chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: small area that is more firm than the rest of the arm; injection site is red and warm; injection site is red and warm; The site is tender and soreness that weekend following injection; the site became itchy; headache; she felt feverish and reported a fever of 102.2; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm), VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE PRURITUS (the site became itchy), VACCINATION SITE ERYTHEMA (injection site is red and warm) and HEADACHE (headache) in a female patient of an unknown age 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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm). On 08-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (she felt feverish and reported a fever of 102.2). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (the site became itchy). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE ERYTHEMA (injection site is red and warm) and VACCINATION SITE PAIN (The site is tender and soreness that weekend following injection). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at an unspecified dose and frequency. On 08-Jan-2021, PYREXIA (she felt feverish and reported a fever of 102.2) had resolved. At the time of the report, VACCINATION SITE INDURATION (small area that is more firm than the rest of the arm), VACCINATION SITE WARMTH (injection site is red and warm), VACCINATION SITE PRURITUS (the site became itchy) and VACCINATION SITE ERYTHEMA (injection site is red and warm) had not resolved and HEADACHE (headache) and VACCINATION SITE PAIN (The site is tender and soreness that weekend following injection) 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 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: Back pain, Chills, Dyspnoea, Headache, Pain
Clinical narrative: Back pain; Pain on left arm; Body ache; Shortness of breath; Red knot at the site of injection; Low grade fever; Headache; Chills; A spontaneous report was received from a consumer, 31-year-old, female who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced chills, low grade fever, pain on left arm, headache, back pain, body ache, shortness of breath and red knot at the site of injection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 08-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 037K20A) on her left arm for prophylaxis of COVID-19 infection.  On 08-JAN-2021, at about 20:00 the patient experienced chills, low grade fever, pain on left arm, headache, back pain, body ache, shortness of breath, and red knot at the site of injection. The patient took Aspirin and symptoms have subsided except red knot which was ongoing  Treatment for the event included Aspirin.  The action taken for Moderna COVID-19 vaccine was unknown.  The outcome of the events, chills, low grade fever, pain on left arm, headache, back pain, body ache, shortness of breath were recovered. The outcome of the event, red knot at the site of injection was not recovered.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site induration
Clinical narrative: Back pain; Pain on left arm; Body ache; Shortness of breath; Red knot at the site of injection; Low grade fever; Headache; Chills; A spontaneous report was received from a consumer, 31-year-old, female who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced chills, low grade fever, pain on left arm, headache, back pain, body ache, shortness of breath and red knot at the site of injection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 08-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 037K20A) on her left arm for prophylaxis of COVID-19 infection.  On 08-JAN-2021, at about 20:00 the patient experienced chills, low grade fever, pain on left arm, headache, back pain, body ache, shortness of breath, and red knot at the site of injection. The patient took Aspirin and symptoms have subsided except red knot which was ongoing  Treatment for the event included Aspirin.  The action taken for Moderna COVID-19 vaccine was unknown.  The outcome of the events, chills, low grade fever, pain on left arm, headache, back pain, body ache, shortness of breath were recovered. The outcome of the event, red knot at the site of injection was not recovered.; 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: itchy; Redness at site; tender; A spontaneous report was received from a consumer who is a 76-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at site, itchy, and tender.  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 metoprolol, aspirin, ascorbic acid, vitamin D and fish oil.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026-L206A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the same day as the vaccination, the patient reported she had redness, itching, and tenderness at the injection site and it measured approximately the size of a half dollar.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events of redness at site, itchy and tender was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Chills, Discomfort, Headache
Clinical narrative: Rapid heart beat; A general feeling of not feeling well; Anxiety; Body aches; chills; Feels feverish but doesn't have a fever; Felt terrible after the injection and stated, "it feels like a truck ran over her".; Lower back pain (last night); Headache (last night); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".) and BACK PAIN (Lower back pain (last night)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and DULOXETINE 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 DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".), BACK PAIN (Lower back pain (last night)) and HEADACHE (Headache (last night)). On 12-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), MYALGIA (Body aches), CHILLS (chills) and PYREXIA (Feels feverish but doesn't have a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".), BACK PAIN (Lower back pain (last night)), HEADACHE (Headache (last night)), MYALGIA (Body aches), CHILLS (chills) and PYREXIA (Feels feverish but doesn't have a fever) outcome was unknown.        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. Further information has been requested
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Rapid heart beat; A general feeling of not feeling well; Anxiety; Body aches; chills; Feels feverish but doesn't have a fever; Felt terrible after the injection and stated, "it feels like a truck ran over her".; Lower back pain (last night); Headache (last night); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".) and BACK PAIN (Lower back pain (last night)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and DULOXETINE 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 DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".), BACK PAIN (Lower back pain (last night)) and HEADACHE (Headache (last night)). On 12-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), MYALGIA (Body aches), CHILLS (chills) and PYREXIA (Feels feverish but doesn't have a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, HEART RATE INCREASED (Rapid heart beat), VACCINATION COMPLICATION (A general feeling of not feeling well), ANXIETY (Anxiety), DISCOMFORT (Felt terrible after the injection and stated, "it feels like a truck ran over her".), BACK PAIN (Lower back pain (last night)), HEADACHE (Headache (last night)), MYALGIA (Body aches), CHILLS (chills) and PYREXIA (Feels feverish but doesn't have a fever) outcome was unknown.        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. Further information has been requested
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia, Vaccination complication
Clinical narrative: Fever; Chills; doesn't feel 100%, in bad shape; Tiredness; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VACCINATION COMPLICATION (doesn't feel 100%, in bad shape), FATIGUE (Tiredness) and DIARRHOEA (Diarrhea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), VACCINATION COMPLICATION (doesn't feel 100%, in bad shape), FATIGUE (Tiredness) and DIARRHOEA (Diarrhea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), VACCINATION COMPLICATION (doesn't feel 100%, in bad shape), FATIGUE (Tiredness) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medications were not provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: form was attached; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dysphagia, Fatigue, Headache, Myalgia
Clinical narrative: Under armpit there is a swollen area; Swelling and tender in the left arm; Swelling and tender in the left arm; Difficulty in swallowing; Under arm was sore, Tender to touch; Little aching; Fatigue; Headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), MYALGIA (Little aching) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included LOSARTAN, VITAMIN D3, CITALOPRAM, ROSUVASTATIN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FAMOTIDINE (PEPCID AC), ZOLPIDEM, CLONAZEPAM (KLONOPIN), OMEPRAZOLE and LEVOTHYROXINE.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), MYALGIA (Little aching), FATIGUE (Fatigue) and HEADACHE (Headache). On 14-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), VACCINATION SITE SWELLING (Swelling and tender in the left arm) and VACCINATION SITE PAIN (Swelling and tender in the left arm). At the time of the report, DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), MYALGIA (Little aching), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling and tender in the left arm) and VACCINATION SITE PAIN (Swelling and tender in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided; 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Under armpit there is a swollen area; Swelling and tender in the left arm; Swelling and tender in the left arm; Difficulty in swallowing; Under arm was sore, Tender to touch; Little aching; Fatigue; Headache; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), MYALGIA (Little aching) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .  Concomitant products included LOSARTAN, VITAMIN D3, CITALOPRAM, ROSUVASTATIN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FAMOTIDINE (PEPCID AC), ZOLPIDEM, CLONAZEPAM (KLONOPIN), OMEPRAZOLE and LEVOTHYROXINE.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), MYALGIA (Little aching), FATIGUE (Fatigue) and HEADACHE (Headache). On 14-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), VACCINATION SITE SWELLING (Swelling and tender in the left arm) and VACCINATION SITE PAIN (Swelling and tender in the left arm). At the time of the report, DYSPHAGIA (Difficulty in swallowing), AXILLARY PAIN (Under arm was sore, Tender to touch), VACCINATION SITE LYMPHADENOPATHY (Under armpit there is a swollen area), MYALGIA (Little aching), FATIGUE (Fatigue), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling and tender in the left arm) and VACCINATION SITE PAIN (Swelling and tender in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided; 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter.   On 07-Jan-2021, patient had symptoms of hot and cold sweating, fever, body ache, cough, congestion, weakness, fatigue and loss of appetite. Treatment medication included Paracetamol for aches and fever.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: joint pain; body aches; temperature of 100.4°; achy; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (tired), PAIN (achy), ARTHRALGIA (joint pain) and MYALGIA (body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011S20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-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 HEADACHE (headache) and FATIGUE (tired). On 09-Jan-2021, the patient experienced PAIN (achy). On an unknown date, the patient experienced ARTHRALGIA (joint pain), MYALGIA (body aches) and PYREXIA (temperature of 100.4°). At the time of the report, HEADACHE (headache), FATIGUE (tired), PAIN (achy), ARTHRALGIA (joint pain) and MYALGIA (body aches) outcome was unknown and PYREXIA (temperature of 100.4°) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 100.4 °F 100.4.     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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: joint pain; body aches; temperature of 100.4°; achy; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (tired), PAIN (achy), ARTHRALGIA (joint pain) and MYALGIA (body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011S20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-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 HEADACHE (headache) and FATIGUE (tired). On 09-Jan-2021, the patient experienced PAIN (achy). On an unknown date, the patient experienced ARTHRALGIA (joint pain), MYALGIA (body aches) and PYREXIA (temperature of 100.4°). At the time of the report, HEADACHE (headache), FATIGUE (tired), PAIN (achy), ARTHRALGIA (joint pain) and MYALGIA (body aches) outcome was unknown and PYREXIA (temperature of 100.4°) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 100.4 °F 100.4.     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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: Urinating every 10 minutes; Fever of 102 deg F; Headache; Arm ache; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Urinating every 10 minutes), PYREXIA (Fever of 102 deg F), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-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 POLLAKIURIA (Urinating every 10 minutes), PYREXIA (Fever of 102 deg F), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, POLLAKIURIA (Urinating every 10 minutes), PYREXIA (Fever of 102 deg F), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 deg f 102 deg F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 these events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, Dyspnoea, Headache
Clinical narrative: Loss of taste in the left side of the mouth; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Weakness; Lungs felt heavy; Pain in the lungs; Headache; Join pain; Body Ache; Nausea; This spontaneous case was reported by a dental assistant and describes the occurrence of AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath) and ASTHENIA (Weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea) had not resolved.        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 medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Nausea, Pulmonary function test, Pulmonary pain
Clinical narrative: Loss of taste in the left side of the mouth; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Weakness; Lungs felt heavy; Pain in the lungs; Headache; Join pain; Body Ache; Nausea; This spontaneous case was reported by a dental assistant and describes the occurrence of AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath) and ASTHENIA (Weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea) had not resolved.        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 medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Loss of taste in the left side of the mouth; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Weakness; Lungs felt heavy; Pain in the lungs; Headache; Join pain; Body Ache; Nausea; This spontaneous case was reported by a dental assistant and describes the occurrence of AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath) and ASTHENIA (Weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea) had not resolved.        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 medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash started, rash is the size of a small saucer; Red; Became itchy; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Became itchy), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Rash started, rash is the size of a small saucer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm sore). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE ERYTHEMA (Red). On 12-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash started, rash is the size of a small saucer). On 08-Jan-2021, VACCINATION SITE PAIN (Arm sore) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Became itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Rash started, rash is the size of a small saucer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment drug calamine-pramocaine hydrochloride was administered to treat itchiness.; 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: All her joints started aching really bad; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (All her joints started aching really bad) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Asthma (The past medical history includes asthma.). Concurrent medical conditions included Allergy to vaccine (The patient is reported as possibly allergic to tetanus injection.). Concomitant products included MONTELUKAST, DESLORATADINE (CLARINEX [DESLORATADINE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 07-Jan-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced ARTHRALGIA (All her joints started aching really bad). At the time of the report, ARTHRALGIA (All her joints started aching really bad) 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.   Treatment details include ibuprofen and aspirin; 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: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: tired; Chills; body aches,minor body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (body aches,minor body aches), PYREXIA (fever) and FATIGUE (tired) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive from 22-Dec-2020 to 31-Dec-2020 and Tendonitis (in the left arm,). Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and METOPROLOL SUCCINATE (TOPROL).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021 at 10:00 PM, the patient experienced CHILLS (Chills), MYALGIA (body aches,minor body aches) and PYREXIA (fever). On 11-Jan-2021, the patient experienced FATIGUE (tired). On 11-Jan-2021 at 5:00 AM, CHILLS (Chills) had resolved. On 12-Jan-2021, MYALGIA (body aches,minor body aches), PYREXIA (fever) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included paracetamol.  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.; 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: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pain in extremity, Swelling of eyelid
Clinical narrative: Arm is sore; Her eye is watering; Eyelid is sowllen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), LACRIMATION INCREASED (Her eye is watering) and SWELLING OF EYELID (Eyelid is sowllen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore), LACRIMATION INCREASED (Her eye is watering) and SWELLING OF EYELID (Eyelid is sowllen). At the time of the report, PAIN IN EXTREMITY (Arm is sore), LACRIMATION INCREASED (Her eye is watering) and SWELLING OF EYELID (Eyelid is sowllen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.    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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Chills; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 102 °f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for these events included acetaminophen.  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.   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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Trismus
Clinical narrative: Lock jaw; Upset stomach; chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TRISMUS (Lock jaw), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 TRISMUS (Lock jaw), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (chills). At the time of the report, TRISMUS (Lock jaw), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (chills) 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 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: Chest pain, Dyspnoea, Fatigue, Gastroenteritis viral
Clinical narrative: it's like the worst stomach flu I've ever had; shortness of breath; physical chest pain; so tired; A spontaneous report was received from a non-healthcare professional concerning a 33 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it's like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired.  No medical history was reported.  No concomitant medication was reported.  On 08-Jan-2021, prior to the onset of the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via an intramuscular route in right arm for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired.  Laboratory details was not provided.  Treatment medication was not reported.  Action taken with mRNA-1273 in response to the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired was not provided.  The outcome of the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired was not provided.  The reporter did not provide the assessment of the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired to study drug.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Needed to catch breath; Loose stool; Arm was sore; Horrible chills; Fever of 99 F; Headache; Body aches; A spontaneous report was received from a consumer who was a 66-year-old, female, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm was sore, horrible chills, fever of 99F, headache, body aches, loose stool, and felt like needed to catch breath.  The patient's medical history included asthma, and COVID-19. Concomitant medications were not reported.  On 08 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, one day after vaccine administration, the patient's arm was sore, she had chills, fever of 99F, headache, and body aches.   On 10 Jan 2021, her previous symptoms resolved but she began to experience loose stool, and felt like she needed to catch her breath. The patient made an appointment with a respirator specialist.  On 11 Jan 2021, her gastrointestinal symptoms went away.  On 12 Jan 2021, the patient's breathing issues were better but she continued to have pain in her arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, sore arm was considered not resolved; outcome of the events, chills, fever of 99F, headache, body aches, were resolved on 10 Jan 2021; outcome of the event, loose stool, was resolved on 11 Jan 2021; outcome of the event, felt like needed to catch breath, were resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old, female patient with medical history of asthma and COVID-19, who experienced expected event of pain, chills, pyrexia, headache, myalgia and unexpected event of diarrhea and dyspnea. The event occurred 2 days after the first dose of mRNA-1273 (Lot number: 027L20A). 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: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Needed to catch breath; Loose stool; Arm was sore; Horrible chills; Fever of 99 F; Headache; Body aches; A spontaneous report was received from a consumer who was a 66-year-old, female, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm was sore, horrible chills, fever of 99F, headache, body aches, loose stool, and felt like needed to catch breath.  The patient's medical history included asthma, and COVID-19. Concomitant medications were not reported.  On 08 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, one day after vaccine administration, the patient's arm was sore, she had chills, fever of 99F, headache, and body aches.   On 10 Jan 2021, her previous symptoms resolved but she began to experience loose stool, and felt like she needed to catch her breath. The patient made an appointment with a respirator specialist.  On 11 Jan 2021, her gastrointestinal symptoms went away.  On 12 Jan 2021, the patient's breathing issues were better but she continued to have pain in her arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, sore arm was considered not resolved; outcome of the events, chills, fever of 99F, headache, body aches, were resolved on 10 Jan 2021; outcome of the event, loose stool, was resolved on 11 Jan 2021; outcome of the event, felt like needed to catch breath, were resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old, female patient with medical history of asthma and COVID-19, who experienced expected event of pain, chills, pyrexia, headache, myalgia and unexpected event of diarrhea and dyspnea. The event occurred 2 days after the first dose of mRNA-1273 (Lot number: 027L20A). 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: Vaccination site cellulitis
Clinical narrative: cellulitis on her arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (cellulitis on her arm). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis on her arm) 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.   No concomitant medications were provided  Patient reports getting antibiotics.; 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.