chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Vomiting; Severe chills; Headache; Redness; Bump; A spontaneous report was received from a consumer for a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/chills, headache, vomiting, redness/injection site erythema and bump/injection site swelling.  The patient's medical history was not reported. No concomitant product use was reported.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M208) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, next day after receiving the vaccine, the patient experienced severe chills for several hours, headache, vomiting, redness and bump. She went to the hospital and had to get rehydrated. No treatment for redness and bump were reported.  Action taken with mRNA-1273 with respect to the events was not reported but patient did not want to get the second dose.  The outcome of the events, bump and redness, was recovered on 07 Feb 2021. The outcome of the events, chills, headache, and vomiting, were considered resolved on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event rash on her both arms and her chest/rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M204) for prophylaxis of COVID-19 infection.  On 21 Feb 2021, nine days after receiving the vaccine, the patient experienced the event rash on both arms and her chest.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Mar 2021 the outcome of event rash was resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Lymphadenopathy, Malaise, Peripheral swelling
Clinical narrative: Significant Swelling; Fever; Chills; Body Malaise; lymph node was swollen to the size of an orange now it is a size of a lemon; swollen is extremely red; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MALAISE (Body Malaise), PERIPHERAL SWELLING (Significant Swelling) and LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) and ERYTHEMA (swollen is extremely red). On 27-Feb-2021 at 11:30 PM, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MALAISE (Body Malaise). On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Significant Swelling). On 01-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and MALAISE (Body Malaise) had resolved. At the time of the report, PERIPHERAL SWELLING (Significant Swelling), LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) and ERYTHEMA (swollen is extremely red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information included Advil for pain relief   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: significant follow-up appendedReporter information, patient demographics, product information, new events and outcome added.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Significant Swelling; Fever; Chills; Body Malaise; lymph node was swollen to the size of an orange now it is a size of a lemon; swollen is extremely red; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MALAISE (Body Malaise), PERIPHERAL SWELLING (Significant Swelling) and LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) and ERYTHEMA (swollen is extremely red). On 27-Feb-2021 at 11:30 PM, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MALAISE (Body Malaise). On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Significant Swelling). On 01-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and MALAISE (Body Malaise) had resolved. At the time of the report, PERIPHERAL SWELLING (Significant Swelling), LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) and ERYTHEMA (swollen is extremely red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information included Advil for pain relief   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: significant follow-up appendedReporter information, patient demographics, product information, new events and outcome added.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal pain, Somnolence, Swelling
Clinical narrative: Exhaustion, Stayed in bed all day; Slept all day; Sore throat; Swelling in left neck (side of injection); Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling in left neck (side of injection)), CHILLS (Chills), FATIGUE (Exhaustion, Stayed in bed all day) and SOMNOLENCE (Slept all day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling in left neck (side of injection)) and CHILLS (Chills). On 26-Feb-2021, the patient experienced FATIGUE (Exhaustion, Stayed in bed all day) and SOMNOLENCE (Slept all day). On 03-Mar-2021, OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling in left neck (side of injection)), CHILLS (Chills), FATIGUE (Exhaustion, Stayed in bed all day) and SOMNOLENCE (Slept all day) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported included antihyperlipidemic medication.  Treatment for the event included paracetamol.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Vaccination complication
Clinical narrative: Felt like had hangover; Kinda achy; Did not feel right; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt like had hangover), PAIN (Kinda achy) and MALAISE (Did not feel right) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (Felt like had hangover), PAIN (Kinda achy) and MALAISE (Did not feel right). At the time of the report, VACCINATION COMPLICATION (Felt like had hangover), PAIN (Kinda achy) and MALAISE (Did not feel right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included a couple Bayer acetylsalicylic acid and a lot of water.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Feeling abnormal, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PAIN (Body aches), PARAESTHESIA (hands tingling) and PARAESTHESIA (all her body is tingling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, INSULIN and LOSARTAN for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PARAESTHESIA (hands tingling) and CHILLS (Chills). On 27-Feb-2021, the patient experienced PAIN (Body aches), PARAESTHESIA (all her body is tingling), INFLAMMATION (inflammed), PAIN IN EXTREMITY (hurts a lot in her hands/hurtful) and ARTHRALGIA (all her joints aches). At the time of the report, FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PAIN (Body aches), PARAESTHESIA (hands tingling), PARAESTHESIA (all her body is tingling), INFLAMMATION (inflammed), PAIN IN EXTREMITY (hurts a lot in her hands/hurtful), ARTHRALGIA (all her joints aches) and CHILLS (Chills) outcome was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PAIN (Body aches), PARAESTHESIA (hands tingling) and PARAESTHESIA (all her body is tingling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, INSULIN and LOSARTAN for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PARAESTHESIA (hands tingling) and CHILLS (Chills). On 27-Feb-2021, the patient experienced PAIN (Body aches), PARAESTHESIA (all her body is tingling), INFLAMMATION (inflammed), PAIN IN EXTREMITY (hurts a lot in her hands/hurtful) and ARTHRALGIA (all her joints aches). At the time of the report, FEELING ABNORMAL (her brain was kind fuzzy/ just felt odd), ERYTHEMA (a weird reaction: underneath her fingernails and toes there was a red strip), PAIN (Body aches), PARAESTHESIA (hands tingling), PARAESTHESIA (all her body is tingling), INFLAMMATION (inflammed), PAIN IN EXTREMITY (hurts a lot in her hands/hurtful), ARTHRALGIA (all her joints aches) and CHILLS (Chills) outcome was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site mass, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Circular little bumps around injection site), VACCINATION SITE DISCOMFORT (Injection site discomfort), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE URTICARIA (Hives round injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (Circular little bumps around injection site), VACCINATION SITE DISCOMFORT (Injection site discomfort), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE URTICARIA (Hives round injection site). At the time of the report, VACCINATION SITE MASS (Circular little bumps around injection site), VACCINATION SITE DISCOMFORT (Injection site discomfort), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE URTICARIA (Hives round injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported    Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event "dry cough" outcome was changed from not recovered to recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Finger deformity, Mobility decreased, Muscular weakness
Clinical narrative: index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing; Cannot straighten his hand completely or put his fingers together; really weird feeling, strange feeling; bent thumb and forefinger; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing), MOBILITY DECREASED (Cannot straighten his hand completely or put his fingers together), FEELING ABNORMAL (really weird feeling, strange feeling) and FINGER DEFORMITY (bent thumb and forefinger) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing), MOBILITY DECREASED (Cannot straighten his hand completely or put his fingers together), FEELING ABNORMAL (really weird feeling, strange feeling) and FINGER DEFORMITY (bent thumb and forefinger). On 05-Mar-2021, FINGER DEFORMITY (bent thumb and forefinger) had resolved. At the time of the report, MUSCULAR WEAKNESS (index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing), MOBILITY DECREASED (Cannot straighten his hand completely or put his fingers together) and FEELING ABNORMAL (really weird feeling, strange feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant FU / 1 extra event and outcome
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site reaction
Clinical narrative: delayed localized reaction/reaction is on her whole arm from shoulder to elbow; reaction is on her whole arm from shoulder to elbow with some induration; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (delayed localized reaction/reaction is on her whole arm from shoulder to elbow) and VACCINATION SITE INDURATION (reaction is on her whole arm from shoulder to elbow with some induration) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (delayed localized reaction/reaction is on her whole arm from shoulder to elbow) and VACCINATION SITE INDURATION (reaction is on her whole arm from shoulder to elbow with some induration). At the time of the report, VACCINATION SITE REACTION (delayed localized reaction/reaction is on her whole arm from shoulder to elbow) and VACCINATION SITE INDURATION (reaction is on her whole arm from shoulder to elbow with some induration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided.  Treatment for the events were done with Zyrtec, Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient initials were updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Pain in extremity, Productive cough
Clinical narrative: coughing up thick mucus; Mucus Sinus; headaches; tight breathing; Body aches; Arm  hurts; couldn't sleep bc arm hurts that much; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (couldn't sleep bc arm hurts that much) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLEEP DEFICIT (couldn't sleep bc arm hurts that much). At the time of the report, SLEEP DEFICIT (couldn't sleep bc arm hurts that much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-032094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032094:Linked, Same reporter,case of daughter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Sleep deficit
Clinical narrative: coughing up thick mucus; Mucus Sinus; headaches; tight breathing; Body aches; Arm  hurts; couldn't sleep bc arm hurts that much; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (couldn't sleep bc arm hurts that much) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLEEP DEFICIT (couldn't sleep bc arm hurts that much). At the time of the report, SLEEP DEFICIT (couldn't sleep bc arm hurts that much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-032094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032094:Linked, Same reporter,case of daughter
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Myalgia
Clinical narrative: swelled up at injection site down to elbow; red; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelled up at injection site down to elbow), ERYTHEMA (red) and MYALGIA (muscle soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 INJECTION SITE SWELLING (swelled up at injection site down to elbow), ERYTHEMA (red) and MYALGIA (muscle soreness). At the time of the report, INJECTION SITE SWELLING (swelled up at injection site down to elbow), ERYTHEMA (red) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Myalgia, Ocular hyperaemia
Clinical narrative: eyes were red; felt very cold; muscle pain; aches in their body; feeling warm; feeling feverish and warm; chills; A spontaneous report was received from a nurse concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling feverish/pyrexia and warm/feeling hot, chills, felt very cold/feeling cold, aches in their body/pain, muscle pain/myalgia, eyes were red/ocular hyperemia.  The patient's medical history was not provided. Concomitant medications reported were gabapentin for diabetic neuropathy every night, melatonin, antihistamine medication, for high blood pressure, vitamins, zinc, omega, glaucoma eye drops for drug use for unknown indication.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event(s) feeling feverish and warm, chills, felt very cold. On 1 Mar 2021, the patient experienced the events aches in their body, muscle pain. On 2 Mar 2021, the patient experienced the events eyes were red.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling feverish and warm, chills, felt very cold, aches in their body, muscle pain, eyes were red was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: eyes were red; felt very cold; muscle pain; aches in their body; feeling warm; feeling feverish and warm; chills; A spontaneous report was received from a nurse concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling feverish/pyrexia and warm/feeling hot, chills, felt very cold/feeling cold, aches in their body/pain, muscle pain/myalgia, eyes were red/ocular hyperemia.  The patient's medical history was not provided. Concomitant medications reported were gabapentin for diabetic neuropathy every night, melatonin, antihistamine medication, for high blood pressure, vitamins, zinc, omega, glaucoma eye drops for drug use for unknown indication.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011A21A) in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event(s) feeling feverish and warm, chills, felt very cold. On 1 Mar 2021, the patient experienced the events aches in their body, muscle pain. On 2 Mar 2021, the patient experienced the events eyes were red.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling feverish and warm, chills, felt very cold, aches in their body, muscle pain, eyes were red was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Pain in extremity, Palpitations
Clinical narrative: Felt a pressure on left side of his head; Sore arm; Dizziness; Flutter with his heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), PALPITATIONS (Flutter with his heartbeat) and HEAD DISCOMFORT (Felt a pressure on left side of his head) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and PALPITATIONS (Flutter with his heartbeat). On 03-Mar-2021, the patient experienced HEAD DISCOMFORT (Felt a pressure on left side of his head). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), PALPITATIONS (Flutter with his heartbeat) and HEAD DISCOMFORT (Felt a pressure on left side of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site for a couple of days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Pain at the injection site for a couple of days). At the time of the report, INJECTION SITE PAIN (Pain at the injection site for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-044628 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Sore arm; Legs weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MUSCULAR WEAKNESS (Legs weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included TRAZODONE, ROSUVASTATIN CALCIUM (CRESTOR) and GABAPENTIN 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 PAIN IN EXTREMITY (Sore arm) and MUSCULAR WEAKNESS (Legs weak). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MUSCULAR WEAKNESS (Legs weak) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-034278 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Wrong patient received product
Clinical narrative: VERY SORE ARM; Participated in NOVAVAX (1ST 6JAN/ 2ND 27JAN) clinical trial; A spontaneous report was received from a consumer concerning her husband who is a 69-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and participated in NOVAVAX (1ST 6JAN/ 2ND 27JAN) clinical trial/interchange of vaccine products and very sore arm/injection site pain.  The patient's medical history Novavac clinical trial. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and unspecified depression medication.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Mar 2021, post vaccination, the reported stated the patient had a very sore arm. The patient also participated in the Novavax clinical trial and was confirmed the patient did receive the vaccine on 06 Jan 2021 and 27 Jan 2021. Per the reporter, the patient had no adverse events.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, participated in NOVAVAX (1ST 6JAN/ 2ND 27JAN) clinical trial/interchange of vaccine products, was considered resolved on 03 Mar 2021.  The outcome of the event, very sore arm/injection site pain, was considered unknown.; Reporter's Comments: This report refers to a case of wrong patient received product for mRNA-1273, lot #012A21A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is really sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is really sore). At the time of the report, PAIN IN EXTREMITY (Arm is really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: arm went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm went numb) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (arm went numb). At the time of the report, HYPOAESTHESIA (arm went numb) 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 assessment.  Patient's arm went numb for 5-10 minutes after the first dose of vaccine.  No concomitant medications were reported. Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Swelling
Clinical narrative: Heavy sweating; Tenderness; Swelling in his armpit; Headaches; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (Heavy sweating), TENDERNESS (Tenderness), SWELLING (Swelling in his armpit) and HEADACHE (Headaches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (COZARIL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Body aches), HEADACHE (Headaches) and CHILLS (Chills). On 03-Mar-2021, the patient experienced HYPERHIDROSIS (Heavy sweating), TENDERNESS (Tenderness) and SWELLING (Swelling in his armpit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), HYPERHIDROSIS (Heavy sweating), TENDERNESS (Tenderness), SWELLING (Swelling in his armpit), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.            Other relevant concomitant medications included: Diabetes med, Blood pressure med and Supplements.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Heavy sweating; Tenderness; Swelling in his armpit; Headaches; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (Heavy sweating), TENDERNESS (Tenderness), SWELLING (Swelling in his armpit) and HEADACHE (Headaches) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (COZARIL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Body aches), HEADACHE (Headaches) and CHILLS (Chills). On 03-Mar-2021, the patient experienced HYPERHIDROSIS (Heavy sweating), TENDERNESS (Tenderness) and SWELLING (Swelling in his armpit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), HYPERHIDROSIS (Heavy sweating), TENDERNESS (Tenderness), SWELLING (Swelling in his armpit), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.            Other relevant concomitant medications included: Diabetes med, Blood pressure med and Supplements.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge, Ocular hyperaemia
Clinical narrative: His left eye looks like it is bleeding on the inside of the eye; Inside the eye with pus; A spontaneous report was received from a consumer concerning a 68 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and his left eye looks like it was bleeding on the inside of the eye with pus.  The patient's medical history included cancer. He received his chemo shot (Lupron) last Tuesday. Relevant concomitant medications included candesartan and aspirin 81 mg.  On 01 Mar 2021, the patient received the first of the two planned doses of mRNA-1273 (Batch No: 025A21A) in right arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, 3 days after vaccination the patient's left eye looks like it was bleeding on the inside of the eye with pus.   Treatment details was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of his left eye looks like it was bleeding on the inside of the eye with pus was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Itching; Redness; swollen arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, CHLORTHALIDONE and MELOXICAM for an unknown indication.    On 03-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 PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm of injection). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Bouts of nausea; Elevated temperatures/fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Bouts of nausea), PYREXIA (Elevated temperatures/fever) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    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 NAUSEA (Bouts of nausea), PYREXIA (Elevated temperatures/fever) and HEADACHE (Headache). At the time of the report, NAUSEA (Bouts of nausea), PYREXIA (Elevated temperatures/fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching a little on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching a little on the Injection Site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis (Patient's pain management doctor allowed her to have Tylenol sometimes in addition to other meds. The patient stopped taking Tylenol prior to vaccination.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching a little on the Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itching a little on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dental paraesthesia, Toothache
Clinical narrative: Woke up with a tooth bothering; Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL PARAESTHESIA (Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold) and TOOTHACHE (Woke up with a tooth bothering) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DENTAL PARAESTHESIA (Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold). On 03-Mar-2021, the patient experienced TOOTHACHE (Woke up with a tooth bothering). At the time of the report, DENTAL PARAESTHESIA (Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold) and TOOTHACHE (Woke up with a tooth bothering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received included No New Information
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Injection site mass, Pain in extremity
Clinical narrative: Itchy arm; Very sore arm; Big red circle on arm; Hard (circle); Hot (circle); Lump on arm by injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump on arm by injection site), PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm) and INDURATION (Hard (circle)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included METOPROLOL TARTRATE, HYDROXYCHLOROQUINE, CLOPIDOGREL BISULFATE (PLAVIX) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Lump on arm by injection site). On 04-Mar-2021, the patient experienced PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm), INDURATION (Hard (circle)) and FEELING HOT (Hot (circle)). At the time of the report, INJECTION SITE MASS (Lump on arm by injection site), PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm), INDURATION (Hard (circle)) and FEELING HOT (Hot (circle)) had resolved.            No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: significant follow up received .Event outcome and second dose information updated
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy arm; Very sore arm; Big red circle on arm; Hard (circle); Hot (circle); Lump on arm by injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump on arm by injection site), PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm) and INDURATION (Hard (circle)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included METOPROLOL TARTRATE, HYDROXYCHLOROQUINE, CLOPIDOGREL BISULFATE (PLAVIX) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE MASS (Lump on arm by injection site). On 04-Mar-2021, the patient experienced PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm), INDURATION (Hard (circle)) and FEELING HOT (Hot (circle)). At the time of the report, INJECTION SITE MASS (Lump on arm by injection site), PRURITUS (Itchy arm), PAIN IN EXTREMITY (Very sore arm), ERYTHEMA (Big red circle on arm), INDURATION (Hard (circle)) and FEELING HOT (Hot (circle)) had resolved.            No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: significant follow up received .Event outcome and second dose information updated
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1-0A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: swollen face; swollen lips; swelling under eyes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), LIP SWELLING (swollen lips) and EYE SWELLING (swelling under eyes) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING FACE (swollen face), LIP SWELLING (swollen lips) and EYE SWELLING (swelling under eyes). At the time of the report, SWELLING FACE (swollen face), LIP SWELLING (swollen lips) and EYE SWELLING (swelling under eyes) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported.