chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: Legs start to hurt and it radiates to lower stomach; Legs start to hurt and it radiates to lower stomach; Fever; Nausea; Headache; Chills; Cannot breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Cannot breathe), PAIN IN EXTREMITY (Legs start to hurt and it radiates to lower stomach), ABDOMINAL PAIN LOWER (Legs start to hurt and it radiates to lower stomach), PYREXIA (Fever) and NAUSEA (Nausea) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Cannot breathe), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (Legs start to hurt and it radiates to lower stomach) and ABDOMINAL PAIN LOWER (Legs start to hurt and it radiates to lower stomach). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Cannot breathe), PAIN IN EXTREMITY (Legs start to hurt and it radiates to lower stomach), ABDOMINAL PAIN LOWER (Legs start to hurt and it radiates to lower stomach), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Legs start to hurt and it radiates to lower stomach; Legs start to hurt and it radiates to lower stomach; Fever; Nausea; Headache; Chills; Cannot breathe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Cannot breathe), PAIN IN EXTREMITY (Legs start to hurt and it radiates to lower stomach), ABDOMINAL PAIN LOWER (Legs start to hurt and it radiates to lower stomach), PYREXIA (Fever) and NAUSEA (Nausea) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Cannot breathe), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (Legs start to hurt and it radiates to lower stomach) and ABDOMINAL PAIN LOWER (Legs start to hurt and it radiates to lower stomach). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Cannot breathe), PAIN IN EXTREMITY (Legs start to hurt and it radiates to lower stomach), ABDOMINAL PAIN LOWER (Legs start to hurt and it radiates to lower stomach), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Illness, Pain, Product dose omission issue
Clinical narrative: More than 42 days and no 2nd shot; Not feeling good off and on; Achy off and on; Sick off and on; Tired off and on; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days and no 2nd shot), FEELING ABNORMAL (Not feeling good off and on), PAIN (Achy off and on), ILLNESS (Sick off and on) and FATIGUE (Tired off and on) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 in January 2021.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling good off and on), PAIN (Achy off and on), ILLNESS (Sick off and on) and FATIGUE (Tired off and on). On 12-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days and no 2nd shot). On 16-Apr-2021, FEELING ABNORMAL (Not feeling good off and on), PAIN (Achy off and on), ILLNESS (Sick off and on) and FATIGUE (Tired off and on) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days and no 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administering the first dose of Moderna COVID-19 vaccine to a patient under 18 years of age) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling of lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included PARAFFIN (VASELINE [PARAFFIN]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced LIP SWELLING (Swelling of lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling of lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment also included steroid injection and Vaseline.   Patient states she was told by her HCP the lip swelling was probably caused by the vaccine and not by chapped lips as she thought.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0006B21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.   On 08-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 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL PAIN (sore throat). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (sore throat) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-123354 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123354:Mother
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-123308 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered 1st dose to a patient who was underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose to a patient who was underage) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose to a patient who was underage). On 13-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose to a patient who was underage) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-123474 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder
Clinical narrative: Cognitive issues; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (Cognitive issues) 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 COGNITIVE DISORDER (Cognitive issues). At the time of the report, COGNITIVE DISORDER (Cognitive issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not provided. Treatment information were not provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 004C21A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Stent placed five years ago). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LOSARTAN, ATORVASTATIN and ISOSORBIDE MONONITRATE for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.            No treatment information was provided. 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    This case was linked to MOD-2021-123403 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hypoaesthesia, Oral herpes
Clinical narrative: cold sore developing/cold sore is at upper side of lip and inside his nose; woke up with feeling hot; numbness; itching; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching) and HEADACHE (headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included KETOTIFEN FUMARATE (ZADITOR) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: cold sore developing/cold sore is at upper side of lip and inside his nose; woke up with feeling hot; numbness; itching; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching) and HEADACHE (headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included KETOTIFEN FUMARATE (ZADITOR) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sore developing/cold sore is at upper side of lip and inside his nose), FEELING HOT (woke up with feeling hot), HYPOAESTHESIA (numbness), PRURITUS (itching), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Erythema, Pyrexia
Clinical narrative: Red lines running down arm; Chills; Fever; Knocked her for a loop; Felt Sluggish/Felt like walking through molasses; Felt Weak; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Knocked her for a loop), SLUGGISHNESS (Felt Sluggish/Felt like walking through molasses), ASTHENIA (Felt Weak), ERYTHEMA (Red lines running down arm) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced CONFUSIONAL STATE (Knocked her for a loop), SLUGGISHNESS (Felt Sluggish/Felt like walking through molasses), ASTHENIA (Felt Weak), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced ERYTHEMA (Red lines running down arm). On 17-Apr-2021, CONFUSIONAL STATE (Knocked her for a loop), SLUGGISHNESS (Felt Sluggish/Felt like walking through molasses), ASTHENIA (Felt Weak), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, ERYTHEMA (Red lines running down arm) had resolved.            Concomitant medications were not reported. No treatment information was provided.   This case was linked to MOD21-066070, MOD21-066079 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20 Jul 2021 contains updated Patient demographics: height and weight, ethnic group, race info. New medical history-Penicillin allergy, updated product info: date of administration of the 1st dose is given and the 2nd dose administration date change from 15-APR-2021 to 14-APR-2021.; Sender's Comments:  MOD21-066070: MOD21-066079:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Red lines running down arm; Chills; Fever; Knocked her for a loop; Felt Sluggish/Felt like walking through molasses; Felt Weak; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Knocked her for a loop), SLUGGISHNESS (Felt Sluggish/Felt like walking through molasses), ASTHENIA (Felt Weak), ERYTHEMA (Red lines running down arm) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced CONFUSIONAL STATE (Knocked her for a loop), SLUGGISHNESS (Felt Sluggish/Felt like walking through molasses), ASTHENIA (Felt Weak), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced ERYTHEMA (Red lines running down arm). On 17-Apr-2021, CONFUSIONAL STATE (Knocked her for a loop), SLUGGISHNESS (Felt Sluggish/Felt like walking through molasses), ASTHENIA (Felt Weak), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, ERYTHEMA (Red lines running down arm) had resolved.            Concomitant medications were not reported. No treatment information was provided.   This case was linked to MOD21-066070, MOD21-066079 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20 Jul 2021 contains updated Patient demographics: height and weight, ethnic group, race info. New medical history-Penicillin allergy, updated product info: date of administration of the 1st dose is given and the 2nd dose administration date change from 15-APR-2021 to 14-APR-2021.; Sender's Comments:  MOD21-066070: MOD21-066079:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered 2nd dose to a patient who was underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2nd dose to a patient who was underage) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 014C21A,) for COVID-19 vaccination.     No Medical History Reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2nd dose to a patient who was underage). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2nd dose to a patient who was underage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided. Symptom text in narrative included Nurse called to report that a patient had been administered the Moderna COVID-19 Vaccine under the age of 18 at the time of her 1st dose. Patient received the 1st dose on 13Apr2021 (LOT: 040B21A Expiry date: 01Jan1900). Patient received the 2nd dose on 12May2021 (LOT: 014C21A, Expiry date: 01Jan1900).The patient did not experience any side effects from the vaccine and is not on any concurrent medication. Nurse only wanted to report the case and did not require any further information. Preferred method of contact is email Consent obtained for safety team to contact for follow-up. No written documentation to be sent to the Nurse.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Frequent bowel movements
Clinical narrative: frequent bowels; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (frequent bowels) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination.     No Medical History Reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (frequent bowels) and CHILLS (Chills). On 26-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, FREQUENT BOWEL MOVEMENTS (frequent bowels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided. Symptom text in narrative included A warm transfer from MCC case #00163798. Consumer reported receiving 1st dose of Moderna COVID-19 Vaccine (Lot#: 018B21A) on 25Mar2021. Side effects include chills and frequent bowels. 2nd dose (Lot# 045B21A) on 27Apr2021. Consent to follow up with safety.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Weakness; Deep muscle chills; Fever; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Deep muscle chills), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 026A21A) for COVID-19 vaccination.     No Medical History Reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-May-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Deep muscle chills), PYREXIA (Fever) and MYALGIA (Muscle aches). At the time of the report, ASTHENIA (Weakness), CHILLS (Deep muscle chills), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Fatigue) was resolving.            No relevant concomitant medications were reported. No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Joint swelling, Peripheral swelling, Vaccination site pain
Clinical narrative: Swollen knee/puffiness on the inner left knee joint; Mild localized arm soreness at injection; puffy and swollen feet; pain caused patient to wake at night; right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (puffy and swollen feet), JOINT SWELLING (Swollen knee/puffiness on the inner left knee joint), INSOMNIA (pain caused patient to wake at night), ARTHRALGIA (right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee) and VACCINATION SITE PAIN (Mild localized arm soreness at injection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Meniscus tear in 2011. Concurrent medical conditions included Penicillin allergy. Concomitant products included OSTEO BI-FLEX GOLD WITH VITAMIN D for an unknown indication.    On 14-Apr-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (puffy and swollen feet), INSOMNIA (pain caused patient to wake at night) and ARTHRALGIA (right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee). On an unknown date, the patient experienced JOINT SWELLING (Swollen knee/puffiness on the inner left knee joint) and VACCINATION SITE PAIN (Mild localized arm soreness at injection). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of UNK, bid. At the time of the report, PERIPHERAL SWELLING (puffy and swollen feet), INSOMNIA (pain caused patient to wake at night) and ARTHRALGIA (right and left knee pain in inner meniscus/felt pain in both inner knees, tendor spot at meniscus on right knee) had not resolved and JOINT SWELLING (Swollen knee/puffiness on the inner left knee joint) and VACCINATION SITE PAIN (Mild localized arm soreness at injection) had resolved.            This case was linked to MOD-2021-219132 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Reporter details, patient demographics, relevant history conditions, product details and events were updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: soreness at injection site after first dose; did not receive second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site after first dose) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Reported.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site after first dose) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, VACCINATION SITE PAIN (soreness at injection site after first dose) and PRODUCT DOSE OMISSION ISSUE (did not receive 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.   Treatment information not provided. Concomitant medications were not provided. Symptom text in narrative included Call warm transferred from Moderna Customer Care, case Nurse calling about herself receiving the Moderna COVID-19 Vaccine (lot: 026L20A, expiration: unknown) on 29Dec2020 in her right arm to prevent COVID-19.  She experienced minor soreness to injection site after first dose.. She was scheduled for her second dose in January but did not receive it. Patient not on any concomitant medication. She wants to know whether she can just get second dose now or if she has to start series over. Caller consent to follow up via email. No primary care physician at the time. She would like the info in writing.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Throat tightness
Clinical narrative: throat closing; feeling dizzy; weak; This spontaneous case was reported by a patient and describes the occurrence of THROAT TIGHTNESS (throat closing), DIZZINESS (feeling dizzy) and ASTHENIA (weak) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced THROAT TIGHTNESS (throat closing), DIZZINESS (feeling dizzy) and ASTHENIA (weak). At the time of the report, THROAT TIGHTNESS (throat closing), DIZZINESS (feeling dizzy) and ASTHENIA (weak) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Rash; Injection site itching; Injection site redness; Injection site little puffy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site little puffy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 0481321A) for COVID-19 vaccination.     The patient's past medical history included Hives (when very young).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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 RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site little puffy). At the time of the report, RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site little puffy) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up was received Patients demographics was updated On 11-Aug-2021: Follow-up received on 11-AUG-2021,contains significant information with updation of weight, Race batch no ,Dose 2 addition
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Malaise
Clinical narrative: A strong headache/like a migraine; Dizziness; Malaise; Flu-like symptoms; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm). On 11-May-2021, the patient experienced HEADACHE (A strong headache/like a migraine). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 08-May-2021, DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, HEADACHE (A strong headache/like a migraine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-123757 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A strong headache/like a migraine; Dizziness; Malaise; Flu-like symptoms; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm). On 11-May-2021, the patient experienced HEADACHE (A strong headache/like a migraine). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 08-May-2021, DIZZINESS (Dizziness), MALAISE (Malaise), INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, HEADACHE (A strong headache/like a migraine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-123757 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Rash, Vaccination site pain
Clinical narrative: Redness; No appetite/lack of appetite leading them; Rash on the stomach; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), ERYTHEMA (Redness), DECREASED APPETITE (No appetite/lack of appetite leading them) and RASH (Rash on the stomach) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C2IA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cancer. Concomitant products included VERAPAMIL HYDROCHLORIDE (VERPAMIL), METFORMIN, VITAMIN D NOS, LETROZOLE and SPIRONOLACTONE for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), DECREASED APPETITE (No appetite/lack of appetite leading them) and RASH (Rash on the stomach). On 12-May-2021, the patient experienced ERYTHEMA (Redness). On 12-May-2021, RASH (Rash on the stomach) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and DECREASED APPETITE (No appetite/lack of appetite leading them) outcome was unknown and ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up included a TCR with no new significant information
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0017C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom). At the time of the report, DIARRHOEA (Every day watery diarrhea,Every other day watery diarrhea,Runs to the bathroom) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Pain in extremity
Clinical narrative: Sore arm; sore arm; Tested positive for Covid-19 after first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 after first dose of Moderna Covid-19 vaccine), PAIN IN EXTREMITY (Sore arm) and PAIN IN EXTREMITY (sore arm) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid-19 after first dose of Moderna Covid-19 vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN IN EXTREMITY (sore arm). At the time of the report, COVID-19 (Tested positive for Covid-19 after first dose of Moderna Covid-19 vaccine), PAIN IN EXTREMITY (Sore arm) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Antibody test: .8 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.     Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR Received on 18-Jun-2021 in which New event added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection area still sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection area still sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection area still sore). At the time of the report, VACCINATION SITE PAIN (injection area still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not reported.   This case was linked to MOD-2021-124820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and contains no significant information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Illness, Immune system disorder, Myalgia
Clinical narrative: Adverse reactions after 2nd dose; Arm's very swollen; Sick after; Didn't feel good 100%; Urinary Tract Infection; Lowered immunity; Tired; Arm's very painful/ achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%) and URINARY TRACT INFECTION (Urinary Tract Infection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-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 an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%), URINARY TRACT INFECTION (Urinary Tract Infection), IMMUNE SYSTEM DISORDER (Lowered immunity), FATIGUE (Tired) and MYALGIA (Arm's very painful/ achy). At the time of the report, VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%), URINARY TRACT INFECTION (Urinary Tract Infection), IMMUNE SYSTEM DISORDER (Lowered immunity), FATIGUE (Tired) and MYALGIA (Arm's very painful/ achy) outcome was unknown.            Patient stated that she is taking other concomitant mediations but no further details provided. Patient stated that she is taking over-the-counter medications for the events and also stated that she is going to take antibiotics tomorrow (13-MAY-2021).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urinary tract infection, Vaccination complication
Clinical narrative: Adverse reactions after 2nd dose; Arm's very swollen; Sick after; Didn't feel good 100%; Urinary Tract Infection; Lowered immunity; Tired; Arm's very painful/ achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%) and URINARY TRACT INFECTION (Urinary Tract Infection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-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 an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%), URINARY TRACT INFECTION (Urinary Tract Infection), IMMUNE SYSTEM DISORDER (Lowered immunity), FATIGUE (Tired) and MYALGIA (Arm's very painful/ achy). At the time of the report, VACCINATION COMPLICATION (Adverse reactions after 2nd dose), PERIPHERAL SWELLING (Arm's very swollen), ILLNESS (Sick after), FEELING ABNORMAL (Didn't feel good 100%), URINARY TRACT INFECTION (Urinary Tract Infection), IMMUNE SYSTEM DISORDER (Lowered immunity), FATIGUE (Tired) and MYALGIA (Arm's very painful/ achy) outcome was unknown.            Patient stated that she is taking other concomitant mediations but no further details provided. Patient stated that she is taking over-the-counter medications for the events and also stated that she is going to take antibiotics tomorrow (13-MAY-2021).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm swelled little; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled little) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm swelled little). At the time of the report, PERIPHERAL SWELLING (arm swelled little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event occurred 7-10 days after getting the shot. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER of 103 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER of 103 degrees Fahrenheit) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included APREMILAST (OTEZLA).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (FEVER of 103 degrees Fahrenheit). At the time of the report, PYREXIA (FEVER of 103 degrees Fahrenheit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.