chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Body Aches; Fatigue; Fever / Temperature; Chills; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body Aches), FATIGUE (Fatigue), PYREXIA (Fever / Temperature) and CHILLS (Chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-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 03-Feb-2021, the patient experienced MYALGIA (Body Aches), FATIGUE (Fatigue), PYREXIA (Fever / Temperature) and CHILLS (Chills). On 05-Feb-2021, MYALGIA (Body Aches), FATIGUE (Fatigue), PYREXIA (Fever / Temperature) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Back Ache; Dizziness; Fever; Chills; Headache; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (Back Ache), DIZZINESS (Dizziness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-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 03-Feb-2021, the patient experienced BACK PAIN (Back Ache), DIZZINESS (Dizziness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). In February 2021, BACK PAIN (Back Ache), DIZZINESS (Dizziness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his arm was sore for a few days a little bit more than with the 1st one) and HYPERTENSION (his blood pressure started going up, 160/170/180/ his pressure was 190/90) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METOPROLOL, AMLODIPINE and SIMVASTATIN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (his arm was sore for a few days a little bit more than with the 1st one). On 13-Mar-2021, the patient experienced HYPERTENSION (his blood pressure started going up, 160/170/180/ his pressure was 190/90). The patient was treated with LISINOPRIL on 17-Feb-2021 for Blood pressure high, at a dose of 10 mg and LISINOPRIL ongoing from 19-Mar-2021 for Blood pressure high, at a dose of 20 mg. At the time of the report, PAIN IN EXTREMITY (his arm was sore for a few days a little bit more than with the 1st one) and HYPERTENSION (his blood pressure started going up, 160/170/180/ his pressure was 190/90) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: 160/170/18 (High) high. In February 2021, Blood pressure measurement: 190/90 (High) high. This case was linked to MOD-2021-052646.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site) was resolving.            No relevant concomitant medication was reported. On 10-MAR-2021 patient reported that the redness at the injection site turned to  pinkish color. Treatment details included use of ice on the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Diarrhea; Chills; Nausea; Fever 100.2 F; Fatigue; Body Aches; Headache; Pain Injection Site; Itching on the Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.2 F) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-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 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.2 F), FATIGUE (Fatigue), MYALGIA (Body Aches), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE PRURITUS (Itching on the Injection Site). On 05-Feb-2021, CHILLS (Chills), PYREXIA (Fever 100.2 F) and MYALGIA (Body Aches) had resolved. On 06-Feb-2021, HEADACHE (Headache) had resolved. On 09-Feb-2021, VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE PRURITUS (Itching on the Injection Site) had resolved. On 10-Feb-2021, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Diarrhea; Chills; Nausea; Fever 100.2 F; Fatigue; Body Aches; Headache; Pain Injection Site; Itching on the Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.2 F) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-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 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever 100.2 F), FATIGUE (Fatigue), MYALGIA (Body Aches), HEADACHE (Headache), VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE PRURITUS (Itching on the Injection Site). On 05-Feb-2021, CHILLS (Chills), PYREXIA (Fever 100.2 F) and MYALGIA (Body Aches) had resolved. On 06-Feb-2021, HEADACHE (Headache) had resolved. On 09-Feb-2021, VACCINATION SITE PAIN (Pain Injection Site) and VACCINATION SITE PRURITUS (Itching on the Injection Site) had resolved. On 10-Feb-2021, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: irritation on arm; very itchy at site of injection; really red at site of injection; swollen at site of injection; a little sore at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritation on arm), VACCINATION SITE PRURITUS (very itchy at site of injection), VACCINATION SITE ERYTHEMA (really red at site of injection), VACCINATION SITE SWELLING (swollen at site of injection) and VACCINATION SITE PAIN (a little sore at site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history information was provided).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (irritation on arm), VACCINATION SITE PRURITUS (very itchy at site of injection), VACCINATION SITE ERYTHEMA (really red at site of injection), VACCINATION SITE SWELLING (swollen at site of injection) and VACCINATION SITE PAIN (a little sore at site of injection). At the time of the report, SKIN IRRITATION (irritation on arm), VACCINATION SITE PRURITUS (very itchy at site of injection), VACCINATION SITE ERYTHEMA (really red at site of injection), VACCINATION SITE SWELLING (swollen at site of injection) and VACCINATION SITE PAIN (a little sore at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: Accidental exposure due to syringe malfunction; A spontaneous report was received from a HCP concerning a 66-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental exposure due to syringe malfunction/accidental exposure to product.  The patient's medical history, as provided by the reporter, included diabetes and high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included metformin, metoprolol, atorvastatin, farxiga, clonidine, and amlodipine. A spontaneous report was received from a healthcare professional concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events accidental exposure due to syringe malfunction.  The patient's medical history was not provided. Concomitant medications reported were Metformin, Metoprolol 200mg BID, Atorvastatin 10mg daily, Farxiga 5mg daily, Clonidine .2mg BID, Amlodipine 10mg daily for drug use for unknown indication.  On 21 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 Mar 2021, the patient experienced the event(s) accidental exposure due to syringe malfunction.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 21 Mar 2021 the outcome of event(s), accidental exposure due to syringe malfunction was resolved.    On 21 Mar 2021, on same day of the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 21 Mar 2021, the patient was administered an invalid dose due to a syringe malfunction the patient and had accidental exposure. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was consider not reported.   The outcome of events, accidental exposure due to syringe malfunction was resolved on 21 Mar 2021.; Sender's Comments: This report refers to a case of expired product administered for mRNA-1273, lot #038A21A with no associated AEs.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Pruritus
Clinical narrative: Redness; Tingling; Itching; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness), PARAESTHESIA (Tingling) and PRURITUS (Itching) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced ERYTHEMA (Redness), PARAESTHESIA (Tingling) and PRURITUS (Itching). At the time of the report, ERYTHEMA (Redness), PARAESTHESIA (Tingling) and PRURITUS (Itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Rash
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of RASH (Raised Red Rash on bilateral Lower Legs and left Forearm), ARTHRALGIA (Joint pain), ARTHRALGIA (Ankle pain), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (chantix), Anxiety and Depression. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and PERPHENAZINE for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for Depression. On 27-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced ARTHRALGIA (Joint pain), ARTHRALGIA (Ankle pain), BACK PAIN (Lower back pain) and FATIGUE (Fatigue). On 29-Jan-2021, the patient experienced RASH (Raised Red Rash on bilateral Lower Legs and left Forearm). On 29-Jan-2021, ARTHRALGIA (Joint pain), ARTHRALGIA (Ankle pain), BACK PAIN (Lower back pain) and FATIGUE (Fatigue) had resolved. On 08-Feb-2021, RASH (Raised Red Rash on bilateral Lower Legs and left Forearm) had resolved. Not Provided. 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. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: new events and co-meds were added.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test, Vertigo
Clinical narrative: Shoulder pain; Vertigo; Numbing in hand and feet; Tingling arms and feet/ feet and hand tingling (re-emerged); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbing in hand and feet), PARAESTHESIA (Tingling arms and feet/ feet and hand tingling (re-emerged)), VERTIGO (Vertigo) and ARTHRALGIA (Shoulder pain) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 31-Jan-2021.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (Numbing in hand and feet) and PARAESTHESIA (Tingling arms and feet/ feet and hand tingling (re-emerged)). On 05-Mar-2021, the patient experienced VERTIGO (Vertigo). On 06-Mar-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 05-Mar-2021, HYPOAESTHESIA (Numbing in hand and feet) and PARAESTHESIA (Tingling arms and feet/ feet and hand tingling (re-emerged)) had resolved. On 07-Mar-2021, VERTIGO (Vertigo) and ARTHRALGIA (Shoulder pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: Tenderness on the left (Non-dominant) arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness on the left (Non-dominant) arm) and MYALGIA (soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021 at 9:03 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Tenderness on the left (Non-dominant) arm) and MYALGIA (soreness). At the time of the report, INJECTION SITE PAIN (Tenderness on the left (Non-dominant) arm) and MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided Treatment information not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: hives; rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face; redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), RASH (rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face), ERYTHEMA (redness) and PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication.     Concurrent medical conditions included Diabetes, Latex allergy and Drug allergy (statin and Vicodin drugs).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (redness) and PRURITUS (itching). On 10-Mar-2021, the patient experienced URTICARIA (hives) and RASH (rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face). At the time of the report, URTICARIA (hives), RASH (rash on breast/rash on inside of both arms and spreading/rash on neck/rash on face), ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; Hives on her legs\  on arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her legs\  on arms) and PRURITUS (Itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to insect sting (Bees), Anaphylaxis, Hypersensitivity reaction and Hives (Severe hives on legs and arms.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URTICARIA (Hives on her legs\  on arms). On an unknown date, the patient experienced PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Mar-2021, URTICARIA (Hives on her legs\  on arms) and PRURITUS (Itching) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: In follow-up information patient demographics, vaccine Information, product dose details, event (i.e.: Itching), event's out come were updated.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pain, SARS-CoV-2 test
Clinical narrative: racing heartbeat; body aches; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (racing heartbeat), PAIN (body aches) and CHILLS (CHILLS) 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 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Feb-2021, the patient experienced HEART RATE INCREASED (racing heartbeat), PAIN (body aches) and CHILLS (CHILLS). At the time of the report, HEART RATE INCREASED (racing heartbeat), PAIN (body aches) and CHILLS (CHILLS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant information use was not reported.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Hordeolum, Swelling face, Tenderness
Clinical narrative: More fluids under her right eyes; Knot under her right eyes; Swollen cheeks (more of the right than left); Cheeks are very tender; Swollen right eye; Sore to the touch right eye; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen cheeks (more of the right than left)), TENDERNESS (Cheeks are very tender), EYE SWELLING (Swollen right eye), EYE PAIN (Sore to the touch right eye) and EYE SWELLING (More fluids under her right eyes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced SWELLING FACE (Swollen cheeks (more of the right than left)), TENDERNESS (Cheeks are very tender), EYE SWELLING (Swollen right eye) and EYE PAIN (Sore to the touch right eye). On 22-Mar-2021, the patient experienced EYE SWELLING (More fluids under her right eyes) and HORDEOLUM (Knot under her right eyes). At the time of the report, SWELLING FACE (Swollen cheeks (more of the right than left)), TENDERNESS (Cheeks are very tender), EYE SWELLING (Swollen right eye), EYE PAIN (Sore to the touch right eye), EYE SWELLING (More fluids under her right eyes) and HORDEOLUM (Knot under her right eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Fatigue, Illness, Pain
Clinical narrative: went to ER; Fever of 100.9; Chills; Tired; Sick; Achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PAIN (Achy), ADVERSE EVENT (went to ER), PYREXIA (Fever of 100.9) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Sick), PAIN (Achy), PYREXIA (Fever of 100.9), CHILLS (Chills) and FATIGUE (Tired). On 05-Mar-2021, the patient experienced ADVERSE EVENT (went to ER). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, ADVERSE EVENT (went to ER) outcome was unknown. At the time of the report, ILLNESS (Sick), PAIN (Achy), PYREXIA (Fever of 100.9), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: went to ER; Fever of 100.9; Chills; Tired; Sick; Achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PAIN (Achy), ADVERSE EVENT (went to ER), PYREXIA (Fever of 100.9) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Sick), PAIN (Achy), PYREXIA (Fever of 100.9), CHILLS (Chills) and FATIGUE (Tired). On 05-Mar-2021, the patient experienced ADVERSE EVENT (went to ER). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, ADVERSE EVENT (went to ER) outcome was unknown. At the time of the report, ILLNESS (Sick), PAIN (Achy), PYREXIA (Fever of 100.9), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Fatigue; feeling more anxiety than normal; Low grade fever; there was splotching by the swelling; swollen lymph node; extremely tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (extremely tender), SWELLING (there was splotching by the swelling), ANXIETY (feeling more anxious than normal), PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.   On 16-Mar-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 17-Mar-2021, the patient experienced ANXIETY (feeling more anxious than normal), PYREXIA (low grade fever) and FATIGUE (fatigue). On 18-Mar-2021, the patient experienced TENDERNESS (extremely tender), SWELLING (there was splotching by the swelling) and LYMPHADENOPATHY (swollen lymph node). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. On 20-Mar-2021, PYREXIA (low grade fever) had resolved. At the time of the report, TENDERNESS (extremely tender), ANXIETY (feeling more anxious than normal) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown and SWELLING (there was splotching by the swelling) and FATIGUE (fatigue) had not resolved.            Concomitant product use was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Fatigue; feeling more anxiety than normal; Low grade fever; there was splotching by the swelling; swollen lymph node; extremely tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (extremely tender), SWELLING (there was splotching by the swelling), ANXIETY (feeling more anxious than normal), PYREXIA (low grade fever) and LYMPHADENOPATHY (swollen lymph node) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported.   On 16-Mar-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 17-Mar-2021, the patient experienced ANXIETY (feeling more anxious than normal), PYREXIA (low grade fever) and FATIGUE (fatigue). On 18-Mar-2021, the patient experienced TENDERNESS (extremely tender), SWELLING (there was splotching by the swelling) and LYMPHADENOPATHY (swollen lymph node). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN 81) at an unspecified dose and frequency. On 20-Mar-2021, PYREXIA (low grade fever) had resolved. At the time of the report, TENDERNESS (extremely tender), ANXIETY (feeling more anxious than normal) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown and SWELLING (there was splotching by the swelling) and FATIGUE (fatigue) had not resolved.            Concomitant product use was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Hot; Red; Swollen; Pain; Stiff neck; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), VACCINATION SITE WARMTH (Hot), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 28-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Feb-2021, HEADACHE (Headache) had resolved. On 02-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; Red; Swollen; Pain; Stiff neck; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), VACCINATION SITE WARMTH (Hot), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 28-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Feb-2021, HEADACHE (Headache) had resolved. On 02-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: pregnant at the time of her shot; mild soreness of the arm; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant at the time of her shot) and PAIN IN EXTREMITY (mild soreness of the arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for an unknown indication.     Concurrent medical conditions included Drug allergy (Neosporin allergy.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and IRON (IRON COMPLEX [IRON]) for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-May-2021. On 21-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant at the time of her shot) and PAIN IN EXTREMITY (mild soreness of the arm). On 21-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant at the time of her shot) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (mild soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Unidentified patient experienced swollen arm after receiving the Moderna vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Unidentified patient experienced swollen arm after receiving the Moderna vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (Unidentified patient experienced swollen arm after receiving the Moderna vaccine.). At the time of the report, PERIPHERAL SWELLING (Unidentified patient experienced swollen arm after receiving the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Lump on neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Lump on neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NECK MASS (Lump on neck). At the time of the report, NECK MASS (Lump on neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: TCR Received-AE Outcome and patient gender provided
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Stomach cramps; Low grade fever; Nausea; Chills; Fatigue; Sore left arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Low grade fever), NAUSEA (Nausea) and CHILLS (Chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Low grade fever), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore left arm). On 12-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-Mar-2021, DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Low grade fever), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Stomach cramps; Low grade fever; Nausea; Chills; Fatigue; Sore left arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Low grade fever), NAUSEA (Nausea) and CHILLS (Chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Low grade fever), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore left arm). On 12-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-Mar-2021, DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Low grade fever), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weakness; out of it and tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and FATIGUE (out of it and tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (weakness) and FATIGUE (out of it and tired). On 27-Feb-2021, ASTHENIA (weakness) and FATIGUE (out of it and tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: TCR follow-up received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her 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 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 PAIN IN EXTREMITY (Pain in her arm). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: she felt queasy; felt fatigued; Her arm was also sore; headache that lasted 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was also sore), HEADACHE (headache that lasted 12 hours), NAUSEA (she felt queasy) and FATIGUE (felt fatigued) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), SIMVASTATIN, METOPROLOL, HYDROCHLOROTHIAZIDE, LORAZEPAM, VITAMIN D NOS, VITAMIN B NOS, PHYTOSTEROLS NOS (CHOLESTOFF ORIGINAL), MAGNESIUM, VITAMIN K NOS and PSYLLIUM [PLANTAGO AFRA] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm was also sore) and HEADACHE (headache that lasted 12 hours). On 12-Mar-2021, the patient experienced NAUSEA (she felt queasy) and FATIGUE (felt fatigued). At the time of the report, PAIN IN EXTREMITY (Her arm was also sore), HEADACHE (headache that lasted 12 hours), NAUSEA (she felt queasy) and FATIGUE (felt fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 2-JUL-2021 ,Outcome of the events updated to recovered/resolved.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Insomnia, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Neck stiffness; Ankle muscle swelling; could not sleep; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck stiffness), JOINT SWELLING (Ankle muscle swelling), INSOMNIA (could not sleep) and GAIT INABILITY (could not walk) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiffness), JOINT SWELLING (Ankle muscle swelling), INSOMNIA (could not sleep) and GAIT INABILITY (could not walk). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck stiffness) was resolving, JOINT SWELLING (Ankle muscle swelling) had not resolved and INSOMNIA (could not sleep) and GAIT INABILITY (could not walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 22-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071431, US-MODERNATX, INC.-MOD-2021-071492 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071492: US-MODERNATX, INC.-MOD-2021-071431:Crosslinked case