chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: a slight swelling under the armpit, it's jelly-like; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a slight swelling under the armpit, it's jelly-like) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, MELOXICAM and TOPIRAMATE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (a slight swelling under the armpit, it's jelly-like). At the time of the report, PERIPHERAL SWELLING (a slight swelling under the armpit, it's jelly-like) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; Strong pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PAIN (Strong pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     Concomitant products included PREDNISOLONE, APIXABAN (ELIQUIS), GABAPENTIN, LEVETIRACETAM, ALLOPURINOL, TOPIRAMATE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), POTASSIUM and MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PAIN (Strong pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 24-Jan-2021, PAIN IN EXTREMITY (sore arm) and PAIN (Strong pain) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-214675 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Localised oedema, Nasal oedema, Tenderness
Clinical narrative: swollen neck; Tenderness in neck; tenderness in nose; swollen nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED OEDEMA (swollen neck), TENDERNESS (Tenderness in neck), TENDERNESS (tenderness in nose) and NASAL OEDEMA (swollen nose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced LOCALISED OEDEMA (swollen neck) and TENDERNESS (Tenderness in neck). On an unknown date, the patient experienced TENDERNESS (tenderness in nose) and NASAL OEDEMA (swollen nose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LOCALISED OEDEMA (swollen neck), TENDERNESS (Tenderness in neck), TENDERNESS (tenderness in nose) and NASAL OEDEMA (swollen nose) outcome was unknown.            The  concomitant medications on use were not provided.  No laboratory data was provided.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: High eye pressure; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (High eye pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pressure intraocular increased.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (High eye pressure). At the time of the report, OCULAR DISCOMFORT (High eye pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included eye drops Treatment information were not provided
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling, Swelling of eyelid, Urticaria
Clinical narrative: swelling; numbness in face; swelling of right eyelid; urticarial rash to right upper abdomen; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (swelling), HYPOAESTHESIA (numbness in face), SWELLING OF EYELID (swelling of right eyelid) and URTICARIA (urticarial rash to right upper abdomen) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), HYPOAESTHESIA (numbness in face), SWELLING OF EYELID (swelling of right eyelid) and URTICARIA (urticarial rash to right upper abdomen). At the time of the report, SWELLING (swelling), HYPOAESTHESIA (numbness in face), SWELLING OF EYELID (swelling of right eyelid) and URTICARIA (urticarial rash to right upper abdomen) 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Large red raise thing that looks like a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Large red raise thing that looks like a rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Large red raise thing that looks like a rash). At the time of the report, VACCINATION SITE RASH (Large red raise thing that looks like a rash) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Vomiting
Clinical narrative: Weakness; Vomiting; body aches; vomiting and had body aches, weakness and chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), VOMITING (Vomiting), PAIN (body aches) and CHILLS (vomiting and had body aches, weakness and chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 immunization.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ASTHENIA (Weakness), VOMITING (Vomiting), PAIN (body aches) and CHILLS (vomiting and had body aches, weakness and chills). At the time of the report, ASTHENIA (Weakness), VOMITING (Vomiting), PAIN (body aches) and CHILLS (vomiting and had body aches, weakness and chills) had resolved.            Concomitant product use was A-lot provided by the reporter.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Case outcome
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Severe Muscle pain; excruciating pain at his left hand side; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe Muscle pain) and PAIN IN EXTREMITY (excruciating pain at his left hand side) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Severe Muscle pain). 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain at his left hand side). At the time of the report, MYALGIA (Severe Muscle pain) and PAIN IN EXTREMITY (excruciating pain at his left hand side) outcome was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Mouth swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: hives on toes; itching ankles/; rash at vaccination site; bruise on the injection site with a rash on my right arm about an 1 inch above the injection site; hands swollen; my tongue was swollen and my lower lip was swollen; itching hands; hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands; hands itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands), PRURITUS (hands itching), MOUTH SWELLING (my tongue was swollen and my lower lip was swollen), VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site) and PERIPHERAL SWELLING (hands swollen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Feb-2021, the patient experienced URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands) and PRURITUS (hands itching). On 26-Feb-2021, the patient experienced MOUTH SWELLING (my tongue was swollen and my lower lip was swollen) and PRURITUS (itching hands). On 27-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site), PERIPHERAL SWELLING (hands swollen), PRURITUS (itching ankles/) and INJECTION SITE RASH (rash at vaccination site). On 28-Feb-2021, the patient experienced URTICARIA (hives on toes). On 27-Feb-2021, URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands) and PRURITUS (itching hands) outcome was unknown. At the time of the report, PRURITUS (hands itching), MOUTH SWELLING (my tongue was swollen and my lower lip was swollen), VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site), PERIPHERAL SWELLING (hands swollen), URTICARIA (hives on toes), PRURITUS (itching ankles/) and INJECTION SITE RASH (rash at vaccination site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: follow up received on 12-mar-2021 no  significant followup received
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: hives on toes; itching ankles/; rash at vaccination site; bruise on the injection site with a rash on my right arm about an 1 inch above the injection site; hands swollen; my tongue was swollen and my lower lip was swollen; itching hands; hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands; hands itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands), PRURITUS (hands itching), MOUTH SWELLING (my tongue was swollen and my lower lip was swollen), VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site) and PERIPHERAL SWELLING (hands swollen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 25-Feb-2021, the patient experienced URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands) and PRURITUS (hands itching). On 26-Feb-2021, the patient experienced MOUTH SWELLING (my tongue was swollen and my lower lip was swollen) and PRURITUS (itching hands). On 27-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site), PERIPHERAL SWELLING (hands swollen), PRURITUS (itching ankles/) and INJECTION SITE RASH (rash at vaccination site). On 28-Feb-2021, the patient experienced URTICARIA (hives on toes). On 27-Feb-2021, URTICARIA (hives/hives on my right butt cheek/hives on feet/hives on ankles/hives on hands) and PRURITUS (itching hands) outcome was unknown. At the time of the report, PRURITUS (hands itching), MOUTH SWELLING (my tongue was swollen and my lower lip was swollen), VACCINATION SITE BRUISING (bruise on the injection site with a rash on my right arm about an 1 inch above the injection site), PERIPHERAL SWELLING (hands swollen), URTICARIA (hives on toes), PRURITUS (itching ankles/) and INJECTION SITE RASH (rash at vaccination site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: follow up received on 12-mar-2021 no  significant followup received
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Myalgia, Pain of skin, Pyrexia
Clinical narrative: Falling hair in handfull; sore scalp; Fever; Bodyache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Falling hair in handfull), PAIN OF SKIN (sore scalp), PYREXIA (Fever), MYALGIA (Bodyache) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and OMEGA-3-ACID ETHYL ESTER (LOVAZA) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever), MYALGIA (Bodyache) and FATIGUE (Tiredness). On 24-Feb-2021, the patient experienced ALOPECIA (Falling hair in handfull) and PAIN OF SKIN (sore scalp). At the time of the report, ALOPECIA (Falling hair in handfull), PAIN OF SKIN (sore scalp), PYREXIA (Fever), MYALGIA (Bodyache) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medications.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms; Left sided numbness on her face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms) and HYPOAESTHESIA (Left sided numbness on her face) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PARAESTHESIA (tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms). In March 2021, the patient experienced HYPOAESTHESIA (Left sided numbness on her face). At the time of the report, PARAESTHESIA (tngling sensation from elbow to fingers which then spread to the legs and pins and needles in bilateral legs and arms) and HYPOAESTHESIA (Left sided numbness on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Patient updated new events .
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Rash
Clinical narrative: Developed a complete circle similar to a shape of football below belly button which lasted for 2 days; Numerous headaches; Didn't feel good for about 5 days; This spontaneous case was reported by a patient and describes the occurrence of RASH (Developed a complete circle similar to a shape of football below belly button which lasted for 2 days), HEADACHE (Numerous headaches) and MALAISE (Didn't feel good for about 5 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00GM20A) for COVID-19 immunization.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (Developed a complete circle similar to a shape of football below belly button which lasted for 2 days), HEADACHE (Numerous headaches) and MALAISE (Didn't feel good for about 5 days). In February 2021, RASH (Developed a complete circle similar to a shape of football below belly button which lasted for 2 days), HEADACHE (Numerous headaches) and MALAISE (Didn't feel good for about 5 days) had resolved.        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.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysphonia, Headache
Clinical narrative: Hoarseness in throat; Burning sensation in throat; Bad headache off and on; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Bad headache off and on), DYSPHONIA (Hoarseness in throat) and BURNING SENSATION (Burning sensation in throat) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 immunisation.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Bad headache off and on). On 11-Mar-2021, the patient experienced DYSPHONIA (Hoarseness in throat) and BURNING SENSATION (Burning sensation in throat). At the time of the report, HEADACHE (Bad headache off and on), DYSPHONIA (Hoarseness in throat) and BURNING SENSATION (Burning sensation in throat) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: A large, red, painful and warm spot on her arm; A large, red, painful and warm spot on her arm; A large, red, painful and warm spot on her arm; chills; Low grade fever went up to 103.; A spontaneous report was received from a consumer concerning a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events the large spot, red, painful, warm spot on her arm (Vaccination site warmth, vaccination site rash, vaccination site erythema, Rash) chills (Chills), and fever (Pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot number: 029A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 10-Mar-2021, the patient experienced the low grade fever that went up to 103 degree Celsius followed by chills. On 11 Mar 2021, the patient experienced the events a large, red, painful, warm spot on her arm.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  On 12 Mar 2021 the outcome of event, chills, fever were considered as recovered/resolved.  The outcome of events, large, red, painful, and warm  spot on her arm 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Mobility decreased, Musculoskeletal chest pain
Clinical narrative: Abnormal breathing; Frequent urination; Mobility affected; Couldn't come out of bed for 1.5 days; Rib cage from down side sore; Fever 100.2; Headache; Weak/  Still feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days) and MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ATENOLOL and ESCITALOPRAM OXALATE (LEXAPRO) 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 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days), MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore), PYREXIA (Fever 100.2), HEADACHE (Headache) and ASTHENIA (Weak/  Still feeling weak). At the time of the report, RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days), MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore), PYREXIA (Fever 100.2), HEADACHE (Headache) and ASTHENIA (Weak/  Still feeling weak) outcome was unknown.            Acetaminophen was given as treatment medication in response to events.   This case was linked to MOD-2021-061000 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia, Respiration abnormal
Clinical narrative: Abnormal breathing; Frequent urination; Mobility affected; Couldn't come out of bed for 1.5 days; Rib cage from down side sore; Fever 100.2; Headache; Weak/  Still feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days) and MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ATENOLOL and ESCITALOPRAM OXALATE (LEXAPRO) 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 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days), MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore), PYREXIA (Fever 100.2), HEADACHE (Headache) and ASTHENIA (Weak/  Still feeling weak). At the time of the report, RESPIRATION ABNORMAL (Abnormal breathing), POLLAKIURIA (Frequent urination), MOBILITY DECREASED (Mobility affected), ILLNESS (Couldn't come out of bed for 1.5 days), MUSCULOSKELETAL CHEST PAIN (Rib cage from down side sore), PYREXIA (Fever 100.2), HEADACHE (Headache) and ASTHENIA (Weak/  Still feeling weak) outcome was unknown.            Acetaminophen was given as treatment medication in response to events.   This case was linked to MOD-2021-061000 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 12-Mar-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 21-May-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Pain in extremity, Tinnitus
Clinical narrative: Ear Sense of Fullness/Ear Blockage; Feels like Mild Tinnitus; Diminished Sense of Hearing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear Sense of Fullness/Ear Blockage), PAIN IN EXTREMITY (Sore arm), TINNITUS (Feels like Mild Tinnitus) and HYPOACUSIS (Diminished Sense of Hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced EAR DISCOMFORT (Ear Sense of Fullness/Ear Blockage), TINNITUS (Feels like Mild Tinnitus) and HYPOACUSIS (Diminished Sense of Hearing). On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, EAR DISCOMFORT (Ear Sense of Fullness/Ear Blockage), TINNITUS (Feels like Mild Tinnitus) and HYPOACUSIS (Diminished Sense of Hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was not provided with any concomitant medication.  No Treatment was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore Throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Vaccination site induration
Clinical narrative: After each dose their arm was sore, very hard and red, and hurt , for a couple of days.; After each dose their arm was sore, very hard and red, and hurt , for a couple of days; After each dose their arm was sore, very hard and red, and hurt , for a couple of days; After each dose their arm was sore, very hard and red, and hurt , for a couple of days.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.), ERYTHEMA (After each dose their arm was sore, very hard and red, and hurt , for a couple of days), PAIN (After each dose their arm was sore, very hard and red, and hurt , for a couple of days) and VACCINATION SITE INDURATION (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.), ERYTHEMA (After each dose their arm was sore, very hard and red, and hurt , for a couple of days), PAIN (After each dose their arm was sore, very hard and red, and hurt , for a couple of days) and VACCINATION SITE INDURATION (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and BENZONATATE at a dose of 200 mg. At the time of the report, PAIN IN EXTREMITY (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.), ERYTHEMA (After each dose their arm was sore, very hard and red, and hurt , for a couple of days), PAIN (After each dose their arm was sore, very hard and red, and hurt , for a couple of days) and VACCINATION SITE INDURATION (After each dose their arm was sore, very hard and red, and hurt , for a couple of days.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included nasal rinse with a neti pot.   This case was linked to MOD21-052130.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Visual impairment
Clinical narrative: Didn't have a good night; Vision was not good; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision was not good) and INSOMNIA (Didn't have a good night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS (Back problems). Concomitant products included METFORMIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and LEAD for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Vision was not good). On an unknown date, the patient experienced INSOMNIA (Didn't have a good night). The patient was treated with NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Vision abnormal, at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (Vision was not good) had not resolved and INSOMNIA (Didn't have a good night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Eye drops.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear infection, Fatigue, Headache, Hypersensitivity
Clinical narrative: Ear infection; Tired; Her sinuses, she was more congested; Impacted her allergies; Arm was sore at injection site; Headache; Cough; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SINUS CONGESTION (Her sinuses, she was more congested), EAR INFECTION (Ear infection), COUGH (Cough), HYPERSENSITIVITY (Impacted her allergies) and INJECTION SITE PAIN (Arm was sore at injection site) in a 71-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.     Concurrent medical conditions included Thyroiditis, unspecified, Blood pressure high and Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced COUGH (Cough) and HEADACHE (Headache). On 18-Feb-2021, the patient experienced SINUS CONGESTION (Her sinuses, she was more congested), HYPERSENSITIVITY (Impacted her allergies) and INJECTION SITE PAIN (Arm was sore at injection site). On 19-Feb-2021, the patient experienced FATIGUE (Tired). On 28-Feb-2021, the patient experienced EAR INFECTION (Ear infection). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Feb-2021, INJECTION SITE PAIN (Arm was sore at injection site) and FATIGUE (Tired) had resolved. On 09-Mar-2021, EAR INFECTION (Ear infection) had resolved. On 11-Mar-2021, SINUS CONGESTION (Her sinuses, she was more congested) and HYPERSENSITIVITY (Impacted her allergies) had resolved. At the time of the report, COUGH (Cough) and HEADACHE (Headache) 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.   Other treatment medications include Flonase and ear drops.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Sinus congestion
Clinical narrative: Ear infection; Tired; Her sinuses, she was more congested; Impacted her allergies; Arm was sore at injection site; Headache; Cough; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SINUS CONGESTION (Her sinuses, she was more congested), EAR INFECTION (Ear infection), COUGH (Cough), HYPERSENSITIVITY (Impacted her allergies) and INJECTION SITE PAIN (Arm was sore at injection site) in a 71-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.     Concurrent medical conditions included Thyroiditis, unspecified, Blood pressure high and Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced COUGH (Cough) and HEADACHE (Headache). On 18-Feb-2021, the patient experienced SINUS CONGESTION (Her sinuses, she was more congested), HYPERSENSITIVITY (Impacted her allergies) and INJECTION SITE PAIN (Arm was sore at injection site). On 19-Feb-2021, the patient experienced FATIGUE (Tired). On 28-Feb-2021, the patient experienced EAR INFECTION (Ear infection). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Feb-2021, INJECTION SITE PAIN (Arm was sore at injection site) and FATIGUE (Tired) had resolved. On 09-Mar-2021, EAR INFECTION (Ear infection) had resolved. On 11-Mar-2021, SINUS CONGESTION (Her sinuses, she was more congested) and HYPERSENSITIVITY (Impacted her allergies) had resolved. At the time of the report, COUGH (Cough) and HEADACHE (Headache) 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.   Other treatment medications include Flonase and ear drops.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not 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.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Vaccination site erythema
Clinical narrative: Felt like her ear was on fire; Ear turned pure red for an hour; Red circle of redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Felt like her ear was on fire), ERYTHEMA (Ear turned pure red for an hour) and VACCINATION SITE ERYTHEMA (Red circle of redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced EAR PAIN (Felt like her ear was on fire), ERYTHEMA (Ear turned pure red for an hour) and VACCINATION SITE ERYTHEMA (Red circle of redness on her arm). On 09-Mar-2021, EAR PAIN (Felt like her ear was on fire) and ERYTHEMA (Ear turned pure red for an hour) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red circle of redness on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Patient's treatment information included Benadryl to treat her symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: Difficulty breathing; Dizziness; High blood pressure; Fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Fast heart beat) and DYSPNOEA (Difficulty breathing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEART RATE INCREASED (Fast heart beat). On 12-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with METOPROLOL at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), HYPERTENSION (High blood pressure) and HEART RATE INCREASED (Fast heart beat) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved. Unknown      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  patient was using nebulizer for treatment.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm; High fever; chills; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (High fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (High fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (High fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site vesicles
Clinical narrative: Small bubble formed 1 inch passed the injection site; Some of it may have been injected subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Some of it may have been injected subcutaneously) and VACCINATION SITE VESICLES (Small bubble formed 1 inch passed the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006H20A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Some of it may have been injected subcutaneously). On an unknown date, the patient experienced VACCINATION SITE VESICLES (Small bubble formed 1 inch passed the injection site). On 12-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Some of it may have been injected subcutaneously) had resolved. At the time of the report, VACCINATION SITE VESICLES (Small bubble formed 1 inch passed the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This report refers to a case of Incorrect route of product administration for mRNA-1273, lot # 006H20A with no associated AEs. 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.; Sender's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273, lot # 006H20A with no associated AEs. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Bloating; Nausea; Abdominal cramps, it gets worse after she eats or drinks anything; Swelling of Injection site; Redness of injection site; Warmth of Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth of Injection site), ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Swelling of Injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Allergic to food dye) and Glaucoma. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth of Injection site), VACCINATION SITE SWELLING (Swelling of Injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site). On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea). On 21-Feb-2021, VACCINATION SITE WARMTH (Warmth of Injection site), VACCINATION SITE SWELLING (Swelling of Injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site) had resolved. At the time of the report, ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant product included 2 eye drops for glaucoma and over the counter allergy medication..  The side effects redness, swelling and warmth at the injection site only lasted for 48 hours.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.