chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Fatigue, Headache, Menstruation irregular
Clinical narrative: Both doses I had a headache, nausea, fatigue and some dizziness but nothing to severe. I have an IUD (my  3rd) and haven?t had a period where I bleed in about 6yrs. After the second dose I have had 3 period cycles where I have actually bled, it is still less than prior to an IUD. Also while I have had cramping over those 6 years they got significantly worse for the last 3 cycles. Also just had a gyno appointment and they said my IUD is still in a good position and there are no other underlying issues.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaginal haemorrhage
Clinical narrative: Both doses I had a headache, nausea, fatigue and some dizziness but nothing to severe. I have an IUD (my  3rd) and haven?t had a period where I bleed in about 6yrs. After the second dose I have had 3 period cycles where I have actually bled, it is still less than prior to an IUD. Also while I have had cramping over those 6 years they got significantly worse for the last 3 cycles. Also just had a gyno appointment and they said my IUD is still in a good position and there are no other underlying issues.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: this actually started with the first does given at my doctors office july 24, 2021. but there was only slight pressure. the 2nd does of Pfizer was given at the Pharmacy the symptoms got worst.. more pressure then ringing in my air mostly when there is ambulation.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain after each injection for about 2 weeks consistant.  On and off ? same feeling? last a very short time of 1 day each time.  In July, symptoms return only constant 24/7, very severe and with numbness/tingling.  Tried everything over the counter to help symptoms, no relief.  A month went by with no relief,  went  into see my Primary care on 8/16/21, described my left arm issue...he was concerned and even agreed with me that this might be vaccine related.  Prescribed a regimen of prescriptions that have helped with the pain but numbness and tingling still there throughout the day, every day.  Im currently taking  Vitamin C, D, Ivermectin, prednisone, Icosapent, atorvastatin.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Hypoaesthesia, Magnetic resonance imaging, Pain in extremity
Clinical narrative: I did have a sore arm the 2 days following injection.  The 5th day following the injection, my left hand fell asleep/ went numb, about 10 min later my left arm had the same feelings, approximately 10-15 min after my arm, my left leg had the same feeling and about 10 minutes after my leg,  my left foot had the same feelings. Approximately 15 minutes after my foot,  I had an intense headache.  My daughter took me to ER where I was treated for stroke symptoms.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Dizziness, Fatigue
Clinical narrative: Weakness; sick all over; feel achy; Irritated throat; Coughing; soar arm; Fever; exhaustion/tired/Feel faint exhaustion/extremely tired; Dizziness/light headed; Feel faint; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included MULTIVITAMINS [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ESSENTIAL OILS NOS and PANTOPRAZOLE for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache). On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weakness), ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache) had resolved. At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever) had not resolved and ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: under 101 (High) under 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient was ingesting DoTERRA essential oils each day to detox from heavy metals and other toxins. Cilantro, frankincense, coriander, cinnamon, lemon,cardamom and a couple of other blends. -5 drops of each. patient has not taken any vitamins and supplements for 2 days other than turmeric, probiotic, Zyrtec. He said he will will resume all vitamins, supplements tomorrow-day4. Dizzy, lite headed, weak were recovered with Ongoing slightly   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up  received on 12-AUG-2021 ,contains patient demographics, allergies, Batch no,concomitant medication and events. On 12-Aug-2021: Significant follow-up appended as events added
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Pain in extremity, Presyncope
Clinical narrative: Weakness; sick all over; feel achy; Irritated throat; Coughing; soar arm; Fever; exhaustion/tired/Feel faint exhaustion/extremely tired; Dizziness/light headed; Feel faint; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included MULTIVITAMINS [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ESSENTIAL OILS NOS and PANTOPRAZOLE for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache). On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weakness), ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache) had resolved. At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever) had not resolved and ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: under 101 (High) under 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient was ingesting DoTERRA essential oils each day to detox from heavy metals and other toxins. Cilantro, frankincense, coriander, cinnamon, lemon,cardamom and a couple of other blends. -5 drops of each. patient has not taken any vitamins and supplements for 2 days other than turmeric, probiotic, Zyrtec. He said he will will resume all vitamins, supplements tomorrow-day4. Dizzy, lite headed, weak were recovered with Ongoing slightly   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up  received on 12-AUG-2021 ,contains patient demographics, allergies, Batch no,concomitant medication and events. On 12-Aug-2021: Significant follow-up appended as events added
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Weakness; sick all over; feel achy; Irritated throat; Coughing; soar arm; Fever; exhaustion/tired/Feel faint exhaustion/extremely tired; Dizziness/light headed; Feel faint; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included MULTIVITAMINS [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ESSENTIAL OILS NOS and PANTOPRAZOLE for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache). On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weakness), ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (Dizziness/light headed), PRESYNCOPE (Feel faint), FATIGUE (exhaustion/tired/Feel faint exhaustion/extremely tired) and HEADACHE (slight headache) had resolved. At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (soar arm) and PYREXIA (Fever) had not resolved and ILLNESS (sick all over), MYALGIA (feel achy), THROAT IRRITATION (Irritated throat) and COUGH (Coughing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: under 101 (High) under 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient was ingesting DoTERRA essential oils each day to detox from heavy metals and other toxins. Cilantro, frankincense, coriander, cinnamon, lemon,cardamom and a couple of other blends. -5 drops of each. patient has not taken any vitamins and supplements for 2 days other than turmeric, probiotic, Zyrtec. He said he will will resume all vitamins, supplements tomorrow-day4. Dizzy, lite headed, weak were recovered with Ongoing slightly   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up  received on 12-AUG-2021 ,contains patient demographics, allergies, Batch no,concomitant medication and events. On 12-Aug-2021: Significant follow-up appended as events added
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Hands trembling / shaking; This case was received (Reference number: 2021-001169) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Hands trembling / shaking) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced TREMOR (Hands trembling / shaking). On 12-Aug-2021, TREMOR (Hands trembling / shaking) was resolving.            No concomitant medication was provided  Treatment medication was not provided by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Nausea
Clinical narrative: shaking muscle; abdominal burning; Headache; Nausea; joint pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (joint pain) in a 70-year-old male 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 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 12-Aug-2021, the patient experienced TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) had not resolved.            No concomitant medications reported.   Treatment information not reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: shaking muscle; abdominal burning; Headache; Nausea; joint pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (joint pain) in a 70-year-old male 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 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 12-Aug-2021, the patient experienced TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, TREMOR (shaking muscle), ABDOMINAL DISCOMFORT (abdominal burning), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) had not resolved.            No concomitant medications reported.   Treatment information not reported.   Reporter did not allow further contact
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first dose in August 2020/second dose yesterday 26-JUL-2021; No additional AE's reported; she is just getting conflicting information from the doctor; This spontaneous report was received from a consumer calling on behalf of her son and refers to a 20-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date in August 2020, the patient received the first dose of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (formulation, strength, exact dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis and for some reason got confused in terms of the schedule. The doctor never called them to schedule the next dose. Caller stated she ended up calling and scheduling the second dose herself. Caller wanted to confirm the schedule for doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Yesterday on 26-JUL-2021, her son received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (formulation, strength, exact dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis and that was a time period of eleven months between the 1st and 2nd dose (inappropriate schedule of product administration). Caller wanted to know when does he get the third dose because she spoke to a doctor yesterday, they suggested she call us to know when to get the third one, and at first wanted them to start the series over. Caller stated the doctor called her back and said they did not need to start over, the first and second doses are cleared. Caller stated she is just getting conflicting information from the doctor (circumstance or information capable of leading to medication error) so she wanted to just confirm the dosing schedule since her son was late receiving the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No additional information was provided. No additional AE's reported (no adverse event). The outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was given after having a temperature excursion/ The vaccin had been storage in the refrigerator; No other issues reported; This spontaneous report has been received from a pharmacist concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On an unspecified date, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T036561, expiration date 28-OCT-2022, which upon internal validation was determined to be valid) (dose, vaccination scheme frequency, routes and anatomical locations of administration were not reported) as prophylaxis (product storage error).   The involved vaccine was stored in the refrigerator and underwent a temperature excursion (exact temperature not provided) for approximately 2 days (not dates specified) per caller; also recorded by a data logger. Was unknown if underwent previous temperature excursions. The reporter inquired about the vaccine storage information. No other issues reported (no adverse event).  This case has been classified as non-valid due to the lack of patient's identifiers.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AEs; administration of an expired vaccine; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not provided.   On 30-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (1 time dose, lot# 1602281, expiration date 21-JUL-2021; strength and route were unknown) for prophylaxis (expired product administered). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Age: 26.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event; The patient received MMRII intramuscularly instead subcutaneously; This spontaneous report was received from a Healthcare Business Professional and refers to a 26-year-old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On 13-AUG-2021, the patient was vaccinated with a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), intramuscularly, lot # S036662, expiration date 14-NOV-2021, (dose not reported)  for prophylaxis. No additional adverse event and no product quality complaint.  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2108USA004588:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: No other AE reported; small amount of the PROQUAD was not administered during the injection; This spontaneous report as received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not provided.  On 16-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin)(PROQUAD) lot # T034823 was confirmed to be valid, expiration date 11-APR-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. During the injection, a "small amount of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin)(PROQUAD) was not administered. No adverse effects were reported.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; Ill-defined disorder; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 70 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 01-DEC-2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, Plaintiff was treated by healthcare provider in a healthcare facility for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related injuries. The outcome of the events was unknown.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 2-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error). The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004878:
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 13-months-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (route of administration, dose number and dose were not provided) (lot#: T034613, expiration date: 10-APR-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004895: US-009507513-2108USA004878: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004892:
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 2-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (therapy type: recombinant human albumin (rHA) (route of administration, dose number and dose were not provided) (lot#: T028299, expiration date: 16-FEB-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004878: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004892:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional Adverse events; expired dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.     On 16-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S019463 has been verified to be valid expiration date 24-JUN-2021, 0.5 milliliter for prophylaxis (strength, frequency and administration route were not reported), (experienced expired product administered). No adverse event was reported .
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Malaise, Pruritus, Pyrexia
Clinical narrative: red bumps/ looked fluid filled.; Red bump; Burning sensation all over skin; very tired; itchy all over; small bumps on her arm; fever; under the weather; This case was reported by a nurse via sales rep and described the occurrence of generalized pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 1st dose of Shingrix. On 7th August 2021, 30 min after receiving Shingrix, the patient experienced generalized pruritus, papular rash, fever and feeling unwell. On 8th August 2021, the patient experienced burning sensation, tiredness and red rash. On 9th August 2021, the patient experienced vesicles. On an unknown date, the outcome of the generalized pruritus, papular rash, fever, feeling unwell, burning sensation, tiredness, vesicles and red rash were unknown.   It was unknown if the reporter considered the generalized pruritus, papular rash, fever, feeling unwell, burning sensation, tiredness, vesicles and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced itching all over and small bump on arm 30 minutes after vaccination. By evening very itchy with fever and under the weather. Next day the same. Burning sensation all over skin, very tired.  Then red bumps appeared on both arms. Two days after vaccination, the bumps spread to torso, abdomen and back and looked fluid filled.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: red bumps/ looked fluid filled.; Red bump; Burning sensation all over skin; very tired; itchy all over; small bumps on her arm; fever; under the weather; This case was reported by a nurse via sales rep and described the occurrence of generalized pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 1st dose of Shingrix. On 7th August 2021, 30 min after receiving Shingrix, the patient experienced generalized pruritus, papular rash, fever and feeling unwell. On 8th August 2021, the patient experienced burning sensation, tiredness and red rash. On 9th August 2021, the patient experienced vesicles. On an unknown date, the outcome of the generalized pruritus, papular rash, fever, feeling unwell, burning sensation, tiredness, vesicles and red rash were unknown.   It was unknown if the reporter considered the generalized pruritus, papular rash, fever, feeling unwell, burning sensation, tiredness, vesicles and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced itching all over and small bump on arm 30 minutes after vaccination. By evening very itchy with fever and under the weather. Next day the same. Burning sensation all over skin, very tired.  Then red bumps appeared on both arms. Two days after vaccination, the bumps spread to torso, abdomen and back and looked fluid filled.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got 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 anyway. The reporter stated that, it was terrible. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer 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 shingles (it was very painful).   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 again. 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 were not provided.
Sex: U
Vaccine: VARZOS, 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received a dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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 details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received Zostavax and both the doses of Shingrix, and the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Still painful years later; This case was reported by a consumer via interactive digital media (suspecetd )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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 still got shingles and was still painful years later. 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; still got them bad; 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 himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles bad. The follow-up would not possible as no contact details were available. 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 social media 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 weeks 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 case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingles vaccine and weeks later had the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. Note: As the number of weeks after which the patient experienced shingles was not confirmed hence considering the worst case approach, this case was considered as suspected vaccination failure case.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female 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 details were provided as follows: The case reported by patient's friend. The age at vaccination was not reported. The reported stated that the patient got shingles then she got the shot to prevent getting shingles again and then she got the shingles again after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and as details regarding laboratory confirmation of shingles was 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, 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 case was reported by patient's friend.  The age at vaccination was not reported. The reporter stated that the patient suffered with shingles after taking the Shingles vaccine, why there were class action lawsuits, but we did not want to talk about that part. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation shingles was not reported. The case has been linked with the case US2021AMR174882 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR174882:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/I got shingles/6 months after/ the shingles shot; shingles; some kind of pain; 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, 6 months 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 details provided were as follows: Age at vaccination was not reported. The case was reported by patient himself/herself. The patient received Shingles vaccine and after 6 months patient experienced shingles and was in some kind of pain. The patient stated that if vaccine was supposed to make it better he/she would hate to see worse. Follow-up would not be possible as no contact details provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/My shingles shot didn't work; My shingles shot didn't work; 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 provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated that the Shingles shot did not work for him/her and experienced shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: I'm miserable; suspected vaccination failure; had 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.   Co-suspect products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for covid-19 prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of MODERNA (MRNA RIBONUCLEIC ACID VACCINE). In May 2021, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the Shingles vaccine last year and had shingles since May. The patient got them after his/her second Moderna vaccine. The patient was miserable. The patient had started a new round of treatment as they didn't quite go away. The patient stated that he/she wouldn't wish this on anybody. It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Moderna vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.