chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have little to no side effects; 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 (I have little to no side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I have little to no side effects). At the time of the report, VACCINATION COMPLICATION (I have little to no side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Pain, Paraesthesia
Clinical narrative: swelling in left arm / swelling still present; pain in left ear was terrible; headache on left side; left foot felt like needles in it; pain all over her body; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over her body), PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), PYREXIA (fever) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], CALCIUM, SPIRONOLACTONE and HYDROCODONE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PAIN (pain all over her body), PYREXIA (fever) and FATIGUE (fatigue). On 29-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), HEADACHE (headache on left side) and PARAESTHESIA (left foot felt like needles in it). At the time of the report, PAIN (pain all over her body), PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache on left side) and PARAESTHESIA (left foot felt like needles in it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: swelling in left arm / swelling still present; pain in left ear was terrible; headache on left side; left foot felt like needles in it; pain all over her body; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over her body), PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), PYREXIA (fever) and FATIGUE (fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], CALCIUM, SPIRONOLACTONE and HYDROCODONE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PAIN (pain all over her body), PYREXIA (fever) and FATIGUE (fatigue). On 29-May-2021, the patient experienced PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), HEADACHE (headache on left side) and PARAESTHESIA (left foot felt like needles in it). At the time of the report, PAIN (pain all over her body), PERIPHERAL SWELLING (swelling in left arm / swelling still present), EAR PAIN (pain in left ear was terrible), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache on left side) and PARAESTHESIA (left foot felt like needles in it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-May-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeds; 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 EPISTAXIS (Nose bleeds) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Nose bleeds). At the time of the report, EPISTAXIS (Nose bleeds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: area got the first shot in a week ago is warm; area got the first shot in a week ago is itchy; area got the first shot in a week ago is hard; area got the first shot in a week ago is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area got the first shot in a week ago is warm), VACCINATION SITE PRURITUS (area got the first shot in a week ago is itchy), VACCINATION SITE INDURATION (area got the first shot in a week ago is hard) and VACCINATION SITE ERYTHEMA (area got the first shot in a week ago is red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (area got the first shot in a week ago is warm), VACCINATION SITE PRURITUS (area got the first shot in a week ago is itchy), VACCINATION SITE INDURATION (area got the first shot in a week ago is hard) and VACCINATION SITE ERYTHEMA (area got the first shot in a week ago is red). At the time of the report, VACCINATION SITE WARMTH (area got the first shot in a week ago is warm), VACCINATION SITE PRURITUS (area got the first shot in a week ago is itchy), VACCINATION SITE INDURATION (area got the first shot in a week ago is hard) and VACCINATION SITE ERYTHEMA (area got the first shot in a week ago is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: Found out I was anaemia; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Found out I was anaemia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (Found out I was anaemia). The patient was treated with BLOOD, WHOLE (BLOOD FOR EXCHANGE TRANSFUSION) for Anaemia, at a dose of 3 blood transfusions. At the time of the report, ANAEMIA (Found out I was anaemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Course redness in the feet; 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 ERYTHEMA (Course redness in the feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ERYTHEMA (Course redness in the feet). At the time of the report, ERYTHEMA (Course redness in the feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Ear discomfort, Tinnitus
Clinical narrative: popping sound in ears/popping is like when you're in an airplane; ringing in ears; dry cough; hoarse at times; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (popping sound in ears/popping is like when you're in an airplane), TINNITUS (ringing in ears), COUGH (dry cough) and DYSPHONIA (hoarse at times) 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 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (popping sound in ears/popping is like when you're in an airplane), TINNITUS (ringing in ears), COUGH (dry cough) and DYSPHONIA (hoarse at times). At the time of the report, EAR DISCOMFORT (popping sound in ears/popping is like when you're in an airplane), TINNITUS (ringing in ears), COUGH (dry cough) and DYSPHONIA (hoarse at times) had not resolved.      No relevant concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: positive covid test  a month after getting the vacinne; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive covid test  a month after getting the vacinne) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive covid test  a month after getting the vacinne). At the time of the report, COVID-19 (positive covid test  a month after getting the vacinne) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: positive (Positive) positive.         No concomitant medication reported  Treatment information not provided
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: was very weak; Arm pain; fever; chills; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (was very weak), MYALGIA (Arm pain), PYREXIA (fever) and CHILLS (chills) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (was very weak), MYALGIA (Arm pain), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. On 05-Feb-2021, ASTHENIA (was very weak), MYALGIA (Arm pain), PYREXIA (fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Birth control pills.  Patient received the 1st dose on 04Jan2021 with lot No:011J20A in upper left deltoid and experienced arm pain, fever, chills, was very weak.   This case was linked to MOD-2021-194475 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: have swelling everywhere; 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 SWELLING (have swelling everywhere) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (have swelling everywhere). At the time of the report, SWELLING (have swelling everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. The patient's treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling Injection Site; Itch  Injection Site; 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 SITE SWELLING (swelling Injection Site) and VACCINATION SITE PRURITUS (Itch  Injection Site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 SITE SWELLING (swelling Injection Site) and VACCINATION SITE PRURITUS (Itch  Injection Site). At the time of the report, VACCINATION SITE SWELLING (swelling Injection Site) and VACCINATION SITE PRURITUS (Itch  Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: my whole right side is numb; right side is numb/tingling; 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 HYPOAESTHESIA (my whole right side is numb) and PARAESTHESIA (right side is numb/tingling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (my whole right side is numb) and PARAESTHESIA (right side is numb/tingling). At the time of the report, HYPOAESTHESIA (my whole right side is numb) and PARAESTHESIA (right side is numb/tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Oxygen saturation
Clinical narrative: Severe coughing due to seasonal allergies since getting the COVID vaccinations/Dry cough; 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 COUGH (Severe coughing due to seasonal allergies since getting the COVID vaccinations/Dry cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Severe coughing due to seasonal allergies since getting the COVID vaccinations/Dry cough). At the time of the report, COUGH (Severe coughing due to seasonal allergies since getting the COVID vaccinations/Dry cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Oxygen saturation: 80s (normal) in 80s.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient's oxygen level stayed in the 80's even after a breathing treatment. Patient had never had anything like this and would have to see a pulmonologist.   Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Productive cough, Sneezing
Clinical narrative: flehm in throat; sneezing; sick; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (flehm in throat), SNEEZING (sneezing) and ILLNESS (sick) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (flehm in throat), SNEEZING (sneezing) and ILLNESS (sick). At the time of the report, PRODUCTIVE COUGH (flehm in throat), SNEEZING (sneezing) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; 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 PAIN (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site rash, Lymphadenopathy, Mammogram
Clinical narrative: COVID arm; Visible bulge under arm; Super hot; Arm Pain Killing me; Redness around the injection site; Swollen lymph nodes under the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site) and LYMPHADENOPATHY (Swollen lymph nodes under the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Sulfa drugs). Concomitant products included METFORMIN, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site) and LYMPHADENOPATHY (Swollen lymph nodes under the arm). On an unknown date, the patient experienced INJECTION SITE RASH (COVID arm). At the time of the report, PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site), LYMPHADENOPATHY (Swollen lymph nodes under the arm) and INJECTION SITE RASH (COVID arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Mammogram: inconclusive (Inconclusive) False results were shown indicating Lymph node cancer. On an unknown date, Ultrasound scan: inconclusive (Inconclusive) Radiologist confirmed it was not cancer and was due to the COVID-19 shot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: COVID arm; Visible bulge under arm; Super hot; Arm Pain Killing me; Redness around the injection site; Swollen lymph nodes under the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site) and LYMPHADENOPATHY (Swollen lymph nodes under the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Sulfa drugs). Concomitant products included METFORMIN, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site) and LYMPHADENOPATHY (Swollen lymph nodes under the arm). On an unknown date, the patient experienced INJECTION SITE RASH (COVID arm). At the time of the report, PERIPHERAL SWELLING (Visible bulge under arm), FEELING HOT (Super hot), PAIN IN EXTREMITY (Arm Pain Killing me), INJECTION SITE ERYTHEMA (Redness around the injection site), LYMPHADENOPATHY (Swollen lymph nodes under the arm) and INJECTION SITE RASH (COVID arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Mammogram: inconclusive (Inconclusive) False results were shown indicating Lymph node cancer. On an unknown date, Ultrasound scan: inconclusive (Inconclusive) Radiologist confirmed it was not cancer and was due to the COVID-19 shot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Myalgia, Swelling, Swollen tongue
Clinical narrative: Swelling mostly at eyes, mouth, tongue areas; Swelling mostly at eyes, mouth, tongue areas; COVID arm; Delayed hives,hives and swelling all over body and got worst everyday, never subsided; Hives and swelling all over body and got worst everyday, never subsided; Swelling mostly at eyes, mouth, tongue areas; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Delayed hives,hives and swelling all over body and got worst everyday, never subsided), MYALGIA (COVID arm), SWELLING (Hives and swelling all over body and got worst everyday, never subsided), EYE SWELLING (Swelling mostly at eyes, mouth, tongue areas) and MOUTH SWELLING (Swelling mostly at eyes, mouth, tongue areas) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (Delayed hives,hives and swelling all over body and got worst everyday, never subsided), MYALGIA (COVID arm), SWELLING (Hives and swelling all over body and got worst everyday, never subsided) and EYE SWELLING (Swelling mostly at eyes, mouth, tongue areas). On an unknown date, the patient experienced MOUTH SWELLING (Swelling mostly at eyes, mouth, tongue areas) and SWOLLEN TONGUE (Swelling mostly at eyes, mouth, tongue areas). The patient was treated with METHYLPREDNISOLONE at a dose of 4 mg, dose pack; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 10 mg once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) at a dose of 25 mg at bedtime. At the time of the report, URTICARIA (Delayed hives,hives and swelling all over body and got worst everyday, never subsided), MYALGIA (COVID arm), SWELLING (Hives and swelling all over body and got worst everyday, never subsided), EYE SWELLING (Swelling mostly at eyes, mouth, tongue areas), MOUTH SWELLING (Swelling mostly at eyes, mouth, tongue areas) and SWOLLEN TONGUE (Swelling mostly at eyes, mouth, tongue areas) outcome was unknown.            No Concomitant medications was reported. It was reported that patient was treated with steroid shot for hives.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Swelling mostly at eyes, mouth, tongue areas; Swelling mostly at eyes, mouth, tongue areas; COVID arm; Delayed hives,hives and swelling all over body and got worst everyday, never subsided; Hives and swelling all over body and got worst everyday, never subsided; Swelling mostly at eyes, mouth, tongue areas; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Delayed hives,hives and swelling all over body and got worst everyday, never subsided), MYALGIA (COVID arm), SWELLING (Hives and swelling all over body and got worst everyday, never subsided), EYE SWELLING (Swelling mostly at eyes, mouth, tongue areas) and MOUTH SWELLING (Swelling mostly at eyes, mouth, tongue areas) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (Delayed hives,hives and swelling all over body and got worst everyday, never subsided), MYALGIA (COVID arm), SWELLING (Hives and swelling all over body and got worst everyday, never subsided) and EYE SWELLING (Swelling mostly at eyes, mouth, tongue areas). On an unknown date, the patient experienced MOUTH SWELLING (Swelling mostly at eyes, mouth, tongue areas) and SWOLLEN TONGUE (Swelling mostly at eyes, mouth, tongue areas). The patient was treated with METHYLPREDNISOLONE at a dose of 4 mg, dose pack; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 10 mg once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) at a dose of 25 mg at bedtime. At the time of the report, URTICARIA (Delayed hives,hives and swelling all over body and got worst everyday, never subsided), MYALGIA (COVID arm), SWELLING (Hives and swelling all over body and got worst everyday, never subsided), EYE SWELLING (Swelling mostly at eyes, mouth, tongue areas), MOUTH SWELLING (Swelling mostly at eyes, mouth, tongue areas) and SWOLLEN TONGUE (Swelling mostly at eyes, mouth, tongue areas) outcome was unknown.            No Concomitant medications was reported. It was reported that patient was treated with steroid shot for hives.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Vaccination site pain
Clinical narrative: Injection site pain; dose administered after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (dose administered after beyond use date) and VACCINATION SITE PAIN (Injection site pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (sulfa), Allergy to homeopathic drugs (fish oil), Hyperlipidemia since 14-Nov-2017, Chronic lymphocytic leukemia since 30-Apr-2018, Type 2 diabetes mellitus since 08-Feb-2017, Chronic candidiasis since 25-Jan-2017, GERD, Arrhythmia, Heart failure and Candidiasis. Concomitant products included AMIODARONE from 28-May-2021 to an unknown date for Arrhythmia, FLUCONAZOLE from 25-May-2021 to an unknown date for Candidiasis, PANTOPRAZOLE from 31-Mar-2021 to an unknown date and SUCRALFATE from 22-Mar-2021 to an unknown date for GERD, METOPROLOL SUCCINATE from 28-May-2021 to an unknown date for Heart failure.   On 26-May-2021 at 11:52 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced OFF LABEL USE (dose administered after beyond use date). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 26-May-2021, OFF LABEL USE (dose administered after beyond use date) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: No new information received. On 06-Jul-2021: Updated information included dose 1 time and dose 2 details, patient's race, ethnic group, medical history and concomitant medications.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm still feel tender after two months; Arm still sore after two months; 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 TENDERNESS (Arm still feel tender after two months) and PAIN IN EXTREMITY (Arm still sore after two months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Arm still feel tender after two months) and PAIN IN EXTREMITY (Arm still sore after two months). At the time of the report, TENDERNESS (Arm still feel tender after two months) and PAIN IN EXTREMITY (Arm still sore after two months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity, Visual impairment
Clinical narrative: Stomach soreness; Leg soreness; Cannot see out of right eye; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Cannot see out of right eye), ABDOMINAL PAIN UPPER (Stomach soreness) and PAIN IN EXTREMITY (Leg soreness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VISUAL IMPAIRMENT (Cannot see out of right eye). On 17-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach soreness) and PAIN IN EXTREMITY (Leg soreness). On 19-May-2021, ABDOMINAL PAIN UPPER (Stomach soreness) and PAIN IN EXTREMITY (Leg soreness) had resolved. At the time of the report, VISUAL IMPAIRMENT (Cannot see out of right eye) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications are not provided. Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Bad reaction that sent him to the hospital; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction that sent him to the hospital) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction that sent him to the hospital). At the time of the report, VACCINATION COMPLICATION (Bad reaction that sent him to the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the first vaccine 4 months ago; 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 PRODUCT DOSE OMISSION ISSUE (got the first vaccine 4 months ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first vaccine 4 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first vaccine 4 months ago) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications and treatment medications were provided by the reporter.  The patient got the vaccine 4 months ago did not received the second dose of vaccine at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hypoaesthesia
Clinical narrative: feels heat and warmth; felt numbness on the bottom of her feet; area on her upper arm that had deeply pink flushed skin; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (felt numbness on the bottom of her feet), FEELING HOT (feels heat and warmth) and FLUSHING (area on her upper arm that had deeply pink flushed skin) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Basal cell carcinoma (nose). Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Vitamin B12 supplementation, ATENOLOL, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN D NOS for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPOAESTHESIA (felt numbness on the bottom of her feet). On an unknown date, the patient experienced FEELING HOT (feels heat and warmth) and FLUSHING (area on her upper arm that had deeply pink flushed skin). At the time of the report, HYPOAESTHESIA (felt numbness on the bottom of her feet) outcome was unknown, FEELING HOT (feels heat and warmth) had not resolved and FLUSHING (area on her upper arm that had deeply pink flushed skin) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Vitamin B12: increased (High) Increased.         The patient saw an Internist at the end of March, who did blood work for her because of a procedure she was to have to remove basal cancer from her nose. She thought her vitamin B12 levels might have been low, however from lab work her B12 levels were actually high and she was advised to stop taking her B12 supplementation at that time. Treatment information was not reported.   This case was linked to MOD-2021-194544 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: Abscessed tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (Abscessed tooth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH ABSCESS (Abscessed tooth). At the time of the report, TOOTH ABSCESS (Abscessed tooth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    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 MALAISE (Feeling sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Myalgia
Clinical narrative: Right Shoulder Bursitis; On 10Mar201, next day after receiving the first dose of Moderna COVID-19 vaccine, the caller; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Right Shoulder Bursitis) and MYALGIA (On 10Mar201, next day after receiving the first dose of Moderna COVID-19 vaccine, the caller) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, DULAGLUTIDE (TRULICITY) from 01-Jun-2021 to an unknown date, GLIPIZIDE, LOSARTAN, ATENOLOL, ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81) and BRINZOLAMIDE (AZOPT) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (On 10Mar201, next day after receiving the first dose of Moderna COVID-19 vaccine, the caller). On 15-Jun-2021, the patient experienced BURSITIS (Right Shoulder Bursitis). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form; CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Muscle relaxant, at a dose of 1 UNK and Physical therapy for Bursitis. At the time of the report, BURSITIS (Right Shoulder Bursitis) and MYALGIA (On 10Mar201, next day after receiving the first dose of Moderna COVID-19 vaccine, the caller) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Multivitamins. Patient received treatment eight weeks of physical therapy       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Contact information and event were updated. On 05-Aug-2021: Follow-up received on 05-Aug-2021 included no new information.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: little bit dizzy; could not sleep; sweating; a little pain in the shoulder; nauseous; little bit of fever; felt a lot of burning from the injection site; loss of appetite; lots of muscle pain; a little headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little bit dizzy), INSOMNIA (could not sleep), HYPERHIDROSIS (sweating), ARTHRALGIA (a little pain in the shoulder) and NAUSEA (nauseous) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (little bit dizzy), INSOMNIA (could not sleep), HYPERHIDROSIS (sweating), ARTHRALGIA (a little pain in the shoulder), NAUSEA (nauseous), PYREXIA (little bit of fever), VACCINATION SITE PAIN (felt a lot of burning from the injection site), DECREASED APPETITE (loss of appetite), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DIZZINESS (little bit dizzy), INSOMNIA (could not sleep), HYPERHIDROSIS (sweating), ARTHRALGIA (a little pain in the shoulder), NAUSEA (nauseous), PYREXIA (little bit of fever), VACCINATION SITE PAIN (felt a lot of burning from the injection site), DECREASED APPETITE (loss of appetite), MYALGIA (lots of muscle pain), HEADACHE (a little headache) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.