chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Muscle tightness, Nausea, Pain in extremity
Clinical narrative: dizziness; arm pain; muscular tightness throughout my neck and back; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea). At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild pain at the shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain at the shot site) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild pain at the shot site). At the time of the report, VACCINATION SITE PAIN (mild pain at the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: pretty bad case of COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment Information was provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Skin irritation, Vaccination site pain
Clinical narrative: itching / It's still itching now; redness; I developed skin irritation; was sore at the injection site; I felt extremely tired, & was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching / It's still itching now), ERYTHEMA (redness), SKIN IRRITATION (I developed skin irritation), VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site). On 15-Jul-2021, the patient experienced PRURITUS (itching / It's still itching now), ERYTHEMA (redness) and SKIN IRRITATION (I developed skin irritation). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching / It's still itching now) had not resolved and ERYTHEMA (redness), SKIN IRRITATION (I developed skin irritation), VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.   This case was linked to MOD-2021-284638 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect) 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) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (Covid-19) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Neck was getting stiff; Extremely tired; Red, raised area about the size of a quarter; Vaccine stung really bad when injected; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Vaccine stung really bad when injected). On 11-Aug-2021, the patient experienced ERYTHEMA (Red, raised area about the size of a quarter). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck was getting stiff) and FATIGUE (Extremely tired). At the time of the report, ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally administered the vaccine to a 13-year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered the vaccine to a 13-year-old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered the vaccine to a 13-year-old) (seriousness criterion medically significant). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally administered the vaccine to a 13-year-old) 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.   Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter.  This is a case of inappropriate age (13yrs) at vaccine administration with no adverse events. Additional information is requested.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received and contains no new information; Sender's Comments: This is a case of inappropriate age (13yrs) at vaccine administration with no adverse events. Additional information is requested. MOD21-129585:cross linked
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: a  terrible diarrhea; nauseated/nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (a  terrible diarrhea) and NAUSEA (nauseated/nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced NAUSEA (nauseated/nausea). On 14-Aug-2021, the patient experienced DIARRHOEA (a  terrible diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of 1 dosage form, 2 tablets. On 15-Aug-2021, DIARRHOEA (a  terrible diarrhea) had resolved. At the time of the report, NAUSEA (nauseated/nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned of taking 2  tablets of Imodium that was  given by a nurse from her  doctor's  office, and it helped to treat her  diarrhea. Patient took doctor pepper and another medication for nausea. Patient  is on some concomitant medications like: Medication for Epilepsy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: additional info received with updated event information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: took the Moderna COVID-19 vaccine and was having a reaction 6 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later). At the time of the report, VACCINATION COMPLICATION (took the Moderna COVID-19 vaccine and was having a reaction 6 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunosuppression, Product dose omission issue, Rash, Rash pruritic
Clinical narrative: my immune system became suppressed,I had some issues with that (immune system); it was very itchy; rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body; didn't receive second shot yet (>42 days following first dose); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)) (seriousness criterion medically significant), RASH PRURITIC (it was very itchy), RASH (rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body) and PRODUCT DOSE OMISSION ISSUE (didn't receive second shot yet (>42 days following first dose)). At the time of the report, IMMUNOSUPPRESSION (my immune system became suppressed,I had some issues with that (immune system)), RASH PRURITIC (it was very itchy) and RASH (rash in my neck,rash went down to my torso,rash moved to my arms, rash continued to move around my body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't receive second shot yet (>42 days following first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Patient does not take any medication regularly and no treatment medications were reported  Patient has seen three doctors, and still has some of the rash.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: Tension; This spontaneous case was reported by a consumer and describes the occurrence of TENSION (Tension) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     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 TENSION (Tension). At the time of the report, TENSION (Tension) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days since received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days since received the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since received the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient experienced SARS-CoV2 infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patient experienced SARS-CoV2 infection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) 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 29-Jul-2021, the patient experienced COVID-19 (patient experienced SARS-CoV2 infection). At the time of the report, COVID-19 (patient experienced SARS-CoV2 infection) 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 medication information was reported. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Peripheral swelling
Clinical narrative: Both legs and feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both legs and feet swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cholesterol medicines causes shortness of breath) and Allergy NOS (Allergic to a lot of things).    On 26-Jul-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 PERIPHERAL SWELLING (Both legs and feet swollen). At the time of the report, PERIPHERAL SWELLING (Both legs and feet swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  The patient was prescribed with hydrocortisone (thrice weekly) but the patient was yet to start the medications.  The patient received first dose of vaccine, lot number was 0a1B21A or 091B21A. The patient had so side effects until a few days later when both legs and feet started to swell. The patient's blood pressure was also raising, so the patient consulted with the physician as the patient thought about having some kind of reaction to the vaccine. The physician suspected that it was probably not related to the vaccine and prescribed hydrocortisone to take three times a week.  The patient was scheduled for second dose on 23-Aug-2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Drug ineffective, Dyspnoea, Pruritus
Clinical narrative: This itchiness is not comfortable, she cannot function correctly.; different types of stuff coming out of her skin/it's ugly; shortness of breath; chest pain; rash; lack of drug effect; severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable), DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included INSULIN, METFORMIN, TORASEMIDE (TORSEMIDE), BISOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), GABAPENTIN, LOSARTAN, ROSUVASTATIN, EZETIMIBE and LORATADINE for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable). On an unknown date, the patient experienced DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), RASH (rash) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable), DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), RASH (rash) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.            Patient lab data includes blood test. Patient went to dermatologist but they are treating this topically and patient felt this is not topical but internal. Concomitant over the counter medication unspecified was taken by patient. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin discharge
Clinical narrative: This itchiness is not comfortable, she cannot function correctly.; different types of stuff coming out of her skin/it's ugly; shortness of breath; chest pain; rash; lack of drug effect; severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable), DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included INSULIN, METFORMIN, TORASEMIDE (TORSEMIDE), BISOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), GABAPENTIN, LOSARTAN, ROSUVASTATIN, EZETIMIBE and LORATADINE for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable). On an unknown date, the patient experienced DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), RASH (rash) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (severe itching that started in her arm only but has spread to the entire body/itching is making her extremely miserable), DISCOMFORT (This itchiness is not comfortable, she cannot function correctly.), SKIN DISCHARGE (different types of stuff coming out of her skin/it's ugly), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), RASH (rash) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.            Patient lab data includes blood test. Patient went to dermatologist but they are treating this topically and patient felt this is not topical but internal. Concomitant over the counter medication unspecified was taken by patient. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Severe pain; more hardness at injection site; Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Vaccination adverse reaction (severe swelling after flu vaccine, yellow fever. And passed out. ) and Osteoporosis. Previously administered products included for an unreported indication: YELLOW FEVER and flu vaccine. Concurrent medical conditions included Contrast media allergy and Lactose intolerant. Concomitant products included TRANEXAMIC ACID (TYRODIN [TRANEXAMIC ACID]) and VITAMINS NOS for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 16-Mar-2021, VACCINATION SITE PAIN (Severe pain), VACCINATION SITE INDURATION (more hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative (Negative) NEGATIVE.         No treatment medication were provided by the reporter Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-285153 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: CD4 lymphocytes, Immunodeficiency
Clinical narrative: Immune compromised; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immune compromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-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 IMMUNODEFICIENCY (Immune compromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immune compromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CD4 lymphocytes: 234 (abnormal) 234.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No medical history was provided. The reporter reported that his CD4 COUNT was 234 when he received his COVID-19 vaccine on march 9, 2021. Also patient was  immune compromised.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information is not to be expected. The patient stated that at the time of vaccination the CD4 count was 234. Therefore, a causal association of immunocompromization and vaccination appears rather unlikely. Implied causality of a spontaneous report applies, however.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information is not to be expected. The patient stated that at the time of vaccination the CD4 count was 234. Therefore, a causal association of immunocompromization and vaccination appears rather unlikely. Implied causality of a spontaneous report applies, however.
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: skin reactions from the vaccine> This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin reactions from 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (skin reactions from the vaccine>). At the time of the report, SKIN REACTION (skin reactions from the vaccine>) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patient received an expired vaccine; Possible temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown and PRODUCT TEMPERATURE EXCURSION ISSUE (Possible temperature excursion) 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 information on concomitant medications were reported.  No Treatment medications were reported.  The vaccines were received to nurse on 30-July-2021 and remained in the refrigerator but was missing the expiration label of when they were previously placed in the fridge. The nurse was unaware that the vaccines were initially received and placed in the fridge 08-July-2021. The max temperature reached was 41.4F and min 40.6F.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister
Clinical narrative: Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD BLISTER (Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red). At the time of the report, BLOOD BLISTER (Inside her lower right eyelid developed a red blister on the inside of her eye that was bloody red) outcome was unknown.            No relevant concomitant product were reported.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chest pain, Pain, Pain in extremity
Clinical narrative: more pain all over the left side of their body; whole left arm hurts; pain in their kidney; pain in their chest; pain under their left arm; left wrist hurts/left elbow hurts; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest) and VACCINATION SITE PAIN (pain at the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 12-Aug-2021, the patient experienced PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest), AXILLARY PAIN (pain under their left arm) and ARTHRALGIA (left wrist hurts/left elbow hurts). At the time of the report, PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest), VACCINATION SITE PAIN (pain at the injection site), AXILLARY PAIN (pain under their left arm) and ARTHRALGIA (left wrist hurts/left elbow hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated they did not take any medications regularly. No Treatment information was provided. After six days of vaccine administration, patient developed more pain all over the left side of their body, their whole left arm hurts, left elbow, left wrist, they have pain under their left arm, in their kidney and their chest.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Vaccination site pain
Clinical narrative: more pain all over the left side of their body; whole left arm hurts; pain in their kidney; pain in their chest; pain under their left arm; left wrist hurts/left elbow hurts; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest) and VACCINATION SITE PAIN (pain at the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 12-Aug-2021, the patient experienced PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest), AXILLARY PAIN (pain under their left arm) and ARTHRALGIA (left wrist hurts/left elbow hurts). At the time of the report, PAIN (more pain all over the left side of their body), PAIN IN EXTREMITY (whole left arm hurts), RENAL PAIN (pain in their kidney), CHEST PAIN (pain in their chest), VACCINATION SITE PAIN (pain at the injection site), AXILLARY PAIN (pain under their left arm) and ARTHRALGIA (left wrist hurts/left elbow hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated they did not take any medications regularly. No Treatment information was provided. After six days of vaccine administration, patient developed more pain all over the left side of their body, their whole left arm hurts, left elbow, left wrist, they have pain under their left arm, in their kidney and their chest.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patient received an expired vaccine past 30 days in the fridge; A possible temperature excursion at her facility; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine past 30 days in the fridge) and PRODUCT TEMPERATURE EXCURSION ISSUE (A possible temperature excursion at her facility) 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 medications reported.  No treatment medications reported.  Nurse reported that the vaccines were received on 08-Jul-2021 and was placed in the refrigerator, later was received to her on 30-Jul-2021 with the expiration label missing. The nurse was unaware that vaccines were placed in the fridge on 08-Jul-2021.The max temperature reached was 41.4F and min 40.6F. 4 vials (Lot# 038C21A)of them were affected and 3 of the vials were used to administer vaccinations to 9 patients over 3 days 09-Aug-2021 to11-Aug-2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Two dots of blood; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Two dots of blood) 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 VACCINATION SITE PAIN (Two dots of blood). At the time of the report, VACCINATION SITE PAIN (Two dots of blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) 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 EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) 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 considered EXPIRED PRODUCT ADMINISTERED (GIVEN 5 MODERNA VACCINE INJECTIONS THAT EXPIRED ON 8/8/21) to be not applicable.    No concomitant and treatment medications provided by reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: lupus flare up; condition aggravated; felt worse than flu; low grade fever of 100; body aches; extreme fatigue (down and out); injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus. Concomitant products included MESALAZINE (DELZICOL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant), FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 800 milligram and PREDNISONE ongoing since an unknown date for SLE flare, at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown and FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 100 (abnormal) low grade fever of 100.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Ibuprofen for vaccine related adverse events and Prednisolone for lupus flare up are the treatment medication reported by reporter.  Patient states that adverse events lasted 3-4 days.  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.   This case was linked to MOD-2021-285120 (Patient Link).; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Systemic lupus erythematosus, Vaccination site pain
Clinical narrative: lupus flare up; condition aggravated; felt worse than flu; low grade fever of 100; body aches; extreme fatigue (down and out); injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus. Concomitant products included MESALAZINE (DELZICOL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant), FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 800 milligram and PREDNISONE ongoing since an unknown date for SLE flare, at an unspecified dose and frequency. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown and FEELING ABNORMAL (felt worse than flu), PYREXIA (low grade fever of 100), MYALGIA (body aches), FATIGUE (extreme fatigue (down and out)) and VACCINATION SITE PAIN (injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 100 (abnormal) low grade fever of 100.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Ibuprofen for vaccine related adverse events and Prednisolone for lupus flare up are the treatment medication reported by reporter.  Patient states that adverse events lasted 3-4 days.  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.   This case was linked to MOD-2021-285120 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired 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 medications were reported.  Treatment information was not provided.