chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pain in my right lung; Pleurisy; blood clot; difficulty breathing; body aches; chills; low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Supraventricular tachycardia on 04-Apr-2017 and AFib since 04-Apr-2017. Concomitant products included VERAPAMIL from 04-May-2017 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN BAYER) from 07-Jan-2003 to an unknown date and TAMSULOSIN HYDROCHLORIDE (FLOWMAX) from 14-Oct-2012 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever). On 02-May-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-May-2021, the patient experienced PLEURISY (Pleurisy), COAGULOPATHY (blood clot) and PULMONARY PAIN (pain in my right lung). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) for Pleurisy, at a dose of 875 mg twice a day. On 15-May-2021, PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4 degree (High) 100.4 degree F. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-May-2021, Blood test: abnormal (abnormal) D-dimer was elevated to 3600, Possible blood clot. On 05-May-2021, Computerised tomogram: abnormal (abnormal) Developed Pleurisy.         Symptoms: Patient reported that he had spiked fever and Difficulty breathing after vaccination.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-103195, MOD-2021-103270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains Significant information: Added Patient Demographics, Medical History, Lab Data, Suspect Drug Information, Concomitant medications, Treatment Medication, New Events added, Event outcome added.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tiredness) in a 49-year-old male 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 and Crohn's disease.    No Medical History information was reported.   On 26-Apr-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 an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Light headed; Tired; Headache; Fever 99.5; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever 99.5) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Hypertension and Cholesterol. Concomitant products included ATORVASTATIN CALCIUM for Cholesterol, METOPROLOL TARTRATE for Hypertension, MULTIVITAMINS [VITAMINS NOS], CALCIUM, VITAMIN D3 and BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) for Nutritional supplement.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Light headed), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever 99.5). On 20-Feb-2021, DIZZINESS (Light headed), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever 99.5) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 99.5 High.         This case was linked to MOD-2021-013859, MOD-2021-013859 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-087683, US-MODERNATX, INC.-MOD-2021-114220 (E2B Linked Report).; Sender's Comments:  MOD21-087683: US-MODERNATX, INC.-MOD-2021-114220:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Her husband had a rash too; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Her husband had a rash too) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Her husband had a rash too). At the time of the report, RASH (Her husband had a rash too) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-087683, US-MODERNATX, INC.-MOD-2021-114214 (E2B Linked Report).; Sender's Comments:  MOD21-087683: US-MODERNATX, INC.-MOD-2021-114214:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site bruising, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: I got Covid arm; redness; Extremely itchy / itchy soulder and neck; Hot to touch; Bruising at the injection site; Sore throat; Feverish to the touch; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), PRURITUS (Extremely itchy / itchy soulder and neck), SKIN WARM (Hot to touch) and INJECTION SITE BRUISING (Bruising at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), PRURITUS (Extremely itchy / itchy soulder and neck), SKIN WARM (Hot to touch), INJECTION SITE BRUISING (Bruising at the injection site), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Feverish to the touch) and VOMITING (Vomiting). At the time of the report, VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), OROPHARYNGEAL PAIN (Sore throat) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site reaction, Vomiting
Clinical narrative: I got Covid arm; redness; Extremely itchy / itchy soulder and neck; Hot to touch; Bruising at the injection site; Sore throat; Feverish to the touch; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), PRURITUS (Extremely itchy / itchy soulder and neck), SKIN WARM (Hot to touch) and INJECTION SITE BRUISING (Bruising at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), PRURITUS (Extremely itchy / itchy soulder and neck), SKIN WARM (Hot to touch), INJECTION SITE BRUISING (Bruising at the injection site), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Feverish to the touch) and VOMITING (Vomiting). At the time of the report, VACCINATION SITE REACTION (I got Covid arm), ERYTHEMA (redness), OROPHARYNGEAL PAIN (Sore throat) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast discomfort, Chills, Headache, Hyperhidrosis
Clinical narrative: Sweats; High pitch tone; Rash from neck to ankles that is pink/red in color; Breast feel heavy(feels like increased a cup size); menstrual period after second dose was also early; rash looks like a scarlet fever rash; Headache; Cold(Teeth chattering); Joint pain; Body ache (like run over by a truck); 102F fever; Breast area and neck lymphnods feel swollen; ringing in ears; Today 5/7 the rash is still there but fading; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)) and MENSTRUAL DISORDER (menstrual period after second dose was also early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A or 037B2HA and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), CHILLS (Cold(Teeth chattering)), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading). At the time of the report, HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment includes Tylenol , Benadryl.   This case was linked to MOD-2021-114267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertonia, Lymphadenopathy, Menstrual disorder, Myalgia, Pyrexia
Clinical narrative: Sweats; High pitch tone; Rash from neck to ankles that is pink/red in color; Breast feel heavy(feels like increased a cup size); menstrual period after second dose was also early; rash looks like a scarlet fever rash; Headache; Cold(Teeth chattering); Joint pain; Body ache (like run over by a truck); 102F fever; Breast area and neck lymphnods feel swollen; ringing in ears; Today 5/7 the rash is still there but fading; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)) and MENSTRUAL DISORDER (menstrual period after second dose was also early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A or 037B2HA and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), CHILLS (Cold(Teeth chattering)), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading). At the time of the report, HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment includes Tylenol , Benadryl.   This case was linked to MOD-2021-114267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash scarlatiniform, Tinnitus
Clinical narrative: Sweats; High pitch tone; Rash from neck to ankles that is pink/red in color; Breast feel heavy(feels like increased a cup size); menstrual period after second dose was also early; rash looks like a scarlet fever rash; Headache; Cold(Teeth chattering); Joint pain; Body ache (like run over by a truck); 102F fever; Breast area and neck lymphnods feel swollen; ringing in ears; Today 5/7 the rash is still there but fading; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)) and MENSTRUAL DISORDER (menstrual period after second dose was also early) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A or 037B2HA and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), CHILLS (Cold(Teeth chattering)), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading). At the time of the report, HYPERHIDROSIS (Sweats), HYPERTONIA (High pitch tone), RASH ERYTHEMATOUS (Rash from neck to ankles that is pink/red in color), BREAST DISCOMFORT (Breast feel heavy(feels like increased a cup size)), MENSTRUAL DISORDER (menstrual period after second dose was also early), RASH SCARLATINIFORM (rash looks like a scarlet fever rash), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Body ache (like run over by a truck)), PYREXIA (102F fever), LYMPHADENOPATHY (Breast area and neck lymphnods feel swollen), TINNITUS (ringing in ears) and RASH (Today 5/7 the rash is still there but fading) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment includes Tylenol , Benadryl.   This case was linked to MOD-2021-114267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Terrible rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Terrible rash) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 09-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 RASH (Terrible rash). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Terrible rash) outcome was unknown. Not Provided          Treatment details include Cortisone cream 5-day course of steroids   This case was linked to MOD-2021-114598 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: He reported that after receiving vaccine he has rash on his ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He reported that after receiving vaccine he has rash on his ankle) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication reported.     On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced RASH (He reported that after receiving vaccine he has rash on his ankle). At the time of the report, RASH (He reported that after receiving vaccine he has rash on his ankle) outcome was unknown. Not Provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hormone level abnormal, Hot flush, Insomnia
Clinical narrative: hot flash; skin ache; hormonal balance if off; barely got good quality sleep; fatigue; muscle pain; joint pain; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (low grade fever). At the time of the report, HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated genetis history of  teradoxic reaction. No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain of skin, Pyrexia
Clinical narrative: hot flash; skin ache; hormonal balance if off; barely got good quality sleep; fatigue; muscle pain; joint pain; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep) and FATIGUE (fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (low grade fever). At the time of the report, HOT FLUSH (hot flash), PAIN OF SKIN (skin ache), HORMONE LEVEL ABNORMAL (hormonal balance if off), INSOMNIA (barely got good quality sleep), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated genetis history of  teradoxic reaction. No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site erythema; Vaccination site pruritus; Vaccination site swelling; Vaccination site rash; Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZA) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site rash and Vaccination site warmth.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.            Reporter did not allow further contact
Age: 58.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Injection site bruising
Clinical narrative: injection site bruising; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE BRUISING (injection site bruising) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Shoulder injury. Concurrent medical conditions included Osteoporosis and Drug allergy (Allergic to Keflex - Manifested by Rash). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, SULFASALAZINE, BUDESONIDE and BALSALAZIDE for Ulcerative colitis, BISOPROLOL for Ventricular contractions premature, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 01-Dec-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE BRUISING (injection site bruising). On 22-Mar-2021, INJECTION SITE BRUISING (injection site bruising) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medicines were reported  Patient is an Non-Tobacco user and Abstains from Alcohol
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: kidney pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidney pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced RENAL PAIN (kidney pain). At the time of the report, RENAL PAIN (kidney pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site reaction
Clinical narrative: Redness; Vaccination site reaction; puffiness; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE REACTION (Vaccination site reaction) and SWELLING (puffiness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ERYTHEMA (Redness), VACCINATION SITE REACTION (Vaccination site reaction) and SWELLING (puffiness). At the time of the report, ERYTHEMA (Redness) and SWELLING (puffiness) outcome was unknown. 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 treatment or concomitant medication was reported
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine) 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine) 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.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  The patient claims that he was not administered a full Moderna COVID-19 vaccine dose and wants to start over (receive 3 doses) or start Pfizer COVID-19 vaccine instead.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine adminstration; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine adminstration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine adminstration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine adminstration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called on 10May2021 and said that she had a patient who received 1st dose of Moderna Covid 19 Vaccine on 22Apr2021and 2nd dose on 10May2021. She said she received 2nd dose less than 25 days time period. She wanted to know if it is safe for her to get 2nd dose this earlier
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia
Clinical narrative: she received Expired vaccine; having pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she received Expired vaccine) and MYALGIA (having pain all over her body) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A71A/038ANA) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first 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 06-May-2021, the patient experienced MYALGIA (having pain all over her body). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (she received Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she received Expired vaccine) and MYALGIA (having pain all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient mentioned her second dose of Moderna vaccine is due on 26May2021.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Influenza, Myalgia
Clinical narrative: My nose is congested; Feels like the flu; My arm hurts; Headache; tired for 3 days; pain in my chest" 3 out of 10 intensity; Chest oppression/Like something was pushing my heart or lungs in the middle of my chest; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (pain in my chest" 3 out of 10 intensity), SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest), NASAL CONGESTION (My nose is congested), INFLUENZA (Feels like the flu) and MYALGIA (My arm hurts) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced CHEST PAIN (pain in my chest" 3 out of 10 intensity), SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest), MYALGIA (My arm hurts), HEADACHE (Headache) and FATIGUE (tired for 3 days). On 09-May-2021, the patient experienced NASAL CONGESTION (My nose is congested) and INFLUENZA (Feels like the flu). On 06-May-2021, CHEST PAIN (pain in my chest" 3 out of 10 intensity), MYALGIA (My arm hurts) and HEADACHE (Headache) had resolved. At the time of the report, SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest) and FATIGUE (tired for 3 days) had not resolved and NASAL CONGESTION (My nose is congested) and INFLUENZA (Feels like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMTANT DRUG WERE USED Treatment Tylenol 500mg PO BID
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Sense of oppression
Clinical narrative: My nose is congested; Feels like the flu; My arm hurts; Headache; tired for 3 days; pain in my chest" 3 out of 10 intensity; Chest oppression/Like something was pushing my heart or lungs in the middle of my chest; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (pain in my chest" 3 out of 10 intensity), SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest), NASAL CONGESTION (My nose is congested), INFLUENZA (Feels like the flu) and MYALGIA (My arm hurts) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced CHEST PAIN (pain in my chest" 3 out of 10 intensity), SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest), MYALGIA (My arm hurts), HEADACHE (Headache) and FATIGUE (tired for 3 days). On 09-May-2021, the patient experienced NASAL CONGESTION (My nose is congested) and INFLUENZA (Feels like the flu). On 06-May-2021, CHEST PAIN (pain in my chest" 3 out of 10 intensity), MYALGIA (My arm hurts) and HEADACHE (Headache) had resolved. At the time of the report, SENSE OF OPPRESSION (Chest oppression/Like something was pushing my heart or lungs in the middle of my chest) and FATIGUE (tired for 3 days) had not resolved and NASAL CONGESTION (My nose is congested) and INFLUENZA (Feels like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMTANT DRUG WERE USED Treatment Tylenol 500mg PO BID
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "side effects? on the Milder side"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION ("side effects? on the Milder side") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION ("side effects? on the Milder side"). At the time of the report, VACCINATION COMPLICATION ("side effects? on the Milder side") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Concomitant product use was not provided. Treatment information was not provided   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Bone pain, Eye pain, Headache
Clinical narrative: Missed second dose of the Moderna COVID-19 Vaccine; I suffer from arthritis; My arm is still sore; Headache; I didn't want to open my eyes; Bone pain; Joints hurts; Osteoporosis; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts) and OSTEOPOROSIS (Osteoporosis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN, METFORMIN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO), GLYCERYL TRINITRATE (NITROGLYCERINE) and LOSARTAN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts) and OSTEOPOROSIS (Osteoporosis). On 11-May-2021, the patient experienced ARTHRITIS (I suffer from arthritis) and PAIN IN EXTREMITY (My arm is still sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine). At the time of the report, HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts), OSTEOPOROSIS (Osteoporosis), ARTHRITIS (I suffer from arthritis) and PAIN IN EXTREMITY (My arm is still sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Information about treatment was not given.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoporosis, Pain in extremity, Product dose omission issue
Clinical narrative: Missed second dose of the Moderna COVID-19 Vaccine; I suffer from arthritis; My arm is still sore; Headache; I didn't want to open my eyes; Bone pain; Joints hurts; Osteoporosis; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts) and OSTEOPOROSIS (Osteoporosis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN, METFORMIN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO), GLYCERYL TRINITRATE (NITROGLYCERINE) and LOSARTAN for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts) and OSTEOPOROSIS (Osteoporosis). On 11-May-2021, the patient experienced ARTHRITIS (I suffer from arthritis) and PAIN IN EXTREMITY (My arm is still sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine). At the time of the report, HEADACHE (Headache), EYE PAIN (I didn't want to open my eyes), BONE PAIN (Bone pain), ARTHRALGIA (Joints hurts), OSTEOPOROSIS (Osteoporosis), ARTHRITIS (I suffer from arthritis) and PAIN IN EXTREMITY (My arm is still sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Information about treatment was not given.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: pain went down the entire arm; "felt like someone punched me in the arm"; "it is tender but there is no bruise"; pain in her left arm an hour later; "I couldn't move it for a few days"; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (pain in her left arm an hour later), MOBILITY DECREASED ("I couldn't move it for a few days"), PAIN IN EXTREMITY (pain went down the entire arm), PAIN IN EXTREMITY ("felt like someone punched me in the arm") and VACCINATION SITE PAIN ("it is tender but there is no bruise") in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE for Depression.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her left arm an hour later), MOBILITY DECREASED ("I couldn't move it for a few days"), PAIN IN EXTREMITY ("felt like someone punched me in the arm") and VACCINATION SITE PAIN ("it is tender but there is no bruise"). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain went down the entire arm). At the time of the report, PAIN IN EXTREMITY (pain in her left arm an hour later), MOBILITY DECREASED ("I couldn't move it for a few days"), PAIN IN EXTREMITY ("felt like someone punched me in the arm") and VACCINATION SITE PAIN ("it is tender but there is no bruise") 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.   Treatment information included Tylenol.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: sore arm; 63 days since first shot without having second shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) 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) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (sore arm) and PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot).            This case was linked to US-MODERNATX, INC.-MOD-2021-117989 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117989:Wife case
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: The vaccine was exposed to sunlight; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight). On 13-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received the first dose of the Moderna COVID-19 vaccine on 13-APR-2021 through a drive-through vaccination facility. He stated that when he received the vaccine, the vaccine was exposed to direct sunlight due to the vaccination provider holding the vial out in direct sunlight. He experienced no side effects.   This case was linked to MOD-2021-135651 (Patient Link).