chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Muscle spasms
Clinical narrative: UPPER ABDOMINAL CRAMPS AND PAIN; This spontaneous case report (827576-1) was extracted through VAERS database on 06-Dec-2019. The case was reported by a consumer via health authority. It described a 49-year-old female consumer who had upper abdominal cramps and pain (PT: Abdominal pain), while being on oral Vivotif (lot number: 3003281) for an unknown indication.  Case report: The consumer took first dose of Vivotif on 07-Aug-2019. She had upper abdominal cramps and pain on 08-Aug-2019. It was reported that the cramps occur every 5-10 minutes and last for 1-2 minutes each.  Medical history included brain aneurysm.  Concomitant medication included multi vitamin, propranolol ER and Flowmax (tamsulosin).  Action taken with Vivotif with respect to the reported event was unknown.  The consumer had not recovered from the reported event.  Company's Comment: A consumer took the first dose of Vivotif and on the next day had abdominal crampy pains. Considering the potential of Vivotif to cause abdominal pain, the causality of the event is assessed as possible with Vivotif.; Sender's Comments: A consumer took the first dose of Vivotif and on the next day had abdominal crampy pains. Considering the potential of Vivotif to cause abdominal pain, the causality of the event is assessed as possible with Vivotif.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Incomplete course of vaccination, Influenza like illness, Pain
Clinical narrative: received dose 1 of Shingrix on August 15, 2019, and has yet to receive dose 2; flu like symptoms; joint pain; fever; fatigue; body ache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 15th August 2019, 4 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, joint pain, fever, fatigue and general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, joint pain, fever, fatigue and general body pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, fever, fatigue and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient after 1st dose of Shingrix in the left arm and experienced flu like symptoms consisting of fatigue, joint pain, body aches, and fever. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: received dose 1 of Shingrix on August 15, 2019, and has yet to receive dose 2; flu like symptoms; joint pain; fever; fatigue; body ache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 15th August 2019, 4 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, joint pain, fever, fatigue and general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, joint pain, fever, fatigue and general body pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, fever, fatigue and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient after 1st dose of Shingrix in the left arm and experienced flu like symptoms consisting of fatigue, joint pain, body aches, and fever. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient consented to follow up.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Flatulence, Gastrointestinal sounds abnormal, Influenza like illness, Malaise
Clinical narrative: FELT OCCASIONAL LIGHT STOMACH GRUMBLING/ GASSY; NAUSEA; FLU LIKE SYMPTOMS; ABDOMINAL PAIN; This spontaneous case report (PVX2019-2353, PTC-000084) received from a consumer on 12-Sep-2019. It describes a female patient who experienced abdominal pain (PT: Abdominal pain), nausea (PT: Nausea), flu like symptoms (PT: Influenza like illness) and felt occasional light stomach grumbling/gassy (PT: Flatulence), after administration of Vivotif (lot number: 3003285 and expiry date: Jun 2020), for an unknown indication.  Case report: The consumer took three doses of Vivotif on 08-Sep-2019, 10-Sep-2019, and 12-Sep-2019, respectively. After taking the first and second dose, she experienced abdominal pain and felt sick with flu like symptoms. She lied down at home and recovered on the same day. On 10-Sep-2019, she also became nauseous because she couldn't lie down at work. On 12-Sep-2019, she took ondansetron for nausea and ibuprofen for pain. Later, she did not feel any flu-like symptoms and did not feel nauseous. She stated she had some mild abdominal pain. Thus, she took two more doses of ondansetron. She reported she was only gassy later in the day, but it resolved by the end of the night.  Action taken with Vivotif with respect to the event was dosage maintained.  The consumer had recovered from the reported events on 13-Sep-2019.  Company's Comment: In this case, it was reported that a female consumer experienced abdominal pain, nausea, flu like symptoms and felt occasional light stomach grumbling/gassy following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, abdominal pain, nausea, flu like symptoms and flatulence are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer experienced abdominal pain, nausea, flu like symptoms and felt occasional light stomach grumbling/gassy following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.Also, abdominal pain, nausea, flu like symptoms and flatulence are labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: FELT OCCASIONAL LIGHT STOMACH GRUMBLING/ GASSY; NAUSEA; FLU LIKE SYMPTOMS; ABDOMINAL PAIN; This spontaneous case report (PVX2019-2353, PTC-000084) received from a consumer on 12-Sep-2019. It describes a female patient who experienced abdominal pain (PT: Abdominal pain), nausea (PT: Nausea), flu like symptoms (PT: Influenza like illness) and felt occasional light stomach grumbling/gassy (PT: Flatulence), after administration of Vivotif (lot number: 3003285 and expiry date: Jun 2020), for an unknown indication.  Case report: The consumer took three doses of Vivotif on 08-Sep-2019, 10-Sep-2019, and 12-Sep-2019, respectively. After taking the first and second dose, she experienced abdominal pain and felt sick with flu like symptoms. She lied down at home and recovered on the same day. On 10-Sep-2019, she also became nauseous because she couldn't lie down at work. On 12-Sep-2019, she took ondansetron for nausea and ibuprofen for pain. Later, she did not feel any flu-like symptoms and did not feel nauseous. She stated she had some mild abdominal pain. Thus, she took two more doses of ondansetron. She reported she was only gassy later in the day, but it resolved by the end of the night.  Action taken with Vivotif with respect to the event was dosage maintained.  The consumer had recovered from the reported events on 13-Sep-2019.  Company's Comment: In this case, it was reported that a female consumer experienced abdominal pain, nausea, flu like symptoms and felt occasional light stomach grumbling/gassy following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, abdominal pain, nausea, flu like symptoms and flatulence are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer experienced abdominal pain, nausea, flu like symptoms and felt occasional light stomach grumbling/gassy following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.Also, abdominal pain, nausea, flu like symptoms and flatulence are labelled as per CCDS.
Age: 39.0
Sex: F
Vaccine: HPV9, HPV4, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; on 3/19/2020, one female patient was administered expired but properly stored GARDASIL 9 (lot NO 17686 & expiration date 2/2/2020).; Patient Date of Birth: 7/18/1980, on 3/19/2020, one female patient was administered expired but properly stored GARDASIL 9; Lot Number N017686 is valid for GARDASIL formulation vial and not valid for GARDASIL 9.; This spontaneous report was received from a nurse practitioner referring to a 39 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided.     On 19-MAR-2020, the patient was vaccinated with expired but properly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot# N017686 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). However, lot# N017686 was valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (expiration date 02-FEB-2020; strength, route and dose detail were not provided) for prophylaxis (expired product administered, product lot number issue and product administered to patient of inappropriate age). No additional adverse effects were reported.
Sex: U
Vaccine: HEPA, PPV, RV5, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored; Did not experience any symptoms; This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown date, the patients were vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date of 17-OCT-2020 and lot # S032055 with expiration date of 09-NOV-2020 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis. Other suspect therapies included pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S012244 with expiration date of 09-FEB-2021 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis; rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S006053 with expiration date of 07-DEC-2020, and  lot # S006050 with expiration date of 12-DEC-2020 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis  The vaccines were exposed to a temperature above 47 °F, during a time frame of 40 minutes and 10 seconds. No previous temperature excursions reported. No adverse events reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies.     On 28-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), 1 dose, by oral route (lot # 1660112, expiration date 18-OCT-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine was stored at a temperature of 2 degree Celsius (1.28 Celsius) for a timeframe of 2 hours and 30 minutes (conflicting information reported as hours) with no previous temperature excursion as recorded by a data logger. No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient received a dose of improperly stored Rotateq; This spontaneous report has been received from a registered nurse referring to a patient of unknown age, gender and race. The patient's pertinent concurrent condition, medical history, drug reactions or allergies and concomitant therapies were not reported.  On 06-NOV-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally (indication, dose, frequency, batch/lot number and expiration date were not reported).   On 06-MAR-2020, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error), administered orally, lot number 1660942, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 06-FEB-2021, as prophylaxis (dose and frequency scheme were not reported). No additional adverse effect was reported. The administered vaccine experienced multiple temperature excursion below to 2 degrees Celsius (C) at 1.28 C. The time frame was reported as 2 hours and 30 hours. In addition, no previous temperature excursion was reported. Digital data logger was involved.
Sex: M
Vaccine: HPV9, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was administered the 2nd dose of GARDAISL 9 (Lot: R025729, Exp: 06/18/2021) in the series on 02/11/2020 and was then administered the 3rd dose of GARDAISL 9 (Lot: R025729, Exp: 06/18/2021) in the series on 03/13/2020.; This spontaneous report was received from a physician assistant referring to a 24 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 11-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R025729 with expiration date 18-JUN-2021; frequency and route were not reported) for prophylaxis. On 13-MAR-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R025729 with expiration date 18-JUN-2021) (inappropriate schedule of product administration). No adverse symptoms were reported. No additional information was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: R025729; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient received fone improperly stored of VARIVAX; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies.     On 26-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S028920, expiration date 16-SEP-2021 as prophylaxis (dosage schedule, anatomical location and route of administration, were not reported) (product storage error). The sterile diluent  used to reconstitute was stored properly.   The administered dose of the vaccine experienced a temperature excursion 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second and a previous temperature excursion 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of V ARIV AX; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided. On 25-FEB-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 16-SEP-2021 for prophylaxis (route of administration, dose and frequency were not reported). The vaccine was reconstituted with a properly stored sterile diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 to 14 degrees of Fahrenheit (F) (5.69 degrees of F), for 1 second. There was a previous temperature excursion: reported as from 6 to 14 degrees of F (5.81 degrees of F) for 28 minutes. No adverse effect reported. This is one of two reports received from the same reporter and concerning the same suspect therapy and the same event.; Sender's Comments:  US-009507513-2003USA008216:
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; A patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 23-MAR-2020, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # S029916, the expiration date: 12-JUN-2021 (dose and frequency were not reported) for prophylaxis. The patient experienced no symptoms (no adverse event).  The temperature reported was 17.7 °F (1cycle) with a time frame of 48 hours. No previously temperature excursion and the call were made due to data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 64 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On 11-JAN-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported). On 13-JUL-2013, as a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer shingles, including any and all of its sequelae. As a result of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The outcome of shingles was reported as not recovered/not resolved. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).     Shingles was considered to be disabling.
Sex: F
Vaccine: TYP
Symptoms: Nausea, Product storage error
Clinical narrative: NAUSEOUS; TOOK UNREFRIGERATED COURSE OF VIVOTIF; This spontaneous case (PVX2019-883) was received from a caregiver on 15-Apr-2019. It describes a female consumer who felt nauseous, after the administration of Vivotif (lot no: 3003242 and expiry date: Nov 2019) for typhoid prophylaxis. The consumer also "took unrefrigerated course of Vivotif".  Case report: The consumer took all four doses of Vivotif before she realized it should be kept refrigerated. It had also made her nauseous. She stated that she was not sure of the exact date of the nausea, but she estimated that it started after the first dose, and it resolved about two to three days after the last dose. She did not eat any unhygienic food or water intake.  The consumer had no medical history.  The consumer was not taking any concomitant or treatment medication   Action taken with Vivotif with respect to the event nauseous was dosage maintained while with the event "took unrefrigerated course of Vivotif" was not applicable.  The clinical outcome of the event nauseous was resolved while with the event "took unrefrigerated course of Vivotif" was unknown.  Company's Comment: In this case, it was reported that the consumer felt nauseous following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer felt nauseous following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "took unrefrigerated course of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: DIARRHEA; VOMITING; This spontaneous case (PVX2019-896) was received from a caregiver on 16-Apr-2019. It describes a female consumer who experienced diarrhea and vomiting, after the administration of Vivotif (lot no: 3003241) for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif on Wednesday, Friday, and Sunday. On 15-Apr-2019, she had diarrhea and vomiting after drinking coffee with creamer. Hence, she was not sure if it was related to Vivotif or not. She stated that she did not have any unhygienic food or water.  The consumer had no medical history.  Concomitant medication at the time of event included Blisovi 24 (norethindrone acetate and ethinyl estradiol) for regulating menstrual cycle.  The consumer had not taken any treatment medication.  Action taken with Vivotif was unknown.   The consumer had recovered from the events diarrhea and vomiting on 15-Apr-2019.  Company's Comment: In this case, it was reported that the consumer had diarrhea and vomiting following the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhea and vomiting following the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: U
Vaccine: TYP
Symptoms: Abdominal discomfort
Clinical narrative: STOMACH DISCOMFORT; This spontaneous case (PVX2019-910) was received from a nurse on 17-Apr-2019 for two consumers.   Based on the information obtained from the nurse, two individual case safety reports PVX201904-000300 (PVX2019-910; consumer 1) and PVX201904-000301 (PVX2019-910; consumer 2) were created and cross-linked in the database.  This case report describes an adult consumer who experienced stomach discomfort, after the administration of Vivotif for an unknown indication.  Case report: The consumer experienced stomach discomfort after taking Vivotif. The consumer took only two doses.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the event stomach discomfort was unknown.  Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201904-000301:
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort
Clinical narrative: STOMACH UPSET; DID NOT TAKE LAST DOSE OF VIVOTIF; This spontaneous case (PVX2019-1039) was received from another healthcare professional on 29-Apr-2019. It describes a female consumer who experienced stomach upset, after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. She also "did not take the last dose of Vivotif".  Case report: The consumer took three doses of Vivotif. She experienced stomach upset after taking of each dose. She did not take last dose due to stomach upset.  The consumer had no medical history.  Concomitant medication at the time of event included birth control pill.  Action taken with Vivotif with respect to the event stomach upset was vaccine discontinued while with respect to the event "did not take the last dose of Vivotif" was not applicable.  The consumer had recovered from the event stomach upset while with the event "did not take the last dose of Vivotif" was unknown.  Company's Comment: In this case, it was reported that the consumer experienced stomach upset, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach upset is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "did not take the last dose of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach upset, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach upset is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.The causality of the event "did not take the last dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: BAD DIARRHEA; This spontaneous case (PVX2019-1155) was received from nurse on 09-May-2019. It describes a 31-year-old female consumer who experienced bad diarrhea, after the administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer experienced bad diarrhea after taking first dose of Vivotif in this week. Apart from taking probiotic, she did not take treatment for the event.   Action taken with Vivotif was unknown.  The consumer had been recovering from the event.  Company's Comment: In this case, it was reported that the consumer had bad diarrhea, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had bad diarrhea,  after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous case was received from a healthcare professional on 14-May-2019. It describes a female consumer who experienced vomiting, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on Saturday. On Monday she had a vomiting.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer experienced vomiting, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced vomiting, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: U
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: ABDOMINAL PAIN; This spontaneous case was received from a physician on 16-May-2019. It describes 15-year-old consumer who had abdominal pain, after the administration of oral Vivotif for an unknown indication.  Case report: The consumer had severe abdominal pain after the administration of the first dose of Vivotif and it got worse after the second dose. The consumer took PeptoBismol for the event.  Action taken with Vivotif was unknown.  The consumer had not recovered from the event.  Company's Comment: In this case, it was reported that the consumer had abdominal pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had abdominal pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Oral administration complication, Vomiting
Clinical narrative: DIARRHEA; VOMITING; This spontaneous case (PVX2019-1255) was received from a nurse on 20-May-2019. It describes a female consumer who had diarrhea and vomiting, after the administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first and second dose of Vivotif on 16-May-2019 and 18-May-2019, respectively. On 19-May-2019, she had vomiting and diarrhea, which was continued till that night. She vomits out intact pill. She was fine after taking the third dose. It was also reported that she did not take any unhygienic food and water.   The consumer had no medical history or allergy.   The consumer had no concomitant medication.  Action taken with Vivotif was dosage maintained.  The consumer had recovered from the events on 20-May-2019.  Company's Comment: In this case, it was reported that the consumer had had diarrhea and vomiting, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had had diarrhea and vomiting, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia
Clinical narrative: Weakness; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness and muscle pain. On an unknown date, the outcome of the weakness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the weakness and muscle pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient wanted to know how long did side effects last like weakness and muscle aches.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Malaise, Vaccine positive rechallenge
Clinical narrative: feeling crappy / general malaise; headache; This case was reported by a consumer via call center representative and described the occurrence of malaise in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHingrix with an associated reaction of malaise (1st dose received on an unknown date, experienced general malise and headache, refer case US2020AMR040869).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced malaise and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise and headache were unknown.   It was unknown if the reporter considered the malaise and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Malaise
Clinical narrative: feeling crappy / general malaise; headache; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced feeling unwell and headache. On an unknown date, the outcome of the feeling unwell and headache were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. For tolerance of 2nd dose, refer case US2020AMR040852.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: 2nd shot yesterday-now fever; 2nd shot yesterday-now body aches /sore; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (for tolerance of 1st dose refr case US2020AMR047401).   On 15th March 2020, the patient received the 2nd dose of Shingrix. On 16th March 2020, 1 days after receiving Shingrix, the patient experienced fever, general body pain and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain and nausea were unknown.   It was unknown if the reporter considered the fever, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaacination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The reporter stated that, on the day of reporting, after vaccination the patient experienced fever, general body pain and nausea. The reporter stated that, the symptoms worse with 2nd dose.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test normal, Fatigue, Headache, Malaise, Vaccine positive rechallenge
Clinical narrative: have a headache; am feeling tired; general malaise; I had a post viral syndrome; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (refer case US2020AMR047412 for tolerance of 1st dose).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, fatigue, malaise and viral syndrome. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fatigue, malaise and viral syndrome were unknown.   It was unknown if the reporter considered the headache, fatigue, malaise and viral syndrome to be related to Shingrix.  Additional details were provided as follows: The patient received 1std dose about 1 month ago from the date of reporting. After vaccination, the patient felt tired, had headache and general malaise. The patient reported that, felt these symptoms since from 1st dose, but did not relate it at the time and had a full blood work up and nothing showed up. The physician stated that, the patien had post viral syndrome.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: have a headache; am feeling tired; general malaise; I had a post viral syndrome; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (refer case US2020AMR047412 for tolerance of 1st dose).   In February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, fatigue, malaise and viral syndrome. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fatigue, malaise and viral syndrome were unknown.   It was unknown if the reporter considered the headache, fatigue, malaise and viral syndrome to be related to Shingrix.  Additional details were provided as follows: The patient received 1std dose about 1 month ago from the date of reporting. After vaccination, the patient felt tired, had headache and general malaise. The patient reported that, felt these symptoms since from 1st dose, but did not relate it at the time and had a full blood work up and nothing showed up. The physician stated that, the patien had post viral syndrome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: her arm hurt for about a week and she had redness at the injection site; her arm hurt for about a week and she had redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis. Concomitant products included certolizumab (Cimzia) and methotrexate.   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the pain in arm and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and experienced pain in arm  for about a week and she had redness at the injection site. The patient stated that she had a history of rheumatoid arthritis and that she took several medications that cause her to have a similar rash or reaction when she is exposed to the sun. The reporter consented to follow up. This case has been linked with US2020AMR047260, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Ear pain, Eyelid function disorder, Facial pain, Facial paralysis
Clinical narrative: Left sided facial numbness; Right sided tongue numbness; Right sided facial pain; Dysfunction of the left eye lid; Started on treatment for bell's palsy / droop of left side of the face; Right ear pain / Bilateral ear pain; This case was reported by a nurse via call center representative and described the occurrence of bell's palsy in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy, ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder were recovered/resolved.   It was unknown if the reporter considered the bell's palsy, ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder to be related to Shingrix.  Additional details were provided as follows: The patient reported that, experienced ear pain 2 to 3 days following vaccination. On 11th February 2020, the patient came in to clinic for right ear pain and on 20th February 2020 for bilateral ear pain, left sided facial numbness, and right sided tongue numbness. On 25th February 2020, the patient came clinic for for right sided facial pain, bilateral ear pain, and continued treatment of bell's palsy. On 3rd March 2020, the nurse did CT scan for facial drooping and dysfunction of the left eye lid and all results came out normal. The patient was started on treatment for bell's palsy. The nurse spoke to the patient on day before reporting and stated that, the patient was better than previously and felt almost normal after long course of steroids. No further details were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Left sided facial numbness; Right sided tongue numbness; Right sided facial pain; Dysfunction of the left eye lid; Started on treatment for bell's palsy / droop of left side of the face; Right ear pain / Bilateral ear pain; This case was reported by a nurse via call center representative and described the occurrence of bell's palsy in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy, ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder were recovered/resolved.   It was unknown if the reporter considered the bell's palsy, ear pain, numbness facial, numbness of tongue, facial pain and eyelid function disorder to be related to Shingrix.  Additional details were provided as follows: The patient reported that, experienced ear pain 2 to 3 days following vaccination. On 11th February 2020, the patient came in to clinic for right ear pain and on 20th February 2020 for bilateral ear pain, left sided facial numbness, and right sided tongue numbness. On 25th February 2020, the patient came clinic for for right sided facial pain, bilateral ear pain, and continued treatment of bell's palsy. On 3rd March 2020, the nurse did CT scan for facial drooping and dysfunction of the left eye lid and all results came out normal. The patient was started on treatment for bell's palsy. The nurse spoke to the patient on day before reporting and stated that, the patient was better than previously and felt almost normal after long course of steroids. No further details were provided.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: -Employee arrived at work this morning and reported the following current symptoms: Dizzy, GI upset, fatigue, nausea, soreness at injection site - VS: 98.0-125/75-93 - Left arm assessed:  full range of motion, radial pulse present and  no redness, warmth or swelling noted - Employee was dismissed from duties today and instructed to seek medical care
Age: 30.0
Sex: M
Vaccine: FLU4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had a raised red area where the Varicella was administered. This area was sore. Patient was advised this reaction will pass if not to come back to the clinic.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Temperature excursion in vaccine refrigerator - vaccines marked do not use and someone took one out and administered it while on the phone with Merck checking the stability. - MMR only vaccine that was not stable.  Occurred at time of well visit check.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Pt was not to get a Pediarix.  Pt should have only received the Dtap instead of Pediarix