chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PRURITUS (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE PAIN (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE ERYTHEMA (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) and INJECTION SITE SWELLING (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE PAIN (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE ERYTHEMA (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) and INJECTION SITE SWELLING (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site). At the time of the report, INJECTION SITE PRURITUS (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE PAIN (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE ERYTHEMA (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) and INJECTION SITE SWELLING (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on 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.; 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm is warm to the touch; Itchy; Redness in her injection site arm that's about 6 inches by 3 inches in size; Raised just a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness in her injection site arm that's about 6 inches by 3 inches in size) and VACCINATION SITE SWELLING (Raised just a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness in her injection site arm that's about 6 inches by 3 inches in size) and VACCINATION SITE SWELLING (Raised just a little). At the time of the report, VACCINATION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Redness in her injection site arm that's about 6 inches by 3 inches in size) and VACCINATION SITE SWELLING (Raised just a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information On 02-Jun-2021: MOD21-074967 added during MI recon- email address added.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Diarrhea; Fever; Nausea; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) 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 reaction (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) 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.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Peripheral swelling
Clinical narrative: Red; Hot; Felt like a blood pressure cuff not being released from elbow to shoulder; Did hurt; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Red), FEELING HOT (Hot), PERIPHERAL SWELLING (Felt like a blood pressure cuff not being released from elbow to shoulder) and PAIN (Did hurt) in a 43-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 No adverse event (no historical condition was reported).    On 28-Dec-2020 at 2:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 5:00 AM, the patient experienced ERYTHEMA (Red), FEELING HOT (Hot) and PERIPHERAL SWELLING (Felt like a blood pressure cuff not being released from elbow to shoulder). 05-Jan-2021 at 5:00 AM, the patient experienced PAIN (Did hurt). At the time of the report, ERYTHEMA (Red), FEELING HOT (Hot), PERIPHERAL SWELLING (Felt like a blood pressure cuff not being released from elbow to shoulder) and PAIN (Did hurt) 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to Touch; arm was itchy around injection site; rash around injection site; arm was really sore and knot pain; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (arm was really sore and knot pain), VACCINATION SITE WARMTH (warm to Touch), VACCINATION SITE PRURITUS (arm was itchy around injection site) and VACCINATION SITE RASH (rash around injection site) in a 35-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 No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore and knot pain). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy around injection site) and VACCINATION SITE RASH (rash around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to Touch). On 14-Jan-2021, PAIN IN EXTREMITY (arm was really sore and knot pain) had resolved. On 20-Jan-2021, VACCINATION SITE PRURITUS (arm was itchy around injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to Touch) and VACCINATION SITE RASH (rash around 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included LEVOTHYROXINE.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore). At the time of the report, INJECTION SITE PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: reaction at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE REACTION (reaction at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE REACTION (reaction at injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE REACTION (reaction 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.   No concomitant medications were provided by the reporter.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Erythema, Pruritus, Rash, Vaccination site pain
Clinical narrative: breast feeding; Redness generalized; Generalized hives; really bad rash all over the body; very itchy mostly on her legs and both arms, elbows and wrists; very mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Generalized hives), VACCINATION SITE PAIN (very mild arm soreness), RASH (really bad rash all over the body), PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists) and ERYTHEMA (Redness generalized) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 08) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (very mild arm soreness). On 14-Jan-2021, the patient experienced RASH (really bad rash all over the body) and PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists). On 15-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Generalized hives) and ERYTHEMA (Redness generalized). On an unknown date, the patient experienced BREAST FEEDING (breast feeding). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ALEGRA) at a dose of 180 mg and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (very mild arm soreness) had resolved. At the time of the report, VACCINATION SITE URTICARIA (Generalized hives), PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists), ERYTHEMA (Redness generalized) and BREAST FEEDING (breast feeding) outcome was unknown and RASH (really bad rash all over the body) had not resolved.            No concomitant medication was reported. event-6 week post partum.   This case was linked to MOD-2021-043776 (Parent-Child Link).   See case MOD-2021-043776 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2021: No specific follow-up information recorded. On 18-Jun-2021: follow up received on 18-jun-2021:second dose details, patient details,events were added
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: breast feeding; Redness generalized; Generalized hives; really bad rash all over the body; very itchy mostly on her legs and both arms, elbows and wrists; very mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Generalized hives), VACCINATION SITE PAIN (very mild arm soreness), RASH (really bad rash all over the body), PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists) and ERYTHEMA (Redness generalized) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 08) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (very mild arm soreness). On 14-Jan-2021, the patient experienced RASH (really bad rash all over the body) and PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists). On 15-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Generalized hives) and ERYTHEMA (Redness generalized). On an unknown date, the patient experienced BREAST FEEDING (breast feeding). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ALEGRA) at a dose of 180 mg and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (very mild arm soreness) had resolved. At the time of the report, VACCINATION SITE URTICARIA (Generalized hives), PRURITUS (very itchy mostly on her legs and both arms, elbows and wrists), ERYTHEMA (Redness generalized) and BREAST FEEDING (breast feeding) outcome was unknown and RASH (really bad rash all over the body) had not resolved.            No concomitant medication was reported. event-6 week post partum.   This case was linked to MOD-2021-043776 (Parent-Child Link).   See case MOD-2021-043776 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2021: No specific follow-up information recorded. On 18-Jun-2021: follow up received on 18-jun-2021:second dose details, patient details,events were added
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Dyspnoea, Ear swelling, Hypoaesthesia
Clinical narrative: Suddenly was short of breath; numbness and tingling in L face on the buccal side and her L arm.; L side of the face and eyelids were swelling; L side of the face and eyelids were swelling; Agitated; Worried; general malaise; Delayed ear swelling; A spontaneous report was received from a healthcare professional concerning a 43-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.   The patient's medical history included breast cancer and axillary swelling.  Concomitant product use was not provided by the reporter.     On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 [LOT#301] for prophylaxis of COVID-19 infection.    The reporter was called to see a patient in drive up lane 7 min post vaccination. The patient immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried. Past medical history of breast cancer and axillary swelling. Initial examination lungs CTA, regular tachycardia. Pt moved to observation area. Initial vitals: BP: 154/82, HR 129, 97 percent O2. BP 154/82, 136, RR 20, O2 sat 99 percent 10:43 am. BP 162/84, HR 131, RR 22, O2 sat 100 percent at 10:49 am. At 10:49 am, she suddenly was short of breath, general malaise, delayed ear swelling, and was put on a stretcher and 10L nonrebreather. She was brought to Medical Center at 10:54.   Treatment for the event included Benadryl 25 mg po given at 10:25 am and 3 mg Epi pen injection given at 10:41am. A second epinephrine 3mg injection given at 10:44 am  The events of hypoaesthesia, swelling face, swelling of eyelids, agitation, anxiety, dyspnoea, malaise and ear swelling were 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.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Swelling face, Swelling of eyelid, Vital signs measurement
Clinical narrative: Suddenly was short of breath; numbness and tingling in L face on the buccal side and her L arm.; L side of the face and eyelids were swelling; L side of the face and eyelids were swelling; Agitated; Worried; general malaise; Delayed ear swelling; A spontaneous report was received from a healthcare professional concerning a 43-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.   The patient's medical history included breast cancer and axillary swelling.  Concomitant product use was not provided by the reporter.     On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 [LOT#301] for prophylaxis of COVID-19 infection.    The reporter was called to see a patient in drive up lane 7 min post vaccination. The patient immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried. Past medical history of breast cancer and axillary swelling. Initial examination lungs CTA, regular tachycardia. Pt moved to observation area. Initial vitals: BP: 154/82, HR 129, 97 percent O2. BP 154/82, 136, RR 20, O2 sat 99 percent 10:43 am. BP 162/84, HR 131, RR 22, O2 sat 100 percent at 10:49 am. At 10:49 am, she suddenly was short of breath, general malaise, delayed ear swelling, and was put on a stretcher and 10L nonrebreather. She was brought to Medical Center at 10:54.   Treatment for the event included Benadryl 25 mg po given at 10:25 am and 3 mg Epi pen injection given at 10:41am. A second epinephrine 3mg injection given at 10:44 am  The events of hypoaesthesia, swelling face, swelling of eyelids, agitation, anxiety, dyspnoea, malaise and ear swelling were 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Pain
Clinical narrative: Pregnant; Horrible body aches; Headache; This spontaneous prospective pregnancy case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), PAIN (Horrible body aches) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Migraine and Allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 19-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), PAIN (Horrible body aches) and HEADACHE (Headache). On 19-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN (Horrible body aches) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: rash; low grade fever; swelling; nausea; headache; fatigue; 12 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (12 weeks pregnant), RASH (rash), PYREXIA (low grade fever), SWELLING (swelling) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 14-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 on an unknown date and the estimated date of delivery was 10-Aug-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (12 weeks pregnant). On 15-Jan-2021, the patient experienced RASH (rash), PYREXIA (low grade fever), SWELLING (swelling), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 14-Jan-2021, EXPOSURE DURING PREGNANCY (12 weeks pregnant) had resolved. At the time of the report, RASH (rash), PYREXIA (low grade fever), SWELLING (swelling), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details provided as Tylenol and Benadryl.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: rash; low grade fever; swelling; nausea; headache; fatigue; 12 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (12 weeks pregnant), RASH (rash), PYREXIA (low grade fever), SWELLING (swelling) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 14-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 on an unknown date and the estimated date of delivery was 10-Aug-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (12 weeks pregnant). On 15-Jan-2021, the patient experienced RASH (rash), PYREXIA (low grade fever), SWELLING (swelling), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 14-Jan-2021, EXPOSURE DURING PREGNANCY (12 weeks pregnant) had resolved. At the time of the report, RASH (rash), PYREXIA (low grade fever), SWELLING (swelling), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details provided as Tylenol and Benadryl.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash; redness; swelling; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness). On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 15-Jan-2021, VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Constipation, Muscular weakness, Nausea
Clinical narrative: Horrendous cramps In her stomach; Constipation; total weakness in her legs; Chills; Nauseated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Horrendous cramps In her stomach), CONSTIPATION (Constipation), MUSCULAR WEAKNESS (total weakness in her legs), CHILLS (Chills) and NAUSEA (Nauseated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer, Drug allergy since an unknown date and Brain operation (Had undergone brain surgery twice). Concurrent medical conditions included Penicillin allergy and Iodine allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Horrendous cramps In her stomach), CONSTIPATION (Constipation), MUSCULAR WEAKNESS (total weakness in her legs), CHILLS (Chills) and NAUSEA (Nauseated). At the time of the report, ABDOMINAL PAIN UPPER (Horrendous cramps In her stomach), CONSTIPATION (Constipation), MUSCULAR WEAKNESS (total weakness in her legs), CHILLS (Chills) and NAUSEA (Nauseated) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported her doctor thought she had UTI and put her on Keflex and laxatives. Patient reported stomach issues after first dose were not due to vaccine but Brussel sprouts.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-Apr-2021. Second details were added.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart started racing; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (Heart started racing) 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.   In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Heart started racing). At the time of the report, PALPITATIONS (Heart started racing) had resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema migrans, Swelling, Vaccination site cellulitis
Clinical narrative: Bulls eye size rash extended down near elbow; Bullseyes size rash extended down near elbow; Swelling; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (Bulls eye size rash extended down near elbow), ERYTHEMA MIGRANS (Bullseyes size rash extended down near elbow), SWELLING (Swelling) and DISCOMFORT (Discomfort) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SWELLING (Swelling) and DISCOMFORT (Discomfort). On 30-Jan-2021, the patient experienced ERYTHEMA MIGRANS (Bullseyes size rash extended down near elbow). On 31-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Bulls eye size rash extended down near elbow). On 20-Jan-2021, SWELLING (Swelling) and DISCOMFORT (Discomfort) had resolved. At the time of the report, VACCINATION SITE CELLULITIS (Bulls eye size rash extended down near elbow) and ERYTHEMA MIGRANS (Bullseyes size rash extended down near elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Whole arm hurting for about a week), PRURITUS (Itching a bit), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash from injection site) and VACCINATION SITE ERYTHEMA (Just red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer survivor) and Chemotherapy.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Whole arm hurting for about a week), PRURITUS (Itching a bit), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash from injection site) and VACCINATION SITE ERYTHEMA (Just red). At the time of the report, PAIN IN EXTREMITY (Whole arm hurting for about a week), PRURITUS (Itching a bit), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (Rash from injection site) and VACCINATION SITE ERYTHEMA (Just red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: email with outcome
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 102.8 F; Body aches; Nausea; Headache; A spontaneous report was received from a Healthcare professional, concerning a 52 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 102.8, body aches, nausea, headache, fever of 103", and had to go to the ER and received a bag of fluid and was 80% better.  The patient's medical history as provided by the reporter includes asthma. No relevant concomitant medications were reported.    On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O25620A) for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced fever of 102.8, body aches, nausea and headache. On 30 Dec 2020 the patient experienced fever of 103" and had to go to the ER and received a bag of fluid and was 80% better.  The patient was treated with Children's medication.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of the events was recovered.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the onset of the reported events, and the known safety  profile of mRNA-1273  a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Almost immediate dizziness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Almost immediate dizziness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SULFA [SULFADIAZINE] (Allergy). Concurrent medical conditions included Hyperlipidemia, Hypertension and Penicillin allergy. Concomitant products included ATORVASTATIN, HCTZ and LOSARTAN POTASSIUM (COZAAR) for an unknown indication.    On 22-Jan-2021 at 10:21 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021 at 11:00 AM, the patient experienced DIZZINESS (Almost immediate dizziness). At the time of the report, DIZZINESS (Almost immediate dizziness) 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: Very sore arm/ extreme soreness; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Very sore arm/ extreme soreness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002MOA) for COVID-19 vaccination.  Family history included Osteoporosis. Concurrent medical conditions included Depression, Anxiety, Cystitis interstitial since 2016, Asthma since 1998, Keratitis since 2008 and Antiphospholipid syndrome (Carrier of) since 05-Feb-2020. Concomitant products included ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for Anticoagulant therapy, BUSPIRONE for Anxiety, MONTELUKAST for Asthma, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Blood disorder, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Nausea, CALCIUM for Osteoporosis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.  On 20-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) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-Sep-2020 and the estimated date of delivery was 04-Jul-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Very sore arm/ extreme soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Very sore arm/ extreme soreness) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Treatment medication was not reported.  This case was linked to MOD-2021-026999 (Patient Link).  Sender's Comments: This is a case of product exposure during pregnancy with AE Vaccination site pain for this 30-year-old female. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Limb discomfort, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; Arm discomfort; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and LIMB DISCOMFORT (Arm discomfort) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth, female 39weeks gestation) on 19-May-2019. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOXYLAMINE;PYRIDOXINE for Pregnancy and Vomiting.    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 on 06-Nov-2020 and the estimated date of delivery was 13-Aug-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and LIMB DISCOMFORT (Arm discomfort). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred on an unknown date.  On 17-Jan-2021, LIMB DISCOMFORT (Arm discomfort) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2020, Pregnancy test: positive (Positive) positive. On 01-Jan-2021, Ultrasound scan: normal (normal) reported normal on 11Jan2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. Patient gave birth to a female child on her previous pregnancy.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache). On 15-Jan-2021, VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Consent to follow-up obtained.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Cholesterol.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure and cholesterol medications. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No new information received; 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 25-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 on an unknown date and the estimated date of delivery was 23-Jun-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant). On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna COVID-19 vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site vesicles
Clinical narrative: tiny little blisters on the injection site; Covid Arm; red arm; itching; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (tiny little blisters on the injection site), VACCINATION SITE REACTION (Covid Arm), ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012.M00M) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE VESICLES (tiny little blisters on the injection site), VACCINATION SITE REACTION (Covid Arm), ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE RASH (Rash). The patient was treated with CORTISONE (topical) for Itching, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE VESICLES (tiny little blisters on the injection site), VACCINATION SITE REACTION (Covid Arm), ERYTHEMA (red arm) and VACCINATION SITE RASH (Rash) had resolved and VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not given.    No laboratory was not given.    No treatment information was not given.