chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Fever; Chills; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 in Nov2020.).   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 PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Pyrexia: 100.6 (Inconclusive) Patient developed Fever 100.6F.         No concomitant medications were reported. No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sore arm; Fever; Chills; Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19 in Nov2020.).   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 PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Pyrexia: 100.6 (Inconclusive) Patient developed Fever 100.6F.         No concomitant medications were reported. No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment medication was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Pain in extremity, Vaccination site swelling
Clinical narrative: softness when touched; light pain when arm is raised; some swelling on injectioin site (right arm); This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 42B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included ROSUVASTATIN, AMLODIPINE and LOSARTAN for Blood pressure high, INSULIN for Diabetes, ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 08-Apr-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)). The patient was treated with PARACETAMOL (TYLENOL) on 08-Apr-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (softness when touched), PAIN IN EXTREMITY (light pain when arm is raised) and VACCINATION SITE SWELLING (some swelling on injectioin site (right arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient used ice pack to treat the adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR received on 08-07-2021 - Events outcome updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Ear pain, Gait disturbance, Headache
Clinical narrative: Needed help getting in bathtub; Legs pain; Neck pain; Jaw pain; Ear pain; Excruciating lower back pain; Severe headache; Stomach was on fire; Sore arm; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach was on fire), GAIT DISTURBANCE (Needed help getting in bathtub), PAIN IN EXTREMITY (Legs pain), NECK PAIN (Neck pain) and PAIN IN JAW (Jaw pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and TENDERNESS (Tenderness). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach was on fire), PAIN IN EXTREMITY (Legs pain), NECK PAIN (Neck pain), PAIN IN JAW (Jaw pain), EAR PAIN (Ear pain), BACK PAIN (Excruciating lower back pain) and HEADACHE (Severe headache). On 08-Apr-2021, the patient experienced GAIT DISTURBANCE (Needed help getting in bathtub). At the time of the report, ABDOMINAL PAIN UPPER (Stomach was on fire), PAIN IN EXTREMITY (Legs pain), NECK PAIN (Neck pain), PAIN IN JAW (Jaw pain), EAR PAIN (Ear pain), PAIN IN EXTREMITY (Sore arm), TENDERNESS (Tenderness), BACK PAIN (Excruciating lower back pain) and HEADACHE (Severe headache) outcome was unknown and GAIT DISTURBANCE (Needed help getting in bathtub) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient have treatment like pain ointment.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pain in jaw, Tenderness
Clinical narrative: Needed help getting in bathtub; Legs pain; Neck pain; Jaw pain; Ear pain; Excruciating lower back pain; Severe headache; Stomach was on fire; Sore arm; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach was on fire), GAIT DISTURBANCE (Needed help getting in bathtub), PAIN IN EXTREMITY (Legs pain), NECK PAIN (Neck pain) and PAIN IN JAW (Jaw pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and TENDERNESS (Tenderness). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach was on fire), PAIN IN EXTREMITY (Legs pain), NECK PAIN (Neck pain), PAIN IN JAW (Jaw pain), EAR PAIN (Ear pain), BACK PAIN (Excruciating lower back pain) and HEADACHE (Severe headache). On 08-Apr-2021, the patient experienced GAIT DISTURBANCE (Needed help getting in bathtub). At the time of the report, ABDOMINAL PAIN UPPER (Stomach was on fire), PAIN IN EXTREMITY (Legs pain), NECK PAIN (Neck pain), PAIN IN JAW (Jaw pain), EAR PAIN (Ear pain), PAIN IN EXTREMITY (Sore arm), TENDERNESS (Tenderness), BACK PAIN (Excruciating lower back pain) and HEADACHE (Severe headache) outcome was unknown and GAIT DISTURBANCE (Needed help getting in bathtub) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient have treatment like pain ointment.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Tremor
Clinical narrative: nausea; chills; fever; shakes; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (chills), PYREXIA (fever), TREMOR (shakes) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), TREMOR (shakes) and NAUSEA (nausea). At the time of the report, CHILLS (chills), PYREXIA (fever), TREMOR (shakes) and NAUSEA (nausea) 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 provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Fever 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.2F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Gall Bladder removed years ago so when she eats greasy food, she gets Diarrhea.).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.2F). At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.2F) had not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: allergic delayed local injection site reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (allergic delayed local injection site reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-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 VACCINATION SITE REACTION (allergic delayed local injection site reactions). At the time of the report, VACCINATION SITE REACTION (allergic delayed local injection site reactions) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment details reported,
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Paraesthesia oral, Pruritus, Swelling, Urticaria
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of SWELLING (had some swelling, slight, size between a quarter and half a dollar), URTICARIA (had some hives in it), PRURITUS (it itched), PARAESTHESIA ORAL (internal mouth sensations, tingling) and ORAL DISCOMFORT (an unusual feeling inside her mouth) in a 73-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 No adverse event. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, ALLOPURINOL for Gout, LOSARTAN, METOPROLOL and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (had some swelling, slight, size between a quarter and half a dollar), URTICARIA (had some hives in it) and PRURITUS (it itched). On an unknown date, the patient experienced PARAESTHESIA ORAL (internal mouth sensations, tingling) and ORAL DISCOMFORT (an unusual feeling inside her mouth). On 07-Apr-2021, SWELLING (had some swelling, slight, size between a quarter and half a dollar), URTICARIA (had some hives in it) and PRURITUS (it itched) had resolved. At the time of the report, PARAESTHESIA ORAL (internal mouth sensations, tingling) and ORAL DISCOMFORT (an unusual feeling inside her mouth) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment : benadryl (oral)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: Vaccine made back pain worse; Extreme muscle pain; Extreme joint pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Vaccine made back pain worse), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Back injury.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Vaccine made back pain worse), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain). The patient was treated with Physical therapy (uses physical therapy for her back pain) for Back pain. At the time of the report, BACK PAIN (Vaccine made back pain worse), MYALGIA (Extreme muscle pain) and ARTHRALGIA (Extreme joint pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       P atient has history of back injury which occurred about 10 months ago, back pain was getting better, but the vaccine has made it worse.Does not take any medications, and uses physical therapy for her back pain.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient is still due for 2nd dose after 42 days since first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient is still due for 2nd dose after 42 days since first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient is still due for 2nd dose after 42 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient is still due for 2nd dose after 42 days since first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: follow up added
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Injection site rash, Movement disorder
Clinical narrative: Can't lift her arm up all the way; Dizziness; Sore arm; Rash at injection site; Rash on stomach and back; Nausea; Headache non stop; Fever highest 100.8 degree celsius; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site) and RASH (Rash on stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 07-Apr-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 MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site), RASH (Rash on stomach and back), NAUSEA (Nausea), HEADACHE (Headache non stop) and PYREXIA (Fever highest 100.8 degree celsius). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site), RASH (Rash on stomach and back), NAUSEA (Nausea), HEADACHE (Headache non stop) and PYREXIA (Fever highest 100.8 degree celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 degree Celsius.         This case was linked to MOD-2021-072760 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Initial follow up added
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash
Clinical narrative: Can't lift her arm up all the way; Dizziness; Sore arm; Rash at injection site; Rash on stomach and back; Nausea; Headache non stop; Fever highest 100.8 degree celsius; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site) and RASH (Rash on stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 07-Apr-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 MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site), RASH (Rash on stomach and back), NAUSEA (Nausea), HEADACHE (Headache non stop) and PYREXIA (Fever highest 100.8 degree celsius). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site), RASH (Rash on stomach and back), NAUSEA (Nausea), HEADACHE (Headache non stop) and PYREXIA (Fever highest 100.8 degree celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 degree Celsius.         This case was linked to MOD-2021-072760 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Initial follow up added
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigue/ feel Excessive tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue/ feel Excessive tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208A) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    The patient's past medical history included Asthma since an unknown date and Rheumatoid arthritis. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue/ feel Excessive tiredness). At the time of the report, FATIGUE (Fatigue/ feel Excessive tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: nausea; tiredness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and PYREXIA (fever). On 06-Mar-2021, NAUSEA (nausea), FATIGUE (tiredness), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient have event like hard spot, rashy arms, shaking chills.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: initial follow up
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash, Vaccination site pain
Clinical narrative: On the night they were big balls and it was itchy.; very little pimples or rash on body and legs, started appearing on arms and face too; arm started hurting, it hurt too much, it's still sensitive; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (On the night they were big balls and it was itchy.), RASH (very little pimples or rash on body and legs, started appearing on arms and face too), VACCINATION SITE PAIN (arm started hurting, it hurt too much, it's still sensitive) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRURITUS (On the night they were big balls and it was itchy.), RASH (very little pimples or rash on body and legs, started appearing on arms and face too), VACCINATION SITE PAIN (arm started hurting, it hurt too much, it's still sensitive) and HEADACHE (headache). At the time of the report, PRURITUS (On the night they were big balls and it was itchy.), RASH (very little pimples or rash on body and legs, started appearing on arms and face too), VACCINATION SITE PAIN (arm started hurting, it hurt too much, it's still sensitive) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Famotidine 20 mg, Dinfeniydramine and Prednisone tablets.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to touch; swollen; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE SWELLING (swollen) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Rash; swelling at the the arm of the injection; heat generation at the the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat generation at the the arm of the injection), RASH (Rash) and VACCINATION SITE SWELLING (swelling at the the arm of the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was reported by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (heat generation at the the arm of the injection) and VACCINATION SITE SWELLING (swelling at the the arm of the injection). On 03-Mar-2021, the patient experienced RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, VACCINATION SITE WARMTH (heat generation at the the arm of the injection), RASH (Rash) and VACCINATION SITE SWELLING (swelling at the the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was also done with ice.   This case was linked to US-MODERNATX, INC.-MOD-2021-072805 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and had no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072805:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Vaccination site cellulitis
Clinical narrative: Cellulitis; Red spot is hard and hot to touch; Hard spot near Vaccination site; Red spot is also itchy; Painful red spot near the injection site; Painful red spot near the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy) and INJECTION SITE PAIN (Painful red spot near the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergic to contrast dye and soy.). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R), METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and PROGESTERONE for an unknown indication.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy), INJECTION SITE PAIN (Painful red spot near the injection site) and INJECTION SITE ERYTHEMA (Painful red spot near the injection site). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy), INJECTION SITE PAIN (Painful red spot near the injection site) and INJECTION SITE ERYTHEMA (Painful red spot near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Cellulitis; Red spot is hard and hot to touch; Hard spot near Vaccination site; Red spot is also itchy; Painful red spot near the injection site; Painful red spot near the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy) and INJECTION SITE PAIN (Painful red spot near the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Allergic to contrast dye and soy.). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R), METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and PROGESTERONE for an unknown indication.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy), INJECTION SITE PAIN (Painful red spot near the injection site) and INJECTION SITE ERYTHEMA (Painful red spot near the injection site). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis), INJECTION SITE WARMTH (Red spot is hard and hot to touch), VACCINATION SITE INDURATION (Hard spot near Vaccination site), INJECTION SITE PRURITUS (Red spot is also itchy), INJECTION SITE PAIN (Painful red spot near the injection site) and INJECTION SITE ERYTHEMA (Painful red spot near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: JUST TIRED FOR A DAY; 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 FATIGUE (JUST TIRED FOR A DAY) 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 FATIGUE (JUST TIRED FOR A DAY). At the time of the report, FATIGUE (JUST TIRED FOR A DAY) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: HYPERTENSION; little headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (HYPERTENSION) and HEADACHE (little headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Tremor. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Tremor.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 HYPERTENSION (HYPERTENSION) and HEADACHE (little headaches). The patient was treated with PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Hypertension, at a dose of 30 mg twice a day. At the time of the report, HYPERTENSION (HYPERTENSION) outcome was unknown and HEADACHE (little headaches) had resolved.            Patient wanted to know if her blood pressure would come to normal as her HCP was not figuring it out.   This case was linked to US-MODERNATX, INC.-MOD-2021-072802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072802:Crossed linked
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm on injection after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm on injection after first shot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03DMD0A and 621B217.) 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) (Intramuscular) 1 dosage form. On 06-Apr-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 PAIN IN EXTREMITY (sore arm on injection after first shot). At the time of the report, PAIN IN EXTREMITY (sore arm on injection after first shot) outcome was unknown. Not Provided          Treatment medications included Advil and Tylenol at least 6 hours in between and for almost 14hours, and a Benadryl. No concomitant medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Lot of heat coming out; Size of a golf ball area (not protruding); Really itchy; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Lot of heat coming out), VACCINATION SITE MASS (Size of a golf ball area (not protruding)), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE SWELLING (Swollen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Glaucoma and Blood pressure high. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Lot of heat coming out), VACCINATION SITE MASS (Size of a golf ball area (not protruding)), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (Lot of heat coming out), VACCINATION SITE MASS (Size of a golf ball area (not protruding)), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also included medication for glaucoma NOS and for high blood pressure NOS. Treatment information mentioned ibuprofen and ice. Patient mentioned she has a tattoo at the site too.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site rash, Vaccination site induration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site induration (hard spot), injection site rash (arm rash) and chills in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 008B21A and 026A21A) for COVID-19 immunization. The patient's past medical history included breast cancer. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 4, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced chills. On Apr 7, 2021, patient experienced vaccination site induration (hard spot) and injection site rash (arm rash). On Apr 4, 2021, chills resolved. At the time of the report, vaccination site induration (hard spot) and injection site rash (arm rash) outcome: unknown. This case linked to MOD-2021-072778 (patient link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TENDERNESS. At the time of the report, TENDERNESS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.    Reporter did not allow further contact.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Constipation, Illness, Myalgia
Clinical narrative: Body ache/ pain; fever of 101°F-102°F; Chills; Vomiting; Constipation; Really sick; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), ILLNESS (Really sick), MYALGIA (Body ache/ pain), PYREXIA (fever of 101°F-102°F) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CONSTIPATION (Constipation), ILLNESS (Really sick), PYREXIA (fever of 101°F-102°F), CHILLS (Chills) and VOMITING (Vomiting). On an unknown date, the patient experienced MYALGIA (Body ache/ pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, CONSTIPATION (Constipation), ILLNESS (Really sick), PYREXIA (fever of 101°F-102°F), CHILLS (Chills) and VOMITING (Vomiting) had resolved. At the time of the report, MYALGIA (Body ache/ pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101°f - 102°f (High) Body temperature 101°F - 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followed up received on 29-jun-2021  that contains event and product information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Body ache/ pain; fever of 101°F-102°F; Chills; Vomiting; Constipation; Really sick; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), ILLNESS (Really sick), MYALGIA (Body ache/ pain), PYREXIA (fever of 101°F-102°F) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CONSTIPATION (Constipation), ILLNESS (Really sick), PYREXIA (fever of 101°F-102°F), CHILLS (Chills) and VOMITING (Vomiting). On an unknown date, the patient experienced MYALGIA (Body ache/ pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, CONSTIPATION (Constipation), ILLNESS (Really sick), PYREXIA (fever of 101°F-102°F), CHILLS (Chills) and VOMITING (Vomiting) had resolved. At the time of the report, MYALGIA (Body ache/ pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101°f - 102°f (High) Body temperature 101°F - 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Followed up received on 29-jun-2021  that contains event and product information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm; Chills; little fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (little fever) and RASH (rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 621B217) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, VITAMIN D NOS and MULTIVITAMIN & MINERAL for an unknown indication.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (little fever). On 07-Apr-2021, the patient experienced RASH (rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm). At the time of the report, CHILLS (Chills), PYREXIA (little fever) and RASH (rash on R arm of injection 3 to 4 inches wide and spreading from outside to inside of R arm) outcome was unknown. Not Provided          Treatment- Advil, Tylenol and Benadryl   This case was linked to MOD-2021-072787 (E2B Linked Report).; Sender's Comments:  MOD-2021-072787:1st dose of vaccine
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Interchange of vaccine products, Product dose omission issue
Clinical narrative: interchange of vaccine doses; Memory loss; Missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine doses), PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) and AMNESIA (Memory loss) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-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 PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine doses) and AMNESIA (Memory loss). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine doses) and AMNESIA (Memory loss) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) had not resolved.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache
Clinical narrative: Headache; Chills; Feels Cold; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FEELING COLD (Feels Cold) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FEELING COLD (Feels Cold). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and FEELING COLD (Feels Cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided were Actemra infusion(monoclonal antibody infusion for Arthritis). Treatment medication were not provided.