chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Slight pain to her left arm after the shot; has chronic pain from sciatica and bulging/herniated disk; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Slight pain to her left arm after the shot) and PAIN (has chronic pain from sciatica and bulging/herniated disk) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 MYALGIA (Slight pain to her left arm after the shot) and PAIN (has chronic pain from sciatica and bulging/herniated disk). At the time of the report, MYALGIA (Slight pain to her left arm after the shot) and PAIN (has chronic pain from sciatica and bulging/herniated disk) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No adverse event. No concomitant medication.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Feeling hot, Hypoaesthesia, Insomnia, Paraesthesia
Clinical narrative: little dots and tiny blisters; can't sleep at night; hands feel swollen; Hands feel warmth; contact dermatitis; some numbness; tingling; rash on right hand / rash then went to right arm; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling), RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night) and DERMATITIS CONTACT (contact dermatitis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN 81), CURCUMA LONGA, PIPER NIGRUM (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), FISH OIL, ASCORBIC ACID (VITAMINE C), VITAMIN D NOS and TIEMONIUM METHYLSULPHATE (VISCERAL) for an unknown indication.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (low grade fever). On 01-May-2021, the patient experienced RASH (rash on right hand / rash then went to right arm). On 02-May-2021, the patient experienced HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling) and DERMATITIS CONTACT (contact dermatitis). On an unknown date, the patient experienced RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night), PERIPHERAL SWELLING (hands feel swollen) and FEELING HOT (Hands feel warmth). At the time of the report, HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling), RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night), DERMATITIS CONTACT (contact dermatitis), PERIPHERAL SWELLING (hands feel swollen), FEELING HOT (Hands feel warmth), RASH (rash on right hand / rash then went to right arm) and PYREXIA (low grade fever) outcome was unknown.            Treatment information included steroid cream   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Significant follow up ; Events Added
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Rash macular
Clinical narrative: little dots and tiny blisters; can't sleep at night; hands feel swollen; Hands feel warmth; contact dermatitis; some numbness; tingling; rash on right hand / rash then went to right arm; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling), RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night) and DERMATITIS CONTACT (contact dermatitis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN 81), CURCUMA LONGA, PIPER NIGRUM (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), FISH OIL, ASCORBIC ACID (VITAMINE C), VITAMIN D NOS and TIEMONIUM METHYLSULPHATE (VISCERAL) for an unknown indication.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (low grade fever). On 01-May-2021, the patient experienced RASH (rash on right hand / rash then went to right arm). On 02-May-2021, the patient experienced HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling) and DERMATITIS CONTACT (contact dermatitis). On an unknown date, the patient experienced RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night), PERIPHERAL SWELLING (hands feel swollen) and FEELING HOT (Hands feel warmth). At the time of the report, HYPOAESTHESIA (some numbness), PARAESTHESIA (tingling), RASH MACULAR (little dots and tiny blisters), INSOMNIA (can't sleep at night), DERMATITIS CONTACT (contact dermatitis), PERIPHERAL SWELLING (hands feel swollen), FEELING HOT (Hands feel warmth), RASH (rash on right hand / rash then went to right arm) and PYREXIA (low grade fever) outcome was unknown.            Treatment information included steroid cream   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Significant follow up ; Events Added
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported. No treatment medication were reported.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pyrexia, Rhinorrhoea, Suspected COVID-19, Throat tightness
Clinical narrative: Runny nose; Stiffness in my throat; Symptoms of COVID; He was in contact with someone who had COVID-19; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), THROAT TIGHTNESS (Stiffness in my throat), SUSPECTED COVID-19 (Symptoms of COVID), EXPOSURE TO SARS-COV-2 (He was in contact with someone who had COVID-19) and PYREXIA (Fever) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced RHINORRHOEA (Runny nose), THROAT TIGHTNESS (Stiffness in my throat), SUSPECTED COVID-19 (Symptoms of COVID), EXPOSURE TO SARS-COV-2 (He was in contact with someone who had COVID-19) and PYREXIA (Fever). On 08-May-2021, EXPOSURE TO SARS-COV-2 (He was in contact with someone who had COVID-19) had resolved. At the time of the report, RHINORRHOEA (Runny nose), THROAT TIGHTNESS (Stiffness in my throat), SUSPECTED COVID-19 (Symptoms of COVID) and PYREXIA (Fever) had not resolved.            No relevant concomitant medications were reported. Treatment for the events included Over the counter cough medicine.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Joint swelling, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Left shoulder is still stiff; left shoulder is still swollen; left shoulder was inflamed; stabbing pain; severe pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left shoulder is still stiff), JOINT SWELLING (left shoulder is still swollen), PAIN (severe pain), PAIN IN EXTREMITY (stabbing pain) and INFLAMMATION (left shoulder was inflamed) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, DICLOFENAC POTASSIUM (VOLTAREN ACTI), DONEPEZIL HYDROCHLORIDE (ARICEPT), ROSUVASTATIN CALCIUM (CRESTOR), VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-May-2021, the patient experienced PAIN (severe pain). On 08-May-2021, the patient experienced PAIN IN EXTREMITY (stabbing pain). On 09-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Left shoulder is still stiff), JOINT SWELLING (left shoulder is still swollen) and INFLAMMATION (left shoulder was inflamed). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 650 mg every 6 hours and METHOCARBAMOL for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Left shoulder is still stiff), JOINT SWELLING (left shoulder is still swollen), PAIN (severe pain), PAIN IN EXTREMITY (stabbing pain) and INFLAMMATION (left shoulder was inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-116660 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116660:Reporter's case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain at injection site that comes and goes; Rash at injection site that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection site that comes and goes) and INJECTION SITE RASH (Rash at injection site that comes and goes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site that comes and goes) and INJECTION SITE RASH (Rash at injection site that comes and goes). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INJECTION SITE PAIN (Pain at injection site that comes and goes) and INJECTION SITE RASH (Rash at injection site that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reported. Patient received second dose of Moderna vaccine on 4-FEB-2021 with lot number 038K20A.   This case was linked to MOD-2021-116537 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 year old patient was accidentally administered the first dose of Moderna covid vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient was accidentally administered the first dose of Moderna covid vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1808982) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient was accidentally administered the first dose of Moderna covid vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient was accidentally administered the first dose of Moderna covid vaccine) 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.   Concomitant product use was not provided by the reported.  Treatment medication use was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Broke out with shingles; Scheduling error - more than 36 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Broke out with shingles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduling error - more than 36 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Shingles vaccine (Completed 2 doses of Shingles vaccine.). Concurrent medical conditions included Sulfonamide allergy and Seasonal allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduling error - more than 36 days). On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Broke out with shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency and PREDNISONE for Shingles, at an unspecified dose and frequency. On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduling error - more than 36 days) had resolved. At the time of the report, HERPES ZOSTER (Broke out with shingles) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received does not contain any significant information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: first dose injection site rash and itching on arm; first dose injection site rash and itching on arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (first dose injection site rash and itching on arm) and VACCINATION SITE RASH (first dose injection site rash and itching on arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041LZ0A and 011421A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SUMATRIPTAN (IMITREX [SUMATRIPTAN]), METOPROLOL, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (first dose injection site rash and itching on arm) and VACCINATION SITE RASH (first dose injection site rash and itching on arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 14-Feb-2021, VACCINATION SITE PRURITUS (first dose injection site rash and itching on arm) and VACCINATION SITE RASH (first dose injection site rash and itching on arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-116575 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nausea
Clinical narrative: dizzy; Weird feeling; Weak; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (Weird feeling), ASTHENIA (Weak) and NAUSEA (nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 041B21A) 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) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DIZZINESS (dizzy), FEELING ABNORMAL (Weird feeling), ASTHENIA (Weak) and NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (Weird feeling), ASTHENIA (Weak) and NAUSEA (nauseous) outcome was unknown. Not Provided          No concomitant and treatment medication was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Parosmia, Urine odour abnormal
Clinical narrative: everything smells like manure; urine smells terrible; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (everything smells like manure), URINE ODOUR ABNORMAL (urine smells terrible) and FATIGUE (very tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PAROSMIA (everything smells like manure), URINE ODOUR ABNORMAL (urine smells terrible) and FATIGUE (very tired). At the time of the report, PAROSMIA (everything smells like manure), URINE ODOUR ABNORMAL (urine smells terrible) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant drug information were provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes all over my neck, chest, stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes all over my neck, chest, stomach and back) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 038B21A) 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) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced RASH (Rashes all over my neck, chest, stomach and back). At the time of the report, RASH (Rashes all over my neck, chest, stomach and back) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: just a little tiredness; left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (just a little tiredness) and PAIN IN EXTREMITY (left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Muscle strain and Neck (lot of stress generally in his neck area with his sometimes getting a stress knot and tightness in his neck and shoulder area.). Concurrent medical conditions included Allergy (allergic angioedema to Advil). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for Seasonal allergy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (just a little tiredness) and PAIN IN EXTREMITY (left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm). On 02-Apr-2021, FATIGUE (just a little tiredness) and PAIN IN EXTREMITY (left arm soreness  not severe pain in that he could feel stiffness but could still lift his arm) had resolved. Not Provided      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.   Treatment medication was not reported.   This case was linked to MOD-2021-116574 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache
Clinical narrative: freeze; Dull Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (freeze), HEADACHE (Dull Headache) and FATIGUE (Tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASA for an unknown indication.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING COLD (freeze), HEADACHE (Dull Headache) and FATIGUE (Tired). On 17-Apr-2021, HEADACHE (Dull Headache) had resolved. At the time of the report, FEELING COLD (freeze) and FATIGUE (Tired) outcome was unknown.            Patient was taking unspecififed blood pressure medication Treatment medications were not mentioned   This case was linked to MOD-2021-053361 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Eructation
Clinical narrative: Belching; heartburn; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (Belching), DYSPEPSIA (heartburn) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced ERUCTATION (Belching), DYSPEPSIA (heartburn) and DIARRHOEA (Diarrhea). At the time of the report, ERUCTATION (Belching), DYSPEPSIA (heartburn) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: summer cold or flu; Flu; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (summer cold or flu) and INFLUENZA (Flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced NASOPHARYNGITIS (summer cold or flu) and INFLUENZA (Flu). At the time of the report, NASOPHARYNGITIS (summer cold or flu) and INFLUENZA (Flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Breathless by walking up a 5 degree incline, out of breath going up stairs, out of breath walking to edge of driveway, feels short of breath when he is laying down, feels like his breathing is restricted; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Breathless by walking up a 5 degree incline, out of breath going up stairs, out of breath walking to edge of driveway, feels short of breath when he is laying down, feels like his breathing is restricted) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011a21a and 012m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL (OMEGA 3 FISH OILS) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DYSPNEA (Breathless by walking up a 5 degree incline, out of breath going up stairs, out of breath walking to edge of driveway, feels short of breath when he is laying down, feels like his breathing is restricted). At the time of the report, DYSPNEA (Breathless by walking up a 5 degree incline, out of breath going up stairs, out of breath walking to edge of driveway, feels short of breath when he is laying down, feels like his breathing is restricted) outcome was unknown. Not Provided          Treatment medications were unknown.  The patient reported that he has not used his inhaler in 2 years.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Urinary tract infection
Clinical narrative: Developed a UTI after 1st Moderna Vaccination; Pain in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Developed a UTI after 1st Moderna Vaccination) and INJECTION SITE PAIN (Pain in injected arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history information was provided.  Concurrent medical conditions included Blood pressure high and Hyperlipidemia. Concomitant products included VITAMINS NOS and PARACETAMOL (TYLENOL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE PAIN (Pain in injected arm). On 07-May-2021, the patient experienced URINARY TRACT INFECTION (Developed a UTI after 1st Moderna Vaccination). At the time of the report, URINARY TRACT INFECTION (Developed a UTI after 1st Moderna Vaccination) and INJECTION SITE PAIN (Pain in injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also  included  High Blood Pressure medications and Antihyperlipidemic medications. No treatment information provided. Patient is going to see MD today for evaluation
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: diarrhea; dizziness; shortness of breath; 101 degree fever; headache; nausea; vomiting; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011a21a and 012m20a) 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 VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches/body aches). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches/body aches) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.     This case was linked to MOD21-088796 (E2B Linked Report).; Sender's Comments:  MOD21-088796:Husband's case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: diarrhea; dizziness; shortness of breath; 101 degree fever; headache; nausea; vomiting; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011a21a and 012m20a) 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 VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches/body aches). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness), DYSPNOEA (shortness of breath), PYREXIA (101 degree fever), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches/body aches) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.     This case was linked to MOD21-088796 (E2B Linked Report).; Sender's Comments:  MOD21-088796:Husband's case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm for 2 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B12A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ARIPIPRAZOLE (ABILIFY), METOPROLOL, LEVOTHYROXINE and BUSPIRONE for an unknown indication.    On 10-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 PERIPHERAL SWELLING (Swollen arm for 2 days). On 12-Apr-2021, PERIPHERAL SWELLING (Swollen arm for 2 days) had resolved. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Muscle spasms, Rash
Clinical narrative: Rash all over her body; For 3 days her period stopped but then it started again, she is having her period almost everyday; severe cramping; Headache; severe cramping; period every other day; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MUSCLE SPASMS (severe cramping), MENSTRUATION IRREGULAR (period every other day), RASH (Rash all over her body), MENSTRUATION IRREGULAR (For 3 days her period stopped but then it started again, she is having her period almost everyday) and the second episode of MUSCLE SPASMS (severe cramping) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced the first episode of MUSCLE SPASMS (severe cramping) and MENSTRUATION IRREGULAR (period every other day). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash all over her body), MENSTRUATION IRREGULAR (For 3 days her period stopped but then it started again, she is having her period almost everyday), the second episode of MUSCLE SPASMS (severe cramping) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Cramps, at a dose of 1 dosage form. At the time of the report, MENSTRUATION IRREGULAR (period every other day), RASH (Rash all over her body), MENSTRUATION IRREGULAR (For 3 days her period stopped but then it started again, she is having her period almost everyday), the last episode of MUSCLE SPASMS (severe cramping) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the events was considered as not applicable No concomitant Medication was reported by reporter.   This case was linked to MOD21-088826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received included second dose information and patient have more event after second dose like headache and rash all over her body
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain
Clinical narrative: dizziness; soreness; Feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (soreness) and FEELING ABNORMAL (Feeling abnormal) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concomitant products included METHADONE for Addiction, NIFEDIPINE for Blood pressure high, MULTIVITAMINS [VITAMINS NOS], FISH OIL and VITAMIN D NOS for an unknown indication.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced DIZZINESS (dizziness), PAIN (soreness) and FEELING ABNORMAL (Feeling abnormal). At the time of the report, DIZZINESS (dizziness), PAIN (soreness) and FEELING ABNORMAL (Feeling abnormal) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used Anti Cholesterol to Lower Cholesterol ,Anti-Acid Reflux For Acid Reflux, Multi-Vitamin,Fish oil, Vitamin D For wellness. No treatment medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Muscle tightness, Myalgia, Neck pain
Clinical narrative: a lot of inflammation in the middle and right side of his neck; a lot of tightness in his neck/ could barely move his neck; neck pain  like severe muscle strain in the middle to the right of the neck; could not sleep; temperature of 99.1 degrees; body aches all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck), NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck), SWELLING (a lot of inflammation in the middle and right side of his neck), INSOMNIA (could not sleep) and PYREXIA (temperature of 99.1 degrees) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle strain. Concurrent medical conditions included Seasonal allergy and Drug allergy (advil). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.   On 29-Mar-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021 at 2:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck), INSOMNIA (could not sleep), PYREXIA (temperature of 99.1 degrees) and MYALGIA (body aches all over). On an unknown date, the patient experienced MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck) and SWELLING (a lot of inflammation in the middle and right side of his neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CYCLOBENZAPRINE (oral) for Muscle relaxant, at a dose of three tablets. On 28-Apr-2021, MYALGIA (body aches all over) had resolved. On 29-Apr-2021, INSOMNIA (could not sleep) had resolved. On 30-Apr-2021, MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck), NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck) and SWELLING (a lot of inflammation in the middle and right side of his neck) had resolved. At the time of the report, PYREXIA (temperature of 99.1 degrees) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) pyrexia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable Patient took Tiger balm and ice pack for treatment   This case was linked to MOD-2021-116556, MOD-2021-116556 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: a lot of inflammation in the middle and right side of his neck; a lot of tightness in his neck/ could barely move his neck; neck pain  like severe muscle strain in the middle to the right of the neck; could not sleep; temperature of 99.1 degrees; body aches all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck), NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck), SWELLING (a lot of inflammation in the middle and right side of his neck), INSOMNIA (could not sleep) and PYREXIA (temperature of 99.1 degrees) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Muscle strain. Concurrent medical conditions included Seasonal allergy and Drug allergy (advil). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.   On 29-Mar-2021 at 3:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021 at 2:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck), INSOMNIA (could not sleep), PYREXIA (temperature of 99.1 degrees) and MYALGIA (body aches all over). On an unknown date, the patient experienced MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck) and SWELLING (a lot of inflammation in the middle and right side of his neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CYCLOBENZAPRINE (oral) for Muscle relaxant, at a dose of three tablets. On 28-Apr-2021, MYALGIA (body aches all over) had resolved. On 29-Apr-2021, INSOMNIA (could not sleep) had resolved. On 30-Apr-2021, MUSCLE TIGHTNESS (a lot of tightness in his neck/ could barely move his neck), NECK PAIN (neck pain  like severe muscle strain in the middle to the right of the neck) and SWELLING (a lot of inflammation in the middle and right side of his neck) had resolved. At the time of the report, PYREXIA (temperature of 99.1 degrees) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) pyrexia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable Patient took Tiger balm and ice pack for treatment   This case was linked to MOD-2021-116556, MOD-2021-116556 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin exfoliation
Clinical narrative: severe rash on face, throat, eyes, and right arm; Rash doesnt have bumps just red and itching; Rash doesnt have bumps just red and itching; Rash with peeling skin; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of RASH (severe rash on face, throat, eyes, and right arm), RASH ERYTHEMATOUS (Rash doesnt have bumps just red and itching), RASH PRURITIC (Rash doesnt have bumps just red and itching) and SKIN EXFOLIATION (Rash with peeling skin) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011421A and 041LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SUMATRIPTAN SUCCINATE (IMITREX DF), METOPROLOL, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 01-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-May-2021, the patient experienced RASH (severe rash on face, throat, eyes, and right arm) and SKIN EXFOLIATION (Rash with peeling skin). 08-May-2021, the patient experienced RASH ERYTHEMATOUS (Rash doesnt have bumps just red and itching) and RASH PRURITIC (Rash doesnt have bumps just red and itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (severe rash on face, throat, eyes, and right arm), RASH ERYTHEMATOUS (Rash doesnt have bumps just red and itching), RASH PRURITIC (Rash doesnt have bumps just red and itching) and SKIN EXFOLIATION (Rash with peeling skin) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-116551 (Patient Link).