chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchy red bump at the site of injection; itchy red bump at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy red bump at the site of injection) and VACCINATION SITE ERYTHEMA (itchy red bump at the site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 VACCINATION SITE PRURITUS (itchy red bump at the site of injection) and VACCINATION SITE ERYTHEMA (itchy red bump at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy red bump at the site of injection) and VACCINATION SITE ERYTHEMA (itchy red bump at the site of injection) had resolved.            Concomitant drug was not reported.  It was reported that event lasted for approximately 3 weeks.   This case was linked to MOD-2021-208304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03 JUN 2021 contains Updated Event outcome from unknown to resolved.; 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: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Warm; The enlarged patch is a hard lump area; firm to touch; Itchy; Enlarged patch area around the injection; Red; Headache; Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection) and VACCINATION SITE ERYTHEMA (Red) in a 60-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.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection), VACCINATION SITE ERYTHEMA (Red), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection), VACCINATION SITE ERYTHEMA (Red), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm; The enlarged patch is a hard lump area; firm to touch; Itchy; Enlarged patch area around the injection; Red; Headache; Tired; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection) and VACCINATION SITE ERYTHEMA (Red) in a 60-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.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection), VACCINATION SITE ERYTHEMA (Red), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE MASS (The enlarged patch is a hard lump area; firm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (Enlarged patch area around the injection), VACCINATION SITE ERYTHEMA (Red), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site inflammation, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Inflammation at the injection site; Warmness at the injection site; Redness at the injection site; Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Vaccination site rash) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with CORTISONE ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INJECTION SITE INFLAMMATION (Inflammation at the injection site), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: On 04-JUN-2021 Folllow up was received and patient denied further Follow up; 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: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Soreness at injection site arm persistently sore at injection site; Itchiness at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE PAIN (soreness at injection site arm persistently sore at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for an unknown indication.  No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE PAIN (soreness at injection site arm persistently sore at injection site). On 09-Jan-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site arm persistently sore at injection site) 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.   Treatment for the event were not known.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Wound up being positive; cough; little sore throat; tickle in the throat; sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (little sore throat), THROAT IRRITATION (tickle in the throat), PAIN IN EXTREMITY (sore arm), SARS-COV-2 TEST POSITIVE (Wound up being positive) and COUGH (cough) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Sleep problem, MELATONIN for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (little sore throat), THROAT IRRITATION (tickle in the throat) and COUGH (cough). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Wound up being positive). On 07-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, OROPHARYNGEAL PAIN (little sore throat), THROAT IRRITATION (tickle in the throat), SARS-COV-2 TEST POSITIVE (Wound up being positive) and COUGH (cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: follow up received on 06-APR-2021: NO NEW INFORMATION; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for COVID-19 which is unlikely.However, the event COVID-positive is unlikely related mRNA-1273. Further information is requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Wound up being positive; cough; little sore throat; tickle in the throat; sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (little sore throat), THROAT IRRITATION (tickle in the throat), PAIN IN EXTREMITY (sore arm), SARS-COV-2 TEST POSITIVE (Wound up being positive) and COUGH (cough) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Sleep problem, MELATONIN for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (little sore throat), THROAT IRRITATION (tickle in the throat) and COUGH (cough). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Wound up being positive). On 07-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, OROPHARYNGEAL PAIN (little sore throat), THROAT IRRITATION (tickle in the throat), SARS-COV-2 TEST POSITIVE (Wound up being positive) and COUGH (cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: follow up received on 06-APR-2021: NO NEW INFORMATION; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for COVID-19 which is unlikely.However, the event COVID-positive is unlikely related mRNA-1273. Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: tremendous arthritis in his hands and had trouble gripping; A spontaneous report was received from a physician concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tremendous arthritis in his hands and had trouble gripping.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient was tested positive for COVID-19 in the March/April or springtime.   On an unspecified date (reported as 3 weeks ago from the reporting date), the patient received mRNA-1273 (LOT# unknown) route unknown and unknown site of administration for prophylaxis of COVID-19 infection.  On an unspecified date, the patient had experienced tremendous arthritis in his hands and had trouble gripping. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event, tremendous arthritis in his hands and had trouble gripping was unknown.; Reporter's Comments: 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itching at injection site; rash at the injection site - 2-inch square; soreness at injection site; headache; fever - lasted for less than 4 hours; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE RASH (rash at the injection site - 2-inch square), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and PYREXIA (fever - lasted for less than 4 hours) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 23-Dec-2020, 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 PRURITUS (itching at injection site), VACCINATION SITE RASH (rash at the injection site - 2-inch square), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and PYREXIA (fever - lasted for less than 4 hours). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE RASH (rash at the injection site - 2-inch square), VACCINATION SITE PAIN (soreness at injection site), HEADACHE (headache) and PYREXIA (fever - lasted for less than 4 hours) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Illness, Vomiting
Clinical narrative: Got sick; Weakness; Sweatiness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), ASTHENIA (Weakness), HYPERHIDROSIS (Sweatiness) and VOMITING (Vomiting) in an 80-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 12-Jan-2021, the patient experienced ILLNESS (Got sick), ASTHENIA (Weakness), HYPERHIDROSIS (Sweatiness) and VOMITING (Vomiting). At the time of the report, ILLNESS (Got sick), ASTHENIA (Weakness), HYPERHIDROSIS (Sweatiness) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Immediately got pain in the arm and sore; Injection site warm to the touch; Injection site swollen; Injection site itch; Felt tired; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (Immediately got pain in the arm and sore), INJECTION SITE WARMTH (Injection site warm to the touch), INJECTION SITE SWELLING (Injection site swollen), INJECTION SITE PRURITUS (Injection site itch) and FATIGUE (Felt tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergic to ceclor, Levaquin and monested.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced INJECTION SITE PAIN (Immediately got pain in the arm and sore), INJECTION SITE WARMTH (Injection site warm to the touch), INJECTION SITE SWELLING (Injection site swollen), INJECTION SITE PRURITUS (Injection site itch) and FATIGUE (Felt tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Immediately got pain in the arm and sore), INJECTION SITE WARMTH (Injection site warm to the touch), INJECTION SITE SWELLING (Injection site swollen), INJECTION SITE PRURITUS (Injection site itch) and FATIGUE (Felt tired) had not 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.   Concomitant medication was not provided.  Treatment includes pain killers for 2 days.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not 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.   Concomitant product use was not provided by the reporter.  Treatment includes cold wash cloth and heating pad. The patient got vaccinated and got pain in the arm continuously since the day. When patient sits in his chair it doesn't bother him. Patient's pharmacist suggested he might be having ascites if the vaccine was given way up his arm and that might be reason for the pain.; Sender's Comments: 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Pain, Pain in extremity
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (soreness of the arm for 2 days), FATIGUE (some fatigue) and PAIN (little body ache) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 25-Mar-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (soreness of the arm for 2 days), FATIGUE (some fatigue) and PAIN (little body ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 16-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 17-Jan-2021, FATIGUE (some fatigue) and PAIN (little body ache) had resolved. On 18-Jan-2021, PAIN IN EXTREMITY (soreness of the arm for 2 days) had resolved.            The date of patient's positive pregnancy test was AUG-2020  The patient previously had a live full-term birth on 19-APR-2019
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Myalgia, Pyrexia
Clinical narrative: Malaise; Body ache; significant painful swollen lymph node under left armpit; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (Medical history not provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positve positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Malaise; Body ache; significant painful swollen lymph node under left armpit; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (Medical history not provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise), MYALGIA (Body ache), LYMPHADENOPATHY (significant painful swollen lymph node under left armpit), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positve positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site swelling
Clinical narrative: Pink swelling in the injection site; Pink swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink swelling in the injection site) and VACCINATION SITE SWELLING (Pink swelling in the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE DISCOLOURATION (Pink swelling in the injection site) and VACCINATION SITE SWELLING (Pink swelling in the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink swelling in the injection site) and VACCINATION SITE SWELLING (Pink swelling in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Vaccination site erythema, Vaccination site pain
Clinical narrative: face and upper body itching; face and upper body burning; she has a 4 inch long red patch; 4 inch long patch that is really red and itchy; soreness at injection site; redness at injection site; itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (face and upper body itching), BURNING SENSATION (face and upper body burning), RASH (she has a 4 inch long red patch), PRURITUS (4 inch long patch that is really red and itchy) and VACCINATION SITE PAIN (soreness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, VITAMIN D3, MULTIVITAMIN & MINERAL, PROGESTERONE and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at injection site). On 09-Jan-2021, the patient experienced RASH (she has a 4 inch long red patch) and PRURITUS (4 inch long patch that is really red and itchy). On 12-Jan-2021, the patient experienced PRURITUS (face and upper body itching) and BURNING SENSATION (face and upper body burning). At the time of the report, PRURITUS (face and upper body itching), BURNING SENSATION (face and upper body burning), RASH (she has a 4 inch long red patch), PRURITUS (4 inch long patch that is really red and itchy), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included cortisone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: face and upper body itching; face and upper body burning; she has a 4 inch long red patch; 4 inch long patch that is really red and itchy; soreness at injection site; redness at injection site; itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (face and upper body itching), BURNING SENSATION (face and upper body burning), RASH (she has a 4 inch long red patch), PRURITUS (4 inch long patch that is really red and itchy) and VACCINATION SITE PAIN (soreness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, VITAMIN D3, MULTIVITAMIN & MINERAL, PROGESTERONE and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at injection site). On 09-Jan-2021, the patient experienced RASH (she has a 4 inch long red patch) and PRURITUS (4 inch long patch that is really red and itchy). On 12-Jan-2021, the patient experienced PRURITUS (face and upper body itching) and BURNING SENSATION (face and upper body burning). At the time of the report, PRURITUS (face and upper body itching), BURNING SENSATION (face and upper body burning), RASH (she has a 4 inch long red patch), PRURITUS (4 inch long patch that is really red and itchy), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included cortisone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; A spontaneous report was received from a consumer concerning a 53 years old female patient who experienced headache and nausea.   The patient's medical history included fibromyalgia and IBS (Irritable bowel syndrome). Products known to have been used by the patient, within two weeks prior to the event, included Aluminium Hydroxide, Dicyclomine Hydrochloride, Amitriptyline, Pregabalin.    The patient received her unknown dose of two planned doses of mRNA-1273 (Batch number: 025J20-2A) on 12 Jan 2021 in the left arm at 10.30am for prophylaxis of COVID-19 infection.    On 12 Jan 2021 the patient experienced headache and nausea. Treatment information were not provided.    Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the event(s) headache and nausea were not reported. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia and Irritable bowel syndrome. Concomitant products included PREGABALIN for Fibromyalgia, ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) and AMITRIPTYLINE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) 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.   Treatment information were not provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: vaccination adverse reaction; Tested positive for Covid-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) and VACCINATION COMPLICATION (vaccination adverse reaction) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) and VACCINATION COMPLICATION (vaccination adverse reaction) 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.   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 event, a causal relationship cannot be excluded. However,   the event  SARS-COV-2 test positive is unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Flushing, Vaccination site pain
Clinical narrative: Unusual dizziness; I could not maintain my balance; generalized flushed feeling; fuzzy feeling from head to toe from the inside. It was very weird; sore arm and tenderness over the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Unusual dizziness), BALANCE DISORDER (I could not maintain my balance), FLUSHING (generalized flushed feeling), FEELING ABNORMAL (fuzzy feeling from head to toe from the inside. It was very weird) and VACCINATION SITE PAIN (sore arm and tenderness over the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL and AMLODIPINE.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm and tenderness over the injection site). On 09-Jan-2021, the patient experienced DIZZINESS (Unusual dizziness), BALANCE DISORDER (I could not maintain my balance), FLUSHING (generalized flushed feeling) and FEELING ABNORMAL (fuzzy feeling from head to toe from the inside. It was very weird). On 09-Jan-2021, VACCINATION SITE PAIN (sore arm and tenderness over the injection site) had resolved. At the time of the report, DIZZINESS (Unusual dizziness), BALANCE DISORDER (I could not maintain my balance), FLUSHING (generalized flushed feeling) and FEELING ABNORMAL (fuzzy feeling from head to toe from the inside. It was very weird) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided. Patient has doubts if this is related to her blood pressure. 11-Jan-21, patient feels quite well but not fully recovered.; 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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine). At the time of the report, COVID-19 (a patient tested positive for COVID-19 after receiving Moderna's COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-005623 (E2B Linked Report).; Sender's Comments: Based on biological implausibility the event of COVID-19 infection is assessed as unlikely related to mRNA-1273.  Very limited information regarding this event has been provided at this time.  Further information has been requested US-MODERNATX, INC.-MOD-2021-005623:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: redness; rash under breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash under breast) and ERYTHEMA (redness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MRN0300183274) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash under breast) and ERYTHEMA (redness). At the time of the report, RASH (rash under breast) and ERYTHEMA (redness) outcome was unknown. On 12JAN2021, the patient's husband phoned the call center to report events, "wife received the Moderna vaccine as the first shot yesterday 11/JAN/2021 in the left arm at 1:pm as the first dose and developed a rash under breast and redness."      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Little bit of soreness in his right arm he felt the soreness in his left arm/when you touch the spot it was a little sore; Little tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little bit of soreness in his right arm he felt the soreness in his left arm/when you touch the spot it was a little sore) and VACCINATION SITE PAIN (Little tenderness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 07-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 PAIN IN EXTREMITY (Little bit of soreness in his right arm he felt the soreness in his left arm/when you touch the spot it was a little sore) and VACCINATION SITE PAIN (Little tenderness). On 09-Jan-2021, PAIN IN EXTREMITY (Little bit of soreness in his right arm he felt the soreness in his left arm/when you touch the spot it was a little sore) and VACCINATION SITE PAIN (Little tenderness) 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.   No relevant concomitant medications were reported.  No treatment medication was 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: welts all over neck; broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    A spontaneous report (United States) was received from a 55 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced welts all over neck broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 14-Jan-2021, prior to the onset of the events welts all over neck broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20-2A) via intramuscular route in right arm for prophylaxis of COVID-19 infection.  On 19-Jan-2021, the patient experienced welts all over neck broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck.  Patient received hydroxyzine pamoate 25mg capsules, Famotidine 40mg and Prednisone 20mg as treatments drugs.  Action taken with mRNA-1273 in response to the events welts all over neck broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck was not provided.  The outcome of the events welts all over neck broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck was not provided.  The reporter did not provide the assessment of the events welts all over neck broke out in a rash/bumps all over leg/and going to her other leg/it's on her neck to study drug.; 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