chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 03-May-2020 and Pregnancy on 02-Jan-2020. Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE for Anxiety, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 06-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Pregnancy test: positive (Positive) Positive.     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 treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Woke with hives on neck; Normal arm pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Woke with hives on neck) and PAIN IN EXTREMITY (Normal arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included CLONAZEPAM (CLONOPIN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Normal arm pain). On 28-Feb-2021, the patient experienced URTICARIA (Woke with hives on neck). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Pain in arm, at an unspecified dose and frequency. At the time of the report, URTICARIA (Woke with hives on neck) and PAIN IN EXTREMITY (Normal arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Little pimples all around the injection site; developed itching at injection site; soreness at injection site while rubbing; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Little pimples all around the injection site), VACCINATION SITE PRURITUS (developed itching at injection site), VACCINATION SITE PAIN (soreness at injection site while rubbing) and VACCINATION SITE ERYTHEMA (redness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE REACTION (Little pimples all around the injection site), VACCINATION SITE PRURITUS (developed itching at injection site), VACCINATION SITE PAIN (soreness at injection site while rubbing) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE REACTION (Little pimples all around the injection site), VACCINATION SITE PRURITUS (developed itching at injection site), VACCINATION SITE PAIN (soreness at injection site while rubbing) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: headache; fever; sore arm; feeling hot; rash; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), RASH (rash), HEADACHE (headache) and PYREXIA (fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus and Hypertension. Concomitant products included LOSARTAN and METFORMIN for an unknown indication.   In February 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. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot) and RASH (rash). On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (feeling hot), RASH (rash), HEADACHE (headache) and PYREXIA (fever) had resolved.            This case was linked to MOD-2020-001419 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Second dose date updated from Jan 2021 to Feb 2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Fatigue, Insomnia
Clinical narrative: pale; weak; diarrhea; difficulty breathing; tired; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), PALLOR (pale), ASTHENIA (weak), DIARRHOEA (diarrhea) and DYSPNOEA (difficulty breathing) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INSOMNIA (couldn't sleep) and FATIGUE (tired). On 21-Mar-2021, the patient experienced PALLOR (pale), ASTHENIA (weak), DIARRHOEA (diarrhea) and DYSPNOEA (difficulty breathing). At the time of the report, INSOMNIA (couldn't sleep), PALLOR (pale), ASTHENIA (weak), DIARRHOEA (diarrhea), DYSPNOEA (difficulty breathing) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: pale; weak; diarrhea; difficulty breathing; tired; couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), PALLOR (pale), ASTHENIA (weak), DIARRHOEA (diarrhea) and DYSPNOEA (difficulty breathing) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INSOMNIA (couldn't sleep) and FATIGUE (tired). On 21-Mar-2021, the patient experienced PALLOR (pale), ASTHENIA (weak), DIARRHOEA (diarrhea) and DYSPNOEA (difficulty breathing). At the time of the report, INSOMNIA (couldn't sleep), PALLOR (pale), ASTHENIA (weak), DIARRHOEA (diarrhea), DYSPNOEA (difficulty breathing) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Myalgia, Ocular hyperaemia
Clinical narrative: facial swelling; right eye is swollen shut with itchiness and throbbing pain; right eye is swollen shut with itchiness and throbbing pain; right eye is swollen shut with itchiness and throbbing pain; redness in the eyes and around the injection site; redness in the eyes and around the injection site; body aches; rashes all over the body look like goose bumps; itchiness in the eyes and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain) and OCULAR HYPERAEMIA (redness in the eyes and around the injection site) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain), OCULAR HYPERAEMIA (redness in the eyes and around the injection site), VACCINATION SITE ERYTHEMA (redness in the eyes and around the injection site), MYALGIA (body aches), RASH (rashes all over the body look like goose bumps) and VACCINATION SITE PRURITUS (itchiness in the eyes and around the injection site). At the time of the report, SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain), OCULAR HYPERAEMIA (redness in the eyes and around the injection site) and VACCINATION SITE PRURITUS (itchiness in the eyes and around the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (redness in the eyes and around the injection site), MYALGIA (body aches) and RASH (rashes all over the body look like goose bumps) was resolving. Not Provided      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 medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-092039 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092039:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: facial swelling; right eye is swollen shut with itchiness and throbbing pain; right eye is swollen shut with itchiness and throbbing pain; right eye is swollen shut with itchiness and throbbing pain; redness in the eyes and around the injection site; redness in the eyes and around the injection site; body aches; rashes all over the body look like goose bumps; itchiness in the eyes and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain) and OCULAR HYPERAEMIA (redness in the eyes and around the injection site) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain), OCULAR HYPERAEMIA (redness in the eyes and around the injection site), VACCINATION SITE ERYTHEMA (redness in the eyes and around the injection site), MYALGIA (body aches), RASH (rashes all over the body look like goose bumps) and VACCINATION SITE PRURITUS (itchiness in the eyes and around the injection site). At the time of the report, SWELLING FACE (facial swelling), EYE SWELLING (right eye is swollen shut with itchiness and throbbing pain), EYE PRURITUS (right eye is swollen shut with itchiness and throbbing pain), EYE PAIN (right eye is swollen shut with itchiness and throbbing pain), OCULAR HYPERAEMIA (redness in the eyes and around the injection site) and VACCINATION SITE PRURITUS (itchiness in the eyes and around the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (redness in the eyes and around the injection site), MYALGIA (body aches) and RASH (rashes all over the body look like goose bumps) was resolving. Not Provided      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 medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-092039 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092039:
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache after a week later which just lasted for a day), MYALGIA (muscle aches 2 days later (10 days ago)) and MYALGIA (back muscle aches 2 days later (10 days ago)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced MYALGIA (muscle ache after a week later which just lasted for a day). On 09-Mar-2021, the patient experienced MYALGIA (muscle aches 2 days later (10 days ago)) and MYALGIA (back muscle aches 2 days later (10 days ago)). On 15-Feb-2021, MYALGIA (muscle ache after a week later which just lasted for a day) outcome was unknown. At the time of the report, MYALGIA (muscle aches 2 days later (10 days ago)) and MYALGIA (back muscle aches 2 days later (10 days ago)) outcome was unknown. Not Provided. 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. concomitant medication was not provided. Patient was taking Tylenol and Advil occasionally to treat symptoms. This case was linked to US-MODERNATX, INC.-MOD-2021-051440 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-051440:Crosslinked with dose 2.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dehydration, Headache
Clinical narrative: dehydration; Hypersomnia; Lethargic; Appetite lost; headache; chills; fever; Myalgia; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration), HYPERSOMNIA (Hypersomnia), LETHARGY (Lethargic), DECREASED APPETITE (Appetite lost) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DEHYDRATION (dehydration), HYPERSOMNIA (Hypersomnia), LETHARGY (Lethargic), DECREASED APPETITE (Appetite lost), HEADACHE (headache), CHILLS (chills), PYREXIA (fever), MYALGIA (Myalgia) and ARTHRALGIA (joint pain). At the time of the report, DEHYDRATION (dehydration), HYPERSOMNIA (Hypersomnia), LETHARGY (Lethargic), DECREASED APPETITE (Appetite lost), HEADACHE (headache), CHILLS (chills), PYREXIA (fever), MYALGIA (Myalgia) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  was not provided by the reporter.   ?No treatment  medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received on 15-JUL-2021 and contains No New Information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Lethargy, Myalgia, Pyrexia
Clinical narrative: dehydration; Hypersomnia; Lethargic; Appetite lost; headache; chills; fever; Myalgia; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration), HYPERSOMNIA (Hypersomnia), LETHARGY (Lethargic), DECREASED APPETITE (Appetite lost) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DEHYDRATION (dehydration), HYPERSOMNIA (Hypersomnia), LETHARGY (Lethargic), DECREASED APPETITE (Appetite lost), HEADACHE (headache), CHILLS (chills), PYREXIA (fever), MYALGIA (Myalgia) and ARTHRALGIA (joint pain). At the time of the report, DEHYDRATION (dehydration), HYPERSOMNIA (Hypersomnia), LETHARGY (Lethargic), DECREASED APPETITE (Appetite lost), HEADACHE (headache), CHILLS (chills), PYREXIA (fever), MYALGIA (Myalgia) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  was not provided by the reporter.   ?No treatment  medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received on 15-JUL-2021 and contains No New Information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: back muscle aches 2 days later (10 days ago); muscle aches 2 days later (10 days ago); This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back muscle aches 2 days later (10 days ago)) and MYALGIA (muscle aches 2 days later (10 days ago)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (back muscle aches 2 days later (10 days ago)). 09-Mar-2021, the patient experienced MYALGIA (muscle aches 2 days later (10 days ago)). At the time of the report, BACK PAIN (back muscle aches 2 days later (10 days ago)) and MYALGIA (muscle aches 2 days later (10 days ago)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient was taking Tylenol and Advil occasionally to treat symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-051435 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051435:Crosslinked with dose 1
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: arm started to get hurt; it knotted up real big all the way across whole upper arm; The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow; The top of shoulder was heating; Kind of like blood bruise that moved down the arm; The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating) and CONTUSION (Kind of like blood bruise that moved down the arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Mar-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 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating), CONTUSION (Kind of like blood bruise that moved down the arm) and VACCINATION SITE SWELLING (The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating), CONTUSION (Kind of like blood bruise that moved down the arm) and VACCINATION SITE SWELLING (The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg) had resolved. Not Provided          No concomitant information was reported. Patient stated the adverse reactions cleared up after a few days. Action taken with mRNA-1273 in response to the events was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was received on 07-MAY-2021, outcome of events were updated from unknown to recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arm started to get hurt; it knotted up real big all the way across whole upper arm; The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow; The top of shoulder was heating; Kind of like blood bruise that moved down the arm; The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating) and CONTUSION (Kind of like blood bruise that moved down the arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Mar-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 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating), CONTUSION (Kind of like blood bruise that moved down the arm) and VACCINATION SITE SWELLING (The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm started to get hurt), PERIPHERAL SWELLING (it knotted up real big all the way across whole upper arm), INFLAMMATION (The top of shoulder was swollen and heating. It felt like a roll of socks underneath my arm pit and elbow), FEELING HOT (The top of shoulder was heating), CONTUSION (Kind of like blood bruise that moved down the arm) and VACCINATION SITE SWELLING (The swelling part moved up until the muscle upper part of houlder right where they gave the shot about the size of an egg) had resolved. Not Provided          No concomitant information was reported. Patient stated the adverse reactions cleared up after a few days. Action taken with mRNA-1273 in response to the events was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was received on 07-MAY-2021, outcome of events were updated from unknown to recovered.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Frequent bowel movements, Pollakiuria, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (frequent bowel movements/constant pressure in the rectum that I have to go to the bathroom immediately), POLLAKIURIA (frequent urination/I have a constant feeling that I need to go to the bathroom every 15 to 30 minutes), DISCOMFORT (little discomfort in general but manageable) and VACCINATION COMPLICATION (If i drink water, I need to go to bathroom in 10 mints and once if I eat anything , then immediately I need to go to the toilet) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for Diabetes.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (frequent bowel movements/constant pressure in the rectum that I have to go to the bathroom immediately), POLLAKIURIA (frequent urination/I have a constant feeling that I need to go to the bathroom every 15 to 30 minutes), DISCOMFORT (little discomfort in general but manageable) and VACCINATION COMPLICATION (If i drink water, I need to go to bathroom in 10 mints and once if I eat anything , then immediately I need to go to the toilet). At the time of the report, FREQUENT BOWEL MOVEMENTS (frequent bowel movements/constant pressure in the rectum that I have to go to the bathroom immediately), POLLAKIURIA (frequent urination/I have a constant feeling that I need to go to the bathroom every 15 to 30 minutes), DISCOMFORT (little discomfort in general but manageable) and VACCINATION COMPLICATION (If i drink water, I need to go to bathroom in 10 mints and once if I eat anything , then immediately I need to go to the toilet) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Patient developed little discomfort after receiving the 2nd dose but he felt manageable. Later on the same day he experienced frequent bowel movements, and frequent urination and he had a constant feeling that he needs to go to the bathroom every15 to 30 minutes. He also felt a constant pressure in the rectum that he felt like going to the bathroom immediately. He did mention that if I drink water then I need to use the bathroom immediately and if I eat something then I need to use the toilet immediately.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever last night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I had a fever last night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PYREXIA (I had a fever last night). At the time of the report, PYREXIA (I had a fever last night) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 12 mg. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), EAR DISCOMFORT (ears started clogging , pressure had built up in ear) and FEELING ABNORMAL (severe case of brain fog) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-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 FEELING ABNORMAL (severe case of brain fog). On 20-Mar-2021, the patient experienced VERTIGO (vertigo) and EAR DISCOMFORT (ears started clogging , pressure had built up in ear). On 20-Mar-2021, FEELING ABNORMAL (severe case of brain fog) had resolved. At the time of the report, VERTIGO (vertigo) and EAR DISCOMFORT (ears started clogging , pressure had built up in ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A218) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    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 VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication,cholesterol medication and mental health pills (Unspecified). No treatment was provided for the experienced adverse events.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dysstasia, Vaccination site pain
Clinical narrative: Couldn't get out her seat; Diarrhea; Very weak; Chills; Swollen and sore at injection site; Swollen and sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills) and VACCINATION SITE SWELLING (Swollen and sore at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills), VACCINATION SITE SWELLING (Swollen and sore at injection site) and VACCINATION SITE PAIN (Swollen and sore at injection site). At the time of the report, DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills), VACCINATION SITE SWELLING (Swollen and sore at injection site) and VACCINATION SITE PAIN (Swollen and sore at injection site) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Couldn't get out her seat; Diarrhea; Very weak; Chills; Swollen and sore at injection site; Swollen and sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills) and VACCINATION SITE SWELLING (Swollen and sore at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills), VACCINATION SITE SWELLING (Swollen and sore at injection site) and VACCINATION SITE PAIN (Swollen and sore at injection site). At the time of the report, DYSSTASIA (Couldn't get out her seat), DIARRHOEA (Diarrhea), ASTHENIA (Very weak), CHILLS (Chills), VACCINATION SITE SWELLING (Swollen and sore at injection site) and VACCINATION SITE PAIN (Swollen and sore at injection site) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Fatigue, Myalgia
Clinical narrative: loss of appetite; diarrhea; fever 100.2F; body ache; nausea; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), FATIGUE (extreme fatigue), PYREXIA (fever 100.2F) and MYALGIA (body ache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (extreme fatigue). On 18-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), PYREXIA (fever 100.2F), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), FATIGUE (extreme fatigue), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever 100.2F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: loss of appetite; diarrhea; fever 100.2F; body ache; nausea; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), FATIGUE (extreme fatigue), PYREXIA (fever 100.2F) and MYALGIA (body ache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (extreme fatigue). On 18-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), PYREXIA (fever 100.2F), MYALGIA (body ache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), FATIGUE (extreme fatigue), MYALGIA (body ache) and NAUSEA (nausea) outcome was unknown and PYREXIA (fever 100.2F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Runny Nose; Sneezing; runny nose; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), the first episode of SNEEZING (Sneezing), RHINORRHOEA (Runny Nose) and the second episode of SNEEZING (Sneezing) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and the first episode of SNEEZING (Sneezing). On 20-Mar-2021, the patient experienced RHINORRHOEA (Runny Nose) and the second episode of SNEEZING (Sneezing). In March 2021, RHINORRHOEA (runny nose) had resolved. At the time of the report, RHINORRHOEA (Runny Nose) and the last episode of SNEEZING (Sneezing) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Action taken with mRNA-1273 in response to the events was not applicable
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling in the injection arm, but felt normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in the injection arm, but felt normal) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for Diabetes.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling in the injection arm, but felt normal). At the time of the report, VACCINATION SITE SWELLING (swelling in the injection arm, but felt normal) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna vaccine dose leaked from syringe-patient didn't get entire dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Moderna vaccine dose leaked from syringe-patient didn't get entire dose) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced UNDERDOSE (Moderna vaccine dose leaked from syringe-patient didn't get entire dose). At the time of the report, UNDERDOSE (Moderna vaccine dose leaked from syringe-patient didn't get entire dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 7-APR-2021 and contains Non significant information. On 08-Apr-2021: Follow up received on 8-APR-2021 and contains non significant information.; Reporter's Comments: This report refers to a case of underdose, for mRNA-1273, lot # unknown, with no associated AEs.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Myalgia
Clinical narrative: felt like getting hit by a teaser; symptoms of covid, much worser than real covid; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt like getting hit by a teaser) and ADVERSE EVENT (symptoms of covid, much worser than real covid) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (4 months back).    In February 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 MYALGIA (felt like getting hit by a teaser) and ADVERSE EVENT (symptoms of covid, much worser than real covid). At the time of the report, MYALGIA (felt like getting hit by a teaser) and ADVERSE EVENT (symptoms of covid, much worser than real covid) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  No treatment information provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling of body temperature change, Myalgia, Pain in extremity, Somnolence
Clinical narrative: She only got sore arm and she is fine; "Arm is killing me"; Slept for 12 hours; Feeling "hot and cold"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("Arm is killing me"), SOMNOLENCE (Slept for 12 hours), FEELING OF BODY TEMPERATURE CHANGE (Feeling "hot and cold") and MYALGIA (She only got sore arm and she is fine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY ("Arm is killing me"), SOMNOLENCE (Slept for 12 hours) and FEELING OF BODY TEMPERATURE CHANGE (Feeling "hot and cold"). On an unknown date, the patient experienced MYALGIA (She only got sore arm and she is fine). At the time of the report, PAIN IN EXTREMITY ("Arm is killing me"), SOMNOLENCE (Slept for 12 hours), FEELING OF BODY TEMPERATURE CHANGE (Feeling "hot and cold") and MYALGIA (She only got sore arm and she is fine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 96.3 (abnormal) 96.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: New event of myalgia was added.