chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: very concerned and anxious about her future prognosis with symptoms lasting now 5 months; left ear pain, fluid, and fullness; left ear pain, fluid, and fullness; left ear pain, fluid, and fullness; very enlarged, firm, and painful lymph nodes; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes), EAR PAIN (left ear pain, fluid, and fullness), ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes). On 15-Jun-2021, the patient experienced EAR PAIN (left ear pain, fluid, and fullness), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness). On an unknown date, the patient experienced ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months). At the time of the report, LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes), EAR PAIN (left ear pain, fluid, and fullness), ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Ultrasound Doppler: abnormal (abnormal) 1 cm node with non-pathological results..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Symptoms: It was reported that on 10-Apr-2021, the patient started experienced a cluster of swollen lymph nodes in supraclavicular fossa on the left side, became enlarged, firm & painful, she had an appointment with ENT for the symptoms as the adenopathy was not completely resolved, pain was resolved but she had non painful nodes in that region. She was prescribed a TMJ regimen. After she was undergone an ultrasound which showed that left ear pain was resolved with minimal fullness, her follow up was schedule for Feb 2022.  No concomitant medications were reported No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse
Clinical narrative: relapse of Multiple Sclerosis; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Blood pressure high, Strength loss of, Walker user and Bladder incontinence. Concomitant products included OCRELIZUMAB (OCREVUS), FUROSEMIDE (LASIX [FUROSEMIDE]), CARVEDILOL, POTASSIUM, OXYBUTYNIN, OLMESARTAN and FAMPRIDINE (AMPYRA) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) had resolved.            Treatment information was not provided by reporter.  It was reported that events occurred 1.5 days after patient received the vaccination and resolved after 1.5 days after started.  This case refers to a 61-year-old female patient with a medical history of Multiple sclerosis, Blood pressure high and Bladder incontinence, who experienced the unexpected event of Multiple Sclerosis Relapse at an unspecified time after exposure to Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. Rechallenge was reported as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a 61-year-old female patient with a medical history of Multiple sclerosis, Blood pressure high and Bladder incontinence, who experienced the unexpected event of Multiple Sclerosis Relapse at an unspecified time after exposure to Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. Rechallenge was reported as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Throat irritation
Clinical narrative: most horrible heartburn he's ever had in his life overnight; felt like his whole throat was going to be burned out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) and THROAT IRRITATION (felt like his whole throat was going to be burned out) in a 51-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) and THROAT IRRITATION (felt like his whole throat was going to be burned out). At the time of the report, DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) had resolved and THROAT IRRITATION (felt like his whole throat was going to be burned out) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-314852, MOD-2021-314862 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (severe abdominal pain). At the time of the report, ABDOMINAL PAIN (severe abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Vaccination site erythema
Clinical narrative: bruise at left arm got very large; left under arm was swollen under armpit; big red spot at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site). At the time of the report, CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Skin mass, Swelling, Vaccination site pain
Clinical narrative: I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone; I found a lump between my left armpit & left breast & it's swollen; soreness in left shoulder at the injection site; I was feeling pain in the middle of my chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I was feeling pain in the middle of my chest), SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone), SWELLING (I found a lump between my left armpit & left breast & it's swollen) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced CHEST PAIN (I was feeling pain in the middle of my chest) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site). On 07-Sep-2021, the patient experienced SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone) and SWELLING (I found a lump between my left armpit & left breast & it's swollen). At the time of the report, CHEST PAIN (I was feeling pain in the middle of my chest), SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone), SWELLING (I found a lump between my left armpit & left breast & it's swollen) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrolyte imbalance
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of electrolyte imbalance  (low electrolytes) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022C21A) for COVID-19 immunization. Concurrent medical conditions included eczema (demographic skin) and multiple allergies. On Mar 8, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced electrolyte imbalance (low electrolytes). At the time of the report, electrolyte imbalance (low electrolytes) outcome unknown/not provided. Diagnostic results: On an unknown date, blood test: low electrolytes. No concomitant medications or treatment information reported. This case linked to MOD-2021-314919 (patient link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cough, Illness, SARS-CoV-2 test
Clinical narrative: COVID-19 pneumonia; too sick; pneumonia-related cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). In September 2021, the patient experienced ILLNESS (too sick) and COUGH (pneumonia-related cough). The patient was treated with CODEINE for Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia), ILLNESS (too sick) and COUGH (pneumonia-related cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was treated with unspecified steroid medications for pneumonia related cough. No concomitant medications were reported. The patient was concerned about the possibility of the vaccine being the cause of testing positive for COVID19  Company comment: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected events of COVID-19 pneumonia. The event occurred approximately 8 days after the second dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The event was downgrade to non-serious due the patient was not hospitalized or meet the criteria for seriousness. The benefit-risk relationship of S mRNA-1273 in not affected by this report.; Sender's Comments: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected events of COVID-19 pneumonia. The event occurred approximately 8 days after the second dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The event was downgrade to non-serious due the patient was not hospitalized or meet the criteria for seriousness. The benefit-risk relationship of S mRNA-1273 in not affected by this report.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm at the injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Allergy to shrimp).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (I had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (I had a sore arm at the injection site) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.    This case was linked to MOD-2021-314922 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Antiphospholipid syndrome, Blood test, Lethargy, Protein S
Clinical narrative: I recently had some blood tests and had an antiphospholipid antibody syndrome; Maybe a bit of lethargy/ very mild; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) in a  patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) (seriousness criterion medically significant) and LETHARGY (Maybe a bit of lethargy/ very mild). At the time of the report, ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) and LETHARGY (Maybe a bit of lethargy/ very mild) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: had an antiphospholipid antibody syndrome (abnormal) had an antiphospholipid antibody syndrome. On an unknown date, Protein S: very low protein s (Low) very low protein S.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a patient with no previous relevant medical history, who experienced the unexpected event of antiphospholipid syndrome and lethargy. The rechallenge was not applicable since no information about the dates available. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a patient with no previous relevant medical history, who experienced the unexpected event of antiphospholipid syndrome and lethargy. The rechallenge was not applicable since no information about the dates available. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Hypersensitivity, Nausea, Paraesthesia
Clinical narrative: Vaccinated twice with Moderna. Both times I had an allergic reaction; Metallic taste in mouth; My lips and right check were tingling; Nausea; First shot: headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Vaccinated twice with Moderna. Both times I had an allergic reaction), DYSGEUSIA (Metallic taste in mouth), PARAESTHESIA (My lips and right check were tingling), NAUSEA (Nausea) and HEADACHE (First shot: headache) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Vaccinated twice with Moderna. Both times I had an allergic reaction), DYSGEUSIA (Metallic taste in mouth), PARAESTHESIA (My lips and right check were tingling), NAUSEA (Nausea) and HEADACHE (First shot: headache). At the time of the report, HYPERSENSITIVITY (Vaccinated twice with Moderna. Both times I had an allergic reaction) and PARAESTHESIA (My lips and right check were tingling) outcome was unknown and DYSGEUSIA (Metallic taste in mouth), NAUSEA (Nausea) and HEADACHE (First shot: headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported   This case was linked to MOD-2021-315328 (Patient Link).   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Skin papilloma
Clinical narrative: More than 35 days from first dose/ second shot has not been given yet; Wart on right wrist; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PAPILLOMA (Wart on right wrist) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Clotting disorder.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced SKIN PAPILLOMA (Wart on right wrist). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet). At the time of the report, SKIN PAPILLOMA (Wart on right wrist) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The historical vaccine Flu shot was reported and adverse event experienced was Wart.  No Treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal
Clinical narrative: Stroke after third dose; On 06Sep2021, patient started to feel poorly; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke after third dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced FEELING ABNORMAL (On 06Sep2021, patient started to feel poorly). On 08-Sep-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke after third dose) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 08-Sep-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke after third dose) had not resolved and FEELING ABNORMAL (On 06Sep2021, patient started to feel poorly) outcome was unknown.            The patient reported to be suffering from a stroke after receiving the third dose of the Moderna COVID-19 vaccine on 04-SEP-2021. On 06-SEP-2021, the patient reportedly started to feel poorly. On 07-SEP-2021, the patient said she went into work and had to leave early. On 08-SEP-2021, the patient was admitted to the hospital for stroke.   Company Comment:  This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 4 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and patient was hospitalized at the same day. The rechallenge was not applicable, as the event happened after the third dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of  mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 4 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and patient was hospitalized at the same day. The rechallenge was not applicable, as the event happened after the third dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of  mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My daughter was 17 and accidentally was administered the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose) in a 17-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose) had resolved.            No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had one shot and a week later had covid.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had one shot and a week later had covid.) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had one shot and a week later had covid.). At the time of the report, COVID-19 (had one shot and a week later had covid.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medications were reported.  Patient was asking should she get the second shot.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms after 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd shot) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd shot). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd shot) outcome was unknown.            No concomitant medications were reported.  No treatment information were reported.   Reporter did not allow further contact
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Dementia Alzheimer's type
Clinical narrative: patient is having a starting dementia; Alzheimer; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (patient is having a starting dementia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Alzheimer's disease.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (patient is having a starting dementia) (seriousness criterion medically significant) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) (seriousness criterion medically significant). At the time of the report, DEMENTIA (patient is having a starting dementia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.  Company Comment: This case concerns a  male subject with relevant family history of Alzheimer who experienced the unexpected events of Dementia and Alzheimer's disease. It does not remain clear if the events occured prior of after the first dose of Spikevax. The rechallenge was not applicable as there is only information of the first dose. The medical family history of Alzheimer could be a  risk  factor for the events. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a  male subject with relevant family history of Alzheimer who experienced the unexpected events of Dementia and Alzheimer's disease. It does not remain clear if the events occured prior of after the first dose of Spikevax. The rechallenge was not applicable as there is only information of the first dose. The medical family history of Alzheimer could be a  risk  factor for the events. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Vaccination site pain
Clinical narrative: his arm was sore; kinda tired for 3 days; Nosebleed; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), VACCINATION SITE PAIN (his arm was sore) and FATIGUE (kinda tired for 3 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced EPISTAXIS (Nosebleed). On an unknown date, the patient experienced VACCINATION SITE PAIN (his arm was sore) and FATIGUE (kinda tired for 3 days). On 10-Apr-2021, EPISTAXIS (Nosebleed) had resolved. At the time of the report, VACCINATION SITE PAIN (his arm was sore) outcome was unknown and FATIGUE (kinda tired for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had nosebleed that just started spontaneously, it lasted for 10 to 15 minutes . Patient did not receive any medication for nosebleed and patient just put pressure on  his nose  with a Kleenex and overtime it clotted.   This case was linked to MOD-2021-297968 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: no serious side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (no serious side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (no serious side effects). At the time of the report, VACCINATION COMPLICATION (no serious side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Increased bronchial secretion, Insomnia
Clinical narrative: fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INCREASED BRONCHIAL SECRETION (fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight) and INSOMNIA (can't sleep) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCREASED BRONCHIAL SECRETION (fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight) and INSOMNIA (can't sleep). At the time of the report, INCREASED BRONCHIAL SECRETION (fluid buildup in my bronchia/Fluid in lungs/Fluid in lungs overnight) and INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment history was not reported.; Sender's Comments: This case concerns a patient of unknown age, sex and history who experienced the unlisted events of Increased bronchial secretions and Insomnia after the first dose of Moderna COVID-19 vaccine. No re-challenge is noted. The benefit-risk relationship of Moderna COVID -19 vaccine is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Throat tightness, Tremor
Clinical narrative: Odd Tightness in his Throat/same type pressure in his throat; Arms and Legs Shaking, Trembling and Quivering; Face turned a little bit red; Arms and Legs Shaking, Trembling and Quivering; This is a spontaneous report from a contactable consumer (patient, self-reported). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9269 and expiry date was not reported), via an unspecified route of administration, on 10Mar2021 at 14:15 (age at vaccination: 55 years), as a single dose for COVID-19 immunization. The patient's medical history included multiple sclerosis (MS) and bee venom allergy. Concomitant medication included fingolimod hydrochloride (GILENYA) for multiple sclerosis. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Feb2021 (age at vaccination: 55 years), as a single dose for COVID-19 immunization and had odd tightness in his throat. Vaccine was not administered at Military Facility. The patient stated that on 10Mar2021, he had his second dose. At that point, it was within 2 hours, he had odd Tightness in his Throat/same type pressure in his throat and his arms and legs were shaking and quivering. He stated that he went to the emergency room and the doctor there gave him medication and he ended up getting discharged. He stated that he woke up this morning and had the same thing, trembling in his arms and legs. The patient stated that his question was, how common was that and when did that go away. He stated that steroids took care of that and a corticosteroid. When he woke up and took it, it had been such a long time since the last dose he took of prednisone. He has waited 2 hours and 10 minutes to talk to call handler, so he did have time. He didn't have the pressure in his throat yesterday because he had prednisone late in the day, so Thursday he didn't have it and today as of this morning he has it. He stated that things were getting better, he was not in the ER, stated he guesses once he gets thorough this and arms and legs weren't shaking, so for now unknown. He will find out tomorrow if his arms and legs weren't shaking. The patient's face turned a little bit red which occurred after both the first and second vaccine and only lasted a short time. The patient took Prednisone once a day, Benadryl every 6 hours by mouth. Outcome of the event odd tightness in his throat/same type pressure in his throat was recovering, face turned a little bit red was recovered on 10Mar2021, and for all other events, it was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Apathy, Body temperature, Body temperature decreased, Depressed mood, Irritability
Clinical narrative: I feel irritable; don't have motivation and depressed; don't have motivation and depressed; body temperature was 95.5; This is a spontaneous report from a Pfizer-sponsored program Acaria Xeljanz Program. A contactable consumer (patient) reported that a 63-year-old female patient received tofacitinib citrate (XELJANZ XR, strength: 11 mg), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg, once a day for an unspecified indication; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Age at vaccination was 63-year-old. Medical history included penicillin allergies, rheumatoid arthritis, and depression. Concomitant medications included metoprolol tartrate, fluticasone propionate, atorvastatin calcium, clopidogrel bisulfate (PLAVIX), ascorbic acid, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX + VITAMIN C), pantoprazole sodium, folic acid, ascorbic acid (VITAMIN C), tramadol hydrochloride, acetylsalicylic acid (ASPIR LOW), alendronate sodium, lisinopril, fish oil, solifenacin succinate (VESICARE), sumatriptan succinate, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), naproxen, prednisone, colecalciferol (VITAMIN D 3), cyanocobalamin (VITAMIN B12), and vitamin D2. Patient indicated she had already started Xeljanz six months ago. As per patient she was fully vaccinated with the Pfizer COVID-19 vaccine. Her second dose was on 05Jul2021.She reported that she was temporarily off Xeljanz between vaccine doses as instructed by her physician but "although she has a history of depression" this feels different. She feels irritable, like she has a fever although her body temperature was 95.5, she doesn't have motivation and depressed. Patient reported she lives alone and confirmed she does not have thoughts of hurting herself or others. Reviewed dose, frequency and administration route. Patient wanted to know if these new symptoms could be related to DDI from Xeljanz and COVID-19 vaccine. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: body aches/ intense Pain; nausea; This is a spontaneous report from a contactable consumer.  A 60-years-old non-pregnant female patient that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number) via an unspecified route of administration, administered on unspecified date in 2021 as Dose 1, single for and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown) via an unspecified route of administration, administered on unspecified date as Dose 2, single (age at vaccination was 60-years-old) for covid-19 immunisation. The patient received most recent COVID-19 vaccine was administered. The patient had unknown allergies. The patient medical history include fibromyalgia and heart disease. Concomitant medication was not reported. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received other medications within 2 weeks of vaccination was unknown. On 23Jul2021, patient experienced body aches, intense pain, nausea. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Polymerase chain reaction
Clinical narrative: Nausea; Vomiting; Fever; Chills; Muscle aches; Extreme fatigue; Swelling; Red circle rash; Pain at injection site; This is a spontaneous report from a contactable consumer (patient) received via the Regulatory Authority. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:00 (Batch/Lot Number: EN6199) (at the age of 28-years-old) as dose 2, single for COVID-19 immunisation. Medical history included bipolar 2; depression; anxiety; obesity. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX); zolpidem tartrate (AMBIEN); lamotrigine (LAMICTAL ER); venlafaxine hydrochloride (VENLAFAXINE XR); cetirizine hydrochloride (ZYRTEC); all taken for an unspecified indication, start and stop dates were not reported. The patient previously took codeine and experienced drug allergy; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 09Feb2021 at 11:45 (Batch/Lot Number: EN9581)  (at the age of 28-years-old) for COVID-19 immunisation and experienced fever, chills, and  pain at injection site. The patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. The patient experienced extreme fatigue on 03Mar2021, night of second dose; nausea, vomiting, fever, chills and muscle aches on 04Mar2021 at 15:00 day after second dose; swelling, red circle rash and pain at injection site on an unspecified date in Mar2021, for 4 days following second dose. The patient underwent laboratory tests which included Saliva rt pcr: negative on 05Mar2021. The patient received Ibuprofen for the events. The adverse events resulted to none. The events were assessed as non-serious. The outcome of events extreme fatigue, nausea, vomiting, fever, chills and muscle aches was recovering; while outcome of events swelling, red circle rash and pain at injection site was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Swelling, Vaccination site pain, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; Chills; Muscle aches; Extreme fatigue; Swelling; Red circle rash; Pain at injection site; This is a spontaneous report from a contactable consumer (patient) received via the Regulatory Authority. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:00 (Batch/Lot Number: EN6199) (at the age of 28-years-old) as dose 2, single for COVID-19 immunisation. Medical history included bipolar 2; depression; anxiety; obesity. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX); zolpidem tartrate (AMBIEN); lamotrigine (LAMICTAL ER); venlafaxine hydrochloride (VENLAFAXINE XR); cetirizine hydrochloride (ZYRTEC); all taken for an unspecified indication, start and stop dates were not reported. The patient previously took codeine and experienced drug allergy; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 09Feb2021 at 11:45 (Batch/Lot Number: EN9581)  (at the age of 28-years-old) for COVID-19 immunisation and experienced fever, chills, and  pain at injection site. The patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. The patient experienced extreme fatigue on 03Mar2021, night of second dose; nausea, vomiting, fever, chills and muscle aches on 04Mar2021 at 15:00 day after second dose; swelling, red circle rash and pain at injection site on an unspecified date in Mar2021, for 4 days following second dose. The patient underwent laboratory tests which included Saliva rt pcr: negative on 05Mar2021. The patient received Ibuprofen for the events. The adverse events resulted to none. The events were assessed as non-serious. The outcome of events extreme fatigue, nausea, vomiting, fever, chills and muscle aches was recovering; while outcome of events swelling, red circle rash and pain at injection site was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: experiencing pain when she takes a deep breath that extends to her right shoulder blade after receiving the first dose of the Pfizer COVID vaccine.; experiencing pain when she takes a deep breath that extends to her right shoulder blade after receiving the first dose of the Pfizer COVID vaccine.; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- unknown), intramuscular in arm right on 23Jul2021 (age at vaccination 51 years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. On 24Jul2021 patient experienced pain when she takes a deep breath that extends to her right shoulder blade after receiving the first dose of the Pfizer COVID vaccine. Therapeutic measures were taken as a result of the adverse events which included Aleve. The outcome of events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.