chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased
Clinical narrative: CK levels were elevated; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BLOOD CREATINE PHOSPHOKINASE INCREASED (CK levels were elevated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced BLOOD CREATINE PHOSPHOKINASE INCREASED (CK levels were elevated). At the time of the report, BLOOD CREATINE PHOSPHOKINASE INCREASED (CK levels were elevated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medication information was provided.  The patient saw their general practitioner and went to emergency room (ER) to be examined. No treatment product information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-218897 (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 event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Joint swelling, Myositis, Oedema, Peripheral swelling
Clinical narrative: swollen wrists; swollen feet; edema; possible myositis; This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (swollen wrists), PERIPHERAL SWELLING (swollen feet), OEDEMA (edema) and MYOSITIS (possible myositis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced JOINT SWELLING (swollen wrists), PERIPHERAL SWELLING (swollen feet) and OEDEMA (edema). In April 2021, the patient experienced MYOSITIS (possible myositis). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swollen wrists), PERIPHERAL SWELLING (swollen feet), OEDEMA (edema) and MYOSITIS (possible myositis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood creatine phosphokinase: elevated level (High) elevated level.         Concomitant product use was not provided by the reporter.  The patient is currently seeing a Rheumatologist and has had a muscle biopsy to get a conclusive diagnosis, however the results were not provided.  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.; 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Heart rate increased, Hypertension
Clinical narrative: Chest pains; Rapid heartbeat; High Blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains), HEART RATE INCREASED (Rapid heartbeat) and HYPERTENSION (High Blood pressure) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2742408-07170) for COVID-19 vaccination.     The patient's past medical history included Gastroparesis in 2003, Irritable bowel syndrome in 1992, GERD in 2003, Migraine in 1986, Depression in 2001 and Anxiety. Concurrent medical conditions included Drug allergy (Allergy to Lamictal), Drug allergy (Allergy to tegretol), Drug allergy (Allergy to trilrptal), Drug allergy (Allergy to Methadone) and Drug allergy (Allergy to Abilify). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Migraine and Nausea, MULTIVITAMINS [VITAMINS NOS] for Nutritional support.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced CHEST PAIN (Chest pains), HEART RATE INCREASED (Rapid heartbeat) and HYPERTENSION (High Blood pressure). At the time of the report, CHEST PAIN (Chest pains), HEART RATE INCREASED (Rapid heartbeat) and HYPERTENSION (High Blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: inconclusive (Inconclusive) Inconclusive. On an unknown date, Electrocardiogram: elevated (High) Elevated Heart Rate and Blood Pressure-recovered.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported that took IV fluid and pain medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 and included Patient's demographics, relevant history, allergies, lab tests, concomitant medications and event information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Vacci nation site sore; the injection site became warm to touch; Flu-like Symptoms  on the same day as the vaccination.; the injection site became itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (the injection site became warm to touch), INFLUENZA LIKE ILLNESS (Flu-like Symptoms  on the same day as the vaccination.), VACCINATION SITE PRURITUS (the injection site became itchy) and INJECTION SITE PAIN (injection site sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE WARMTH (the injection site became warm to touch), INFLUENZA LIKE ILLNESS (Flu-like Symptoms  on the same day as the vaccination.) and VACCINATION SITE PRURITUS (the injection site became itchy). On an unknown date, the patient experienced INJECTION SITE PAIN (injection site sore). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (the injection site became warm to touch), INFLUENZA LIKE ILLNESS (Flu-like Symptoms  on the same day as the vaccination.), VACCINATION SITE PRURITUS (the injection site became itchy) and INJECTION SITE PAIN (injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-218957 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feeling very dizzy, dizzy after second dose; 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 DIZZINESS (feeling very dizzy, dizzy after second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feeling very dizzy, dizzy after second dose). At the time of the report, DIZZINESS (feeling very dizzy, dizzy after second dose) outcome was unknown.            No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Diarrhea; stomach ache, rated pain as 7 out of 10, 10 being the highest; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach ache, rated pain as 7 out of 10, 10 being the highest) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach ache, rated pain as 7 out of 10, 10 being the highest) and NAUSEA (Nausea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach ache, rated pain as 7 out of 10, 10 being the highest) and NAUSEA (Nausea) had resolved.            No concomitant medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU received as "update on outcome ". The symptoms settled in about four days. No issues after that. She said she is fine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history were provided by the reporter.    On 04-Jun-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. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided Treatment medications were not provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non significant follow up
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: Stiff knee; knee swelling; Severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knee), JOINT SWELLING (knee swelling) and ARTHRALGIA (Severe joint pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 009C21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (she had surgery several years ago.). Concomitant products included TRAMADOL for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ARTHRALGIA (Severe joint pain). On 17-Apr-2021, the patient experienced JOINT STIFFNESS (Stiff knee) and JOINT SWELLING (knee swelling). At the time of the report, JOINT STIFFNESS (Stiff knee), JOINT SWELLING (knee swelling) and ARTHRALGIA (Severe joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not  provided by the reporter. The patient had consultation with the physician in orthopedic clinic regarding the knee problems.   This case was linked to MOD-2021-218965.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: follow-up document received on 24-06-2021 and contain non significant information. On 09-Aug-2021: Significant Follow-up received and added new events of knee swelling and stiff knee
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Vaccination site discomfort, Vaccination site swelling
Clinical narrative: now the rash on the shoulder area looks like an eczema; discomfort when touched at the injection site; big bump that has swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (now the rash on the shoulder area looks like an eczema), VACCINATION SITE DISCOMFORT (discomfort when touched at the injection site) and VACCINATION SITE SWELLING (big bump that has swollen at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ECZEMA (now the rash on the shoulder area looks like an eczema), VACCINATION SITE DISCOMFORT (discomfort when touched at the injection site) and VACCINATION SITE SWELLING (big bump that has swollen at the injection site). At the time of the report, ECZEMA (now the rash on the shoulder area looks like an eczema), VACCINATION SITE DISCOMFORT (discomfort when touched at the injection site) and VACCINATION SITE SWELLING (big bump that has swollen at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication were not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Palpitations, Pyrexia
Clinical narrative: palpitations; body aches; fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease since an unknown date and Hypothyroidism since an unknown date. Concurrent medical conditions included Allergy to antibiotic (macrolides). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-2000 to an unknown date for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PALPITATIONS (palpitations), MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-004043 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Part of vaccine leaked out of a faulty syringe during administration of first shot; it leaked out of a faulty syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Part of vaccine leaked out of a faulty syringe during administration of first shot) and SYRINGE ISSUE (it leaked out of a faulty syringe) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced UNDERDOSE (Part of vaccine leaked out of a faulty syringe during administration of first shot) and SYRINGE ISSUE (it leaked out of a faulty syringe). At the time of the report, UNDERDOSE (Part of vaccine leaked out of a faulty syringe during administration of first shot) and SYRINGE ISSUE (it leaked out of a faulty syringe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain, Pyrexia, Vaccination site movement impairment
Clinical narrative: Pain; Couldn't lift the arm; fever; headache; Numbness in the left side of her face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift the arm), PYREXIA (fever), HEADACHE (headache) and HYPOAESTHESIA (Numbness in the left side of her face) 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 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced PAIN (Pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift the arm), PYREXIA (fever), HEADACHE (headache) and HYPOAESTHESIA (Numbness in the left side of her face). On 10-Jun-2021, PAIN (Pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't lift the arm), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, HYPOAESTHESIA (Numbness in the left side of her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information given. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gastritis
Clinical narrative: Upset stomach; Gastritis; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), GASTRITIS (Gastritis) and DIARRHEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ABDOMINAL DISCOMFORT (Upset stomach), GASTRITIS (Gastritis) and DIARRHEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), GASTRITIS (Gastritis) and DIARRHEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated the lining of stomach had gotten inflamed due to the vaccine. The stomach, gall bladder, or something else the vaccine was aggravating. Concomitant medication was not provided. Treatment incuded Probiotics and stomach lining repair pills. Any delayed side effects of upset stomach, gastritis, or diarrhea after 2nd moderna vaccine was not conformed     Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13-JUL-2021: Updated patient gender. Added treatment details in I-narrative.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: raised bumps at the the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (raised bumps at the the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (raised bumps at the the injection site). At the time of the report, VACCINATION SITE MASS (raised bumps at the the injection site) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-218901 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: He waited awhile before getting the next dose / he waited 3 months; He had Covid-19; vomiting; fever; chills; tiredness, very tired, fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited awhile before getting the next dose / he waited 3 months), COVID-19 (He had Covid-19), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced COVID-19 (He had Covid-19), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness, very tired, fatigued). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited awhile before getting the next dose / he waited 3 months). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited awhile before getting the next dose / he waited 3 months), COVID-19 (He had Covid-19), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness, very tired, fatigued) outcome was unknown.            No treatment medications were reported. No concomitant medications were reported. Reporter stated that "When asked for demographics, caller declined. "I think I may have gone a little too far with this."
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: He waited awhile before getting the next dose / he waited 3 months; He had Covid-19; vomiting; fever; chills; tiredness, very tired, fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited awhile before getting the next dose / he waited 3 months), COVID-19 (He had Covid-19), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced COVID-19 (He had Covid-19), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness, very tired, fatigued). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited awhile before getting the next dose / he waited 3 months). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He waited awhile before getting the next dose / he waited 3 months), COVID-19 (He had Covid-19), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness, very tired, fatigued) outcome was unknown.            No treatment medications were reported. No concomitant medications were reported. Reporter stated that "When asked for demographics, caller declined. "I think I may have gone a little too far with this."
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in the knee was still there; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (pain in the knee was still there) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 009C21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS. Concomitant products included TRAMADOL for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ARTHRALGIA (pain in the knee was still there). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (pain in the knee was still there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Med Info Agent:  AE: Patient states that she received the first dose of the Moderna vaccine on 16APR2021 (Lot #: 037B21A, Exp Unknown) in her left arm. The next day on 17APR2021 she felt severe joint pain in her left knee where she had surgery several years ago. She then had her second vaccine on 21MAY2021 (Lot#: 009C21A, Exp Unknown) in the left arm but the pain in the knee was still there. She states her knee is popped so she has an immobilizer to keep it in place.  She has been to the ER and has also seen an orthopedic doctor. She has now been scheduled for an MRI.   Consent for follow up with safety given
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were used. No treatment medication were used.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Extreme fatigue; Dizziness; Nausea at times; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), DIZZINESS (Dizziness), NAUSEA (Nausea at times) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue), DIZZINESS (Dizziness), NAUSEA (Nausea at times) and HEADACHE (Headache). At the time of the report, FATIGUE (Extreme fatigue), DIZZINESS (Dizziness), NAUSEA (Nausea at times) and HEADACHE (Headache) outcome was unknown.            No treatment medication was reported by the reporter. No concomitant medications were reported. Chatbot case. Reporter stated that ,"on Sunday her husband received second vaccine and still have fatigue, dizziness, nausea at times, and headache".
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: hasn't received second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasn't received second 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 13-Apr-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 (hasn't received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasn't received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 19-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 04-Jun-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. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken for m-RNA -1273 Moderna COVID -19 vaccine was not applicable.  No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.). On 07-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (we'd given the 1st dose of the Moderna Covid-19 vaccine to a 16 yr old.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information given.
Sex: U
Vaccine: COVID19
Symptoms: Induration, Swelling
Clinical narrative: swollen; hard around the injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of SWELLING (swollen) and INDURATION (hard around the injection) 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 SWELLING (swollen) and INDURATION (hard around the injection). At the time of the report, SWELLING (swollen) and INDURATION (hard around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2 days of fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (2 days of fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (2 days of fever). At the time of the report, PYREXIA (2 days of fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported   This case was linked to MOD-2021-218190 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the second dose of the vaccine 17 days later vs. 28 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    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 (Got the second dose of the vaccine 17 days later vs. 28 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose of the vaccine 17 days later vs. 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose of the vaccine 17 days later vs. 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with the mRNA-1273, is considered as not applicable Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness, Wheezing
Clinical narrative: Wheezing is from throat; Tightness in throat; 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 WHEEZING (Wheezing is from throat) and THROAT TIGHTNESS (Tightness in throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing is from throat) and THROAT TIGHTNESS (Tightness in throat). At the time of the report, WHEEZING (Wheezing is from throat) and THROAT TIGHTNESS (Tightness in throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient did not get the second vaccine.  No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Vaccination site erythema
Clinical narrative: huge red mark a injection site; arm is hot and itchy; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (huge red mark a injection site), FEELING HOT (arm is hot and itchy) and PERIPHERAL SWELLING (arm is swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST, ATORVASTATIN, VENLAFAXINE, SPIRONOLACTONE, THIOCTIC ACID, UBIDECARENONE (COENZYME Q10 + ALIPOIC ACID) and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (huge red mark a injection site), FEELING HOT (arm is hot and itchy) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (huge red mark a injection site), FEELING HOT (arm is hot and itchy) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Shot Received 38 days after the first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot Received 38 days after the first shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot Received 38 days after the first shot). On 11-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot Received 38 days after the first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Hypokinesia, Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Covid club where he can not use his arms and  just hang there; Could not lift leg or hips up; vaccination complication; could not lift hips up; Bedridden; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up) and BEDRIDDEN (Bedridden) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up), BEDRIDDEN (Bedridden) and PAIN (A lot of pain). At the time of the report, HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up), BEDRIDDEN (Bedridden) and PAIN (A lot of pain) outcome was unknown.            No concomitant medications were reported.     Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up (TCR)  received on 30-Jun-2021 contains No New Information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid club where he can not use his arms and  just hang there; Could not lift leg or hips up; vaccination complication; could not lift hips up; Bedridden; A lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up) and BEDRIDDEN (Bedridden) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up), BEDRIDDEN (Bedridden) and PAIN (A lot of pain). At the time of the report, HYPOKINESIA (Covid club where he can not use his arms and  just hang there), LIMB DISCOMFORT (Could not lift leg or hips up), VACCINATION COMPLICATION (vaccination complication), MUSCULOSKELETAL DISCOMFORT (could not lift hips up), BEDRIDDEN (Bedridden) and PAIN (A lot of pain) outcome was unknown.            No concomitant medications were reported.     Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up (TCR)  received on 30-Jun-2021 contains No New Information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.