chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: I feel disgusted; She says that she cannot sleep at night due to the pain; She says that she was sick for a day; knees have been very painful; wasn't able to do anything on Sunday, hard time getting in and out of bathtub; started having flu-like symptoms; sore throat; aches and pains; headache; very fatigued; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub) and FEELING ABNORMAL (I feel disgusted) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever). On 07-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub). On an unknown date, the patient experienced FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful). On 08-Nov-2021, INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever) outcome was unknown. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub), FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful) outcome was unknown.            No treatment medication reported. Concomitant medication contains Allergy shot   This case was linked to MOD-2021-242526, MOD-2021-242504 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I feel disgusted; She says that she cannot sleep at night due to the pain; She says that she was sick for a day; knees have been very painful; wasn't able to do anything on Sunday, hard time getting in and out of bathtub; started having flu-like symptoms; sore throat; aches and pains; headache; very fatigued; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub) and FEELING ABNORMAL (I feel disgusted) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever). On 07-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub). On an unknown date, the patient experienced FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful). On 08-Nov-2021, INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever) outcome was unknown. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub), FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful) outcome was unknown.            No treatment medication reported. Concomitant medication contains Allergy shot   This case was linked to MOD-2021-242526, MOD-2021-242504 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 10 doses were removed, and then the vial was placed back in the fridge.; Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (10 doses were removed, and then the vial was placed back in the fridge.) and EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 022C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (10 doses were removed, and then the vial was placed back in the fridge.) and EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured). On 29-Nov-2021, PRODUCT STORAGE ERROR (10 doses were removed, and then the vial was placed back in the fridge.) and EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose past 12 hour puncture/a booster dose of the Moderna Covid-19 Vaccine was given on 29Nov2021 to a patient more than 12 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took more than 12 hours after the vial was punctured. Date the vial was initially stored in the refrigerator on 17-NOV-2021. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow up received contains added reporter details( Non significant), patient initials and updated event start date( Significant information)
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pyrexia
Clinical narrative: Fever; joint pain; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No meds no allergies.     On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea). On 30-Nov-2021, PYREXIA (Fever), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Decreased appetite, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Beginning the next day, she had a low grade fever and body aches. Over the next several days (over a week) she felt extreme fatigue falling asleep frequently and not being able to participate in school and daily activities and had to miss school. In addition to fatigue, she was pale, had abdominal pain, back and body pain, lost appetite, and had low grade fevers.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pallor, Pyrexia, Somnolence
Clinical narrative: Beginning the next day, she had a low grade fever and body aches. Over the next several days (over a week) she felt extreme fatigue falling asleep frequently and not being able to participate in school and daily activities and had to miss school. In addition to fatigue, she was pale, had abdominal pain, back and body pain, lost appetite, and had low grade fevers.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia, Muscular weakness
Clinical narrative: Bell's Palsy... classic symptoms... numbness, drooping, nerve/muscular weakness on right side of face. Hospital visit after 36 hours of first signs.  Given diagnosis then immediately began taking Anti-viral medication (Acyclovir 800mg 5x daily for 7 days), Steroid (Prednisone 20mg  3-3, 2-3,1-3 / 9days), eye gel nightly for dry eye that won't blink or close correctly
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm. Fever,  chills and aching
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; Expired dose of M-M-R II was administered to patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 29-NOV-2021 (reported as: yesterday), the patient was vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) 1 dose (lot # S037502 has been verified to be a valid lot number, expiration date was reported and established as 20-NOV-2021; exact dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported), as prophylaxis. It was confirmed that the dose was properly stored up through the time of administration. No additional adverse events were reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event, Product storage error
Clinical narrative: No additional AE/PQC information; a dose of ROTATEQ was administered to a patient after undergoing a temperature excursion; Dose of ROTATEQ was reported as 0.5 mL; This spontaneous report has been received from a medical assistant and a healthcare professional (qualification unknown) referring to a 9 weeks old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided   On 01-DEC-2021, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) after undergoing a temperature excursion (lot# 1742428 has been verified to be a valid lot number and expiration date was 01-SEP-2022; 0.5 mL orally) for prophylaxis (product storage error and incorrect dose administered). The vaccine was within desired temperature during administration. The administered dose experienced the temperature excursion of 50 Fahrenheit (F) for 5 minutes which was detected by a digital data logger. The reporter also noted that a dose of Pneumococcal Vaccine CONJ 13V (CRM197) (PREVNAR 13) that underwent the same temperature excursion was also administered to an unspecified patient. No previous temperature excursions were reported. There was no additional adverse event.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA001317:
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Additional AE; The first dose was given on 30-AUG-2021 and the second dose was given on 01-DEC-2021; This spontaneous report received from a registered nurse and refers to a patient of unknown age and gender.      The information about patient's concurrent condition, medical and drug history and concomitant medications were unknown.  On 30-AUG-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose one (exact dose, strength, vaccination scheme, frequency, route of administration and anatomical site of vaccination, lot#U005994 and expiration date 10-SEP-2022) as prophylaxis. The patient received second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) late as the patient missed the 4 months appointment. On 01-DEC-2021, the patient was vaccinated with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (exact dose, strength, vaccination scheme, frequency, route of administration and anatomical site of vaccination, were not reported for prophylaxis (Inappropriate schedule of product administration).No additional AE reported.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no other AE's; administration of 2 doses of PNEUMOVAX23 at a dosing interval outside of the PI recommendations; This spontaneous report was received from a nurse referring to a 71 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 12-FEB-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On 03-DEC-2021, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U023170, expiration date 19-JAN-2023, 0.5 ml one time) at a dosing interval outside of the PI recommendations (inappropriate schedule of product administration). No other adverse event (AE) was reported.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional information; MMRII dose that was administered 4 days after expiration; This spontaneous report as received from a registered nurse refers to a 30-year-old female patient.There was no information about the patient's medical history, concurrent conditions or concomitant medication.  Historical vaccine include a COVID 19 Vaccine administered on 17-NOV-2021.  On 08-DEC-2021, the patient was vaccinated with an expired second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)rHA, lot # S039312, expiration date: 04-DEC-2021, subcutaneous in the right arm for prophylaxis (dose unspecified)( expired product administered) at public health clinical/hospital. The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) had no previous temperature excursions. No product quality complaint was involved. No additional information.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: a patient received MMII vaccine via intramuscular route instead of subcutaneous route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     On 08-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (lot # T013725, expiration date 30-APR-2022, 1 dose) via intramuscular route instead of subcutaneous route for prophylaxis (incorrect route of product administration).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; patient erroneously received a dose of PNEUMOV AX 23 instead of the intended dose of PREVNAR 13 .; This spontaneous report has been received from a healthcare professional, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On 02-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, lot number and expiration date not reported), then, on 14-DEC-2021, the patient erroneously received another dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # U018309 and expiration date 08-JAN-2023, 0.5 milliliter (route not reported) for prophylaxis; instead of the intended dose of pneumococcal vaccine conj 13v (crm197)(PREVENAR 13) (Wrong vaccine administered). No additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; a patient received an expired VAQTA; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies and concurrent conditions were not reported.   On 15-DEC-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) as prophylaxis (vaccine scheme, route of administration and anatomical site of vaccination were not reported; lot number T013204 has been verified to be valid, expiration date reported and established as 03-DEC-2021) (expired product administered). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired MMR-II was administered; This spontaneous report was received from a vaccine administrator refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, historical drugs, allergies and concurrent conditions. No concomitant therapies were reported.     On 14-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 5 ml (route of administration and indication were not provided), lot # S039313 and expiration date since it make matches with the autopopulated expiration date 04-DEC-2021. No additional adverse event was reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Abnormal sensation in eye, Eye contusion, Pain in extremity
Clinical narrative: PNEUMOVAX 23 for pneumocaccal disease; Black eye; Sore arm; My eyes were hot after the shot; I received the first dose of PNEUMOVAX 23 in late 2020; This spontaneous report was received from a female patient reporting on herself, a 66-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unspecified date in 2020, reported as "late 2020", the patient received the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for pneumocaccal disease (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On 17-DEC-2021, the patient was vaccinated with the second dose Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in her right arm for pneumocaccal disease (strength, dose number, route of administration, lot number and expiration date were not reported). It was not on the exact date because she had received her COVID-19 vaccine and had to wait.  The same day, after the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine, the patient had a sore arm (pain in extremity), and her eyes were hot after the shot.  The patient had tried not rubbing her eyes and she did not remember hitting her  eye. The patient did not know if she rubbed her eye or if she hit it while she was sleeping but her eyes were hot (abnormal sensation in eye) all day on 18-DEC-2021, reported as "Saturday" and when she laid down to go to bed. When she went to sleep, she did not have any other side effects but on 19-DEC-2021, also reported as Sunday, the patient woke up with a black eye that is a dark purple and looks horrible. I did not have this with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine. Treatment was not given for the events.  The outcome of the events and the causal relationship between the events and vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 66 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 26-JUL-2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 01-JUN-2009, the patient was administered the zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated by a healthcare providers at the hospital for Bell's palsy and other zoster-related conditions. The outcome of the events was not reported. The reporter considered all events to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of Bell's Palsy was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 19-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered left sided facial droop with numbness and was diagnosed with Left Bell's Palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), he sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, he suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of Bell's Palsy was considered to be not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of Bell's Palsy was determined to be disabling and medically significant.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Neck pain, Rash, Rash erythematous
Clinical narrative: Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer. The lawyer considered the event shingles to be disabling.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neck pain, Rash, Rash macular, Sensitive skin
Clinical narrative: Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer. The lawyer considered the event shingles to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Cerebrovascular accident, Fatigue, Herpes zoster, Pain
Clinical narrative: herpes zoster/severe pain, fatigue; Post Herpetic Neuralgia/severe pain; CVA/Cilioretinal Artery Occlusion; CVA/Cilioretinal Artery Occlusion/vision loss; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On 08-MAR-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered severe pain, fatigue and vision loss, and was diagnosed with herpes zoster, postherpetic neuralgia (PHN), cerebrovascular accident (CVA)/cilioretinal artery occlusion. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.   Herpes zoster, postherpetic neuralgia, retinal artery occlusion and cerebrovascular accident were considered as disabling events by the reporter.   Upon internal review, the events retinal artery occlusion and cerebrovascular accident were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Retinal artery occlusion
Clinical narrative: herpes zoster/severe pain, fatigue; Post Herpetic Neuralgia/severe pain; CVA/Cilioretinal Artery Occlusion; CVA/Cilioretinal Artery Occlusion/vision loss; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On 08-MAR-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered severe pain, fatigue and vision loss, and was diagnosed with herpes zoster, postherpetic neuralgia (PHN), cerebrovascular accident (CVA)/cilioretinal artery occlusion. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.   Herpes zoster, postherpetic neuralgia, retinal artery occlusion and cerebrovascular accident were considered as disabling events by the reporter.   Upon internal review, the events retinal artery occlusion and cerebrovascular accident were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; bit tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and tiredness. In December 2021, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 1st shot a week ago from the date of reporting.  The patient experienced sore arm and a bit tired the next two days, but nothing really noteworthy, considering that strong reactions to vaccines were common for the patient.  The patient said second jab would be a different story, but he/she ready for it. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is sour; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 2 times).   On 14th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had stated of having shingles twice. The patient got shot on Tuesday and his/her arm was sour, but no pain.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (SHINGRIX) for prophylaxis. Co-suspect products included Herpes zoster (SHINGRIX) for prophylaxis. Previously administered products included Shingles vaccine (received the original shingles shot years ago from the date of reporting). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and incomplete course of vaccination were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The physician wanted the patient to get the new SHINGRIX vaccine. It was two separate injections. The patient broke out with shingles. The patient refused to get the 2nd injection, that was 3 years ago. The patient still had breakouts on eyes, lips, face and foot. No contact details were reported. The case had been linked with US2021AMR259450 (deleted) reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259450:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: extreme arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received first dose of Shingles vaccine and experienced extreme pain in arm which lasted for over a month. The patient didn't experience any event after second dose. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles vaccine and got the shingles terrible. They cleared, finally. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available. For second outbreak of shingles refer case US2021AMR260215, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR260215:same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: broke out after first shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported for his/her son in law. Age at vaccination was not reported. The patient now all broke out after first shot for shingles. The follow-up would not be possible as no contact details were available.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The case was reported by the patient. The patient had first Shingrix shot 4 days ago. The patient had experienced fever of 101 degree Celcius for 2 days, better on day 3. Fever back on day 4 and having 101.2 degree Celcius fever on the day of reporting.
Sex: U
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Myalgia
Clinical narrative: left deltoid sore; This case was reported by a consumer via other manufacturer and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and COVID 19 VACCINE PFIZER (batch number BNT162B2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix, Influenza vaccine Quadrivalent unspecified season and COVID 19 VACCINE PFIZER. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. Shingrix was the breeze. Been 2021 pincushion 3 vaccine of Pfizer Covid vaccine, Flu shot and now this Shingrix. But the patient left deltoid was sore .
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was fully vaccinated and just had a case of Shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (Patient received first Shingrix dose 7 months ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: Age at vaccination was not applicable for this report. The patient received first dose of Shingrix 7 months before reporting and went for second dose. The reporter wanted to know if they need to restart the series. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Illness, Incomplete course of vaccination
Clinical narrative: super sick; shingles; got the 1st shot Did not get the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced sickness, shingles and incomplete course of vaccination. On an unknown date, the outcome of the sickness, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The patient got the first shot. The patient did not get the second shot because he/she got super sick from the first shot, which led to incomplete course of vaccination. The patient informed that wasn't worth it to for him/her. The patient further stated that shingles were awful and the patient had them twice and he/she didn't want ever had them again. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had all Shingles vaccines and booster, which led to extra dose administered. The patient then got shingles a week ago and never had chicken pox. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting. Note: From the narrative it was not clear if the patient received all vaccine from gsk or non gsk vaccine. Hence only 2 suspect were coded conservatively, 1 suspect for all vaccine and 1 suspect for booster dose and no extra dose was coded as an event.