chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25120A) 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 15-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: Pain in extremity
Clinical narrative: Soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Eye pruritus, Eye swelling, Faeces discoloured
Clinical narrative: Clay/gray colored stool; Mild nausea; Headache; Mild fatigue; Eye is swollen; Itchy eyes; Diarrhea; Runny nose; Stomach ache; Itchy Skin; Hives upper body; Rashes over the body; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), FAECES DISCOLOURED (Clay/gray colored stool) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Improvement) since 06-Jan-1992, Hypothyroidism since 2001, Anxiety since 1992, Anemia (Improvement) since 1974, ADHD, Food allergy (Allergic to fresh fruit, tree nuts.) and Pollen allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (AMPHETAMINE MIXED SALTS) and AMPHETAMINE for ADHD, LORATADINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LEVOTHYROXINE for Hypothyroidism, IBUPROFEN for Pain.    On 14-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body) and INJECTION SITE PAIN (Pain at injection site). On 15-Jan-2021, the patient experienced FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea), HEADACHE (Headache) and FATIGUE (Mild fatigue). On 15-Jan-2021, EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 17-Jan-2021, FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea) and FATIGUE (Mild fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Loratadine-D and a dose of Flonase and ibuprofen were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient demographic added. Patient relevant history and concomitant medications were added. The outcome of the events from recovering to recovered updated. New events (hives, injection site soreness, nausea, fatigue, headache) were added.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pruritus
Clinical narrative: Clay/gray colored stool; Mild nausea; Headache; Mild fatigue; Eye is swollen; Itchy eyes; Diarrhea; Runny nose; Stomach ache; Itchy Skin; Hives upper body; Rashes over the body; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), FAECES DISCOLOURED (Clay/gray colored stool) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Improvement) since 06-Jan-1992, Hypothyroidism since 2001, Anxiety since 1992, Anemia (Improvement) since 1974, ADHD, Food allergy (Allergic to fresh fruit, tree nuts.) and Pollen allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (AMPHETAMINE MIXED SALTS) and AMPHETAMINE for ADHD, LORATADINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LEVOTHYROXINE for Hypothyroidism, IBUPROFEN for Pain.    On 14-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body) and INJECTION SITE PAIN (Pain at injection site). On 15-Jan-2021, the patient experienced FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea), HEADACHE (Headache) and FATIGUE (Mild fatigue). On 15-Jan-2021, EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 17-Jan-2021, FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea) and FATIGUE (Mild fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Loratadine-D and a dose of Flonase and ibuprofen were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient demographic added. Patient relevant history and concomitant medications were added. The outcome of the events from recovering to recovered updated. New events (hives, injection site soreness, nausea, fatigue, headache) were added.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea, Urticaria
Clinical narrative: Clay/gray colored stool; Mild nausea; Headache; Mild fatigue; Eye is swollen; Itchy eyes; Diarrhea; Runny nose; Stomach ache; Itchy Skin; Hives upper body; Rashes over the body; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), FAECES DISCOLOURED (Clay/gray colored stool) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Improvement) since 06-Jan-1992, Hypothyroidism since 2001, Anxiety since 1992, Anemia (Improvement) since 1974, ADHD, Food allergy (Allergic to fresh fruit, tree nuts.) and Pollen allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (AMPHETAMINE MIXED SALTS) and AMPHETAMINE for ADHD, LORATADINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LEVOTHYROXINE for Hypothyroidism, IBUPROFEN for Pain.    On 14-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body) and INJECTION SITE PAIN (Pain at injection site). On 15-Jan-2021, the patient experienced FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea), HEADACHE (Headache) and FATIGUE (Mild fatigue). On 15-Jan-2021, EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 17-Jan-2021, FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea) and FATIGUE (Mild fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Loratadine-D and a dose of Flonase and ibuprofen were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient demographic added. Patient relevant history and concomitant medications were added. The outcome of the events from recovering to recovered updated. New events (hives, injection site soreness, nausea, fatigue, headache) were added.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Heart rate increased
Clinical narrative: Increased heart rate (100 beats per minute); Face was red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face was red) and HEART RATE INCREASED (Increased heart rate (100 beats per minute)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026190A) 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) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced ERYTHEMA (Face was red). On 15-Jan-2021, the patient experienced HEART RATE INCREASED (Increased heart rate (100 beats per minute)). On 14-Jan-2021, ERYTHEMA (Face was red) had resolved. On 15-Jan-2021, HEART RATE INCREASED (Increased heart rate (100 beats per minute)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications details not reported by the reporter. Treatment details not reported 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 events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever at 102 F; Bad headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 102 degree Celsius (High) Body temperature-102 degree celsius.     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 medication details not reported by the reporter. Treatment included ibuprofen.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dizziness, Heart rate
Clinical narrative: Light headed; Aches, extremely sore; No feeling in the soles of her feet; Fever of 104; Really bad chills; Pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light headed), PAIN (Aches, extremely sore), HYPOAESTHESIA (No feeling in the soles of her feet) and PYREXIA (Fever of 104) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia in April 2020 and COVID-19 in March 2020.    On an unknown date, 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 IN EXTREMITY (Pain in arm). On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), PAIN (Aches, extremely sore), HYPOAESTHESIA (No feeling in the soles of her feet), PYREXIA (Fever of 104) and CHILLS (Really bad chills). On 14-Jan-2021, PAIN (Aches, extremely sore) outcome was unknown. On 15-Jan-2021, PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light headed), HYPOAESTHESIA (No feeling in the soles of her feet), PYREXIA (Fever of 104) and CHILLS (Really bad chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Blood pressure measurement: 155/90 mmHg (High) Blood pressure high. On 12-Jan-2021, Body temperature: 104 degree Celsius (High) body temperature increases. On 12-Jan-2021, Heart rate: 127 (High) Pulse rate increases.     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 were not reported by the reporter. Treatment included Tylenol and Motril.; 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Light headed; Aches, extremely sore; No feeling in the soles of her feet; Fever of 104; Really bad chills; Pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light headed), PAIN (Aches, extremely sore), HYPOAESTHESIA (No feeling in the soles of her feet) and PYREXIA (Fever of 104) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia in April 2020 and COVID-19 in March 2020.    On an unknown date, 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 IN EXTREMITY (Pain in arm). On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), PAIN (Aches, extremely sore), HYPOAESTHESIA (No feeling in the soles of her feet), PYREXIA (Fever of 104) and CHILLS (Really bad chills). On 14-Jan-2021, PAIN (Aches, extremely sore) outcome was unknown. On 15-Jan-2021, PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light headed), HYPOAESTHESIA (No feeling in the soles of her feet), PYREXIA (Fever of 104) and CHILLS (Really bad chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Blood pressure measurement: 155/90 mmHg (High) Blood pressure high. On 12-Jan-2021, Body temperature: 104 degree Celsius (High) body temperature increases. On 12-Jan-2021, Heart rate: 127 (High) Pulse rate increases.     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 were not reported by the reporter. Treatment included Tylenol and Motril.; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: It felt like bumble bee or wasp bit and tingling; Rash on her right upper arm; Mild site injection soreness/ Injection site tender to the touch; Red rash on her upper right arm; Injection site was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen). At the time of the report, INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen) 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 medication details were not reported by the reporter. Treatment included compress.; 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: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Got a rash on the left arm pit; Itchiness at injection site; Redness around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Got a rash on the left arm pit), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunization.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE NA) for Thyroid disorder.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced RASH (Got a rash on the left arm pit), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, RASH (Got a rash on the left arm pit) and VACCINATION SITE ERYTHEMA (Redness around the injection site) was resolving and VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl for itchiness.; 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: Asthenia, Blood pressure increased, Dizziness, Pain in extremity, Paraesthesia
Clinical narrative: Blood pressure approx. 180/110 mmhg; Tachycardia up to 140 bpm; Arm soreness; Dizziness; Weakness; Tingling sensation of both hands and feet; A spontaneous report was received on 24 Jan 2021 via the call center regarding a 40-year-old female patient who reported receiving the Moderna COVID-19 Vaccine (mRNA-1273) and experienced tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness.  The patient's medical history was not provided. The patient was allergic to Demerol. Concomitant medication included Vyvanse for (ADHD) attention deficit hyperactivity disorder.   On 23 Jan 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient reported tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness (still evident). No treatment medication was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 was resolved on 23 Jan 2021. The outcome of the event was arm soreness unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with no provided medical history who received her first of two planned doses of mRNA-1273, and on the same day experienced non-serious unlisted events of tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Blood pressure approx. 180/110 mmhg; Tachycardia up to 140 bpm; Arm soreness; Dizziness; Weakness; Tingling sensation of both hands and feet; A spontaneous report was received on 24 Jan 2021 via the call center regarding a 40-year-old female patient who reported receiving the Moderna COVID-19 Vaccine (mRNA-1273) and experienced tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness.  The patient's medical history was not provided. The patient was allergic to Demerol. Concomitant medication included Vyvanse for (ADHD) attention deficit hyperactivity disorder.   On 23 Jan 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient reported tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness (still evident). No treatment medication was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 was resolved on 23 Jan 2021. The outcome of the event was arm soreness unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with no provided medical history who received her first of two planned doses of mRNA-1273, and on the same day experienced non-serious unlisted events of tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Running back and forth to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Running back and forth to the restroom) in a 79-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) at an unspecified dose. On 15-Jan-2021, the patient experienced DIARRHOEA (Running back and forth to the restroom). At the time of the report, DIARRHOEA (Running back and forth to the restroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-008233 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, SARS-CoV-2 test positive, Tremor
Clinical narrative: Fever; Body aches; Tremors; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors), PYREXIA (Fever) and MYALGIA (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 14-Jan-2021, the patient experienced TREMOR (Tremors). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, TREMOR (Tremors), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 101.9 (Inconclusive) 101.9. On 13-Jan-2021, SARS-CoV-2 test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant details were reported by the reporter. No treatment details were reported by the reporter.; Sender's Comments: Based on biological implausibility the event of COVID-19 test positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events of (Pyrexia, Myalgia, Tremor), a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives on her back; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her back) and PYREXIA (Low grade fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 URTICARIA (Hives on her back) and PYREXIA (Low grade fever). At the time of the report, URTICARIA (Hives on her back) and PYREXIA (Low grade fever) 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.   Concomitant medications details were not reported by the reporter. Treatment included Benadryl.; 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: Urticaria
Clinical narrative: Developed hives on her arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Developed hives on her arms and legs) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Jan-2021, the patient experienced URTICARIA (Developed hives on her arms and legs). At the time of the report, URTICARIA (Developed hives on her arms and legs) had not 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.   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.; 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: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 13-Jan-2021, the patient 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 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was also not provided.  Treatment activities for event was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unspecified age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Heart rate, Heart rate increased
Clinical narrative: Eyes were swollen; Heart rate increase; Eyes were burning; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes were burning), EYE SWELLING (Eyes were swollen) and HEART RATE INCREASED (Heart rate increase) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: LIDOCAINE.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced EYE IRRITATION (Eyes were burning) and HEART RATE INCREASED (Heart rate increase). On 13-Jan-2021, the patient experienced EYE SWELLING (Eyes were swollen). On 12-Jan-2021, HEART RATE INCREASED (Heart rate increase) had resolved. At the time of the report, EYE IRRITATION (Eyes were burning) and EYE SWELLING (Eyes were swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Heart rate: (High) Rapid heart beat which subsided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Very large triangular shaped very red area on her arm, around the injection site.; Injection site slightly itchy; Muscle at injection site is somewhat painful; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful). At the time of the report, VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication also included for thyroid disorder. Treatment details not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Possible NNI
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: body aches; headache; fatigue; nausea; runny nose; sneezing; 99.2 fever; wheezing in the chest; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (runny nose), WHEEZING (wheezing in the chest), SNEEZING (sneezing), PYREXIA (99.2 fever) and NAUSEA (nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure since 15-Jan-2021, Asthma since 15-Jan-2021 and Heart attack since 15-Jan-2021. Concurrent medical conditions included Diabetes since 15-Jan-2021, Cholesterol since 15-Jan-2021, Hypertension on 15-Jan-2021 and Heart disease, unspecified since 15-Jan-2021. Concomitant products included METFORMIN , GLIMEPIRIDE, DULAGLUTIDE (TRULICITY), CARVEDILOL, LISINOPRIL, FUROSEMIDE, PRAVASTATIN, FENOFIBRATE and ACETYLSALICYLIC ACID (BABY ASPIRIN).    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 WHEEZING (wheezing in the chest). On 14-Jan-2021, the patient experienced RHINORRHOEA (runny nose), SNEEZING (sneezing) and PYREXIA (99.2 fever). On 15-Jan-2021, the patient experienced NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Jan-2021, WHEEZING (wheezing in the chest) had resolved. At the time of the report, RHINORRHOEA (runny nose), SNEEZING (sneezing), PYREXIA (99.2 fever), NAUSEA (nausea), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included aspirin and 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Wheezing
Clinical narrative: body aches; headache; fatigue; nausea; runny nose; sneezing; 99.2 fever; wheezing in the chest; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (runny nose), WHEEZING (wheezing in the chest), SNEEZING (sneezing), PYREXIA (99.2 fever) and NAUSEA (nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure since 15-Jan-2021, Asthma since 15-Jan-2021 and Heart attack since 15-Jan-2021. Concurrent medical conditions included Diabetes since 15-Jan-2021, Cholesterol since 15-Jan-2021, Hypertension on 15-Jan-2021 and Heart disease, unspecified since 15-Jan-2021. Concomitant products included METFORMIN , GLIMEPIRIDE, DULAGLUTIDE (TRULICITY), CARVEDILOL, LISINOPRIL, FUROSEMIDE, PRAVASTATIN, FENOFIBRATE and ACETYLSALICYLIC ACID (BABY ASPIRIN).    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 WHEEZING (wheezing in the chest). On 14-Jan-2021, the patient experienced RHINORRHOEA (runny nose), SNEEZING (sneezing) and PYREXIA (99.2 fever). On 15-Jan-2021, the patient experienced NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Jan-2021, WHEEZING (wheezing in the chest) had resolved. At the time of the report, RHINORRHOEA (runny nose), SNEEZING (sneezing), PYREXIA (99.2 fever), NAUSEA (nausea), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included aspirin and 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Sore arm at the injection site; Fatigue; Feel "funny"; Fever of 102 and next morning fever of 101; Severe shivering; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Feel "funny"), VACCINATION SITE PAIN (Sore arm at the injection site), PYREXIA (Fever of 102 and next morning fever of 101), CHILLS (Severe shivering) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (thalessemia trait) since 10-Dec-1958, Palpitations since 02-Jun-1970 and Dry eyes since 14-Aug-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 01-Jul-2015 to an unknown date, PROGESTERONE from 01-Jul-2015 to an unknown date and TESTOSTERONE from 01-Jul-2015 to an unknown date for Menopause, MULTI VITAMIN ONE A DAY and FISH OIL for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (Fever of 102 and next morning fever of 101) and CHILLS (Severe shivering). On 11-Jan-2021 at 10:00 PM, the patient experienced FEELING ABNORMAL (Feel "funny"). On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (Fatigue). On 12-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, FEELING ABNORMAL (Feel "funny"), VACCINATION SITE PAIN (Sore arm at the injection site), PYREXIA (Fever of 102 and next morning fever of 101) and CHILLS (Severe shivering) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 102 (High) 102. On 12-Jan-2021, Body temperature: 101 (High) 101.     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.   Patient was on unspecified antibiotics before the first dose was administered.  Patient reports self-treating with acetaminophen.   This case was linked to MOD-2021-090019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Updated concomitant medications, updated event details
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site; Fatigue; Feel "funny"; Fever of 102 and next morning fever of 101; Severe shivering; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Feel "funny"), VACCINATION SITE PAIN (Sore arm at the injection site), PYREXIA (Fever of 102 and next morning fever of 101), CHILLS (Severe shivering) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (thalessemia trait) since 10-Dec-1958, Palpitations since 02-Jun-1970 and Dry eyes since 14-Aug-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 01-Jul-2015 to an unknown date, PROGESTERONE from 01-Jul-2015 to an unknown date and TESTOSTERONE from 01-Jul-2015 to an unknown date for Menopause, MULTI VITAMIN ONE A DAY and FISH OIL for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (Fever of 102 and next morning fever of 101) and CHILLS (Severe shivering). On 11-Jan-2021 at 10:00 PM, the patient experienced FEELING ABNORMAL (Feel "funny"). On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (Fatigue). On 12-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, FEELING ABNORMAL (Feel "funny"), VACCINATION SITE PAIN (Sore arm at the injection site), PYREXIA (Fever of 102 and next morning fever of 101) and CHILLS (Severe shivering) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 102 (High) 102. On 12-Jan-2021, Body temperature: 101 (High) 101.     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.   Patient was on unspecified antibiotics before the first dose was administered.  Patient reports self-treating with acetaminophen.   This case was linked to MOD-2021-090019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Updated concomitant medications, updated event details
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Can´t lift it up, can´t move hand; Extreme soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can´t lift it up, can´t move hand) and VACCINATION SITE PAIN (Extreme soreness in her arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal.    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 VACCINATION SITE PAIN (Extreme soreness in her arm). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can´t lift it up, can´t move hand). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can´t lift it up, can´t move hand) and VACCINATION SITE PAIN (Extreme soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes cholesterol and blood pressure medication.  Treatment information includes: Put ice, 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.