chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling around the injection site), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE PAIN (painful around the injection site) and VACCINATION SITE PRURITUS (itches around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. NO treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021. No medical history information was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. NO treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  were not reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: weakness; Dizziness; Chills; fever 102.4F; Nausea; Terrible Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 PCR test positive on 29-Dec-2020. Concurrent medical conditions included Drug allergy (streptomycin) and Mycobacterium avium complex infection since 2018. Concomitant products included BUDESONIDE (BENACORT), MAGNESIUM, STEROIDS, Dulcosite sodium                                               Stool softener, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), OLMESARTAN MEDOXOMIL (BENICAR), ESTRADIOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F), NAUSEA (Nausea) and HEADACHE (Terrible Headache). On an unknown date, the patient experienced ASTHENIA (weakness). On 18-Feb-2021, DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F), NAUSEA (Nausea) and HEADACHE (Terrible Headache) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown.      Concomitant medications taken included cholesterol medicines. Treatment details included Tylenol and Reglan.   This case was linked to MOD-2021-101503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Dose 2 related information was updated. Action taken was updated, new conmeds were added, patient details updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weakness; Dizziness; Chills; fever 102.4F; Nausea; Terrible Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 PCR test positive on 29-Dec-2020. Concurrent medical conditions included Drug allergy (streptomycin) and Mycobacterium avium complex infection since 2018. Concomitant products included BUDESONIDE (BENACORT), MAGNESIUM, STEROIDS, Dulcosite sodium                                               Stool softener, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), OLMESARTAN MEDOXOMIL (BENICAR), ESTRADIOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F), NAUSEA (Nausea) and HEADACHE (Terrible Headache). On an unknown date, the patient experienced ASTHENIA (weakness). On 18-Feb-2021, DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (fever 102.4F), NAUSEA (Nausea) and HEADACHE (Terrible Headache) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown.      Concomitant medications taken included cholesterol medicines. Treatment details included Tylenol and Reglan.   This case was linked to MOD-2021-101503 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Dose 2 related information was updated. Action taken was updated, new conmeds were added, patient details updated.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Fatigue, Headache, Nausea
Clinical narrative: Headache; Mild Nausea; High level of fatigue; No energy; intestinal discomfort/cramp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-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 information was reported.     On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-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 information was reported.     On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; Mild Nausea; High level of fatigue; No energy; intestinal discomfort/cramp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-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 information was reported.     On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-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 information was reported.     On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: After the vaccine she saw stars for a couple of minutes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     NO medical history information was reported.     On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes). On 18-Feb-2021, VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) had resolved. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.     Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     NO medical history information was reported.     On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes). On 18-Feb-2021, VISUAL IMPAIRMENT (After the vaccine she saw stars for a couple of minutes) had resolved. Not Provided          No relevant Concomitant medications were reported.   No Treatment information for the event was provided.     Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) 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 VACCINATION SITE PAIN (Arm is sore). At the time of the report, VACCINATION SITE PAIN (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) 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 VACCINATION SITE PAIN (Arm is sore). At the time of the report, VACCINATION SITE PAIN (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Herpes zoster, Rash
Clinical narrative: stomach pain; Rash; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Stomach pain (history of stomach pain for 8 months) since an unknown date and Fatty liver since an unknown date.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Stomach pain (history of stomach pain for 8 months) since an unknown date and Fatty liver since an unknown date.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rash). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (stomach pain) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Tremor, Vaccination site pain
Clinical narrative: chills; shaking; joint aching; soreness; her left arm is extremely sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts). At the time of the report, CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts). At the time of the report, CHILLS (chills), TREMOR (shaking), ARTHRALGIA (joint aching), PAIN (soreness) and VACCINATION SITE PAIN (her left arm is extremely sore and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: mild headache/I felt a little headache; tiredness; I had injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (I had injection site pain), HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Stroke. Concomitant products included EZETIMIBE (ZETIA) for Cholesterol.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (I had injection site pain). On an unknown date, the patient experienced HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness). At the time of the report, INJECTION SITE PAIN (I had injection site pain), HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Influenza like illness, Pyrexia
Clinical narrative: Fever; Chills; Flu like symptoms; weakness; I fell on the floor and could not get up for 15 minutes today.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness) and FALL (I fell on the floor and could not get up for 15 minutes today.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FALL (I fell on the floor and could not get up for 15 minutes today.). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ASTHENIA (weakness). At the time of the report, PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness) and FALL (I fell on the floor and could not get up for 15 minutes today.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Fatigue, Hypersomnia
Clinical narrative: slept 3/4 of the day; exhausted; lower back, shoulder and neck hurt; lower back, shoulder and neck hurt; had a hard time with it; hurt all over; lower back, shoulder and neck hurt; tried to turn and I couldn't; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't) and HYPERSOMNIA (slept 3/4 of the day) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Degenerative disc disease (In her lower back).    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 ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't), NECK PAIN (lower back, shoulder and neck hurt) and ARTHRALGIA (lower back, shoulder and neck hurt). On 08-Feb-2021, the patient experienced HYPERSOMNIA (slept 3/4 of the day) and FATIGUE (exhausted). On 08-Feb-2021, ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't), NECK PAIN (lower back, shoulder and neck hurt) and ARTHRALGIA (lower back, shoulder and neck hurt) had resolved. At the time of the report, HYPERSOMNIA (slept 3/4 of the day) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication was not provided.  Treatment medication was not given.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Neck pain, Pain
Clinical narrative: slept 3/4 of the day; exhausted; lower back, shoulder and neck hurt; lower back, shoulder and neck hurt; had a hard time with it; hurt all over; lower back, shoulder and neck hurt; tried to turn and I couldn't; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't) and HYPERSOMNIA (slept 3/4 of the day) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Degenerative disc disease (In her lower back).    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 ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't), NECK PAIN (lower back, shoulder and neck hurt) and ARTHRALGIA (lower back, shoulder and neck hurt). On 08-Feb-2021, the patient experienced HYPERSOMNIA (slept 3/4 of the day) and FATIGUE (exhausted). On 08-Feb-2021, ILLNESS (had a hard time with it), PAIN (hurt all over), BACK PAIN (lower back, shoulder and neck hurt), ASTHENIA (tried to turn and I couldn't), NECK PAIN (lower back, shoulder and neck hurt) and ARTHRALGIA (lower back, shoulder and neck hurt) had resolved. At the time of the report, HYPERSOMNIA (slept 3/4 of the day) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication was not provided.  Treatment medication was not given.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: tested positive for COVID she is asymptomatic.; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) and DRUG INEFFECTIVE (Lack of drug effect) in a 33-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) and DRUG INEFFECTIVE (Lack of drug effect). On 17-Feb-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-1 test: positive (Positive) Positive.         Treatment and concomitant medications were not provided by reporter.  This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  Asymptomatic COVID-19 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Upon internal review on 06-Aug-2021, event of Lack of drug effect was added. Lab data and dose 1 information were also updated.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  Asymptomatic COVID-19 is assessed as not applicable.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; high fever of 100.3.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (high fever of 100.3.) 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 Leukemia lymphocytic chronic and COVID-19 in December 2020.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (high fever of 100.3.). At the time of the report, CHILLS (chills) and PYREXIA (high fever of 100.3.) 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.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-017163 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site; Rash at injection site; warmness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site) had resolved and INJECTION SITE RASH (Rash at injection site) and INJECTION SITE WARMTH (warmness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-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) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). At the time of the report, PAIN IN EXTREMITY (Little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included 2 Advil before the shot, 2 Tylenol.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Vomiting
Clinical narrative: Back ache; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011320A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, BACK PAIN (Back ache), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided but mentions being on a blood thinner, of unspecified type.  Treatment medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Myalgia
Clinical narrative: Bone and muscle ache; muscle pain; joint pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bone and muscle ache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (treated for cancer and is on immunotherapy).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced BONE PAIN (Bone and muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BONE PAIN (Bone and muscle ache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-090440, US-MODERNATX, INC.-MOD-2021-090431 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-Apr-2021. AE contact information Updated and additional event added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090431: US-MODERNATX, INC.-MOD-2021-090440:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Sleep deficit
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history.). On 09-Feb-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 18-Feb-2021, the patient experienced PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep). At the time of the report, PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment: Benadryl (diphenhydramine HCL). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient's address added.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037J20A) for COVID-19 vaccination.     Concomitant products included PROPAFENONE, EZETIMIBE, PRAVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE, ALPRAZOLAM, LATANOPROST, CICLOSPORIN (RESTASIS), ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMINS [VITAMINS NOS], FISH OIL and UBIDECARENONE (CO ENZYME Q10 [UBIDECARENONE]) 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 21-Jan-2021, the patient experienced BURNING SENSATION (Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs). The patient was treated with GABAPENTIN for Burning sensation, at an unspecified dose and frequency. On 22-Jan-2021, BURNING SENSATION (Extreme burning sensation in my extremities, elbow to fingertips and knees to toes / terrible burning in her limbs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-214641 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Significant Follow up received on 01-FEB-2021 and includes treatment, address, second dose details and additional events after second dose.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Peripheral swelling
Clinical narrative: exhaustion; Fever; Chills; Headache; Badly swollen arms; Aches and pains; Were feeling awful; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and PERIPHERAL SWELLING (Badly swollen arms) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful). At the time of the report, FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: exhaustion; Fever; Chills; Headache; Badly swollen arms; Aches and pains; Were feeling awful; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and PERIPHERAL SWELLING (Badly swollen arms) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful). At the time of the report, FATIGUE (exhaustion), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PERIPHERAL SWELLING (Badly swollen arms), PAIN (Aches and pains) and VACCINATION COMPLICATION (Were feeling awful) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Hypersensitivity, Nasal congestion, Oropharyngeal pain
Clinical narrative: significant allergic reaction; eyes swelled up; nose was congested; throat was swollen; throat was sore; itching throughout her body,ears, butt, on back; itching on eyes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen) and OROPHARYNGEAL PAIN (throat was sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and FAMOTIDINE (PEPCID AC) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: significant allergic reaction; eyes swelled up; nose was congested; throat was swollen; throat was sore; itching throughout her body,ears, butt, on back; itching on eyes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen) and OROPHARYNGEAL PAIN (throat was sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and FAMOTIDINE (PEPCID AC) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (significant allergic reaction), EYE SWELLING (eyes swelled up), NASAL CONGESTION (nose was congested), PHARYNGEAL SWELLING (throat was swollen), OROPHARYNGEAL PAIN (throat was sore), PRURITUS (itching throughout her body,ears, butt, on back) and EYE PRURITUS (itching on eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Disorientation, Fatigue, Feeling abnormal
Clinical narrative: disorientated; brain was foggy; totally crashed and had to go to sleep; severe diarrhea,like never before. Still not having normal bowel movements; sore arm; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) and PAIN IN EXTREMITY (sore arm) in a 63-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 information was reported.    On 09-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 DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills). On 10-Feb-2021, DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), FATIGUE (fatigue) and CHILLS (chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Imodium. No concomitant medications were provided by reporter.