chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Covid-19; Loss of taste; General congestion; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), SINUS CONGESTION (General congestion) and COVID-19 (Covid-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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 21-Jan-2021, the patient experienced SINUS CONGESTION (General congestion). On 25-Jan-2021, the patient experienced AGEUSIA (Loss of taste). On 27-Jan-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, AGEUSIA (Loss of taste), SINUS CONGESTION (General congestion) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Induration, Limb mass, Lip swelling
Clinical narrative: felt hard lump on the bottom lip; Swelling occur 1inch below lump on the bottom lip; swelling on legs; rash on legs; hardness, lump, rash on legs; hardness, lump, rash on legs; Rash on legs; itchiness in arm; bright red swelling; hardness; bruise 3.5 by 3.5inches; exhausted; nausea; redness around injection site; Hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around injection site), VACCINATION SITE INDURATION (Hardness at injection site), FATIGUE (exhausted), NAUSEA (nausea) and PRURITUS (itchiness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site). On 19-Jan-2021, the patient experienced FATIGUE (exhausted) and NAUSEA (nausea). On 22-Jan-2021, the patient experienced PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches). On 31-Jan-2021, the patient experienced INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs). On 03-Feb-2021, the patient experienced SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event following immunisation, at an unspecified dose and frequency. On 17-Jan-2021, VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 23-Jan-2021, FATIGUE (exhausted), NAUSEA (nausea), PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches) had resolved. On 02-Feb-2021, INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs) had resolved. At the time of the report, SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip) 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
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus, Rash, Skin mass
Clinical narrative: felt hard lump on the bottom lip; Swelling occur 1inch below lump on the bottom lip; swelling on legs; rash on legs; hardness, lump, rash on legs; hardness, lump, rash on legs; Rash on legs; itchiness in arm; bright red swelling; hardness; bruise 3.5 by 3.5inches; exhausted; nausea; redness around injection site; Hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around injection site), VACCINATION SITE INDURATION (Hardness at injection site), FATIGUE (exhausted), NAUSEA (nausea) and PRURITUS (itchiness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site). On 19-Jan-2021, the patient experienced FATIGUE (exhausted) and NAUSEA (nausea). On 22-Jan-2021, the patient experienced PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches). On 31-Jan-2021, the patient experienced INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs). On 03-Feb-2021, the patient experienced SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event following immunisation, at an unspecified dose and frequency. On 17-Jan-2021, VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 23-Jan-2021, FATIGUE (exhausted), NAUSEA (nausea), PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches) had resolved. On 02-Feb-2021, INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs) had resolved. At the time of the report, SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip) 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
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site induration
Clinical narrative: felt hard lump on the bottom lip; Swelling occur 1inch below lump on the bottom lip; swelling on legs; rash on legs; hardness, lump, rash on legs; hardness, lump, rash on legs; Rash on legs; itchiness in arm; bright red swelling; hardness; bruise 3.5 by 3.5inches; exhausted; nausea; redness around injection site; Hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around injection site), VACCINATION SITE INDURATION (Hardness at injection site), FATIGUE (exhausted), NAUSEA (nausea) and PRURITUS (itchiness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site). On 19-Jan-2021, the patient experienced FATIGUE (exhausted) and NAUSEA (nausea). On 22-Jan-2021, the patient experienced PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches). On 31-Jan-2021, the patient experienced INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs). On 03-Feb-2021, the patient experienced SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event following immunisation, at an unspecified dose and frequency. On 17-Jan-2021, VACCINATION SITE ERYTHEMA (redness around injection site) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 23-Jan-2021, FATIGUE (exhausted), NAUSEA (nausea), PRURITUS (itchiness in arm), SWELLING (bright red swelling), INDURATION (hardness) and CONTUSION (bruise 3.5 by 3.5inches) had resolved. On 02-Feb-2021, INDURATION (hardness, lump, rash on legs), LIMB MASS (hardness, lump, rash on legs), RASH (Rash on legs), PERIPHERAL SWELLING (swelling on legs) and RASH (rash on legs) had resolved. At the time of the report, SKIN MASS (felt hard lump on the bottom lip) and LIP SWELLING (Swelling occur 1inch below lump on the bottom lip) 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
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: swollen; itchy; red; warm to touch; lump; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swollen), PRURITUS (itchy), ERYTHEMA (red), SKIN WARM (warm to touch) and AXILLARY MASS (lump) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), PRURITUS (itchy), ERYTHEMA (red), SKIN WARM (warm to touch) and AXILLARY MASS (lump). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen), PRURITUS (itchy), ERYTHEMA (red), SKIN WARM (warm to touch) and AXILLARY MASS (lump) 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Having an allergic reaction; Arm has swelled up; Arm has a red patch that is getting bigger; It is like hive and itchy; It is like hive and itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Having an allergic reaction), PERIPHERAL SWELLING (Arm has swelled up), ERYTHEMA (Arm has a red patch that is getting bigger), URTICARIA (It is like hive and itchy) and PRURITUS (It is like hive and itchy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Having an allergic reaction), PERIPHERAL SWELLING (Arm has swelled up), ERYTHEMA (Arm has a red patch that is getting bigger), URTICARIA (It is like hive and itchy) and PRURITUS (It is like hive and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Having an allergic reaction), PERIPHERAL SWELLING (Arm has swelled up), ERYTHEMA (Arm has a red patch that is getting bigger), URTICARIA (It is like hive and itchy) and PRURITUS (It is like hive and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: arm is painful; cannot move arm; difficult to do her job; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm is painful), MOBILITY DECREASED (cannot move arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to do her job) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is painful), MOBILITY DECREASED (cannot move arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to do her job). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN IB) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is painful), MOBILITY DECREASED (cannot move arm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficult to do her job) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included acetaminophen, ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events  is not applicable
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery.    On 23-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 DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash, Vaccination site warmth
Clinical narrative: a red area lump at vaccine site; that area only had a 101°F temperature; 2 inch red rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a red area lump at vaccine site), VACCINATION SITE WARMTH (that area only had a 101°F temperature) and VACCINATION SITE RASH (2 inch red rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A or 037K2DA) 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 23-Jan-2021, the patient experienced VACCINATION SITE MASS (a red area lump at vaccine site), VACCINATION SITE WARMTH (that area only had a 101°F temperature) and VACCINATION SITE RASH (2 inch red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at a dose of 1 dosage form. On 28-Jan-2021, VACCINATION SITE MASS (a red area lump at vaccine site), VACCINATION SITE WARMTH (that area only had a 101°F temperature) and VACCINATION SITE RASH (2 inch red rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Decreased appetite, Fatigue, Headache
Clinical narrative: Lloss of appetite; Myalgia; Arthralgia; Fatigue; Headache; Fever; Left arm injection site pain; A spontaneous report was received from a healthcare professional concerning a 64-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events myalgia, arthralgia, fatigue, headache, loss of appetite, fever (101.5 °f) and left arm injection site pain.  The patient's medical history included Covid-19 and tested positive for 44 days.( Mar 2020).The patient also had a history of heart surgery -mitral valve repair( Sep 2020). No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced  myalgia, arthralgia, fatigue, headache, loss of appetite, fever (101.5 °f) and  left arm injection site pain.The patient felt better on26 Jan 2021.  Lab information included body temperature which was 101.5 F on 23 Jan 2021.  Treatment details included Tylenol 1,000mg every 4 hours and Advil 600mg every 6 hours..  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of events-myalgia, arthralgia, fatigue, headache, loss of appetite, fever (101.5°f) and  left arm injection site pain- was considered to be recovering/resolving.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Lloss of appetite; Myalgia; Arthralgia; Fatigue; Headache; Fever; Left arm injection site pain; A spontaneous report was received from a healthcare professional concerning a 64-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events myalgia, arthralgia, fatigue, headache, loss of appetite, fever (101.5 °f) and left arm injection site pain.  The patient's medical history included Covid-19 and tested positive for 44 days.( Mar 2020).The patient also had a history of heart surgery -mitral valve repair( Sep 2020). No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced  myalgia, arthralgia, fatigue, headache, loss of appetite, fever (101.5 °f) and  left arm injection site pain.The patient felt better on26 Jan 2021.  Lab information included body temperature which was 101.5 F on 23 Jan 2021.  Treatment details included Tylenol 1,000mg every 4 hours and Advil 600mg every 6 hours..  Action taken with mRNA-1273 in response to the events was Unknown.  The outcome of events-myalgia, arthralgia, fatigue, headache, loss of appetite, fever (101.5°f) and  left arm injection site pain- was considered to be recovering/resolving.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: redness; itching; Hot to touch a little lower than the injection site and keeps going further around the arm; There is a Rash; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching), FEELING HOT (Hot to touch a little lower than the injection site and keeps going further around the arm) and RASH (There is a Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL for an unknown indication.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itching), FEELING HOT (Hot to touch a little lower than the injection site and keeps going further around the arm) and RASH (There is a Rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 01-Feb-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (redness), PRURITUS (itching), FEELING HOT (Hot to touch a little lower than the injection site and keeps going further around the arm) and RASH (There is a Rash) outcome was unknown. 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.
Sex: M
Vaccine: COVID19
Symptoms: Breast tenderness
Clinical narrative: Breast Tenderness, bi-laterally left greater than right; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BREAST TENDERNESS (Breast Tenderness, bi-laterally left greater than right) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 BREAST TENDERNESS (Breast Tenderness, bi-laterally left greater than right). At the time of the report, BREAST TENDERNESS (Breast Tenderness, bi-laterally left greater than right) had not resolved. happened approximately 5 days after injection      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test positive
Clinical narrative: Covid-19 positive; loss of sense of smell; loss of sense of taste; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANOSMIA (loss of sense of smell), AGEUSIA (loss of sense of taste) and SARS-COV-2 TEST POSITIVE (Covid-19 positive) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 17-Jan-2021 to 25-Jan-2021.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ANOSMIA (loss of sense of smell) and AGEUSIA (loss of sense of taste). On 17-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 positive). On 23-Jan-2021, ANOSMIA (loss of sense of smell) and AGEUSIA (loss of sense of taste) had resolved. On 25-Jan-2021, SARS-COV-2 TEST POSITIVE (Covid-19 positive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Generalize rash from neck to groin; This spontaneous case was reported by a physician and describes the occurrence of RASH (Generalize rash from neck to groin) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Generalize rash from neck to groin). The patient was treated with CORTISONE on 03-Feb-2021 for Rash, at a dose of 1 dosage form. At the time of the report, RASH (Generalize rash from neck to groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm soreness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MYALGIA (Arm soreness). At the time of the report, MYALGIA (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Headache, Myalgia, Pruritus
Clinical narrative: Headache; A rash on her right side between her waist and her breast red; A rash on her right side between her waist and her breast; pain in the muscle on the left side; It was itchy on the internal side of the elbow/on the other arm/on the other arm; A little anxiety attack; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (A little anxiety attack), PRURITUS (It was itchy on the internal side of the elbow/on the other arm/on the other arm), ERYTHEMA (A rash on her right side between her waist and her breast red), RASH (A rash on her right side between her waist and her breast) and MYALGIA (pain in the muscle on the left side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia (not on medication at present.) in 2019.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced the first episode of HEADACHE (Headache). On 24-Jan-2021, the patient experienced ANXIETY (A little anxiety attack). On 25-Jan-2021, the patient experienced PRURITUS (It was itchy on the internal side of the elbow/on the other arm/on the other arm) and MYALGIA (pain in the muscle on the left side). On 27-Jan-2021, the patient experienced ERYTHEMA (A rash on her right side between her waist and her breast red) and RASH (A rash on her right side between her waist and her breast). On 29-Jan-2021, the patient experienced the second episode of HEADACHE (Headache). The patient was treated with CAMPHOR, EUCALYPTUS SPP. OIL, MENTHOL (VAPORUB) at an unspecified dose and frequency. At the time of the report, ANXIETY (A little anxiety attack), PRURITUS (It was itchy on the internal side of the elbow/on the other arm/on the other arm), ERYTHEMA (A rash on her right side between her waist and her breast red), RASH (A rash on her right side between her waist and her breast), MYALGIA (pain in the muscle on the left side) and the last episode of HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included VapoRub cream.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Headache; A rash on her right side between her waist and her breast red; A rash on her right side between her waist and her breast; pain in the muscle on the left side; It was itchy on the internal side of the elbow/on the other arm/on the other arm; A little anxiety attack; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (A little anxiety attack), PRURITUS (It was itchy on the internal side of the elbow/on the other arm/on the other arm), ERYTHEMA (A rash on her right side between her waist and her breast red), RASH (A rash on her right side between her waist and her breast) and MYALGIA (pain in the muscle on the left side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia (not on medication at present.) in 2019.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced the first episode of HEADACHE (Headache). On 24-Jan-2021, the patient experienced ANXIETY (A little anxiety attack). On 25-Jan-2021, the patient experienced PRURITUS (It was itchy on the internal side of the elbow/on the other arm/on the other arm) and MYALGIA (pain in the muscle on the left side). On 27-Jan-2021, the patient experienced ERYTHEMA (A rash on her right side between her waist and her breast red) and RASH (A rash on her right side between her waist and her breast). On 29-Jan-2021, the patient experienced the second episode of HEADACHE (Headache). The patient was treated with CAMPHOR, EUCALYPTUS SPP. OIL, MENTHOL (VAPORUB) at an unspecified dose and frequency. At the time of the report, ANXIETY (A little anxiety attack), PRURITUS (It was itchy on the internal side of the elbow/on the other arm/on the other arm), ERYTHEMA (A rash on her right side between her waist and her breast red), RASH (A rash on her right side between her waist and her breast), MYALGIA (pain in the muscle on the left side) and the last episode of HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included VapoRub cream.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Epistaxis, Headache, Pain, Pain in extremity
Clinical narrative: pain in intestines; nose bleed; headache was terrible; shoulder and arm kind of sore; Hurt everywhere (head, shoulders, stomach, rib cage, back); A spontaneous report was received from a healthcare professional concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in the intestines, blood in mouth,  headache , shoulder and arm soreness, and  hurting everywhere all through their body.   The patient's medical history included Crohn's disease. Concomitant medications reported were atorvastatin calcium and  gabapentin.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient began experienced pain in the intestines, shoulder and arm. It was also reported that the patient woke up with blood in the mouth, from a nose bleed. On 27 Jan 2021, the patient experienced headache , shoulder and arm soreness and  pain everywhere all through their body, so much pain could not lay in bed, could not lay down or sit up, hurt everywhere (head, shoulders, stomach, rib cage, back). Treatment details included Vicodin..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event,  intestine pain, blood in mouth, headache, shoulder and arm soreness, pain everywhere,  was considered recovered/ resolved on 01 Feb 2021.; Reporter's Comments: The events were consistent with increased risk of complications associated with Crohn's disease confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm to the touch around IS; Itch; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch around IS), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (redness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 VACCINATION SITE WARMTH (warm to the touch around IS), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (warm to the touch around IS), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Warmness at the site of Injection; Pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the site of Injection) and VACCINATION SITE PAIN (Pain at the site of injection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the site of Injection) and VACCINATION SITE PAIN (Pain at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warmness at the site of Injection) and VACCINATION SITE PAIN (Pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia
Clinical narrative: Fever; difficult for him to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and INSOMNIA (difficult for him to sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and INSOMNIA (difficult for him to sleep). At the time of the report, PYREXIA (Fever) and INSOMNIA (difficult for him to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding these events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Exposure during pregnancy, Eye irritation, Lacrimation increased, Pyrexia
Clinical narrative: Pregnancy; Fever 38.3C; soreness at injection site; burning watery eyes; burning watery eyes; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), EXPOSURE DURING PREGNANCY (Pregnancy), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site) had not resolved and EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 38.3c (High) 38.3C.         Concomitant product use was not provided by the reporter.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Pregnancy has been added.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pregnancy; Fever 38.3C; soreness at injection site; burning watery eyes; burning watery eyes; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), EXPOSURE DURING PREGNANCY (Pregnancy), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Feb-2021, the patient experienced EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EYE IRRITATION (burning watery eyes), LACRIMATION INCREASED (burning watery eyes), PYREXIA (Fever 38.3C) and VACCINATION SITE PAIN (soreness at injection site) had not resolved and EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 38.3c (High) 38.3C.         Concomitant product use was not provided by the reporter.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Pregnancy has been added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Peripheral swelling
Clinical narrative: burning feeling in my arm; Felt like a thickness like my arm was full down to fingers; lump that formed at the injection site; she had a mild headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (burning feeling in my arm), PERIPHERAL SWELLING (Felt like a thickness like my arm was full down to fingers), INJECTION SITE MASS (lump that formed at the injection site) and HEADACHE (she had a mild headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-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 (burning feeling in my arm), PERIPHERAL SWELLING (Felt like a thickness like my arm was full down to fingers), INJECTION SITE MASS (lump that formed at the injection site) and HEADACHE (she had a mild headache). At the time of the report, INJECTION SITE PAIN (burning feeling in my arm), PERIPHERAL SWELLING (Felt like a thickness like my arm was full down to fingers), INJECTION SITE MASS (lump that formed at the injection site) and HEADACHE (she had a mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Tremor, Urticaria, Vertigo
Clinical narrative: fever (104); vibrations; vertigo; hives; dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever (104)), TREMOR (vibrations), VERTIGO (vertigo), URTICARIA (hives) and DIZZINESS (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 PYREXIA (fever (104)), TREMOR (vibrations), VERTIGO (vertigo), URTICARIA (hives) and DIZZINESS (dizziness). At the time of the report, PYREXIA (fever (104)), TREMOR (vibrations), VERTIGO (vertigo), URTICARIA (hives) and DIZZINESS (dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details include Zertec, Benadryl.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Injection site pain
Clinical narrative: Abdominal pain; pain and soreness at the site of administration; Slight headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), INJECTION SITE PAIN (pain and soreness at the site of administration) and HEADACHE (Slight headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE PAIN (pain and soreness at the site of administration) and HEADACHE (Slight headache). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain), INJECTION SITE PAIN (pain and soreness at the site of administration) and HEADACHE (Slight headache) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph node swelling; ymph node swelling in left breast; lymph node swelling in left side of neck; couldn't lift left arm; A spontaneous report was received from a Consumer concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lymph node swelling left side of body, lymph node swelling in left breast, lymph node swelling in left side of neck, couldn't lift left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events lymph node swelling left side of body . On an unknown date, the patient experienced the events lymph node swelling in left breast . On an unknown date, the patient experienced the events lymph node swelling in left side of neck . On an unknown date, the patient experienced the events couldn't lift left arm.  Treatment details included Ice and heat compresses, ibuprofen  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, lymph node swelling left side of body, lymph node swelling in left breast, lymph node swelling in left side of neck, couldn't lift left arm was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: Rash; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and INJECTION SITE PAIN (Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History provided).    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and INJECTION SITE PAIN (Injection site pain). At the time of the report, RASH (Rash) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.