chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Emotional distress, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: SUFFER; WEIGHT LOSS; SIDE EFFECTS; BOTH MY LEGS FROM THE BOTTOM OF MY FEET TO MY THIGHS STARTED HURTING ME REALLY BAD; NAUSEA, START FEELING SICK TO MY STOMACH SO I STOP EATING; VOMITING; BODY ACHES; HEAT INSIDE THAT SEEMS TO MAKE MY BODY FEEL LIKE IT WAS JUST ON FIRE; BROKE OUT IN A SWEAT SOAKING MY CLOTHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the patient experienced heat inside that seems to make my body feel like it was just on fire. On 23-JUL-2021, the patient experienced broke out in a sweat soaking my clothes. On 23-JUL-2021, the patient experienced body aches. On an unspecified date, the patient experienced suffer, weight loss, side effects, both my legs from the bottom of my feet to my thighs started hurting me really bad, nausea, start feeling sick to my stomach so i stop eating, and vomiting. Laboratory data (dates unspecified) included: Blood test (not provided) Normal and COVID-19 virus test (not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heat inside that seems to make my body feel like it was just on fire, broke out in a sweat soaking my clothes, and body aches on 26-JUL-2021, had not recovered from nausea, start feeling sick to my stomach so i stop eating, both my legs from the bottom of my feet to my thighs started hurting me really bad, vomiting, and weight loss, and the outcome of suffer and side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting, Weight decreased
Clinical narrative: SUFFER; WEIGHT LOSS; SIDE EFFECTS; BOTH MY LEGS FROM THE BOTTOM OF MY FEET TO MY THIGHS STARTED HURTING ME REALLY BAD; NAUSEA, START FEELING SICK TO MY STOMACH SO I STOP EATING; VOMITING; BODY ACHES; HEAT INSIDE THAT SEEMS TO MAKE MY BODY FEEL LIKE IT WAS JUST ON FIRE; BROKE OUT IN A SWEAT SOAKING MY CLOTHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the patient experienced heat inside that seems to make my body feel like it was just on fire. On 23-JUL-2021, the patient experienced broke out in a sweat soaking my clothes. On 23-JUL-2021, the patient experienced body aches. On an unspecified date, the patient experienced suffer, weight loss, side effects, both my legs from the bottom of my feet to my thighs started hurting me really bad, nausea, start feeling sick to my stomach so i stop eating, and vomiting. Laboratory data (dates unspecified) included: Blood test (not provided) Normal and COVID-19 virus test (not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heat inside that seems to make my body feel like it was just on fire, broke out in a sweat soaking my clothes, and body aches on 26-JUL-2021, had not recovered from nausea, start feeling sick to my stomach so i stop eating, both my legs from the bottom of my feet to my thighs started hurting me really bad, vomiting, and weight loss, and the outcome of suffer and side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 07-SEP-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced administration of expired vaccine. On 08-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from administration of expired vaccine, and the outcome of off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: VACCINE REALLY MESSED UP; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine really messed up. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine really messed me up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED 1.5 HOUR AFTER BEYOND THE USE TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-SEP-2021, the patient experienced vaccine was administered 1.5 hour after beyond the use time. On 09-SEP-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered 1.5 hour after beyond the use time and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: GOT PERIOD AFTER VACCINATION; This spontaneous report received from a patient concerned a 62 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had been in menopause since 2018 and some other history about the patient was 9/11(09-SEP-2001) survivor and had cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient who was in menopause received janssen covid-19 vaccine and her period came two days after the vaccination and it lasted for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from patient in menopause and got period after receiving the janssen covid-19 vaccine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210920831-Covid-19 vaccine ad26.cov2.s-Got period after vaccination. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cerebrovascular accident, Depression, SARS-CoV-2 test, Thrombosis
Clinical narrative: CLOT ON THE LEFT SIDE OF NECK; STROKE; DEPRESSED; ANXIOUS; This spontaneous report received from a patient concerned a 52 year old  female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported,1 total, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, 20 days after the vaccination, the patient started experiencing a terrible headache. The patient took tylenol for headache but it did not work. The patient went to the doctor of medicine (MD) and the doctor gave her a shot for the headache. On an unspecified date, the patient had a negative Covid-19 test. The patient was hospitalized for 7 days. When the patient woke up, she was not able to speak and was told that she had a stroke and a clot on the left side of her neck. The patient was transferred to another hospital and was there for 3 weeks and 4 days. The patient was not taking any medication after she was discharged from the hospital. The patient was still taking tylenol and could walk, talk and move now. The stroke affected the right side of the patient. The patient was going to speech therapy and physical therapy. She was still going for follow-up appointments, this month so far she had been for an appointment twice. The patient was very anxious following the events of stroke and this was a current situation and not the one that occurred during the stroke. On an unspecified date, the patient was depressed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of depressed, clot on the left side of neck and anxious was not reported. This report was serious (Hospitalization Caused / Prolonged).     .; Sender's Comments: V0: 20210921019-Covid-19 vaccine ad26.cov2.s-Stroke, Clot on the left side of neck. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: SORENESS/ACHE IN LEFT LEG; TINGLING IN LEFT LEG; NUMBNESS IN LEFT LEG; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 170 pounds, and height was 70 inches. The patient's concurrent conditions included: seasonal allergy, smoker, and alcohol user, and other pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A-H expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, the patient experienced soreness/ache in left leg. On 30-AUG-2021, the patient experienced tingling in left leg. On 30-AUG-2021, the patient experienced numbness in left leg. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tingling in left leg, soreness/ache in left leg, and numbness in left leg. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site urticaria, Nausea
Clinical narrative: Throat swelling; Heart palpitations; Itching, redness and hive over injection site; Injection Site Hives; Injection site redness; Nausea; fatigue; Armpit pain and local site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain and local site reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives), INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations) and NAUSEA (Nausea) outcome was unknown, VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved and AXILLARY PAIN (Armpit pain and local site reaction) and FATIGUE (fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported. No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pharyngeal swelling, Vaccination site pruritus
Clinical narrative: Throat swelling; Heart palpitations; Itching, redness and hive over injection site; Injection Site Hives; Injection site redness; Nausea; fatigue; Armpit pain and local site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain and local site reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives), INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations) and NAUSEA (Nausea) outcome was unknown, VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved and AXILLARY PAIN (Armpit pain and local site reaction) and FATIGUE (fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; Loss of taste; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. p26C21A) for COVID-19 vaccination.     Ty2 2 diabetic controlled, CAD, CKD stage 3b, psoriatic arthritis, rehumatoid arthritis, hypothyroidism, high blood pressure.   Allergic to Cimziai, Remicade,Methrotexate, Psudephrine, latex.  Concurrent medical conditions included Diabetes (Type 2 diabetes, controlled), Coronary artery disease, Chronic kidney disease (Stage 3B), Psoriatic arthritis, Rheumatoid arthritis, Hypothyroidism, Hypertension, Drug allergy (Allergic to Cimziai, Remicade, Methrotexate, Psudephrine) and Latex allergy.    On 25-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue). On 07-Sep-2021, DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DYSPNOEA (Shortness of breath), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) to be possibly related.    Sender's (Case) Safety Report Unique Identifier- -2021-001245 No concomitant medication information provided by reporter. No treatment information provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received contains non significant information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Laboratory test, Pregnancy test, Vitamin B12 decreased, Vitamin D decreased
Clinical narrative: My mensural cycle has stopped. I haven't had a cycle since I took the Moderna Vaccine; that was 5 months ago!. Prior to the shot my cycles were regular. My iron levels and Vitamin B levels are now very low and that has never been an issue before. My vitamin D is also low however this has been low before.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Rash, Somnolence
Clinical narrative: Constantly tired since the vaccination, the eyes just close and you almost fall asleep on the chair for 30 hours rash on the hands and reddish skin on the body
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Breast pain, Hypoaesthesia, Pain
Clinical narrative: On Tuesday I woke up (the day after first shot) with pains on my right side of my back, I would move a certain way and the pain would burn, Wednesday I woke up at the pain moved slight closer to my arm pit but is still the same. Today, Thursday, I woke up and now the inside of my right HURTS and it's on my breast as well, if i sit up, I am in pain, it's a burning pain. My Breast is also numb
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Catheter directed thrombolysis, Chest X-ray, Chest pain
Clinical narrative: Shortness of breath, chest pain, extreme fatigue. Diagnosed with multiple pulmonary embolisms in emergency room. Transferred to Hospital, where they performed the EKOS procedure to dissolve clots. I survived but am on blood thinners for at least 6 months, maybe life.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Fatigue, Pulmonary embolism
Clinical narrative: Shortness of breath, chest pain, extreme fatigue. Diagnosed with multiple pulmonary embolisms in emergency room. Transferred to Hospital, where they performed the EKOS procedure to dissolve clots. I survived but am on blood thinners for at least 6 months, maybe life.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Sinusitis
Clinical narrative: Severe headache, 9-14-21 around 7am Sinus Inflammation, 9-15 Muscle stiffness in Neck
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site induration, Injection site pain, Nausea
Clinical narrative: Dizziness & nausea (lasting 1day), pounding headaches(going on day 4), hardening of the injection site, soreness of the injection site, subdermal bruising (dark red/blue) about the size of a dime
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Subdural haematoma
Clinical narrative: Dizziness & nausea (lasting 1day), pounding headaches(going on day 4), hardening of the injection site, soreness of the injection site, subdermal bruising (dark red/blue) about the size of a dime
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Menstruation irregular, Ultrasound scan
Clinical narrative: Heavy and unusual heavy menstrual bleeding which included large clots. Period lasts for approximately 10 days, stops for 8, then starts again. Blood clots are 2-3 inches in size.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered on 08/23/2021 following a temperature excursion; This spontaneous report was received from an officer manager and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, pertinent medical history and drug reactions/allergies was not provided.  On 23-AUG-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, frequency, route of administration and anatomical location were not reported), lot # T034824 (rHA) and expiration date established as 11-APR-2022 (conflicting information, reported as 01-APR-2023) following a temperature excursion (product storage error) for prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of -10.7 degree Celsius for 192 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: shingles/few days; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the 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 patient had the Shingrix shot and within a few days developed a few shingles spots and inquired was that normal. The patient stated that, he/she had another shingles and had not any shingles at all for 2 years until he/she received the shot. The patient inquired why did he/she show signs without any prior outbreak to the shot. The patient asked about receiving Shingrix while experiencing an outbreak of shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: shingles until I received the shot / suspected vaccination failure; shingles; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had another shingles. The patient reported that he or she did not have any shingles at all for 2 year's until he or she received the shot. Therefore the patient asked why did he or she showed signs without ant prior outbreak to the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Herpes zoster, Vaccination failure
Clinical narrative: Had both doses and got shingles / Suspected vaccination failure; Got shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient stated that she had shingles in the past before getting the vaccine).   In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the Shingrix series vaccine at the end of June 2020.  Patient stated that she had shingles in the past before getting the vaccine. Patient also reports that she had shingles when she got the vaccine. Patient did not clarify if it was after the 1st dose or the 2nd dose. Patient did not provide the dates of each vaccine. The patient only provided at the end of June 2020 when she got the vaccine. Patient stated she had shingles the entire year after that. Not all information was available. Lot and expiration dates were unknown. Patient sounded confuse when providing information of having shingles. She reported having them before the vaccine , when she got the vaccine and after getting the vaccine. She stated she got vaccinated in June 2020 and since then she has had Shingles and it does not go away. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The reporter requesting consent to follow up. This case has been linked with US2021192927 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192927:Same reporter, Same patient. 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke after each shot; This case was reported by a consumer via interactive digital media and described the occurrence of stroke 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 stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was recovered/resolved.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she know the patient who took the Shingle shot and experienced stroke after the shot. For the tolerance of the 2nd dose, refer case US2021AMR193830.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR193830:same patient/same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Vaccine positive rechallenge
Clinical narrative: stroke after each shot; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of cerebrovascular accident (1st dose received on an unknown date, refer case US2021AMR193810).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she know the patient who took the Shingle shot and experienced stroke after the shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR193810:same patient/same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose 10 years ago and was fine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the current Shingles vaccine and was sick as a dog. The patient thought that he/she would rather suffer the disease. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: diagnosed with guillain barre syndrome; This case was reported by a physician via other manufacturer and described the occurrence of guillain barre syndrome in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with Guillain barre syndrome after receiving the flu vaccine. No further information was provided.  No additional adverse effects reported and no product quality complaint.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Neuralgia, Pain, Paraesthesia
Clinical narrative: nerve pain; burning; pricking pain; pricking sensations; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nerve pain, burning sensation, pain and tingling sensation. On an unknown date, the outcome of the nerve pain, burning sensation, pain and tingling sensation were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, burning sensation, pain and tingling sensation to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix in an unknown arm and was still dealing with nerve pain, burning, pricking pain/ sensations on his/her back same side as the shot in his/her arm. The follow-up could not be possible as no contact details were available.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the at 60 got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reproted by the patient. The patient got the Shingles vaccine and 4 months later got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: first dose three weeks ago, just got a mild case of them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, less than 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   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 by the patient. The age at vaccination was not reported. The patient got the dose of Shingles 3 weeks prior to the report and just got the a mild case of Shingles. As per the patient, it was not fun but could not imagine if he/she did not have the 1st dose.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after second shot/Suspected vaccination failure; shingles; 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 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 reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles vaccine and got the shingles after 2nd shot. So the reporter thought it would be safe to say yes. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Bronchitis, Feeling abnormal, Herpes zoster, Herpes zoster oticus
Clinical narrative: Shingles in ear/shingles, issues on face, ear and mouth; shingles, issues on face, ear and mouth; Shingles in mouth/shingles, issues on face, ear and mouth; ear filled with blisters; Horrible case of bronchitis; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster otitis externa in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant), shingles, oral herpes, blister, bronchitis and feeling miserable. The patient was treated with diazepam + isopropamide iodide (Valtrax), gabapentin, steroids nos (Steroids) and antibiotics nos. On an unknown date, the outcome of the herpes zoster otitis externa, shingles and oral herpes were not recovered/not resolved and the outcome of the blister, bronchitis and feeling miserable were unknown.   It was unknown if the reporter considered the herpes zoster otitis externa, shingles, oral herpes, blister, bronchitis and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles 3rd time. The patient had 1st Shingles shot in October 2020 and had the shingles in the month of August and still had issue in his/her face, ear and mouth. The ear was filled with the blisters and had the horrible case of bronchitis in the middle of that. The patient had 2 rounds of steroids and high powered antibiotics besides the 14 days of Valtrex and gabapentin which was still taken by the patient. The patient felt miserable and would not wish it on his/her worst enemy.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Shingles in ear/shingles, issues on face, ear and mouth; shingles, issues on face, ear and mouth; Shingles in mouth/shingles, issues on face, ear and mouth; ear filled with blisters; Horrible case of bronchitis; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of herpes zoster otitis externa in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant), shingles, oral herpes, blister, bronchitis and feeling miserable. The patient was treated with diazepam + isopropamide iodide (Valtrax), gabapentin, steroids nos (Steroids) and antibiotics nos. On an unknown date, the outcome of the herpes zoster otitis externa, shingles and oral herpes were not recovered/not resolved and the outcome of the blister, bronchitis and feeling miserable were unknown.   It was unknown if the reporter considered the herpes zoster otitis externa, shingles, oral herpes, blister, bronchitis and feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles 3rd time. The patient had 1st Shingles shot in October 2020 and had the shingles in the month of August and still had issue in his/her face, ear and mouth. The ear was filled with the blisters and had the horrible case of bronchitis in the middle of that. The patient had 2 rounds of steroids and high powered antibiotics besides the 14 days of Valtrex and gabapentin which was still taken by the patient. The patient felt miserable and would not wish it on his/her worst enemy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This shot GAVE me Shingles/suspected vaccination failure; shingles; 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.   The patient's past medical history included measles (never had chickenpox, only the measles).   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles after getting the Shingles shot. The patient hoped that vaccine was better today than when it 1st came out. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Got my shot I had shingles/suspected vaccination failure; shingles once in the eye; 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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and had the shingles once in the eye and that was no fun and could get them more than once. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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 and shingles were unknown.   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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles 5 times. The patient reported that, if it could be prevented, he/she would like to know how and also stated that, Shingles shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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, several months 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 and shingles were unknown.   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 patient had reported for him/herself. The age at vaccination was not reported. Few months after receiving Shingles vaccine, the patient got shingles but a mild case. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots, still get shingles/ suspected vaccination failure; dealing with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 1st dose of Shingles vaccine and the 2nd 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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 the case. The age at vaccination was not reported. The patient received shingle shots and still got shingles. The patient dealing with the shingles. The patient now had the shots usually get them every couple of months. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were unknown.