chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Limb discomfort, Myelitis transverse, Paraesthesia
Clinical narrative: Dx: Transverse Myelitis; presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest; presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest; presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest; tightness in chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 14 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "if covid prior vaccination:Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZOLOFT; VYVANSE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Right), administration date: 05Jun2021, when the patient was 13-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Right), administration date: 15May2021, when the patient was 13-year-old, for COVID-19 Immunization. The following information was reported: MYELITIS TRANSVERSE (hospitalization, disability, medically significant) with onset 04Feb2022, outcome "recovering", described as "Dx: Transverse Myelitis"; LIMB DISCOMFORT (hospitalization, disability), PARAESTHESIA (hospitalization, disability), DYSPNOEA (hospitalization, disability) all with onset 04Feb2022, outcome "recovering" and all described as "presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest"; CHEST DISCOMFORT (hospitalization, disability) with onset 04Feb2022, outcome "recovering", described as "tightness in chest". The patient was hospitalized for myelitis transverse, limb discomfort, paraesthesia, dyspnoea, chest discomfort (hospitalization duration: 11 day(s)). The events "dx: transverse myelitis", "presented in er (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest" and "tightness in chest" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of myelitis transverse, limb discomfort, paraesthesia, dyspnoea, chest discomfort which included 5 day steroid treatment  Clinical course: Patient did not receive other vaccine within four weeks of covid vaccine. Patient tested for covid post vaccination. No known allergies.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Dx: Transverse Myelitis; presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest; presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest; presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest; tightness in chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 14 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "if covid prior vaccination:Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZOLOFT; VYVANSE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Right), administration date: 05Jun2021, when the patient was 13-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Right), administration date: 15May2021, when the patient was 13-year-old, for COVID-19 Immunization. The following information was reported: MYELITIS TRANSVERSE (hospitalization, disability, medically significant) with onset 04Feb2022, outcome "recovering", described as "Dx: Transverse Myelitis"; LIMB DISCOMFORT (hospitalization, disability), PARAESTHESIA (hospitalization, disability), DYSPNOEA (hospitalization, disability) all with onset 04Feb2022, outcome "recovering" and all described as "presented in ER (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest"; CHEST DISCOMFORT (hospitalization, disability) with onset 04Feb2022, outcome "recovering", described as "tightness in chest". The patient was hospitalized for myelitis transverse, limb discomfort, paraesthesia, dyspnoea, chest discomfort (hospitalization duration: 11 day(s)). The events "dx: transverse myelitis", "presented in er (1 of 2) with immobility of legs, tingling sensation in arms, difficulty breathing and tightness in chest" and "tightness in chest" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of myelitis transverse, limb discomfort, paraesthesia, dyspnoea, chest discomfort which included 5 day steroid treatment  Clinical course: Patient did not receive other vaccine within four weeks of covid vaccine. Patient tested for covid post vaccination. No known allergies.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: arm hurts
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurts
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acne, Rash
Clinical narrative: I have a rash, red raised rash each elbow, below elbow, and the neck; I have a rash, red raised rash each elbow, below elbow, and the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose), administration date: 07Oct2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (2nd dose), administration date: 09Apr2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (1st dose), administration date: 19Mar2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: RASH (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset Apr2022, outcome "unknown" and all described as "I have a rash, red raised rash each elbow, below elbow, and the neck". Therapeutic measures were taken as a result of rash, rash erythematous.  Additional information: Consumer stated that he just want to report an adverse reaction regarding the COVID Vaccine. He got reaction from the COVID Vaccine that's why he got confused. Consumer was informed about the role of Pfizer Drug Safety. Email Address: Consumer stated that withheld (Not phonetically clarified hence not captured in tab). Expiration Date: Consumer stated that he had no idea, it did not said. Other Medical Conditions: Consumer stated that yes, need the conditions that he was suffering from or got to list them. He had a rash, red raised rash each elbow, below elbow, and the neck. When probed if these are the side effects from the vaccine then consumer stated that yes it was the second booster. Other Medical Conditions: Consumer stated that no. Date of Vaccination: Consumer stated that 1st was 3.19.21, 2nd 4.9.21 and then we need 3rd that was the 1st booster 10.07.21 and no side effects from either of them any of those. Date of Vaccination (Second booster): Consumer stated that is correct 18April2022. Prior vaccination (4 weeks): Consumer stated that he mean he had vaccination his whole life so he didn't know that's a pretty common question. No that was the only other vaccination he had was in Oct2021. Anatomical Site of Vaccination: Consumer stated that he had it on the left (arm). Treatment for Adverse Event: Consumer stated that no really he took Benadryl and used a spray Benadryl. Reassurance: Consumer stated that no.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: I have a rash, red raised rash each elbow, below elbow, and the neck; I have a rash, red raised rash each elbow, below elbow, and the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose), administration date: 07Oct2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (2nd dose), administration date: 09Apr2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (1st dose), administration date: 19Mar2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: RASH (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset Apr2022, outcome "unknown" and all described as "I have a rash, red raised rash each elbow, below elbow, and the neck". Therapeutic measures were taken as a result of rash, rash erythematous.  Additional information: Consumer stated that he just want to report an adverse reaction regarding the COVID Vaccine. He got reaction from the COVID Vaccine that's why he got confused. Consumer was informed about the role of Pfizer Drug Safety. Email Address: Consumer stated that withheld (Not phonetically clarified hence not captured in tab). Expiration Date: Consumer stated that he had no idea, it did not said. Other Medical Conditions: Consumer stated that yes, need the conditions that he was suffering from or got to list them. He had a rash, red raised rash each elbow, below elbow, and the neck. When probed if these are the side effects from the vaccine then consumer stated that yes it was the second booster. Other Medical Conditions: Consumer stated that no. Date of Vaccination: Consumer stated that 1st was 3.19.21, 2nd 4.9.21 and then we need 3rd that was the 1st booster 10.07.21 and no side effects from either of them any of those. Date of Vaccination (Second booster): Consumer stated that is correct 18April2022. Prior vaccination (4 weeks): Consumer stated that he mean he had vaccination his whole life so he didn't know that's a pretty common question. No that was the only other vaccination he had was in Oct2021. Anatomical Site of Vaccination: Consumer stated that he had it on the left (arm). Treatment for Adverse Event: Consumer stated that no really he took Benadryl and used a spray Benadryl. Reassurance: Consumer stated that no.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Contusion, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt fainted  the morning after receiving IMZ. She also had local inflammation, but this resolved within a few days
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Syncope
Clinical narrative: Pt fainted  the morning after receiving IMZ. She also had local inflammation, but this resolved within a few days
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Syncope
Clinical narrative: Pt fainted  the morning after receiving IMZ. She also had local inflammation, but this resolved within a few days
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood glucose normal, Dizziness, Electrocardiogram normal, Injection site pain
Clinical narrative: Lightheaded, Blanked out for 20 minutes on 2 occasions. Took Tylenol 500mg Q6h
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injury, Loss of consciousness, Mobility decreased
Clinical narrative: Lightheaded, Blanked out for 20 minutes on 2 occasions. Took Tylenol 500mg Q6h
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood glucose, Blood pressure measurement, Contusion, Dizziness
Clinical narrative: Lightheaded, Blanked out for 20 minutes on 2 occasions. Took Tylenol 500mg Q6h
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Electrocardiogram, Injury, Loss of consciousness, Oxygen saturation
Clinical narrative: Lightheaded, Blanked out for 20 minutes on 2 occasions. Took Tylenol 500mg Q6h
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin abrasion, Vaccination site pain, Vaccination site swelling
Clinical narrative: Lightheaded, Blanked out for 20 minutes on 2 occasions. Took Tylenol 500mg Q6h
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Lightheaded, Blanked out for 20 minutes on 2 occasions. Took Tylenol 500mg Q6h
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: pt called 3 days after the vaccine and complained about muscle aches and weakness all over body. have no problem with previous shots
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Chest discomfort, Chest pain, Chills, Dyspnoea
Clinical narrative: That evening I started having chills, an irregular heartbeat and chest pain. Went to the ER and I was admitted to the ICU unit with heart failure. I stayed 3 days. After admittance I was started on metoprolol succ. extended release 12.5mg, furosemide 2mg, Entresto 24mg, and potassium chloride 20. On 4/10/2021 I had to go back to the ER because I was having trouble breathing and I felt severe pressure on my chest. My shortness of breath was so bad that I couldn't lay down. They found that I had fluid on my lungs. I had my follow up appt. with Pulmonologist. It's believed that my having fluid on my lungs that was subsequent to my heart failure might be from the vaccine. I'm starting Cardiac Rehabilitation, then I'll get another Echocardiogram.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate irregular, Intensive care, Pulmonary oedema
Clinical narrative: That evening I started having chills, an irregular heartbeat and chest pain. Went to the ER and I was admitted to the ICU unit with heart failure. I stayed 3 days. After admittance I was started on metoprolol succ. extended release 12.5mg, furosemide 2mg, Entresto 24mg, and potassium chloride 20. On 4/10/2021 I had to go back to the ER because I was having trouble breathing and I felt severe pressure on my chest. My shortness of breath was so bad that I couldn't lay down. They found that I had fluid on my lungs. I had my follow up appt. with Pulmonologist. It's believed that my having fluid on my lungs that was subsequent to my heart failure might be from the vaccine. I'm starting Cardiac Rehabilitation, then I'll get another Echocardiogram.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Menstruation 7 days longer than normal. 14 days long menstruation. Period started on the date of the 3rd vaccine booster and ended 14 days later. However normal is 7 days for me
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Pain, Palpitations
Clinical narrative: Severe shortness of breath, chest pain and pressure. Pounding heartbeat. Occasional sharp pain
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Utilizing cooler to keep punctured vial refrigerated; Expired doses administered to 6 Patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 3:41 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Apr-2022 at 3:41 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Date the vial was initially stored in the refrigerator was 15-Apr-2022.  Date and time vial was first punctured was 19-Apr-2022 at 13:00.  The vial didn't undergo temperature excursion.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 5 minutes.  Treatment medication was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Vaccination site swelling
Clinical narrative: redness in site of injection; swollen arm the size of a baseball; incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE ERYTHEMA (redness in site of injection), VACCINATION SITE SWELLING (swollen arm the size of a baseball) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 010M20A, 043L20A and 039F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes, Heart disease, unspecified and Contrast media allergy (Contrast dyes). Concomitant products included HYDROCHLOROTHIAZIDE, CLOPIDOGREL BISULFATE (PLAVIX), ESTROGENS CONJUGATED (PREMARIN), FLECAINIDE and DILTIAZEM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular). On 20-Apr-2022, the patient experienced INJECTION SITE ERYTHEMA (redness in site of injection) and VACCINATION SITE SWELLING (swollen arm the size of a baseball). On 21-Apr-2022, INJECTION SITE ERYTHEMA (redness in site of injection) and VACCINATION SITE SWELLING (swollen arm the size of a baseball) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect site of injection: 2 hands down from the shoulder/incorrect route of injection: tissue instead of intramuscular) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient never had tested COVID positive. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient did not experience a similar event in the past and did not seek medical care for the AE..  Treatment medications were not reported.   This case was linked to MOD-2022-547355, MOD-2022-547408, MOD-2022-547429 (Patient Link).
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs reported; Caller reported expired dose of VAQTA administered; This spontaneous report was received from a medical assistant and refers to a 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-MAR-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, 1 ml, lot # T034003, expiration date: 28-MAR-2022, first dose, administered intramuscularly in left arm (strength was not provided) for prophylaxis (expired product administered). It was reported that the vaccine was reserviced/refurbished prior to the administration. The reporter stated that prescription drug treatment was required due to the experience, but no details regarding used drugs were provided. The outcome of the event was reported as recovered/resolved (coded as unknown per company guideline). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; An expired dose of ROTATEQ was inadvertently administered to a patient. No additional AE details or PQC.; This spontaneous report was received from  an office manager, and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-APR-2022, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot number: T034512, administered orally for prophylaxis (strength was not provided). The dose expired on 25-MAR-2022. No adverse events were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; MMR II administered after reconstitution with expired diluent; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided.  On 11-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot# reported as T012860 (lot number T012860 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)), expiration date reported as 14-APR-2022, 0.5 ml, subcutaneously (anatomical location not provided) for prophylaxis. The vaccine was administered after reconstitution with an expired Sterile Diluent, lot# S024969, expiration date 17-MAR-2022. No additional adverse events and product quality complaints reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to an currently 69-year-old patient of unknown gender. The patient's concurrent condition, concomitant medication or medical history were not provided. On or about 01-APR-2012, the patient was administered the zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist. Subsequently (unspecified date), the patient was treated by a health care provider for the following injuries resulting from patient's zoster vaccine live(ZOSTAVAX) use: shingles and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live(ZOSTAVAX).
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: uveitis; other zoster-related conditions; This initial spontaneous report was received from a lawyer, regarding a case in litigation and refers to a currently 70-year-old patient (pt) of unknown gender, whose age at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 63 years old. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or about 2015, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine (lot #, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist at a pharmacy. Subsequently, on an unknown date, the pt was treated by a physician at a medical department for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): uveitis and other zoster-related conditions. The outcome of uveitis and other zoster-related conditions was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of uveitis was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; Medical Assistant reporting the administration of expired VAQTA and inquiring viability of the administration of expired dose.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications pertinent medical history or drug reactions/allergies was not provided.  On 18-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, dose of 1 mL, lot number: U004367 was confirmed to be valid, expiration date: 11-APR-2022 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events reported (no adverse event). No product quality complaints reported. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: arm is still swollen; arm warm; red skin expanded almost to elbow; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the swelling arm, skin warm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, skin warm and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine 5 days ago (from the date of reporting) and his/her arm was still swollen, warm and the red skin has expanded almost to his/her elbow.  The patient asked how should he/she treat this. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: husband had a extreme sore arm with the first injection; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male 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 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 Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: This case was reported by the patient's wife. The patient received dose of Shingrix vaccine and experienced an extreme sore arm. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain for 6 months all day; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles about seven years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and felt blessed that the nerve pain lasted six months but it was all day everyday. The patient stated that he/she wouldn't wish it on his/her worst enemy. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: got my shingle shot and 3 days later I got shingles; so much pain; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient stated that, did not fall for false hope.  The patient got his/her shingle shot and 3 days later got shingles and had them for a whole year and they opened up his/her whole right side.  It was 9 inches long 3 inches wide and 4 inches deep. This was the 4th time he/she had them.  The patient had never been in so much pain in his/her entire life.  The shot could give shingles.  The patient would not ever do that shot or any shot again. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in the arm; Tingling in fingers; Numbness in fingers; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 64-year-old female 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 pain in arm, tingling of extremity and numbness in fingers. On an unknown date, the outcome of the pain in arm, tingling of extremity and numbness in fingers were unknown.   It was unknown if the reporter considered the pain in arm, tingling of extremity and numbness in fingers to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-APR-2022  Reporter's Comments: This case was reported by pharmacist for herself. The patient received 1st dose of Shingrix in right arm and had severe pain in the arm, tingling and numbness in fingers of arm used for injection. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: fever; slept a lot; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a day after receiving Shingles vaccine, the patient experienced fever and sleep excessive. On an unknown date, the outcome of the fever and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the fever and sleep excessive to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received his/her shingles shot 3 days ago.  The patient stated that, need to take easy for 2 days.  The patient had fever the first day, slept a lot and after everything was fine. The patient would receive his/her second shot at the beginning of July. The patient was very happy because he/she received the shot. The patient stated that, he/she needed to protect himself/herself. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the 2 part vaccine, still get shingles/suspected vaccination failure; 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several years 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 Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient stated that he/she had the 2 part vaccine series several years ago but still got shingles. The patient asked if he/she was immunocompromised. Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding the laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Cough, Fatigue, Nasopharyngitis, Quarantine
Clinical narrative: Just finished quarantine for covid (14 days); Moderate cold symptoms; Tiredness; Coughing; Just finished quarantine for covid (14 days); This case was reported by a consumer via call center representative and described the occurrence of covid-19 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 covid-19, cold symptoms, tiredness, cough and quarantine. On an unknown date, the outcome of the covid-19 and quarantine were unknown and the outcome of the cold symptoms was recovering/resolving and the outcome of the tiredness and cough were not recovered/not resolved.   It was unknown if the reporter considered the covid-19, cold symptoms, tiredness and cough to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's comment: This case was reported by patient. The patient just finished quarantine for Covid (14 days) and had moderate cold symptoms and was better and still had some tiredness and coughing. The patient was scheduled for second dose of Shingrix in 2 days. The patient asked should he/she postpone Shingirx booster dose. The patient asked would receiving GlaxoSmithKline vaccine lower a patient's immune system and make them more susceptible to COVID-19. The patient was not felt comfortable for giving his/her personal information. He/she just wanted to know if the effectiveness of the vaccine would be compromised. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot in Sept 2021; This case was reported by a consumer 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 (1st dose received in September 2021).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: The case was received from consumer via  interactive digital media. The patient had first Shingrix shot in September 2021 and asked if it was too late to have the 2nd shot. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: stabbing pain in right foot; moderate to severe pain in my right ankle; This case was reported by a consumer via interactive digital media and described the occurrence of foot pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced foot pain and pain ankle. The patient was treated with morphine. On 2nd April 2022, the outcome of the foot pain was recovered/resolved. On an unknown date, the outcome of the pain ankle was not recovered/not resolved.   It was unknown if the reporter considered the foot pain and pain ankle to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and went to the ER (Emergency Room Visit) with severe stabbing pain in his/her right foot.  The patient was given morphine which did help and by 2nd April 2022 the foot pain was gone, but he/she continued to had moderate to severe pain in his/her right ankle. The reporter ended chat abruptly before GlaxoSmithKline could ask for contact information. The patient did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The vaccine made my shingles way worse/Suspected vaccination failure; The vaccine made my shingles way worse/I've had them 15 times in 4yrs since the shot.; 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.   The patient's past medical history included shingles.   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 Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient stated that the vaccine made his/her shingles way worse. The patient only had shingles once before the vaccination and now the patient had them 15 times in 4 years since the shot.  Additional Supportive information: The case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the injections and I also getting the shingles/ suspected vaccination failure; I had the injections and I also getting the shingles.; pain; 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.   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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had the injections for the shingles and also got the shingles. The shingles were really painful.  Additional Supportive information: The case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site injury, Joint injury, Limb injury, Neoplasm malignant
Clinical narrative: cancer; severe injury to left shoulder; severe injury to left wrist/ severe injury to left hip; This case was reported by a lawyer and described the occurrence of cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received Shingrix. On 1st October 2019, 6 days after receiving Shingrix, the patient experienced injection site injury and wrist injury. On 19th December 2019, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer, injection site injury and wrist injury were unknown.   It was unknown if the reporter considered the cancer, injection site injury and wrist injury to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: The shingrix vaccine was injected into Plaintiff's left shoulder on or about September 25, 2019 and on or about October 1, 2019, 6 days after vaccination, the plaintiff suffered severe injuries to his left shoulder, left wrist and left hip. On or about December 19, 2019, 85 days after vaccination, the Plaintiff was diagnosed with cancer.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, C-reactive protein increased, Fatigue, Myalgia
Clinical narrative: muscle ache; fatigue; Elevated HS-CRP; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disorder.   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle pain, fatigue and high-sensitivity c-reactive protein increased. On an unknown date, the outcome of the muscle pain, fatigue and high-sensitivity c-reactive protein increased were unknown.   It was unknown if the reporter considered the muscle pain, fatigue and high-sensitivity c-reactive protein increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The member of public reported that, she had received Shingrix and her blood was drawn 40 hrs later, the results of the blood work came as elevated HS-CRP (High-sensitivity C-reactive protein) and would like to know if Shignrix could cause it.  The patient also experienced muscle ache and fatigue after the shingrix shot. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2018, did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The pharmacist stated that the patient received first dose of the Shingrix series in 2018, but they did not receive second dose.  The patient had now come in to pharmacy requesting second dose.  The first dose was administered at a different location so the reporter did not have the exact date, lot number, or expiration date information. At the time of reporting, the second dose had not been administered. The reporter consented to follow up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The case has been linked with the case US2022066310 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066310:Same Reporter
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain of skin
Clinical narrative: tenderness under the skin of his mid to lower back; pain is spreading to the front of his body; This case was reported by a consumer via call center representative and described the occurrence of skin tenderness in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2022, 3 days after receiving Shingrix, the patient experienced skin tenderness and radiating pain. On an unknown date, the outcome of the skin tenderness and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the skin tenderness and radiating pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's comment: The patient received Shingrix in an unknown deltoid. Approximately 3 days later patient began to experience a tenderness under the skin of his mid to lower back.   He stated this pain was spreading to the front of his body.  The pain was unresolved.  No Lot number or Expiration date was known for the vaccine. The reporter gave permission to contact Health care professional.