chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash, Urticaria
Clinical narrative: A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows; It feels like hives on the top of my head; I couldn't sleep because of the itching; Rash in both shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head), INSOMNIA (I couldn't sleep because of the itching) and RASH (Rash in both shoulder) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for Pain: Cortisone shot (Patient got cortisone shot between the two shots. It was on the opposite arm and in his right shoulder) on 03-Mar-2021. Concurrent medical conditions included Pain (Patient had pain from another injury (fell)), Vitamin D low, Leukemia and Hypokalaemia. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head), INSOMNIA (I couldn't sleep because of the itching) and RASH (Rash in both shoulder). At the time of the report, PRURITUS (A lot of itching up to my forehead, sides of my head and down to my neck/It also concentrated in the right of my shoulder/It is going down to my elbows), URTICARIA (It feels like hives on the top of my head) and INSOMNIA (I couldn't sleep because of the itching) outcome was unknown and RASH (Rash in both shoulder) had not resolved.      Concomitant medications included medications for leukemia, low potassium, low vitamin D and pain. The patient stated 4 medications a day, 6-7 pills per day.   The patient's HCP recommended diphenhydramine and hydrocortisone cream to apply to the arm and shoulder. The patient had not started treatment at the time of this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Hard injection site; Itchy injection site; Redness at injection site; Swollen injection site; Sore arm; Sore injection site...painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE PAIN (Sore injection site...painful), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site...painful) and MYALGIA (Sore arm). On 13-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE PAIN (Sore injection site..painful), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swollen injection site) and MYALGIA (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient reported that she has not taken anything (no treatment medications) to alleviate the symptoms.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Hard injection site; Itchy injection site; Redness at injection site; Swollen injection site; Sore arm; Sore injection site...painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE PAIN (Sore injection site...painful), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site...painful) and MYALGIA (Sore arm). On 13-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE INDURATION (Hard injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE PAIN (Sore injection site..painful), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swollen injection site) and MYALGIA (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient reported that she has not taken anything (no treatment medications) to alleviate the symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: not feeling well/good; fever; chills; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well/good), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE 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 12-Mar-2021, the patient experienced MALAISE (not feeling well/good), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well/good), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information included paracetamol. On an unknown date second shot was received via unknown route of administration (Batch LOT no 036B21A).   This case was linked to MOD-2021-072746, MOD-2021-072746 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information was updated. On 11-May-2021: Updated batch number.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: a dry cough until he has no air; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a dry cough until he has no air) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced COUGH (a dry cough until he has no air) and PYREXIA (Fever). At the time of the report, COUGH (a dry cough until he has no air) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included a blood pressure medication and gastritis medication (not specified).  Treatment information was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Face is flushed; Feels like she has a fever/head feels warm; Just felt terrible; Achy all over; Soreness at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Just felt terrible), FLUSHING (Face is flushed), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (Just felt terrible), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced FLUSHING (Face is flushed) and PYREXIA (Feels like she has a fever/head feels warm). On 11-Mar-2021, VACCINATION COMPLICATION (Just felt terrible), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) had resolved. At the time of the report, FLUSHING (Face is flushed) and PYREXIA (Feels like she has a fever/head feels warm) had not resolved.            No concomitant medication provided.   Treatment information included acetaminophen, lots of water and Gatorade.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Face is flushed; Feels like she has a fever/head feels warm; Just felt terrible; Achy all over; Soreness at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Just felt terrible), FLUSHING (Face is flushed), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (Just felt terrible), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced FLUSHING (Face is flushed) and PYREXIA (Feels like she has a fever/head feels warm). On 11-Mar-2021, VACCINATION COMPLICATION (Just felt terrible), MYALGIA (Achy all over), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) had resolved. At the time of the report, FLUSHING (Face is flushed) and PYREXIA (Feels like she has a fever/head feels warm) had not resolved.            No concomitant medication provided.   Treatment information included acetaminophen, lots of water and Gatorade.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vomiting
Clinical narrative: feel weak; vomiting; violent headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feel weak), VOMITING (vomiting) and HEADACHE (violent headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concurrent medical conditions included Thyroid disorder, Hypertension and Heart disease, unspecified.    On 10-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 VOMITING (vomiting) and HEADACHE (violent headache). On 12-Mar-2021, the patient experienced ASTHENIA (feel weak). The patient was treated with MORPHINE for Headache, at an unspecified dose and frequency. At the time of the report, ASTHENIA (feel weak) had not resolved, VOMITING (vomiting) was resolving and HEADACHE (violent headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported taking concomitant medication for thyroid, blood pressure, and heart (not specified).  The patient went to the ER on 11MAR2021 due to violent headache and vomiting. medicine for vomiting (not specified).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: felt a little under the weather; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (felt a little under the weather) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus (Has had lupus for about 13 years). Concurrent medical conditions included Mixed connective tissue disease (Has had for about 13 years). Concomitant products included HYDROXYCHLOROQUINE and PREDNISONE (RAYOS) for Lupus erythematosus and Mixed connective tissue disease.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt a little under the weather). At the time of the report, VACCINATION COMPLICATION (felt a little under the weather) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Chills, Fatigue, Headache, Lacrimation increased
Clinical narrative: Migraine; watery eyes; tremors in her whole body; started feeling little headachy again; stomach is queasy; chills; headache; tiredness; nausea/queasiness; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (watery eyes), TREMOR (tremors in her whole body), MIGRAINE (Migraine), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Hypothyroidism. Concomitant products included DIHYDROERGOTAMINE MESILATE (MIGRANAL) for Migraine, THYROID (ARMOUR THYROID), ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D [VITAMIN D NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID], CALCIUM and DIAZEPAM for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headache), FATIGUE (tiredness) and NAUSEA (nausea/queasiness). On 11-Mar-2021, the patient experienced HEADACHE (started feeling little headachy again) and NAUSEA (stomach is queasy). In May 2021, the patient experienced TREMOR (tremors in her whole body). On an unknown date, the patient experienced LACRIMATION INCREASED (watery eyes) and MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Mar-2021, CHILLS (chills), HEADACHE (headache), FATIGUE (tiredness) and NAUSEA (nausea/queasiness) had resolved. In May 2021, TREMOR (tremors in her whole body) had resolved. At the time of the report, LACRIMATION INCREASED (watery eyes), MIGRAINE (Migraine), HEADACHE (started feeling little headachy again) and NAUSEA (stomach is queasy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Thyroid function test: low (Low) After second dose, patient's thyroid hormone test showed low.. On 30-Apr-2021, Thyroid function test: low (Low) Patient's thyroid hormone level showed low normal.. On 01-Jun-2021, Blood thyroid stimulating hormone: normal (normal) Patient's TSH level showed normal..         This case was linked to MOD21-108068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021: Updated concomitants, lab data, medical history.Added new events tremor and migraine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Thyroid function test, Tremor
Clinical narrative: Migraine; watery eyes; tremors in her whole body; started feeling little headachy again; stomach is queasy; chills; headache; tiredness; nausea/queasiness; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (watery eyes), TREMOR (tremors in her whole body), MIGRAINE (Migraine), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Hypothyroidism. Concomitant products included DIHYDROERGOTAMINE MESILATE (MIGRANAL) for Migraine, THYROID (ARMOUR THYROID), ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D [VITAMIN D NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID], CALCIUM and DIAZEPAM for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headache), FATIGUE (tiredness) and NAUSEA (nausea/queasiness). On 11-Mar-2021, the patient experienced HEADACHE (started feeling little headachy again) and NAUSEA (stomach is queasy). In May 2021, the patient experienced TREMOR (tremors in her whole body). On an unknown date, the patient experienced LACRIMATION INCREASED (watery eyes) and MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Mar-2021, CHILLS (chills), HEADACHE (headache), FATIGUE (tiredness) and NAUSEA (nausea/queasiness) had resolved. In May 2021, TREMOR (tremors in her whole body) had resolved. At the time of the report, LACRIMATION INCREASED (watery eyes), MIGRAINE (Migraine), HEADACHE (started feeling little headachy again) and NAUSEA (stomach is queasy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Thyroid function test: low (Low) After second dose, patient's thyroid hormone test showed low.. On 30-Apr-2021, Thyroid function test: low (Low) Patient's thyroid hormone level showed low normal.. On 01-Jun-2021, Blood thyroid stimulating hormone: normal (normal) Patient's TSH level showed normal..         This case was linked to MOD21-108068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021: Updated concomitants, lab data, medical history.Added new events tremor and migraine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second COVID-19 vaccination; First COVID-19 vaccination; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First COVID-19 vaccination) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second COVID-19 vaccination) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First COVID-19 vaccination). On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second COVID-19 vaccination). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First COVID-19 vaccination) had resolved. On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were provided. No treatment information were provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Fatigue, Headache, Myalgia
Clinical narrative: Feeling a pressure on both eyes; Fatigue; Headache; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Feeling a pressure on both eyes), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Heartburn, Cholesterol, Glaucoma and Prostate. Concomitant products included ATORVASTATIN for Cholesterol, LATANOPROST for Glaucoma, OMEPRAZOLE for Heartburn, IRBESARTAN for Hypertension, PROBIOTICS NOS, VITAMIN B COMPLEX (B COMPLEX (B50)), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) and for prostate for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced EYE PAIN (Feeling a pressure on both eyes), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, EYE PAIN (Feeling a pressure on both eyes) was resolving. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling a pressure on both eyes; Fatigue; Headache; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Feeling a pressure on both eyes), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Heartburn, Cholesterol, Glaucoma and Prostate. Concomitant products included ATORVASTATIN for Cholesterol, LATANOPROST for Glaucoma, OMEPRAZOLE for Heartburn, IRBESARTAN for Hypertension, PROBIOTICS NOS, VITAMIN B COMPLEX (B COMPLEX (B50)), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMIN & CHONDROITIN) and for prostate for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced EYE PAIN (Feeling a pressure on both eyes), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, EYE PAIN (Feeling a pressure on both eyes) was resolving. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Was pink at the injection site; Very itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Was pink at the injection site) and VACCINATION SITE PRURITUS (Very itchy at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Was pink at the injection site) and VACCINATION SITE PRURITUS (Very itchy at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Was pink at the injection site) and VACCINATION SITE PRURITUS (Very itchy at the injection site) outcome was unknown. Not Provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Second dose administered in 18 days; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose administered in 18 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002BQ1A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced OFF LABEL USE (Second dose administered in 18 days). On 12-Mar-2021, OFF LABEL USE (Second dose administered in 18 days) had resolved. Not Provided          No concomitant medications reported by reporter.  Treatment of these events were not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Epistaxis, Joint stiffness, Peripheral swelling
Clinical narrative: right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand; wrist stiff; wrist inflamed; got 3 terrible nosebleeds for over an hour; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand), JOINT STIFFNESS (wrist stiff), ARTHRITIS (wrist inflamed) and EPISTAXIS (got 3 terrible nosebleeds for over an hour) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06M20A) for COVID-19 immunisation.     The patient's past medical history included Fracture (Fractured right wrist 10 years ago). Concurrent medical conditions included Arthritis (Arthritis in little finger).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PERIPHERAL SWELLING (right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand), JOINT STIFFNESS (wrist stiff), ARTHRITIS (wrist inflamed) and EPISTAXIS (got 3 terrible nosebleeds for over an hour). At the time of the report, PERIPHERAL SWELLING (right hand swelled up; still swollen but not as swollen; at one point twice the size of her left hand) had not resolved, JOINT STIFFNESS (wrist stiff) and ARTHRITIS (wrist inflamed) outcome was unknown and EPISTAXIS (got 3 terrible nosebleeds for over an hour) had resolved.            No concomitant medications were reported.  Treatment included heat application, aspirin, and running her hand under hot water.   This case was linked to MOD-2021-056616 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pruritus
Clinical narrative: Itching under the arm; Headache; Received both dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both dose of the vaccine), PRURITUS (Itching under the arm) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both dose of the vaccine). On 12-Mar-2021, the patient experienced PRURITUS (Itching under the arm) and HEADACHE (Headache). On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both dose of the vaccine) had resolved. On 12-Mar-2021, PRURITUS (Itching under the arm) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 036A21A. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Paraesthesia
Clinical narrative: Could not use hand, it did have movement but she was unable to grasp things; tingling in hand; This spontaneous case was reported by an other health care professional and describes the occurrence of MOTOR DYSFUNCTION (Could not use hand, it did have movement but she was unable to grasp things) and PARAESTHESIA (tingling in hand) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A-03) for COVID-19 vaccination.     Concurrent medical conditions included Incontinence. Concomitant products included PROGESTERONE from 01-Aug-2019 to an unknown date and ESTRADIOL for Incontinence, VITAMIN D3 for Vitamin deficiency NOS.    On 11-Mar-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MOTOR DYSFUNCTION (Could not use hand, it did have movement but she was unable to grasp things). 11-Mar-2021, the patient experienced PARAESTHESIA (tingling in hand). On 12-Mar-2021, MOTOR DYSFUNCTION (Could not use hand, it did have movement but she was unable to grasp things) and PARAESTHESIA (tingling in hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow up received included patient demographic details, Dosage Batch number, Concomitant medications, and  an event were added On 14-Jul-2021: Follow up received included no new significant information
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: sweat; feeling lousy; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweat), MALAISE (feeling lousy), CHILLS (Chills) and PYREXIA (fever) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweat), MALAISE (feeling lousy), CHILLS (Chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweat), MALAISE (feeling lousy), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient was feeling lousy, chills, fever, sweating at about 2 am in the morning.   No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014RH20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Obesity. Concomitant products included SAXAGLIPTIN (ONGLYZA [SAXAGLIPTIN]), METOPROLOL, AMLODIPINE, ATORVASTATIN, SERTRALINE, ASPIRIN [ACETYLSALICYLIC ACID], METFORMIN, UBIDECARENONE (COQ 10), BIOTIN and COLECALCIFEROL (D3 5000) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Low grade fever). On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency and WATER ongoing since an unknown date at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (Low grade fever) had resolved. On 05-Mar-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant as of 08MAR2021; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant as of 08MAR2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant as of 08MAR2021). On 10-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant as of 08MAR2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information not provided.  08-Mar-2021, pregnancy results positive
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Ocular hyperaemia
Clinical narrative: Sore throat; Right eye is red; Headache; Achy body/ achy muscles; Achy joints; Tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles) and ARTHRALGIA (Achy joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles), ARTHRALGIA (Achy joints) and FATIGUE (Tired). On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles), ARTHRALGIA (Achy joints) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided by the reporter. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Reporter contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; Right eye is red; Headache; Achy body/ achy muscles; Achy joints; Tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles) and ARTHRALGIA (Achy joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles), ARTHRALGIA (Achy joints) and FATIGUE (Tired). On 10-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), OCULAR HYPERAEMIA (Right eye is red), HEADACHE (Headache), MYALGIA (Achy body/ achy muscles), ARTHRALGIA (Achy joints) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided by the reporter. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Reporter contact information updated
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  Treatment medications included unspecified antibiotics and a steroid pack.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Erythema, Headache
Clinical narrative: lower arms were red and itching real bad; Heart palpitations after 1st dose; Lightheaded/ Dizzy; Shortness of breath; Lower arms red and itching real bad after 1st dose; Whole body covered in rash after 1st dose; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ) and ERYTHEMA (Lower arms red and itching real bad after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Cholesterol and Mitral valve prolapse. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ), ERYTHEMA (Lower arms red and itching real bad after 1st dose), RASH (Whole body covered in rash after 1st dose) and HEADACHE (Bad headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ) and ERYTHEMA (Lower arms red and itching real bad after 1st dose) outcome was unknown, RASH (Whole body covered in rash after 1st dose) was resolving and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: fluctuating Fluctuating.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Rash
Clinical narrative: lower arms were red and itching real bad; Heart palpitations after 1st dose; Lightheaded/ Dizzy; Shortness of breath; Lower arms red and itching real bad after 1st dose; Whole body covered in rash after 1st dose; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ) and ERYTHEMA (Lower arms red and itching real bad after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure, Cholesterol and Mitral valve prolapse. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ), ERYTHEMA (Lower arms red and itching real bad after 1st dose), RASH (Whole body covered in rash after 1st dose) and HEADACHE (Bad headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (lower arms were red and itching real bad), PALPITATIONS (Heart palpitations after 1st dose), DIZZINESS (Lightheaded/ Dizzy), DYSPNOEA (Shortness of breath ) and ERYTHEMA (Lower arms red and itching real bad after 1st dose) outcome was unknown, RASH (Whole body covered in rash after 1st dose) was resolving and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: fluctuating Fluctuating.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in both shoulders) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in both shoulders). At the time of the report, ARTHRALGIA (Pain in both shoulders) outcome was unknown.            Concomitant medication used was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-213190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 5-May-2021 included no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: feels like someone beat her up; is hurting; nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feels like someone beat her up; is hurting), NAUSEA (nausea) and HEADACHE (slight headache) in a 62-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, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (feels like someone beat her up; is hurting), NAUSEA (nausea) and HEADACHE (slight headache). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) at an unspecified dose and frequency. At the time of the report, PAIN (feels like someone beat her up; is hurting), NAUSEA (nausea) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.