chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Night sweats
Clinical narrative: hot flashes; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes) and NIGHT SWEATS (night sweats) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy since an unknown date.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-abdominal) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes) and NIGHT SWEATS (night sweats). At the time of the report, HOT FLUSH (hot flashes) and NIGHT SWEATS (night sweats) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Non-significant followup added to include AE contact info,gender,initials updated
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles; Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles; Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles; Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles), CHILLS (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles), NAUSEA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles) and MYALGIA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergy to honey).    On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 20-Jun-2021, the patient experienced PYREXIA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles), CHILLS (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles), NAUSEA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles) and MYALGIA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency. On 21-Jun-2021, PYREXIA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles), CHILLS (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles), NAUSEA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles) and MYALGIA (Temperature 39,3 for 25 hours, severe chills, nausea, severe pain in muscles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   Treatment included Paracetamol.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears always ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears always ringing) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Undifferentiated connective tissue disease and Depression. Concomitant products included BUPROPION for Depression.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced TINNITUS (Ears always ringing). On 22-Jun-2021, TINNITUS (Ears always ringing) had resolved.            No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site exfoliation, Injection site warmth
Clinical narrative: Injection site turned red and warm, then started to peel like a sunburn.; Injection site turned red and warm, then started to peel like a sunburn.; Injection site turned red and warm, then started to peel like a sunburn.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXFOLIATION (Injection site turned red and warm, then started to peel like a sunburn.), INJECTION SITE WARMTH (Injection site turned red and warm, then started to peel like a sunburn.) and INJECTION SITE ERYTHEMA (Injection site turned red and warm, then started to peel like a sunburn.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE EXFOLIATION (Injection site turned red and warm, then started to peel like a sunburn.), INJECTION SITE WARMTH (Injection site turned red and warm, then started to peel like a sunburn.) and INJECTION SITE ERYTHEMA (Injection site turned red and warm, then started to peel like a sunburn.). At the time of the report, INJECTION SITE EXFOLIATION (Injection site turned red and warm, then started to peel like a sunburn.), INJECTION SITE WARMTH (Injection site turned red and warm, then started to peel like a sunburn.) and INJECTION SITE ERYTHEMA (Injection site turned red and warm, then started to peel like a sunburn.) was resolving.            Not concomitant therapy information was provided.  No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Musculoskeletal discomfort, Oropharyngeal discomfort, Pharyngeal swelling
Clinical narrative: Daily swelling of glands in throat /internal swelling in central portion of neck / throat; Throat discomfort; Neck discomfort; Inappropriate route of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Daily swelling of glands in throat /internal swelling in central portion of neck / throat), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and MUSCULOSKELETAL DISCOMFORT (Neck discomfort) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Hypothyroidism since 01-Jan-2003. Concomitant products included LEVOTHYROXINE from 01-Jan-2003 to an unknown date for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 05-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Daily swelling of glands in throat /internal swelling in central portion of neck / throat), OROPHARYNGEAL DISCOMFORT (Throat discomfort) and MUSCULOSKELETAL DISCOMFORT (Neck discomfort). The patient was treated with IBUPROFEN ongoing from 05-Feb-2021 for Throat swelling, at a dose of UNK, prn. On 03-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PHARYNGEAL SWELLING (Daily swelling of glands in throat /internal swelling in central portion of neck / throat) outcome was unknown and OROPHARYNGEAL DISCOMFORT (Throat discomfort) and MUSCULOSKELETAL DISCOMFORT (Neck discomfort) had not resolved.            Patient after receiving vaccine, patient experienced daily internal swelling in the central portion of my neck/throat. Patient said not a sore throat and there is no pain in swallowing. It is more of a slight strangulation type feeling.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow-up received 27Jul2021 contains throat discomfort and neck discomfort.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: collar bone have been sore; armpit areas have been sore; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (collar bone have been sore) and AXILLARY PAIN (armpit areas have been sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (collar bone have been sore) and AXILLARY PAIN (armpit areas have been sore). At the time of the report, LYMPHADENOPATHY (collar bone have been sore) and AXILLARY PAIN (armpit areas have been sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-JUN-2021 contains no significant information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate abnormal, Loss of personal independence in daily activities, Myalgia
Clinical narrative: I can't perform cna job today; Heart rate is extremely as if I been scared by something; Soar arm chills tiredness; Soar arm chills tiredness; Soar arm chills tiredness/My arm is sore; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't perform cna job today), HEART RATE ABNORMAL (Heart rate is extremely as if I been scared by something), CHILLS (Soar arm chills tiredness), FATIGUE (Soar arm chills tiredness) and MYALGIA (Soar arm chills tiredness/My arm is sore) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 22-Jun-2021, the patient experienced CHILLS (Soar arm chills tiredness), FATIGUE (Soar arm chills tiredness) and MYALGIA (Soar arm chills tiredness/My arm is sore). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't perform cna job today) and HEART RATE ABNORMAL (Heart rate is extremely as if I been scared by something). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't perform cna job today) and HEART RATE ABNORMAL (Heart rate is extremely as if I been scared by something) outcome was unknown and CHILLS (Soar arm chills tiredness), FATIGUE (Soar arm chills tiredness) and MYALGIA (Soar arm chills tiredness/My arm is sore) had not resolved.        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.   No concomitant medication was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-Jun-2021 contained new events (loss of personal independence in daily activities, heart rate abnormal).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia, Vertigo
Clinical narrative: fast heartbeat; dizziness; vertigo; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heartbeat), DIZZINESS (dizziness) and VERTIGO (vertigo) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced TACHYCARDIA (fast heartbeat), DIZZINESS (dizziness) and VERTIGO (vertigo). On 23-Jun-2021, TACHYCARDIA (fast heartbeat), DIZZINESS (dizziness) and VERTIGO (vertigo) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that the patient sometimes feels pain when at work. No concomitant medication reported. No treatment medication was reported.   This case was linked to MOD-2021-236025, MOD-2021-236025 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Paraesthesia, Rash, Vaccination site rash
Clinical narrative: Have a red spot near the injection site. That looks like a rash; Rash, sweats, numbness and tingling; Rash, sweats, numbness and tingling; Rash, sweats, numbness and tingling; Rash, sweats, numbness and tingling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Rash, sweats, numbness and tingling), HYPOAESTHESIA (Rash, sweats, numbness and tingling), PARAESTHESIA (Rash, sweats, numbness and tingling), RASH (Rash, sweats, numbness and tingling) and VACCINATION SITE RASH (Have a red spot near the injection site. That looks like a rash) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination.     Sojgrens, Lupus, arthritis, small fiber neuropathy.  Concurrent medical conditions included Sjogren's, Lupus syndrome, Arthritis and Small fiber neuropathy.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERHIDROSIS (Rash, sweats, numbness and tingling), HYPOAESTHESIA (Rash, sweats, numbness and tingling), PARAESTHESIA (Rash, sweats, numbness and tingling) and RASH (Rash, sweats, numbness and tingling). On an unknown date, the patient experienced VACCINATION SITE RASH (Have a red spot near the injection site. That looks like a rash). At the time of the report, HYPERHIDROSIS (Rash, sweats, numbness and tingling), HYPOAESTHESIA (Rash, sweats, numbness and tingling), PARAESTHESIA (Rash, sweats, numbness and tingling), RASH (Rash, sweats, numbness and tingling) and VACCINATION SITE RASH (Have a red spot near the injection site. That looks like a rash) had not resolved.            Concomitant products were not reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-Jun-2021 contains significant information and an event is added(Have a red spot near the injection site) with unknown date and unknown outcome.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of urticaria (hives traveling all over body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included drug allergy. Allergic to sulfa. On Jun 15, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 16, 2021, patient experienced urticaria (hives traveling all over body). The patient treated with hydrocortisone for itching, at an unspecified dose and frequency. At the time of the report, urticaria (hives traveling all over body): not resolved. For mRNA-1273 (Moderna COVID-19 vaccine), intramuscular dosing remained unchanged. Concomitant medications not reported. Patient experienced itchy, red bumps; popping up all over body (including scalp).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin irritation
Clinical narrative: Rash/skin irritation continuing 2 months after getting the vaccine; Rash/skin irritation continuing 2 months after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Rash/skin irritation continuing 2 months after getting the vaccine) and RASH (Rash/skin irritation continuing 2 months after getting the vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Allergic to dogs, cats, dust mites, cockroaches.  Concurrent medical conditions included Allergic to dogs, Allergic to cats, Dust allergy and Cockroach allergy.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced SKIN IRRITATION (Rash/skin irritation continuing 2 months after getting the vaccine) and RASH (Rash/skin irritation continuing 2 months after getting the vaccine). On 27-Jun-2021, RASH (Rash/skin irritation continuing 2 months after getting the vaccine) had not resolved. At the time of the report, SKIN IRRITATION (Rash/skin irritation continuing 2 months after getting the vaccine) had not resolved.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Headache, Incorrect route of product administration, Injection site pain
Clinical narrative: Pain in left side of face/left side of my face was very tender to the touch; Headache/terrible headache; fatigued/extremely tired for 3 days; Injection site pain; Felt very nauseaous; Intravenous route of administration; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Pain in left side of face/left side of my face was very tender to the touch), HEADACHE (Headache/terrible headache), FATIGUE (fatigued/extremely tired for 3 days), INJECTION SITE PAIN (Injection site pain) and NAUSEA (Felt very nauseaous) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Anxiety.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced FACIAL PAIN (Pain in left side of face/left side of my face was very tender to the touch), HEADACHE (Headache/terrible headache), FATIGUE (fatigued/extremely tired for 3 days), INJECTION SITE PAIN (Injection site pain), NAUSEA (Felt very nauseaous) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration). On 25-Jun-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration) had resolved. On 27-Jun-2021, INJECTION SITE PAIN (Injection site pain) had resolved. On 02-Jul-2021, FACIAL PAIN (Pain in left side of face/left side of my face was very tender to the touch), HEADACHE (Headache/terrible headache), FATIGUE (fatigued/extremely tired for 3 days) and NAUSEA (Felt very nauseaous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided. The concurrent condition of the patient was reported as problems with cholesterol.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up document was received and had significant information. Added patient demographics, new events( nausea ).Updated outcome of events from not recovered to recovered, stop date of the events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Pain in left side of face/left side of my face was very tender to the touch; Headache/terrible headache; fatigued/extremely tired for 3 days; Injection site pain; Felt very nauseaous; Intravenous route of administration; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Pain in left side of face/left side of my face was very tender to the touch), HEADACHE (Headache/terrible headache), FATIGUE (fatigued/extremely tired for 3 days), INJECTION SITE PAIN (Injection site pain) and NAUSEA (Felt very nauseaous) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Anxiety.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced FACIAL PAIN (Pain in left side of face/left side of my face was very tender to the touch), HEADACHE (Headache/terrible headache), FATIGUE (fatigued/extremely tired for 3 days), INJECTION SITE PAIN (Injection site pain), NAUSEA (Felt very nauseaous) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration). On 25-Jun-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intravenous route of administration) had resolved. On 27-Jun-2021, INJECTION SITE PAIN (Injection site pain) had resolved. On 02-Jul-2021, FACIAL PAIN (Pain in left side of face/left side of my face was very tender to the touch), HEADACHE (Headache/terrible headache), FATIGUE (fatigued/extremely tired for 3 days) and NAUSEA (Felt very nauseaous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided. The concurrent condition of the patient was reported as problems with cholesterol.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up document was received and had significant information. Added patient demographics, new events( nausea ).Updated outcome of events from not recovered to recovered, stop date of the events.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: extreme fatigue; unsteady on feet; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jun-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) and GAIT DISTURBANCE (unsteady on feet) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced FATIGUE (extreme fatigue) and GAIT DISTURBANCE (unsteady on feet). On 05-Jun-2021, FATIGUE (extreme fatigue) and GAIT DISTURBANCE (unsteady on feet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Significant follow up. Information regarding events from first dose updated to reflect follow-up information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Pyrexia
Clinical narrative: slight arm discomfort; I only ran a fever of 100.6 for 6 hours; 2nd Vacc developed severe ache in R lg musc.Went to R shoulder.Constant & need meds after3 months; This case was reported through a regulatory authority by a registered user and has provided consent for follow-up contact. You may send follow-up letter at:  ******************* START OF PRODUCT TAB ********************** -----------------START OF Moderna Vaccine---------------------------------  ##Vaccine Dose Number in Series (Vaccine use only) :Second Dose ##Site of administration :Right Arm ##Will additional vaccine be administered? (For Vaccine Use Only) :Unknown -------------------END OF Moderna Vaccine--------------------------------- ******************* END OF PRODUCT TAB ********************** ******************* START OF EVENT TAB ********************** -----------------START OF 2nd Vacc developed severe ache in R lg musc.Went to R shoulder.Constant & need meds after3 months---------------------------------  ##Describe the side effect in more detail and if any treatment was needed: Cannot take NSAIDS but I take Tylenol and on some days Vicodin as the pain is so constant and severe I can't  sleep or get ant relief. The entire large muscle aches and goes up into my R shoulder . NEVER had ANY problems until I got the COVID Vaccine. I only ran a fever of 100.6 for 6 hours with slight arm discomfort after #2 which was controlled with Tylenol. ##Was the side effect serious?: Unknown -------------------END OF 2nd Vacc developed severe ache in R lg musc.Went to R shoulder.Constant & need meds after3 months--------------------------------- ******************* END OF EVENT TAB ********************** *******************START OF  Patient ******************** ##What is the gender of the person experiencing the side effect?: Female ##Was or are they pregnant?: No ##Please provide results of tests/labs, medical history, allergies, etc. Do not provide any patient identifiable information (e.g. name, DOB) in this box:: Healthy, active female allergic to Morphine, Diladid, Tordol, Haldol, Tetanus   ********************END OF  Patient ********************
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Condition aggravated, Tinnitus
Clinical narrative: pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of; Tinnitus with a volume of about 7-8 out of 10; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus with a volume of about 7-8 out of 10) and CONDITION AGGRAVATED (pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001b21a and 011m20a) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (volume of 1-2 out of 10 for 5 years). Previously administered products included for an unreported indication: HYDROXYCHLOROQUINE (I have had tinnitus at the 1-2/10 level for 5 years that was triggered by a 3 month course of hydroxychloroquine for my rheumatoid arthritis.). Concurrent medical conditions included Fibromyalgia, Rheumatoid arthritis, Osteo arthritis knees (Osteo arthritis), Blood pressure, Sjogren's and Sulfonamide allergy (Sulpha medications.). Concomitant products included LISINOPRIL, LEVOTHYROXINE, GABAPENTIN, AMITRIPTYLINE and VITAMIN D NOS for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus with a volume of about 7-8 out of 10). On 25-Mar-2021, the patient experienced CONDITION AGGRAVATED (pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of). The patient was treated with PREDNISONE (oral) on 05-Apr-2021 at a dose of 50 mg once a day. On 15-Mar-2021, TINNITUS (Tinnitus with a volume of about 7-8 out of 10) had resolved. At the time of the report, CONDITION AGGRAVATED (pre existing tinnitus that was at a volume of 1-2 out of 10 for 5 years, increased to a volume of 7-8 out of) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: very good hearing (normal) My hearing was not changed from last hearing test which was 5 years ago.  Audiologist said I have very good hearing..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received, patient demographic details updated, patient medical history updated, concomitant medications added, event outcome for the event tinnitus volume around 7-8/10 changed to recovered.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Food tastes bitter; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Food tastes bitter) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Food tastes bitter). At the time of the report, DYSGEUSIA (Food tastes bitter) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever/I have a fever of 100.4-100.5 all day I got my second shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever/I have a fever of 100.4-100.5 all day I got my second shot) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PYREXIA (fever/I have a fever of 100.4-100.5 all day I got my second shot). At the time of the report, PYREXIA (fever/I have a fever of 100.4-100.5 all day I got my second shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Body temperature: 100.4-100.5 increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided.   This case was linked to MOD-2021-189743 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021 and contains no new information
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009DZIA) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transdermal) 1 dosage form once. On 29-Jun-2021, the patient experienced PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever) and NAUSEA (Nausea) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-Significant Follow-up Appended
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: facial numbness; right side of the face tingling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (facial numbness) and PARAESTHESIA (right side of the face tingling) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine headache.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced HYPOAESTHESIA (facial numbness) and PARAESTHESIA (right side of the face tingling). At the time of the report, HYPOAESTHESIA (facial numbness) and PARAESTHESIA (right side of the face tingling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Photophobia, Vomiting
Clinical narrative: Crippling migraine; Light sensitivity; pain; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Crippling migraine), PHOTOPHOBIA (Light sensitivity), PAIN (pain), VOMITING (vomiting) and NAUSEA (nausea) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 03-Jun-2021, the patient experienced MIGRAINE (Crippling migraine), PHOTOPHOBIA (Light sensitivity), PAIN (pain), VOMITING (vomiting) and NAUSEA (nausea). On 04-Jun-2021, MIGRAINE (Crippling migraine), PHOTOPHOBIA (Light sensitivity), PAIN (pain), VOMITING (vomiting) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by reporter. No treatment information was provided by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac output, Influenza like illness, Loss of consciousness
Clinical narrative: Passed out a month after vaccine due to heart output insufficiency; Flu like symptoms 48 hrs; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out a month after vaccine due to heart output insufficiency) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out a month after vaccine due to heart output insufficiency) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms 48 hrs). On 28-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out a month after vaccine due to heart output insufficiency) and INFLUENZA LIKE ILLNESS (Flu like symptoms 48 hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Cardiac output: insufficient (Low) Heart output insufficiency.         No concomitant medication reported. No treatment information was provided. The patient reported that the immune response to the second dose caused the adverse events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s age (69 years) is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s age (69 years) is a confounder.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Heart rate
Clinical narrative: Severe body rigors; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Severe body rigors) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025LEOA) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement (replacement of mitral and aortic valves) in 2017 and Aortic valve replacement in 2017. Concurrent medical conditions included Hodgkin's lymphoma (Non Hodgkins Lymphoma in 2002 and is in remission.) since 2002, Cancer and Heart disorder.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced CHILLS (Severe body rigors) (seriousness criterion hospitalization prolonged). At the time of the report, CHILLS (Severe body rigors) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood pressure measurement: low (Low) Low blood pressure. On 01-May-2021, Heart rate: high (High) Fast heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CHILLS (Severe body rigors) to be possibly related.    No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: The follow-up document was received on 10 August 2021 and contains no new information.; Sender's Comments: Although patient's medical history is confounding, based on the current available information, a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: The patient was administered VARIVAX on 19-JUL-2021. She had a positive pregnancy test at home on 21-JUL-2021; No additional adverse events reported; This spontaneous prospective pregnancy report was received from a nurse prescriber, regarding a 37-year-old female patient.   On an unspecified date (reported as, prior vaccine administration), the patient had an negative urine pregnancy test, negative human chorionic gonadotropin (HCG) test, and an unspecified negative ultrasound; ;also, laboratories were performed, which determined that she was non-immune to varicella but was immune to measles, mumps and rubella (MMR). The reporter stated the patient could had polycystic ovary syndrome (PCOS) for which the patient was started on medication to help with her ovulation as well as prenatal vitamins (not further specified). The patient's drug reactions or allergies were not reported. The patient became pregnant with last menstrual period (LMP) reported as 27-JUN-2021 (and estimated date of delivery (EDD) of 03-APR-2022), based on a pregnancy gestation reported as three weeks (3 weeks) at the time of the report.  On 19-JUL-2021, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T035400, has been verified to be a valid lot number, expiration date reported and established as: 16-OCT-2022) (vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis; however, on 21-JUN-2021, the patient had a home pregnancy test which reported a positive result (exposure during pregnancy). At the time of the report, the pregnancy outcome was pending, the fetal outcome was not provided, and the patient did not experience any additional adverse events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 09-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the Zoster Vaccine Live (ZOSTAVAX) the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers, and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient's symptoms had resulted in physical limitations do not present prior to the vaccine, also mental and emotional distress due to resulting physical limitations and seriousness of her condition. Patient sustained severe and permanent personal injuries. Further, as a tragic consequence, patient suffered serious, progressive, permanent, and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Also, had suffered and incurred damages, including medical expenses, loss of accumulations, and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster was considered as not recovered. The reporters considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event reported; expired dose of vaccine was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-SEP-2019, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # N028443 has been verified to be a valid lot number, expiration date was reported as 09-APR-2019, albumin status rHA (formulation, strength, frequency and route of administration were not reported) for prophylaxis. No additional adverse event was reported. The medical assistant noticed the event going through records. No temperature excursion was for this lot #.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; post-herpetic neuralgia; all of its sequelae; This spontaneous report was received from a lawyer and a 56-year-old female patient regarding a case in litigation on 10-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In March 2018, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location and indication was not provided), she had 56-year-old when she received the vaccine. As a result of her receipt Zoster Vaccine Live (ZOSTAVAX), in March 2018, the patient suffered shingles and post-herpetic neuralgia, including any and all of its sequelae. As a result of the foregoing acts and omissions, the patient was caused to suffered serious and dangerous side effects including shingles and post-herpetic neuralgia, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and or medications. As a result of the foregoing acts and omissions the patient required and will require more health care and services and did incur medical, health, she will in the future be required to obtain further medical and hospital care, attention and services. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Deafness bilateral, Deafness neurosensory, Exposure keratitis, Facial paralysis
Clinical narrative: Bilateral Sensorinerural Hearing Loss; Ramsey Hunt Syndrome; Paralytic Lagophthalmos; Exposure Keratopathy; Severe Ocular synkinesis; tinnitus; herpes zoster; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 10-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around 23-AUG-2010, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient suffered left sided facial paralysis, blisters, ringing in her ears, and vision problems and was diagnosed with herpes zoster, bilateral sensorineural hearing loss, tinnitus, ramsey hunt syndrome, paralytic lagophthalmos, severe ocular synkinesis, and exposure keratopathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events deafness neurosensory, herpes zoster oticus, and paralytic lagophthalmos were considered to be medically significant.