chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue; aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (aches and pains) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 FATIGUE (fatigue) and MYALGIA (aches and pains). At the time of the report, FATIGUE (fatigue) and MYALGIA (aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-082942, US-MODERNATX, INC.-MOD-2021-082955, US-MODERNATX, INC.-MOD-2021-082980, US-MODERNATX, INC.-MOD-2021-082989 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082955: US-MODERNATX, INC.-MOD-2021-082980: US-MODERNATX, INC.-MOD-2021-082942: US-MODERNATX, INC.-MOD-2021-082989:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in her arm for the past month since her first injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in her arm for the past month since her first injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 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 MYALGIA (pain in her arm for the past month since her first injection). At the time of the report, MYALGIA (pain in her arm for the past month since her first injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient was on blood thinners for unknown indication.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced LIP SWELLING (swollen lip). At the time of the report, LIP SWELLING (swollen lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Oesophagitis
Clinical narrative: hurting in her esophagus; really weak; shortness of breath; really bad headaches; tired; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (hurting in her esophagus), ASTHENIA (really weak), DYSPNOEA (shortness of breath), HEADACHE (really bad headaches) and FATIGUE (tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced OESOPHAGITIS (hurting in her esophagus), ASTHENIA (really weak), DYSPNOEA (shortness of breath), HEADACHE (really bad headaches) and FATIGUE (tired). At the time of the report, OESOPHAGITIS (hurting in her esophagus), ASTHENIA (really weak), DYSPNOEA (shortness of breath), HEADACHE (really bad headaches) and FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Lethargy, Pain
Clinical narrative: Body aches; sweating; Skin pain; Lethargic; Fatigue; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic), FATIGUE (Fatigue), PYREXIA (Low grade fever) and HEADACHE (Headache). The patient was treated with PREDNISONE (oral) at an unspecified dose and frequency; DEXAMETHASONE PHOSPHATE (DECADRON [DEXAMETHASONE PHOSPHATE]) (oral) at an unspecified dose and frequency; METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) (oral) at an unspecified dose and frequency; OFLOXACIN (ZENFLOX [OFLOXACIN]) (oral) at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic), FATIGUE (Fatigue), PYREXIA (Low grade fever) and HEADACHE (Headache) had not resolved. Not Provided          No Concomitant Medications were reported. Treatment Medication includes; Prednisone, Decadron, Medrol, Zenefrax and Cipro. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-082906 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia
Clinical narrative: Body aches; sweating; Skin pain; Lethargic; Fatigue; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic), FATIGUE (Fatigue), PYREXIA (Low grade fever) and HEADACHE (Headache). The patient was treated with PREDNISONE (oral) at an unspecified dose and frequency; DEXAMETHASONE PHOSPHATE (DECADRON [DEXAMETHASONE PHOSPHATE]) (oral) at an unspecified dose and frequency; METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) (oral) at an unspecified dose and frequency; OFLOXACIN (ZENFLOX [OFLOXACIN]) (oral) at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic), FATIGUE (Fatigue), PYREXIA (Low grade fever) and HEADACHE (Headache) had not resolved. Not Provided          No Concomitant Medications were reported. Treatment Medication includes; Prednisone, Decadron, Medrol, Zenefrax and Cipro. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-082906 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash (both arms, eyes and left cheek) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A) for COVID-19 immunization. No medical history reported. On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 25, 2021, patient experienced rash (both arms, eyes and left cheek). At the time of the report, rash (both arms, eyes and left cheek): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication list not provided. Treatment provided include allergy medication. Most recent follow-up information incorporated: On May 20, 2021: Follow-up received on May 20, 2021. Reporter's email address added. It contains non-significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Lethargy, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), MYALGIA (Body ache), FATIGUE (Fatigue) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A /017B21A and 017B21A) 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 PREDNISONE, DEXAMETHASONE ACETATE (DECADRON A), METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]), CYANOCOBALAMIN, FOLIC ACID, IRON PENTACARBONYL, ZINC (ZENFER Z) and CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), MYALGIA (Body ache), FATIGUE (Fatigue), HEADACHE (Headache), PAIN OF SKIN (Skin pain) and PYREXIA (Low grade fever). At the time of the report, HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), FATIGUE (Fatigue), HEADACHE (Headache), PAIN OF SKIN (Skin pain) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication include Prednisone, Decadron, Medrol, Zenefrax and Cipro. Concomitant product use was not provided.   This case was linked to MOD-2021-082902 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), MYALGIA (Body ache), FATIGUE (Fatigue) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A /017B21A and 017B21A) 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 PREDNISONE, DEXAMETHASONE ACETATE (DECADRON A), METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]), CYANOCOBALAMIN, FOLIC ACID, IRON PENTACARBONYL, ZINC (ZENFER Z) and CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), MYALGIA (Body ache), FATIGUE (Fatigue), HEADACHE (Headache), PAIN OF SKIN (Skin pain) and PYREXIA (Low grade fever). At the time of the report, HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), FATIGUE (Fatigue), HEADACHE (Headache), PAIN OF SKIN (Skin pain) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication include Prednisone, Decadron, Medrol, Zenefrax and Cipro. Concomitant product use was not provided.   This case was linked to MOD-2021-082902 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: right outer thigh has 2 purple bruises; Yesterday they were kneeling and now they have bruises in both knees; increased bruising of the skin; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (increased bruising of the skin), CONTUSION (Yesterday they were kneeling and now they have bruises in both knees) and CONTUSION (right outer thigh has 2 purple bruises) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CONTUSION (increased bruising of the skin). On 20-Apr-2021, the patient experienced CONTUSION (Yesterday they were kneeling and now they have bruises in both knees). On 21-Apr-2021, the patient experienced CONTUSION (right outer thigh has 2 purple bruises). At the time of the report, CONTUSION (increased bruising of the skin), CONTUSION (Yesterday they were kneeling and now they have bruises in both knees) and CONTUSION (right outer thigh has 2 purple bruises) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable  Concomitant medication was not provided Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling really fatigued/feeling sort of tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling really fatigued/feeling sort of tired all the time) 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 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 an unknown date, the patient experienced FATIGUE (feeling really fatigued/feeling sort of tired all the time). At the time of the report, FATIGUE (feeling really fatigued/feeling sort of tired all the time) outcome was unknown. Unknown          Concomitant and treatment information were not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Low grade fever; headache; fatigue; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Low grade fever), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills). At the time of the report, PYREXIA (Low grade fever), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Fatigue, Fibromyalgia, Headache, Heart rate increased
Clinical narrative: Lost 17 pounds; Not getting second dose; Vomiting; Blood pressure shoot up; Heart rate shoot up; Fibromyalgia; headache; Fever; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (Fever), FATIGUE (Extreme fatigue), VOMITING (Vomiting) and WEIGHT DECREASED (Lost 17 pounds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METOPROLOL and ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache), PYREXIA (Fever), FATIGUE (Extreme fatigue) and FIBROMYALGIA (Fibromyalgia). On 17-Mar-2021, the patient experienced VOMITING (Vomiting), BLOOD PRESSURE INCREASED (Blood pressure shoot up) and HEART RATE INCREASED (Heart rate shoot up). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 17 pounds) and PRODUCT DOSE OMISSION ISSUE (Not getting second dose). At the time of the report, HEADACHE (headache), WEIGHT DECREASED (Lost 17 pounds) and PRODUCT DOSE OMISSION ISSUE (Not getting second dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Extreme fatigue), VOMITING (Vomiting), FIBROMYALGIA (Fibromyalgia), BLOOD PRESSURE INCREASED (Blood pressure shoot up) and HEART RATE INCREASED (Heart rate shoot up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Lost 17 pounds; Not getting second dose; Vomiting; Blood pressure shoot up; Heart rate shoot up; Fibromyalgia; headache; Fever; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (Fever), FATIGUE (Extreme fatigue), VOMITING (Vomiting) and WEIGHT DECREASED (Lost 17 pounds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METOPROLOL and ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache), PYREXIA (Fever), FATIGUE (Extreme fatigue) and FIBROMYALGIA (Fibromyalgia). On 17-Mar-2021, the patient experienced VOMITING (Vomiting), BLOOD PRESSURE INCREASED (Blood pressure shoot up) and HEART RATE INCREASED (Heart rate shoot up). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 17 pounds) and PRODUCT DOSE OMISSION ISSUE (Not getting second dose). At the time of the report, HEADACHE (headache), WEIGHT DECREASED (Lost 17 pounds) and PRODUCT DOSE OMISSION ISSUE (Not getting second dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Extreme fatigue), VOMITING (Vomiting), FIBROMYALGIA (Fibromyalgia), BLOOD PRESSURE INCREASED (Blood pressure shoot up) and HEART RATE INCREASED (Heart rate shoot up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis since an unknown date and Muscle strain since an unknown date.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) had resolved. Not Provided          Concomitant information was not provided. No treatment was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-082928 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082928:2nd dose of vaccine
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills, myalgia (body ache) and headache in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 21, 2021, patient had pyrexia (fever), chills, myalgia (body ache) and headache. At the time of the report, pyrexia (fever), chills, myalgia (body ache) and headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pruritus, Throat irritation
Clinical narrative: itchiness in my chest/lungs; "tickle in her throat"; Mild itchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT ("tickle in her throat"), THROAT IRRITATION (Mild itchy throat) and PRURITUS (itchiness in my chest/lungs ) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity (Sensitivity to MSG(monosodium glutamate)). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT ("tickle in her throat") and THROAT IRRITATION (Mild itchy throat). On an unknown date, the patient experienced PRURITUS (itchiness in my chest/lungs ). At the time of the report, OROPHARYNGEAL DISCOMFORT ("tickle in her throat") and THROAT IRRITATION (Mild itchy throat) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: ADR Form
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint aches; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Muscle injury.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ARTHRALGIA (Joint aches) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Joint aches) and MYALGIA (muscle aches) outcome was unknown. Not Provided          No concomitant medications were provided. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-082921 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082921:1st dose of vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Her arm was tender; can barely move her arm,; Brain fog; Constipation; dizziness; she has pain in the arm that is almost unbearable; she has chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation) and DIZZINESS (dizziness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dairy intolerance (Dairy allergy), Allergy to animal dander and Seasonal allergy. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy, MULTIVITAMIN FOR WOMEN for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation), DIZZINESS (dizziness), VACCINATION SITE PAIN (she has pain in the arm that is almost unbearable), CHILLS (she has chills), NAUSEA (nausea) and FATIGUE (fatigue). On 30-Apr-2021, TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation), DIZZINESS (dizziness), VACCINATION SITE PAIN (she has pain in the arm that is almost unbearable), CHILLS (she has chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-204090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 03-JUN-2021include the following new information, Dose 1 and 2 details, patient demographics, medical history and new events added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Tenderness, Vaccination site pain
Clinical narrative: Her arm was tender; can barely move her arm,; Brain fog; Constipation; dizziness; she has pain in the arm that is almost unbearable; she has chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation) and DIZZINESS (dizziness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dairy intolerance (Dairy allergy), Allergy to animal dander and Seasonal allergy. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy, MULTIVITAMIN FOR WOMEN for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation), DIZZINESS (dizziness), VACCINATION SITE PAIN (she has pain in the arm that is almost unbearable), CHILLS (she has chills), NAUSEA (nausea) and FATIGUE (fatigue). On 30-Apr-2021, TENDERNESS (Her arm was tender), MOBILITY DECREASED (can barely move her arm,), FEELING ABNORMAL (Brain fog), CONSTIPATION (Constipation), DIZZINESS (dizziness), VACCINATION SITE PAIN (she has pain in the arm that is almost unbearable), CHILLS (she has chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-204090 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 03-JUN-2021include the following new information, Dose 1 and 2 details, patient demographics, medical history and new events added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dry mouth, Fatigue, Heavy menstrual bleeding
Clinical narrative: menstrual cycle lasted a week, it was heavy; menstrual cycle lasted a week, it was heavy; felt horrible, worse than flu,it felt like the flu; extremely fatigued; constant chills; high fever; injection site felt hard like a rock; barely move her left arm; body aches; kept falling asleep; profusely sweating; super thirsty; dry mouth; back isn't hurting at all now; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating) and THIRST (super thirsty) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (back isn't hurting at all now) and VACCINATION SITE PAIN (pain at the injection site). On 19-Apr-2021, the patient experienced HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating), THIRST (super thirsty), DRY MOUTH (dry mouth), MALAISE (felt horrible, worse than flu,it felt like the flu), FATIGUE (extremely fatigued), CHILLS (constant chills), PYREXIA (high fever) and VACCINATION SITE INDURATION (injection site felt hard like a rock). On an unknown date, the patient experienced OLIGOMENORRHOEA (menstrual cycle lasted a week, it was heavy) and HEAVY MENSTRUAL BLEEDING (menstrual cycle lasted a week, it was heavy). At the time of the report, HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating), THIRST (super thirsty), DRY MOUTH (dry mouth), BACK PAIN (back isn't hurting at all now), OLIGOMENORRHOEA (menstrual cycle lasted a week, it was heavy), MALAISE (felt horrible, worse than flu,it felt like the flu), FATIGUE (extremely fatigued), CHILLS (constant chills), PYREXIA (high fever), VACCINATION SITE INDURATION (injection site felt hard like a rock) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown and HEAVY MENSTRUAL BLEEDING (menstrual cycle lasted a week, it was heavy) had resolved.            Patient has no medical history  No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received on 12-May-2021 .Events added.reporter email address was added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypokinesia, Malaise, Oligomenorrhoea, Pain
Clinical narrative: menstrual cycle lasted a week, it was heavy; menstrual cycle lasted a week, it was heavy; felt horrible, worse than flu,it felt like the flu; extremely fatigued; constant chills; high fever; injection site felt hard like a rock; barely move her left arm; body aches; kept falling asleep; profusely sweating; super thirsty; dry mouth; back isn't hurting at all now; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating) and THIRST (super thirsty) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (back isn't hurting at all now) and VACCINATION SITE PAIN (pain at the injection site). On 19-Apr-2021, the patient experienced HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating), THIRST (super thirsty), DRY MOUTH (dry mouth), MALAISE (felt horrible, worse than flu,it felt like the flu), FATIGUE (extremely fatigued), CHILLS (constant chills), PYREXIA (high fever) and VACCINATION SITE INDURATION (injection site felt hard like a rock). On an unknown date, the patient experienced OLIGOMENORRHOEA (menstrual cycle lasted a week, it was heavy) and HEAVY MENSTRUAL BLEEDING (menstrual cycle lasted a week, it was heavy). At the time of the report, HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating), THIRST (super thirsty), DRY MOUTH (dry mouth), BACK PAIN (back isn't hurting at all now), OLIGOMENORRHOEA (menstrual cycle lasted a week, it was heavy), MALAISE (felt horrible, worse than flu,it felt like the flu), FATIGUE (extremely fatigued), CHILLS (constant chills), PYREXIA (high fever), VACCINATION SITE INDURATION (injection site felt hard like a rock) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown and HEAVY MENSTRUAL BLEEDING (menstrual cycle lasted a week, it was heavy) had resolved.            Patient has no medical history  No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received on 12-May-2021 .Events added.reporter email address was added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Thirst, Vaccination site induration, Vaccination site pain
Clinical narrative: menstrual cycle lasted a week, it was heavy; menstrual cycle lasted a week, it was heavy; felt horrible, worse than flu,it felt like the flu; extremely fatigued; constant chills; high fever; injection site felt hard like a rock; barely move her left arm; body aches; kept falling asleep; profusely sweating; super thirsty; dry mouth; back isn't hurting at all now; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating) and THIRST (super thirsty) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced BACK PAIN (back isn't hurting at all now) and VACCINATION SITE PAIN (pain at the injection site). On 19-Apr-2021, the patient experienced HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating), THIRST (super thirsty), DRY MOUTH (dry mouth), MALAISE (felt horrible, worse than flu,it felt like the flu), FATIGUE (extremely fatigued), CHILLS (constant chills), PYREXIA (high fever) and VACCINATION SITE INDURATION (injection site felt hard like a rock). On an unknown date, the patient experienced OLIGOMENORRHOEA (menstrual cycle lasted a week, it was heavy) and HEAVY MENSTRUAL BLEEDING (menstrual cycle lasted a week, it was heavy). At the time of the report, HYPOKINESIA (barely move her left arm), PAIN (body aches), SOMNOLENCE (kept falling asleep), HYPERHIDROSIS (profusely sweating), THIRST (super thirsty), DRY MOUTH (dry mouth), BACK PAIN (back isn't hurting at all now), OLIGOMENORRHOEA (menstrual cycle lasted a week, it was heavy), MALAISE (felt horrible, worse than flu,it felt like the flu), FATIGUE (extremely fatigued), CHILLS (constant chills), PYREXIA (high fever), VACCINATION SITE INDURATION (injection site felt hard like a rock) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown and HEAVY MENSTRUAL BLEEDING (menstrual cycle lasted a week, it was heavy) had resolved.            Patient has no medical history  No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: FU received on 12-May-2021 .Events added.reporter email address was added.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMIN D NOS 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 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) on 16-Apr-2021 for UTI, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.            Concomitant products also include Zyrtec.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a fever 100.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a fever 100.7) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included DULOXETINE, THYROID (ARMOUR THYROID), PANTOPRAZOLE and PRAVASTATIN for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (a fever 100.7). At the time of the report, PYREXIA (a fever 100.7) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site bruising
Clinical narrative: bruising around the shot site; nausea; aches,pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruising around the shot site), NAUSEA (nausea) and PAIN IN EXTREMITY (aches,pains) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced NAUSEA (nausea) and PAIN IN EXTREMITY (aches,pains). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruising around the shot site). At the time of the report, VACCINATION SITE BRUISING (bruising around the shot site), NAUSEA (nausea) and PAIN IN EXTREMITY (aches,pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-082892, MOD21-079883, US-MODERNATX, INC.-MOD-2021-082955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082892: MOD21-079883: US-MODERNATX, INC.-MOD-2021-082955:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red feet; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red feet) 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red feet). At the time of the report, ERYTHEMA (Red feet) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitants were provided no treatment medications were provided.   This case was linked to MOD21-0749404 (E2B Linked Report).; Sender's Comments:  MOD21-0749404:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: really bad headache; temperature 103; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headache) and PYREXIA (temperature 103) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (really bad headache) and PYREXIA (temperature 103). At the time of the report, HEADACHE (really bad headache) and PYREXIA (temperature 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: soreness of both breast after 1st shot; Soreness of both breast got worse after second shot; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (soreness of both breast after 1st shot) and BREAST PAIN (Soreness of both breast got worse after second shot) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. 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 BREAST PAIN (soreness of both breast after 1st shot) and BREAST PAIN (Soreness of both breast got worse after second shot). At the time of the report, BREAST PAIN (soreness of both breast after 1st shot) had not resolved and BREAST PAIN (Soreness of both breast got worse after second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082968:First Dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ear) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 012L20A) 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) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (ringing in her ear). At the time of the report, TINNITUS (ringing in her ear) outcome was unknown.            No concomitant drugs and treatment medications were reported.   This case was linked to MOD-2021-225542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Followup received contains  :-No  new information On 03-Aug-2021: Follow up received contains:- Updated reporter contact information, reporter email addressed.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed the dosing window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the dosing window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the dosing window). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the dosing window) had resolved. Not Provided          Concomitant information was not reported.  Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: TCR received updated Second dose details, Events onset date Added.