chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal discomfort, Tongue discomfort, Tongue erythema
Clinical narrative: heavy throat; burning tongue; tongue is red; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (heavy throat), TONGUE DISCOMFORT (burning tongue), TONGUE ERYTHEMA (tongue is red) and HEADACHE (headache) in a 54-year-old female patient 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 an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (heavy throat), TONGUE DISCOMFORT (burning tongue), TONGUE ERYTHEMA (tongue is red) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL DISCOMFORT (heavy throat), TONGUE DISCOMFORT (burning tongue), TONGUE ERYTHEMA (tongue is red) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Gait disturbance, Headache
Clinical narrative: I had trouble getting up; I had trouble walking; Fatigue; Muscle aches; Chills every now and then; Slight headache; Swelling and red rash around the injection site; Runny nose; Cough; A lot of soreness; Swelling and red rash around the injection site; Swelling and red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), RHINORRHOEA (Runny nose), COUGH (Cough) and VACCINATION SITE PAIN (A lot of soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site). On 03-Jun-2021, the patient experienced HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 07-Jun-2021, HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. At the time of the report, RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site) outcome was unknown.            Treatment information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-116526 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Rhinorrhoea, Vaccination site erythema, Vaccination site pain
Clinical narrative: I had trouble getting up; I had trouble walking; Fatigue; Muscle aches; Chills every now and then; Slight headache; Swelling and red rash around the injection site; Runny nose; Cough; A lot of soreness; Swelling and red rash around the injection site; Swelling and red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), RHINORRHOEA (Runny nose), COUGH (Cough) and VACCINATION SITE PAIN (A lot of soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site). On 03-Jun-2021, the patient experienced HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 07-Jun-2021, HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. At the time of the report, RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site) outcome was unknown.            Treatment information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-116526 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: I had trouble getting up; I had trouble walking; Fatigue; Muscle aches; Chills every now and then; Slight headache; Swelling and red rash around the injection site; Runny nose; Cough; A lot of soreness; Swelling and red rash around the injection site; Swelling and red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), RHINORRHOEA (Runny nose), COUGH (Cough) and VACCINATION SITE PAIN (A lot of soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site). On 03-Jun-2021, the patient experienced HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 07-Jun-2021, HYPOKINESIA (I had trouble getting up), GAIT DISTURBANCE (I had trouble walking), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. At the time of the report, RHINORRHOEA (Runny nose), COUGH (Cough), VACCINATION SITE PAIN (A lot of soreness), VACCINATION SITE SWELLING (Swelling and red rash around the injection site), VACCINATION SITE RASH (Swelling and red rash around the injection site), CHILLS (Chills every now and then), HEADACHE (Slight headache) and VACCINATION SITE ERYTHEMA (Swelling and red rash around the injection site) outcome was unknown.            Treatment information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-116526 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscle spasms, Pain
Clinical narrative: pain; muscle spasms about 15 hours later/Contracting of shoulder muscle; Contracting of shoulder muscle of shot arm. Agony.; SEVERE headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), MUSCLE SPASMS (muscle spasms about 15 hours later/Contracting of shoulder muscle), ARTHRALGIA (Contracting of shoulder muscle of shot arm. Agony.) and HEADACHE (SEVERE headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), MUSCLE SPASMS (muscle spasms about 15 hours later/Contracting of shoulder muscle), ARTHRALGIA (Contracting of shoulder muscle of shot arm. Agony.) and HEADACHE (SEVERE headache). At the time of the report, PAIN (pain), MUSCLE SPASMS (muscle spasms about 15 hours later/Contracting of shoulder muscle), ARTHRALGIA (Contracting of shoulder muscle of shot arm. Agony.) and HEADACHE (SEVERE headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Had vomiting for a day; Feeling nauseous; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt very tired), VOMITING (Had vomiting for a day) and NAUSEA (Feeling nauseous) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to sulfa), Latex allergy, Drug allergy (Allergic to symbalta), Drug allergy, Asthma since 01-Jan-1980, Chronic back pain on 01-Jan-2008, Blood pressure since 01-Jan-2016, Anxiety since 01-Jan-2019 and Acid reflux (esophageal) since 01-Jan-2014. Concomitant products included OMEPRAZOLE from 01-Jan-2014 to an unknown date for Acid reflux (esophageal), VENLAFAXINE from 01-Jan-2019 to an unknown date for Anxiety, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (BUPRENORPHINE/NALOXONE) from 01-Jan-2019 to an unknown date for Back pain, AMLODIPINE from 01-Jan-2016 to an unknown date for Blood pressure.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced FATIGUE (Felt very tired) and NAUSEA (Feeling nauseous). On 26-Apr-2021, the patient experienced VOMITING (Had vomiting for a day). In April 2021, FATIGUE (Felt very tired) and NAUSEA (Feeling nauseous) had resolved. At the time of the report, VOMITING (Had vomiting for a day) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-190478 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received contains additional information of patient demographics, vaccination details, medical history, concomitant medications, new event for first dose.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Fever; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.    Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Increased migraine headache; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Increased migraine headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Migraine headache (Migraine headache).   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In May 2021, the patient experienced MIGRAINE (Increased migraine headache). At the time of the report, MIGRAINE (Increased migraine headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: arm is swollen; arm in throbbing pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen) and PAIN (arm in throbbing pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Uknkown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is swollen) and PAIN (arm in throbbing pain). At the time of the report, PERIPHERAL SWELLING (arm is swollen) and PAIN (arm in throbbing pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Headache, Illness, Pain in extremity
Clinical narrative: Leg pain; Feeling abnormal; Sickness; Headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (Feeling abnormal), ILLNESS (Sickness) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (Feeling abnormal), ILLNESS (Sickness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (Feeling abnormal) and HEADACHE (Headache) had not resolved and ILLNESS (Sickness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen axillary and clavicular lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen axillary and clavicular lymph nodes) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen axillary and clavicular lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen axillary and clavicular lymph nodes) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Body aches; Diarrhea; Fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Allergy NOS (No known allergy).   On 26-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) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 28-May-2021, the patient experienced PAIN (Body aches), DIARRHOEA (Diarrhea) and PYREXIA (Fever). At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Itchy; Swelling arm; Pyrexia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Pyrexia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Pyrexia). At the time of the report, PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm) and PYREXIA (Pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101963, MOD-2021-101963 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: sore throat; Feeling sick; 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 OROPHARYNGEAL PAIN (sore throat) and MALAISE (Feeling sick) 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 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 OROPHARYNGEAL PAIN (sore throat) and MALAISE (Feeling sick). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and MALAISE (Feeling sick) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills
Clinical narrative: This spontaneous case reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus) and chills in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included plasmapheresis (plasma infusion done) on Feb 24, 2021. Concurrent medical conditions included cancer (takes unspecified cancer meds). On Feb 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 24, 2021, patient had COVID-19 (COVID-19 virus) and chills. At the time of the report, COVID-19 (COVID-19 virus) and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications included unspecified cancer medication. Treatment for COVID-19 event included a plasma infusion.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C21A) for COVID-19 vaccination.     The patient's past medical history included Back pain since an unknown date. Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included OLMESARTAN and ATENOLOL for Blood pressure high, ROSUVASTATIN for Cholesterol.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced BACK PAIN (back pain). The patient was treated with IBUPROFEN ongoing since an unknown date for Back pain, at a dose of 1 dosage form. At the time of the report, BACK PAIN (back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of limb discomfort (sore arm after the 1st dose) and pain in extremity (sore arm after the 2nd dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022C21A and 0B6C21A) for COVID-19 immunization. No medical history reported. On May 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, patient experienced limb discomfort (sore arm after the 1st dose). On Jun 7, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced pain in extremity (sore arm after the 2nd dose). The patient treated with Tylenol (paracetamol); 1 dosage form. At the time of the report, limb discomfort (sore arm after the 1st dose) and pain in extremity (sore arm after the 2nd dose) outcome: unknown. No concomitant medications reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 2nd dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports no concomitant medication use.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm pain after 1st dose; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after 1st dose) and FATIGUE (Fatigue after 1st dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 040a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain after 1st dose) and FATIGUE (Fatigue after 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm pain after 1st dose) and FATIGUE (Fatigue after 1st dose) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.  Action taken with respect to mRNA-1273 was not applicable.  Additional information added by the patient was that they were trying to conceive but had to postpone IVF because her hormones were all over.   This case was linked to MOD-2021-213764 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received his second Moderna dose on day 18; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his second Moderna dose on day 18) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his second Moderna dose on day 18). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his second Moderna dose on day 18) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Rotator cuff syndrome, Vaccination site erythema
Clinical narrative: Rotator cuff tendinitis; Vaccination site erythema; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff tendinitis), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendinitis), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness). At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff tendinitis) was resolving and VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE ERYTHEMA (Vaccination site erythema) and FATIGUE (Tiredness) to be probably related. No further causality assessment was provided for ROTATOR CUFF SYNDROME (Rotator cuff tendinitis).    Treatment information was not provided Action taken with mRNA-1273 in response to the events is not applicable
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: having a bruise now for over a week or so; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (having a bruise now for over a week or so) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (having a bruise now for over a week or so). At the time of the report, CONTUSION (having a bruise now for over a week or so) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; 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 VACCINATION COMPLICATION (side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: it has been 6 or 7 weeks since they received their first dose (>35 days); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since they received their first dose (>35 days)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since they received their first dose (>35 days)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it has been 6 or 7 weeks since they received their first dose (>35 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were reported.   No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUNE-2021, no new information On 30-Jun-2021: Follow-up information received on 30-Jun-2021 contains no new information On 31-Jul-2021: Follow-up received on 31 Jul 2021 contained no new information.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: smell cigarette/smoke all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smell cigarette/smoke all the time) 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 27-May-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 PAROSMIA (smell cigarette/smoke all the time). At the time of the report, PAROSMIA (smell cigarette/smoke all the time) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: got vaccine after 30 day refrigeration expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccine after 30 day refrigeration expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027c21A) 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 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccine after 30 day refrigeration expiration date). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (got vaccine after 30 day refrigeration expiration date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information provided. These administration errors occurred between 7 May 2021 and 26 May 2021, and the vaccines were placed into the refrigerator on 06 Apr 2021.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >42 days of not getting the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>42 days of not getting the second dose) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (>42 days of not getting the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>42 days of not getting the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported limited information No concomitant and treatment medications were provided   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Feeding disorder, Headache, Heavy menstrual bleeding
Clinical narrative: Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose; Nausea after 2nd dose; Chills after 2nd dose; Couldn't stand after 2nd dose; Couldn't eat after 2nd dose; Periods have been messed up since 2nd dose; Shorter cycles after 2nd dose; Flow is extremely heavy for 2 days after 2nd dose/Flow is unusual after 2nd dose/Huge flow after 2nd dose; Hormones are all over the place after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose), NAUSEA (Nausea after 2nd dose), CHILLS (Chills after 2nd dose), DYSSTASIA (Couldn't stand after 2nd dose) and FEEDING DISORDER (Couldn't eat after 2nd dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose), NAUSEA (Nausea after 2nd dose), CHILLS (Chills after 2nd dose), DYSSTASIA (Couldn't stand after 2nd dose), FEEDING DISORDER (Couldn't eat after 2nd dose), MENSTRUATION IRREGULAR (Periods have been messed up since 2nd dose), POLYMENORRHOEA (Shorter cycles after 2nd dose), HEAVY MENSTRUAL BLEEDING (Flow is extremely heavy for 2 days after 2nd dose/Flow is unusual after 2nd dose/Huge flow after 2nd dose) and HORMONE LEVEL ABNORMAL (Hormones are all over the place after 2nd dose). At the time of the report, HEADACHE (Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose), NAUSEA (Nausea after 2nd dose), CHILLS (Chills after 2nd dose), DYSSTASIA (Couldn't stand after 2nd dose), FEEDING DISORDER (Couldn't eat after 2nd dose), MENSTRUATION IRREGULAR (Periods have been messed up since 2nd dose), POLYMENORRHOEA (Shorter cycles after 2nd dose), HEAVY MENSTRUAL BLEEDING (Flow is extremely heavy for 2 days after 2nd dose/Flow is unusual after 2nd dose/Huge flow after 2nd dose) and HORMONE LEVEL ABNORMAL (Hormones are all over the place after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided by reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Menstruation irregular, Nausea, Polymenorrhoea
Clinical narrative: Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose; Nausea after 2nd dose; Chills after 2nd dose; Couldn't stand after 2nd dose; Couldn't eat after 2nd dose; Periods have been messed up since 2nd dose; Shorter cycles after 2nd dose; Flow is extremely heavy for 2 days after 2nd dose/Flow is unusual after 2nd dose/Huge flow after 2nd dose; Hormones are all over the place after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose), NAUSEA (Nausea after 2nd dose), CHILLS (Chills after 2nd dose), DYSSTASIA (Couldn't stand after 2nd dose) and FEEDING DISORDER (Couldn't eat after 2nd dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose), NAUSEA (Nausea after 2nd dose), CHILLS (Chills after 2nd dose), DYSSTASIA (Couldn't stand after 2nd dose), FEEDING DISORDER (Couldn't eat after 2nd dose), MENSTRUATION IRREGULAR (Periods have been messed up since 2nd dose), POLYMENORRHOEA (Shorter cycles after 2nd dose), HEAVY MENSTRUAL BLEEDING (Flow is extremely heavy for 2 days after 2nd dose/Flow is unusual after 2nd dose/Huge flow after 2nd dose) and HORMONE LEVEL ABNORMAL (Hormones are all over the place after 2nd dose). At the time of the report, HEADACHE (Headache after 2nd dose/Localized pain on the inside of left side of head after 2nd dose), NAUSEA (Nausea after 2nd dose), CHILLS (Chills after 2nd dose), DYSSTASIA (Couldn't stand after 2nd dose), FEEDING DISORDER (Couldn't eat after 2nd dose), MENSTRUATION IRREGULAR (Periods have been messed up since 2nd dose), POLYMENORRHOEA (Shorter cycles after 2nd dose), HEAVY MENSTRUAL BLEEDING (Flow is extremely heavy for 2 days after 2nd dose/Flow is unusual after 2nd dose/Huge flow after 2nd dose) and HORMONE LEVEL ABNORMAL (Hormones are all over the place after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin mass
Clinical narrative: little bumps on back/ little bumps on across shoulder; rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little bumps on back/ little bumps on across shoulder) and RASH (rash) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizures.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (little bumps on back/ little bumps on across shoulder) and RASH (rash). At the time of the report, SKIN MASS (little bumps on back/ little bumps on across shoulder) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant included medications for seizures. No treatment was reported.   This case was linked to MOD-2021-044944 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Covid-19 antibody test below 4; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST (Covid-19 antibody test below 4) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Enzyme abnormality (Patient's past medical history included: Enzyme.). Concurrent medical conditions included Multiple sclerosis (Patient's concurrent condition included: Relapsing forms of Multiple Sclerosis.). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST (Covid-19 antibody test below 4). At the time of the report, SARS-COV-2 ANTIBODY TEST (Covid-19 antibody test below 4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 antibody test: <4 (Inconclusive) On 28-Apr-2021, it was reported that patient experienced: Covid Antibody test below 4..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment  was provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: felt a little run down; sore arm; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (felt a little run down) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt a little run down) and MYALGIA (sore arm). At the time of the report, ASTHENIA (felt a little run down) and MYALGIA (sore arm) outcome was unknown.            concomitant medication information was not provided.   Reporter did not allow further contact