chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: swelling and redness on injection arm; swelling and redness on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling and redness on injection arm) and INJECTION SITE ERYTHEMA (swelling and redness on injection arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling and redness on injection arm) and INJECTION SITE ERYTHEMA (swelling and redness on injection arm). At the time of the report, VACCINATION SITE SWELLING (swelling and redness on injection arm) and INJECTION SITE ERYTHEMA (swelling and redness on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Additional information
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itch; Red; Swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination.     No Medical History information was reported.    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 PRURITUS (Itch), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (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 were provided No treatment information provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes; Itchy red spots on hands, thigh, under breast and itching all over body; swells up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes), ERYTHEMA (Itchy red spots on hands, thigh, under breast and itching all over body) and SWELLING (swells up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PRURITUS (Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes), ERYTHEMA (Itchy red spots on hands, thigh, under breast and itching all over body) and SWELLING (swells up). The patient was treated with HYDROXYZINE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes), ERYTHEMA (Itchy red spots on hands, thigh, under breast and itching all over body) and SWELLING (swells up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  Zyrtec was given as treatment medications with instructions to take for 1 month and then stop to see if it has improved and continue if there was no improvement in symptoms. Patient stated since she has been taking  Zyrtec her hands aren't as bad however but she continued to develop red itchy spots,has one on her thigh and under her breast now.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added Treatment medications and additional event (swells up).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter contact information was added.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: injection site got itchy; injection site got swollen at about 5 inches long.; A spontaneous report was received from a consumer connecting a 48 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pruritis, injection site swelling.  The patient's medical history was not provided. The concomitant medications were Claritin.  On 22-jan-2021 prior to the onset of events,the patient received her first dose of two planned doses of mRNA-1273 lot no; 025J20-2A of unknown route of administration and unknown site of administration for prophylaxis of COVID-19 infection.  On 29-jan-2021 the patient experienced the injection site got itchy,injection site got swollen at about 5 inches long.  The patient had not undergone any treatment. Action Taken with mRNA-1273 in response to the events was not reported.  The outcome of event was not reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth, Sinusitis
Clinical narrative: arm of the injection site was red; arm of the injection site was warm; sinus infection symptoms; feeling bad; A spontaneous report was received from a healthcare professional concerning a 52 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sinus infection symptoms, feeling bad, redness at the site of injection in the arm and warmth at the site of infection in the arm.  The patient's medical history was not provided.  The concomitant medications reported were unknown blood pressure medication, unknown cholesterol medication, 2 unknown anti-depressants and estrogen replacement (unknown).  On 20 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the arm for prophylaxis of COVID-19 infection. The patient route of administration was unknown.  On 25 JAN 2021, the patient experienced sinus infection symptoms and was feeling bad. On 31 JAN 2021, the patient experienced redness at the site of injection in the arm and warmth at the site of infection in the arm.   Treatment included Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of the events sinus infection symptoms and feeling bad  was resolved. At the time of this report, the outcome of the events redness at the site of injection in the arm and warmth at the site of infection in the arm was unknown.  The consent to be contacted was received from the patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleed; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (nosebleed) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 31-Dec-2020, the patient experienced EPISTAXIS (nosebleed). On 03-Jan-2021, EPISTAXIS (nosebleed) had lasted for three days.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching all over her body but more at ankle and inside of elbow.; immediately after vaccination her face become red for 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (immediately after vaccination her face become red for 15 minutes) and PRURITUS (Itching all over her body but more at ankle and inside of elbow.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9000182) 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) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced ERYTHEMA (immediately after vaccination her face become red for 15 minutes). On 22-Jan-2021, the patient experienced PRURITUS (Itching all over her body but more at ankle and inside of elbow.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) ongoing since an unknown date at an unspecified dose and frequency; TRIAMCINOLONE ongoing since an unknown date at an unspecified dose and frequency and ACETONIDE DE FLUOCINOLONE at a dose of unknown. At the time of the report, ERYTHEMA (immediately after vaccination her face become red for 15 minutes) had resolved and PRURITUS (Itching all over her body but more at ankle and inside of elbow.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: tender enlargement of the lymph node on the neck; regular tenderness or arm pain; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (regular tenderness or arm pain) and VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j2A) for COVID-19 vaccination.     Historical condition of the patient is not mentioned and concomitant list is provided.  Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) and FLUOXETINE HYDROCHLORIDE (PROZAC).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (regular tenderness or arm pain). On 19-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck). At the time of the report, VACCINATION SITE PAIN (regular tenderness or arm pain) and VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck) 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 considered VACCINATION SITE PAIN (regular tenderness or arm pain) and VACCINATION SITE LYMPHADENOPATHY (tender enlargement of the lymph node on the neck) to be possibly related.    Concomitant drugs are vitamin-D and prozac
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Severe swelling at site of injection which spread around 4 to 6 cm; A spontaneous report was received from other health professional concerning a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe swelling at site of injection which spread around 4 to 6 cm.     The patient's medical history was not provided. No relevant concomitant medications were reported.     On 19 Jan 2021, nine days prior to the onset of the event severe swelling at site of injection which spread around 4 to 6 cm, the patient received their dose of mRNA-1273 (lot/batch: 012l20A) for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient experienced severe swelling at site of injection which spread around 4 to 6 cm. Treatment for the event included steroids.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event severe swelling at site of injection which spread around 4 to 6 cm was recovering (subside).; 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: Abdominal pain, Fatigue, Headache, Illness, Nausea
Clinical narrative: very sick; nausea; abdominal cramp; low grade fever; headache; feels very tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very sick), NAUSEA (nausea), ABDOMINAL PAIN (abdominal cramp), PYREXIA (low grade fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), NAUSEA (nausea), ABDOMINAL PAIN (abdominal cramp), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (feels very tired). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: very sick; nausea; abdominal cramp; low grade fever; headache; feels very tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very sick), NAUSEA (nausea), ABDOMINAL PAIN (abdominal cramp), PYREXIA (low grade fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), NAUSEA (nausea), ABDOMINAL PAIN (abdominal cramp), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (feels very tired). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.). At the time of the report, RASH PRURITIC (A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching (injection arm); Bad rush (injection area); Really bad headache; Shaking; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to the company on 26-Jan-2021.    Case reference number MOD-2021-013998 is a spontaneous case report sent by a Other on 25-JAN-2021 00:00:00 .  On 25-JAN-2021 the patient developed headache. and started shaking which eventually went away. Later, the patient also developed Bad rush (injection area),Itching (injection arm) on the lower part of the arm where she got the vaccine (right arm)  15-Jan- 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 028L20A ) for prophylaxis of COVID-19 infection.    The patient was adviced to take Bendaryl.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Inflammation, Myalgia, Pain in extremity
Clinical narrative: inflammation from my elbow to the shoulder; pain in my arm; arm was swollen; arm was beet red; itchy; slight aches and pains for a couple days; physically exhausted; slight discomfort in arm; A spontaneous report was received from a  consumer  concerning a  72Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events like slight discomfort in my arm, physically exhausted, slight aches and pains, arm itchy, term arm swollen, arm beet red, inflammation is from my elbow to the shoulder, pain in my arm.    The patient's medical history is not reported. No relevant concomitant medications were reported.        On 13th Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.      On date 13th Jan 2021, The patient experienced the events like slight discomfort in my arm, physically exhausted, slight aches and pains. On date 21st Jan 2021, the patient experienced the events like arm itchy, arm swollen, arm beet red, inflammation is from my elbow to the shoulder, pain in my arm.  Laboratory details not provided.       No treatment information was provided.       Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events like slight discomfort in my arm, physically exhausted were resolved on date 13th Jan 2021. The outcome of the event like slight aches and pains was resolved on date 15th Jan 2021. The outcome of the event like arm itchy, pain in my arm were resolved on date 22nd Jan 2021 The outcome of the events like arm swollen, arm beet red is unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site pain
Clinical narrative: inflammation from my elbow to the shoulder; pain in my arm; arm was swollen; arm was beet red; itchy; slight aches and pains for a couple days; physically exhausted; slight discomfort in arm; A spontaneous report was received from a  consumer  concerning a  72Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  events like slight discomfort in my arm, physically exhausted, slight aches and pains, arm itchy, term arm swollen, arm beet red, inflammation is from my elbow to the shoulder, pain in my arm.    The patient's medical history is not reported. No relevant concomitant medications were reported.        On 13th Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.      On date 13th Jan 2021, The patient experienced the events like slight discomfort in my arm, physically exhausted, slight aches and pains. On date 21st Jan 2021, the patient experienced the events like arm itchy, arm swollen, arm beet red, inflammation is from my elbow to the shoulder, pain in my arm.  Laboratory details not provided.       No treatment information was provided.       Action taken with mRNA-1273 in response to the events was not reported.       The outcome of the events like slight discomfort in my arm, physically exhausted were resolved on date 13th Jan 2021. The outcome of the event like slight aches and pains was resolved on date 15th Jan 2021. The outcome of the event like arm itchy, pain in my arm were resolved on date 22nd Jan 2021 The outcome of the events like arm swollen, arm beet red is unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: On 22-Jan-2021 at 9:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Respiratory symptom
Clinical narrative: Fever; Headache; Upper respiratory; A spontaneous report was received from a consumer concerning a 64 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory symptom/upper respiratory, fever/pyrexia, headache.  The patient's medical history was not reported.  The Concomitant medications were not reported.   On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) Intramuscularly in an unknown location for prophylaxis of COVID-19 infection.  On 07 Feb 2021, patient developed upper respiratory symptom.  On 11 Feb 2021 , patient developed headache. On 13 Feb 2021, patient developed fever.  The treatment information was reported as guaifenesin, fluticasone propionate-steroid spray and Sinusitis spray.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events upper respiratory symptom, headache and fever were considered as unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: tendonitis (severe pain in the opposite arm of the injection); A spontaneous report was received from consumer, concerning herself, 56 year old female patient who received Moderna's COVID-19 vaccine and experienced tendonitis.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 11-Feb-2021, prior to the onset of the event, the patient received the first of their first planned doses of mRNA-1273 (lot number 007M20A) in the left arm for prophylaxis of COVID-19 infection.  On12Feb2021, the patient experienced severe pain in the opposite arm of the vaccination, went to the hospital, and and was diagnosed with tendonitis.  The patient was treated with Tylenol.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, tendonitis, 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 event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site scar
Clinical narrative: circle about 3 inches; vaccination arm was itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (circle about 3 inches), VACCINATION SITE PRURITUS (vaccination arm was itchy) and VACCINATION SITE ERYTHEMA (red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SCAR (circle about 3 inches), VACCINATION SITE PRURITUS (vaccination arm was itchy) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SCAR (circle about 3 inches), VACCINATION SITE PRURITUS (vaccination arm was itchy) and VACCINATION SITE ERYTHEMA (red) 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 and concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Pain at the injection site; swelling of lymph nodes; hotness along the injection site; redness along the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site), LYMPHADENOPATHY (swelling of lymph nodes), VACCINATION SITE WARMTH (hotness along the injection site) and VACCINATION SITE ERYTHEMA (redness along the site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site), LYMPHADENOPATHY (swelling of lymph nodes), VACCINATION SITE WARMTH (hotness along the injection site) and VACCINATION SITE ERYTHEMA (redness along the site). At the time of the report, INJECTION SITE PAIN (Pain at the injection site), LYMPHADENOPATHY (swelling of lymph nodes), VACCINATION SITE WARMTH (hotness along the injection site) and VACCINATION SITE ERYTHEMA (redness along the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Pyrexia, Sinus congestion
Clinical narrative: cough; fever; achiness; sinus congestion; headache; Localized soreness in arm/ Tenderness at local site; inflammation at local site for 2 hours; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion), HEADACHE (headache), VACCINATION SITE PAIN (Localized soreness in arm/ Tenderness at local site) and VACCINATION SITE SWELLING (inflammation at local site for 2 hours). On 12-Jan-2021, VACCINATION SITE SWELLING (inflammation at local site for 2 hours) had resolved. On 15-Jan-2021, COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion), HEADACHE (headache) and VACCINATION SITE PAIN (Localized soreness in arm/ Tenderness at local site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: cough; fever; achiness; sinus congestion; headache; Localized soreness in arm/ Tenderness at local site; inflammation at local site for 2 hours; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion), HEADACHE (headache), VACCINATION SITE PAIN (Localized soreness in arm/ Tenderness at local site) and VACCINATION SITE SWELLING (inflammation at local site for 2 hours). On 12-Jan-2021, VACCINATION SITE SWELLING (inflammation at local site for 2 hours) had resolved. On 15-Jan-2021, COUGH (cough), PYREXIA (fever), PAIN (achiness), SINUS CONGESTION (sinus congestion), HEADACHE (headache) and VACCINATION SITE PAIN (Localized soreness in arm/ Tenderness at local site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Nausea
Clinical narrative: flu like symptoms; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (Nausea) and FATIGUE (Tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (Nausea) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (Nausea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant treatment medication were used   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Non-significant follow up appended.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site irritation, Injection site rash
Clinical narrative: Injection site irritated / rush; Little bruise next to injection site; Injection site irritated / rush; Red spot around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site irritated / rush), INJECTION SITE BRUISING (Little bruise next to injection site), INJECTION SITE RASH (Injection site irritated / rush) and INJECTION SITE ERYTHEMA (Red spot around injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE IRRITATION (Injection site irritated / rush), INJECTION SITE BRUISING (Little bruise next to injection site), INJECTION SITE RASH (Injection site irritated / rush) and INJECTION SITE ERYTHEMA (Red spot around injection site). At the time of the report, INJECTION SITE IRRITATION (Injection site irritated / rush), INJECTION SITE BRUISING (Little bruise next to injection site), INJECTION SITE RASH (Injection site irritated / rush) and INJECTION SITE ERYTHEMA (Red spot around injection site) outcome was unknown. 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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: one week later its been itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (one week later its been itchy) and RASH (rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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. On an unknown date, the patient experienced PRURITUS (one week later its been itchy) and RASH (rash). At the time of the report, PRURITUS (one week later its been itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment information include rubbing alcohol.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: no information
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site inflammation, Injection site pain, Malaise
Clinical narrative: Felt miserable; Slight sinus congestion; Slight minimal productive cough; Inflammation at local site; Fever; Achiness; Headache; Localized soreness in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt miserable), SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), INJECTION SITE INFLAMMATION (Inflammation at local site) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 MALAISE (Felt miserable), SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), INJECTION SITE INFLAMMATION (Inflammation at local site), PYREXIA (Fever), MYALGIA (Achiness), HEADACHE (Headache) and INJECTION SITE PAIN (Localized soreness in the arm). On 12-Jan-2021, INJECTION SITE INFLAMMATION (Inflammation at local site) had resolved. On 13-Jan-2021, MALAISE (Felt miserable) had resolved. On 15-Jan-2021, SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), PYREXIA (Fever), MYALGIA (Achiness), HEADACHE (Headache) and INJECTION SITE PAIN (Localized soreness in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 99.8 °F. On 13-Jan-2021, Body temperature: 100.4 °F.     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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Productive cough, Pyrexia, Sinus congestion
Clinical narrative: Felt miserable; Slight sinus congestion; Slight minimal productive cough; Inflammation at local site; Fever; Achiness; Headache; Localized soreness in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt miserable), SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), INJECTION SITE INFLAMMATION (Inflammation at local site) and PYREXIA (Fever) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 MALAISE (Felt miserable), SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), INJECTION SITE INFLAMMATION (Inflammation at local site), PYREXIA (Fever), MYALGIA (Achiness), HEADACHE (Headache) and INJECTION SITE PAIN (Localized soreness in the arm). On 12-Jan-2021, INJECTION SITE INFLAMMATION (Inflammation at local site) had resolved. On 13-Jan-2021, MALAISE (Felt miserable) had resolved. On 15-Jan-2021, SINUS CONGESTION (Slight sinus congestion), PRODUCTIVE COUGH (Slight minimal productive cough), PYREXIA (Fever), MYALGIA (Achiness), HEADACHE (Headache) and INJECTION SITE PAIN (Localized soreness in the arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 99.8 °F. On 13-Jan-2021, Body temperature: 100.4 °F.     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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pruritus, Nausea, Pain
Clinical narrative: swollen below the injection site; really sore; itchiness; chills; fever up to 100.5 ° F; body aches; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Depression, Hypertension and Muscular pain. Concomitant products included MUSCLE RELAXANTS from 11-Jan-2021 to an unknown date, ANTIHYPERTENSIVES, ANXIOLYTICS and ESTRADIOL.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea). On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen below the injection site), VACCINATION SITE PAIN (really sore) and INJECTION SITE PRURITUS (itchiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 12-Jan-2021 at an unspecified dose and frequency. On 13-Jan-2021, CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 21-Jan-2021, VACCINATION SITE SWELLING (swollen below the injection site), VACCINATION SITE PAIN (really sore) and INJECTION SITE PRURITUS (itchiness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen below the injection site; really sore; itchiness; chills; fever up to 100.5 ° F; body aches; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Depression, Hypertension and Muscular pain. Concomitant products included MUSCLE RELAXANTS from 11-Jan-2021 to an unknown date, ANTIHYPERTENSIVES, ANXIOLYTICS and ESTRADIOL.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea). On 14-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen below the injection site), VACCINATION SITE PAIN (really sore) and INJECTION SITE PRURITUS (itchiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 12-Jan-2021 at an unspecified dose and frequency. On 13-Jan-2021, CHILLS (chills), PYREXIA (fever up to 100.5 ° F), PAIN (body aches), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 21-Jan-2021, VACCINATION SITE SWELLING (swollen below the injection site), VACCINATION SITE PAIN (really sore) and INJECTION SITE PRURITUS (itchiness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore left arm; Chills; Fever up to 100.8F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), CHILLS (Chills) and PYREXIA (Fever up to 100.8F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Anxiety and Hypothyroidism (Thyroid was reported.).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), CHILLS (Chills) and PYREXIA (Fever up to 100.8F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, PAIN IN EXTREMITY (Sore left arm), CHILLS (Chills) and PYREXIA (Fever up to 100.8F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 100.8f (Inconclusive) Fever up to 100.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included blood pressure medication, thyroid medication, medication for anxiety.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter email id adedd
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Got extremely tired; This spontaneous case was reported by a non-health professional and describes the occurrence of FATIGUE (Got extremely tired) 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 (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Got extremely tired). At the time of the report, FATIGUE (Got extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Warmth at injection site; Induration at injection site; Redness at injection site; A spontaneous report  was received from a health care professional concerning a 34-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed injection site induration/vaccination site induration, injection site redness/vaccination site erythema, and injection site warmth/vaccination site warmth.     The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 28-Dec-2020, approximately one week prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch# 039k20-2a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06-Jan-2021, the patient developed delayed injection site induration, redness, and warmth. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, injection site induration, injection site redness, and injection site warmth, were 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.