chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (watery diarrhea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (watery diarrhea). At the time of the report, DIARRHOEA (watery diarrhea) outcome was unknown.            No concomitant and treatment information was provided. Treatment information not provided. The action taken with mRNA-1273 with respect to the event was not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: SORE ARM; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) and PYREXIA (FEVER) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM) and PYREXIA (FEVER). At the time of the report, VACCINATION SITE PAIN (SORE ARM) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  Concomitant medications  were not given.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-Significant FU - Address Provided; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Palpitations, Paraesthesia
Clinical narrative: it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine; "chills running through veins"; Paresthesia (Pins and needles in face); Vison changes; Weakness; Felt faint; Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint) and PALPITATIONS (Heart racing) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included ESCITALOPRAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint), PALPITATIONS (Heart racing) and CHILLS ("chills running through veins"). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine). At the time of the report, PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint), PALPITATIONS (Heart racing), PRODUCT DOSE OMISSION ISSUE (it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine) and CHILLS ("chills running through veins") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: No new information On 23-Jun-2021: Follow up received on 23-jun-2021. significant follow up. The event is added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vision blurred
Clinical narrative: it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine; "chills running through veins"; Paresthesia (Pins and needles in face); Vison changes; Weakness; Felt faint; Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint) and PALPITATIONS (Heart racing) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included ESCITALOPRAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint), PALPITATIONS (Heart racing) and CHILLS ("chills running through veins"). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine). At the time of the report, PARAESTHESIA (Paresthesia (Pins and needles in face)), VISION BLURRED (Vison changes), ASTHENIA (Weakness), DIZZINESS (Felt faint), PALPITATIONS (Heart racing), PRODUCT DOSE OMISSION ISSUE (it has already passed 3 months since she got her first dose of the Moderna COVID-19 Vaccine) and CHILLS ("chills running through veins") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: No new information On 23-Jun-2021: Follow up received on 23-jun-2021. significant follow up. The event is added.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Ocular discomfort, Vision blurred
Clinical narrative: blurred vision; discomfort in left eye; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), OCULAR DISCOMFORT (discomfort in left eye) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and O13M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VISION BLURRED (blurred vision), OCULAR DISCOMFORT (discomfort in left eye) and HEADACHE (headache). At the time of the report, VISION BLURRED (blurred vision), OCULAR DISCOMFORT (discomfort in left eye) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.         Treatment information not provided. List of concomitant medication were not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-079942 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079942:DOSE1
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: breakout spread more and keeps breaking out on her body; rash break out in different parts of her whole body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash break out in different parts of her whole body) and RASH (breakout spread more and keeps breaking out on her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (rash break out in different parts of her whole body). On an unknown date, the patient experienced RASH (breakout spread more and keeps breaking out on her body). At the time of the report, RASH (rash break out in different parts of her whole body) and RASH (breakout spread more and keeps breaking out on her body) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were probiotics which was stopped upon occurence of adverse events.  No laboratory investigations were provided. The Treatment information included Antihistamine (loratadine) 10 mg twice daily
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Rash
Clinical narrative: some kind of pain; rash is still there; spread even more down her arm; left arm started to swell up; small rash; was itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm started to swell up), RASH (small rash), PRURITUS (was itchy), PAIN (some kind of pain) and RASH (rash is still there) in a female patient of an unknown age 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm started to swell up), RASH (small rash) and PRURITUS (was itchy). On 18-Apr-2021, the patient experienced RASH (spread even more down her arm). On 19-Apr-2021, the patient experienced PAIN (some kind of pain) and RASH (rash is still there). At the time of the report, PERIPHERAL SWELLING (left arm started to swell up), RASH (small rash), PRURITUS (was itchy), PAIN (some kind of pain), RASH (rash is still there) and RASH (spread even more down her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid infection after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid infection after receiving the 1st dose of Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (tested positive for covid infection after receiving the 1st dose of Moderna vaccine). At the time of the report, COVID-19 (tested positive for covid infection after receiving the 1st dose of Moderna vaccine) 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 Medical History information was reported. No concomitant information was reported. Treatment information was not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dehydration, Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Dehydrated; Upset with her stomach; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), ABDOMINAL DISCOMFORT (Upset with her stomach) and VACCINATION SITE PAIN (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 15-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and ABDOMINAL DISCOMFORT (Upset with her stomach). On 19-Mar-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and ABDOMINAL DISCOMFORT (Upset with her stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. The patient did not receive any treatment
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: less than 18 year-old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (less than 18 year-old) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-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 19-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (less than 18 year-old). On 19-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (less than 18 year-old) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu-like symptoms; Chills; Fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle aches) 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 02-Apr-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-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle aches) outcome was unknown.            No concomitant drugs and treatment drugs are provided. Treatment information not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: both legs and feet numb; both legs and feet with pins and needles; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both legs and feet numb) and PARAESTHESIA (both legs and feet with pins and needles) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, PREDNISOLONE, ESTRADIOL (ESTROGEN), PROGESTERONE and THYROID (ARMOUR THYROID) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (both legs and feet numb) and PARAESTHESIA (both legs and feet with pins and needles). At the time of the report, HYPOAESTHESIA (both legs and feet numb) and PARAESTHESIA (both legs and feet with pins and needles) was resolving. Not Provided          Treatment details are not provided   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain assessment, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: arm started to itch and became red; red splotches on her arm; arm was a little puffy but not painful; On a pain scale of 1-10, the pain was 0.5.; arm was a pinkish color; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm started to itch and became red), ERYTHEMA (red splotches on her arm), PERIPHERAL SWELLING (arm was a little puffy but not painful), SKIN DISCOLOURATION (arm was a pinkish color) and PAIN ASSESSMENT (On a pain scale of 1-10, the pain was 0.5.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced SKIN DISCOLOURATION (arm was a pinkish color). On 16-Apr-2021, the patient experienced PRURITUS (arm started to itch and became red), ERYTHEMA (red splotches on her arm), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN ASSESSMENT (On a pain scale of 1-10, the pain was 0.5.). At the time of the report, PRURITUS (arm started to itch and became red), ERYTHEMA (red splotches on her arm), PERIPHERAL SWELLING (arm was a little puffy but not painful), SKIN DISCOLOURATION (arm was a pinkish color) and PAIN ASSESSMENT (On a pain scale of 1-10, the pain was 0.5.) outcome was unknown. Not Provided          Treatment information not provided. List of concomitant medication were not given.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: spinning, a terrible vertigo; my head felt light, empy; very dizzy; my head "went away"; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (spinning, a terrible vertigo), DIZZINESS (my head felt light, empy), DIZZINESS (very dizzy) and HEADACHE (my head "went away") in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D), BITIONOL and ASCORBIC ACID (VITAMIN C) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (spinning, a terrible vertigo), DIZZINESS (my head felt light, empy), DIZZINESS (very dizzy) and HEADACHE (my head "went away"). At the time of the report, VERTIGO (spinning, a terrible vertigo), DIZZINESS (my head felt light, empy), DIZZINESS (very dizzy) and HEADACHE (my head "went away") outcome was unknown.            Concomitant medication reported as 5mg/day high blood pressure med. Treatment was recommended Dramamine, but patient haven't bought it yet.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: arm was a pinkish color; Arm started to Itch; arm started to itch and became red; red splotches on her arm which were little puffy but not painful; arm was a little puffy but not painful; On a pain scale of 1-10, the pain was 0.5.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful) and PERIPHERAL SWELLING (arm was a little puffy but not painful) in a 71-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 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN IN EXTREMITY (On a pain scale of 1-10, the pain was 0.5.). At the time of the report, VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN IN EXTREMITY (On a pain scale of 1-10, the pain was 0.5.) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: arm was a pinkish color; Arm started to Itch; arm started to itch and became red; red splotches on her arm which were little puffy but not painful; arm was a little puffy but not painful; On a pain scale of 1-10, the pain was 0.5.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful) and PERIPHERAL SWELLING (arm was a little puffy but not painful) in a 71-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 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN IN EXTREMITY (On a pain scale of 1-10, the pain was 0.5.). At the time of the report, VACCINATION SITE DISCOLOURATION (arm was a pinkish color), PRURITUS (Arm started to Itch), ERYTHEMA (arm started to itch and became red), RASH MACULAR (red splotches on her arm which were little puffy but not painful), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN IN EXTREMITY (On a pain scale of 1-10, the pain was 0.5.) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Hypokinesia, Joint stiffness
Clinical narrative: did not get second shot; weak; hands are swollen; hands are swollen, numb and tingling; hands are swollen, numb and tingling; every bone in my body felt stiff; I couldn't move and I had to throw myself from my body to get up and go to the bathroom; tired; significant whole body pain; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get second shot), ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling) and PARAESTHESIA (hands are swollen, numb and tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neutropenia and COVID-19 pneumonia (for 2.5 months, approximately 8-9 months ago.). Concurrent medical conditions included Asthma and Arthritis.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling), PARAESTHESIA (hands are swollen, numb and tingling), JOINT STIFFNESS (every bone in my body felt stiff), HYPOKINESIA (I couldn't move and I had to throw myself from my body to get up and go to the bathroom), FATIGUE (tired) and MYALGIA (significant whole body pain). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second shot). On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not get second shot) had resolved. At the time of the report, ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling), PARAESTHESIA (hands are swollen, numb and tingling), JOINT STIFFNESS (every bone in my body felt stiff), HYPOKINESIA (I couldn't move and I had to throw myself from my body to get up and go to the bathroom), FATIGUE (tired) and MYALGIA (significant whole body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medicines for asthma. She has talked to her PCP by video visit for her symptoms who referred her to a "bone specialist." Additionally he recommended that she should not receive the second dose of the vaccine. She had been to the emergency room for her symptoms twice. The first time they provided her narcos for her pain which provided relief for about 30 minutes before returning again. The ER doctors also said that her symptoms were due to an arthritis flare up. She said that her white blood cells were normal at those visits. Her last ER visit was on 15-APR-2021   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: No new information reported On 21-Jul-2021: No new information reported
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Peripheral swelling, Product dose omission issue
Clinical narrative: did not get second shot; weak; hands are swollen; hands are swollen, numb and tingling; hands are swollen, numb and tingling; every bone in my body felt stiff; I couldn't move and I had to throw myself from my body to get up and go to the bathroom; tired; significant whole body pain; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get second shot), ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling) and PARAESTHESIA (hands are swollen, numb and tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neutropenia and COVID-19 pneumonia (for 2.5 months, approximately 8-9 months ago.). Concurrent medical conditions included Asthma and Arthritis.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling), PARAESTHESIA (hands are swollen, numb and tingling), JOINT STIFFNESS (every bone in my body felt stiff), HYPOKINESIA (I couldn't move and I had to throw myself from my body to get up and go to the bathroom), FATIGUE (tired) and MYALGIA (significant whole body pain). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second shot). On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not get second shot) had resolved. At the time of the report, ASTHENIA (weak), PERIPHERAL SWELLING (hands are swollen), HYPOAESTHESIA (hands are swollen, numb and tingling), PARAESTHESIA (hands are swollen, numb and tingling), JOINT STIFFNESS (every bone in my body felt stiff), HYPOKINESIA (I couldn't move and I had to throw myself from my body to get up and go to the bathroom), FATIGUE (tired) and MYALGIA (significant whole body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medicines for asthma. She has talked to her PCP by video visit for her symptoms who referred her to a "bone specialist." Additionally he recommended that she should not receive the second dose of the vaccine. She had been to the emergency room for her symptoms twice. The first time they provided her narcos for her pain which provided relief for about 30 minutes before returning again. The ER doctors also said that her symptoms were due to an arthritis flare up. She said that her white blood cells were normal at those visits. Her last ER visit was on 15-APR-2021   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: No new information reported On 21-Jul-2021: No new information reported
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year old daughter received the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old daughter received the first dose of the vaccine) in a 16-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 (16-year old daughter received the first dose of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old daughter received the first dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore when she lifted it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore when she lifted it) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-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 PAIN IN EXTREMITY (arm was sore when she lifted it). At the time of the report, PAIN IN EXTREMITY (arm was sore when she lifted it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Occasionally pain pill for arthritis. Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080145 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080145:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tiredness/fatigue; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Tiredness/fatigue) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, FATIGUE (Tiredness/fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient had a low grade fever next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had a low grade fever next day after receiving 1st dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLORTHIAZID) and ATENOLOL for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Apr-2021, the patient experienced PYREXIA (Patient had a low grade fever next day after receiving 1st dose). At the time of the report, PYREXIA (Patient had a low grade fever next day after receiving 1st dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Since patient is having Low grade fever due to vaccination, Patient  wants to know if can take TYLENOL.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache; Nausea; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 30-Jan-2021.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Apr-2021, NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. On 13-Apr-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea
Clinical narrative: Diarrhea; Upset stomach; Chills - just shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (Chills - just shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (Chills - just shaking). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (Chills - just shaking) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD21-077983, US-MODERNATX, INC.-MOD-2021-080116 (E2B Linked Report).; Sender's Comments:  MOD21-077983:Crossed linked as per source doc US-MODERNATX, INC.-MOD-2021-080116:Crossed linked
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore injection site arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) and HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm) and HEADACHE (Slight headache). On 22-Mar-2021, VACCINATION SITE PAIN (Sore injection site arm) and HEADACHE (Slight headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided    This case was linked to MOD-2021-079985 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Started to get itchy; Small hives all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Started to get itchy) and URTICARIA (Small hives all over body) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PRURITUS (Started to get itchy) and URTICARIA (Small hives all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Started to get itchy) and URTICARIA (Small hives all over body) 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of contusion (bruise on her leg, below her knee), fatigue (tiredness) and headache in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037A21B) for COVID-19 immunization. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 9, 2021, patient experienced contusion (bruise on her leg, below her knee). On an unknown date, patient experienced fatigue (tiredness) and headache. At the time of the report, contusion (bruise on her leg, below her knee): not resolved; and fatigue (tiredness) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use, causality assessments and treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.; 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 PRODUCT STORAGE ERROR (Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.) 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 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.). On 12-Apr-2021, PRODUCT STORAGE ERROR (Vaccine may not have been stored at right temperature and was asked to repeat 2nd dose.) had resolved. Not Provided          Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Hard; Itchy; Red circle; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04B21A) 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 VACCINATION SITE PAIN (Sore arm). On 16-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red circle). At the time of the report, VACCINATION SITE INDURATION (Hard), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Pruritus, Vaccination site rash
Clinical narrative: Middle finger become numb and she can not bend it; Middle finger swollen too and itchy; Right ring finger swollen/Middle finger swollen too and itchy; Rash on left arm at shot site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Middle finger become numb and she can not bend it), PERIPHERAL SWELLING (Right ring finger swollen/Middle finger swollen too and itchy), PRURITUS (Middle finger swollen too and itchy) and VACCINATION SITE RASH (Rash on left arm at shot site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash on left arm at shot site). On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (Right ring finger swollen/Middle finger swollen too and itchy). On 16-Apr-2021, the patient experienced PRURITUS (Middle finger swollen too and itchy). On 19-Apr-2021, the patient experienced HYPOAESTHESIA (Middle finger become numb and she can not bend it). At the time of the report, HYPOAESTHESIA (Middle finger become numb and she can not bend it), PERIPHERAL SWELLING (Right ring finger swollen/Middle finger swollen too and itchy), PRURITUS (Middle finger swollen too and itchy) and VACCINATION SITE RASH (Rash on left arm at shot site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for Covid-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse effect (No information was reported.).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced COVID-19 (Tested Positive for Covid-19). At the time of the report, COVID-19 (Tested Positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information about any concomitant and treatment medications.