chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte count, Peripheral coldness, Pyrexia
Clinical narrative: her hands and feet were so cold; 101 temperature; Tired; Little Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (her hands and feet were so cold), PYREXIA (101 temperature), FATIGUE (Tired), HEADACHE (Little Headache) and CHILLS (Chills) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL COLDNESS (her hands and feet were so cold), PYREXIA (101 temperature), FATIGUE (Tired), HEADACHE (Little Headache) and CHILLS (Chills). At the time of the report, PERIPHERAL COLDNESS (her hands and feet were so cold), PYREXIA (101 temperature), FATIGUE (Tired), HEADACHE (Little Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101 (Inconclusive) 101 temperature. On 10-Mar-2021, Granulocyte count: high (High) high. On 10-Mar-2021, Monocyte count: high (High) high.         No Concomitant medications was reported Treatment information was not provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: hardness, itching, redness and swelling; hardness, itching, redness and swelling; hardness, itching, redness and swelling; hardness, itching, redness and swelling; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (hardness, itching, redness and swelling), PRURITUS (hardness, itching, redness and swelling), ERYTHEMA (hardness, itching, redness and swelling) and SWELLING (hardness, itching, redness and swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INDURATION (hardness, itching, redness and swelling), PRURITUS (hardness, itching, redness and swelling), ERYTHEMA (hardness, itching, redness and swelling) and SWELLING (hardness, itching, redness and swelling). At the time of the report, INDURATION (hardness, itching, redness and swelling), PRURITUS (hardness, itching, redness and swelling), ERYTHEMA (hardness, itching, redness and swelling) and SWELLING (hardness, itching, redness and swelling) outcome was unknown.            No Concomitant medications was reported Treatment information was not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: right arm from shoulder to elbow got swollen; right arm from shoulder to elbow got hot; right arm from shoulder to elbow got red; right arm from shoulder to elbow got tender; right arm from shoulder to elbow got itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right arm from shoulder to elbow got swollen), FEELING HOT (right arm from shoulder to elbow got hot), ERYTHEMA (right arm from shoulder to elbow got red), TENDERNESS (right arm from shoulder to elbow got tender) and PRURITUS (right arm from shoulder to elbow got itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and OXYBUTYNIN HYDROCHLORIDE (OXYBUTIN) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm from shoulder to elbow got swollen), FEELING HOT (right arm from shoulder to elbow got hot), ERYTHEMA (right arm from shoulder to elbow got red), TENDERNESS (right arm from shoulder to elbow got tender) and PRURITUS (right arm from shoulder to elbow got itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (right arm from shoulder to elbow got swollen), FEELING HOT (right arm from shoulder to elbow got hot), ERYTHEMA (right arm from shoulder to elbow got red), TENDERNESS (right arm from shoulder to elbow got tender) and PRURITUS (right arm from shoulder to elbow got itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported the events lasted for over a week.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: shingles; circles on her chest; Covid arm; stiffness; soreness; raised red rash that is circular and itchy; raised red rash that is circular and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy) and ERYTHEMA (raised red rash that is circular and itchy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Primary sclerosing cholangitis (liver disease). Concomitant products included URSODIOL and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy) and ERYTHEMA (raised red rash that is circular and itchy). On 13-Mar-2021, the patient experienced RASH (circles on her chest). On 20-Mar-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy), ERYTHEMA (raised red rash that is circular and itchy), HERPES ZOSTER (shingles) and RASH (circles on her chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site reaction
Clinical narrative: shingles; circles on her chest; Covid arm; stiffness; soreness; raised red rash that is circular and itchy; raised red rash that is circular and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy) and ERYTHEMA (raised red rash that is circular and itchy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Primary sclerosing cholangitis (liver disease). Concomitant products included URSODIOL and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy) and ERYTHEMA (raised red rash that is circular and itchy). On 13-Mar-2021, the patient experienced RASH (circles on her chest). On 20-Mar-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, VACCINATION SITE REACTION (Covid arm), MUSCULOSKELETAL STIFFNESS (stiffness), PAIN (soreness), RASH PRURITIC (raised red rash that is circular and itchy), ERYTHEMA (raised red rash that is circular and itchy), HERPES ZOSTER (shingles) and RASH (circles on her chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the only thing was the sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (the only thing was the sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ML20A) 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 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (the only thing was the sore arm). At the time of the report, PAIN IN EXTREMITY (the only thing was the sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Treatment details were not provided. Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-034443 (Patient Link).   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Muscle spasms, Nausea
Clinical narrative: Redness on her arm; Cramps; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on her arm), MUSCLE SPASMS (Cramps), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BAYER ASPIRIN) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced ERYTHEMA (Redness on her arm), MUSCLE SPASMS (Cramps), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, ERYTHEMA (Redness on her arm), MUSCLE SPASMS (Cramps), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified cholesterol medications. No treatment information was provided.   This case was linked to MOD-2021-083661 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; Chills; Nausea; Fatigue; Tender; Heat sensation in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat sensation in arm), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (severe allergy with Tylenol with codeine).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat sensation in arm), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Tender). On 06-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Heat sensation in arm), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Tender) 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.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-062524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062524:case for dose 2
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Headache; Chills; Nausea; Fatigue; Tender; Heat sensation in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat sensation in arm), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (severe allergy with Tylenol with codeine).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat sensation in arm), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Tender). On 06-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Heat sensation in arm), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Tender) 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.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-062524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062524:case for dose 2
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Skin lesion, Vasculitis
Clinical narrative: vasculitis; had a sore arm; she developed a rash on both of her legs; Lesions on both legs, non -itchy.; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (vasculitis), PAIN IN EXTREMITY (had a sore arm), RASH (she developed a rash on both of her legs) and SKIN LESION (Lesions on both legs, non -itchy.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    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 VASCULITIS (vasculitis), PAIN IN EXTREMITY (had a sore arm), RASH (she developed a rash on both of her legs) and SKIN LESION (Lesions on both legs, non -itchy.). At the time of the report, VASCULITIS (vasculitis), PAIN IN EXTREMITY (had a sore arm), RASH (she developed a rash on both of her legs) and SKIN LESION (Lesions on both legs, non -itchy.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: injection site hard; feels pain/hurt; covid arm; injection site red; injection site itchy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 23-Mar-2021, VACCINATION SITE PRURITUS (injection site itchy) had resolved. At the time of the report, VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: injection site hard; feels pain/hurt; covid arm; injection site red; injection site itchy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 23-Mar-2021, VACCINATION SITE PRURITUS (injection site itchy) had resolved. At the time of the report, VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037KZ0A and 041L20A.) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever; chills; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN for Fever and Headache, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) had resolved, CHILLS (chills) and MYALGIA (muscle aches) had not resolved and HEADACHE (headache) 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.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever last Thursday and Friday with a temperature of 100.5-.8 deg F.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever last Thursday and Friday with a temperature of 100.5-.8 deg F.) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (fever last Thursday and Friday with a temperature of 100.5-.8 deg F.). At the time of the report, PYREXIA (fever last Thursday and Friday with a temperature of 100.5-.8 deg F.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 100.5-8 (Inconclusive) temperature of 100.5-8 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter  Treatment caller was not sure if his father took Tylenol  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Gait disturbance, Lip swelling, Oral herpes, Tremor
Clinical narrative: swelling of lips; fever blisters; cracking of the upper lip; tremors in the kneecap, arms started shaking and shaking everywhere; was barely able to walk; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors in the kneecap, arms started shaking and shaking everywhere), GAIT DISTURBANCE (was barely able to walk), LIP SWELLING (swelling of lips), ORAL HERPES (fever blisters) and CHAPPED LIPS (cracking of the upper lip) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Road traffic accident and Accident automobile. Concomitant products included GABAPENTIN, CARBAMAZEPINE and CLONAZEPAM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (tremors in the kneecap, arms started shaking and shaking everywhere) and GAIT DISTURBANCE (was barely able to walk). On an unknown date, the patient experienced LIP SWELLING (swelling of lips), ORAL HERPES (fever blisters) and CHAPPED LIPS (cracking of the upper lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LORAZEPAM at an unspecified dose and frequency. At the time of the report, TREMOR (tremors in the kneecap, arms started shaking and shaking everywhere), GAIT DISTURBANCE (was barely able to walk), LIP SWELLING (swelling of lips), ORAL HERPES (fever blisters) and CHAPPED LIPS (cracking of the upper lip) 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.   Treatment medications included Benadryl and Lorazepam.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I am pregnant and I was told I have to register in the pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant and I was told I have to register in the pregnancy registry) in a 37-year-old female patient (gravida 7, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroid issue. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROXYPROGESTERONE CAPROATE (MAKENA), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 23-Feb-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 10-Oct-2020 and the estimated date of delivery was 17-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant and I was told I have to register in the pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (I am pregnant and I was told I have to register in the pregnancy registry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, post vaccination, the patient reported that she experienced symtpoms of exposure during pregnancy.  It was reported that, the patient had NIPT test and several ultrasounds on an unknown dates for which the result was unknown.  No treatment information was provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Half the dose on elbow; A spontaneous report  was received from a consumer concerning herself, a 47-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced half the dose ended up on elbow (underdose).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 05 Feb 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 013M2CA), intramuscularly, in the left non dominant arm, for prophylaxis of COVID-19 infection.   On 05 Mar 2021, the patient received her second of the two planned doses of mRNA-1273 (Lot number: 029A21A), via unknown route, in the left non dominant arm, for prophylaxis of COVID-19 infection. It was reported that the patient noticed during vaccine administration that half the dose ended up on elbow.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   The outcome of event was considered resolved on 05 Mar 2021.; Reporter's Comments: This report refers to a case of Underdose,  for mRNA-1273, lot #: 029A21A,  with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054715:1st dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Gastrooesophageal reflux disease, Nausea
Clinical narrative: Acid Reflux; Diarrhea / Upset stomach; Nausea; Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore; Fatigued; Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach; Site of injection is hard; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach), DIARRHOEA (Diarrhea / Upset stomach), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), VACCINATION SITE INDURATION (Site of injection is hard) and FATIGUE (Fatigued) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach) and VACCINATION SITE INDURATION (Site of injection is hard). On 18-Mar-2021, the patient experienced FATIGUE (Fatigued). On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea / Upset stomach) and NAUSEA (Nausea). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach), DIARRHOEA (Diarrhea / Upset stomach), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), VACCINATION SITE INDURATION (Site of injection is hard), FATIGUE (Fatigued), VACCINATION SITE PAIN (Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore) and NAUSEA (Nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-081598 (E2B Linked Report).; Sender's Comments:  MOD-2021-081598:For second dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Acid Reflux; Diarrhea / Upset stomach; Nausea; Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore; Fatigued; Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach; Site of injection is hard; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach), DIARRHOEA (Diarrhea / Upset stomach), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), VACCINATION SITE INDURATION (Site of injection is hard) and FATIGUE (Fatigued) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach) and VACCINATION SITE INDURATION (Site of injection is hard). On 18-Mar-2021, the patient experienced FATIGUE (Fatigued). On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhea / Upset stomach) and NAUSEA (Nausea). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Deep pain in her stomach / Experiencing pain at the bottom of patient's stomach), DIARRHOEA (Diarrhea / Upset stomach), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), VACCINATION SITE INDURATION (Site of injection is hard), FATIGUE (Fatigued), VACCINATION SITE PAIN (Site of injection is hard and hurting her/Muscle part of patient's arm at injection site is sore) and NAUSEA (Nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-081598 (E2B Linked Report).; Sender's Comments:  MOD-2021-081598:For second dose
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Lymph node pain, Sensitisation
Clinical narrative: Soreness in the left armpit lymph nodes; Extensive effort to lift arm; Can't even touch arm it is so sensitive; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Soreness in the left armpit lymph nodes), JOINT RANGE OF MOTION DECREASED (Extensive effort to lift arm) and SENSITISATION (Can't even touch arm it is so sensitive) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LYMPH NODE PAIN (Soreness in the left armpit lymph nodes), JOINT RANGE OF MOTION DECREASED (Extensive effort to lift arm) and SENSITISATION (Can't even touch arm it is so sensitive). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CANNABIDIOL at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (Soreness in the left armpit lymph nodes), JOINT RANGE OF MOTION DECREASED (Extensive effort to lift arm) and SENSITISATION (Can't even touch arm it is so sensitive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen and CBD.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Lump in his arm pit; Pain in left arm near the shoulder; Sweatiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump in his arm pit), PAIN IN EXTREMITY (Pain in left arm near the shoulder), HYPERHIDROSIS (Sweatiness) and PYREXIA (Fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced AXILLARY MASS (Lump in his arm pit), PAIN IN EXTREMITY (Pain in left arm near the shoulder), HYPERHIDROSIS (Sweatiness) and PYREXIA (Fever). On 21-Mar-2021, PAIN IN EXTREMITY (Pain in left arm near the shoulder), HYPERHIDROSIS (Sweatiness) and PYREXIA (Fever) had resolved. At the time of the report, AXILLARY MASS (Lump in his arm pit) outcome was unknown.        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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath 5 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath 5 days after receiving 1st dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 11-Mar-2021, the patient experienced DYSPNOEA (shortness of breath 5 days after receiving 1st dose). At the time of the report, DYSPNOEA (shortness of breath 5 days after receiving 1st dose) 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 provided.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Malaise, Pain in extremity, Pyrexia
Clinical narrative: More pain in left arm than the first dose; Did not feel well; Felt a little feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (More pain in left arm than the first dose), MALAISE (Did not feel well) and PYREXIA (Felt a little feverish) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (More pain in left arm than the first dose), MALAISE (Did not feel well) and PYREXIA (Felt a little feverish). At the time of the report, PAIN IN EXTREMITY (More pain in left arm than the first dose), MALAISE (Did not feel well) and PYREXIA (Felt a little feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Anti-thyroid antibody: high (High) high. On 15-Mar-2021, Blood thyroid stimulating hormone: high (High) High.         No treatment information was provided. The action taken with the drug was Not applicable.   This case was linked to MOD-2021-054736 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications included.  Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-may-2021, patient updated that no side effects to the COVID-19 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Pain in extremity, Rhinorrhoea
Clinical narrative: Sore arm; Numbness; runny nose; deep heavy pressure in the chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA (Numbness), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (deep heavy pressure in the chest) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA (Numbness), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (deep heavy pressure in the chest). At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOAESTHESIA (Numbness), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (deep heavy pressure in the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No treatment medications provided.   This case was linked to MOD-2021-061139 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: EYE LID SWELLING; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (EYE LID SWELLING) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING OF EYELID (EYE LID SWELLING). At the time of the report, SWELLING OF EYELID (EYE LID SWELLING) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included eye drops. No treatment information was reported. The reporter stated that the patient experienced eye lid swelling after receiving the vaccine but the doctors said it was not because of eye drop medication. Then when the patient used the eye drop medication again, he experienced it again so the reporter stated that it was not because of Moderna vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea, Sinusitis, Sneezing
Clinical narrative: Sinus allergy infection in her head; Runny nose; Sneezing; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus allergy infection in her head), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cardiac disorder.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus allergy infection in her head), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). At the time of the report, SINUSITIS (Sinus allergy infection in her head) had not resolved and RHINORRHOEA (Runny nose), SNEEZING (Sneezing), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included high blood pressure and cardiac medicines.  Treatment medication included Coccidian for colds.  The patient had experienced similar symptoms for years. She was due to get her second dose of vaccine on 24-Mar-2021.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 001a21a) for COVID-19 vaccination.     No medical history reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided          Other concomitant medications included unspecified thyroid medication. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Patient was doing fine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR received. Clinical information updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Worse arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Worse arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PAIN IN EXTREMITY (Worse arm sore). At the time of the report, PAIN IN EXTREMITY (Worse arm sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-054215 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054215:Husband Case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Feeling hot, Product dose omission issue, Rash, Swelling face
Clinical narrative: Heat In face; Swollen face; "Slits" for eyes; Rash on arms, face, neck and sides; Hives on arms, face, neck and sides; Missed second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose), URTICARIA (Hives on arms, face, neck and sides), FEELING HOT (Heat In face), SWELLING FACE (Swollen face) and EYE DISORDER ("Slits" for eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical reported history provided by the reporter.   Concomitant products included GLIPIZIDE, METFORMIN, VERAPAMIL and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced URTICARIA (Hives on arms, face, neck and sides) and RASH (Rash on arms, face, neck and sides). In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On 17-Mar-2021, the patient experienced FEELING HOT (Heat In face), SWELLING FACE (Swollen face) and EYE DISORDER ("Slits" for eyes). In March 2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose), URTICARIA (Hives on arms, face, neck and sides), FEELING HOT (Heat In face), SWELLING FACE (Swollen face), EYE DISORDER ("Slits" for eyes) and RASH (Rash on arms, face, neck and sides) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information included, oral prednisone and diphenhydramine was provided.  Patients Chronic or long-standing health condition included diabetes but no recent change in status of chronic condition was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY 2021 contains Patient address updated, Patient demographic details and Anatomical location was updated