chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Tenderness, Vertigo
Clinical narrative: headaches at the top of his head; his ears was bothering him specifically the back of the ear; some dizziness; He almost passed out when he stood up; his bones hurt a little bit; exacerbated his arthritis; his arm was a little touchy; turning his head was very difficult; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (his bones hurt a little bit), TENDERNESS (his arm was a little touchy), ARTHRITIS (exacerbated his arthritis), VERTIGO (turning his head was very difficult) and DIZZINESS (some dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.    On 22-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 VERTIGO (turning his head was very difficult). On 24-Jan-2021, the patient experienced TENDERNESS (his arm was a little touchy). On 26-Jan-2021, the patient experienced BONE PAIN (his bones hurt a little bit), ARTHRITIS (exacerbated his arthritis), DIZZINESS (some dizziness) and PRESYNCOPE (He almost passed out when he stood up). On 09-Feb-2021, the patient experienced EAR PAIN (his ears was bothering him specifically the back of the ear). On 15-Feb-2021, the patient experienced CLUSTER HEADACHE (headaches at the top of his head). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BONE PAIN (his bones hurt a little bit), TENDERNESS (his arm was a little touchy), ARTHRITIS (exacerbated his arthritis), VERTIGO (turning his head was very difficult), DIZZINESS (some dizziness), PRESYNCOPE (He almost passed out when he stood up), EAR PAIN (his ears was bothering him specifically the back of the ear) and CLUSTER HEADACHE (headaches at the top of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  When he drinks water or milkshake, it helps clear the headache or back of his neck for a while. He also took a towel and a belt around his neck to create a neck support collar.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Gait inability, Lethargy
Clinical narrative: lethargic; visual disorientation; unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), DISORIENTATION (visual disorientation) and GAIT INABILITY (unable to walk) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LETHARGY (lethargic), DISORIENTATION (visual disorientation) and GAIT INABILITY (unable to walk). On 10-Feb-2021, LETHARGY (lethargic), DISORIENTATION (visual disorientation) and GAIT INABILITY (unable to walk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: whole deltoid muscle that was injected and is bright red/ underarm is also bright red; her arm started to hurt again/underarm red and sore; very sore; joints were painful/ joints were really sore; muscles and joints were really sore/ whole body ached; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started to hurt again/underarm red and sore), VACCINATION SITE PAIN (very sore), ARTHRALGIA (joints were painful/ joints were really sore), VACCINATION SITE ERYTHEMA (whole deltoid muscle that was injected and is bright red/ underarm is also bright red) and MYALGIA (muscles and joints were really sore/ whole body ached) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (very sore). In February 2021, the patient experienced ARTHRALGIA (joints were painful/ joints were really sore) and MYALGIA (muscles and joints were really sore/ whole body ached). On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (her arm started to hurt again/underarm red and sore). On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (whole deltoid muscle that was injected and is bright red/ underarm is also bright red). At the time of the report, PAIN IN EXTREMITY (her arm started to hurt again/underarm red and sore) and VACCINATION SITE ERYTHEMA (whole deltoid muscle that was injected and is bright red/ underarm is also bright red) outcome was unknown, VACCINATION SITE PAIN (very sore) had resolved and ARTHRALGIA (joints were painful/ joints were really sore) and MYALGIA (muscles and joints were really sore/ whole body ached) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  On 18-FEB-2021, patient's underarm became bright red and very sore. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information received reporter contact details updated.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 FATIGUE (exhaustion). At the time of the report, FATIGUE (exhaustion) outcome was unknown.        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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: rash; headache; felt sore; my arm was tender; spacey; dizzy; I had to be thoughtful on how I was walking; slight headache; The injection site was sore; muscle aches; joint pain; nausea; vomiting (4 times); fever; chills; took temperature with peak 100.6 F; neck pain; She felt she was going to die; headache; fatigued; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (fatigued), NECK PAIN (neck pain) and MYALGIA (muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZELASTINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm). On 17-Jan-2021, the patient experienced the first episode of HEADACHE (headache) and FATIGUE (fatigued). On 14-Feb-2021, the patient experienced NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die) and MYALGIA (The injection site was sore). On 15-Feb-2021, the patient experienced HEADACHE (slight headache). On 16-Feb-2021, the patient experienced DIZZINESS (dizzy) and ARTHRALGIA (I had to be thoughtful on how I was walking). On 17-Feb-2021, the patient experienced FEELING ABNORMAL (spacey). On 18-Feb-2021, the patient experienced TENDERNESS (my arm was tender) and MYALGIA (felt sore). On an unknown date, the patient experienced RASH (rash) and the second episode of HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (fatigued), NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), DIZZINESS (dizzy), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die), HEADACHE (slight headache), ARTHRALGIA (I had to be thoughtful on how I was walking), FEELING ABNORMAL (spacey), TENDERNESS (my arm was tender), RASH (rash), MYALGIA (The injection site was sore), MYALGIA (felt sore) and the last episode of HEADACHE (headache) outcome was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: rash; headache; felt sore; my arm was tender; spacey; dizzy; I had to be thoughtful on how I was walking; slight headache; The injection site was sore; muscle aches; joint pain; nausea; vomiting (4 times); fever; chills; took temperature with peak 100.6 F; neck pain; She felt she was going to die; headache; fatigued; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (fatigued), NECK PAIN (neck pain) and MYALGIA (muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZELASTINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm). On 17-Jan-2021, the patient experienced the first episode of HEADACHE (headache) and FATIGUE (fatigued). On 14-Feb-2021, the patient experienced NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die) and MYALGIA (The injection site was sore). On 15-Feb-2021, the patient experienced HEADACHE (slight headache). On 16-Feb-2021, the patient experienced DIZZINESS (dizzy) and ARTHRALGIA (I had to be thoughtful on how I was walking). On 17-Feb-2021, the patient experienced FEELING ABNORMAL (spacey). On 18-Feb-2021, the patient experienced TENDERNESS (my arm was tender) and MYALGIA (felt sore). On an unknown date, the patient experienced RASH (rash) and the second episode of HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (fatigued), NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), DIZZINESS (dizzy), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die), HEADACHE (slight headache), ARTHRALGIA (I had to be thoughtful on how I was walking), FEELING ABNORMAL (spacey), TENDERNESS (my arm was tender), RASH (rash), MYALGIA (The injection site was sore), MYALGIA (felt sore) and the last episode of HEADACHE (headache) outcome was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tenderness, Vomiting
Clinical narrative: rash; headache; felt sore; my arm was tender; spacey; dizzy; I had to be thoughtful on how I was walking; slight headache; The injection site was sore; muscle aches; joint pain; nausea; vomiting (4 times); fever; chills; took temperature with peak 100.6 F; neck pain; She felt she was going to die; headache; fatigued; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (fatigued), NECK PAIN (neck pain) and MYALGIA (muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZELASTINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm). On 17-Jan-2021, the patient experienced the first episode of HEADACHE (headache) and FATIGUE (fatigued). On 14-Feb-2021, the patient experienced NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die) and MYALGIA (The injection site was sore). On 15-Feb-2021, the patient experienced HEADACHE (slight headache). On 16-Feb-2021, the patient experienced DIZZINESS (dizzy) and ARTHRALGIA (I had to be thoughtful on how I was walking). On 17-Feb-2021, the patient experienced FEELING ABNORMAL (spacey). On 18-Feb-2021, the patient experienced TENDERNESS (my arm was tender) and MYALGIA (felt sore). On an unknown date, the patient experienced RASH (rash) and the second episode of HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (fatigued), NECK PAIN (neck pain), MYALGIA (muscle aches), ARTHRALGIA (joint pain), NAUSEA (nausea), VOMITING (vomiting (4 times)), PYREXIA (fever), CHILLS (chills), DIZZINESS (dizzy), PYREXIA (took temperature with peak 100.6 F), FEELING ABNORMAL (She felt she was going to die), HEADACHE (slight headache), ARTHRALGIA (I had to be thoughtful on how I was walking), FEELING ABNORMAL (spacey), TENDERNESS (my arm was tender), RASH (rash), MYALGIA (The injection site was sore), MYALGIA (felt sore) and the last episode of HEADACHE (headache) outcome was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Decreased activity, Decreased appetite, Diarrhoea
Clinical narrative: stomach pain; an uncomfortable feeling in my intestines; very loose stool; I can eat, but not like used to do; fatigued; felt a little listless and not as active; felt a little listless and not as active; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active), PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Feb-2021, LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Listless, Pain in extremity
Clinical narrative: stomach pain; an uncomfortable feeling in my intestines; very loose stool; I can eat, but not like used to do; fatigued; felt a little listless and not as active; felt a little listless and not as active; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active), PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Feb-2021, LISTLESS (felt a little listless and not as active), DECREASED ACTIVITY (felt a little listless and not as active) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (an uncomfortable feeling in my intestines), DIARRHOEA (very loose stool), DECREASED APPETITE (I can eat, but not like used to do) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Ear discomfort, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Slight closing of throat), DYSPEPSIA (Heartburn), EAR DISCOMFORT (Pressure in ear), INJECTION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE ERYTHEMA (Redness at site of injection) in a 58-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. No medical history was provided by the reporter. Concomitant products included SERTRALINE, ASCORBIC ACID (VITAMIN C ACID), MAGNESIUM, ZINC and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE SWELLING (Swelling at site of injection). On 17-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at site of injection). On 18-Feb-2021, the patient experienced THROAT TIGHTNESS (Slight closing of throat), DYSPEPSIA (Heartburn), EAR DISCOMFORT (Pressure in ear) and INJECTION SITE RASH (red rash at site of injection). At the time of the report, THROAT TIGHTNESS (Slight closing of throat), DYSPEPSIA (Heartburn), EAR DISCOMFORT (Pressure in ear), INJECTION SITE PRURITUS (Itchiness at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE RASH (red rash at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE SWELLING (Swelling at site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was provided by the reporter as multivitamins. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information was received on 04 Jun 2021, Reporter contact detail and vaccine route of administration was updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Throat tightness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Slight closing of throat), DYSPEPSIA (Heartburn), EAR DISCOMFORT (Pressure in ear), INJECTION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE ERYTHEMA (Redness at site of injection) in a 58-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. No medical history was provided by the reporter. Concomitant products included SERTRALINE, ASCORBIC ACID (VITAMIN C ACID), MAGNESIUM, ZINC and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE SWELLING (Swelling at site of injection). On 17-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at site of injection). On 18-Feb-2021, the patient experienced THROAT TIGHTNESS (Slight closing of throat), DYSPEPSIA (Heartburn), EAR DISCOMFORT (Pressure in ear) and INJECTION SITE RASH (red rash at site of injection). At the time of the report, THROAT TIGHTNESS (Slight closing of throat), DYSPEPSIA (Heartburn), EAR DISCOMFORT (Pressure in ear), INJECTION SITE PRURITUS (Itchiness at site of injection), INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE RASH (red rash at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE SWELLING (Swelling at site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was provided by the reporter as multivitamins. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up information was received on 04 Jun 2021, Reporter contact detail and vaccine route of administration was updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site irritation, Lacrimation increased, Pain, Rhinorrhoea
Clinical narrative: runny nose on the side of the vaccine; the injection site irritated; watery eye on the side of the vaccine; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), INJECTION SITE IRRITATION (the injection site irritated), LACRIMATION INCREASED (watery eye on the side of the vaccine) and RHINORRHOEA (runny nose on the side of the vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN and SIMVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 17-Feb-2021, the patient experienced PAIN (body ache). On 18-Feb-2021, the patient experienced INJECTION SITE IRRITATION (the injection site irritated) and LACRIMATION INCREASED (watery eye on the side of the vaccine).   On an unknown date, the patient experienced RHINORRHOEA (runny nose on the side of the vaccine). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency.   On 18-Feb-2021, PAIN (body ache) and INJECTION SITE IRRITATION (the injection site irritated) had resolved.   At the time of the report, LACRIMATION INCREASED (watery eye on the side of the vaccine) and RHINORRHOEA (runny nose on the side of the vaccine) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Pruritus, Rash, Rash erythematous
Clinical narrative: Itching throughout the whole body; Feels like sunburn throughout his body; little bumps on his face; Rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching throughout the whole body), RASH ERYTHEMATOUS (Feels like sunburn throughout his body), MASS (little bumps on his face) and RASH (Rash on his face) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SERTRALINE for an unknown indication.    On 13-Feb-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 PRURITUS (Itching throughout the whole body), RASH ERYTHEMATOUS (Feels like sunburn throughout his body), MASS (little bumps on his face) and RASH (Rash on his face). At the time of the report, PRURITUS (Itching throughout the whole body), RASH ERYTHEMATOUS (Feels like sunburn throughout his body), MASS (little bumps on his face) and RASH (Rash on his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore Right arm, states worse than the flu shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore Right arm, states worse than the flu shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore Right arm, states worse than the flu shot). On 15-Mar-2021, VACCINATION SITE PAIN (sore Right arm, states worse than the flu shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Headache, Presyncope
Clinical narrative: Was very close to passing out; Stumbling in her words; Really bad, extremely bad headache in front of her head; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Was very close to passing out), DYSARTHRIA (Stumbling in her words) and HEADACHE (Really bad, extremely bad headache in front of her head) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PRESYNCOPE (Was very close to passing out), DYSARTHRIA (Stumbling in her words) and HEADACHE (Really bad, extremely bad headache in front of her head). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 15-Jan-2021, PRESYNCOPE (Was very close to passing out), DYSARTHRIA (Stumbling in her words) and HEADACHE (Really bad, extremely bad headache in front of her head) had resolved.            Concomitant product use was not provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm- 5inches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm- 5inches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm- 5inches). At the time of the report, PAIN IN EXTREMITY (Sore arm- 5inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Injection site mass, Limb discomfort, Pain
Clinical narrative: pain; I get pain in my upper arm; When I have both arms at my sides, my left arm feels heavier; Three days later, it all broke out again with the same 2-inch ring, swelling, soreness; swollen arm/2-inch ring around my arm; a small dot, like a mosquito bite type thing; Sometimes it feels numb and tingly all the way down to my fingers; Sometimes it feels numb and tingly all the way down to my fingers; some chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness) and PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-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 PAIN (pain), PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness), PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm), INJECTION SITE MASS (a small dot, like a mosquito bite type thing), HYPOAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers), PARAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) and CHILLS (some chills). At the time of the report, PAIN (pain) and INJECTION SITE MASS (a small dot, like a mosquito bite type thing) had not resolved, PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), HYPOAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) and PARAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) outcome was unknown and VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness), PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm) and CHILLS (some chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Vaccination site discomfort
Clinical narrative: pain; I get pain in my upper arm; When I have both arms at my sides, my left arm feels heavier; Three days later, it all broke out again with the same 2-inch ring, swelling, soreness; swollen arm/2-inch ring around my arm; a small dot, like a mosquito bite type thing; Sometimes it feels numb and tingly all the way down to my fingers; Sometimes it feels numb and tingly all the way down to my fingers; some chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness) and PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-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 PAIN (pain), PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness), PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm), INJECTION SITE MASS (a small dot, like a mosquito bite type thing), HYPOAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers), PARAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) and CHILLS (some chills). At the time of the report, PAIN (pain) and INJECTION SITE MASS (a small dot, like a mosquito bite type thing) had not resolved, PAIN IN EXTREMITY (I get pain in my upper arm), LIMB DISCOMFORT (When I have both arms at my sides, my left arm feels heavier), HYPOAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) and PARAESTHESIA (Sometimes it feels numb and tingly all the way down to my fingers) outcome was unknown and VACCINATION SITE DISCOMFORT (Three days later, it all broke out again with the same 2-inch ring, swelling, soreness), PERIPHERAL SWELLING (swollen arm/2-inch ring around my arm) and CHILLS (some chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: a tingling sensation in lips and tongue; heart racing; unable to sleep all night; Weakness; Diarrhea; fight or flight sensation/adrenaline rush sensation; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (a tingling sensation in lips and tongue), PALPITATIONS (heart racing), INSOMNIA (unable to sleep all night), ASTHENIA (Weakness) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  On 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 PARAESTHESIA ORAL (a tingling sensation in lips and tongue), PALPITATIONS (heart racing), INSOMNIA (unable to sleep all night), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING ABNORMAL (fight or flight sensation/adrenaline rush sensation), PYREXIA (Fever) and FATIGUE (Fatigue).   At the time of the report, PARAESTHESIA ORAL (a tingling sensation in lips and tongue), PALPITATIONS (heart racing), INSOMNIA (unable to sleep all night), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING ABNORMAL (fight or flight sensation/adrenaline rush sensation), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      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.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia oral, Pyrexia
Clinical narrative: a tingling sensation in lips and tongue; heart racing; unable to sleep all night; Weakness; Diarrhea; fight or flight sensation/adrenaline rush sensation; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (a tingling sensation in lips and tongue), PALPITATIONS (heart racing), INSOMNIA (unable to sleep all night), ASTHENIA (Weakness) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  On 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 PARAESTHESIA ORAL (a tingling sensation in lips and tongue), PALPITATIONS (heart racing), INSOMNIA (unable to sleep all night), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING ABNORMAL (fight or flight sensation/adrenaline rush sensation), PYREXIA (Fever) and FATIGUE (Fatigue).   At the time of the report, PARAESTHESIA ORAL (a tingling sensation in lips and tongue), PALPITATIONS (heart racing), INSOMNIA (unable to sleep all night), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING ABNORMAL (fight or flight sensation/adrenaline rush sensation), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: injection site is swollen (size of a fig); injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site is swollen (size of a fig)) and INJECTION SITE PRURITUS (injection site is itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site is swollen (size of a fig)) and INJECTION SITE PRURITUS (injection site is itchy).   At the time of the report, VACCINATION SITE SWELLING (injection site is swollen (size of a fig)) and INJECTION SITE PRURITUS (injection site is itchy) outcome was unknown.      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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; redness at injection site; injection arm throbbing; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection arm throbbing), INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.  On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (injection arm throbbing).   On 07-Feb-2021, the patient experienced INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   On 05-Feb-2021, INJECTION SITE PAIN (injection arm throbbing) had resolved. At the time of the report, INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) had not resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Injection site swelling, Lymphadenopathy, SARS-CoV-2 test negative
Clinical narrative: loss of taste and smell; loss of taste and smell; Purple , red circle on the injection site; swelling on the injection site; developed a lump underneath her arm that lasted for one week; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell), LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell), LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, ANOSMIA (loss of taste and smell) and AGEUSIA (loss of taste and smell) had not resolved and LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test negative: negative (Negative) negative. On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided. Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Follow up received on 18-FEB-2021 contain significant information about additional events after first dose, and outcome of previous events unknown to not recovered. Added lab data information. On 14-Jun-2021: Follow-up received on 14-Jun-2021 and does not contain any new information.