chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Diarrhoea, Dizziness, Eye pain, Fatigue
Clinical narrative: diarrhea; pain in eye that wraps around the head; pain in her neck; she is very uncomfortable; feeling dizzy; left breast swollen; left arm swollen; horrible headache; nauseated; site of injection is swollen; so exhausted that she sleeps; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), VACCINATION COMPLICATION (she is very uncomfortable), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps). On 14-Jan-2021, the patient experienced EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head), NECK PAIN (pain in her neck), VACCINATION COMPLICATION (she is very uncomfortable), DIARRHOEA (diarrhea), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps) 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.   Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, Peripheral swelling, Vaccination complication
Clinical narrative: diarrhea; pain in eye that wraps around the head; pain in her neck; she is very uncomfortable; feeling dizzy; left breast swollen; left arm swollen; horrible headache; nauseated; site of injection is swollen; so exhausted that she sleeps; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), VACCINATION COMPLICATION (she is very uncomfortable), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps). On 14-Jan-2021, the patient experienced EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head), NECK PAIN (pain in her neck), VACCINATION COMPLICATION (she is very uncomfortable), DIARRHOEA (diarrhea), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps) 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.   Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: diarrhea; pain in eye that wraps around the head; pain in her neck; she is very uncomfortable; feeling dizzy; left breast swollen; left arm swollen; horrible headache; nauseated; site of injection is swollen; so exhausted that she sleeps; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), VACCINATION COMPLICATION (she is very uncomfortable), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps). On 14-Jan-2021, the patient experienced EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head), NECK PAIN (pain in her neck), VACCINATION COMPLICATION (she is very uncomfortable), DIARRHOEA (diarrhea), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps) 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.   Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.; 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid; A spontaneous report was received from a consumer concerning herself, a 64 years old female patient, who recieved Moderna's COVID-19 vaccine and tested positive for Covid a week later of vaccination.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received first of two planned doses of mRNA-1273:[Batch number not provided] on 07-JAN-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  The patient was exposed by a side coworker a week ago, lost her smell and taste and tested positive on 14-JAN-2021. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Myalgia, Pyrexia
Clinical narrative: Soreness; Severe back ache; Toes are throbbing and aching; Fever 101.6F; A spontaneous report was received from a consumer concerning a 53-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, severe back ache, toes are throbbing and aching, fever 101.6F.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 18 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025120-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, prior to receiving mRNA-1273, the patient felt soreness, severe back ache, toes are throbbing and aching, fever 101.6F. Treatment for the events included paracetamol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The events,soreness, severe back ache, toes are throbbing and aching, fever 101.6F were considered unknown on 19 Jan 2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Neck pain, Rhinorrhoea
Clinical narrative: Neck pain; Sniffles; Body pain; Injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of NECK PAIN (Neck pain), RHINORRHOEA (Sniffles), MYALGIA (Body pain) and INJECTION SITE PAIN (Injection site pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012N20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     No Medical History information was reported.    On 16-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 NECK PAIN (Neck pain), RHINORRHOEA (Sniffles), MYALGIA (Body pain) and INJECTION SITE PAIN (Injection site pain). At the time of the report, NECK PAIN (Neck pain), RHINORRHOEA (Sniffles), MYALGIA (Body pain) and INJECTION SITE PAIN (Injection site pain) 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.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Swelling in the joint of her knee replacement and above it in her thigh area; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area) 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 Knee replacement on 08-Sep-2020.    On 11-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 JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area). At the time of the report, JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Non Significant Follow-up Append; Sender's Comments: Very limited information regarding the event has been provided at this time.  However, the patient's history of knee replacement surgery approximately 4 months before receiving the vaccine confounds causality assessment.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Touched it and it was warm; Hard and firm for a week/Injection area hard/Hard elevelated area/Bump; Arm soreness; Injection area slightly red/After putting ice, it was more red (added redness); Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Touched it and it was warm), VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump), VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Arm soreness) in a 36-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 VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)) and VACCINATION SITE SWELLING (Swollen). On 09-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump) and VACCINATION SITE PAIN (Arm soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Touched it and it was warm). On 10-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Touched it and it was warm), VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump), VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient used cold compress for treatment.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Blood pressure increased, Heart rate increased, Rash erythematous, Rash pruritic, Vaccination site induration
Clinical narrative: Covid Arm; itchy rash; little knot there; Red rash; HR increased; BP increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (HR increased), BLOOD PRESSURE INCREASED (BP increased), VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash) and VACCINATION SITE INDURATION (little knot there) in a 62-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.    Co-suspect products included non-company products Los for an unknown indication and INSULIN LISPRO (HUMALOG) for an unknown indication.    Concurrent medical conditions included Diabetes, Hypertension, High cholesterol and Asthma.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started Los (unknown route) at an unspecified dose and INSULIN LISPRO (HUMALOG) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced HEART RATE INCREASED (HR increased) and BLOOD PRESSURE INCREASED (BP increased). On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash), VACCINATION SITE INDURATION (little knot there) and RASH ERYTHEMATOUS (Red rash ). At the time of the report, HEART RATE INCREASED (HR increased) and BLOOD PRESSURE INCREASED (BP increased) had resolved and VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash), VACCINATION SITE INDURATION (little knot there) and RASH ERYTHEMATOUS (Red rash ) 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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Vaccination site rash
Clinical narrative: Covid Arm; itchy rash; little knot there; Red rash; HR increased; BP increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (HR increased), BLOOD PRESSURE INCREASED (BP increased), VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash) and VACCINATION SITE INDURATION (little knot there) in a 62-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.    Co-suspect products included non-company products Los for an unknown indication and INSULIN LISPRO (HUMALOG) for an unknown indication.    Concurrent medical conditions included Diabetes, Hypertension, High cholesterol and Asthma.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started Los (unknown route) at an unspecified dose and INSULIN LISPRO (HUMALOG) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced HEART RATE INCREASED (HR increased) and BLOOD PRESSURE INCREASED (BP increased). On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash), VACCINATION SITE INDURATION (little knot there) and RASH ERYTHEMATOUS (Red rash ). At the time of the report, HEART RATE INCREASED (HR increased) and BLOOD PRESSURE INCREASED (BP increased) had resolved and VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash), VACCINATION SITE INDURATION (little knot there) and RASH ERYTHEMATOUS (Red rash ) 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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: he developed bright red rash from shoulder bone to her elbow; injection site is still red; experiencing lot of pain on upper arm left; This spontaneous case was reported by an occupational therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (he developed bright red rash from shoulder bone to her elbow), VACCINATION SITE ERYTHEMA (injection site is still red) and VACCINATION SITE PAIN (experiencing lot of pain on upper arm left) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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) dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (he developed bright red rash from shoulder bone to her elbow), VACCINATION SITE ERYTHEMA (injection site is still red) and VACCINATION SITE PAIN (experiencing lot of pain on upper arm left). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (he developed bright red rash from shoulder bone to her elbow), VACCINATION SITE ERYTHEMA (injection site is still red) and VACCINATION SITE PAIN (experiencing lot of pain on upper arm left) 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Her arm felt like it was going to fall off; Hurt bad for 4 days; chills; body ache; headache; not feeling good; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Her arm felt like it was going to fall off), PAIN (Hurt bad for 4 days), CHILLS (chills), PAIN (body ache) and HEADACHE (headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included birth control pills.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced FEELING ABNORMAL (Her arm felt like it was going to fall off), PAIN (Hurt bad for 4 days), CHILLS (chills), PAIN (body ache), HEADACHE (headache) and FEELING ABNORMAL (not feeling good). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Her arm felt like it was going to fall off), PAIN (Hurt bad for 4 days), CHILLS (chills), PAIN (body ache), HEADACHE (headache) and FEELING ABNORMAL (not feeling good) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test (positive-positive positive): positive positive.     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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (Soreness at injection site). At the time of the report, ARTHRALGIA (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; A spontaneous report was received from a (Consumer) concerning an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and fatigue. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 41L20A) unknown route and site for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced sore arm and fatigue. Laboratory details not provided. No treatment details were reported. Action taken with mRNA-1273 in response to the events was not reported.  At the time of the report, the outcome of the event was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site infection, Vaccination site inflammation
Clinical narrative: infection at the injection site; long raised red itchy hard spot at injection site and was raised and hot; redness at injection site; injection site itch; A spontaneous report was received from a Consumer concerning a  78Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 14-JAN-2021, The patient experienced the events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site.  Laboratory details were not provided.  Treatment details in narrative include Her neighbor got the vaccine at the same location and they said it was an infection and gave antibiotics. She went to her doctor and he said he would give her antibiotics in case. She is wondering if this is a normal reaction.  Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site was Not Recovered/Not Resolved.  The reporter assessed the events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site related to the study drug was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: chills; fever; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METOPROLOL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Immune disorder prophylaxis, AMITRIPTYLINE for an unknown indication.    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 CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site). On 17-Jan-2021, CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 101 degree Farenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took 2 acetaminophen to treat the symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Temperature of 100.7; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 100.7) and CHILLS (chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Temperature of 100.7) and CHILLS (chills). At the time of the report, PYREXIA (Temperature of 100.7) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature increased: 100.7 Unit not specified.     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 provided.   Patient took two ibuprofen for his symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Felt warm; Tender; Red Blotches from site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 1:45 PM, 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 WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site). At the time of the report, VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm is red; arm was hot; "but itches like a bug bite."; hardness at the injection site; area has some dots and looks rashy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite.") and VACCINATION SITE INDURATION (hardness at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite."), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE RASH (area has some dots and looks rashy). On 12-Jan-2021, VACCINATION SITE PAIN (sore arm) had not resolved. At the time of the report, VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite."), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE RASH (area has some dots and looks rashy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm is red; arm was hot; "but itches like a bug bite."; hardness at the injection site; area has some dots and looks rashy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite.") and VACCINATION SITE INDURATION (hardness at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite."), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE RASH (area has some dots and looks rashy). On 12-Jan-2021, VACCINATION SITE PAIN (sore arm) had not resolved. At the time of the report, VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite."), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE RASH (area has some dots and looks rashy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site started itching; arm has been reddish; sore arm; Swollen; A spontaneous report was received from a (Reporter like HCP) concerning a 81 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11/Jan/2021  , The patient experienced the events list (verbatims)  Call was transferred from Moderna Customer Care (case #00032052) Caller received 1st dose of the Moderna COVID-19 vaccine on 11JAN2021. She received the shot on her non-dominant (left) arm. Her arm has been reddish, sore, and swollen since she received the vaccine. 2-3 days ago, around 19JAN2021, the injection site started itching and has been extremely itchy since then. None of the reactions have subsided or gotten better. She has been putting ice packs on it and that seems to help with the itching. Consent given for Safety follow-up with patient. Consent given for Safety follow-up with HCP. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On  11/Jan/2021 date, the outcome of the event(s) was, not resolved
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive) 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 event.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Covid positive). At the time of the report, COVID-19 (Covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Pain in extremity
Clinical narrative: arm pain; cellulitis; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain and injection site cellulitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On Feb-10-2021, after the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) for prophylaxis of COVID-19 infection.  On 05-Feb-2021, the patient experienced arm pain and injection site cellulitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event (injection site cellulitis) was resolved. The outcome of the event (arm pain) was unknown.  Follow-up received on 11-Feb-2021 included information regarding the second dose of the vaccine and the recovery of the injection site cellulitis.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: tested positive on january 15th; sore throat; runny nose; body aches; felt like winded; A spontaneous report was received from a  Consumer concerning a 50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid 19,the symptoms were sore throat and a runny nose, felt like winded, and also body ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch:037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 15 Jan 2021, The patient tested positive with covid 19,the symptoms were sore throat and a runny nose but a week before testing positive the caller reported that felt like winded, it wasn't bad. The sore throat and also body aches appeared when the patient took the test   Treatment details are not provided.  The second dose of the Moderna COVID 19 Vaccine on January 22nd.Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event(s) tested positive with covid 19,the symptoms were sore throat and a runny nose, felt like winded, and also body ache, was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; A spontaneous report (United States) was received from a Reporter concerning about male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  Patient reported sore arm upon injection No treatment details was provided Action taken with mRNA-1273 in response to the events was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: Injection site hives; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site urticaria.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced an allergic reaction kind of hive-like around the injection site.  No laboratory details provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event is not recovered/ resolved.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Red; Soreness; A spontaneous report was received from a HCP concerning a 71 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain and vaccination site erythema.  The patient's medical history was not provided.  Relevant concomitant medication was provided as Irbesartan, Pantoprazole, Tamsulosin and Doxycycline.  On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location which is unknown for prophylaxis of COVID-19 infection.  On 04-FEB-2021, The patient experienced the events vaccination site pain and vaccination site erythema. No Lab details provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   Recovering, ongoing, not resolved or unknown outcomes: At the time of this report, the outcome of the event(s) (vaccination site pain and vaccination site erythema.) was recovering.  The reporter assessed the event(s), [vaccination site pain and vaccination site erythema], as related to study drug.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011917:Reporter case
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia, Vaccination complication
Clinical narrative: not feeling well; Chill; Fever; Injection site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain). At the time of the report, VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided. Treatment included Tylenol and Ibuprofen
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site redness; Injection site swollen; Injection site extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy) 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: muscle tightness in my shoulder up to my neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tightness in my shoulder up to my neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 21-Jan-2021 at 11:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 12:00 PM, the patient experienced MUSCLE TIGHTNESS (muscle tightness in my shoulder up to my neck). At the time of the report, MUSCLE TIGHTNESS (muscle tightness in my shoulder up to my neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to cross link MOD21-11080 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Diarrhoea, Dizziness, Feeling abnormal, Skin discolouration
Clinical narrative: Diarrhea; glucose also shot up to 208 without eating; light headedness; Cheeks are pink; feeling little abnormal not better than last night; small rash on her injection site; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink) and FEELING ABNORMAL (feeling little abnormal not better than last night) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure (Due to blockage) in August 2019, Corona virus infection (UK H1 Coronavirus) in March 2018, Pneumonia (she was on oxygen therapy in ICU and took months to recover, almost died.) in March 2018 and Oxygen therapy in March 2018. Concurrent medical conditions included Diabetes, Asthma, Heart disorder (Heart condition, heart damage due to COVID), Myelomalacia and UTI (she is takin Augmentin for her UTI from last 9 days).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink), FEELING ABNORMAL (feeling little abnormal not better than last night) and VACCINATION SITE RASH (small rash on her injection site). At the time of the report, DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink), FEELING ABNORMAL (feeling little abnormal not better than last night) and VACCINATION SITE RASH (small rash on her injection site) 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.   Patient takes Blood thinner 3 mg daily concomitantly, and is on Augmentin for her Urinary tract infection for last 9 days, but according to patient she did not have diarrhea with Augmentin. No treatment medications were reported.