chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: slight allergic, my lips were tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (slight allergic, my lips were tingling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) 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) (unknown route) 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA ORAL (slight allergic, my lips were tingling). On 08-Feb-2021, PARAESTHESIA ORAL (slight allergic, my lips were tingling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinusitis and Pollen allergy (pollen count).   On 15-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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headaches) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swollen tongue, Tongue discomfort
Clinical narrative: swollen glands in her neck; tongue burning; tongue swelling; This spontaneous case was reported by a patient and describes the occurrence of TONGUE DISCOMFORT (tongue burning), SWOLLEN TONGUE (tongue swelling) and LYMPHADENOPATHY (swollen glands in her neck) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Allergy NOS.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue burning) and SWOLLEN TONGUE (tongue swelling). On 15-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen glands in her neck). On 08-Mar-2021, TONGUE DISCOMFORT (tongue burning) and SWOLLEN TONGUE (tongue swelling) had resolved. At the time of the report, LYMPHADENOPATHY (swollen glands in her neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure pill (unspecified).  No treatment medications included.  The patient consulted pharmacist for her allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough
Clinical narrative: lingering cough; tested positive after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (lingering cough) and COVID-19 (tested positive after first dose) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (tested positive after first dose). On an unknown date, the patient experienced COUGH (lingering cough). At the time of the report, COUGH (lingering cough) and COVID-19 (tested positive after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Rash
Clinical narrative: little dizziness; bit nausea; bit body aches; little bit headache; like welt, like swelling at the injection site; big rash on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizziness), RASH (big rash on her left arm), NAUSEA (bit nausea), MYALGIA (bit body aches) and VACCINATION SITE SWELLING (like welt, like swelling at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 015M20A) 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 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 RASH (big rash on her left arm) and VACCINATION SITE SWELLING (like welt, like swelling at the injection site). On 15-Mar-2021, the patient experienced DIZZINESS (little dizziness), NAUSEA (bit nausea), MYALGIA (bit body aches) and HEADACHE (little bit headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (little dizziness), RASH (big rash on her left arm), NAUSEA (bit nausea), MYALGIA (bit body aches), VACCINATION SITE SWELLING (like welt, like swelling at the injection site) and HEADACHE (little bit headache) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: little dizziness; bit nausea; bit body aches; little bit headache; like welt, like swelling at the injection site; big rash on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizziness), RASH (big rash on her left arm), NAUSEA (bit nausea), MYALGIA (bit body aches) and VACCINATION SITE SWELLING (like welt, like swelling at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 015M20A) 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 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 RASH (big rash on her left arm) and VACCINATION SITE SWELLING (like welt, like swelling at the injection site). On 15-Mar-2021, the patient experienced DIZZINESS (little dizziness), NAUSEA (bit nausea), MYALGIA (bit body aches) and HEADACHE (little bit headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (little dizziness), RASH (big rash on her left arm), NAUSEA (bit nausea), MYALGIA (bit body aches), VACCINATION SITE SWELLING (like welt, like swelling at the injection site) and HEADACHE (little bit headache) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 66-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 04-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 RASH (Rash). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Insomnia, Rhinorrhoea
Clinical narrative: has felt crummy; the sniffles; didn't sleep well; chills; his head felt dull; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), HEADACHE (his head felt dull), INSOMNIA (didn't sleep well), FEELING ABNORMAL (has felt crummy) and RHINORRHOEA (the sniffles) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 5:00 PM, the patient experienced CHILLS (chills) and HEADACHE (his head felt dull). On 11-Mar-2021, the patient experienced INSOMNIA (didn't sleep well). On an unknown date, the patient experienced FEELING ABNORMAL (has felt crummy) and RHINORRHOEA (the sniffles). At the time of the report, CHILLS (chills), HEADACHE (his head felt dull), INSOMNIA (didn't sleep well), FEELING ABNORMAL (has felt crummy) and RHINORRHOEA (the sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Heart rate, Heart rate increased, Pain in jaw, Pruritus
Clinical narrative: Pain jaw; Pain behind ear; Palpations; itchiness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain jaw), EAR PAIN (Pain behind ear), HEART RATE INCREASED (Palpations), PRURITUS (itchiness) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concomitant products included LEVOTHYROXINE, ALLOPURINOL (ZYLOPRIM), FUROSEMIDE, DONEPEZIL HYDROCHLORIDE (ARICEPT), LOSARTAN POTASSIUM, SIMVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 PRURITUS (itchiness) and RASH (Rash). On 13-Mar-2021, the patient experienced PAIN IN JAW (Pain jaw), EAR PAIN (Pain behind ear) and HEART RATE INCREASED (Palpations). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at an unspecified dose and frequency. On 13-Mar-2021, PRURITUS (itchiness) and RASH (Rash) had resolved. At the time of the report, PAIN IN JAW (Pain jaw), EAR PAIN (Pain behind ear) and HEART RATE INCREASED (Palpations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: palpations (High) Palpations.         Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pain jaw; Pain behind ear; Palpations; itchiness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Pain jaw), EAR PAIN (Pain behind ear), HEART RATE INCREASED (Palpations), PRURITUS (itchiness) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concomitant products included LEVOTHYROXINE, ALLOPURINOL (ZYLOPRIM), FUROSEMIDE, DONEPEZIL HYDROCHLORIDE (ARICEPT), LOSARTAN POTASSIUM, SIMVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 PRURITUS (itchiness) and RASH (Rash). On 13-Mar-2021, the patient experienced PAIN IN JAW (Pain jaw), EAR PAIN (Pain behind ear) and HEART RATE INCREASED (Palpations). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at an unspecified dose and frequency. On 13-Mar-2021, PRURITUS (itchiness) and RASH (Rash) had resolved. At the time of the report, PAIN IN JAW (Pain jaw), EAR PAIN (Pain behind ear) and HEART RATE INCREASED (Palpations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: palpations (High) Palpations.         Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Myalgia
Clinical narrative: Lost taste; Lost smell; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell), MYALGIA (Body aches) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]), RIZATRIPTAN BENZOATE (MAXALT), ESTRADIOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    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 MYALGIA (Body aches) and HEADACHE (Headache). On 12-Feb-2021, the patient experienced AGEUSIA (Lost taste) and ANOSMIA (Lost smell). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; NAPROXEN at an unspecified dose and frequency; ASCORBIC ACID, ZINC GLUCONATE (VITAMIN C + ZINK KAPSELN) at an unspecified dose and frequency and GALPHIMIA GLAUCA, HISTAMINE HYDROCHLORIDE, LUFFA OPERCULATA, SULFUR (ZICAM ALLERGY RELIEF [GALPHIMIA GLAUCA;HISTAMINE HYDROCHLORIDE;LUFFA OPERCULATA;SULFUR]) at an unspecified dose and frequency. On 15-Feb-2021, AGEUSIA (Lost taste), ANOSMIA (Lost smell), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-054295, US-MODERNATX, INC.-MOD-2021-060723 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13-JUL-2021 contains Non-significant Information.; Sender's Comments:  MOD21-054295:cross link case US-MODERNATX, INC.-MOD-2021-060723:case for events occurred after first dose
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Sleep disorder
Clinical narrative: Waking up; Discomfort on the left side of my head, jaw, and side; Frequent headaches, nearly every day; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Waking up), DISCOMFORT (Discomfort on the left side of my head, jaw, and side) and HEADACHE (Frequent headaches, nearly every day) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SLEEP DISORDER (Waking up), DISCOMFORT (Discomfort on the left side of my head, jaw, and side) and HEADACHE (Frequent headaches, nearly every day). At the time of the report, SLEEP DISORDER (Waking up), DISCOMFORT (Discomfort on the left side of my head, jaw, and side) and HEADACHE (Frequent headaches, nearly every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 10-Mar-2021, the patient reported that for the past three weeks, she had had frequent headaches, nearly every day. The nature of them was as follows. They were shooting pains in the back of the head and behind the right ear; one-sided pain, both left and right, most nights when she was going to bed; and was waking up with a severe headache in the middle of the night; and had an experience of discomfort on the left side of my head, jaw, and side. As per the patient she had decided to skip the second dose, which was due on 13-Mar-2021. No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Lymph node pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain Lymph node under the Left Arm; Pain in forearms; Sore left Arm Pit; Headache; Sore Left Arm at the injection Site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPH NODE PAIN (Pain Lymph node under the Left Arm), PAIN IN EXTREMITY (Pain in forearms), AXILLARY PAIN (Sore left Arm Pit), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Left Arm at the injection Site) in a 35-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 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 HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Left Arm at the injection Site). On 14-Mar-2021, the patient experienced LYMPH NODE PAIN (Pain Lymph node under the Left Arm), PAIN IN EXTREMITY (Pain in forearms) and AXILLARY PAIN (Sore left Arm Pit). On 11-Mar-2021, HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Left Arm at the injection Site) had resolved. On 15-Mar-2021, LYMPH NODE PAIN (Pain Lymph node under the Left Arm) and AXILLARY PAIN (Sore left Arm Pit) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in forearms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported.  No treatment information were reported
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Incorrect route of product administration, Insomnia, Pain in extremity
Clinical narrative: Believes Injection went into the joint not the muscle; Unable to move arm; lost sleep/lack of sleep; severe pain in arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Believes Injection went into the joint not the muscle), HYPOKINESIA (Unable to move arm), INSOMNIA (lost sleep/lack of sleep), PAIN IN EXTREMITY (severe pain in arm) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (No reported medical history).   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 11-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Believes Injection went into the joint not the muscle), HYPOKINESIA (Unable to move arm), INSOMNIA (lost sleep/lack of sleep), PAIN IN EXTREMITY (severe pain in arm) and HEADACHE (headache). On 11-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Believes Injection went into the joint not the muscle) had resolved. At the time of the report, HYPOKINESIA (Unable to move arm) and PAIN IN EXTREMITY (severe pain in arm) was resolving and INSOMNIA (lost sleep/lack of sleep) and HEADACHE (headache) outcome was unknown.            This case was linked to MOD-2021-061635 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Headache, Hypokinesia, Pain in extremity and Insomnia, a causal relationship cannot be excluded.  This report also refers to a case of Incorrect route of Product administration for mRNA-1273, lot # 030A21A.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Soreness; Itchy around the injection site; Red, like 3 inches in diameter, around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red, like 3 inches in diameter, around the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red, like 3 inches in diameter, around the injection site). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) had resolved and VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red, like 3 inches in diameter, around the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Second dose details updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Physical disability
Clinical narrative: cannot currently walk without assistance; no sensation from the waist; This spontaneous case was reported by a consumer and describes the occurrence of PHYSICAL DISABILITY (cannot currently walk without assistance) and HYPOAESTHESIA (no sensation from the waist) 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 PHYSICAL DISABILITY (cannot currently walk without assistance) and HYPOAESTHESIA (no sensation from the waist). At the time of the report, PHYSICAL DISABILITY (cannot currently walk without assistance) and HYPOAESTHESIA (no sensation from the waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: is going to be out 63 days out before she can get her second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is going to be out 63 days out before she can get her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is going to be out 63 days out before she can get her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (is going to be out 63 days out before she can get her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 028L20A) with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Nausea, Pain in extremity
Clinical narrative: it's like they're going to get hoarsness; arm was sore; been feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), DYSPHONIA (it's like they're going to get hoarsness) and NAUSEA (been feeling nauseous) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Catheterization arterial (catheterization done on the right arm) on 19-Mar-2021. Concurrent medical conditions included Hypertension and GERD. Concomitant products included FAMOTIDINE for GERD, CLOPIDOGREL for an unknown indication.    On 11-Mar-2021 at 4:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced NAUSEA (been feeling nauseous). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 13-Mar-2021, the patient experienced DYSPHONIA (it's like they're going to get hoarsness). At the time of the report, PAIN IN EXTREMITY (arm was sore) had resolved and DYSPHONIA (it's like they're going to get hoarsness) and NAUSEA (been feeling nauseous) 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's concomitant medications included unspecified blood thinners, high blood pressure medication and supplements.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-044215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044215:cross linked
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: some of the vaccine sprayed out while giving 1st dose using Vanish point needle; repeated full dose of 1st dose in the other arm(right arm); A spontaneous report was received from a Healthcare Professional (HCP) to report a 33 year old female patient who received Moderna's COVID-19 Vaccine, and who experienced some of the vaccine sprayed out while giving 1st dose using Vanish point needle (incorrect dose administered) and who received a repeated full dose of 1stdose in the other arm(right arm).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 15 Mar 2021 prior to the onset of events, the patient received their first dose of mRNA-1273 (lot number 001B21A) via intramuscular route in her left arm for COVID-19 infection prophylaxis. On same date 15 Mar 2021, the patient received a repeated full doses of mRNA-1273 (lot number 001B21A) via intramuscular in her right arm for COVID-19 infection prophylaxis.  Action taken with mRNA-1273 in response to the events was reported as unknown.  The outcome of the event was resolved at the time of this report.; Reporter's Comments: This report refers to a case of incorrect dose administered, and overdose for mRNA-1273, lot # 001B21A with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 70-year-old female patient 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, 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 PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site mass
Clinical narrative: red ring the size of a tennis ball, arm redness; arm lumpy; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red ring the size of a tennis ball, arm redness), VACCINATION SITE MASS (arm lumpy) and PAIN IN EXTREMITY (Arm sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-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 15-Mar-2021, the patient experienced ERYTHEMA (red ring the size of a tennis ball, arm redness), VACCINATION SITE MASS (arm lumpy) and PAIN IN EXTREMITY (Arm sore). At the time of the report, ERYTHEMA (red ring the size of a tennis ball, arm redness), VACCINATION SITE MASS (arm lumpy) and PAIN IN EXTREMITY (Arm sore) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: injection leaked out of the syringe over his arm and on to the floor; my husband's injection leaked out of the syringe over his arm and on to the floor; A spontaneous report was received from patient's wife for a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection leaked out of the syringe over his arm and on to the floor.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date patient received their first of two planned doses of mRNA-1273 (Lot number : unknown). On 11-Mar-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 11-Mar-2021, While getting the vaccine the patient's injection leaked out of the syringe over his arm and on the floor. The reporter was unsure if patient had enough to get complete protection.  Treatment information was not provided.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, injection leaked out of the syringe over his arm and on to the floor was considered resolved.; Reporter's Comments: This report refers to a case of vaccine Underdose and  Device connection issue for mRNA-1273, lot # unknown with no associated Adverse Events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: A red, itchy, growing lump at the injection site; A red, itchy, growing lump at the injection site; A red, itchy, growing lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A red, itchy, growing lump at the injection site), VACCINATION SITE PRURITUS (A red, itchy, growing lump at the injection site) and VACCINATION SITE ERYTHEMA (A red, itchy, growing lump at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (A red, itchy, growing lump at the injection site), VACCINATION SITE PRURITUS (A red, itchy, growing lump at the injection site) and VACCINATION SITE ERYTHEMA (A red, itchy, growing lump at the injection site). At the time of the report, VACCINATION SITE MASS (A red, itchy, growing lump at the injection site), VACCINATION SITE PRURITUS (A red, itchy, growing lump at the injection site) and VACCINATION SITE ERYTHEMA (A red, itchy, growing lump at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination; This spontaneous case was reported by a physician and describes the occurrence of EXPOSURE VIA BREAST MILK (Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination) in an 8-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE VIA BREAST MILK (Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination). On 26-Jan-2021, EXPOSURE VIA BREAST MILK (Infant asymptomatic and resumed breastfeeding 2.5 hours after vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medication were reported. Infant (8.5 months old) exposed to the reporter's breastmilk remained asymptomatic.   This case was linked to MOD-2021-029952 (Patient Link).; Sender's Comments: This is a case of product exposure via breast mikl with no associated adverse events. Patient will continue to be contacted for further monitoring of adverse events.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Mobility decreased
Clinical narrative: Swelling of wrists; Mobility decreased; Redness; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), JOINT SWELLING (Swelling of wrists), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Shoulder pain) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AC1A) 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 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder pain). On 16-Mar-2021, the patient experienced ERYTHEMA (Redness). On an unknown date, the patient experienced JOINT SWELLING (Swelling of wrists) and MOBILITY DECREASED (Mobility decreased). At the time of the report, ERYTHEMA (Redness) and ARTHRALGIA (Shoulder pain) had resolved and JOINT SWELLING (Swelling of wrists) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.            No relevant concomitant medications were reported.  Treatment included cold compress.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow-up received , outcome of the events erythema and pain in shoulder updated from unknown to recovered and new events are added.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Immune system disorder
Clinical narrative: immune system did not respond to her anxiety and depression medicine; A spontaneous report was received from a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event immune system did not respond to her anxiety and depression medicine.  The patient's concurrent medical conditions included anxiety and depression. Concomitant medication included sertraline.  On 29 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, prior to the onset of the event the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient experienced the event immune system did not respond to her anxiety and depression medicine. The patient called her doctor and mentioned that she started taking double dose according to doctor but did not work. And on 05 Mar 2021, a week after the second dose of vaccine, the patient again experienced the same thing and felt her medication was not working.  No treatment information for the event was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Swelling
Clinical narrative: Bumps appeared in the right arm; She started getting blotches on her left arm and legs, were kind of bumpy and very itchy; The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas; She started getting blotches on her left arm and legs, were kind of bumpy and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Bumps appeared in the right arm), PRURITUS (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy), SWELLING (The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas) and RASH MACULAR (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, TRIAMTERENE, ENALAPRIL, GABAPENTIN, VITAMIN D NOS, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-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 PRURITUS (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy), SWELLING (The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas) and RASH MACULAR (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy). On 16-Mar-2021, the patient experienced RASH MACULAR (Bumps appeared in the right arm). At the time of the report, RASH MACULAR (Bumps appeared in the right arm), PRURITUS (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy) and SWELLING (The bumps were about 1-2 inches in diameter and it seems like the skin is elevated in these areas) outcome was unknown and RASH MACULAR (She started getting blotches on her left arm and legs, were kind of bumpy and very itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided included hand sanitizer to stop itch.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Arthralgia, Fatigue, Somnolence
Clinical narrative: Problem with her mood; Problems waking up; Very bad fatigue; Had alot of joint pain; This spontaneous case was reported by a consumer and describes the occurrence of AFFECTIVE DISORDER (Problem with her mood), SOMNOLENCE (Problems waking up), FATIGUE (Very bad fatigue) and ARTHRALGIA (Had alot of joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced AFFECTIVE DISORDER (Problem with her mood), SOMNOLENCE (Problems waking up), FATIGUE (Very bad fatigue) and ARTHRALGIA (Had alot of joint pain). At the time of the report, AFFECTIVE DISORDER (Problem with her mood), SOMNOLENCE (Problems waking up) and FATIGUE (Very bad fatigue) had not resolved and ARTHRALGIA (Had alot of joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in the muscle above shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (pain in the muscle above shoulder) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (pain in the muscle above shoulder). At the time of the report, MYALGIA (pain in the muscle above shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 42 days have passed between first dose and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed between first dose and second dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed between first dose and second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed between first dose and second dose) outcome was unknown. Not Provided      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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache on the right side back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on the right side back of the head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, VITAMIN D3 and OLMESARTAN MEDOXOMIL for an unknown indication.    On 14-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 HEADACHE (headache on the right side back of the head). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 15-Mar-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache on the right side back of the head) had not 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.