chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Middle ear effusion
Clinical narrative: Ear ache; Fluid on her ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR PAIN (Ear ache) and MIDDLE EAR EFFUSION (Fluid on her ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced EAR PAIN (Ear ache). In January 2021, the patient experienced MIDDLE EAR EFFUSION (Fluid on her ears). At the time of the report, EAR PAIN (Ear ache) and MIDDLE EAR EFFUSION (Fluid on her ears) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company Comment  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Injection site pain, Nausea, Neck pain
Clinical narrative: Pain in the base of the cervical spine; Pain in the hands; Pain in the neck; Loss of appetite; Pain in the shoulders, arm joints; Nausea; Pain in the injection site; This spontaneous case was reported by a physician and describes the occurrence of SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Pain in the shoulders, arm joints) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included AMIODARONE for Blood pressure.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Pain in the injection site). On 05-Jan-2021, the patient experienced SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite), ARTHRALGIA (Pain in the shoulders, arm joints) and NAUSEA (Nausea). On 02-Jan-2021, INJECTION SITE PAIN (Pain in the injection site) had resolved. At the time of the report, SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite), ARTHRALGIA (Pain in the shoulders, arm joints) and NAUSEA (Nausea) 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.   The patient began to experience pain at the injection site the first two days after receiving the vaccine and then it resolved. The patient went to urgent care and was prescribed Natroxe and Vitamin B complex.  Treatment information was not provided.  Company Comment - 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's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Spinal pain
Clinical narrative: Pain in the base of the cervical spine; Pain in the hands; Pain in the neck; Loss of appetite; Pain in the shoulders, arm joints; Nausea; Pain in the injection site; This spontaneous case was reported by a physician and describes the occurrence of SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite) and ARTHRALGIA (Pain in the shoulders, arm joints) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included AMIODARONE for Blood pressure.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE PAIN (Pain in the injection site). On 05-Jan-2021, the patient experienced SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite), ARTHRALGIA (Pain in the shoulders, arm joints) and NAUSEA (Nausea). On 02-Jan-2021, INJECTION SITE PAIN (Pain in the injection site) had resolved. At the time of the report, SPINAL PAIN (Pain in the base of the cervical spine), PAIN IN EXTREMITY (Pain in the hands), NECK PAIN (Pain in the neck), DECREASED APPETITE (Loss of appetite), ARTHRALGIA (Pain in the shoulders, arm joints) and NAUSEA (Nausea) 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.   The patient began to experience pain at the injection site the first two days after receiving the vaccine and then it resolved. The patient went to urgent care and was prescribed Natroxe and Vitamin B complex.  Treatment information was not provided.  Company Comment - 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'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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Mild joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Mild joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (Mild joint pain). In January 2021, ARTHRALGIA (Mild joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and pain at the injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness and pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and pain at the injection site) outcome was unknown.        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.  Company Comment - 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: Nausea, Vaccination site pain
Clinical narrative: Nausea; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site tenderness) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site tenderness). On 12-Jan-2021, the patient experienced NAUSEA (Nausea). On 08-Jan-2021, VACCINATION SITE PAIN (Injection site tenderness) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hurting bad her left arm), HEADACHE (headaches) and VACCINATION SITE PAIN (starting hurting her right arm at the site injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis, Cancer and Gout. Concurrent medical conditions included Blood pressure high. Concomitant products included TRAMADOL, L-THYROXINE [LEVOTHYROXINE], ALLOPURINOL, AMLODIPINE MALEATE (MELODIPINE), DICYCLOMINE [DICYCLOVERINE], LISINOPRIL, PANTOPRAZOLE, BIOTIN and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (headaches). On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (starting hurting her right arm at the site injection). On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (hurting bad her left arm). At the time of the report, PAIN IN EXTREMITY (hurting bad her left arm), HEADACHE (headaches) and VACCINATION SITE PAIN (starting hurting her right arm at the site 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.   Treatment medication not provided by reporter.; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Site of her injection is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Site of her injection is swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Site of her injection is swollen). At the time of the report, VACCINATION SITE SWELLING (Site of her injection is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product was not provided.  Patient did not received any treatment.  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.   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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain in jaw
Clinical narrative: shortness of breath; chest pain; right jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and PAIN IN JAW (right jaw pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not provided).    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and PAIN IN JAW (right jaw pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and PAIN IN JAW (right jaw pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Body temperature, Decreased appetite, Fatigue
Clinical narrative: 8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast; No Appetite; No Energy; fever of 103.9; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast), DECREASED APPETITE (No Appetite), ASTHENIA (No Energy), PYREXIA (fever of 103.9) and FATIGUE (Tired) in an 81-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ABDOMINAL PAIN (8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast), DECREASED APPETITE (No Appetite), ASTHENIA (No Energy), PYREXIA (fever of 103.9) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) 09-Jan-2021 for Fever, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) 09-Jan-2021 for Abdominal pain, at an unspecified dose and frequency. On 09-Jan-2021, ABDOMINAL PAIN (8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast), DECREASED APPETITE (No Appetite), ASTHENIA (No Energy), PYREXIA (fever of 103.9) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Body temperature: 103.9 (High) Fever 103.9 was reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast; No Appetite; No Energy; fever of 103.9; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast), DECREASED APPETITE (No Appetite), ASTHENIA (No Energy), PYREXIA (fever of 103.9) and FATIGUE (Tired) in an 81-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ABDOMINAL PAIN (8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast), DECREASED APPETITE (No Appetite), ASTHENIA (No Energy), PYREXIA (fever of 103.9) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) 09-Jan-2021 for Fever, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) 09-Jan-2021 for Abdominal pain, at an unspecified dose and frequency. On 09-Jan-2021, ABDOMINAL PAIN (8 or 9 inch pain which ran down her abdomen about 1 inch under her left breast), DECREASED APPETITE (No Appetite), ASTHENIA (No Energy), PYREXIA (fever of 103.9) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Body temperature: 103.9 (High) Fever 103.9 was reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache; Injection site soreness; Injection site redness; A spontaneous report (United States) was received from a consumer, concerning himself, a 71-years-old male patient, who received Moderna's COVID-19 Vaccine and developed headache, injection site soreness and injection site redness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 17-Jan-2021 evening, the patient started having side effects. These side effects include headache, soreness and redness at the site of injection. On 18-Jan-2021, the patient was treated with acetaminophen 100mg and it helped him with his headache. However, he was still having soreness and redness at the site of injection. Patient also reported that he has not contacted his healthcare provider yet.  Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the event, headache was considered resolved on an unspecified date in jan-2021. The outcome of the events, injection site soreness and injection site redness were considered not resolved at the time of this report.; Reporter's Comments: This case concerns a 71 year-old, male patient, who experienced events of  headache, injection site soreness and injection site redness. The events occurred the same evening after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph nodes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LYMPHADENOPATHY (Enlarged lymph nodes). At the time of the report, LYMPHADENOPATHY (Enlarged lymph nodes) 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.   No concomitant medications were provided 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 date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Swelling
Clinical narrative: Neck is noticeable larger; Swelling of supraclavicular lymph nodes; Axillary tenderness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck is noticeable larger), LYMPHADENOPATHY (Swelling of supraclavicular lymph nodes) and AXILLARY PAIN (Axillary tenderness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced AXILLARY PAIN (Axillary tenderness). On 06-Jan-2021, the patient experienced SWELLING (Neck is noticeable larger) and LYMPHADENOPATHY (Swelling of supraclavicular lymph nodes). On 04-Jan-2021, AXILLARY PAIN (Axillary tenderness) had resolved. At the time of the report, SWELLING (Neck is noticeable larger) and LYMPHADENOPATHY (Swelling of supraclavicular lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events paracetamol was reported.   Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: CHILLS; fever (100.7° F); A spontaneous report was received from a consumer concerning a 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (100.7° F) and chills.  The patient's medical history, as provided by the reporter, included that he is on Diabetes treatment. He was diagnosed with COVID-19 on 06 Dec 2021. No Concomitant medications were provided.  On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.   On the morning of 07 Jan 2021, the patient experienced fever (100.7° F) and chills. Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events,fever (100.7° F) and chills were unknown.; 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: Exposure during pregnancy, Fatigue, Headache
Clinical narrative: Slight headache; pregnancy; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy), FATIGUE (Fatigue) and HEADACHE (Slight headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (5 total).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Aug-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy) and FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced HEADACHE (Slight headache). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. On 10-Jan-2021, FATIGUE (Fatigue) and HEADACHE (Slight headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  For the events of fatigue and headache, 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: Headache
Clinical narrative: Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) 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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      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 product use was not provided by the reporter.  No treatment information was provided.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Investigation, Pyrexia
Clinical narrative: chills; Fever 99.6; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever 99.6), FATIGUE (Fatigue) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included POTASSIUM 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 CHILLS (chills), PYREXIA (Fever 99.6), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, CHILLS (chills), PYREXIA (Fever 99.6), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Tylenol and Advil for fever.  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.; Sender'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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: swollen; experiencing a widening rash; joint pain in her neck to shoulder area; arms was itchy near the injection site; Nausea; Arm Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash), VACCINATION SITE PRURITUS (arms was itchy near the injection site) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Fatigue). On 03-Jan-2021, the patient experienced NAUSEA (Nausea). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arms was itchy near the injection site). On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash) and ARTHRALGIA (joint pain in her neck to shoulder area). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash), VACCINATION SITE PRURITUS (arms was itchy near the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (joint pain in her neck to shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment details 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: swollen; experiencing a widening rash; joint pain in her neck to shoulder area; arms was itchy near the injection site; Nausea; Arm Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash), VACCINATION SITE PRURITUS (arms was itchy near the injection site) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Fatigue). On 03-Jan-2021, the patient experienced NAUSEA (Nausea). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arms was itchy near the injection site). On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash) and ARTHRALGIA (joint pain in her neck to shoulder area). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PERIPHERAL SWELLING (swollen), RASH (experiencing a widening rash), VACCINATION SITE PRURITUS (arms was itchy near the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and ARTHRALGIA (joint pain in her neck to shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment details 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin reaction, Suppressed lactation, Urticaria, Vaccination site pruritus
Clinical narrative: felt like supply decreased (breast milk); Experienced a half dollar sized hive at the injection sit; arm became itchy; generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back); Random patches of hives in the same areas; Skin reactions; Pruritus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Skin reactions), PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)), URTICARIA (Random patches of hives in the same areas), SUPPRESSED LACTATION (felt like supply decreased (breast milk)) and VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Seasonal allergy.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Dec-2020, the patient experienced SKIN REACTION (Skin reactions) and PRURITUS (Pruritus ). On 01-Jan-2021, the patient experienced PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)) and URTICARIA (Random patches of hives in the same areas). On 09-Jan-2021, the patient experienced SUPPRESSED LACTATION (felt like supply decreased (breast milk)), VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) and VACCINATION SITE PRURITUS (arm became itchy). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 02-Jan-2021, URTICARIA (Random patches of hives in the same areas) had resolved. On 09-Jan-2021, VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) had resolved. At the time of the report, SKIN REACTION (Skin reactions), PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)), SUPPRESSED LACTATION (felt like supply decreased (breast milk)), VACCINATION SITE PRURITUS (arm became itchy) and PRURITUS (Pruritus ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: felt like supply decreased (breast milk); Experienced a half dollar sized hive at the injection sit; arm became itchy; generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back); Random patches of hives in the same areas; Skin reactions; Pruritus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Skin reactions), PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)), URTICARIA (Random patches of hives in the same areas), SUPPRESSED LACTATION (felt like supply decreased (breast milk)) and VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Seasonal allergy.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Dec-2020, the patient experienced SKIN REACTION (Skin reactions) and PRURITUS (Pruritus ). On 01-Jan-2021, the patient experienced PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)) and URTICARIA (Random patches of hives in the same areas). On 09-Jan-2021, the patient experienced SUPPRESSED LACTATION (felt like supply decreased (breast milk)), VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) and VACCINATION SITE PRURITUS (arm became itchy). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 02-Jan-2021, URTICARIA (Random patches of hives in the same areas) had resolved. On 09-Jan-2021, VACCINATION SITE URTICARIA (Experienced a half dollar sized hive at the injection sit) had resolved. At the time of the report, SKIN REACTION (Skin reactions), PRURITUS (generalized itchiness all over her body(including arms, cheeks, thighs, abdominal area and back)), SUPPRESSED LACTATION (felt like supply decreased (breast milk)), VACCINATION SITE PRURITUS (arm became itchy) and PRURITUS (Pruritus ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Feeling hot, Influenza like illness, Injection site erythema
Clinical narrative: Lymph nodes on her clavicle and armpit; joint pain; Hard lump on her arm; red ring; Metallic taste; Flu aches in her neck and shoulder region.; Wet sensation on her arm and warm feeling; A spontaneous report was received from a health care professional, who is a 42-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced metallic taste, wet sensation on her arm, warmth feeling, flu aches in neck and shoulder region, red ring and hard lump on her arm (that was itchy and sore), joint pain and lymph nodes on her clavicle and armpit (which was warm, red and swollen)   The patient's medical history was not provided. No concomitant medications were reported.  On 08 JAN 2021, the patient received their first dose of mRNA-1273 (Batch number: 011J20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  On 08 JAN 2021, the patient received her first dose at 9:45 am. Immediately after the vaccine the patient experienced metallic taste which disappeared after 5 minutes. The patient stated that after 2 hours she felt wet sensation on her arm, warmth feeling that was resolved. After 6 hours she had flu aches in neck and shoulder region. On 9 JAN 2021, she noticed red ring and hard lump on her arm (which was itchy and sore). On 13 JAN 2021, she experienced joint pain. The patient also reported that she had lymph nodes on her clavicle and armpits (which was warm, red and swollen).  Treatment included was ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, metallic taste, wet sensation on her arm, warmth feeling, flu aches in neck and shoulder region, were resolved on 09JAN 2021 and red ring and hard lump on her arm (that was itchy and sore), were resolved on 12 JAN 2021 and joint pain was considered resolved on 13 JAN 2021. Lymph nodes on her clavicle and armpit (which was warm, red and swollen), were considered not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Lymphadenopathy
Clinical narrative: Lymph nodes on her clavicle and armpit; joint pain; Hard lump on her arm; red ring; Metallic taste; Flu aches in her neck and shoulder region.; Wet sensation on her arm and warm feeling; A spontaneous report was received from a health care professional, who is a 42-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced metallic taste, wet sensation on her arm, warmth feeling, flu aches in neck and shoulder region, red ring and hard lump on her arm (that was itchy and sore), joint pain and lymph nodes on her clavicle and armpit (which was warm, red and swollen)   The patient's medical history was not provided. No concomitant medications were reported.  On 08 JAN 2021, the patient received their first dose of mRNA-1273 (Batch number: 011J20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  On 08 JAN 2021, the patient received her first dose at 9:45 am. Immediately after the vaccine the patient experienced metallic taste which disappeared after 5 minutes. The patient stated that after 2 hours she felt wet sensation on her arm, warmth feeling that was resolved. After 6 hours she had flu aches in neck and shoulder region. On 9 JAN 2021, she noticed red ring and hard lump on her arm (which was itchy and sore). On 13 JAN 2021, she experienced joint pain. The patient also reported that she had lymph nodes on her clavicle and armpits (which was warm, red and swollen).  Treatment included was ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, metallic taste, wet sensation on her arm, warmth feeling, flu aches in neck and shoulder region, were resolved on 09JAN 2021 and red ring and hard lump on her arm (that was itchy and sore), were resolved on 12 JAN 2021 and joint pain was considered resolved on 13 JAN 2021. Lymph nodes on her clavicle and armpit (which was warm, red and swollen), were considered not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced FATIGUE (Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft). On 11-Jan-2021, FATIGUE (Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft) had 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 relevant concomitant medications were reported.   No treatment information was provided.; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain in extremity
Clinical narrative: Arm sore; Arm sensitive; Feel tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Arm sensitive) and FATIGUE (Feel tired) in a 72-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 Cough.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Arm sensitive) and FATIGUE (Feel tired). At the time of the report, PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Arm sensitive) and FATIGUE (Feel tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events were not reported.  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.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Palpitations, Somnolence
Clinical narrative: short of breath; strong heart palpitation; feeling unwell; drowsy; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (strong heart palpitation), MALAISE (feeling unwell) and SOMNOLENCE (drowsy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20/2A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and ESCITALOPRAM for an unknown indication.    On 08-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 DYSPNOEA (short of breath), PALPITATIONS (strong heart palpitation), MALAISE (feeling unwell) and SOMNOLENCE (drowsy). At the time of the report, DYSPNOEA (short of breath) and MALAISE (feeling unwell) outcome was unknown and PALPITATIONS (strong heart palpitation) and SOMNOLENCE (drowsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; 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.