chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Feeling achy; Hot to the touch at the injection site; Itchy at the injection site; Headache; Swollen lymph nodes in the arm at the injection site; Big red spot on the arm close to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling achy), VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the arm at the injection site) and VACCINATION SITE ERYTHEMA (Big red spot on the arm close to the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the arm at the injection site) and VACCINATION SITE ERYTHEMA (Big red spot on the arm close to the injection site). On 08-Mar-2021, the patient experienced PAIN (Feeling achy), VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and HEADACHE (Headache). On 08-Mar-2021, VACCINATION SITE ERYTHEMA (Big red spot on the arm close to the injection site) had resolved. At the time of the report, PAIN (Feeling achy), VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in the arm at the injection site) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Illness
Clinical narrative: had aches/had pains; muscle pain; joint pain; headache; fatigue; started to get sick; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), PAIN (had aches/had pains), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), FOLIC ACID, ATORVASTATIN CALCIUM (LIPITOR), CLONAZEPAM (KLONOPIN), CYANOCOBALAMIN (VITAMIN B-12) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN (had aches/had pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) had resolved. At the time of the report, PAIN (had aches/had pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication taken by the patient include Gatorade.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Additional Event and Treatment Details were updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: had aches/had pains; muscle pain; joint pain; headache; fatigue; started to get sick; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), PAIN (had aches/had pains), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), FOLIC ACID, ATORVASTATIN CALCIUM (LIPITOR), CLONAZEPAM (KLONOPIN), CYANOCOBALAMIN (VITAMIN B-12) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN (had aches/had pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) had resolved. At the time of the report, PAIN (had aches/had pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication taken by the patient include Gatorade.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Additional Event and Treatment Details were updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: chalky taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (chalky taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (chalky taste). At the time of the report, DYSGEUSIA (chalky taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: shingles on buttocks with multiple cold sores around her mouth; shingles on buttocks with multiple cold sores around her mouth; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles on buttocks with multiple cold sores around her mouth) and ORAL HERPES (shingles on buttocks with multiple cold sores around her mouth) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Stress causes shingles reported.). Previously administered products included for Product used for unknown indication: Tetanus toxoid. Concurrent medical conditions included Drug allergy (ASA), Drug allergy (Vioxx) and Allergy to antibiotic (Augmentin).   On 29-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (shingles on buttocks with multiple cold sores around her mouth). On 08-Mar-2021, the patient experienced ORAL HERPES (shingles on buttocks with multiple cold sores around her mouth). The patient was treated with ACYCLOVIR [ACICLOVIR] for Antiviral treatment, at an unspecified dose and frequency. On 08-Mar-2021, HERPES ZOSTER (shingles on buttocks with multiple cold sores around her mouth) had resolved. At the time of the report, ORAL HERPES (shingles on buttocks with multiple cold sores around her mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-208855 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient demographics, Relevant medical history, Dose 2 details, Event Onset date were updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Cough, Feeding disorder, Feeling hot
Clinical narrative: Sore Arm; Feeling I had Phylum in Throat; Could Not Eat; Sore Lymph Nodes Right Armpit; Could not lift the arm; Tender to the touch Right Armpit; Cough for 1 minute; Extreme Ache Entire Body; Burning up Fever 100.3 F; Muscle Ache; Nausea; Feeling Warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat) and LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (Feeling Warm). On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm), AXILLARY PAIN (Tender to the touch Right Armpit), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea). The patient was treated with AZELASTINE (nasal) at a dose of 1 dosage form. On 15-Feb-2021, FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea) had resolved. On 27-Feb-2021, LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm) and AXILLARY PAIN (Tender to the touch Right Armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100.3 (High) Fever 100.3F. On 13-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Antibody test was reactive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter mailing address was updated. The relevant medical history and the  lab data was added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymph node pain, Myalgia, Nausea, Pain
Clinical narrative: Sore Arm; Feeling I had Phylum in Throat; Could Not Eat; Sore Lymph Nodes Right Armpit; Could not lift the arm; Tender to the touch Right Armpit; Cough for 1 minute; Extreme Ache Entire Body; Burning up Fever 100.3 F; Muscle Ache; Nausea; Feeling Warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat) and LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (Feeling Warm). On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm), AXILLARY PAIN (Tender to the touch Right Armpit), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea). The patient was treated with AZELASTINE (nasal) at a dose of 1 dosage form. On 15-Feb-2021, FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea) had resolved. On 27-Feb-2021, LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm) and AXILLARY PAIN (Tender to the touch Right Armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100.3 (High) Fever 100.3F. On 13-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Antibody test was reactive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter mailing address was updated. The relevant medical history and the  lab data was added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Sore Arm; Feeling I had Phylum in Throat; Could Not Eat; Sore Lymph Nodes Right Armpit; Could not lift the arm; Tender to the touch Right Armpit; Cough for 1 minute; Extreme Ache Entire Body; Burning up Fever 100.3 F; Muscle Ache; Nausea; Feeling Warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat) and LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING HOT (Feeling Warm). On 13-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm), AXILLARY PAIN (Tender to the touch Right Armpit), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea). The patient was treated with AZELASTINE (nasal) at a dose of 1 dosage form. On 15-Feb-2021, FEELING HOT (Feeling Warm), LIMB DISCOMFORT (Sore Arm), PRODUCTIVE COUGH (Feeling I had Phylum in Throat), FEEDING DISORDER (Could Not Eat), COUGH (Cough for 1 minute), PAIN (Extreme Ache Entire Body), PYREXIA (Burning up Fever 100.3 F), MYALGIA (Muscle Ache) and NAUSEA (Nausea) had resolved. On 27-Feb-2021, LYMPH NODE PAIN (Sore Lymph Nodes Right Armpit), LIMB DISCOMFORT (Could not lift the arm) and AXILLARY PAIN (Tender to the touch Right Armpit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 100.3 (High) Fever 100.3F. On 13-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Antibody test was reactive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter mailing address was updated. The relevant medical history and the  lab data was added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Bowel movement irregularity, Chills, Decreased appetite
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills), NAUSEA (feeling queasy) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills), NAUSEA (feeling queasy) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product include OTC Thyroid medication.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills), NAUSEA (feeling queasy) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DECREASED APPETITE (not eating much only mild bland stuff), BOWEL MOVEMENT IRREGULARITY (loose bowel movements), DIARRHEA (diarrhea), NAUSEA (nausea), HEADACHE (headache), CHILLS (chills), NAUSEA (feeling queasy) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product include OTC Thyroid medication.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on her arm (COVID arm); Red rash; Itchy rash; Warm rash; When she went touch it felt like bee sting; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Rash on her arm (COVID arm)), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Warm rash) and RASH (When she went touch it felt like bee sting) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DERMATITIS ALLERGIC (Rash on her arm (COVID arm)), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Warm rash) and RASH (When she went touch it felt like bee sting). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 07-Mar-2021, DERMATITIS ALLERGIC (Rash on her arm (COVID arm)), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Warm rash) and RASH (When she went touch it felt like bee sting) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: sore arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011L220A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No relevant Concomitant medications were reported.      This case was linked to MOD-2021-036393 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011L220A) for COVID-19 vaccination.     NO Medical History Information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No relevant Concomitant medications were reported.      This case was linked to MOD-2021-036393 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe muscle pain in whole body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe muscle pain in whole body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Severe muscle pain in whole body). At the time of the report, MYALGIA (Severe muscle pain in whole body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated outcome of event  and updated Information of Second dose of vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site pruritus
Clinical narrative: hives on back, neck, arms; itching at injection site; bumps on back, neck and arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on back, neck, arms), INJECTION SITE PRURITUS (itching at injection site) and RASH (bumps on back, neck and arms) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced URTICARIA (hives on back, neck, arms), INJECTION SITE PRURITUS (itching at injection site) and RASH (bumps on back, neck and arms). At the time of the report, URTICARIA (hives on back, neck, arms) and INJECTION SITE PRURITUS (itching at injection site) outcome was unknown and RASH (bumps on back, neck and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information include alcohol and salve on it.   This case was linked to MOD-2021-101475 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of the event Rash and Treatment information was updated.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: HIT HER HARD; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (HIT HER HARD) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (HIT HER HARD). At the time of the report, VACCINATION COMPLICATION (HIT HER HARD) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: Pregnancy; sore arm; Sore throat; Chills; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy), PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 27-Aug-2016. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety and Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, NITROFURANTOIN (MACROBID [NITROFURANTOIN]) for Urinary tract infection.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Nov-2020 and the estimated date of delivery was 28-Aug-2021. On 05-Mar-2021, the patient experienced PREGNANCY (Pregnancy), PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 07-Mar-2021, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnancy; sore arm; Sore throat; Chills; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy), PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 27-Aug-2016. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety and Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, NITROFURANTOIN (MACROBID [NITROFURANTOIN]) for Urinary tract infection.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Nov-2020 and the estimated date of delivery was 28-Aug-2021. On 05-Mar-2021, the patient experienced PREGNANCY (Pregnancy), PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 07-Mar-2021, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Bladder infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Bladder infection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder infection. Concomitant products included CIPROFLOXACIN for Bladder infection, BENAZEPRIL, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CYSTITIS (Bladder infection). At the time of the report, CYSTITIS (Bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included- Ciprofloxacin (for bladder infection).   This case was linked to US-MODERNATX, INC.-MOD-2021-101999 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: On 03-MAY-2021, a Follow up was received through Telephone Contact. It contained information about the second dose of suspect product and events associated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101999:second dose case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: Vaccine exposure during pregnancy; Vaccination site pain; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash since its first appearance even until today.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash since its first appearance even until today.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Rash both legs (rash on her upper thighs and upper arms) since 31-Dec-2020 and Hypertension since an unknown date. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash since its first appearance even until today.). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash since its first appearance even until today.) outcome was unknown.            Reported concomitant medication including blood pressure medication and statin. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash since its first appearance even until today.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Rash both legs (rash on her upper thighs and upper arms) since 31-Dec-2020 and Hypertension since an unknown date. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (rash since its first appearance even until today.). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (rash since its first appearance even until today.) outcome was unknown.            Reported concomitant medication including blood pressure medication and statin.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site reaction
Clinical narrative: Red swollen hot itchy Bump; Suspected Swollen lymph node of inside of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Red swollen hot itchy Bump) and LYMPHADENOPATHY (Suspected Swollen lymph node of inside of injection arm) in an 81-year-old patient of an unknown gender 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 25-Feb-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 REACTION (Red swollen hot itchy Bump) and LYMPHADENOPATHY (Suspected Swollen lymph node of inside of injection arm). At the time of the report, VACCINATION SITE REACTION (Red swollen hot itchy Bump) and LYMPHADENOPATHY (Suspected Swollen lymph node of inside of injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Antihistamine, Hydrocortisone cream, ice pack.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Vaccination site pain
Clinical narrative: Plaque psoriasis Flare-up with Humira (Adalimumab); Soreness in left arm after getting Moderna vaccination; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Plaque psoriasis Flare-up with Humira (Adalimumab)) and VACCINATION SITE PAIN (Soreness in left arm after getting Moderna vaccination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Feb-2021, the patient experienced PSORIASIS (Plaque psoriasis Flare-up with Humira (Adalimumab)) and VACCINATION SITE PAIN (Soreness in left arm after getting Moderna vaccination). At the time of the report, PSORIASIS (Plaque psoriasis Flare-up with Humira (Adalimumab)) had not resolved and VACCINATION SITE PAIN (Soreness in left arm after getting Moderna vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles). At the time of the report, HERPES ZOSTER (Diagnosed with shingles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she started taking antiviral medications for treatment. Concomitant medications were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: developed a lump on her leg, below her knee.; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (developed a lump on her leg, below her knee.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (developed a lump on her leg, below her knee.). At the time of the report, NODULE (developed a lump on her leg, below her knee.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment drugs were provided
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Developed a lump on her leg, below her knee; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Developed a lump on her leg, below her knee) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Developed a lump on her leg, below her knee). At the time of the report, PERIPHERAL SWELLING (Developed a lump on her leg, below her knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (Inconclusive) temperature of 98.7F, lowest 98F for 13 days.         The treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: Chills; Diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 CHILLS (Chills) and DIARRHOEA (Diarrhea). At the time of the report, CHILLS (Chills) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: Abdominal pain; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-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 ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) ongoing since an unknown date at a dose of 1 dosage form once a day. At the time of the report, ABDOMINAL PAIN (Abdominal pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment details included, Benadryl of 25mg administered orally and the patient was monitored an additional 30 minutes by a registered nurse.    Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Follow up report received on -08-MAR-2021 and included no new information