chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included citalopram. On 6th June 2018 11:00, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th June 2018, several hours after receiving SHINGRIX, the patient experienced headache, fever and nausea. On 6th June 2018 16:00, the patient experienced fatigue. On 6th June 2018 22:00, the patient experienced chills. On 7th June 2018, the outcome of the headache, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving.  The reporter considered the fatigue, headache, fever, chills and nausea to be related to SHINGRIX. Additional details were provided as follows: The reporter herself was the patient. The patient received dose around 11:00 AM, and that by 4:00 PM, she felt fatigued and at 10: PM she had chills and during the night she had nausea with dry heaves, fever with body temperature of 101.2 degrees F, and severe headache. The patient reported that, nausea lasted through most of next day and then resolved and that headache, chills and fever resolved around mid-day next day. On the day of reporting, she continues to feel fatigued.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included citalopram. On 6th June 2018 11:00, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th June 2018, several hours after receiving SHINGRIX, the patient experienced headache, fever and nausea. On 6th June 2018 16:00, the patient experienced fatigue. On 6th June 2018 22:00, the patient experienced chills. On 7th June 2018, the outcome of the headache, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving.  The reporter considered the fatigue, headache, fever, chills and nausea to be related to SHINGRIX. Additional details were provided as follows: The reporter herself was the patient. The patient received dose around 11:00 AM, and that by 4:00 PM, she felt fatigued and at 10: PM she had chills and during the night she had nausea with dry heaves, fever with body temperature of 101.2 degrees F, and severe headache. The patient reported that, nausea lasted through most of next day and then resolved and that headache, chills and fever resolved around mid-day next day. On the day of reporting, she continues to feel fatigued.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 89-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: One day after receiving SHINGRIX, the patient experienced redness, swelling, pain and warmth at the injection site. The patient put ice at the injection site. The symptoms have not resolved as of 8th June 2018. No doctor's visit was done. The pharmacist believed that yes, Shingrix was the causality. No additional information provided.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Guillain-Barre syndrome requiring hospitalization, symptoms began 7 days after receiving her first SHINGRIX vaccine. Initial symptom was back pain and tingling in the upper extremities, followed by muscle spasms and nausea, then tingling in all extremities and finally weakness in all extremities by 6/4. Treated with IVIG.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Borrelia test negative, CSF test normal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre syndrome requiring hospitalization, symptoms began 7 days after receiving her first SHINGRIX vaccine. Initial symptom was back pain and tingling in the upper extremities, followed by muscle spasms and nausea, then tingling in all extremities and finally weakness in all extremities by 6/4. Treated with IVIG.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms, Muscular weakness, Nausea, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: Guillain-Barre syndrome requiring hospitalization, symptoms began 7 days after receiving her first SHINGRIX vaccine. Initial symptom was back pain and tingling in the upper extremities, followed by muscle spasms and nausea, then tingling in all extremities and finally weakness in all extremities by 6/4. Treated with IVIG.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Schwannoma
Clinical narrative: Guillain-Barre syndrome requiring hospitalization, symptoms began 7 days after receiving her first SHINGRIX vaccine. Initial symptom was back pain and tingling in the upper extremities, followed by muscle spasms and nausea, then tingling in all extremities and finally weakness in all extremities by 6/4. Treated with IVIG.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site (deltoid muscle) continuing for two months.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Erythema
Clinical narrative: Weakness, lost appetite, chills, sweats, dizzy, and muscle cramp in my right leg. Lasted from Saturday - Wednesday. Stayed in bed for Sat-Tuesday. My left arm was swollen and red and painful but doctor's office warned me about that not the other.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: Weakness, lost appetite, chills, sweats, dizzy, and muscle cramp in my right leg. Lasted from Saturday - Wednesday. Stayed in bed for Sat-Tuesday. My left arm was swollen and red and painful but doctor's office warned me about that not the other.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: HARD, RED, HOT, AREA GROWING IN SIZE OVER 3 DAYS.
Sex: F
Vaccine: FLUX
Symptoms: Conjunctival hyperaemia, Corneal infiltrates, Eye pain, Hypersensitivity, Keratitis
Clinical narrative: A literature abstract has been received from a health professional. The report concerns a retrospective chart review of a 42-year-old female patient of unknown ethnic origin. No medical history was reported. No concomitant products were reported. On an unknown date, Two days after the administration of the influenza virus vaccine live, (intranasal), the patient presented with pain, redness, tearing, and discomfort in both eyes. Examination of the eyelids was unremarkable in both eyes. Anterior segment examination of the both eyes showed conjunctival hyperemia, and several corneal sub-epithelial peripheral infiltrates separated from the limbus by a clear zone. Anterior chamber and posterior segments were unremarkable in both eyes. It was diagnosed as a hypersensitivity reaction, which manifests in the form of marginal keratitis. The condition resolved with topical antibiotics and corticosteroids. It was unknown if any action was taken with influenza virus vaccine live, (intranasal). The patient recovered from the event(s) of bilateral marginal keratitis and hypersensitivity reaction on an unspecified date. The events were considered serious (important medical event). The reporter considered the following event(s) related to treatment with influenza virus vaccine live, (intranasal): hypersensitivity reaction and bilateral marginal keratitis. The authors commented: "Ocular complications of vaccines are rare. Intranasal live-attenuated influenza virus vaccine may trigger a hypersensitivity reaction, which manifests in the form of marginal keratitis. To the best of our knowledge, this is the first report of such complication after the administration of an influenza virus vaccine." Sender's Comments: Bilateral marginal keratitis is not listed in the company core data sheet for intranasal live-attenuated influenza virus vaccine. The event occurred 2 days after the administration of the suspect vaccine. The listed event of Hypersensitivity could be possibly confounding. Due to missing information on exact administration dates of the suspect vaccine with indication and dose, exact event onset date, underlying comorbidities, relevant medical history, concomitant medication, further diagnostic workup it is not possible to make a conclusive assessment of the causal relationship of event and suspect vaccine. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Sex: F
Vaccine: FLUX
Symptoms: Lacrimation increased, Ocular discomfort, Ocular hyperaemia
Clinical narrative: A literature abstract has been received from a health professional. The report concerns a retrospective chart review of a 42-year-old female patient of unknown ethnic origin. No medical history was reported. No concomitant products were reported. On an unknown date, Two days after the administration of the influenza virus vaccine live, (intranasal), the patient presented with pain, redness, tearing, and discomfort in both eyes. Examination of the eyelids was unremarkable in both eyes. Anterior segment examination of the both eyes showed conjunctival hyperemia, and several corneal sub-epithelial peripheral infiltrates separated from the limbus by a clear zone. Anterior chamber and posterior segments were unremarkable in both eyes. It was diagnosed as a hypersensitivity reaction, which manifests in the form of marginal keratitis. The condition resolved with topical antibiotics and corticosteroids. It was unknown if any action was taken with influenza virus vaccine live, (intranasal). The patient recovered from the event(s) of bilateral marginal keratitis and hypersensitivity reaction on an unspecified date. The events were considered serious (important medical event). The reporter considered the following event(s) related to treatment with influenza virus vaccine live, (intranasal): hypersensitivity reaction and bilateral marginal keratitis. The authors commented: "Ocular complications of vaccines are rare. Intranasal live-attenuated influenza virus vaccine may trigger a hypersensitivity reaction, which manifests in the form of marginal keratitis. To the best of our knowledge, this is the first report of such complication after the administration of an influenza virus vaccine." Sender's Comments: Bilateral marginal keratitis is not listed in the company core data sheet for intranasal live-attenuated influenza virus vaccine. The event occurred 2 days after the administration of the suspect vaccine. The listed event of Hypersensitivity could be possibly confounding. Due to missing information on exact administration dates of the suspect vaccine with indication and dose, exact event onset date, underlying comorbidities, relevant medical history, concomitant medication, further diagnostic workup it is not possible to make a conclusive assessment of the causal relationship of event and suspect vaccine. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Sex: U
Vaccine: MMR, MNQ, VARCEL
Symptoms: Product preparation error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 24-MAY-2018, the patient was vaccinated for prophylaxis with M-M-R II lot number N014482, expiration date 10-MAY-2019 (strength, dose number, anatomical location, route of administration) and VARIVAX lot number N028715, expiration date 13-OCT-2019 (strength, dose number, anatomical location, route of administration). Both vaccines were reconstituted with 2 separate MENACTRA instead of Merck diluent.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, and information about drug reactions or allergies, if any, were not provided. The registered nurse reported that, on an unspecified date, the patient was inadvertently vaccinated with improperly stored PNEUMOVAX 23 for prophylaxis (dose, dose number, frequency, route and anatomical location of administration were not provided; lot number N025563, expiration date 08-APR-2019). The doses of PNEUMOVAX 23 were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F (also reported as "47.6 °F") during a time frame of 2 hours, which was detected by the Digital Data Logger. There was no previous temperature excursion. No adverse effects or product quality complaints reported. Further information was not provided.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, and drug reactions or allergies, if any, were not provided. On an unspecified date in May 2015 (reported as "3 years ago"), the patient was vaccinated with the first dose of PNEUMOVAX 23, one dosage form, for prophylaxis (frequency, route and anatomical location of administration were not provided; lot number and expiration date were unknown by the nurse). Three years after the patient received the first dose of PNEUMOVAX 23, on 31-MAY-2018, the patient was vaccinated with the second dose of PNEUMOVAX23, one dosage form, for prophylaxis (frequency, route and anatomical location of administration were not provided; lot number R009162, expiration date 06-JAN-2020). No adverse effects or product quality complains were reported. Further information was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant, concerning 26 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 04-JUN-2018, the patient received a dose of the pediatric/adolescent VAQTA for prophylaxis (strength, route of administration or anatomical location were not provided); which was considered as an inappropriate age at vaccine administration. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R002931, expiration date 29-JUL-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent lot # R002518, expiration date 12-DEC-2019 (concomitant therapy). The temperature excursion was -12.5 Centigrade degrees (°C), during 4 hours 19 minutes. However, a previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA006184.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive
Clinical narrative: This spontaneous pregnancy retrospective report was received from a female patient of unknown age concerning herself. There were no pertinent medical history, concurrent conditions or drug allergies/drug reactions. The patient's concomitant medication included unspecified birth control therapy. It was reported that "around the year, 2013, the patient completed series with the three GARDASIL vaccinations, as routine vaccination (strength, frequency, route of administration, lot # and expiration date were not provided). After the patient completed series with GARDASIL, she gave birth to her daughter and reported that she currently was 3 months postpartum, approximately in March 2018. The last menstrual period was not reported. It was mentioned that after that, she "had two HPV positive tests results". It was reported that "after second HPV positive test result she had a colposcopy (results not provided). The patient did not seek medical attention and there was no treatment given for the adverse event. The outcome of the HPV test positive was unknown at the time of the report. The causal assessment between the aforementioned event and GARDASIL was not reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nephrolithiasis, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a 58 year old female consumer with hypercholesterolaemia and colon polyps, referring to herself. Concomitant therapies included simvastatin and hydrochlorothiazide. The patient had no drug reactions or allergies. On 04-DEC-2015, the patient was vaccinated with ZOSTAVAX lot number L031271, expiration date: 19-NOV-2016, subcutaneously, for prevention of shingles (dosage schedule were not reported). In April 2018 (reported as "two months ago"), the patient went to the emergency room and had an unspecified scan performed which showed kidney stones and the patient was prescribed prednisone and promethazine. The consumer reported that the kidney stones passed on their own on an unspecified date in 2018. Approximately on 30-MAY-2018 (reported as "a week ago"), the patient started to experience very itchy marks on her back and neck that she thought were bug bites. The patient reported that an unspecified amount of time later, these marks turned into full rashes that were blistering and itchy on the back, neck and shoulders; which were described by the reporter as shingles. On 05-JUN-2018, the patient went to the physician's office and was prescribed acyclovir and prednisone. The outcome of herpes zoster was reported as not recovered. The reporter did not assess the relatedness of nephrolithiasis and shingles with ZOSTAVAX. Upon internal review, nephrolithiasis was determined to be a medically significant event.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Renal scan abnormal
Clinical narrative: This spontaneous report was received from a 58 year old female consumer with hypercholesterolaemia and colon polyps, referring to herself. Concomitant therapies included simvastatin and hydrochlorothiazide. The patient had no drug reactions or allergies. On 04-DEC-2015, the patient was vaccinated with ZOSTAVAX lot number L031271, expiration date: 19-NOV-2016, subcutaneously, for prevention of shingles (dosage schedule were not reported). In April 2018 (reported as "two months ago"), the patient went to the emergency room and had an unspecified scan performed which showed kidney stones and the patient was prescribed prednisone and promethazine. The consumer reported that the kidney stones passed on their own on an unspecified date in 2018. Approximately on 30-MAY-2018 (reported as "a week ago"), the patient started to experience very itchy marks on her back and neck that she thought were bug bites. The patient reported that an unspecified amount of time later, these marks turned into full rashes that were blistering and itchy on the back, neck and shoulders; which were described by the reporter as shingles. On 05-JUN-2018, the patient went to the physician's office and was prescribed acyclovir and prednisone. The outcome of herpes zoster was reported as not recovered. The reporter did not assess the relatedness of nephrolithiasis and shingles with ZOSTAVAX. Upon internal review, nephrolithiasis was determined to be a medically significant event.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 01-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007093: US-009507513-1806USA007092: US-009507513-1806USA007090: US-009507513-1806USA007091.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Joint stiffness, Lethargy
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in May 2018 (reported as "within the past month"), the patient was vaccinated with a dose of GARDASIL 9 1 injection in the arm (lot number and expiration date were not reported) for prophylaxis (reported as "prevent HCP"). On an unknown date in 2018, 1 week after the vaccination, the patient experienced full body joint pain, stiffness in her knees and lethargy. She was treated with an unspecified non-steroidal anti-inflammatory medication. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age or gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 20-JUL-2017, the patient was vaccinated with GARDASIL 9 dose 1, lot # N001533, expiry date: 16-OCT-2019, and on 17-APR-2018, dose 2, lot # N025428, expiry date: 19-JUN-2020; both 0.5 ml, intramuscularly, for prophylaxis. There was no adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On unspecified date, the patient was inadvertently vaccinated with an improperly stored dose of PROQUAD lot # N025926 with expiration date on 18-MAR-2019 (strength, anatomical location or route of administration were not provided), for prophylaxis; which was previously reconstituted with a properly stored sterile diluent (manufacturer unknown). The storage temperature of the vaccine was reported as -9 to 8 degrees Celsius (°C) for a time frame of 10 hours and 25 minutes. There was a previous temperature excursion at the same temperatures for 4 hours and 40 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concurrent conditions were not reported. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R002931, expiration date 29-JUL-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent lot # R002518, expiration date 12-DEC-2019 (concomitant therapy). The temperature excursion was -12.5 Centigrade degrees (°C), during 4 hours 19 minutes. However, a previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA002454.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2016, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2017, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2011, the patient was treated at a hospital for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 01-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1806USA003811: US-009507513-1806USA007091: US-009507513-1806USA007092: US-009507513-1806USA007093.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 01-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA003811: US-009507513-1806USA007090: US-009507513-1806USA007092: US-009507513-1806USA007093.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 31-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1806USA003811: US-009507513-1806USA007090: US-009507513-1806USA007091: US-009507513-1806USA007093.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 31-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA003811: US-009507513-1806USA007090: US-009507513-1806USA007091: US-009507513-1806USA007092.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent which was used for the reconstitution of ZOSTAVAX. On 11-JUN-2018, the patient was vaccinated with ZOSTAVAX (dose, units and frequency not reported) (lot# and expiration date not reported), intramuscularly. No side effects were reported. No product quality complaint was involved.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Lymph node pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (had multiple bouts over the past 2 years). Concomitant products included SYNTHROID. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd April 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, pain in arm, chills and lymph node pain. In June 2018, the patient experienced shingles. The patient was treated with TYLENOL. On an unknown date, the outcome of the shingles was unknown and the outcome of the fever, pain in arm, chills and lymph node pain were recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. The reporter considered the fever, pain in arm, chills and lymph node pain to be related to SHINGRIX. Additional information was reported as follows: At 09:30, the patient received the SHINGRIX in the left arm. The patient had sore arm right after receiving the SHINGRIX which persisted for 4 days. She put an ice pack on her arm which helped. About 10 to 12 hours after receiving the SHINGRIX vaccine, she developed fever (body temperature 103.1 degree F) with chills for a couple hours. Less than a day after receiving SHINGRIX, the patient developed lymph node pain for a day. She took half a TYLENOL for the symptoms and went to bed early. About 6 weeks after receiving the SHINGRIX, she developed shingles. She hope that, this would be the last. She planned to receive the 2nd dose of SHINGRIX towards the end of June.
Sex: F
Vaccine: MEN
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 18-year-old female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved. It was unknown if the reporter considered the feeling abnormal to be related to Meningococcal B vaccine. Additional details were provided as follows: The patient's mother reported this case.  The age at vaccination was not reported. The reporter did not know the brand name of Men-B vaccine. The reporter did not specify patient's symptoms. The reporter wanted to know about her daughter having side effects from the vaccine. The reporter states it had been a week and still the patient was not feeling good. The reporter was going to take the patient to emergency room on the day of reporting. No other information obtained from chatter before the chat was closed; contact information obtained because chatter initiated another chat with the agency.
Age: 56.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included gabapentin, Tetanus vaccine, TRAMADOL and BACLOFEN. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever and shivering. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever and shivering were recovered/resolved. The reporter considered the fever and shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received Tetanus vaccine on an unknown date in April 2018 and SHINGRIX in on left arm. The patient developed shivering and a fever of 102.1 degree F, 10 hours after getting the vaccination. The patient took Ibuprofen every 5 to 6 hours.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Injection site pain, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included lisinopril and lovastatin. On 31st May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, axillary pain, pain and swelling. On 1st June 2018, the patient experienced headache. The patient was treated with naproxen. On 1st June 2018, the outcome of the headache was recovered/resolved. On 2nd June 2018, the outcome of the pain was recovered/resolved. On 4th June 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the axillary pain was not recovered/not resolved and the outcome of the swelling was recovering/resolving. The reporter considered the injection site pain, axillary pain, pain, swelling and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on Thursday afternoon at 1.00 pm in the left deltoid. The patient developed pain at the injection site which resolved on Monday evening. The patient also stated that, he had under arm pain and swelling near the pectoral muscle that was not resolved. The patient stated that, he experienced soreness and added that he experienced a headache, 1 day after vaccination on Friday which resolved with Naproxen administration.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included squamous cell carcinoma (named head, neck and shoulder cancer and required chemo and radiation 10-15 years ago), thyroidectomy and cancer surgery. Concurrent medical conditions included muscle atrophy (muscle loss in his left arm from cancer surgery done 10 to 15 years ago). Concomitant products included Baking Soda, Levothyroxine, Magnesium, morphine, MUCINEX, PERCOCET and Potassium. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The SHINGRIX vaccine was administered in the right arm and pain presented in his right arm 2 to 3 hours after receiving the SHINGRIX vaccine and resolved after 3 days although was so severe at the time it was immobilizing. The patient was not certain of the exact date of the first shot but assumed it was 2 months ago because his pharmacy called him to remind him to come in to get the second shot. This case was linked with US2018GSK107452, reported for same patient for 2nd dose of SHINGRIX.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold sores lip in a 53-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th June 2018, 2 days after receiving SHINGRIX, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. The reporter considered the cold sores lip to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The healthcare professional (HCP) stated that the patient developed cold sore on lips after receiving SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction and activities of daily living impaired. On an unknown date, the outcome of the adverse reaction was unknown and the outcome of the activities of daily living impaired was recovered/resolved. It was unknown if the reporter considered the adverse reaction and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported an adverse event (AE). The patient said that she experienced nearly every single adverse reaction (except for the very rare ones) to the SHINGRIX vaccine. It was literally kept away the patient from her normal activities for 7 days. The patient's nurse practitioner (PCP) only said that they might not want the patient to have the 2nd dose. The patient was scared to death to take it and need to know where to go to find out more about this new vaccine and people's reactions to it to date. She already had found obvious reports from the FDA (Food and Drug Administration) and asked to print out more. The patient quickly left the chat with no detailed information.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lethargic in a 63-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of Shingrix. In March 2018, 1 day after receiving SHINGRIX, the patient experienced lethargic and pain. On an unknown date, the outcome of the lethargic and pain were recovered/resolved. The reporter considered the lethargic and pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received Shingrix on left arm. Next day, after vaccination the patient experienced lethargic and achy. This case has been linked with US2018GSK106673, reported by the same reporter for 2nd dose.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 51-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 26th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fatigue, fever and malaise. On an unknown date, the outcome of the fatigue and malaise were not recovered/not resolved and the outcome of the fever was recovered/resolved. The reporter considered the fatigue, fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The pharmacist said that one of his patients received the SHINGRIX. At the time of reporting the patient called the reporting pharmacist and said she was still experiencing fatigue and malaise but had recovered from the fever. The patient experienced 103 degree F fever that lasted a few days.
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory symptom
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of respiratory symptom in a male patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced respiratory symptom. On an unknown date, the outcome of the respiratory symptom was unknown. It was unknown if the reporter considered the respiratory symptom to be related to SHINGRIX. Additional details were reported as follows: The case was received via click to chat by a Medical Assistant. The age at vaccination was not reported. The healthcare professional stated that the patient had respiratory symptoms. The patient was requested antibiotics one day after receiving the SHINGRIX vaccine. The healthcare professional did not provide any further information.