and third dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer started Vivotif on 08-Nov-2019. He took his second dose according to schedule on 10-Nov-2019 but took the third dose on 11-Nov-2019. The nurse reported that the consumer was in his 40's age.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown. . Company Comment: It was reported that a patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). The causality of the event is assessed as not related to Vivotif.; Sender's Comments: It was reported that a patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). The causality of the event is assessed as not related to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2838) was received from a pharmacist on 16-Nov-2019. It described a consumer who "took unrefrigerated Vivotif" (PT: Product storage error). She was receiving Vivotif for an unknown indication.  Case report: The consumer took Vivotif that was kept out of the refrigerator for weeks.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: It was reported that a patient took unrefrigerated Vivotif which was kept out of the refrigerator for weeks (Product storage error). The causality of the event is assessed as not related to Vivotif. .; Sender's Comments: It was reported that a patient took unrefrigerated Vivotif which was kept out of the refrigerator for weeks (Product storage error). The causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: SKIPPED TWO DAYS BEFORE TAKING THIRD DOSE; This spontaneous case report (PVX2019-2839) was received from a nurse on 18-Nov-2019. It described an adult female consumer who "skipped two days before taking dose 3" (PT: Inappropriate schedule of product administration) while being on Vivotif for an unknown indication.  Case report: The consumer took the first and the second dose of Vivotif according to schedule. The doses were taken on 12-Nov-2019 and 14-Nov-2019, respectively. Later, she skipped two days before taking the third dose. The dose was taken on 17-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient took second dose of Vivotif as per the schedule and skipped two days before taking the third dose (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A patient took second dose of Vivotif as per the schedule and skipped two days before taking the third dose (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Sex: F
Vaccine: TYP, UNK
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: STARTED MINOCYCLINE THEN STARTED VIVOTIF; This spontaneous case report (PVX2019-2841) was received from a nurse on 18-Nov-2019. It described a 21-year-old adult female consumer who "started minocycline then started Vivotif" (PT: Labelled drug-drug interaction medication error). She was receiving Vivotif for an unknown indication and Minocycline for acne.  Case report: The consumer received Vivotif in July 2019 but did not start her vaccine yet. It was reported that she started taking minocycline for acne on an unknown date and then she started taking Vivotif on 17-Nov-2019.  Action taken with Vivotif and Minocycline with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient who was on minocycline for acne took a dose of Vivotif (Labelled drug-drug interaction medication error). Antibiotics (Minocycline) has a potential to inhibit the growth of the vaccine strain and may result in attenuation of the immune response. The event is labelled as per Agency. Considering the case information and the nature of the event, the causality of the event Labelled drug-drug interaction medication error is assessed as not related to minocycline. ; Sender's Comments: A patient who was on minocycline for acne took a dose of Vivotif (Labelled drug-drug interaction medication error). Antibiotics (Minocycline) has a potential to inhibit the growth of the vaccine strain and may result in attenuation of the immune response. The event is labelled as per Agency. Considering the case information and the nature of the event, the causality of the event  Labelled drug-drug interaction medication error is assessed as not related to minocycline.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: DID NOT TAKE HIS SECOND AND THIRD DOSE; This spontaneous case report (PVX2019-2844) was received from a physician on 18-Nov-2019. It described an adult male consumer who "did not take his second and third dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 13-Nov-2019 and went away. The physician reported that the consumer missed the second dose of Vivotif, and he wanted that the consumer should continue the remaining doses every other day starting 18-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient forgot to take the second and third dose of Vivotif (missed dose). The causality of the event missed dose is not related to Vivotif.; Sender's Comments: A patient forgot to take the second and third dose of Vivotif (missed dose). The causality of the event missed dose is not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT SKIP A DAY BETWEEN SECOND AND THIRD DOSE; This spontaneous case report (PVX2019-2855) was received from a pharmacist on 19-Nov-2019. It described a female consumer who "did not skip a day between second and third dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: It was reported that consumer did not skip a day between the second and the third dose of Vivotif. She took doses on days 1, 3, and 4.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.; Sender's Comments: A patient did not skip a day between second and third dose of Vivotif (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product dose omission
Clinical narrative: TOOK ONLY ONE DOSE; This spontaneous case report (PVX2019-2856) was received from a pharmacist on 19-Nov-2019. It described an adult (18 to 22-year-old) male consumer who "took only one dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took only first dose of Vivotif on 14-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company comment: It was reported that a patient only took one dose of Vivotif (missed dose). Further detail of the event is limited.  Considering the nature of the event, the causality of the event missed dose is assessed as not related.; Sender's Comments: It was reported that a patient only took one dose of Vivotif (missed dose). Further detail of the event is limited.  Considering the nature of the event, the causality of the event missed dose is assessed as not related.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-670) on 18-Mar-2019. It described a 50-year-old female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took unrefrigerated doses of Vivotif. The first dose was taken on 10-Mar-2019 and the last dose on 16-Mar-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 storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-664) on 15-Mar-2019. It described an 11-year-old male consumer who "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 full course of unrefrigerated doses of Vivotif. The fourth dose was taken on 14-Mar-2019.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK FULL COURSE OF VIVOTIF WITH FOOD; This spontaneous case report was received from a nurse (PVX2019-689) on 21-Mar-2019. It described an adult female consumer who "took full course of Vivotif with food". The consumer was receiving Vivotif (one dose every other day) for typhoid prophylaxis.  It was reported that the consumer took all the doses of Vivotif with food.  The action taken with Vivotif with respect to the event "took full course of Vivotif with food" was not applicable.  The clinical outcome of the event "took full course of Vivotif with food" was unknown.  Company's Comment: The causality of the event "took full course of Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took full course of Vivotif with food" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSE; This spontaneous case report was received from a caregiver (PVX2019-703) on 22-Mar-2019. It described a 26-year-old adult male consumer who "took two unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid prophylaxis.  It was reported that the consumer took the first two doses of Vivotif on 15-Mar-2019 and 17-Mar-2019, respectively. Then, he left the doses unrefrigerated at room temperature and took the third and the fourth dose on 19-Mar-2019 and 21-Mar-2019, respectively.  The action taken with Vivotif with respect to the event "took two unrefrigerated doses" was not applicable.  The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK FOUR UNREFRIGERATED DOSE; This spontaneous case (PVX2019-731) was received from a pharmacist on 26-Mar-2019. It describes a female consumer who "took four unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took 4 unrefrigerated doses of Vivotif.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took four unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-736) was received from pharmacist on 27-Mar-2019. It describes a female adult consumer who "took unrefrigerated doses", while being on Vivotif for an unknown indication.  Case report: The consumer left Vivotif doses out of the fridge for 2 to 3 weeks and then took the full course of the vaccine.  Action taken with Vivotif 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
Clinical narrative: TOOK ONLY TWO DOSE; This spontaneous case (PVX2019-747) was received from a pharmacist on 27-Mar-2019. It describes a male consumer who "took only two dose", while being on Vivotif for an unknown indication.   Case report: The consumer took two doses of Vivotif and did not take any further dose for a week.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "took only two dose" was unknown.  Company's Comment: The causality of the event "took only two dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only two dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK DOSES ON DAY 1, 2 AND 4; This spontaneous case (PVX2019-734) was received from a nurse on 26-Mar-2019. It describes an adult female consumer who "took doses on day 1, 2 and 4", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer did not take Vivotif doses according to schedule. The doses were taken on day 1, day 2 and day 4.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took doses on day 1, 2 and 4" was unknown.  Company's Comment: The causality of the event "took doses on day 1, 2 and 4" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses on day 1, 2 and 4" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product dose omission
Clinical narrative: TOOK THREE UNREFRIGERATED DOSE; MISSED THE LAST DOSE; This spontaneous case (PVX2019-773) was received from a pharmacist on 29-Mar-2019. It describes a female consumer who "took three unrefrigerated dose" and "missed the last dose", while being on Vivotif for an unknown indication.   Case report: The consumer took three unrefrigerated doses of Vivotif and also missed the last dose.  Action taken with Vivotif was not applicable.   The clinical outcome of the events "took three unrefrigerated dose" and "missed the last dose" was unknown.  Company's Comment: The causality of the event "took three unrefrigerated dose" and "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated dose" and "missed the last dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 01-Apr-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201904-000254 (PVX2019-780; female) and PVX201904-000255 (PVX2019-781, male) were created and cross-linked in the database.  This case report describes a female consumer who "took two unrefrigerated doses", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took two doses of Vivotif, which was unrefrigerated for 48 to 72 hours at 68 degree Fahrenheit.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201904-000255:
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: DRANK COFFEE 30 TO 40 MINUTES AFTER TAKING VIVOTIF; This spontaneous case (PVX2019-791) was received from pharmacist on 02-Apr-2019. It describes a female consumer who "drank coffee 30 to 40 minutes after taking Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer drank coffee 30 to 40 minutes after taking the third dose of Vivotif on 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "drank coffee 30 to 40 minutes after taking Vivotif" was unknown.  Company's Comment: The causality of the event "drank coffee 30 to 40 minutes after taking Vivotif"  was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "drank coffee 30 to 40 minutes after taking Vivotif"  was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: FORGOT TO TAKE NEXT DOSES; This spontaneous case (PVX2019-797) was received from consumer on 02-Apr-2019. It describes a male consumer who "forgot to take next doses", while being on Vivotif for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 28-Mar-2018 and then forgot to take the second dose till 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "forgot to take next doses" was unknown.  Company's Comment: The causality of the event "forgot to take next doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take next doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-836) was received from a consumer on 09-Apr-2019. It describes a 33-year-old female consumer who "took an unrefrigerated dose", while being on Vivotif for an unknown indication.   Case report: The consumer took an unrefrigerated dose of Vivotif on 09-Apr-2019.  Action taken with Vivotif 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: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-866) was received from a consumer on 11-Apr-2019. It describes a 38-year-old male consumer who "took two doses in a row", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took Vivotif doses in an inappropriate way. The doses were taken on day 1, 3, and day 4 (11-Apr-2019).  Action taken with Vivotif 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: Incomplete course of vaccination
Clinical narrative: FORGOT TO TAKE THE FOURTH DOSE; This spontaneous case (PVX2019-874) was received from a nurse on 12-Apr-2019. It describes an adult male consumer who "forgot to take the fourth dose", while being on Vivotif capsule for an unknown indication.  Case report: The consumer took three doses of Vivotif but forgot to take the fourth dose. It had been 5 days since the last dose was scheduled.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "forgot to take the fourth dose" was unknown.  Company's Comment: The causality of the event "forgot to take the fourth dose"  was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the fourth dose"  was considered as not applicable.
Sex: M
Vaccine: TYP, UNK
Symptoms: Contraindication to vaccination, Skin laceration
Clinical narrative: CUT ON HIS TOE; TOOK CEPHALEXIN WHILE ON VIVOTIF; This spontaneous case (PVX2019-924) was received from a consumer on 18-Apr-2019. It describes a 73-year-old elderly male consumer who had a "cut on his toe", after the administration of Vivotif for an unknown indication. He also "took cephalexin while on Vivotif" for toe injury.  Case report: The consumer took Vivotif doses on 12-Apr-2019, 14-Apr-2019, 16-Apr-2019, and 18-Apr-2019, respectively. He had a cut on his right foot's big toe either on 15-Apr-2019 or 16-Apr-2019 because of the accident either by a podiatrist at a routine foot care checkup or because of his golf shoes. Later, on 16-Apr-2019 he went to a doctor for the cut. Doctor prescribed cephalexin for the injury. He took cephalexin (500 mg) on 17-Apr-2019. Cephalexin course was a week long and he had a planned trip on 28-Apr-2019.  Action taken with Vivotif with respect to the event "cut on his toe" was dosage maintained while with respect to the event "took cephalexin while on Vivotif" was not applicable.  Action taken with cephalexin with respect to the event "cut on his toe" and "took cephalexin while on Vivotif" was not applicable.  The clinical outcome of the events "cut on his toe" and "took cephalexin while on Vivotif" was unknown.  The reporter considered the event cut on his toe was unrelated to vaccine.  Company's Comment: The causality of the events "cut on his toe" and "took cephalexin while on Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment : The causality of the events  "cut on his toe" and "took cephalexin while on Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MISSED SECOND DOSE; This spontaneous case (PVX2019-955) was received from a pharmacist on 22-Apr-2019. It describes a female consumer who "missed second dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 19-Apr-2019, then she stored Vivotif in freezer, thus missed to take the second dose, which was due on 21-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed second dose" was unknown.  Company's Comment: The causality of the event "missed second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed second dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK 3 UNREFRIGERATED DOSES OF VIVOTIF; A spontaneous case report was received from a caregiver on 29-May-2019 for two consumers.  Based on the information obtained from a caregiver, two individual case safety reports PVX201905-000436 (PVX2019-1366; first daughter) and PVX201905-000437 (PVX2019-1367, second daughter) were created and cross-linked in the database.  This case describes a female consumer who "took 3 unrefrigerated doses of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif at 73 degree Fahrenheit and then, took three unrefrigerated doses. She took the first dose of Vivotif on 25-May-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 3 unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000436: