chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Nausea, Pyrexia
Clinical narrative: Tight pressure feeling in the chest; Fever; Chills; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST PAIN (Tight pressure feeling in the chest), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). On 07-Apr-2021, the patient experienced CHEST PAIN (Tight pressure feeling in the chest). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 07-Apr-2021, PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, CHEST PAIN (Tight pressure feeling in the chest) had not resolved.            Other relevant medication history included Anxiety Medication. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-071394 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071394:First Dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Raising Heart for 24 hours after first shot of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Raising Heart for 24 hours after first shot of Moderna vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse.    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 TACHYCARDIA (Raising Heart for 24 hours after first shot of Moderna vaccine). At the time of the report, TACHYCARDIA (Raising Heart for 24 hours after first shot of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypotension, Pyrexia
Clinical narrative: Low blood pressure; Fever; Chills; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Exhaustion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HYPOTENSION (Low blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Exhaustion). At the time of the report, HYPOTENSION (Low blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: travelled to my chest and the rest of my body; itch; rash near the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (travelled to my chest and the rest of my body), PRURITUS (itch) and VACCINATION SITE RASH (rash near the shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-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 VACCINATION SITE RASH (rash near the shot). On an unknown date, the patient experienced RASH (travelled to my chest and the rest of my body) and PRURITUS (itch). At the time of the report, RASH (travelled to my chest and the rest of my body), PRURITUS (itch) and VACCINATION SITE RASH (rash near the shot) had resolved.            Concomitant medicine was not provided. Treatment included triamcinolone acetonide cream USP 0.1%   This case was linked to MOD-2021-071424 (E2B Linked Report).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Myalgia, Vaccination site erythema
Clinical narrative: has the red arm; severe anterior nosebleed that went on for an hour and the half; had body aches; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (severe anterior nosebleed that went on for an hour and the half), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (has the red arm) and MYALGIA (had body aches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B514 and 027421A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tiredness). On 06-Apr-2021, the patient experienced MYALGIA (had body aches). On 24-Apr-2021, the patient experienced EPISTAXIS (severe anterior nosebleed that went on for an hour and the half). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (has the red arm). The patient was treated with PARACETAMOL (TYLENOL) 06-Apr-2021 at a dose of 1 dosage form twice a day. At the time of the report, EPISTAXIS (severe anterior nosebleed that went on for an hour and the half), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (has the red arm) and MYALGIA (had body aches) outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Updated the Description as reported in the event Epistaxis Severe posterior nosebleed that went on for an hour and the half to Severe anterior nosebleed that went on for an hour and the half
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: watering mouth; nausea; vomiting; chills; headache; fever; fatigue; sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), PYREXIA (fever), FATIGUE (fatigue) and HYPERHIDROSIS (sweats). At the time of the report, SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), PYREXIA (fever), FATIGUE (fatigue) and HYPERHIDROSIS (sweats) outcome was unknown. Not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Salivary hypersecretion, Vomiting
Clinical narrative: watering mouth; nausea; vomiting; chills; headache; fever; fatigue; sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), PYREXIA (fever), FATIGUE (fatigue) and HYPERHIDROSIS (sweats). At the time of the report, SALIVARY HYPERSECRETION (watering mouth), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), PYREXIA (fever), FATIGUE (fatigue) and HYPERHIDROSIS (sweats) outcome was unknown. Not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Myalgia, Throat irritation
Clinical narrative: sore arm; something with her throat; voice hoarse; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (something with her throat), APHONIA (voice hoarse) and MYALGIA (sore arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seizure.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THROAT IRRITATION (something with her throat) and APHONIA (voice hoarse). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, THROAT IRRITATION (something with her throat) and APHONIA (voice hoarse) had not resolved and MYALGIA (sore arm) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: swolleness on arm; itchiness; rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swolleness on arm), PRURITUS (itchiness) and RASH (rash on arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swolleness on arm), PRURITUS (itchiness) and RASH (rash on arm). At the time of the report, PERIPHERAL SWELLING (swolleness on arm), PRURITUS (itchiness) and RASH (rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment included Loratadine was self administered thinking that was some kind of allergic reaction.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site rash
Clinical narrative: soreness; psoriatic patch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and VACCINATION SITE RASH (psoriatic patch) 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 Psoriasis.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (soreness) and VACCINATION SITE RASH (psoriatic patch). At the time of the report, PAIN (soreness) and VACCINATION SITE RASH (psoriatic patch) outcome was unknown. Not Provided       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at injection site; Soreness at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided        Concomitant product use was not provided by the reporter.  Treatment for the event included acetylsalicylic acid.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-077195, MOD-2021-070988, MOD-2021-072067, MOD-2021-070997 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (bad 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 No adverse event (No medical history reported.).    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and HEADACHE (bad headache). At the time of the report, DIZZINESS (dizziness) and HEADACHE (bad headache) outcome was unknown.            The patient reported he experienced dizziness and bad headache within 11 hours of vaccination.   Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nightmare
Clinical narrative: bad dreams; terrible pain, especially in an area around her ankle where she was bitten by a bug about four years ago; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (bad dreams) and ARTHRALGIA (terrible pain, especially in an area around her ankle where she was bitten by a bug about four years ago) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced NIGHTMARE (bad dreams) and ARTHRALGIA (terrible pain, especially in an area around her ankle where she was bitten by a bug about four years ago). At the time of the report, NIGHTMARE (bad dreams) and ARTHRALGIA (terrible pain, especially in an area around her ankle where she was bitten by a bug about four years ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; fuzzy mind; probems walking; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy mind), GAIT DISTURBANCE (probems walking) and SARS-COV-2 TEST POSITIVE (tested positive for covid) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (fuzzy mind) and GAIT DISTURBANCE (probems walking). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid). At the time of the report, FEELING ABNORMAL (fuzzy mind), GAIT DISTURBANCE (probems walking) and SARS-COV-2 TEST POSITIVE (tested positive for covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Patient recently tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: face red; loss of appetite; chills; fever; headache; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, and HEADACHE in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, HEADACHE, MYALGIA, NAUSEA, and FATIGUE. At the time of the report, ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, HEADACHE, MYALGIA, NAUSEA, and FATIGUE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment medication not provided   Most recent FOLLOW-UP information incorporated above included On 10-May-2021: Event outcome updated to resolved.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: face red; loss of appetite; chills; fever; headache; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, and HEADACHE in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, HEADACHE, MYALGIA, NAUSEA, and FATIGUE. At the time of the report, ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, HEADACHE, MYALGIA, NAUSEA, and FATIGUE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment medication not provided   Most recent FOLLOW-UP information incorporated above included On 10-May-2021: Event outcome updated to resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (I have tested positive for COVID a couple of days after the shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. Concomitant products included PREDNISONE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), METHOTREXATE, ALENDRONATE SODIUM and GABAPENTIN for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (I have tested positive for COVID a couple of days after the shot). At the time of the report, SARS-COV-2 TEST POSITIVE (I have tested positive for COVID a couple of days after the shot) outcome was unknown. Not Provided. 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. Other relevant concomitant medications included Noxafil Possaconazole, Timolol eye drops, Prednisone eye drops and OTC multivitamin. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itch; Rash on chest and rest of his body; rash near the shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), RASH (Rash on chest and rest of his body) and RASH (rash near the shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch), RASH (Rash on chest and rest of his body) and RASH (rash near the shot). The patient was treated with TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency. At the time of the report, PRURITUS (itch) had not resolved and RASH (Rash on chest and rest of his body) and RASH (rash near the shot) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-071410, US-MODERNATX, INC.-MOD-2021-071410 (E2B Linked Report).; Sender's Comments:  MOD-2021-071410:First dose case US-MODERNATX, INC.-MOD-2021-071410:Second dose case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown. Not Provided          Concomitant medication not provided.   Treatment medication not provided  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD21-071658 (E2B Linked Report).; Sender's Comments:  MOD21-071658:2nd dose of vaccine-MOD-2021-071436
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071621:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine; 16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included  (Medical history was not provided).    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine). On 17-Mar-2021, WRONG PRODUCT ADMINISTERED (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old daughter accidently got the Moderna vaccine instead of Pfizer vaccine) had resolved. Not Provided          Treatment information not provided. Concomitant medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flatulence, Lymphadenopathy, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore Throat; Congestion; Stuffy; Aching Arm; Stomach air bubbles; Swelling of Lymph Nodes of the neck; postnasal drip; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm) and FLATULENCE (Stomach air bubbles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), ALLOPURINOL and MULTIVITAMINS & MINERALS PLUS LUTEIN.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm), FLATULENCE (Stomach air bubbles), LYMPHADENOPATHY (Swelling of Lymph Nodes of the neck), UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm), FLATULENCE (Stomach air bubbles), LYMPHADENOPATHY (Swelling of Lymph Nodes of the neck), UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Upper-airway cough syndrome
Clinical narrative: Sore Throat; Congestion; Stuffy; Aching Arm; Stomach air bubbles; Swelling of Lymph Nodes of the neck; postnasal drip; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm) and FLATULENCE (Stomach air bubbles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), ALLOPURINOL and MULTIVITAMINS & MINERALS PLUS LUTEIN.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm), FLATULENCE (Stomach air bubbles), LYMPHADENOPATHY (Swelling of Lymph Nodes of the neck), UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm), FLATULENCE (Stomach air bubbles), LYMPHADENOPATHY (Swelling of Lymph Nodes of the neck), UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was Not Applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-052928, US-MODERNATX, INC.-MOD-2021-052937, US-MODERNATX, INC.-MOD-2021-071492, US-MODERNATX, INC.-MOD-2021-053066 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information was received from the initial reporter: The reporter mail ID was added; Sender's Comments: US-MODERNATX, INC.-MOD-2021-052928:Crosslinked case; US-MODERNATX, INC.-MOD-2021-052937:Crosslinked case; US-MODERNATX, INC.-MOD-2021-071492:Crosslinked case US-MODERNATX, INC.-MOD-2021-053066:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: 30 weeks pregnant; received Moderna vaccine 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant; received Moderna vaccine 1st dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 08-Apr-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 09-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 08-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant; received Moderna vaccine 1st dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 08-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant; received Moderna vaccine 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal
Clinical narrative: upset stomach; feeling crappy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (feeling crappy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-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 ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (feeling crappy). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (feeling crappy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Oropharyngeal pain, Speech disorder
Clinical narrative: When she woke up this morning, she lost her voice; could barely talk; She has little cough; Her throat is sore; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (When she woke up this morning, she lost her voice), SPEECH DISORDER (could barely talk), COUGH (She has little cough) and OROPHARYNGEAL PAIN (Her throat is sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced APHONIA (When she woke up this morning, she lost her voice), SPEECH DISORDER (could barely talk), COUGH (She has little cough) and OROPHARYNGEAL PAIN (Her throat is sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, APHONIA (When she woke up this morning, she lost her voice), SPEECH DISORDER (could barely talk), COUGH (She has little cough) and OROPHARYNGEAL PAIN (Her throat is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine include Gabapentin, Muscle relaxer  Treatment medicine include Tylenol
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: needle went a little bit into her arm and then the liquid went down her arm.; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (needle went a little bit into her arm and then the liquid went down her arm.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-Apr-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (needle went a little bit into her arm and then the liquid went down her arm.). On 07-Apr-2021, INCORRECT DOSE ADMINISTERED (needle went a little bit into her arm and then the liquid went down her arm.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-071658 (E2B Linked Report).; Sender's Comments:  MOD21-071658:1st dose of vaccine-MOD-2021-071426
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dysphonia, Eye swelling, Fatigue, Hypersensitivity
Clinical narrative: raspy voice; delayed allergic reaction; fatigued; broke out on her face; sore throat; swollen eyelids; a lump in the lymph node under her nose; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction) and EYE SWELLING (swollen eyelids) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), EYE SWELLING (swollen eyelids) and LYMPHADENOPATHY (a lump in the lymph node under her nose). On 08-Apr-2021, the patient experienced DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction) and FATIGUE (fatigued). At the time of the report, ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction), EYE SWELLING (swollen eyelids), LYMPHADENOPATHY (a lump in the lymph node under her nose) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: raspy voice; delayed allergic reaction; fatigued; broke out on her face; sore throat; swollen eyelids; a lump in the lymph node under her nose; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction) and EYE SWELLING (swollen eyelids) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), EYE SWELLING (swollen eyelids) and LYMPHADENOPATHY (a lump in the lymph node under her nose). On 08-Apr-2021, the patient experienced DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction) and FATIGUE (fatigued). At the time of the report, ACNE (broke out on her face), OROPHARYNGEAL PAIN (sore throat), DYSPHONIA (raspy voice), HYPERSENSITIVITY (delayed allergic reaction), EYE SWELLING (swollen eyelids), LYMPHADENOPATHY (a lump in the lymph node under her nose) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 27-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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site induration
Clinical narrative: Feeling hot; had like a hard hard ball; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (Feeling hot) and VACCINATION SITE INDURATION (had like a hard hard ball) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING HOT (Feeling hot) and VACCINATION SITE INDURATION (had like a hard hard ball). At the time of the report, FEELING HOT (Feeling hot) outcome was unknown and VACCINATION SITE INDURATION (had like a hard hard ball) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication information was provided. No treatment product information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received from 11-May-2021, event outcome was updated.
Sex: M
Vaccine: COVID19
Symptoms: Alcohol problem, Chills, Myalgia, Night sweats, Pain
Clinical narrative: very sensitive to alcohol; Severe chills; Night sweats; Muscle pain; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain), ALCOHOL PROBLEM (very sensitive to alcohol), CHILLS (Severe chills), NIGHT SWEATS (Night sweats) and MYALGIA (Muscle pain) 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 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced PAIN (little pain). On an unknown date, the patient experienced ALCOHOL PROBLEM (very sensitive to alcohol), CHILLS (Severe chills), NIGHT SWEATS (Night sweats) and MYALGIA (Muscle pain). At the time of the report, ALCOHOL PROBLEM (very sensitive to alcohol), CHILLS (Severe chills), NIGHT SWEATS (Night sweats) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-071835 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: 1-2 days he got really sick like he got the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (1-2 days he got really sick like he got the flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (1-2 days he got really sick like he got the flu). At the time of the report, INFLUENZA LIKE ILLNESS (1-2 days he got really sick like he got the flu) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-072301 (E2B Linked Report).; Sender's Comments:  MOD21-072301:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (reaction because of the polyethylene glycol in the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication is not provided.  Reporter declined for followup
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation
Clinical narrative: stomach cramps; very constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and CONSTIPATION (very constipated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and CONSTIPATION (very constipated). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and CONSTIPATION (very constipated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 had Telephone Contact Report attached and it contain no new information.