chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Influenza like illness, Myalgia, Pain of skin
Clinical narrative: Flu like symptoms; Severe skin pain; Severe dehydration; High grade fever of 102F; Muscle pain; Joint pain; A spontaneous report was received from a consumer, concerning himself, a 29-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, severe skin pain, joint pain, severe dehydration, muscle pain and high grade fever of 102F.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A or 025T20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, four hours after the vaccine administration, the patient started too have flu like symptoms, then after eight hours he experienced fever of 100F and also severe skin pain and joint pain. The following morning, patient went to emergency room (ER) and was confirmed to be have a negative reaction to the Moderna vaccine. However, additionally, patient experienced severe dehydration, muscle pain and high-grade fever of 102F. Treatment for the events fever and dehydration included IV fluid and acetaminophen. No treatment information was provided for the events flu like symptoms, severe skin pain, joint pain and muscle pain.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the experienced flu like symptoms, severe skin pain, joint pain, severe dehydration, muscle pain and high-grade fever of 102F were not reported.; Reporter's Comments: This case concerns a 29 year old, , male patient, who experienced a non-serious unexpected event of influenza like illness, pain of skin, and dehydration, among others, 1 days after receiving mRNA- 1273 (Lot# 025J20A or 025T20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms; Severe skin pain; Severe dehydration; High grade fever of 102F; Muscle pain; Joint pain; A spontaneous report was received from a consumer, concerning himself, a 29-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, severe skin pain, joint pain, severe dehydration, muscle pain and high grade fever of 102F.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, four hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A or 025T20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, four hours after the vaccine administration, the patient started too have flu like symptoms, then after eight hours he experienced fever of 100F and also severe skin pain and joint pain. The following morning, patient went to emergency room (ER) and was confirmed to be have a negative reaction to the Moderna vaccine. However, additionally, patient experienced severe dehydration, muscle pain and high-grade fever of 102F. Treatment for the events fever and dehydration included IV fluid and acetaminophen. No treatment information was provided for the events flu like symptoms, severe skin pain, joint pain and muscle pain.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the experienced flu like symptoms, severe skin pain, joint pain, severe dehydration, muscle pain and high-grade fever of 102F were not reported.; Reporter's Comments: This case concerns a 29 year old, , male patient, who experienced a non-serious unexpected event of influenza like illness, pain of skin, and dehydration, among others, 1 days after receiving mRNA- 1273 (Lot# 025J20A or 025T20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red circular ring around the injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circular ring around the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circular ring around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circular ring around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitants were provided no treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: An additional document was received on 19 APR 2021 with email address updated
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Hyperhidrosis, Nausea
Clinical narrative: just sweating like someone was pouring sweat on me; a little weakness; went to the bathroom but it wasn't diarrhea; a bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (just sweating like someone was pouring sweat on me), ASTHENIA (a little weakness), ADVERSE EVENT (went to the bathroom but it wasn't diarrhea) and NAUSEA (a bit of nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (patient reported having a long list of medication allergies(not specified)).    On 27-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021 at 11:00 AM, the patient experienced HYPERHIDROSIS (just sweating like someone was pouring sweat on me), ASTHENIA (a little weakness), ADVERSE EVENT (went to the bathroom but it wasn't diarrhea) and NAUSEA (a bit of nausea). On 28-Jan-2021, HYPERHIDROSIS (just sweating like someone was pouring sweat on me), ASTHENIA (a little weakness), ADVERSE EVENT (went to the bathroom but it wasn't diarrhea) and NAUSEA (a bit of nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Patient did not use any medications for treatment
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tongue pruritus
Clinical narrative: funny sensation on the tip of her tongue was itching kinda; tired; This spontaneous case was reported by a patient and describes the occurrence of TONGUE PRURITUS (funny sensation on the tip of her tongue was itching kinda) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced TONGUE PRURITUS (funny sensation on the tip of her tongue was itching kinda) and FATIGUE (tired). At the time of the report, TONGUE PRURITUS (funny sensation on the tip of her tongue was itching kinda) and FATIGUE (tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications are not reported. Patient reported taking diphenhydramine to treat her symptoms.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bladder disorder
Clinical narrative: Pressure on my bladder; severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISORDER (Pressure on my bladder) and ABDOMINAL PAIN UPPER (severe stomach pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BLADDER DISORDER (Pressure on my bladder) and ABDOMINAL PAIN UPPER (severe stomach pain). At the time of the report, BLADDER DISORDER (Pressure on my bladder) and ABDOMINAL PAIN UPPER (severe stomach pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (once or twice a week before pregnancy.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 26-Sep-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of positive pregnancy test was 16-Jan-2021. The patient has an established prenatal care. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Mass, Vaccination site erythema, Vaccination site rash
Clinical narrative: adverse effect; Knot in the arm; vaccination site erythema; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse effect), MASS (Knot in the arm), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ADVERSE REACTION (adverse effect), MASS (Knot in the arm), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash).   At the time of the report, ADVERSE REACTION (adverse effect), MASS (Knot in the arm), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: New adverse event "knot in the arm" and "red rash around the injection site" are added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Facial pain, Fatigue, Headache
Clinical narrative: Cough; Diarrhoea; Facial pain; weak; Headaches and Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea) and FACIAL PAIN (Facial pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced HEADACHE (Headaches and Body aches) and MYALGIA (Headaches and Body aches). On 24-Jan-2021, the patient experienced FATIGUE (weak). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea). On 27-Jan-2021, the patient experienced FACIAL PAIN (Facial pain) and COUGH (cough). At the time of the report, HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea), FACIAL PAIN (Facial pain) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.   Patient received treatment including Advil 200 mg, Aspirin 325 mg and Tylenol 500 mg. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea) and FACIAL PAIN (Facial pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced HEADACHE (Headaches and Body aches) and MYALGIA (Headaches and Body aches). On 24-Jan-2021, the patient experienced FATIGUE (weak). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea). On 27-Jan-2021, the patient experienced FACIAL PAIN (Facial pain) and COUGH (cough). At the time of the report, HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea), FACIAL PAIN (Facial pain) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.   Patient received treatment including Advil 200 mg, Aspirin 325 mg and Tylenol 500 mg.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Cough; Diarrhoea; Facial pain; weak; Headaches and Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea) and FACIAL PAIN (Facial pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced HEADACHE (Headaches and Body aches) and MYALGIA (Headaches and Body aches). On 24-Jan-2021, the patient experienced FATIGUE (weak). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea). On 27-Jan-2021, the patient experienced FACIAL PAIN (Facial pain) and COUGH (cough). At the time of the report, HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea), FACIAL PAIN (Facial pain) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.   Patient received treatment including Advil 200 mg, Aspirin 325 mg and Tylenol 500 mg. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea) and FACIAL PAIN (Facial pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced HEADACHE (Headaches and Body aches) and MYALGIA (Headaches and Body aches). On 24-Jan-2021, the patient experienced FATIGUE (weak). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea). On 27-Jan-2021, the patient experienced FACIAL PAIN (Facial pain) and COUGH (cough). At the time of the report, HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea), FACIAL PAIN (Facial pain) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.   Patient received treatment including Advil 200 mg, Aspirin 325 mg and Tylenol 500 mg.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Pyrexia
Clinical narrative: all the symptoms associated with the flu; 99.6 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (all the symptoms associated with the flu) and PYREXIA (99.6 degree fever) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INFLUENZA (all the symptoms associated with the flu) and PYREXIA (99.6 degree fever). At the time of the report, INFLUENZA (all the symptoms associated with the flu) and PYREXIA (99.6 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 99.6 degree (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient felt pretty bad. Concomitant medications were not provided. Treatment information was not reported.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided.  No treatment details were reported.  Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information added: Reporter Email id added This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection arm) and VACCINATION SITE SWELLING (swelling on injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided.  No treatment details were reported.  Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information added: Reporter Email id added
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not provided. Treatment information included was acetaminophen 100mg occasionally when she was having the headache. The patient received the 1st dose of Moderna COVID-19 vaccine at Hospital.  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not provided. Treatment information included was acetaminophen 100mg occasionally when she was having the headache. The patient received the 1st dose of Moderna COVID-19 vaccine at Hospital.
Sex: M
Vaccine: COVID19
Symptoms: Ear swelling, Erythema
Clinical narrative: Right ear red; Right ear swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Right ear red) and EAR SWELLING (Right ear swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease and Dementia.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Right ear red) and EAR SWELLING (Right ear swollen). At the time of the report, ERYTHEMA (Right ear red) and EAR SWELLING (Right ear swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Right ear red) and EAR SWELLING (Right ear swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease and Dementia.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Right ear red) and EAR SWELLING (Right ear swollen). At the time of the report, ERYTHEMA (Right ear red) and EAR SWELLING (Right ear swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: pain got better then came back; Pain in left arm/ hurt so bad; saw stars; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/ hurt so bad), DIZZINESS (saw stars) and PAIN IN EXTREMITY (pain got better then came back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) and DIZZINESS (saw stars). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (pain got better then came back). On 24-Dec-2020, PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) had resolved. At the time of the report, DIZZINESS (saw stars) had not resolved and PAIN IN EXTREMITY (pain got better then came back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has taken ibuprofen and acetaminophen for pain. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/ hurt so bad), DIZZINESS (saw stars) and PAIN IN EXTREMITY (pain got better then came back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ZOLPIDEM TARTRATE (AMBIEN) and CALCIUM for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) and DIZZINESS (saw stars). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (pain got better then came back). On 24-Dec-2020, PAIN IN EXTREMITY (Pain in left arm/ hurt so bad) had resolved. At the time of the report, DIZZINESS (saw stars) had not resolved and PAIN IN EXTREMITY (pain got better then came back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has taken ibuprofen and acetaminophen for pain.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: swetted down; Diarrhoea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (swetted down), DIARRHOEA (Diarrhoea), VOMITING (Vomiting) and PYREXIA (Fever) 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 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 14-Feb-2021, the patient experienced HYPERHIDROSIS (swetted down), DIARRHOEA (Diarrhoea), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (swetted down), DIARRHOEA (Diarrhoea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: 2nd dose details provided and action take with drug updated accordingly. New events details added associated with 2nd dose. Patient's contact information updated.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever). On 23-Jan-2021, PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Relevant laboratory results were not provided.  Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever). On 23-Jan-2021, PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Relevant laboratory results were not provided.  Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Tired; Weak; This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (Weak) and FATIGUE (Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Weak). On 23-Jan-2021, the patient experienced FATIGUE (Tired). At the time of the report, ASTHENIA (Weak) and FATIGUE (Tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (Weak) and FATIGUE (Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Weak). On 23-Jan-2021, the patient experienced FATIGUE (Tired). At the time of the report, ASTHENIA (Weak) and FATIGUE (Tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swelling lymph node under armpit in the same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling lymph node under armpit in the same arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Gait inability, Headache, Nausea
Clinical narrative: Thought she was dying; tremendous pain; headache; nausea; couldn't stand up; pain in the left side of her chest and shot up through her left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) 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.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea), GAIT INABILITY (couldn't stand up) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm). At the time of the report, FEELING ABNORMAL (Thought she was dying), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) outcome was unknown and PAIN (tremendous pain), HEADACHE (headache) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) 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.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea), GAIT INABILITY (couldn't stand up) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm). At the time of the report, FEELING ABNORMAL (Thought she was dying), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) outcome was unknown and PAIN (tremendous pain), HEADACHE (headache) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Thought she was dying; tremendous pain; headache; nausea; couldn't stand up; pain in the left side of her chest and shot up through her left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) 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.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea), GAIT INABILITY (couldn't stand up) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm). At the time of the report, FEELING ABNORMAL (Thought she was dying), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) outcome was unknown and PAIN (tremendous pain), HEADACHE (headache) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) 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.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (Thought she was dying), PAIN (tremendous pain), HEADACHE (headache), NAUSEA (nausea), GAIT INABILITY (couldn't stand up) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm). At the time of the report, FEELING ABNORMAL (Thought she was dying), NAUSEA (nausea) and GAIT INABILITY (couldn't stand up) outcome was unknown and PAIN (tremendous pain), HEADACHE (headache) and CHEST PAIN (pain in the left side of her chest and shot up through her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore left arm). At the time of the report, INJECTION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore left arm). At the time of the report, INJECTION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: It is warm to touch; red spot/rash around the injection site; red spot/rash around the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE WARMTH (It is warm to touch), INJECTION SITE ERYTHEMA (red spot/rash around the injection site) and INJECTION SITE RASH (red spot/rash around the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (It is warm to touch), INJECTION SITE ERYTHEMA (red spot/rash around the injection site) and INJECTION SITE RASH (red spot/rash around the injection site). At the time of the report, INJECTION SITE WARMTH (It is warm to touch), INJECTION SITE ERYTHEMA (red spot/rash around the injection site) and INJECTION SITE RASH (red spot/rash around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported by the reporter.  Treatment medications for these events were not reported by the reporter.   This case was linked to MOD-2021-212754 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: TCR: AE outcome
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired a week after; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling tired a week after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (feeling tired a week after). At the time of the report, FATIGUE (feeling tired a week after) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling tired a week after) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was reported.     On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (feeling tired a week after). At the time of the report, FATIGUE (feeling tired a week after) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.