chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Pyrexia, Tongue discomfort
Clinical narrative: diarrhea; stomach cramps; body aches; fever; felt like tongue was on fire; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), TONGUE DISCOMFORT (felt like tongue was on fire), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever) and TONGUE DISCOMFORT (felt like tongue was on fire). On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches). At the time of the report, PYREXIA (fever), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches) outcome was unknown and TONGUE DISCOMFORT (felt like tongue was on fire) had resolved.            No concomitant medications were reported. No treatment information was provided
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: can't use arm for daily activities - right arm; can't lie down on right side, really painful - right arm; can't use the muscle - right arm; pretty severely sore - right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pretty severely sore - right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't use arm for daily activities - right arm), PAIN IN EXTREMITY (can't lie down on right side, really painful - right arm) and MYALGIA (can't use the muscle - right arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (pretty severely sore - right arm). On 16-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can't use arm for daily activities - right arm), PAIN IN EXTREMITY (can't lie down on right side, really painful - right arm) and MYALGIA (can't use the muscle - right arm). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 15-Mar-2021, PAIN IN EXTREMITY (pretty severely sore - right arm) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (can't use arm for daily activities - right arm), PAIN IN EXTREMITY (can't lie down on right side, really painful - right arm) and MYALGIA (can't use the muscle - right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Feeling constant nausea; Occasionally vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feeling constant nausea) and VOMITING (Occasionally vomiting) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013620A) 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 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Feeling constant nausea) and VOMITING (Occasionally vomiting). The patient was treated with CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (Feeling constant nausea) and VOMITING (Occasionally vomiting) had not resolved. Unknown          No Concomitant medications was reported
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.  The patient wanted to know if she is contagious to others in the house.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: substantially higher blood sugar levels; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (substantially higher blood sugar levels) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (His blood sugar levels increased since he received  the vaccine.).   On 17-Mar-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-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (substantially higher blood sugar levels). At the time of the report, BLOOD GLUCOSE INCREASED (substantially higher blood sugar levels) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medication were not provided.  Patient mentioned of having high blood sugar level after first dose.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ageusia, Arthralgia, Feeling of body temperature change, Headache
Clinical narrative: migraines; loss of taste; felt really hot/cold; right arm really sore; stomach problems; body is aching so bad, it hasn't stopped; headaches; joint hurt/now worse; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), AGEUSIA (loss of taste), FEELING OF BODY TEMPERATURE CHANGE (felt really hot/cold), PAIN IN EXTREMITY (right arm really sore) and ABDOMINAL DISCOMFORT (stomach problems) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain (Had joint pain prior to vaccine.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (joint hurt/now worse). On an unknown date, the patient experienced MIGRAINE (migraines), AGEUSIA (loss of taste), FEELING OF BODY TEMPERATURE CHANGE (felt really hot/cold), PAIN IN EXTREMITY (right arm really sore), ABDOMINAL DISCOMFORT (stomach problems), MYALGIA (body is aching so bad, it hasn't stopped) and HEADACHE (headaches). At the time of the report, MIGRAINE (migraines), AGEUSIA (loss of taste), FEELING OF BODY TEMPERATURE CHANGE (felt really hot/cold), PAIN IN EXTREMITY (right arm really sore), ABDOMINAL DISCOMFORT (stomach problems) and HEADACHE (headaches) outcome was unknown and MYALGIA (body is aching so bad, it hasn't stopped) and ARTHRALGIA (joint hurt/now worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that her joint hurt. She has been experiencing migraines, headaches, loss of taste, felt hot/cold, body is aching so bad, it hasn't stopped. She states she is now using knee brace. She stated she had joint pain already prior to vaccine but is now worse. Migraine is killing her and her body is significantly sore. Patient stated her right arm was sore afterwards the shot.  Patient did not take any medications for her symptoms as she can't due to stomach problems.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain in extremity
Clinical narrative: migraines; loss of taste; felt really hot/cold; right arm really sore; stomach problems; body is aching so bad, it hasn't stopped; headaches; joint hurt/now worse; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), AGEUSIA (loss of taste), FEELING OF BODY TEMPERATURE CHANGE (felt really hot/cold), PAIN IN EXTREMITY (right arm really sore) and ABDOMINAL DISCOMFORT (stomach problems) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain (Had joint pain prior to vaccine.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (joint hurt/now worse). On an unknown date, the patient experienced MIGRAINE (migraines), AGEUSIA (loss of taste), FEELING OF BODY TEMPERATURE CHANGE (felt really hot/cold), PAIN IN EXTREMITY (right arm really sore), ABDOMINAL DISCOMFORT (stomach problems), MYALGIA (body is aching so bad, it hasn't stopped) and HEADACHE (headaches). At the time of the report, MIGRAINE (migraines), AGEUSIA (loss of taste), FEELING OF BODY TEMPERATURE CHANGE (felt really hot/cold), PAIN IN EXTREMITY (right arm really sore), ABDOMINAL DISCOMFORT (stomach problems) and HEADACHE (headaches) outcome was unknown and MYALGIA (body is aching so bad, it hasn't stopped) and ARTHRALGIA (joint hurt/now worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that her joint hurt. She has been experiencing migraines, headaches, loss of taste, felt hot/cold, body is aching so bad, it hasn't stopped. She states she is now using knee brace. She stated she had joint pain already prior to vaccine but is now worse. Migraine is killing her and her body is significantly sore. Patient stated her right arm was sore afterwards the shot.  Patient did not take any medications for her symptoms as she can't due to stomach problems.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Feeling cold, Feeling hot
Clinical narrative: weakness; hurt all over; sick to her stomach; hot, feels like she is on fire; cold; nausea; drained; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire) and FEELING COLD (cold) 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.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire), FEELING COLD (cold), NAUSEA (nausea) and FATIGUE (drained). At the time of the report, ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire), FEELING COLD (cold), NAUSEA (nausea) and FATIGUE (drained) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided    Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: weakness; hurt all over; sick to her stomach; hot, feels like she is on fire; cold; nausea; drained; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire) and FEELING COLD (cold) 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.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire), FEELING COLD (cold), NAUSEA (nausea) and FATIGUE (drained). At the time of the report, ASTHENIA (weakness), PAIN (hurt all over), ABDOMINAL DISCOMFORT (sick to her stomach), FEELING HOT (hot, feels like she is on fire), FEELING COLD (cold), NAUSEA (nausea) and FATIGUE (drained) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided    Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed minor rash/vaccination site rash.  The patient's medical history was not provided. relevant concomitant products usage were not reported by the reporter.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event,  delayed minor rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event,  delayed minor rash was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: feeling better but not back to normal; all the possible side effects being reported; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (all the possible side effects being reported) and FEELING ABNORMAL (feeling better but not back to normal) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included OMEPRAZOLE for GERD.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (all the possible side effects being reported). On 17-Mar-2021, the patient experienced FEELING ABNORMAL (feeling better but not back to normal). At the time of the report, VACCINATION COMPLICATION (all the possible side effects being reported) and FEELING ABNORMAL (feeling better but not back to normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that as part of the questionnaire prior to receiving the vaccine she was asked if she had ever been diagnosed with Covid. She was sick in december but wasn't sick enough to see HCP and get tested. Patient was wondering if in fact, she could've had Covid, and if so, if it was okay to receive vaccine. Patient inquiring if it was wise to get 2nd dose since she experienced all possible side effects.   This case was linked to MOD21-056062 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Moderna vaccine administration during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Moderna vaccine administration during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 25-Oct-2020 and the estimated date of delivery was 01-Aug-2021. On 16-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Moderna vaccine administration during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 16-Mar-2021, EXPOSURE DURING PREGNANCY (Moderna vaccine administration during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Apr-2021. On 11-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On 11-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications include Prenatal medicines.; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs and pregnancy outcome.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site nodule, Vaccination site pain, Vaccination site pruritus
Clinical narrative: A knob at the injection site/It's slowly expanding above the injection site.; It's hot; It's hard; Very painful arm after the vaccine; It's little itchy; It's red; It's swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine) and VACCINATION SITE PRURITUS (It's little itchy) in a 51-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.     Concomitant products included UBIDECARENONE (COQ-10) and VITAMIN D NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine), VACCINATION SITE PRURITUS (It's little itchy), VACCINATION SITE ERYTHEMA (It's red) and VACCINATION SITE SWELLING (It's swelled). At the time of the report, VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine), VACCINATION SITE PRURITUS (It's little itchy), VACCINATION SITE ERYTHEMA (It's red) and VACCINATION SITE SWELLING (It's swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Allergy pill.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains Non-Significant Information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: A knob at the injection site/It's slowly expanding above the injection site.; It's hot; It's hard; Very painful arm after the vaccine; It's little itchy; It's red; It's swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine) and VACCINATION SITE PRURITUS (It's little itchy) in a 51-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.     Concomitant products included UBIDECARENONE (COQ-10) and VITAMIN D NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine), VACCINATION SITE PRURITUS (It's little itchy), VACCINATION SITE ERYTHEMA (It's red) and VACCINATION SITE SWELLING (It's swelled). At the time of the report, VACCINATION SITE NODULE (A knob at the injection site/It's slowly expanding above the injection site.), VACCINATION SITE WARMTH (It's hot), VACCINATION SITE INDURATION (It's hard), VACCINATION SITE PAIN (Very painful arm after the vaccine), VACCINATION SITE PRURITUS (It's little itchy), VACCINATION SITE ERYTHEMA (It's red) and VACCINATION SITE SWELLING (It's swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Allergy pill.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains Non-Significant Information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: bumps; Red itchy spots on his left arm; Red bumps like insect bites that itch like crazy all over his body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Red itchy spots on his left arm), ERYTHEMA (Red bumps like insect bites that itch like crazy all over his body) and RASH PAPULAR (bumps) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRURITUS (Red itchy spots on his left arm) and ERYTHEMA (Red bumps like insect bites that itch like crazy all over his body). On an unknown date, the patient experienced RASH PAPULAR (bumps). The patient was treated with PERMETHRIN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Red itchy spots on his left arm), ERYTHEMA (Red bumps like insect bites that itch like crazy all over his body) and RASH PAPULAR (bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment medication also include Antibiotics, allergy pillsand prescribed Allegra   This case was linked to MOD-2021-221266 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Ophthalmic migraine
Clinical narrative: optical migraine; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC MIGRAINE (optical migraine), CHILLS (chills) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine (optical migraine). Concurrent medical conditions included Pollen allergy, Dust allergy, Egg allergy and Dairy intolerance. Concomitant products included PARACETAMOL (TYLENOL), DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM), DIAZEPAM (VALIUM), RALOXIFENE HYDROCHLORIDE (EVISTA), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]), BIOTIN, POLYCARBOPHIL CALCIUM (FIBER), CYANOCOBALAMIN (VIT B12) and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced OPHTHALMIC MIGRAINE (optical migraine), CHILLS (chills) and HEADACHE (Headache). At the time of the report, OPHTHALMIC MIGRAINE (optical migraine), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-109782 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109782:MOD21-055918
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain assessment, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain one hour after the shot, but it got worse. It seems that it was swelling; Bone pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm pain one hour after the shot, but it got worse. It seems that it was swelling) and BONE PAIN (Bone pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm pain one hour after the shot, but it got worse. It seems that it was swelling) and BONE PAIN (Bone pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm pain one hour after the shot, but it got worse. It seems that it was swelling) and BONE PAIN (Bone pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 20 (High) 20.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Tremor
Clinical narrative: Felt bad; Body was Shaky; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), TREMOR (Body was Shaky), FATIGUE (Fatigue) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 039k20a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad), TREMOR (Body was Shaky), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Mar-2021, FEELING ABNORMAL (Felt bad), TREMOR (Body was Shaky), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.            No Concomitant medications was reported Treatment information was not provided
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity, Vaccination site movement impairment, X-ray
Clinical narrative: diagnosed him with cellulitis; Pain in arm; cannot move his arm; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (diagnosed him with cellulitis), PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move his arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8878) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move his arm). On 17-Mar-2021, the patient experienced CELLULITIS (diagnosed him with cellulitis). At the time of the report, CELLULITIS (diagnosed him with cellulitis), PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move his arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: no results provided (Inconclusive) X-Ray of  arm.         No concomitant information was given. On 08-Apr-2021, received second dose of vaccine. Treatment information was given as the patient was advised to take two anti inflammatory and two antibiotics.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter contact details updated.Laboratory details updated.New event added.Second dose information updated.Treatment information added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Severe abdominal pain/Severe abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain/Severe abdominal cramping) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (Severe abdominal pain/Severe abdominal cramping). On 16-Mar-2021, ABDOMINAL PAIN (Severe abdominal pain/Severe abdominal cramping) outcome was unknown.            No Concomitant medications was reported Treatment information was not provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: when i stretch i get pain in my arm; arm i got the vaccine is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (when i stretch i get pain in my arm) and VACCINATION SITE PAIN (arm i got the vaccine is still sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (when i stretch i get pain in my arm) and VACCINATION SITE PAIN (arm i got the vaccine is still sore). At the time of the report, PAIN IN EXTREMITY (when i stretch i get pain in my arm) and VACCINATION SITE PAIN (arm i got the vaccine is still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dyspnoea, Rash
Clinical narrative: Bruised Upper Body but not itching; Difficulty Breathing; Rash Upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruised Upper Body but not itching), DYSPNOEA (Difficulty Breathing) and RASH (Rash Upper body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Asthma.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced CONTUSION (Bruised Upper Body but not itching), DYSPNOEA (Difficulty Breathing) and RASH (Rash Upper body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Mar-2021, CONTUSION (Bruised Upper Body but not itching) and RASH (Rash Upper body) had resolved. At the time of the report, DYSPNOEA (Difficulty Breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Non significant follow up received on 07-MAY-2021, no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving vaccine 40 days after first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving vaccine 40 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving vaccine 40 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: runny nose; severe diarrhea; pain; Shortness of breath; cough; swollen; bodyache; fatigue; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath) and COUGH (cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q40A21A and Q31L20A) 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 ONDANSETRON (ZOFRAN MELT), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CARVEDILOL (COREG) and LOSARTAN POTASSIUM (COZAAR) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            Patient was treated with Zofran. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Rhinorrhoea
Clinical narrative: runny nose; severe diarrhea; pain; Shortness of breath; cough; swollen; bodyache; fatigue; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath) and COUGH (cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q40A21A and Q31L20A) 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 ONDANSETRON (ZOFRAN MELT), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CARVEDILOL (COREG) and LOSARTAN POTASSIUM (COZAAR) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            Patient was treated with Zofran. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: runny nose; severe diarrhea; pain; Shortness of breath; cough; swollen; bodyache; fatigue; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath) and COUGH (cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q40A21A and Q31L20A) 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 ONDANSETRON (ZOFRAN MELT), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CARVEDILOL (COREG) and LOSARTAN POTASSIUM (COZAAR) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, RHINORRHOEA (runny nose), DIARRHOEA (severe diarrhea), PAIN (pain), DYSPNOEA (Shortness of breath), COUGH (cough), SWELLING (swollen), MYALGIA (bodyache), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            Patient was treated with Zofran. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: some of the dose leaked out; some of the dose leaked out; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (some of the dose leaked out) and DEVICE CONNECTION ISSUE (some of the dose leaked out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced UNDERDOSE (some of the dose leaked out) and DEVICE CONNECTION ISSUE (some of the dose leaked out). On 15-Mar-2021, UNDERDOSE (some of the dose leaked out) and DEVICE CONNECTION ISSUE (some of the dose leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction she had to the vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (reaction she had to the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction she had to the vaccine). At the time of the report, VACCINATION SITE REACTION (reaction she had to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shot on 08FEB2021 and is about to go beyond the 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot on 08FEB2021 and is about to go beyond the 42 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot on 08FEB2021 and is about to go beyond the 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot on 08FEB2021 and is about to go beyond the 42 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications provided. No treatment information provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy
Clinical narrative: Weird; Lethargic; In a daze; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Weird), LETHARGY (Lethargic) and FEELING ABNORMAL (In a daze) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Weird), LETHARGY (Lethargic) and FEELING ABNORMAL (In a daze). At the time of the report, FEELING ABNORMAL (Weird), LETHARGY (Lethargic) and FEELING ABNORMAL (In a daze) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: about to get the second dose more than 60 days after the first one; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (about to get the second dose more than 60 days after the first one) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (about to get the second dose more than 60 days after the first one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (about to get the second dose more than 60 days after the first one) 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 medications are not provided. Treatment information does not provided.