chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Head discomfort, Headache, Incontinence
Clinical narrative: she had to slide her feet; my head pounded; I've been getting tired more easily; such pain behind my eyes/when I blinked, they hurt terribly; my eyes felt swollen; there was pressure/ felt pressure in my brain; I could hardly eat; I couldn't stand up; I was incontinent; left side of the chest hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (such pain behind my eyes/when I blinked, they hurt terribly), EYE SWELLING (my eyes felt swollen), HEAD DISCOMFORT (there was pressure/ felt pressure in my brain), DECREASED APPETITE (I could hardly eat) and DYSSTASIA (I couldn't stand up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EYE PAIN (such pain behind my eyes/when I blinked, they hurt terribly), EYE SWELLING (my eyes felt swollen), HEAD DISCOMFORT (there was pressure/ felt pressure in my brain), DECREASED APPETITE (I could hardly eat), DYSSTASIA (I couldn't stand up), INCONTINENCE (I was incontinent), CHEST PAIN (left side of the chest hurt really bad), HEADACHE (my head pounded) and FATIGUE (I've been getting tired more easily). On an unknown date, the patient experienced GAIT DISTURBANCE (she had to slide her feet). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pain, at a dose of 1 dosage form. At the time of the report, EYE PAIN (such pain behind my eyes/when I blinked, they hurt terribly), EYE SWELLING (my eyes felt swollen), HEAD DISCOMFORT (there was pressure/ felt pressure in my brain), DECREASED APPETITE (I could hardly eat), DYSSTASIA (I couldn't stand up), INCONTINENCE (I was incontinent), CHEST PAIN (left side of the chest hurt really bad), GAIT DISTURBANCE (she had to slide her feet), HEADACHE (my head pounded) and FATIGUE (I've been getting tired more easily) outcome was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: allergic reaction; Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and RASH (Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced RASH (Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) and RASH (Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest) 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 reported. The patient was given treatment for allergic reactions.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy a couple hours after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy a couple hours after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy a couple hours after the vaccine). At the time of the report, PRURITUS (itchy a couple hours after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nervousness, Pyrexia, Skin burning sensation
Clinical narrative: skin is burning where the hives are; skin is burning where the hives are; hives; I was a little nervous about the 2nd shot so I spaced it out; fever of 102 F; headache was worse with 1st one; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), NERVOUSNESS (I was a little nervous about the 2nd shot so I spaced it out), SKIN WARM (skin is burning where the hives are), SKIN BURNING SENSATION (skin is burning where the hives are) and PYREXIA (fever of 102 F) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included Zyrtec for Birth control, Juliet (estrogen) for an unknown indication.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced NERVOUSNESS (I was a little nervous about the 2nd shot so I spaced it out), PYREXIA (fever of 102 F) and HEADACHE (headache was worse with 1st one). On 30-May-2021, the patient experienced URTICARIA (hives). On 02-Aug-2021, the patient experienced SKIN WARM (skin is burning where the hives are) and SKIN BURNING SENSATION (skin is burning where the hives are). On 30-Jul-2021, NERVOUSNESS (I was a little nervous about the 2nd shot so I spaced it out) had resolved. At the time of the report, URTICARIA (hives), SKIN WARM (skin is burning where the hives are), SKIN BURNING SENSATION (skin is burning where the hives are), PYREXIA (fever of 102 F) and HEADACHE (headache was worse with 1st one) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Body temperature: 102 (High) approximately 8 hours after receiving 1st dose high fever of 102 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient never had any allergies where it has caused an anaphylactic reaction.  Juliet & Zyrtec medications are taken in low doses.  Treatment medications was not provided.   This case was linked to MOD-2021-273099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: significant follow up appended-addition of new event skin warm  and skin burning sensation.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: skin is burning where the hives are; skin is burning where the hives are; hives; I was a little nervous about the 2nd shot so I spaced it out; fever of 102 F; headache was worse with 1st one; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), NERVOUSNESS (I was a little nervous about the 2nd shot so I spaced it out), SKIN WARM (skin is burning where the hives are), SKIN BURNING SENSATION (skin is burning where the hives are) and PYREXIA (fever of 102 F) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included Zyrtec for Birth control, Juliet (estrogen) for an unknown indication.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced NERVOUSNESS (I was a little nervous about the 2nd shot so I spaced it out), PYREXIA (fever of 102 F) and HEADACHE (headache was worse with 1st one). On 30-May-2021, the patient experienced URTICARIA (hives). On 02-Aug-2021, the patient experienced SKIN WARM (skin is burning where the hives are) and SKIN BURNING SENSATION (skin is burning where the hives are). On 30-Jul-2021, NERVOUSNESS (I was a little nervous about the 2nd shot so I spaced it out) had resolved. At the time of the report, URTICARIA (hives), SKIN WARM (skin is burning where the hives are), SKIN BURNING SENSATION (skin is burning where the hives are), PYREXIA (fever of 102 F) and HEADACHE (headache was worse with 1st one) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Body temperature: 102 (High) approximately 8 hours after receiving 1st dose high fever of 102 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient never had any allergies where it has caused an anaphylactic reaction.  Juliet & Zyrtec medications are taken in low doses.  Treatment medications was not provided.   This case was linked to MOD-2021-273099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: significant follow up appended-addition of new event skin warm  and skin burning sensation.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Myalgia
Clinical narrative: Feeling bloated; Body aches; Abdominal cramping/Mild abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping/Mild abdominal pain), ABDOMINAL DISTENSION (Feeling bloated) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping/Mild abdominal pain). On 01-Aug-2021, the patient experienced ABDOMINAL DISTENSION (Feeling bloated) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 mg, a couple of times. On 01-Aug-2021, MYALGIA (Body aches) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal cramping/Mild abdominal pain) and ABDOMINAL DISTENSION (Feeling bloated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified sleep medication.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The patient has not received their second dose, and it has been more than 36 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient has not received their second dose, and it has been more than 36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received their second dose, and it has been more than 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient has not received their second dose, and it has been more than 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was given.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was delayed beyond 36 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed beyond 36 days) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed beyond 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was delayed beyond 36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: some sorenessin arm; Little rush; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some sorenessin arm) and RASH (Little rush) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Hernia operation). Concurrent medical conditions included Bronchitis and COPD. Concomitant products included ALBUTEROL [SALBUTAMOL], IPRATROPIUM BROMIDE and RANIBIZUMAB (LUCENTIS) for an unknown indication.    On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some sorenessin arm) and RASH (Little rush). At the time of the report, PAIN IN EXTREMITY (some sorenessin arm) and RASH (Little rush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered). At the time of the report, UNDERDOSE (Vaccine leaked from syringe while patient was receiving the shot, more than half to 3 quarters of vaccine was administered) 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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Left ankle swelled up; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left ankle swelled up) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included Ankle fracture (Broken both ankles.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced JOINT SWELLING (Left ankle swelled up). On 22-Apr-2021, JOINT SWELLING (Left ankle swelled up) had resolved.            No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-273111 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Skin warm, Urticaria
Clinical narrative: Skin is hot where hives are; Had hives again started on her arms and spread all the way to her neck and trunk; Headache also; Fever with this one also but not quite as high; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Had hives again started on her arms and spread all the way to her neck and trunk), SKIN WARM (Skin is hot where hives are), HEADACHE (Headache also) and PYREXIA (Fever with this one also but not quite as high) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included DESOGESTREL (JULIET) for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced HEADACHE (Headache also) and PYREXIA (Fever with this one also but not quite as high). On 31-Jul-2021, the patient experienced URTICARIA (Had hives again started on her arms and spread all the way to her neck and trunk). On 02-Aug-2021, the patient experienced SKIN WARM (Skin is hot where hives are). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Aug-2021, URTICARIA (Had hives again started on her arms and spread all the way to her neck and trunk) was resolving. At the time of the report, SKIN WARM (Skin is hot where hives are), HEADACHE (Headache also) and PYREXIA (Fever with this one also but not quite as high) outcome was unknown.            This case was linked to MOD-2021-273064 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unspecific adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific adverse event). At the time of the report, VACCINATION COMPLICATION (Unspecific adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided by reporter. No treatment medication are provided by reporter.  Caller did not specify any adverse event.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient felt a little tired but also feels tired all the time due to underlying condition; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Patient felt a little tired but also feels tired all the time due to underlying condition) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Drug-induced lupus erythematosus ((resolved by December)) in December 2020. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PROPRANOLOL, LEFLUNOMIDE, FOLIC ACID, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), PROBIOTICS NOS and METHOTREXATE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (Patient felt a little tired but also feels tired all the time due to underlying condition). On 31-Dec-2020, FATIGUE (Patient felt a little tired but also feels tired all the time due to underlying condition) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant medications include ArthroStop Infusion and Certex.  No treatment information was provided.   This case was linked to MOD-2021-273123 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.            No concomitant medications were reported.  No treatment  medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Left ankle swelled up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Left ankle swelled up) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SWELLING (Left ankle swelled up). On 22-Apr-2021, SWELLING (Left ankle swelled up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-273091, MOD-2021-273091 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Lymphadenopathy, Malaise, Product dose omission issue
Clinical narrative: only received one moderna vaccine; flu like systems within the first 24 hours of vaccine; really hasn't felt well since getting the vaccine until recently; swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away; headache that was pushing down from the top of her skull and lasted several weeks; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like systems within the first 24 hours of vaccine), MALAISE (really hasn't felt well since getting the vaccine until recently), LYMPHADENOPATHY (swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away), HEADACHE (headache that was pushing down from the top of her skull and lasted several weeks) and PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03(4or9)K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like systems within the first 24 hours of vaccine), MALAISE (really hasn't felt well since getting the vaccine until recently), LYMPHADENOPATHY (swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away) and HEADACHE (headache that was pushing down from the top of her skull and lasted several weeks). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (flu like systems within the first 24 hours of vaccine), MALAISE (really hasn't felt well since getting the vaccine until recently), LYMPHADENOPATHY (swollen lymph nodes on both sides/swollen, hurt and be sore, and then go away) and HEADACHE (headache that was pushing down from the top of her skull and lasted several weeks) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (only received one moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive second dose within the recommended window/received the 1st dose of the Moderna COVID-19 vaccine on 01May2021, It's been 3 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose within the recommended window/received the 1st dose of the Moderna COVID-19 vaccine on 01May2021, It's been 3 months) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose within the recommended window/received the 1st dose of the Moderna COVID-19 vaccine on 01May2021, It's been 3 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose within the recommended window/received the 1st dose of the Moderna COVID-19 vaccine on 01May2021, It's been 3 months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: she has not gotten the second one; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she has not gotten the second one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PRODUCT DOSE OMISSION ISSUE (she has not gotten the second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (she has not gotten the second one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment products were reported.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue
Clinical narrative: Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling) and PRODUCT DOSE OMISSION ISSUE (Missed dose). On 06-Mar-2021, LYMPHADENOPATHY (Swelling in her lymph nodes/30 minutes after receiving the 1st dose she experienced lymph node swelling) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. Patient stated that she has experienced similar symptom of swelling of lymph nodes in the past in reaction to certain medications.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received  contains significant information. updated and added reporter information, updated patient age to 39, updated dose start date and lot number, updated event outcome to recovered, start date of the drug updated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Peripheral swelling
Clinical narrative: thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is; right thumb went numb; felt a little bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bad), HYPOAESTHESIA (right thumb went numb) and PERIPHERAL SWELLING (thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced FEELING ABNORMAL (felt a little bad). On 01-Aug-2021, the patient experienced HYPOAESTHESIA (right thumb went numb). On 02-Aug-2021, the patient experienced PERIPHERAL SWELLING (thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is). On 30-Jul-2021, FEELING ABNORMAL (felt a little bad) had resolved. At the time of the report, HYPOAESTHESIA (right thumb went numb) and PERIPHERAL SWELLING (thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Illness, Lethargy, Pain in extremity
Clinical narrative: felt like she might get sick, but she didn't; Shingles symptoms; Lethargy; Sore arm; a little tired; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm), HERPES ZOSTER (Shingles symptoms), ILLNESS (felt like she might get sick, but she didn't) and FATIGUE (a little tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis and Drug-induced lupus erythematosus. Concomitant products included PROPRANOLOL, LEFLUNOMIDE, FOLIC ACID, GLUCOSAMINE SULFATE (ARTHROSTOP [GLUCOSAMINE SULFATE]), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), METHOTREXATE and PROBIOTIC 10 for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (a little tired). On 26-Jan-2021, the patient experienced LETHARGY (Lethargy) and PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles symptoms). On an unknown date, the patient experienced ILLNESS (felt like she might get sick, but she didn't). The patient was treated with LIDOCAINE for Shingles, at an unspecified dose and frequency and PREGABALIN for Shingles, at an unspecified dose and frequency. On 31-Dec-2020, FATIGUE (a little tired) outcome was unknown. On 28-Jan-2021, LETHARGY (Lethargy) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. On 08-Apr-2021, HERPES ZOSTER (Shingles symptoms) had resolved. At the time of the report, ILLNESS (felt like she might get sick, but she didn't) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications included  Certex.  The patient was diagnosed with shingles on 16-Feb-2021 when she went to her doctor. It was a very significant case and it crossed two dermatomes. The patient received steroids to treat it.   This case was linked to MOD-2021-273108 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of product dose omission issue (missed 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002C21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (missed 2nd dose). At the time of the report, product dose omission issue (missed 2nd dose): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eczema, Rash erythematous, Rash pruritic
Clinical narrative: red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.; rashy areas that were itchy in several areas of body; several periods of dizziness; eczema; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.), RASH PRURITIC (rashy areas that were itchy in several areas of body), DIZZINESS (several periods of dizziness) and ECZEMA (eczema) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.), RASH PRURITIC (rashy areas that were itchy in several areas of body), DIZZINESS (several periods of dizziness) and ECZEMA (eczema). At the time of the report, RASH ERYTHEMATOUS (red rashy areas that were in several areas of body / These areas included; arms, legs, scalp, back of neck and chest.), RASH PRURITIC (rashy areas that were itchy in several areas of body), DIZZINESS (several periods of dizziness) and ECZEMA (eczema) had not resolved.            Around 2 weeks following the second administration of the vaccine, the patient began to experience the events. The areas included in itchy rash are arms, legs, scalp, back of neck and chest.  The treatment information includes eczema medications, steroid creams, anti-itchy cream, peppermint oil, hydrocortisone cream.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No relevant medical history or concomitant medication.     On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021/Invalid dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided. No treatment  information was provided.  One vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2F) beyond 12 hours. The vial was first punctured at 1:01PM on 31JUL2021 and that is when it was first moved to the room temperature.Patient number four received his first dose of Moderna COVID-19 Vaccine on 01AUG2021 at 11:27AM (10 hours and 26 minutes beyond punctured vial 12 hour expiration at room temperature).   This case was linked to MOD21-125492, MOD21-125573, MOD21-125575, MOD21-125577, and MOD21-125580, MOD-2021-273049 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Migraine, Pyrexia, Visual impairment
Clinical narrative: pain in the left eye; swollen eyes like puffy; excruciating migraine above eyes; fever; difficulty seeing; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in the left eye), VISUAL IMPAIRMENT (difficulty seeing), EYE SWELLING (swollen eyes like puffy), MIGRAINE (excruciating migraine above eyes) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Drug allergy (Codeine allergy), Sulfonamide allergy (Sulfa drugs), Drug allergy (Prednisone), Penicillin allergy, Allergy to antibiotic (Erythromycin), Fruit allergy (Tomato allergy) and Fruit allergy (Banana allergy).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced VISUAL IMPAIRMENT (difficulty seeing), MIGRAINE (excruciating migraine above eyes) and PYREXIA (fever). On an unknown date, the patient experienced EYE PAIN (pain in the left eye) and EYE SWELLING (swollen eyes like puffy). On 31-Jul-2021, MIGRAINE (excruciating migraine above eyes) and PYREXIA (fever) had resolved. At the time of the report, EYE PAIN (pain in the left eye), VISUAL IMPAIRMENT (difficulty seeing) and EYE SWELLING (swollen eyes like puffy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was received by the patient Concomitant medications include cholesterol medications, vitamin supple.ments.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Headache, Illness, Pyrexia
Clinical narrative: sick; bad cough; lack of appetite; high fever; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), COUGH (bad cough), DECREASED APPETITE (lack of appetite), PYREXIA (high fever) and HEADACHE (headaches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Back injury. Concomitant products included LORATADINE for Allergy, DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced ILLNESS (sick), COUGH (bad cough), DECREASED APPETITE (lack of appetite), PYREXIA (high fever) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick), COUGH (bad cough), DECREASED APPETITE (lack of appetite), PYREXIA (high fever) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had been to the ER her HCP  twice.  Concomitant medications included a Muscle relaxant.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: legs have been swelling where they can barely walk in the morning; Hands, are very hard  ever since  second shot; hand swelling after second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs have been swelling where they can barely walk in the morning), LIMB DISCOMFORT (Hands, are very hard  ever since  second shot) and PERIPHERAL SWELLING (hand swelling after second dose.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (legs have been swelling where they can barely walk in the morning), LIMB DISCOMFORT (Hands, are very hard  ever since  second shot) and PERIPHERAL SWELLING (hand swelling after second dose.). At the time of the report, PERIPHERAL SWELLING (legs have been swelling where they can barely walk in the morning), LIMB DISCOMFORT (Hands, are very hard  ever since  second shot) and PERIPHERAL SWELLING (hand swelling after second dose.) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Reporter demographic details was added, patient Date of birth  and gender added dose 1 & dose 2 information was added
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Pain in extremity
Clinical narrative: left sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left sore arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included DULOXETINE, METOPROLOL, LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS] and APPLE CIDER VINEGAR for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced PAIN IN EXTREMITY (left sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (left sore arm) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Blood pressure measurement: 176/111 (High) high and 156/98 (abnormal) lowest blood pressure reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication hydralazine was just prescribed has not taken yet by the patient  as her doctor "just prescribed"