chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: continuous discomfort on her left arm; big rash 8 inches in length and 3-4 inches width; itching; hot; tender; sweaty; hot/She stated she woke up feeling hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PAIN (tender) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (tender), HYPERHIDROSIS (sweaty) and FEELING HOT (hot/She stated she woke up feeling hot). At the time of the report, VACCINATION SITE DISCOMFORT (continuous discomfort on her left arm), VACCINATION SITE RASH (big rash 8 inches in length and 3-4 inches width), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (tender), HYPERHIDROSIS (sweaty) and FEELING HOT (hot/She stated she woke up feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was mentioned. Treatment medication includes Benadryl and Cortisone cream.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm at the injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J02A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore left arm at the injection site.). At the time of the report, VACCINATION SITE PAIN (Sore left arm at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  The consumer stated that she took treatment, but did not specified at the time of reporting.   This case was linked to MOD-2021-313029 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Looked like a sunburn all over my body except my face; Very itchy; Felt like shards of glass on my skin; Very painful; Skin rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Looked like a sunburn all over my body except my face), PRURITUS (Very itchy), PAIN (Felt like shards of glass on my skin), PAIN (Very painful) and RASH (Skin rash all over) 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 RASH ERYTHEMATOUS (Looked like a sunburn all over my body except my face), PRURITUS (Very itchy), PAIN (Felt like shards of glass on my skin), PAIN (Very painful) and RASH (Skin rash all over). At the time of the report, RASH ERYTHEMATOUS (Looked like a sunburn all over my body except my face), PRURITUS (Very itchy), PAIN (Felt like shards of glass on my skin), PAIN (Very painful) and RASH (Skin rash all over) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information included kena given to the patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Pyrexia
Clinical narrative: had a fever; unable to sleep; felt uncomfortable; tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), FEELING ABNORMAL (felt uncomfortable), FATIGUE (tired) and PYREXIA (had a fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J02A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced INSOMNIA (unable to sleep), FEELING ABNORMAL (felt uncomfortable) and FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (had a fever). At the time of the report, INSOMNIA (unable to sleep), FEELING ABNORMAL (felt uncomfortable), FATIGUE (tired) and PYREXIA (had a fever) outcome was unknown.            No concomitant medications were provided. Caller took treatments.   This case was linked to MOD-2021-313006 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Bodyaches, headache, fever, red area at injection site and painful arm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block, Cardiac discomfort, Chest X-ray normal, Dizziness, Dyspnoea
Clinical narrative: 3 days after my second dose I started having the following symptoms: heart racing, palpitations, extreme shortness of breath, dizziness. These symptoms have escalated over the past three weeks And I have been seen at the ER twice and saw my primary care team three times. I have had two EKGs , Three different rounds of blood draws and numerous tests done I have had two chest x-rays and a CT scan of my chest done with contrast as well as ultrasounds of my legs.  During my last ER visit I was treated for cardiac inflammation with an IV dose of Toradol and I was sent home with a seven day prescription for an anti-inflammatory pill.  After my last ER visit I was sent to my PCM to be scheduled for an ultrasound of both of my legs as they have swollen up quite a bit and my D dimer levels indicated that there could be blood clots forming. No clots were found on any of the scans or ultrasounds . my cardiac symptoms improved slightly after the IV medication three days ago but symptoms have not resolved if anything I feel like they are now getting more acute especially in the evenings.  I have been referred to a cardiac specialist and will reach out to them on Monday as today the weekend.  I feel like I am having one constant heart attack and I am unable to sleep or do most things right now including basic physical activity when prior to my second Covid shot I was in great physical condition and able to walk my son to school almost every day which is 3 miles away when now I can?t even walk across my room without feeling like my heart is going to explode and I?m going to faint. I have every symptom of myocarditis And have no pre-existing heart conditions.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer increased, Heart rate, Heart rate increased, Insomnia
Clinical narrative: 3 days after my second dose I started having the following symptoms: heart racing, palpitations, extreme shortness of breath, dizziness. These symptoms have escalated over the past three weeks And I have been seen at the ER twice and saw my primary care team three times. I have had two EKGs , Three different rounds of blood draws and numerous tests done I have had two chest x-rays and a CT scan of my chest done with contrast as well as ultrasounds of my legs.  During my last ER visit I was treated for cardiac inflammation with an IV dose of Toradol and I was sent home with a seven day prescription for an anti-inflammatory pill.  After my last ER visit I was sent to my PCM to be scheduled for an ultrasound of both of my legs as they have swollen up quite a bit and my D dimer levels indicated that there could be blood clots forming. No clots were found on any of the scans or ultrasounds . my cardiac symptoms improved slightly after the IV medication three days ago but symptoms have not resolved if anything I feel like they are now getting more acute especially in the evenings.  I have been referred to a cardiac specialist and will reach out to them on Monday as today the weekend.  I feel like I am having one constant heart attack and I am unable to sleep or do most things right now including basic physical activity when prior to my second Covid shot I was in great physical condition and able to walk my son to school almost every day which is 3 miles away when now I can?t even walk across my room without feeling like my heart is going to explode and I?m going to faint. I have every symptom of myocarditis And have no pre-existing heart conditions.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Palpitations, Peripheral swelling, Scan normal, Ventilation/perfusion scan
Clinical narrative: 3 days after my second dose I started having the following symptoms: heart racing, palpitations, extreme shortness of breath, dizziness. These symptoms have escalated over the past three weeks And I have been seen at the ER twice and saw my primary care team three times. I have had two EKGs , Three different rounds of blood draws and numerous tests done I have had two chest x-rays and a CT scan of my chest done with contrast as well as ultrasounds of my legs.  During my last ER visit I was treated for cardiac inflammation with an IV dose of Toradol and I was sent home with a seven day prescription for an anti-inflammatory pill.  After my last ER visit I was sent to my PCM to be scheduled for an ultrasound of both of my legs as they have swollen up quite a bit and my D dimer levels indicated that there could be blood clots forming. No clots were found on any of the scans or ultrasounds . my cardiac symptoms improved slightly after the IV medication three days ago but symptoms have not resolved if anything I feel like they are now getting more acute especially in the evenings.  I have been referred to a cardiac specialist and will reach out to them on Monday as today the weekend.  I feel like I am having one constant heart attack and I am unable to sleep or do most things right now including basic physical activity when prior to my second Covid shot I was in great physical condition and able to walk my son to school almost every day which is 3 miles away when now I can?t even walk across my room without feeling like my heart is going to explode and I?m going to faint. I have every symptom of myocarditis And have no pre-existing heart conditions.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram normal
Clinical narrative: Received a Pfizer shot at a pharmacy.  Two or three days after the second dose, I began feeling a tightness in my chest.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Hardness, swelling, redness, and severe itch 8 days after vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: got rash 2 weeks after first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (got rash 2 weeks after first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (got rash 2 weeks after first shot). At the time of the report, RASH (got rash 2 weeks after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment history was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Alpha 1 globulin, Head discomfort
Clinical narrative: he started feeling pressure sensation around his head; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (he started feeling pressure sensation around his head) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEAD DISCOMFORT (he started feeling pressure sensation around his head). At the time of the report, HEAD DISCOMFORT (he started feeling pressure sensation around his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Alpha 1 globulin (0.2-0.3): high (High) 0.4.         It was stated that patient visited a neurologist and test results were normal except for one abnormal factor.  No concomitant medications were reported by reporter Treatment information was not provided by reporter
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient administered 1st Moderna dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st Moderna dose). On 05-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: He has not had a 2nd dose. It's been 76 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He has not had a 2nd dose. It's been 76 days.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, 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 DOSE OMISSION ISSUE (He has not had a 2nd dose. It's been 76 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He has not had a 2nd dose. It's been 76 days.) 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.   Concomitant medications were not reported.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine administered to 100 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to 100 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) 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 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to 100 patients). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to 100 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly, The Nurse had a temperature high alert for vaccine stored in the refrigerator. 600 doses were affected. No patients had received any of the vaccine. The vials were closed and were stored in their boxes.   Lot 034C21A had 200 doses  Lot number 008C21A with expiration date 31-OCT-2021 had 400 doses. The vials were placed in the refrigerator on 10-MAY-2021.  Doses were administered to approximately 100 patients since 10-JUN-2021 from Moderna Covid-19 vaccine that had been stored in the refrigerator since the beyond used date passed on 10-JUN-2021.  Generalized Adverse event had been reported. No patients information was available.  Nurse and physician had granted permission for Safety to contact her with e-mail or telephone.  Concomitant product use was not provided.  Treatment product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow-up  received on 14-Sep-2021 and contains NNI.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose > 6 months after first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose > 6 months after first shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose > 6 months after first shot). On 08-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose > 6 months after first shot) had resolved.        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 product use was provided by the reporter. No treatment medication was provided.  The patient ever received the second dose because he felt that he had 70% efficacy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received 54 days after the 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 54 days after the 1st dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088d21a and 3002332) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 54 days after the 1st dose). On 08-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 54 days after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: worried and concerned; dizzy; she feels yucky and miserable; she's experimenting blurry vision, blurred vision; headaches; achy/ got hit like a ton of bricks; one minute she has fever, next minute the fever is broken; her arm aches from the shot; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY, dizzy, VACCINATION COMPLICATION, VISION BLURRED, and HEADACHES in a 59-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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced ANXIETY, DIZZINESS, VACCINATION COMPLICATION, VISION BLURRED, HEADACHE, MYALGIA, PYREXIA, and VACCINATION SITE PAIN. At the time of the report, ANXIETY, DIZZINESS, VACCINATION COMPLICATION, VISION BLURRED, HEADACHE, MYALGIA, PYREXIA, and VACCINATION SITE PAIN outcome was unknown.            No concomitant medications were reported. No treatment details were reported. She provided one lot number 033C21A, but could not specify of which dose it was.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vision blurred
Clinical narrative: worried and concerned; dizzy; she feels yucky and miserable; she's experimenting blurry vision, blurred vision; headaches; achy/ got hit like a ton of bricks; one minute she has fever, next minute the fever is broken; her arm aches from the shot; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY, dizzy, VACCINATION COMPLICATION, VISION BLURRED, and HEADACHES in a 59-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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced ANXIETY, DIZZINESS, VACCINATION COMPLICATION, VISION BLURRED, HEADACHE, MYALGIA, PYREXIA, and VACCINATION SITE PAIN. At the time of the report, ANXIETY, DIZZINESS, VACCINATION COMPLICATION, VISION BLURRED, HEADACHE, MYALGIA, PYREXIA, and VACCINATION SITE PAIN outcome was unknown.            No concomitant medications were reported. No treatment details were reported. She provided one lot number 033C21A, but could not specify of which dose it was.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Nasal congestion
Clinical narrative: some nose bleeding; nasal congestion; having on and off chills for 1 week; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (some nose bleeding), NASAL CONGESTION (nasal congestion) and CHILLS (having on and off chills for 1 week) 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) (Intramuscular) 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 EPISTAXIS (some nose bleeding), NASAL CONGESTION (nasal congestion) and CHILLS (having on and off chills for 1 week). At the time of the report, EPISTAXIS (some nose bleeding), NASAL CONGESTION (nasal congestion) and CHILLS (having on and off chills for 1 week) outcome was unknown.            No Concomitant medication was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis, Malaise, Myalgia
Clinical narrative: Patient sat on stairs and developed a very bad sunburn; Had severe body aches; Patient was sweating; Patient felt very unwell; Patient coloring was off; Patient looked flushed; Patient was super thirsty; Patient had chills; Fever of 99.9F,Fever spiked to 104 F.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Patient was sweating), MALAISE (Patient felt very unwell), PALLOR (Patient coloring was off), FLUSHING (Patient looked flushed) and THIRST (Patient was super thirsty) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PYREXIA (Fever of 99.9F,Fever spiked to 104 F.) and CHILLS (Patient had chills). On 03-Sep-2021, the patient experienced HYPERHIDROSIS (Patient was sweating), MALAISE (Patient felt very unwell), PALLOR (Patient coloring was off), FLUSHING (Patient looked flushed), THIRST (Patient was super thirsty) and MYALGIA (Had severe body aches). On 04-Sep-2021, the patient experienced SUNBURN (Patient sat on stairs and developed a very bad sunburn). At the time of the report, HYPERHIDROSIS (Patient was sweating), MALAISE (Patient felt very unwell), PALLOR (Patient coloring was off), FLUSHING (Patient looked flushed), THIRST (Patient was super thirsty), SUNBURN (Patient sat on stairs and developed a very bad sunburn), PYREXIA (Fever of 99.9F,Fever spiked to 104 F.), MYALGIA (Had severe body aches) and CHILLS (Patient had chills) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Pyrexia, Sunburn, Thirst
Clinical narrative: Patient sat on stairs and developed a very bad sunburn; Had severe body aches; Patient was sweating; Patient felt very unwell; Patient coloring was off; Patient looked flushed; Patient was super thirsty; Patient had chills; Fever of 99.9F,Fever spiked to 104 F.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Patient was sweating), MALAISE (Patient felt very unwell), PALLOR (Patient coloring was off), FLUSHING (Patient looked flushed) and THIRST (Patient was super thirsty) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PYREXIA (Fever of 99.9F,Fever spiked to 104 F.) and CHILLS (Patient had chills). On 03-Sep-2021, the patient experienced HYPERHIDROSIS (Patient was sweating), MALAISE (Patient felt very unwell), PALLOR (Patient coloring was off), FLUSHING (Patient looked flushed), THIRST (Patient was super thirsty) and MYALGIA (Had severe body aches). On 04-Sep-2021, the patient experienced SUNBURN (Patient sat on stairs and developed a very bad sunburn). At the time of the report, HYPERHIDROSIS (Patient was sweating), MALAISE (Patient felt very unwell), PALLOR (Patient coloring was off), FLUSHING (Patient looked flushed), THIRST (Patient was super thirsty), SUNBURN (Patient sat on stairs and developed a very bad sunburn), PYREXIA (Fever of 99.9F,Fever spiked to 104 F.), MYALGIA (Had severe body aches) and CHILLS (Patient had chills) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Insomnia, Myalgia, Rash, Vaccination site swelling
Clinical narrative: barely slept; bad rash; Swelling at the injection site; arm soreness which really hurt his muscles so bad; armpit hurt; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm soreness which really hurt his muscles so bad), INSOMNIA (barely slept), RASH (bad rash), VACCINATION SITE SWELLING (Swelling at the injection site) and AXILLARY PAIN (armpit hurt) in a 50-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 14-Aug-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (arm soreness which really hurt his muscles so bad), INSOMNIA (barely slept), RASH (bad rash), VACCINATION SITE SWELLING (Swelling at the injection site) and AXILLARY PAIN (armpit hurt). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, MYALGIA (arm soreness which really hurt his muscles so bad), INSOMNIA (barely slept), RASH (bad rash), VACCINATION SITE SWELLING (Swelling at the injection site) and AXILLARY PAIN (armpit hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported by reporter
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient administered first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient administered first dose of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient administered first dose of Moderna vaccine). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient administered first dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up received and reporter contact details was updated
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: nerve vibration on both legs, both feet, both hands, both knees, and back.; nerve tingling both legs, both feet, both hands, both knees, and back.; numbness on both legs, both feet, both hands, both knees, and back.; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve vibration on both legs, both feet, both hands, both knees, and back.) in a 56-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 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve vibration on both legs, both feet, both hands, both knees, and back.) (seriousness criterion medically significant), PARAESTHESIA (nerve tingling both legs, both feet, both hands, both knees, and back.) and HYPOAESTHESIA (numbness on both legs, both feet, both hands, both knees, and back.). At the time of the report, NEUROPATHY PERIPHERAL (nerve vibration on both legs, both feet, both hands, both knees, and back.), PARAESTHESIA (nerve tingling both legs, both feet, both hands, both knees, and back.) and HYPOAESTHESIA (numbness on both legs, both feet, both hands, both knees, and back.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was no provided.  Patient had reached out to HCP who has done blood test and MRI  Patient did not have her vaccination card present and unable to provide lot #sor expiration dates of the products. Patient stated that the adverse events started few days before (11Jun2021) her 2nd dose of the vaccine. The adverse events were still ongoing Patient has reached out to HCP who has done blood test and MRI. Physicians were still not able to figure out the cause. Patient has not been prescribed any medications to alleviate the symptoms by HCP. Patient gave safety consent to follow up via email. Patient gave consent to follow up with vaccination site.; Sender's Comments: This case concerns a 56-year-old, female subject with no significant medical history reported, who experienced the unexpected events of neuropathy peripheral, paresthesia, and hypoaesthesia. The events occurred 5-days prior to study drug administration. The rechallenge is not applicable in this case. The reporter's assessment is not provided in this case.The benefit-risk relationship of the vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Almost sure I have  COVID; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Almost sure I have  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 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Almost sure I have  COVID). At the time of the report, SUSPECTED COVID-19 (Almost sure I have  COVID) 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm, Ultrasound scan
Clinical narrative: 3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Aneurysm (It was found that the size had increased to 4.2 cm.). Concomitant products included AMLODIPINE, ASPIRIN, and VITAMIN C for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANEURYSM (3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm). At the time of the report, ANEURYSM (3 weeks after getting the 1st shot, I had an ultrasound of the aneurysm/it went up to 4.2 cm from 3 cm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal 4.2 cm Size.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamin once a day. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: the tingling numbness in her left hand got worse; tingling numbness moved into her left leg; the tingling numbness moved into her left arm and moved into her whole left side; numbness in her left hand; felt totally wiped out; pain in her left hand; tingling in her left hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her left hand), PARAESTHESIA (tingling in her left hand), HYPOAESTHESIA (the tingling numbness in her left hand got worse), HYPOAESTHESIA (tingling numbness moved into her left leg) and HYPOAESTHESIA (the tingling numbness moved into her left arm and moved into her whole left side) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052CorE21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in her left hand) and PARAESTHESIA (tingling in her left hand). On 06-Sep-2021, the patient experienced FATIGUE (felt totally wiped out). On 07-Sep-2021, the patient experienced HYPOAESTHESIA (numbness in her left hand). On 08-Sep-2021, the patient experienced HYPOAESTHESIA (the tingling numbness in her left hand got worse), HYPOAESTHESIA (tingling numbness moved into her left leg) and HYPOAESTHESIA (the tingling numbness moved into her left arm and moved into her whole left side). At the time of the report, PAIN IN EXTREMITY (pain in her left hand), PARAESTHESIA (tingling in her left hand), HYPOAESTHESIA (the tingling numbness in her left hand got worse), HYPOAESTHESIA (tingling numbness moved into her left leg), HYPOAESTHESIA (the tingling numbness moved into her left arm and moved into her whole left side), HYPOAESTHESIA (numbness in her left hand) and FATIGUE (felt totally wiped out) outcome was unknown.            Patient had reported that she tested negative twice then but felt all the symptoms and felt the worst in the house as other in the house were Covid positive and sick. Patient also reported that on 06-SEP-2021 she felt worse with the vaccine than she did in July of 2020. On Tuesday she got better but had numbness in her hand that got worse and radiate to her left arm, then left leg and to the whole left side of body.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Tingling left shoulder; Pain  left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling left shoulder) and ARTHRALGIA (Pain  left shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PARAESTHESIA (Tingling left shoulder) and ARTHRALGIA (Pain  left shoulder). At the time of the report, PARAESTHESIA (Tingling left shoulder) and ARTHRALGIA (Pain  left shoulder) outcome was unknown.            Patient advised he visited his PCF and was being referred to a Neurologist.   No concomitant medication listed.  No treatment information provided.   This case was linked to MOD-2021-313197 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: head hurts; feels like vertigo; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head hurts) and VERTIGO (feels like vertigo) 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 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head hurts) and VERTIGO (feels like vertigo). At the time of the report, HEADACHE (head hurts) and VERTIGO (feels like vertigo) outcome was unknown.            No concomitant medications were reported by reporter Treatment information was not provided by reporter
Sex: U
Vaccine: COVID19
Symptoms: Eye disorder, Headache, Muscular weakness
Clinical narrative: appears he is experiencing muscle weakness; eye drooping; persistent headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCULAR WEAKNESS (appears he is experiencing muscle weakness), EYE DISORDER (eye drooping) and HEADACHE (persistent headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.    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 MUSCULAR WEAKNESS (appears he is experiencing muscle weakness), EYE DISORDER (eye drooping) and HEADACHE (persistent headache). At the time of the report, MUSCULAR WEAKNESS (appears he is experiencing muscle weakness), EYE DISORDER (eye drooping) and HEADACHE (persistent headache) outcome was unknown.        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 relevant concomitant medications were reported. No treatment information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: my right arm is sore; pressure in my chest; tingly feeling in my head; felt a little bit funny/ feel a little bit off; heat in my stomach/ my stomach was so hot; Weird side effects; very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure in my chest), PARAESTHESIA (tingly feeling in my head), FEELING ABNORMAL (felt a little bit funny/ feel a little bit off), ABDOMINAL DISCOMFORT (heat in my stomach/ my stomach was so hot) and VACCINATION COMPLICATION (Weird side effects) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced CHEST DISCOMFORT (pressure in my chest), PARAESTHESIA (tingly feeling in my head), FEELING ABNORMAL (felt a little bit funny/ feel a little bit off), ABDOMINAL DISCOMFORT (heat in my stomach/ my stomach was so hot), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (very tired). On an unknown date, the patient experienced MYALGIA (my right arm is sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (pressure in my chest), PARAESTHESIA (tingly feeling in my head), FEELING ABNORMAL (felt a little bit funny/ feel a little bit off), ABDOMINAL DISCOMFORT (heat in my stomach/ my stomach was so hot), VACCINATION COMPLICATION (Weird side effects), FATIGUE (very tired) and MYALGIA (my right arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes citrocine two a day (Regularly but not everyday)
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination complication
Clinical narrative: my right arm is sore; pressure in my chest; tingly feeling in my head; felt a little bit funny/ feel a little bit off; heat in my stomach/ my stomach was so hot; Weird side effects; very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure in my chest), PARAESTHESIA (tingly feeling in my head), FEELING ABNORMAL (felt a little bit funny/ feel a little bit off), ABDOMINAL DISCOMFORT (heat in my stomach/ my stomach was so hot) and VACCINATION COMPLICATION (Weird side effects) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced CHEST DISCOMFORT (pressure in my chest), PARAESTHESIA (tingly feeling in my head), FEELING ABNORMAL (felt a little bit funny/ feel a little bit off), ABDOMINAL DISCOMFORT (heat in my stomach/ my stomach was so hot), VACCINATION COMPLICATION (Weird side effects) and FATIGUE (very tired). On an unknown date, the patient experienced MYALGIA (my right arm is sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (pressure in my chest), PARAESTHESIA (tingly feeling in my head), FEELING ABNORMAL (felt a little bit funny/ feel a little bit off), ABDOMINAL DISCOMFORT (heat in my stomach/ my stomach was so hot), VACCINATION COMPLICATION (Weird side effects), FATIGUE (very tired) and MYALGIA (my right arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes citrocine two a day (Regularly but not everyday)