chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves patient of unknown demography who received a dose of expired  vaccine ACT-HIB (lot number not reported and expiration date 18-Nov-2018) via unknown route on an unknown site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Exposure during pregnancy, Gait inability, Hyperhidrosis
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 28 years old pregnant female patient who was feeling dizzy, sweaty, vomiting, nauseous and unable to walk due to weakness, while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported that the patient received vaccine at 30 Weeks of pregnancy. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U5979AA and expiration date 13-Jun-2020) via unknown route in the left arm. On an unknown date, the patient had been feeling dizzy, sweaty, vomiting, nauseous and unable to walk due to weakness, with 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This was a case of vaccine exposure during pregnancy. (Other relevant tests included No lab data reported). Final diagnosis was nauseous, vomiting, weakness, sweaty, feeling dizzy and unable to walk. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 28 years old pregnant female patient who was feeling dizzy, sweaty, vomiting, nauseous and unable to walk due to weakness, while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported that the patient received vaccine at 30 Weeks of pregnancy. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U5979AA and expiration date 13-Jun-2020) via unknown route in the left arm. On an unknown date, the patient had been feeling dizzy, sweaty, vomiting, nauseous and unable to walk due to weakness, with 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This was a case of vaccine exposure during pregnancy. (Other relevant tests included No lab data reported). Final diagnosis was nauseous, vomiting, weakness, sweaty, feeling dizzy and unable to walk. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. List of documents held by sender: none.
Sex: M
Vaccine: FLUX, HEPA, HIBV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 34 months old male patient who was vaccinated with a 0.5 ml dose of ADACEL (Batch number: U5533AA, expiration date: 18-Jan-2018, site of administration : right thigh and route was not reported) on 19-Nov-2018 and also was vaccinated with a dose of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. Concomitant medications included was HIB VACCINE (HAEMOPHILUS INFLUENZAE B [HIB VACCINE]) influenza vaccine  and HEPATITIS A VACCINE (HEPATITIS A) on same day of vaccination. The patients medical history medications were not reported. It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. A patient received ADACEL instead of DAPTACEL. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ043AB, expiration date: 22-May-2019, route: intramuscular and site of administration was right deltoid) on 26-Nov-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. Nurse states that she accidentally gave a FLUZONE HIGH DOSE injection to a patient after a temperature excursion/no AE. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Migraine
Clinical narrative: Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a physician via email. This case involves an Adult female patient (age not reported) who experienced migraines four days after injection, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s),family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series were not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious migraines (migraine) after four days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. No lab test was reported.  Final diagnosis was migraines four days after injection. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for migraines four days after injection. Document held by the sender: none
Sex: U
Vaccine: FLU4
Symptoms: Immune thrombocytopenic purpura
Clinical narrative: Initial information received on 26-Nov-2018 regarding an unsolicited valid serious case received from a consumer (reporter country, country of incident was not reported). This case involves a Child patient who experienced child who may have developed ITP (Idiopathic thrombocytopenic purpura) following flu vaccination, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious child who may have developed ITP (Idiopathic thrombocytopenic purpura) following flu vaccination (immune thrombocytopenic purpura) following the administration of Influenza Vaccine. This event was assessed as medically significant. (Other relevant tests included No lab data.) Final diagnosis was child who may have developed ITP (Idiopathic thrombocytopenic purpura) following flu vaccination. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for ITP (Idiopathic thrombocytopenic purpura). List of documents held by sender: none. Sender's Comments: This case concern a young Patient who presented with Idiopathic thrombocytopenic purpura after vaccination and got hospitalized for unknown days for the event. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves Neonate patient (age and gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: UT626TMA, expiry date: Jun-2019, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was given to a newborn. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 6 years old female patient who was vaccinated with FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s),family history and concomitant medications were not provided. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1807, expiry date: 27-Jun-2019) via intramuscular route in unknown administration site. This was a case of actual medication error due to inappropriate age at vaccine administration because safety and effectiveness of Flublok Quadrivalent have not been established in children 3 years to less than 18 years of age. If administered to person less than 18 years of age, they should be re-vaccinated with age appropriate influenza vaccine. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Full blood count normal, Intensive care, Metabolic function test normal, Polymerase chain reaction
Clinical narrative: Patient had apneic event with loss of pulse, required resuscitation by mother and EMS, was stabilized in ED and transferred to PICU, and observed overnight with return to normal health/behavior.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pulse absent, Respiratory viral panel, Resuscitation
Clinical narrative: Patient had apneic event with loss of pulse, required resuscitation by mother and EMS, was stabilized in ED and transferred to PICU, and observed overnight with return to normal health/behavior.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Reports numbness, tingling feeling on and off, especially in the evening on left arm 2 days after receiving vaccination. She did not seek any medical attention.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Influenza like illness, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. This same consumer reported similar events for 2 patients. This is the first of 2 reports. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date and MENACTRA (lot number and expiration date unknown) both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, fever and rash on the arm all on an unspecified date. The outcome of the event was unknown. The following information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018495286 same product and events, different patient.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Influenza like illness, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. This same consumer reported similar events for 2 patients. This is the second of 2 reports. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date unknown) and MENACTRA (lot number and expiration date unknown) both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, fever and rash on the arm all on an unspecified date. The outcome of the event was unknown. The following information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018492475 same product and event, different patient.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever spiking to 105 degrees F, sustained at 104 degree F for approximately 11 hours, accompanied by severe nausea. Treated with max dose of TYLENOL.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Syncope
Clinical narrative: Patient got warm and lightheaded about 6 mins after being given the vaccine. Patient was helped up and said he may have blacked out either from the shot or the needle itself he is unsure. He passed out or fainted.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage
Clinical narrative: Administered vaccine. Immediately pt did bleed and hematoma developed just above the injection site.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Impaired work ability, Insomnia, Malaise, Musculoskeletal chest pain
Clinical narrative: Stated developed general malaise and weakness within 8 hrs. of receiving flu shot. Progressed into "really bad" rib case and bilateral thigh pain and inability to sleep that night. Had to call out sick the next day at work. States "It's gotten worse and worse each year for the last 3 flu shots I've gotten over the past 3 years".
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Stated developed general malaise and weakness within 8 hrs. of receiving flu shot. Progressed into "really bad" rib case and bilateral thigh pain and inability to sleep that night. Had to call out sick the next day at work. States "It's gotten worse and worse each year for the last 3 flu shots I've gotten over the past 3 years".
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Eye movement disorder, Gait disturbance, Neck pain, Pain in extremity
Clinical narrative: C/O not being able to focus - eyes deviating to (R) couldn't walk straight - lack of appetite for 24 hours - everything seemed to move to (R) - (L) arm pain and slight (L) neck pain.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: C/O not being able to focus - eyes deviating to (R) couldn't walk straight - lack of appetite for 24 hours - everything seemed to move to (R) - (L) arm pain and slight (L) neck pain.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Bone pain, Headache
Clinical narrative: Fever 100 degrees, severe pain in the right shoulder, all body muscle pain, stomach pain, nausea, severe headache, pain in joints and bones, rapid heartbeat, sleeplessness, extreme body weakness next day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site pain, Insomnia, Myalgia, Nausea
Clinical narrative: Fever 100 degrees, severe pain in the right shoulder, all body muscle pain, stomach pain, nausea, severe headache, pain in joints and bones, rapid heartbeat, sleeplessness, extreme body weakness next day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 100 degrees, severe pain in the right shoulder, all body muscle pain, stomach pain, nausea, severe headache, pain in joints and bones, rapid heartbeat, sleeplessness, extreme body weakness next day.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced cellulitis left arm deltoid muscle on an unspecified date with outcome of unknown. Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role in triggering the occurrence of cellulitis left arm deltoid muscle. More information such as medical history, concomitant medication and vaccination site are needed for meaningfully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 19 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient's pertinent drug allergies/drug reactions were not reported. On an unknown date in June 2017 and august 207, the patient was vaccinated with first and second dose of GARDASIL 9 (dose, frequency, lot# and expiry date were unknown) route via intramuscular for an unknown indication at unknown locations. Patient was currently at the pharmacy to receive the third dose in the series today (26-NOV-2018) (inappropriate schedule of product administration) and no adverse effects have been reported in the patient (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 11-OCT-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-MAR-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 30-MAY-2012, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. In 2015, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Malaise, Pain, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 10th September 2018 03:30, the patient received the 1st dose of SHINGRIX. On 10th September 2018 08:00, 4 hrs 30 min after receiving SHINGRIX, the patient experienced back pain, pain localized and feeling unwell. In September 2018, the patient experienced shingles and rash. The patient was treated with gabapentin and antivirals for systemic use (Antiviral). On 5th October 2018, the outcome of the shingles and rash were recovered/resolved. On an unknown date, the outcome of the back pain, pain localized and feeling unwell were recovered/resolved. It was unknown if the reporter considered the shingles, rash, back pain, pain localized and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The consumer reported her pharmacy had already called inquiring about the percentage of individuals that acquired shingles after first vaccination, but she was calling with additional questions. By 8pm that night of vaccination the patient was experiencing back and side aches, not feeling well and didn't sleep well due to the pain. The patient noted it lasted through the week. On Friday by 12:30 in the afternoon, 3 days and 21 hours after vaccination, the patient noticed a rash that was confirmed by her physician at an visit on the same day, on 14th September 2018 at 1:30 pm she had shingles. The patient was placed on an antiviral for 7 days and given gabapentin.  The patient stated she had the rash for 3 weeks. The patient on the day of reporting to see if any individuals that had contracted shingles in the study had previously had the live vaccine on the market because she did get it in the past and should she get the second dose of SHINGRIX.  The prescribing information clinical study data for exclusion criteria was reviewed and that in the incidence of SHINGRIX that was after the two doses were received. The patient had been referred to her physician for guidance and she provided her doctor's information for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 10th September 2018 03:30, the patient received the 1st dose of SHINGRIX. On 10th September 2018 08:00, 4 hrs 30 min after receiving SHINGRIX, the patient experienced back pain, pain localized and feeling unwell. In September 2018, the patient experienced shingles and rash. The patient was treated with gabapentin and antivirals for systemic use (Antiviral). On 5th October 2018, the outcome of the shingles and rash were recovered/resolved. On an unknown date, the outcome of the back pain, pain localized and feeling unwell were recovered/resolved. It was unknown if the reporter considered the shingles, rash, back pain, pain localized and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The consumer reported her pharmacy had already called inquiring about the percentage of individuals that acquired shingles after first vaccination, but she was calling with additional questions. By 8pm that night of vaccination the patient was experiencing back and side aches, not feeling well and didn't sleep well due to the pain. The patient noted it lasted through the week. On Friday by 12:30 in the afternoon, 3 days and 21 hours after vaccination, the patient noticed a rash that was confirmed by her physician at an visit on the same day, on 14th September 2018 at 1:30 pm she had shingles. The patient was placed on an antiviral for 7 days and given gabapentin.  The patient stated she had the rash for 3 weeks. The patient on the day of reporting to see if any individuals that had contracted shingles in the study had previously had the live vaccine on the market because she did get it in the past and should she get the second dose of SHINGRIX.  The prescribing information clinical study data for exclusion criteria was reviewed and that in the incidence of SHINGRIX that was after the two doses were received. The patient had been referred to her physician for guidance and she provided her doctor's information for follow-up.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via patient support programs and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Co-suspect products included epoprostenol sodium (Flolan) powder for infusion for pulmonary arterial hypertension and glycine, sodium chloride, mannitol (Flolan Diluent Ph 12) solution for injection for pulmonary arterial hypertension. On 15th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 6th October 2017, the patient started Flolan 1.5 mg at an unknown frequency and Flolan Diluent Ph 12 at an unknown dose and frequency. On 15th November 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season and 1 year and 40 days after starting Flolan and Flolan Diluent Ph 12, the patient experienced influenza-like symptoms. The action taken with Flolan was unknown (Dechallenge was unknown). Rechallenge with Flolan was unknown. The action taken with Flolan Diluent Ph 12 was unknown (Dechallenge was unknown). Rechallenge with Flolan Diluent Ph 12 was unknown. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent 2018-2019 season, Flolan and Flolan Diluent Ph 12. Additional details were provided as follows: The day before reporting, the patient received flu vaccine and experienced flu like symptoms on the same day. No other information was reported. This case had been linked with the cases A1013859A, US2017GSK073365, US2017GSK133031, US2017GSK137081, US2017GSK148310, US2017GSK184381 and US2018GSK196642, reported for the same patient.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm and erythema. On an unknown date, the outcome of the swelling arm and erythema were recovered/resolved. It was unknown if the reporter considered the swelling arm and erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that several patients had received BEXSERO and had a red swollen arm for approximately 36 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pleuritic pain, Product supply issue
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pleuritic pain in a 82-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included neoplasm malignant and idiopathic thrombocytopenic purpura. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pleuritic pain, herpes zoster and product supply issue. The patient was treated with VALTREX. On an unknown date, the outcome of the pleuritic pain, herpes zoster and product supply issue were unknown. It was unknown if the reporter considered the pleuritic pain and herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient history was malignancy and ITP. The patient was on an 8 hours plane flight and after landing developed pleuritic chest pain, no rash. Workup for pulmonary embolism is not conclusive, room air SA02 was normal. In June 2018, the patient had 1st dose of SHINGRIX. The Health care professional was considering herpes zoster in differential and considering starting VALTREX and requesting info on VE of 1st dose of SHINGRIX. The health care professional would like to give the patient a 2nd dose of SHINGRIX and given supply issues cannot locate a 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (1st dose received on 29th April 2018). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were received as follows: The age at vaccination was not applicable for this report. On 29th October 2018, the patient was due for 2nd dose of Shingles vaccine but could not find. The patient started to look in August 2018. According to the patient's pharmacist, the patient had a year to got the second dose. The patient was thought it was six months. The patient was asking\about the efficacy of the vaccine when the second dose was longer then six months. The patient know that it was about 90 percent within the six month window. The patient asked the pharmacist regarding the vaccine availability in future and the pharmacist replied that it might be in January. The patient pharmacy was on the locator and know they did not have any.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient came in and the reporting pharmacist was going to give the 2nd dose of SHINGRIX. The patient had a red spot the size of a hand where the injection was given. It went away after a week.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cardiac arrest, Death, Guillain-Barre syndrome, Malaise
Clinical narrative: This case was reported by a consumer via other and described the occurrence of Guillain Barre syndrome in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre syndrome (serious criteria death, hospitalization and GSK medically significant), cardiac arrest (serious criteria death and GSK medically significant) and feeling unwell. On an unknown date, the outcome of the Guillain Barre syndrome and cardiac arrest were fatal and the outcome of the feeling unwell was unknown. The patient died on 24th November 2018. The reported cause of death was cardiac arrest and Guillain Barre syndrome. It was unknown if the reporter considered the Guillain Barre syndrome, cardiac arrest and feeling unwell to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a good friend of a friend passed away past Saturday before the time of reporting and said that it was such a shock as she had not been ill. The patient had the new 2 dose shingles vaccine and then a flu shot and commented how she did not feel well after all of that. The husband of the patient took her to hospital on Friday and was diagnosed with Guillain Barre Syndrome. The patient went into cardiac arrest and then died. The patient had bridge at her home on Monday evening, went into hospital on Friday and died a week later on Saturday. Reported Cause(s) of Death: cardiac arrest; Guillain Barre Syndrome.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 17th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, as soon as she received her dose of SHINGRIX, she started experiencing pain in her arm. She stated, the injection supposedly went into her deltoid muscle, but she thought it might have been a little outside of the deltoid. The pain was at the injection site which extends down her arm towards her elbow. The pain was constant and had not improved any at the time of reporting. The reporter did not consent to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 20 years in right arm, before the date of reporting). On 15th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 21 days after receiving SHINGRIX, the patient experienced shoulder pain, pain in arm and discomfort. On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved and the outcome of the discomfort was unknown. It was unknown if the reporter considered the shoulder pain, pain in arm and discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a PhD, but was not a healthcare professional. The patient received SHINGRIX in the right arm. Three to four weeks after receiving SHINGRIX, the patient experienced an annoying dull pain in his right arm, which went down from the shoulder to the elbow. It was not bad, he did not need to take drugs to treat it, but it did make it difficult to get comfortable sleep at night. The patient had not lost any function in his arm. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 20 years in right arm, before the date of reporting). On 15th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 21 days after receiving SHINGRIX, the patient experienced shoulder pain, pain in arm and discomfort. On an unknown date, the outcome of the shoulder pain and pain in arm were not recovered/not resolved and the outcome of the discomfort was unknown. It was unknown if the reporter considered the shoulder pain, pain in arm and discomfort to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a PhD, but was not a healthcare professional. The patient received SHINGRIX in the right arm. Three to four weeks after receiving SHINGRIX, the patient experienced an annoying dull pain in his right arm, which went down from the shoulder to the elbow. It was not bad, he did not need to take drugs to treat it, but it did make it difficult to get comfortable sleep at night. The patient had not lost any function in his arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. On 9th November 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, she did not feel well after receiving SHINGRIX. The patient did not elaborate or specify which event she experienced other than not feeling well. The caller disconnected the call when informed her that, could not provide medical advice or treatment regimen for any side effect.