chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: local reaction; one and a half by two inches, raised; erythematous/arm is still red where delayed reaction occurred; intensely pruritic; painful, tender; palpable; started to feel the axillary node on the injection side; A spontaneous report was received from a physician concerning a 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic.  Medical history was not provided.  Concomitant medication was not provided.  On 04-Jan-2021, prior to the onset of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 300042721) via intramuscular route in left arm for prophylaxis of COVID-19 infection.  On 09-Jan-2021, the patient experienced started to feel the axillary node on the injection side, painful and on 10-Jan-2021 experienced painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic.  Laboratory details was not reported.  Treatment medication included Benadryl and hydrocortisone at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic was not provided.  The outcome of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, , intensely pruritic was recovered on 16-Feb-2021 and  the outcome of the event erythematous/arm is still red where delayed reaction occurred was not recovered.  The reporter did not provide the assessment of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic to study drug.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: local reaction; one and a half by two inches, raised; erythematous/arm is still red where delayed reaction occurred; intensely pruritic; painful, tender; palpable; started to feel the axillary node on the injection side; A spontaneous report was received from a physician concerning a 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic.  Medical history was not provided.  Concomitant medication was not provided.  On 04-Jan-2021, prior to the onset of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 300042721) via intramuscular route in left arm for prophylaxis of COVID-19 infection.  On 09-Jan-2021, the patient experienced started to feel the axillary node on the injection side, painful and on 10-Jan-2021 experienced painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic.  Laboratory details was not reported.  Treatment medication included Benadryl and hydrocortisone at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic was not provided.  The outcome of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, , intensely pruritic was recovered on 16-Feb-2021 and  the outcome of the event erythematous/arm is still red where delayed reaction occurred was not recovered.  The reporter did not provide the assessment of the events started to feel the axillary node on the injection side, painful, tender, palpable, local reaction; one and a half by two inches, raised, erythematous/arm is still red where delayed reaction occurred, intensely pruritic to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Fear, Headache
Clinical narrative: Back pain; Legs pain; Swelling of the lymph nodes through all her body; Extremely exhausted; Headache; Dizzy; Nausea; Felt really sick; Teeth hurts; Face swelling; Fast heartbeat rate; Freaking out; A spontaneous report was received from a consumer concerning a  67 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and patient experienced extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling.  The patient's medical history were not provided. Concomitant medications Tylenol for symptoms were reported.   On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.  On unknown date , prior to receiving mRNA-1273, the patient experienced extremely exhausted, very tired, headache and dizzy, nausea two hours after received vaccine. Patient slept for about 2 hours and then she couldn't open her eyes and had  lymph nodes were swelling every where. The patient  felt really sick. She had arm pain, tenderness not terrific. That night patient tried to sleep but she has an extraordinary pain in her back and legs. Patient could feel her nodes with the hand, teeth hurts, face swelling and fast heartbeat rate. For 3 days she was freaking out.  No Treatment for the events were reported. No Laboratory details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling were considered as unknown.; 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: Heart rate increased, Lymphadenopathy, Malaise, Nausea, Pain in extremity
Clinical narrative: Back pain; Legs pain; Swelling of the lymph nodes through all her body; Extremely exhausted; Headache; Dizzy; Nausea; Felt really sick; Teeth hurts; Face swelling; Fast heartbeat rate; Freaking out; A spontaneous report was received from a consumer concerning a  67 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and patient experienced extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling.  The patient's medical history were not provided. Concomitant medications Tylenol for symptoms were reported.   On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.  On unknown date , prior to receiving mRNA-1273, the patient experienced extremely exhausted, very tired, headache and dizzy, nausea two hours after received vaccine. Patient slept for about 2 hours and then she couldn't open her eyes and had  lymph nodes were swelling every where. The patient  felt really sick. She had arm pain, tenderness not terrific. That night patient tried to sleep but she has an extraordinary pain in her back and legs. Patient could feel her nodes with the hand, teeth hurts, face swelling and fast heartbeat rate. For 3 days she was freaking out.  No Treatment for the events were reported. No Laboratory details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling were considered as unknown.; 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: Swelling face, Toothache
Clinical narrative: Back pain; Legs pain; Swelling of the lymph nodes through all her body; Extremely exhausted; Headache; Dizzy; Nausea; Felt really sick; Teeth hurts; Face swelling; Fast heartbeat rate; Freaking out; A spontaneous report was received from a consumer concerning a  67 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and patient experienced extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling.  The patient's medical history were not provided. Concomitant medications Tylenol for symptoms were reported.   On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.  On unknown date , prior to receiving mRNA-1273, the patient experienced extremely exhausted, very tired, headache and dizzy, nausea two hours after received vaccine. Patient slept for about 2 hours and then she couldn't open her eyes and had  lymph nodes were swelling every where. The patient  felt really sick. She had arm pain, tenderness not terrific. That night patient tried to sleep but she has an extraordinary pain in her back and legs. Patient could feel her nodes with the hand, teeth hurts, face swelling and fast heartbeat rate. For 3 days she was freaking out.  No Treatment for the events were reported. No Laboratory details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, extremely exhausted, very tired, headache, dizzy, nausea and couldn't open her eyes after sleep, lymph nodes swelling everywhere and felt her nodes with her hand, Arm pain, tenderness not terrific, extraordinary pain in back and in legs. Teeth hurts, fast heartbeat rate, face swelling were considered as unknown.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (hot extremely itchy), VACCINATION SITE PRURITUS (red, hot, raised, extremely itchy red "spot/circle" at the injection site), VACCINATION SITE SWELLING (puffy and swollen) and VACCINATION SITE ERYTHEMA (Red mark on right arm, red, hot, raised, extremely itchy red "spot/circle" at the injection site.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included Skin rash. Concurrent medical conditions included Drug allergy (Sulfur medications) and Seasonal allergy (Hay fever allergies). Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASPIRIN [ACETYLSALICYLIC ACID] and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot extremely itchy), VACCINATION SITE PRURITUS (red, hot, raised, extremely itchy red "spot/circle" at the injection site) and VACCINATION SITE ERYTHEMA (Red mark on right arm, red, hot, raised, extremely itchy red "spot/circle" at the injection site.). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (puffy and swollen). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot extremely itchy), VACCINATION SITE PRURITUS (red, hot, raised, extremely itchy red "spot/circle" at the injection site), VACCINATION SITE SWELLING (puffy and swollen) and VACCINATION SITE ERYTHEMA (Red mark on right arm, red, hot, raised, extremely itchy red "spot/circle" at the injection site.) had resolved. Second event after second shot: 3 days later woke up with red, hot, reased and not as itchy red "spot" not as defined a circle as the first one. Took Bendaryl and iced it as needed for about 3 days. It eventually went away in about 2 weeks. (could still see a shadow of the "spot" wasn't hot, or raised or itchy. This case was linked to MOD-2021-089784 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Event details updated, patient details updated, concomitant medication list updated. On 28-Apr-2021: patient date of birth and phone number details was  provided in TCR.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event following immunisation, COVID-19
Clinical narrative: he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID; he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included SARS-CoV-2 infection.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID). At the time of the report, COVID-19 (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) and ADVERSE EVENT FOLLOWING IMMUNISATION (he had COVID and he had more of a severe reaction than his colleagues that got the vaccine/he had COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Lip swelling
Clinical narrative: mild delayed inflammatory response; lumps in lips; A spontaneous report was received from other health care professional, via letter,  concerning an unknown age female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced delayed inflammatory response (inflammation) and lumps on lips (lip swelling).  The patient's medical history was not provided. History of application of lip filler (1 milliliter of Restylane kysse) to upper and lower lips on 08-Dec-2020. No relevant concomitant medications were reported.     On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 05-Jan-2021, 6 days post  vaccination, per HCP the patient had mild delayed inflammatory response and lumps in lips. Treatment included Medrol pack and antihistamine for the reported events.  No laboratory data was provided.  Action taken with mRNA-1273 in response to the event delayed inflammatory response (inflammation) and lumps on lips (lip swelling) was not provided.  The outcome of the delayed inflammatory response (inflammation) and lumps on lips (lip swelling) was not recovered/not resolved.  No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Severe headaches; Nausea; Fever up to 100.2; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches), NAUSEA (Nausea) and PYREXIA (Fever up to 100.2) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Severe headaches), NAUSEA (Nausea) and PYREXIA (Fever up to 100.2). At the time of the report, HEADACHE (Severe headaches), NAUSEA (Nausea) and PYREXIA (Fever up to 100.2) 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.  Treatment information included that patient took unspecified medications for nausea and headaches.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: headache; fever; soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and High cholesterol.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (soreness). On 20-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, ARTHRALGIA (soreness), HEADACHE (headache) and PYREXIA (fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinner medication, medication for diabetes, high blood pressure and high cholesterol medication.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pulmonary function test, Vaccination site pain
Clinical narrative: On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING ABNORMAL (Not feeling just right) and VACCINATION SITE PAIN (Felt like someone shot him in the arm). At the time of the report, FEELING ABNORMAL (Not feeling just right) and VACCINATION SITE PAIN (Felt like someone shot him in the arm) outcome was unknown and NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pulmonary function test: abnormal abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient received the first dose of moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) in a 36-year-old female patient 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. The patient's last menstrual period was in August 2020 and the estimated date of delivery was on an unknown date. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.     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 treatment information was provided. No concomitant medication was provided. Gestational stage  20 weeks was reported. Estimated due date was in Jun 2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site warmth
Clinical narrative: hard feeling; circular lump the size an orange; hot to touch; it was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (circular lump the size an orange), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE INDURATION (hard feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025LZ(or 2)0A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol. Concurrent medical conditions included Milk allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Drug allergy. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and ATORVASTATIN CALCIUM (LIPITOR) 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 09-Jan-2021, the patient experienced VACCINATION SITE MASS (circular lump the size an orange), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE ERYTHEMA (it was red). On 16-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard feeling). At the time of the report, VACCINATION SITE MASS (circular lump the size an orange), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE INDURATION (hard feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication also included allergy shot.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: she is pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and received the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and received the vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (she is pregnant and received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site swelling
Clinical narrative: Soreness; Reddish color; So much swelling in arm in area got vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), ERYTHEMA (Reddish color) and VACCINATION SITE SWELLING (So much swelling in arm in area got vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness), ERYTHEMA (Reddish color) and VACCINATION SITE SWELLING (So much swelling in arm in area got vaccine). At the time of the report, PAIN IN EXTREMITY (Soreness), ERYTHEMA (Reddish color) and VACCINATION SITE SWELLING (So much swelling in arm in area got vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymphadenopathy, Pain in extremity
Clinical narrative: Fatigue; feeling like "a little something was brewing in my body; Slight soreness after receiving the vaccine; Supraclavicular lymph node swollen and hard; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Slight soreness after receiving the vaccine), FEELING ABNORMAL (feeling like "a little something was brewing in my body), FATIGUE (fatigue) and LYMPHADENOPATHY (Supraclavicular lymph node swollen and hard) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Postmenopausal symptoms.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Slight soreness after receiving the vaccine). On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (Supraclavicular lymph node swollen and hard). On an unknown date, the patient experienced FEELING ABNORMAL (feeling like "a little something was brewing in my body) and FATIGUE (fatigue). On 14-Jan-2021, PAIN IN EXTREMITY (Slight soreness after receiving the vaccine) had resolved. At the time of the report, FEELING ABNORMAL (feeling like "a little something was brewing in my body), FATIGUE (fatigue) and LYMPHADENOPATHY (Supraclavicular lymph node swollen and hard) 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 treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: tenderness at site if injection; Hotness to the touch at the injection site; Swelling at the injection site; Redness at the injection site; Pain at the injection site; Little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache). On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (tenderness at site if injection). On 15-Jan-2021, VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache) had resolved. At the time of the report, INJECTION SITE PAIN (tenderness at site if injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: tenderness at site if injection; Hotness to the touch at the injection site; Swelling at the injection site; Redness at the injection site; Pain at the injection site; Little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache). On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (tenderness at site if injection). On 15-Jan-2021, VACCINATION SITE WARMTH (Hotness to the touch at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Little bit of a headache) had resolved. At the time of the report, INJECTION SITE PAIN (tenderness at site if injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: localized reaction was red and warm to the touch; localized reaction was red and warm to the touch; localized reaction was red and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (localized reaction was red and warm to the touch), the first episode of INJECTION SITE ERYTHEMA (localized reaction was red and warm to the touch) and the second episode of INJECTION SITE ERYTHEMA (localized reaction was red and warm to the touch) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE WARMTH (localized reaction was red and warm to the touch) and the first episode of INJECTION SITE ERYTHEMA (localized reaction was red and warm to the touch). On 19-Jan-2021, the patient experienced the second episode of INJECTION SITE ERYTHEMA (localized reaction was red and warm to the touch). On 16-Jan-2021, INJECTION SITE WARMTH (localized reaction was red and warm to the touch) had resolved. At the time of the report, last episode of INJECTION SITE ERYTHEMA (localized reaction was red and warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided (patient reported she did not try anything to treat it).  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Injection sight pain; 3 lymph nodes under left arm that are swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Injection sight pain) and LYMPHADENOPATHY (3 lymph nodes under left arm that are swollen) 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.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection sight pain) and LYMPHADENOPATHY (3 lymph nodes under left arm that are swollen). At the time of the report, LYMPHADENOPATHY (3 lymph nodes under left arm that are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment.   This case was linked to MOD-2021-010135 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Redness on her nose and cheeks with butterfly pattern; Arem was itching at the injection site/ The sire was very itchy; Rash; Large red area around the injection site about 5 in. long and 2 in. wide; Soremess at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on her nose and cheeks with butterfly pattern), VACCINATION SITE PRURITUS (Arem was itching at the injection site/ The sire was very itchy), RASH (Rash), VACCINATION SITE ERYTHEMA (Large red area around the injection site about 5 in. long and 2 in. wide) and VACCINATION SITE PAIN (Soremess at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ampicille (rash)) since 1982, Ulcerative colitis since 1982 and Hypercholesterolemia. Concomitant products included LORATADINE for Allergy, PRAVASTATIN for Hypercholesterolemia, MESALAMINE for Ulcerative colitis, VITAMIN D [VITAMIN D NOS] and CHLORPHENIRAMINE [CHLORPHENAMINE] for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soremess at the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Arem was itching at the injection site/ The sire was very itchy), RASH (Rash) and VACCINATION SITE ERYTHEMA (Large red area around the injection site about 5 in. long and 2 in. wide). On 21-Jan-2021, the patient experienced ERYTHEMA (Redness on her nose and cheeks with butterfly pattern). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of cream and tablets. On 26-Jan-2021, ERYTHEMA (Redness on her nose and cheeks with butterfly pattern), VACCINATION SITE PRURITUS (Arem was itching at the injection site/ The sire was very itchy), RASH (Rash) and VACCINATION SITE ERYTHEMA (Large red area around the injection site about 5 in. long and 2 in. wide) had resolved. At the time of the report, VACCINATION SITE PAIN (Soremess at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       A day after the first dose of vaccine, the patient had slight soreness at the injection site and that was the only reaction until one week after the shot. The patient treated it with diphenhydramine cream and tablets.  On 9-Feb-2021, the patient received second dose of Moderna COVID-19 vaccine with lot number 013M20A intramuscularly at right arm.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received included patient demographic details, medical history, vaccine dose details, concomitant medication and events outcome.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: redness extending up arm into neck/face; Swelling  extending up arm into neck/face; A spontaneous report was received from a physician for a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced erythema (redness extending up arm into neck/face) and swelling (swelling extending up arm into neck/face).  The patient's medical history was not provided. No concomitant product use was reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient had experienced redness and swelling that extended up arm into neck/face.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the event, vaccine was administered to a 16 year old, was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Dense swellings under the skin of shoulder; skin became red; Skin became itchy; Case reference number MOD-2021-012194 is a spontaneous case report sent by a Other on 22-JAN-2021 00:00:00. .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some    later,  the patient developed Dense swellings under the skin of shoulder. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed skin became red,Skin became itchy. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Swelling . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between Dense swellings under the skin of shoulder and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age-  ,  Sex-  ,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Itchy throat; Hives on right arm at injection site; Red patch at injection site (gotten worse); This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat), VACCINATION SITE URTICARIA (Hives on right arm at injection site) and VACCINATION SITE ERYTHEMA (Red patch at injection site (gotten worse)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Itchy throat), VACCINATION SITE URTICARIA (Hives on right arm at injection site) and VACCINATION SITE ERYTHEMA (Red patch at injection site (gotten worse)). At the time of the report, THROAT IRRITATION (Itchy throat), VACCINATION SITE URTICARIA (Hives on right arm at injection site) and VACCINATION SITE ERYTHEMA (Red patch at injection site (gotten worse)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that the events started a week and a half after the vaccine dose. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up was received on 19-APR-2021. All reported events' outcome was updated to recovered/resolved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Exposure during pregnancy, Pregnancy test, Scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 42-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included In vitro fertilization on 22-Jun-2020. Concurrent medical conditions included Drug allergy (Allergic to dermerol.), Allergy to nuts (Allergic to brazil nuts.), Fruit allergy (Allergic to mangoes.) and Environmental allergy.    On 08-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 10-Mar-2021. On 08-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 03-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 3061 grams (6lbs 12oz). The outcome was reported as Term Birth w/o Complications. On 08-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Pregnancy test: positive (Positive) Positive. In September 2020, Scan: normal (normal) Fetal scan -normal. In October 2020, Echocardiogram: normal (normal) Fetal ECHO -normal.     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 provided. Date of conception reported was 22-Jun-2020. Date of positive pregnancy test reported was 04-Jul-2020.  On 03-Mar-2021, the patient gave birth to live full-term  female baby (length 20) without any perinatal complications. No fetal/infant abnormalities were detected on delivery or at one month post-partum.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information received included LMP date, pregnancy outcome details and lab data.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: Vertigo; Minimal soreness at injection site; A spontaneous report was received from other health care professional concerning a female patient of an unknown age who received Modena's COVID-19 vaccine (mRNA-1273) and experienced minimal soreness at injection site (vaccination site pain) and vertigo.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 02 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch unknown) on left arm for prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient called on behalf of her mother, who received Moderna COVID-19 vaccine and experienced minimal soreness at injection site.  On 04 Jan 2021, the patient experienced vertigo. Treatment information not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event minimal soreness at injection site was resolved on 02 Jan 2021. The outcome of the event vertigo was 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.