chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Hot flush, Pruritus
Clinical narrative: Arms started to itch; Fatigue; Pink rash; Hot flashes; Shaking and tremor feeling when trying to open anything or write; Flushing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FLUSHING (Flushing), PRURITUS (Arms started to itch), FATIGUE (Fatigue) and RASH (Pink rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). On 02-Feb-2021, the patient experienced FLUSHING (Flushing). On an unknown date, the patient experienced PRURITUS (Arms started to itch), FATIGUE (Fatigue), RASH (Pink rash), HOT FLUSH (Hot flashes) and TREMOR (Shaking and tremor feeling when trying to open anything or write). On 01-Feb-2021, HEADACHE (Headache) had resolved. On 03-Feb-2021, FLUSHING (Flushing) had resolved. At the time of the report, PRURITUS (Arms started to itch), FATIGUE (Fatigue), RASH (Pink rash), HOT FLUSH (Hot flashes) and TREMOR (Shaking and tremor feeling when trying to open anything or write) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tremor
Clinical narrative: Arms started to itch; Fatigue; Pink rash; Hot flashes; Shaking and tremor feeling when trying to open anything or write; Flushing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FLUSHING (Flushing), PRURITUS (Arms started to itch), FATIGUE (Fatigue) and RASH (Pink rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). On 02-Feb-2021, the patient experienced FLUSHING (Flushing). On an unknown date, the patient experienced PRURITUS (Arms started to itch), FATIGUE (Fatigue), RASH (Pink rash), HOT FLUSH (Hot flashes) and TREMOR (Shaking and tremor feeling when trying to open anything or write). On 01-Feb-2021, HEADACHE (Headache) had resolved. On 03-Feb-2021, FLUSHING (Flushing) had resolved. At the time of the report, PRURITUS (Arms started to itch), FATIGUE (Fatigue), RASH (Pink rash), HOT FLUSH (Hot flashes) and TREMOR (Shaking and tremor feeling when trying to open anything or write) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: MY smart watch told me that my heart rate was 158; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (MY smart watch told me that my heart rate was 158) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-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 HEART RATE INCREASED (MY smart watch told me that my heart rate was 158). At the time of the report, HEART RATE INCREASED (MY smart watch told me that my heart rate was 158) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site injury, Injection site swelling
Clinical narrative: needle spit out blood during the administration; black and blue, at the injection site; raised and bumpy lump which looks like the size of a dime at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INJURY (needle spit out blood during the administration), INJECTION SITE DISCOLOURATION (black and blue, at the injection site) and INJECTION SITE SWELLING (raised and bumpy lump which looks like the size of a dime at the 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. 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 INJECTION SITE INJURY (needle spit out blood during the administration), INJECTION SITE DISCOLOURATION (black and blue, at the injection site) and INJECTION SITE SWELLING (raised and bumpy lump which looks like the size of a dime at the injection site). At the time of the report, INJECTION SITE INJURY (needle spit out blood during the administration), INJECTION SITE DISCOLOURATION (black and blue, at the injection site) and INJECTION SITE SWELLING (raised and bumpy lump which looks like the size of a dime at the injection site) outcome was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Worsening diarrhea since 1st dose; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Worsening diarrhea since 1st dose) and HEADACHE (Bad headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced DIARRHOEA (Worsening diarrhea since 1st dose) and HEADACHE (Bad headache). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea aggravated, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Worsening diarrhea since 1st dose) had resolved and HEADACHE (Bad headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant information  provided.  Treatment included Gatorade for Dehydration.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received contains updated information of outcome of diarrhea, action taken with the suspect and treatment medication.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included AZO and waiting for doctor to give antibiotic.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: pregnant;received both doses of Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant;received both doses of Moderna COVID-19 vaccine) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Delivery (Live, full-term birth) on 19-Dec-2012 and Alcohol use (Ocassionally). Concurrent medical conditions included Anxiety. Concomitant products included PARACETAMOL (TYLENOL) for Ache, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, MAGNESIUM for Headache, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROBIOTICS NOS for Upset stomach and Bloating.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-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 in September 2020 and the estimated date of delivery was 10-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant;received both doses of Moderna COVID-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant;received both doses of Moderna COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive Positive.         The date of positive pregnancy test was Oct-2020 and estimated date of conception was Sept-2020. The patient has an established prenatal care. On an unknown date, ultrasound, blood work, and urine sample test was performed which was reported to be normal. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: Internal review conducted on 21-JUL-2021, resulted in updates to the pregnancy details, vaccine information, relevant history, lab data, concomitant medications, action taken, event onset/stop dates, event outcome, and iNarrative supplement.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: burning in her arm; right arm and right leg became numb; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning in her arm) and HYPOAESTHESIA (right arm and right leg became numb) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BURNING SENSATION (burning in her arm) and HYPOAESTHESIA (right arm and right leg became numb). At the time of the report, BURNING SENSATION (burning in her arm) and HYPOAESTHESIA (right arm and right leg became numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. Treatment included Tylenol and documenting all the times that she took it.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, SARS-CoV-2 test
Clinical narrative: tested positive for covid; cough; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (cough), HEADACHE (headache) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced COVID-19 (tested positive for covid). On an unknown date, the patient experienced COUGH (cough), HEADACHE (headache) and CHILLS (Chills). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown and COUGH (cough), HEADACHE (headache) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal source of sample.         No concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 in which contact Information was added and second dose details were added. On 26-Jul-2021: Follow up received. Asthma added as medical history. Events were added. Second dose information picked from follow up 1 source document and action taken with suspect product updated accordingly.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (his arm hurt for 4 days), NAUSEA (nauseous for 4-5 days), ASTHENIA (He is just feeling really crappy, like no energy), FATIGUE (He gets exhausted doing nothing) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (his arm hurt for 4 days), NAUSEA (nauseous for 4-5 days), ASTHENIA (He is just feeling really crappy, like no energy) and FATIGUE (He gets exhausted doing nothing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dry mouth, Fatigue, Pyrexia
Clinical narrative: Fever 102.2; Chills; Dry mouth; Lost of appetite; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 102.2), CHILLS (Chills), DRY MOUTH (Dry mouth), DECREASED APPETITE (Lost of appetite) and FATIGUE (Tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (Fever 102.2), CHILLS (Chills), DRY MOUTH (Dry mouth), DECREASED APPETITE (Lost of appetite) and FATIGUE (Tired). At the time of the report, PYREXIA (Fever 102.2), CHILLS (Chills), DRY MOUTH (Dry mouth), DECREASED APPETITE (Lost of appetite) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm at the site of injection; Redness at the site of the injection; Itchy at the site of injection; A spontaneous report was received from a Reporter like Consumer concerning a 72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the site of the injection, warm and slightly itchy.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14-JAN-2021, approximately 12 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.  On 26-JAN-2021, The patient experienced the events redness at the site of the injection, warm and slightly itchy were reported.Laboratory details not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events redness at the site of the injection, warm and slightly itchy was unknown.  The reporter assessed the events redness at the site of the injection, warm and slightly itchy as related to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swollen injection site) 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.    On 12-Feb-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 INJECTION SITE SWELLING (swollen injection site). At the time of the report, INJECTION SITE SWELLING (swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Icing
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Where the site was, it started to become a knot; red; very very hot; swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Where the site was, it started to become a knot), VACCINATION SITE SWELLING (swelled), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (very very hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelled) and VACCINATION SITE WARMTH (very very hot). On an unknown date, the patient experienced VACCINATION SITE REACTION (Where the site was, it started to become a knot) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (Where the site was, it started to become a knot), VACCINATION SITE SWELLING (swelled), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (very very hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Patient stated that she kept swimming and exercising because she read that online.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Migraine, Nausea, Pain
Clinical narrative: Stayed in bed; migraine; Painful swelling; Body aches; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On 24-Jan-2021, the patient experienced ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: TCR Attached-NNI
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Stayed in bed; migraine; Painful swelling; Body aches; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On 24-Jan-2021, the patient experienced ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: TCR Attached-NNI
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site inflammation, Lymphadenopathy, Peripheral swelling, Vaccination site induration
Clinical narrative: Swelling up to the size of tennis ball; pretty inflammed under armpit; lump under injection arm on the left side; lymph node is pretty sore- under the arm pit; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (lump under injection arm on the left side), LYMPHADENOPATHY (lymph node is pretty sore- under the arm pit), INJECTION SITE INFLAMMATION (pretty inflammed under armpit) and PERIPHERAL SWELLING (Swelling up to the size of tennis ball) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (lump under injection arm on the left side), LYMPHADENOPATHY (lymph node is pretty sore- under the arm pit), INJECTION SITE INFLAMMATION (pretty inflammed under armpit) and PERIPHERAL SWELLING (Swelling up to the size of tennis ball). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Inflammation, at an unspecified dose and frequency and SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (lump under injection arm on the left side), LYMPHADENOPATHY (lymph node is pretty sore- under the arm pit), INJECTION SITE INFLAMMATION (pretty inflammed under armpit) and PERIPHERAL SWELLING (Swelling up to the size of tennis ball) 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.   The second dose of mRNA-1273 will be between 09- 12Feb2021. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Added Reporter details , Patient details , Treatment medications and updated Events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Incomplete course of vaccination, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Moderate reaction; Red bad rash at injection site; Red bad rash at injection site; Did not receive her 2nd dose due to side effects; Breakouts at the site of injection; Itchy at the site of injection; Hives at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Breakouts at the site of injection), ADVERSE REACTION (Moderate reaction), VACCINATION SITE ERYTHEMA (Red bad rash at injection site), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE URTICARIA (Hives at the site of injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010DM20) 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 recorded medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE REACTION (Breakouts at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE URTICARIA (Hives at the site of injection). On an unknown date, the patient experienced ADVERSE REACTION (Moderate reaction), VACCINATION SITE ERYTHEMA (Red bad rash at injection site), VACCINATION SITE RASH (Red bad rash at injection site) and INCOMPLETE COURSE OF VACCINATION (Did not receive her 2nd dose due to side effects). In February 2021, VACCINATION SITE URTICARIA (Hives at the site of injection) had resolved. At the time of the report, VACCINATION SITE REACTION (Breakouts at the site of injection) and VACCINATION SITE PRURITUS (Itchy at the site of injection) had resolved, ADVERSE REACTION (Moderate reaction), VACCINATION SITE ERYTHEMA (Red bad rash at injection site) and INCOMPLETE COURSE OF VACCINATION (Did not receive her 2nd dose due to side effects) outcome was unknown and VACCINATION SITE RASH (Red bad rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-070717 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Dose number, anatomical location were updated. New events moderate reaction, red bad rash at injection site were reported. On 03-May-2021: Second follow up received and appended. Information on second dose updated. Patient states was advised by her physician to not receive her second dose due to her side effects from the first dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070717:Crosslinked
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site urticaria
Clinical narrative: Moderate reaction; Red bad rash at injection site; Red bad rash at injection site; Did not receive her 2nd dose due to side effects; Breakouts at the site of injection; Itchy at the site of injection; Hives at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Breakouts at the site of injection), ADVERSE REACTION (Moderate reaction), VACCINATION SITE ERYTHEMA (Red bad rash at injection site), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE URTICARIA (Hives at the site of injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010DM20) 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 recorded medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE REACTION (Breakouts at the site of injection), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE URTICARIA (Hives at the site of injection). On an unknown date, the patient experienced ADVERSE REACTION (Moderate reaction), VACCINATION SITE ERYTHEMA (Red bad rash at injection site), VACCINATION SITE RASH (Red bad rash at injection site) and INCOMPLETE COURSE OF VACCINATION (Did not receive her 2nd dose due to side effects). In February 2021, VACCINATION SITE URTICARIA (Hives at the site of injection) had resolved. At the time of the report, VACCINATION SITE REACTION (Breakouts at the site of injection) and VACCINATION SITE PRURITUS (Itchy at the site of injection) had resolved, ADVERSE REACTION (Moderate reaction), VACCINATION SITE ERYTHEMA (Red bad rash at injection site) and INCOMPLETE COURSE OF VACCINATION (Did not receive her 2nd dose due to side effects) outcome was unknown and VACCINATION SITE RASH (Red bad rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-070717 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Dose number, anatomical location were updated. New events moderate reaction, red bad rash at injection site were reported. On 03-May-2021: Second follow up received and appended. Information on second dose updated. Patient states was advised by her physician to not receive her second dose due to her side effects from the first dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070717:Crosslinked
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Nausea
Clinical narrative: Headache; Chills; uncomfortable; Nausea; Night sweat; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea) and NIGHT SWEATS (Night sweat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 07-Feb-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 HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea), NIGHT SWEATS (Night sweat) and ASTHENIA (Weakness). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Headache; Chills; uncomfortable; Nausea; Night sweat; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea) and NIGHT SWEATS (Night sweat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 07-Feb-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 HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea), NIGHT SWEATS (Night sweat) and ASTHENIA (Weakness). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Body temperature, Pain, Tenderness, Vaccination complication
Clinical narrative: a little sore; tenderness; a little bit off; it affected her glucose numbers/numbers have been running high in the 170s; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little sore), TENDERNESS (tenderness), VACCINATION COMPLICATION (a little bit off) and BLOOD GLUCOSE INCREASED (it affected her glucose numbers/numbers have been running high in the 170s) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.    On 23-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 PAIN (a little sore), TENDERNESS (tenderness), VACCINATION COMPLICATION (a little bit off) and BLOOD GLUCOSE INCREASED (it affected her glucose numbers/numbers have been running high in the 170s). At the time of the report, PAIN (a little sore), TENDERNESS (tenderness), VACCINATION COMPLICATION (a little bit off) and BLOOD GLUCOSE INCREASED (it affected her glucose numbers/numbers have been running high in the 170s) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 170 High. On an unknown date, Body temperature: 98.3 (Inconclusive) degrees Fahrenheit (patient noted following vaccination).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In response to the increase in her glucose numbers (running high, in the 170s), the patient had to increase her units of insulin. No additional treatment for the events was reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain in shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced MYALGIA (Muscle pain in shoulder). At the time of the report, MYALGIA (Muscle pain in shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. No Treatment information  provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Pain in the hips; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the hips) and MYALGIA (Myalgia ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Thyroid disorder. Concomitant products included LISINOPRIL for an unknown indication, THYROID.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ARTHRALGIA (Pain in the hips) and MYALGIA (Myalgia ). At the time of the report, ARTHRALGIA (Pain in the hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Dizziness, Fatigue
Clinical narrative: red rash; dizzy; 100.2 F temperature; fatigued; chills; soreness in the arm; COVID like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), COVID-19 (COVID like symptoms), RASH ERYTHEMATOUS (red rash), DIZZINESS (dizzy) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20a) 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), COVID-19 (COVID like symptoms) and CHILLS (chills). On 20-Feb-2021, the patient experienced DIZZINESS (dizzy). 20-Feb-2021, the patient experienced PYREXIA (100.2 F temperature) and FATIGUE (fatigued). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash). On 20-Feb-2021, DIZZINESS (dizzy) and CHILLS (chills) had resolved. On 21-Feb-2021, COVID-19 (COVID like symptoms), PYREXIA (100.2 F temperature) and FATIGUE (fatigued) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and RASH ERYTHEMATOUS (red rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 100.2f (Inconclusive) 100.2F.         no concomitants were provided. no treatment medication were provided.   This case was linked to MOD-2021-224883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: followup has done on 16-jun-2021 and unknown date patient administered second dose. event  were updated  that rash on her arm
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: red rash; dizzy; 100.2 F temperature; fatigued; chills; soreness in the arm; COVID like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), COVID-19 (COVID like symptoms), RASH ERYTHEMATOUS (red rash), DIZZINESS (dizzy) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20a) 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), COVID-19 (COVID like symptoms) and CHILLS (chills). On 20-Feb-2021, the patient experienced DIZZINESS (dizzy). 20-Feb-2021, the patient experienced PYREXIA (100.2 F temperature) and FATIGUE (fatigued). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash). On 20-Feb-2021, DIZZINESS (dizzy) and CHILLS (chills) had resolved. On 21-Feb-2021, COVID-19 (COVID like symptoms), PYREXIA (100.2 F temperature) and FATIGUE (fatigued) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and RASH ERYTHEMATOUS (red rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 100.2f (Inconclusive) 100.2F.         no concomitants were provided. no treatment medication were provided.   This case was linked to MOD-2021-224883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: followup has done on 16-jun-2021 and unknown date patient administered second dose. event  were updated  that rash on her arm
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash, Rash pruritic
Clinical narrative: I have not received the 2nd shot in the series; Rash bothers her but is not painful; She had developed a rash on the tops of her hands; rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash bothers her but is not painful), RASH (She had developed a rash on the tops of her hands), RASH (rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area) and PRODUCT DOSE OMISSION ISSUE (I have not received the 2nd shot in the series) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 RASH PRURITIC (Rash bothers her but is not painful), RASH (She had developed a rash on the tops of her hands) and RASH (rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area). On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I have not received the 2nd shot in the series). On 16-Feb-2021, PRODUCT DOSE OMISSION ISSUE (I have not received the 2nd shot in the series) had resolved. At the time of the report, RASH PRURITIC (Rash bothers her but is not painful), RASH (She had developed a rash on the tops of her hands) and RASH (rash had extended up her right arm and around the right side of her trunk at the level of her abdomen and flank area) 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 for the event includes Breast milk, Hydrocortisone cream   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2021: No specific follow-up information recorded. On 15-Apr-2021: No specific follow-up information recorded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.; Arm was swollen, red, and very warm near the injection site; Arm was swollen, red, and very warm near the injection site; Arm was swollen, red, and very warm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was swollen, red, and very warm near the injection site), LIMB DISCOMFORT (arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.), VACCINATION SITE ERYTHEMA (Arm was swollen, red, and very warm near the injection site) and VACCINATION SITE SWELLING (Arm was swollen, red, and very warm near the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm was swollen, red, and very warm near the injection site), VACCINATION SITE ERYTHEMA (Arm was swollen, red, and very warm near the injection site) and VACCINATION SITE SWELLING (Arm was swollen, red, and very warm near the injection site). On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) (oral) on 26-Jan-2021 for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm was swollen, red, and very warm near the injection site), LIMB DISCOMFORT (arm was blotchy, oblong shaped from the top ofthe shoulder down 5inches and 3 inches wide.), VACCINATION SITE ERYTHEMA (Arm was swollen, red, and very warm near the injection site) and VACCINATION SITE SWELLING (Arm was swollen, red, and very warm near the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided    This case was linked to MOD-2021-020825 (Patient Link).