chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; headache; body aches; joint pain; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     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 PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 101.3 °F High and 99.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: Vaccination site pain
Clinical narrative: Fever; headache; body aches; joint pain; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     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 PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (headache), MYALGIA (body aches), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 101.3 °F High and 99.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Jan-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were drugs used for bipolar, blood pressure, heart stiffness and heart disease. Treatment for the event was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the event, 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 onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Lymph node swelling under the arm I received the vaccine; Tenderness under the arm; A spontaneous report was received from a consumer concerning a female patient of unknownage,  who experienced lymph node swelling under the arm where they received the vaccine and tenderness under the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received her first of two planed doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after receiving the vaccine, the patient experienced lymph node swelling under the arm and tenderness under the arm.  On 06 Jan 2021, the patient had swollen lymph nodes in both the arms.   Treatment of these events were not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, lymphadenopathy and axillary pain 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis at injection site; red, swollen, warm, and painful) 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 Gastritis. Concomitant products included SUCRALFATE (CARAFATE), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and FAMOTIDINE for Gastritis.    On 07-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 VACCINATION SITE CELLULITIS (Cellulitis at injection site; red, swollen, warm, and painful). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis at injection site; red, swollen, warm, and painful) 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.; 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: Pain, Rash, Urticaria
Clinical narrative: Hives; Really bad body aches; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PAIN (Really bad body aches) and RASH (Rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced URTICARIA (Hives), PAIN (Really bad body aches) and RASH (Rash). At the time of the report, URTICARIA (Hives), PAIN (Really bad body aches) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Benadryl, Zyrtec and Pepcid.  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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chest pain, Insomnia, Nausea
Clinical narrative: She had a fever of 101 F; pain in underarm; chest pain; pain in her arm; Left arm where the injection was administered was itchy; She hasn't slept all night; Nausea; Has been throwing up since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), INSOMNIA (She hasn't slept all night), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy) and AXILLARY PAIN (pain in underarm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart murmur and Hypertension.    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 INSOMNIA (She hasn't slept all night), VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy), NAUSEA (Nausea) and VOMITING (Has been throwing up since yesterday). On 08-Jan-2021, the patient experienced CHEST PAIN (chest pain), PAIN IN EXTREMITY (pain in her arm) and AXILLARY PAIN (pain in underarm). On 08-Jan-2021 at 3:00 AM, the patient experienced PYREXIA (She had a fever of 101 F). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy) had resolved. At the time of the report, CHEST PAIN (chest pain), INSOMNIA (She hasn't slept all night), PAIN IN EXTREMITY (pain in her arm), AXILLARY PAIN (pain in underarm), NAUSEA (Nausea) and VOMITING (Has been throwing up since yesterday) had not resolved and PYREXIA (She had a fever of 101 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 101 °F (High) 101°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using High Blood Pressure pills (unspecified) concomitantly.; 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: Pain in extremity, Pyrexia, Vaccination site pruritus, Vomiting
Clinical narrative: She had a fever of 101 F; pain in underarm; chest pain; pain in her arm; Left arm where the injection was administered was itchy; She hasn't slept all night; Nausea; Has been throwing up since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), INSOMNIA (She hasn't slept all night), PAIN IN EXTREMITY (pain in her arm), VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy) and AXILLARY PAIN (pain in underarm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart murmur and Hypertension.    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 INSOMNIA (She hasn't slept all night), VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy), NAUSEA (Nausea) and VOMITING (Has been throwing up since yesterday). On 08-Jan-2021, the patient experienced CHEST PAIN (chest pain), PAIN IN EXTREMITY (pain in her arm) and AXILLARY PAIN (pain in underarm). On 08-Jan-2021 at 3:00 AM, the patient experienced PYREXIA (She had a fever of 101 F). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PRURITUS (Left arm where the injection was administered was itchy) had resolved. At the time of the report, CHEST PAIN (chest pain), INSOMNIA (She hasn't slept all night), PAIN IN EXTREMITY (pain in her arm), AXILLARY PAIN (pain in underarm), NAUSEA (Nausea) and VOMITING (Has been throwing up since yesterday) had not resolved and PYREXIA (She had a fever of 101 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 101 °F (High) 101°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using High Blood Pressure pills (unspecified) concomitantly.; 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: Vaccination site reaction
Clinical narrative: Developed a reaction in her arms at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Developed a reaction in her arms at the injection site) 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 effect.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Developed a reaction in her arms at the injection site). At the time of the report, VACCINATION SITE REACTION (Developed a reaction in her arms at the injection site) 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.   No relevant concomitant medications were reported. 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.   Reporter did not allow further contact; Reporter'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: Pain in extremity
Clinical narrative: Her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse effect (Medical History not provided).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm was sore). At the time of the report, PAIN IN EXTREMITY (Her arm was sore) 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 for this event was not provided with the exception of the two naproxen taken by the patient. Her inquiry was to whether or not she could rub the hand with rubbing alcohol as it was still very sore.  Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the event, 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 onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at the site of injection following vaccine. 2 inch diameter. round shape; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the site of injection following vaccine. 2 inch diameter. round shape) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0317K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the site of injection following vaccine. 2 inch diameter. round shape). On 05-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at the site of injection following vaccine. 2 inch diameter. round shape) 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.   No relevant concomitant medications were reported. Treatment for the event was Unknown.  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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant Nurse got vaccine today; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant Nurse got vaccine today) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in April 2020 and the estimated date of delivery was 21-Feb-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant Nurse got vaccine today). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant Nurse got vaccine today) had resolved. 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.   No concomitant or treatment medications provided by reporter.; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 33 year old female who is 8 months pregnant. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: redness at injection; swollen injecyion site; itchiness at injection site; Round ring at injection; Sore arm; A spontaneous report was received from a 58-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, and developed a red, swollen, itchy injection site that had a round ring.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, after receiving the vaccine, the patient's arm was sore for two days. On 7 Jan 2021, the injection site became red, swollen, itchy and had a round ring. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, sore arm, was considered resolved on 2 Jan 2021.The outcome of the events, developed a red, swollen, itchy injection site that had a round ring, were considered 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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm was red; Very low grade fever; Arm pain/Arm was sore and tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain/Arm was sore and tender), VACCINATION SITE ERYTHEMA (Arm was red) and PYREXIA (Very low grade fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain/Arm was sore and tender) and PYREXIA (Very low grade fever). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red). On 04-Jan-2021, VACCINATION SITE PAIN (Arm pain/Arm was sore and tender) and PYREXIA (Very low grade fever) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was 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.; 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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Became positive after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Became positive after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Became positive after receiving the Moderna vaccine). At the time of the report, COVID-19 (Became positive after receiving the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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. No treatment related information has been reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle soreness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Essential hypertension.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced MYALGIA (muscle soreness). At the time of the report, MYALGIA (muscle soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment for the event included acetaminophen.  Company Comment: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded.  Myalgia is consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported event and the product use cannot be excluded.  Myalgia is consistent with the known safety profile of the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Body aches; Nausea; Vomiting; Low grade fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body aches), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Low grade fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN (Body aches), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Low grade fever). On 03-Jan-2021, PAIN (Body aches), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Low grade fever) 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.   Concomitant product use was not provided by the reporter.  Treatments of these events 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; 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis is acting up; A spontaneous report was received from a consumer concerning a 64-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced arthritis is acting up (Arthritis).  The patient's medical history was not provided. Concomitant medications included rivaroxaban, omeprazole, thyroid.  On an unspecified date, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number 037K20A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   Approximately about a week after receiving the vaccination, the patient experienced arthritis is acting up. Treatment included methylprednisolone.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, arthritis acting up (Arthritis) was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: the size of a naval orange; site became hard; site became swollen about the size of a cherry tomato; soreness at the injection site; red; Itching at the site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE INDURATION (site became hard), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (site became hard) with VACCINATION SITE MASS (the size of a naval orange), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site). At the time of the report, VACCINATION SITE INDURATION (site became hard), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site) 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.; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: the size of a naval orange; site became hard; site became swollen about the size of a cherry tomato; soreness at the injection site; red; Itching at the site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE INDURATION (site became hard), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (site became hard) with VACCINATION SITE MASS (the size of a naval orange), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site). At the time of the report, VACCINATION SITE INDURATION (site became hard), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site) 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.; 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: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen around the injection site; Red around the injection site; Soar around the injection site; A spontaneous report  was received from a consumer, concerning herself, a female patient of an unspecified age who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced delayed allergy reaction at the injection site, swollen around the injection site, red around the injection site and sore around the injection site.  The patient's medical history reported included allergies. Concomitant medications were not reported.   On 31 Dec 2020, 8 days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 07 Jan 2021, after vaccination, the patient experienced a delayed allergy reaction at the injection site, which was about the size of a decode card and had the shape of a plane care. Patient also experienced swollen, red and soar around the injection site. Treatment for the events included diphenhydramine.~  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events delayed allergy reaction at the injection site, swollen around the injection site, red around the injection site and soar around the injection site were considered not resolved at the time of this report.; Reporter'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: Injection site pain
Clinical narrative: Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INJECTION SITE PAIN (Soreness in arm). At the time of the report, INJECTION SITE PAIN (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details was 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. Further information has been requested
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Fear, Pain
Clinical narrative: extreme confusion; anxiety; scared; injection hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (extreme confusion), PAIN (injection hurt), ANXIETY (anxiety) and FEAR (scared) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Meningitis in 1972 and Neurological complication associated with device in 1972. Concurrent medical conditions included Anxiety on 08-Jan-2021.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (injection hurt). On 07-Jan-2021, the patient experienced CONFUSIONAL STATE (extreme confusion), ANXIETY (anxiety) and FEAR (scared). At the time of the report, CONFUSIONAL STATE (extreme confusion), PAIN (injection hurt) and FEAR (scared) had resolved and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: The red spot is warm to the touch and getting bigger; Vaccine site started to get itchy and red; Vaccine site started to get itchy and red; She felt fatigued and then she was fine; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The red spot is warm to the touch and getting bigger), VACCINATION SITE PRURITUS (Vaccine site started to get itchy and red), FATIGUE (She felt fatigued and then she was fine), VACCINATION SITE PAIN (arm hurt) and VACCINATION SITE ERYTHEMA (Vaccine site started to get itchy and red) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (She felt fatigued and then she was fine) and VACCINATION SITE PAIN (arm hurt). On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccine site started to get itchy and red) and VACCINATION SITE ERYTHEMA (Vaccine site started to get itchy and red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (The red spot is warm to the touch and getting bigger). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL CHILDREN [DIPHENHYDRAMINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (The red spot is warm to the touch and getting bigger), VACCINATION SITE PRURITUS (Vaccine site started to get itchy and red), VACCINATION SITE PAIN (arm hurt) and VACCINATION SITE ERYTHEMA (Vaccine site started to get itchy and red) outcome was unknown and FATIGUE (She felt fatigued and then she was fine) had resolved.        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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Vaccination site pain
Clinical narrative: Feel terrible; Chills; Arm is very tender; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel terrible), VACCINATION SITE PAIN (Arm is very tender) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm is very tender). On 09-Jan-2021, the patient experienced FEELING ABNORMAL (Feel terrible) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Feel terrible), VACCINATION SITE PAIN (Arm is very tender) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was 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.; 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: his hand itched, late onset; delayed hypersensitivity reaction; Itching; A spontaneous report was received from a physician who was a 57-year-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced itching and a delayed hypersensitivity reaction, tuberculin reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 025J20-2A) for prophylaxis of COVID-19 infection.   On 29-Dec-2020 patient experienced itching.  Then, after 10 days on 07-Jan-2021, his hand itched and he experienced what he referred to as a delayed hypersensitivity reaction, a tuberculin reaction.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, itching and a delayed hypersensitivity reaction, tuberculin reaction, was not provided.   The outcome of the events, itching and a delayed hypersensitivity reaction, tuberculin reaction, was not reported.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen at site; Redness at site, She started seeing redness at injection site; soreness at site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Swollen at site), VACCINATION SITE ERYTHEMA (Redness at site, She started seeing redness at injection site) and VACCINATION SITE PAIN (soreness at site) in a 27-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 No adverse event (No medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swollen at site), VACCINATION SITE ERYTHEMA (Redness at site, She started seeing redness at injection site) and VACCINATION SITE PAIN (soreness at site). On 01-Jan-2021, VACCINATION SITE SWELLING (Swollen at site) and VACCINATION SITE PAIN (soreness at site) had resolved and VACCINATION SITE ERYTHEMA (Redness at site, She started seeing redness at injection site) 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 relevant concomitant medications were reported. No treatment information was 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: Influenza like illness
Clinical narrative: Flu-like symptoms; A regulatory report was received from a 67 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  flu-like symptoms.  The patient's medical history included Stage 1 adenocarcinoma of the endometrium and orthopedic issues. On 01 Dec 2020, patient was diagnosed with COVID-19. The relevant concomitant medications were baby aspirin and oral lysin.  On 25 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 025J20-2A) through unknown route of administration  for prophylaxis of COVID-19 infection.  On 25 Dec 2020, after the first dose, patient experienced flu-like symptoms. Laboratory data was not provided. Treatment information was also not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event flu-like symptom was unknown.  Follow-up received on 30 Mar 2021 included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: warm to touch; itching; a welt on upper left shoulder; swelling on tatoo; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (a welt on upper left shoulder) and VACCINATION SITE SWELLING (swelling on tatoo) in a 25-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 medical history reported).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (a welt on upper left shoulder) and VACCINATION SITE SWELLING (swelling on tatoo). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (a welt on upper left shoulder) and VACCINATION SITE SWELLING (swelling on tatoo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included birth control Treatment medication included Topical Antibiotics.  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.