chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain at the injection site; Fatigue; Patient ID:     Investigator Site:   Case reference number MOD-2021-008928 is a clinical trial case report which refers to a 76 Years old Female patient.  The patient experienced Pain at the injection site which resulted in .  This occurred while participating in Protocol   -   .  The patients relevant medical history included: No adverse event   The following drugs are known to have been taken by the patient prior to the event: AMLODIPINE[] ,SIMVASTATIN[] ,LOSARTAN[] ,EVISTA[]  .  The patients started Moderna COVID-19 Vaccine on  .  Some  1 day  later, the patient developed Pain at the injection site.'  Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:   The eventual diagnosis made was Vaccination site pain .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . The event(s) were:  Pain at the injection site - Unknown,Fatigue - Unknown. An autopsy was performed on  . .  The investigator considered the Pain at the injection site  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included <STATE ALL OTHER FACTORS> and the patients age/history or other factors <LIST OTHER RELEVANT FACTORS>; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Vaccination complication
Clinical narrative: pretty bad reactions; residual issues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty bad reactions) and ILL-DEFINED DISORDER (residual issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION COMPLICATION (pretty bad reactions) and ILL-DEFINED DISORDER (residual issues). At the time of the report, VACCINATION COMPLICATION (pretty bad reactions) and ILL-DEFINED DISORDER (residual issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Influenza like illness
Clinical narrative: flu like symptoms; temperature and had 101°F; chills; Headache; Exhaused when temperature calm down; Completely dehydrated; Shaky; neck ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder NOS, ATORVASTATIN CALCIUM (ATORVASTIN) and PANTOPRAZOLE for an unknown indication.    On 14-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL DISCOMFORT (neck ache), NERVOUSNESS (Shaky) and FATIGUE (Exhaused when temperature calm down). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 500 mg. On 15-Jan-2021, DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache), MUSCULOSKELETAL DISCOMFORT (neck ache), NERVOUSNESS (Shaky) and FATIGUE (Exhaused when temperature calm down) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nervousness, Pain in extremity, Pyrexia
Clinical narrative: flu like symptoms; temperature and had 101°F; chills; Headache; Exhaused when temperature calm down; Completely dehydrated; Shaky; neck ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder NOS, ATORVASTATIN CALCIUM (ATORVASTIN) and PANTOPRAZOLE for an unknown indication.    On 14-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL DISCOMFORT (neck ache), NERVOUSNESS (Shaky) and FATIGUE (Exhaused when temperature calm down). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 500 mg. On 15-Jan-2021, DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache), MUSCULOSKELETAL DISCOMFORT (neck ache), NERVOUSNESS (Shaky) and FATIGUE (Exhaused when temperature calm down) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Arm  sore; Began throwing up for hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  sore) and VOMITING (Began throwing up for hours) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm  sore) and VOMITING (Began throwing up for hours). At the time of the report, VOMITING (Began throwing up for hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Inflammation on the injection site; "kind of red" on the injection site; "itchy" on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE ERYTHEMA ("kind of red" on the injection site) and INJECTION SITE PRURITUS ("itchy" on the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE ERYTHEMA ("kind of red" on the injection site) and INJECTION SITE PRURITUS ("itchy" on the injection site). At the time of the report, INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE ERYTHEMA ("kind of red" on the injection site) and INJECTION SITE PRURITUS ("itchy" on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic pain, Vaccination site pain
Clinical narrative: Liver seems to hurt more; Sharp, intermittent pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC PAIN (Liver seems to hurt more) and VACCINATION SITE PAIN (Sharp, intermittent pain at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Fatty liver.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sharp, intermittent pain at the injection site). On an unknown date, the patient experienced HEPATIC PAIN (Liver seems to hurt more). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, VACCINATION SITE PAIN (Sharp, intermittent pain at the injection site) had resolved. At the time of the report, HEPATIC PAIN (Liver seems to hurt more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Real fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Real fast heart beat) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Heart fluttering.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HEART RATE INCREASED (Real fast heart beat). At the time of the report, HEART RATE INCREASED (Real fast heart beat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports a history of heart fluttering.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: quite severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (quite severe side effects) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (quite severe side effects). At the time of the report, VACCINATION COMPLICATION (quite severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (quite severe side effects) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (quite severe side effects). At the time of the report, VACCINATION COMPLICATION (quite severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dyspnoea, Headache, Neck pain
Clinical narrative: serious pain in arm; neck and shoulder pain; stomach pain; serious headache; heavy panting; in a panic; neck and shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of   in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take Extra strength Tylenol as a Treatment drug
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Panic attack
Clinical narrative: serious pain in arm; neck and shoulder pain; stomach pain; serious headache; heavy panting; in a panic; neck and shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of   in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take Extra strength Tylenol as a Treatment drug
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen; Red; Its hot; itching real bad at the 2 diameter site; A Spontaneous case report was received from a consumer who was 66 year old female patient who received Moderna COVID-19 Vaccine 10 days ago , it started itching real bad at the 2" diameter site on 17-JAN-2021;its hot.She is not sue if its something to be concerned about.It just came out of the blue and was fine prior to that. Patient received the vaccine on 08-JAN-2021 on left arm as IM injection.It was found to be red,warm and swollen after 10 days.Patient medical history was not provided.she had applied Aquaphor and also tried calamine but no change.Then she contacted a primary care doctor and doctor advised her to take Benadryl and put ice pack. The outcome is unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site movement impairment
Clinical narrative: arm is killing her.; Arm was swollen and felt like it was going to burst open; Harder and harder to move her arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is killing her.), PERIPHERAL SWELLING (Arm was swollen and felt like it was going to burst open) and VACCINATION SITE MOVEMENT IMPAIRMENT (Harder and harder to move her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm is killing her.), PERIPHERAL SWELLING (Arm was swollen and felt like it was going to burst open) and VACCINATION SITE MOVEMENT IMPAIRMENT (Harder and harder to move her arm). At the time of the report, PAIN IN EXTREMITY (arm is killing her.), PERIPHERAL SWELLING (Arm was swollen and felt like it was going to burst open) and VACCINATION SITE MOVEMENT IMPAIRMENT (Harder and harder to move her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Shortness of breath; Wheezing on exertion; Cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), WHEEZING (Wheezing on exertion) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concurrent medical conditions included ivig.    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, the patient experienced DYSPNOEA (Shortness of breath), WHEEZING (Wheezing on exertion) and COUGH (Cough). At the time of the report, DYSPNOEA (Shortness of breath), WHEEZING (Wheezing on exertion) and COUGH (Cough) outcome was unknown.            No concomitant information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Injection site warmth, Vaccination complication, Vaccination site erythema
Clinical narrative: Injection site was raised; Injection site was hard; Injection site was hot; Injection site was red; Left armpit was very tender; Chills; Overall not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VACCINATION COMPLICATION (Overall not feeling well), AXILLARY PAIN (Left armpit was very tender), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was raised) in a female 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 No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills) and VACCINATION COMPLICATION (Overall not feeling well). On 15-Jan-2021, the patient experienced AXILLARY PAIN (Left armpit was very tender). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site was raised), VACCINATION SITE INDURATION (Injection site was hard) and INJECTION SITE WARMTH (Injection site was hot). On 07-Jan-2021, CHILLS (Chills) and VACCINATION COMPLICATION (Overall not feeling well) had resolved. At the time of the report, AXILLARY PAIN (Left armpit was very tender), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was raised), VACCINATION SITE INDURATION (Injection site was hard) and INJECTION SITE WARMTH (Injection site was hot) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: Injection site was raised; Injection site was hard; Injection site was hot; Injection site was red; Left armpit was very tender; Chills; Overall not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VACCINATION COMPLICATION (Overall not feeling well), AXILLARY PAIN (Left armpit was very tender), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was raised) in a female 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 No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills) and VACCINATION COMPLICATION (Overall not feeling well). On 15-Jan-2021, the patient experienced AXILLARY PAIN (Left armpit was very tender). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site was raised), VACCINATION SITE INDURATION (Injection site was hard) and INJECTION SITE WARMTH (Injection site was hot). On 07-Jan-2021, CHILLS (Chills) and VACCINATION COMPLICATION (Overall not feeling well) had resolved. At the time of the report, AXILLARY PAIN (Left armpit was very tender), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was raised), VACCINATION SITE INDURATION (Injection site was hard) and INJECTION SITE WARMTH (Injection site was hot) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: inverse reaction; 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 VACCINATION COMPLICATION (inverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 VACCINATION COMPLICATION (inverse reaction). At the time of the report, VACCINATION COMPLICATION (inverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Lymphadenopathy
Clinical narrative: Itching at injection site; Rash and redness at the injection site; Under armpit swollen; rash and redness at the injection site; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced itching at the injection site, rash and redness at the injection site and under armpit swollen.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, after the shot of vaccine on tuesday, the patient experienced rash and redness at the injection site, which had gone away. However, on an unspecified date in Jan-2021, additionally the patient developed itching at the injection site and under armpit was also swollen. Treatment information was not provided.  Action taken with mRNA-1273 in response to events were not reported.  The outcome of events, rash and redness at the injection site was considered resolved on an unspecified date in Jan-2021. The outcome of events, itching at the injection site and under armpit swollen was considered unknown. Reporter's Comments: This case concerns a female patient,  who experienced  a non-serious unexpected event of injection site pruritus, and non-serious expected events of  injection site rash and injection site erythema and lymphadenopathy. The events of injection site pruritus, injection site rash, injection site erythema, and lymphadenopathy occurred after first dose of mRNA-1273, COVID-19 vaccine . Based on the current available information and temporal association between the use of the product and onset of the events , a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Site of injection was itchy; Site of injection was red; Site of injection was swollen; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Cortisone cream. On 18-Jan-2021, the redness and itchiness at the site of injection returned.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site mass, Vaccination site pain
Clinical narrative: Soreness at the injection site; hardness at the injection site.; rash on my neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my neck), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE MASS (hardness at the injection site.) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (rash on my neck). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE MASS (hardness at the injection site.). At the time of the report, RASH (rash on my neck), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE MASS (hardness at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: felt a little dizziness; felt hot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a little dizziness) and FEELING HOT (felt hot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  The patient's past medical history included No adverse event (No medical history was not provided by the reporter). Concomitant products included LOSARTAN from 10-Sep-2016 to an unknown date and OMEPRAZOLE from 08-Jul-2016 to an unknown date.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (felt a little dizziness) and FEELING HOT (felt hot). On 15-Jan-2021, DIZZINESS (felt a little dizziness) and FEELING HOT (felt hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.   This case was linked to MOD-2021-088997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Patient demography and concomitant drugs added.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: arm greatly swollen; fever; Itchy; injection site redness; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (arm greatly swollen), PYREXIA (fever), PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (injection site redness) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm greatly swollen), PYREXIA (fever), PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, PERIPHERAL SWELLING (arm greatly swollen), PYREXIA (fever), PRURITUS (Itchy) and INJECTION SITE ERYTHEMA (injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter,
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Slightly Warm at injection site; Itching; Red, at injection site; Sore at injection site; Was probing about two and half inch diameter within 10 days; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Slightly Warm at injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red, at injection site), VACCINATION SITE PAIN (Sore at injection site) and VACCINATION SITE RASH (Was probing about two and half inch diameter within 10 days) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011-J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (Slightly Warm at injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red, at injection site), VACCINATION SITE PAIN (Sore at injection site) and VACCINATION SITE RASH (Was probing about two and half inch diameter within 10 days). On 18-Jan-2021, VACCINATION SITE ERYTHEMA (Red, at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Slightly Warm at injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Sore at injection site) and VACCINATION SITE RASH (Was probing about two and half inch diameter within 10 days) was resolving.        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 provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included no new information. On 18-Jun-2021: Non-Significant Follow-up
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Tongue disorder
Clinical narrative: Numbness; Weird feeling in his tongue; tingling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness), TONGUE DISORDER (Weird feeling in his tongue) and PARAESTHESIA (tingling) 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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness), TONGUE DISORDER (Weird feeling in his tongue) and PARAESTHESIA (tingling). On 16-Feb-2021, HYPOAESTHESIA (Numbness), TONGUE DISORDER (Weird feeling in his tongue) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Joint swelling, Limb discomfort, Muscular weakness
Clinical narrative: Swelling in left hand; Bruise on right knee; big knot on right knee; could not lift left arm; left arm weakness; pain extending from arm pits to breast; Broke out in the bend of my right arm; Itching; A spontaneous report was received from a consumer who is a 61-year old, female patient who received and experienced rash at the bend of right arm, itching, swelling in the left hand, itching on the left hand, itching on the right knee, bruise on the right knee, big knot on right knee, could not lift left arm, left arm weakness, and pain in armpit to breast.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient began to break out in the bend of her right arm and experienced itching about 5-6 mins after vaccination. Initial symptoms ended the same day.   On 31 Dec 2020, the patient went to the emergency room because the itching returned.  Treatment for the event included prednisone and hydroxyzine pamoate 25mg. Treatment worked for a while.  On 06 Jan 2021, the patient reported she experienced swelling and itching in the left hand, Itching, a bruise, and a big knot on right knee. She was not able to lift her left arm with left arm weakness and had pain from her arm pits to her breast.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event of rash at the bend of right arm was recovered/resolved on 30 Dec 2020.    The outcome of the events, itching, swelling in the left hand, itching on the left hand, itching on the right knee, bruise on the right knee, big knot on right knee, could not lift left arm, left arm weakness and pain in armpit to breast was unknown.; Reporter's Comments: This case concerns a 61 Y/O F with nonserious events of unexpected pruritus, muscular weakness, limb discomfort, peripheral swelling, joint swelling, contusion and expected axillary pain, rash.  Event onset the same day as first dose mRNA-1273. Treated with prednisone and hydroxyzine. Rash resolved, but other outcomes unknown. Based on 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Swelling in left hand; Bruise on right knee; big knot on right knee; could not lift left arm; left arm weakness; pain extending from arm pits to breast; Broke out in the bend of my right arm; Itching; A spontaneous report was received from a consumer who is a 61-year old, female patient who received and experienced rash at the bend of right arm, itching, swelling in the left hand, itching on the left hand, itching on the right knee, bruise on the right knee, big knot on right knee, could not lift left arm, left arm weakness, and pain in armpit to breast.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient began to break out in the bend of her right arm and experienced itching about 5-6 mins after vaccination. Initial symptoms ended the same day.   On 31 Dec 2020, the patient went to the emergency room because the itching returned.  Treatment for the event included prednisone and hydroxyzine pamoate 25mg. Treatment worked for a while.  On 06 Jan 2021, the patient reported she experienced swelling and itching in the left hand, Itching, a bruise, and a big knot on right knee. She was not able to lift her left arm with left arm weakness and had pain from her arm pits to her breast.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event of rash at the bend of right arm was recovered/resolved on 30 Dec 2020.    The outcome of the events, itching, swelling in the left hand, itching on the left hand, itching on the right knee, bruise on the right knee, big knot on right knee, could not lift left arm, left arm weakness and pain in armpit to breast was unknown.; Reporter's Comments: This case concerns a 61 Y/O F with nonserious events of unexpected pruritus, muscular weakness, limb discomfort, peripheral swelling, joint swelling, contusion and expected axillary pain, rash.  Event onset the same day as first dose mRNA-1273. Treated with prednisone and hydroxyzine. Rash resolved, but other outcomes unknown. Based on 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: arm swollen up; swollen arm red; arm was hot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm swollen up), ERYTHEMA (swollen arm red) and FEELING HOT (arm was hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included anti-infalmmatory shot from 13-Jan-2021 to an unknown date for Inflammation, DENOSUMAB (PROLIA) from 13-Jan-2021 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 PERIPHERAL SWELLING (arm swollen up), ERYTHEMA (swollen arm red) and FEELING HOT (arm was hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency and CORTISONE for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swollen up), ERYTHEMA (swollen arm red) and FEELING HOT (arm was hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient visited rheumatologist and received Prolia and anti-inflammatory shots on 13-Jan-2021 after vaccination on 08-Jan-2021
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: red swelling around the area and has been feeling pretty warm; red swelling around the area and has been feeling pretty warm and itchy; red swelling around the area; was sore for two days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (red swelling around the area and has been feeling pretty warm), PAIN (was sore for two days), VACCINATION SITE PRURITUS (red swelling around the area and has been feeling pretty warm and itchy) and VACCINATION SITE ERYTHEMA (red swelling around the area) 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-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN (was sore for two days). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (red swelling around the area and has been feeling pretty warm), VACCINATION SITE PRURITUS (red swelling around the area and has been feeling pretty warm and itchy) and VACCINATION SITE ERYTHEMA (red swelling around the area). On 08-Jan-2021, PAIN (was sore for two days) had resolved. At the time of the report, VACCINATION SITE WARMTH (red swelling around the area and has been feeling pretty warm), VACCINATION SITE PRURITUS (red swelling around the area and has been feeling pretty warm and itchy) and VACCINATION SITE ERYTHEMA (red swelling around the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient stated that red swelling area grew to a larger area on her arm. No treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: know if red and itching in her arm is normal; know if red and itching in her arm is normal; her left arm was red, swollen, hot and itchy; her left arm was red, swollen, hot and itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (know if red and itching in her arm is normal), PRURITUS (know if red and itching in her arm is normal), PERIPHERAL SWELLING (her left arm was red, swollen, hot and itchy) and TENDERNESS (her left arm was red, swollen, hot and itchy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 ERYTHEMA (know if red and itching in her arm is normal), PRURITUS (know if red and itching in her arm is normal), PERIPHERAL SWELLING (her left arm was red, swollen, hot and itchy) and TENDERNESS (her left arm was red, swollen, hot and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (know if red and itching in her arm is normal), PRURITUS (know if red and itching in her arm is normal), PERIPHERAL SWELLING (her left arm was red, swollen, hot and itchy) and TENDERNESS (her left arm was red, swollen, hot and itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: The outcome of events and treatment medication was provided by the reporter
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: quite a redness - at the injection site and around it, about 3inches across and 2 inches wide; large area that looks swollen - at the injection site and around it, about 3 inches across; arm hurt; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm hurt), VACCINATION SITE ERYTHEMA (quite a redness - at the injection site and around it, about 3inches across and 2 inches wide) and VACCINATION SITE SWELLING (large area that looks swollen - at the injection site and around it, about 3 inches across) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Sjogren's syndrome in 1995 and Interstitial lung disease in 2006. Concurrent medical conditions included Hypertension since 1997 and Hyperlipidemia since 2002. Concomitant products included ALLOPURINOL for Gout, POTASSIUM CHLORIDE for Hyperkalemia, ROSUVASTATIN CALCIUM (CRESTOR) for Hyperlipidemia, IRBESARTAN (AVAPRO), HYDROCHLOROTHIAZIDE and DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) for Hypertension, FAMCICLOVIR (FAMVIR [FAMCICLOVIR]) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for Infection, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMINE D) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced MYALGIA (arm hurt). On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (quite a redness - at the injection site and around it, about 3inches across and 2 inches wide) and VACCINATION SITE SWELLING (large area that looks swollen - at the injection site and around it, about 3 inches across). At the time of the report, MYALGIA (arm hurt), VACCINATION SITE ERYTHEMA (quite a redness - at the injection site and around it, about 3inches across and 2 inches wide) and VACCINATION SITE SWELLING (large area that looks swollen - at the injection site and around it, about 3 inches across) had resolved. Not Provided          Patient had allergy to Adhesive Patient stopped taking Mycophenolate 1500mg BID which he is taking from 2009 he stopped  before 3 days of vaccination and then restarted it after 3 days of vaccination. Patient stated Redness at the injection has spread after a few hours through next two days ,then started to get bigger at day 7 and after few days it subsided Patient wants to know if this is normal, and can he get second dose   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow up is significant , there is addition of Medical history, Updating Suspect product dosage ,concomitant medications ,Updating of Event outcome, Addition of causality
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Chest cough), PAIN (Body aches) and PYREXIA (Fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced COUGH (Chest cough), PAIN (Body aches) and PYREXIA (Fever). At the time of the report, COUGH (Chest cough), PAIN (Body aches) and PYREXIA (Fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included unspecified cough syrup.