chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Vaccination site pain
Clinical narrative: Swelling; Itching; Redness; Pain at injection site; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), PRURITUS (Itching), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 13-Jan-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itching) and ERYTHEMA (Redness). On 06-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, SWELLING (Swelling), PRURITUS (Itching) and ERYTHEMA (Redness) 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 details not reported by the reporter. Treatment details not reported by the reported.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: two hours later, her fillers were swollen; A spontaneous report (United States) was received from a (Consumer) concerning a  75 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced two hours later, her fillers were swollen/ Swelling face. The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, approximately same prior to the onset of the events, the patient received their unknown of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route and left site for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced Swelling face just two hours after the vaccination.  Laboratory details not provided. Treatment details were reported as Benadryl. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was reported to be Recovered/Resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 Vaccination.     No medical history was provided by the reporter.  Concomitant products included CORTISONE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and RASH (Rash). At the time of the report, PRURITUS (Itchy) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site redness; It is very big like the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (It is very big like the size of a quarter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     Concomitant products included CORTISONE from 13-Jan-2021 to an unknown date for Knee pain, LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), THYROID (ARMOUR THYROID) and IBUPROFEN for an unknown indication.    On 03-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (It is very big like the size of a quarter). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness) had not resolved and INJECTION SITE SWELLING (It is very big like the size of a quarter) outcome was unknown. 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 the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experiencing soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Experiencing soreness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experiencing soreness). At the time of the report, VACCINATION SITE PAIN (Experiencing soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Capillary disorder, Injection site pain, Musculoskeletal discomfort, Rash
Clinical narrative: Like a cellulitis or poison ivy rash; Discomfort today on the left hip; Broken capillaries 4 inches long; Soreness at the point of injection; Rash at the waist; A spontaneous report was received from a physician concerning a 66-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced soreness at the point of injection, discomfort today on the left hip, broken capillaries four inches long, rash at waist and cellulitis or poison ivy rash.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Tylenol.  On 14 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 041I20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient had soreness at the injection site.   On 15 Jan 2021, he noticed a rash on his waist, no blood on the skin and broken capillaries under the surface four inches long under the rash poison ivy or cellulitis, and discomfort on left hip. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.   The event soreness at the point of injection was considered recovered/resolved on 15 Jan 2021. The outcome of the events discomfort on left hip, broken capillary four inches long, rash at the waist without blood on skin and like a cellulitis or poison ivy rash was not reported.; Reporter's Comments: This case concerns a 66-year old, male patient, who experienced non-serious unexpected events of musculoskeletal discomfort (left hip), capillary disorder, and rash, a non-serious expected event of injection site pain. The event of injection site pain occurred 1 day after first dose of mRNA-1273, lot # 041l20a. The event of musculoskeletal discomfort (left hip), capillary disorder occurred 2 days after first dose of mRNA-1273, lot # 041l20a. The event of rash occurred on an unspecified date after first dose of mRNA-1273, lot # 041l20a. Treatment included Tylenol. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen; red; itching; Hot; hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard) and INJECTION SITE ERYTHEMA (red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date after the first vaccination, the patient put lotion Hempz to the injection site, washed it off, then developed all events. Concomitant medications were not provided. Treatment information was not reported.; 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: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling like feeling in her foot; Numbness in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot). At the time of the report, PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment for the event included diphenhydramine, naproxen and warm compresses.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: foggy head; Nasal congestion; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue) outcome was unknown. Event outcome reported as unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative, Pain in extremity
Clinical narrative: Negative igG antibody test; a little bit sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST NEGATIVE (Negative igG antibody test) and PAIN IN EXTREMITY (a little bit sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (a little bit sore arm). On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Negative igG antibody test). At the time of the report, ANTIBODY TEST NEGATIVE (Negative igG antibody test) and PAIN IN EXTREMITY (a little bit sore arm) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody with IgG and the result was negative.   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 concomitant products were provided. Treatment products were not provided.  Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness; Shortness of breath; A spontaneous report was received from a consumer, concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest discomfort and dyspnea.  The patient's medical history was not provided. Concomitant medication includes Hydrochlorthiazide 12.5 mg daily for an unknown indication.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O25620A) for prophylaxis of COVID-19 infection.  On 18 Jan 2021, The patient experienced chest tightness and shortness of breath.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events were not reported.   On 20 Jan 2021, the outcome of the events was resolved.; Reporter's Comments: This case concerns a 68-year-old, female patient. The patient's medical history was not provided. The patient experienced unexpected event of chest discomfort and dyspnea 17 days after the first dose of mRNA-1273 (lot/batch: O25620A) was administered. No treatment information was provided. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the body; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives all over the body) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced URTICARIA (Hives all over the body). At the time of the report, URTICARIA (Hives all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The treatment medication was reported as one dose of Famotidine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Feeling terrible; Body was shaking from chills aggressively; Fever; Joint pain; Fatigue; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling terrible), TREMOR (Body was shaking from chills aggressively), PYREXIA (Fever), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 78-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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 14-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling terrible) and TREMOR (Body was shaking from chills aggressively). At the time of the report, FEELING ABNORMAL (Feeling terrible), TREMOR (Body was shaking from chills aggressively), PYREXIA (Fever), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment drug administered included acetaminophen, ondansetron and icy hot.; 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: Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Feeling terrible; Body was shaking from chills aggressively; Fever; Joint pain; Fatigue; Headache; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling terrible), TREMOR (Body was shaking from chills aggressively), PYREXIA (Fever), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 78-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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 14-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling terrible) and TREMOR (Body was shaking from chills aggressively). At the time of the report, FEELING ABNORMAL (Feeling terrible), TREMOR (Body was shaking from chills aggressively), PYREXIA (Fever), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment drug administered included acetaminophen, ondansetron and icy hot.; 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: Slight fever; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and PYREXIA (Slight fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131020A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (Cough). On 15-Jan-2021, the patient experienced PYREXIA (Slight fever). At the time of the report, COUGH (Cough) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that, he might have COVID-19 because his wife was diagnosed with COVID-19 on 11 Jan 2021. Concomitant medications were not provided. Treatment information was not reported.; 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: Injection site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Red square, red dot, bump, raised; Hot at touch; Red dot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (Red square, red dot, bump, raised), VACCINATION SITE WARMTH (Hot at touch) and INJECTION SITE ERYTHEMA (Red dot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE MASS (Red square, red dot, bump, raised), VACCINATION SITE WARMTH (Hot at touch) and INJECTION SITE ERYTHEMA (Red dot). At the time of the report, VACCINATION SITE MASS (Red square, red dot, bump, raised), VACCINATION SITE WARMTH (Hot at touch) and INJECTION SITE ERYTHEMA (Red dot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient was given diphenhydramine as a treatment medication.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: post vaccine (left) arm soreness with hardness and redness around the injection site; redness is still there it is warm to the touch; post vaccine (left) arm soreness with hardness and redness around the injection site; post vaccine (left) arm soreness with hardness and redness around the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE INDURATION (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE ERYTHEMA (post vaccine (left) arm soreness with hardness and redness around the injection site) and VACCINATION SITE WARMTH (redness is still there it is warm to the touch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE INDURATION (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE ERYTHEMA (post vaccine (left) arm soreness with hardness and redness around the injection site) and VACCINATION SITE WARMTH (redness is still there it is warm to the touch). At the time of the report, VACCINATION SITE PAIN (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE INDURATION (post vaccine (left) arm soreness with hardness and redness around the injection site), VACCINATION SITE ERYTHEMA (post vaccine (left) arm soreness with hardness and redness around the injection site) and VACCINATION SITE WARMTH (redness is still there it is warm to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-093874 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Follow up was attached and it contains AE related information; 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: Arthralgia, Ear discomfort, Erythema, Swelling, Urticaria
Clinical narrative: Hives on her neck; Redness; Swelling; Ears were burning; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on her neck), ERYTHEMA (Redness), SWELLING (Swelling), EAR DISCOMFORT (Ears were burning) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced URTICARIA (Hives on her neck), ERYTHEMA (Redness), SWELLING (Swelling), EAR DISCOMFORT (Ears were burning) and ARTHRALGIA (Joint pain). At the time of the report, URTICARIA (Hives on her neck), ERYTHEMA (Redness), SWELLING (Swelling), EAR DISCOMFORT (Ears were burning) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included diphenhydramine for the relief of symptoms but no effect.; 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Joint stiffness, Mastication disorder, Pain in jaw, Sensory loss
Clinical narrative: Pain on the right side of jaw and teeth; Jaw was locking and couldn't open it; Cannot feel anything on the right; can't bite or chew; Bruise (greenish); This spontaneous case was reported by an other health care professional and describes the occurrence of CONTUSION (Bruise (greenish)), PAIN IN JAW (Pain on the right side of jaw and teeth), JOINT STIFFNESS (Jaw was locking and couldn't open it), SENSORY LOSS (Cannot feel anything on the right) and MASTICATION DISORDER (can't bite or chew) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CONTUSION (Bruise (greenish)). On 14-Jan-2021, the patient experienced PAIN IN JAW (Pain on the right side of jaw and teeth), JOINT STIFFNESS (Jaw was locking and couldn't open it), SENSORY LOSS (Cannot feel anything on the right) and MASTICATION DISORDER (can't bite or chew). On 15-Jan-2021, MASTICATION DISORDER (can't bite or chew) had resolved. At the time of the report, CONTUSION (Bruise (greenish)), JOINT STIFFNESS (Jaw was locking and couldn't open it) and SENSORY LOSS (Cannot feel anything on the right) outcome was unknown and PAIN IN JAW (Pain on the right side of jaw and teeth) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment of the events included ibuprofen and hot compress.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Trismus updated to Jaw stiffness, Pain in jaw added as new event.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: sore; Muscle pain; Joint pain; Low grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Low grade fever) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Depression, Arthritis and Enlarged prostate. Concomitant products included MELOXICAM for Arthritis, ATORVASTATIN for Cholesterol, CITALOPRAM for Depression, TAMSULOSIN for Enlarged prostate, ACETYLSALICYLIC ACID (ASPIRIN 81) for Hypertension.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Low grade fever) and CHILLS (Chills). On 16-Jan-2021, VACCINATION SITE PAIN (sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Low grade fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-099943 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patients demographic details updated. Additional info AE outcome and recovery date updated. Concomitant medications updated and medical history updated. Patients 2nd dose details also updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Myalgia
Clinical narrative: Developed a cough; Developed body aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Developed a cough) and PAIN (Developed body aches) in an 85-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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Developed a cough) and PAIN (Developed body aches). At the time of the report, COUGH (Developed a cough) and PAIN (Developed body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site swelling
Clinical narrative: Hard at injection site; Swollen at injection site; Red at injection site; Rash at injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE RASH (Rash at injection site) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE RASH (Rash at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were provided as High blood pressure; Reporter'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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema
Clinical narrative: Pain; arm is red/redness has spread down to the elbow/color is mild; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Pain) and VACCINATION SITE ERYTHEMA (arm is red/redness has spread down to the elbow/color is mild) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (Pain) and VACCINATION SITE ERYTHEMA (arm is red/redness has spread down to the elbow/color is mild). At the time of the report, PAIN (Pain) and VACCINATION SITE ERYTHEMA (arm is red/redness has spread down to the elbow/color is mild) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included "Mepitor". Treatment medication included Tylenol.; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in the arm; A spontaneous report was received from a consumer concerning a 39-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain in the arm.   The patient's medical history, as provided by the reporter, included fibroids. Concomitant product use was not reported.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.    On 05 Jan 2021, after vaccine administration, the patient experienced pain in the arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, pain in the arm, was unknown.; Reporter's Comments: This case concerns a 39-year-old, female, with medical history of fibroids, who experienced non-serious expected event of injection site pain. The events occurred 1 days after mRNA-1273 (Lot# 011J20A). Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Limb discomfort, Pain, Rash
Clinical narrative: body aches; felt shocking in feet; fast heart rate; blurry vision; rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision) and RASH (rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision), RASH (rash) and HEADACHE (headache). At the time of the report, PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: body aches; felt shocking in feet; fast heart rate; blurry vision; rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision) and RASH (rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision), RASH (rash) and HEADACHE (headache). At the time of the report, PAIN (body aches), LIMB DISCOMFORT (felt shocking in feet), HEART RATE INCREASED (fast heart rate), VISION BLURRED (blurry vision), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Extremely Achy; Vomited 4 times; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extremely Achy) and VOMITING (Vomited 4 times) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Extremely Achy) and VOMITING (Vomited 4 times). At the time of the report, PAIN (Extremely Achy) and VOMITING (Vomited 4 times) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The relevant concomitant medications are Allergy shot twice a month. Treatment details was not reported by the reporter.   Reporter did not allow further contact; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: vaccination site urticaria; vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on the her left arm  that was itchy as well) and PRURITUS (hives on the her left arm  that was itchy as well) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (hives on the her left arm  that was itchy as well) and PRURITUS (hives on the her left arm  that was itchy as well). At the time of the report, URTICARIA (hives on the her left arm  that was itchy as well) and PRURITUS (hives on the her left arm  that was itchy as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information and concomitant medications  were 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): No medical history was provided by the reporter.  The mother's past medical history included No adverse event (No reported medical history).    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Jan-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). On 14-Jan-2021, EXPOSURE VIA BREAST MILK (Breastfeeding) 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.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in the left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the left arm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in the left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.