chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site became hard; injection site became swollen; injection site became sore; redness came back and injection site became red; redness at injection site; headache; arm hurt; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE PAIN (injection site became sore) and VACCINATION SITE ERYTHEMA (redness came back and injection site became red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache). On 11-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE PAIN (injection site became sore) and VACCINATION SITE ERYTHEMA (redness came back and injection site became red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE SWELLING (injection site became swollen), VACCINATION SITE PAIN (injection site became sore), VACCINATION SITE ERYTHEMA (redness came back and injection site became red), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache) 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.   This case was linked to MOD21-054701, MOD-2021-046326, MOD-2021-046269 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated outcome  of events Resolved
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slightly sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slightly sore arm at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) on 13-Apr-2011 and Pacemaker battery replacement on 20-Jan-2020. Previously administered products included for Osteoporosis: Prolia (injection) on 10-Dec-2020. Concurrent medical conditions included Osteoporosis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, EZETIMIBE, ZOLPIDEM TARTRATE, MAGNESIUM OXIDE, UBIDECARENONE (COQ 10), VITAMIN D NOS and IPRATROPIUM BROMIDE for an unknown indication.    On 28-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Slightly sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Slightly sore arm at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2021-132000 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Laziness, Vaccination site swelling
Clinical narrative: feeling lazy; Swelling at injection site; very tired; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (feeling lazy), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (very tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LAZINESS (feeling lazy), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (very tired). On 16-Mar-2021, LAZINESS (feeling lazy), VACCINATION SITE SWELLING (Swelling at injection site) and FATIGUE (very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.   This case was linked to MOD21-054800, MOD21-054802, US-MODERNATX, INC.-MOD-2021-046313 (Linked Report).; Sender's Comments:  MOD21-054800: MOD21-054802: US-MODERNATX, INC.-MOD-2021-046313:cosslinked
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough decreased, Therapeutic response unexpected
Clinical narrative: cough went down about 50% right away; after second injection cough is completely gone; This spontaneous case was reported by a consumer and describes the occurrence of COUGH DECREASED (cough went down about 50% right away) and THERAPEUTIC RESPONSE UNEXPECTED (after second injection cough is completely gone) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic cough.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH DECREASED (cough went down about 50% right away) and THERAPEUTIC RESPONSE UNEXPECTED (after second injection cough is completely gone). At the time of the report, COUGH DECREASED (cough went down about 50% right away) and THERAPEUTIC RESPONSE UNEXPECTED (after second injection cough is completely gone) had resolved.            No concomitant medication use was provided by the reporter. No treatment of events was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: breaking out in bumps on arms and legs; breaking out behind right knee real bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (breaking out in bumps on arms and legs) and RASH (breaking out behind right knee real bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (breaking out in bumps on arms and legs) and RASH (breaking out behind right knee real bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form and CORTISONE for Rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (breaking out in bumps on arms and legs) and RASH (breaking out behind right knee real bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st dose). On 13-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose and scheduled to receive 2nd dose on day 42 after 1st 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 Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: allergic reaction; really itchy from her knees up to her neck; rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PRURITUS (really itchy from her knees up to her neck) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), PRURITUS (really itchy from her knees up to her neck) and RASH (rash). At the time of the report, HYPERSENSITIVITY (allergic reaction), PRURITUS (really itchy from her knees up to her neck) and RASH (rash) outcome was unknown.            No concomitant medication use was provided by the reporter.  No treatment of events was reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: patient received less than the recommended dose; syringe malfunction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received less than the recommended dose) and SYRINGE ISSUE (syringe malfunction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 16-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 ACCIDENTAL UNDERDOSE (patient received less than the recommended dose) and SYRINGE ISSUE (syringe malfunction). On 16-Mar-2021, ACCIDENTAL UNDERDOSE (patient received less than the recommended dose) and SYRINGE ISSUE (syringe malfunction) 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.   This report refers to a case of Underdose and syringe issue, for mRNA-1273, lot # unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Underdose and syringe issue, for mRNA-1273, lot # unknown,  with no associated AEs.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pain, Rash
Clinical narrative: Redness on his palms and bottom of his feet; Felt like pins and needles; Rash on forearms and chest; Progressively worse; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness on his palms and bottom of his feet), PAIN (Felt like pins and needles), CONDITION AGGRAVATED (Progressively worse) and RASH (Rash on forearms and chest) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL), ZIPRASIDONE and VITAMINS NOS (MULTIVITE [VITAMINS NOS]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CONDITION AGGRAVATED (Progressively worse). On 16-Mar-2021, the patient experienced ERYTHEMA (Redness on his palms and bottom of his feet), PAIN (Felt like pins and needles) and RASH (Rash on forearms and chest). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness on his palms and bottom of his feet), PAIN (Felt like pins and needles), CONDITION AGGRAVATED (Progressively worse) and RASH (Rash on forearms and chest) 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: heard from others they had side effects after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (heard from others they had side effects after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (heard from others they had side effects after vaccination). At the time of the report, ADVERSE REACTION (heard from others they had side effects after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Terrible" chills that developed today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Terrible" chills that developed today) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (Terrible" chills that developed today). At the time of the report, CHILLS (Terrible" chills that developed today) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications provided mentioned blood thinners NOS.  Treatment information was not provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: runny nose; tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and COVID-19 (tested positive for Covid) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048421A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 RHINORRHOEA (runny nose) and COVID-19 (tested positive for Covid). At the time of the report, RHINORRHOEA (runny nose) and COVID-19 (tested positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 medication use was provided by the reporter. No treatment of events was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter informed that patient is fine now and provided email ID
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: Room was literally spinning; I feel a little weird,; Got hot and cold; Still not feeling 100%...felt a little sick; Arm was a little sore; fever; Chills; Head got so bad, I was in tears; Very pale and lips were pale; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MUCOSAL DISCOLOURATION (Very pale and lips were pale), DIZZINESS (Dizzy), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,) and FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 03-Mar-2021, the patient experienced MUCOSAL DISCOLOURATION (Very pale and lips were pale), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,), FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold), MALAISE (Still not feeling 100%...felt a little sick), VACCINATION SITE PAIN (Arm was a little sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (Head got so bad, I was in tears). The patient was treated with PARACETAMOL (TYLENOL) on 03-Mar-2021 at a dose of 1 dosage form. At the time of the report, MUCOSAL DISCOLOURATION (Very pale and lips were pale), DIZZINESS (Dizzy), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,), FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold), MALAISE (Still not feeling 100%..felt a little sick), VACCINATION SITE PAIN (Arm was a little sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (Head got so bad, I was in tears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mucosal discolouration, Pyrexia, Vaccination site pain, Vertigo
Clinical narrative: Room was literally spinning; I feel a little weird,; Got hot and cold; Still not feeling 100%...felt a little sick; Arm was a little sore; fever; Chills; Head got so bad, I was in tears; Very pale and lips were pale; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of MUCOSAL DISCOLOURATION (Very pale and lips were pale), DIZZINESS (Dizzy), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,) and FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Dizzy). On 03-Mar-2021, the patient experienced MUCOSAL DISCOLOURATION (Very pale and lips were pale), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,), FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold), MALAISE (Still not feeling 100%...felt a little sick), VACCINATION SITE PAIN (Arm was a little sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (Head got so bad, I was in tears). The patient was treated with PARACETAMOL (TYLENOL) on 03-Mar-2021 at a dose of 1 dosage form. At the time of the report, MUCOSAL DISCOLOURATION (Very pale and lips were pale), DIZZINESS (Dizzy), VERTIGO (Room was literally spinning), FEELING ABNORMAL (I feel a little weird,), FEELING OF BODY TEMPERATURE CHANGE (Got hot and cold), MALAISE (Still not feeling 100%..felt a little sick), VACCINATION SITE PAIN (Arm was a little sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (Head got so bad, I was in tears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives on arms , legs , torsos; Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on arms , legs , torsos) and 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on arms , legs , torsos) and RASH (Rash). At the time of the report, URTICARIA (Hives on arms , legs , torsos) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Muscular power was significantly reduced; Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%) and MUSCULAR WEAKNESS (Muscular power was significantly reduced) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscular dystrophy and Walker user.    On 09-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 MOBILITY DECREASED (Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscular power was significantly reduced). At the time of the report, MOBILITY DECREASED (Before was able to stand up with walker and move to another chair, her ability to do this has decreased by 50% to 75%) and MUSCULAR WEAKNESS (Muscular power was significantly reduced) had resolved with sequelae.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  No treatment medications were reported.  Follow-up update: Patient is reported to have regained some of her ability back, but is still not as good as before the Moderna shot. She is now able to transfer, but with the help of another person. Second shot administration was discontinued to minimize risk of her losing all ability to transfer.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow-up appended: changed outcome from unknown to recovered/resolved with sequalae
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Nausea, Vaccination site pain
Clinical narrative: stomach pain; Joint pain; injection site pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (injection site pain) and NAUSEA (nausea) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (injection site pain) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (injection site pain) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick 4 days) 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 ILLNESS (Sick 4 days). At the time of the report, ILLNESS (Sick 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-046640 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046640:Reporter's case
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Vaccination site pain
Clinical narrative: soreness in the back and pelvic area; the second shot was more painful than the first injection; chills; extreme fatigue , felt with no energy; Rash on the left arm (which was the arm of the injection); nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in the back and pelvic area), VACCINATION SITE PAIN (the second shot was more painful than the first injection), CHILLS (chills), FATIGUE (extreme fatigue , felt with no energy) and VACCINATION SITE RASH (Rash on the left arm (which was the arm of the injection)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MYALGIA (soreness in the back and pelvic area), VACCINATION SITE PAIN (the second shot was more painful than the first injection), CHILLS (chills), FATIGUE (extreme fatigue , felt with no energy), VACCINATION SITE RASH (Rash on the left arm (which was the arm of the injection)) and NAUSEA (nausea). At the time of the report, MYALGIA (soreness in the back and pelvic area), VACCINATION SITE PAIN (the second shot was more painful than the first injection), CHILLS (chills), FATIGUE (extreme fatigue , felt with no energy), VACCINATION SITE RASH (Rash on the left arm (which was the arm of the injection)) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment details were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: soreness in the back and pelvic area; the second shot was more painful than the first injection; chills; extreme fatigue , felt with no energy; Rash on the left arm (which was the arm of the injection); nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in the back and pelvic area), VACCINATION SITE PAIN (the second shot was more painful than the first injection), CHILLS (chills), FATIGUE (extreme fatigue , felt with no energy) and VACCINATION SITE RASH (Rash on the left arm (which was the arm of the injection)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced MYALGIA (soreness in the back and pelvic area), VACCINATION SITE PAIN (the second shot was more painful than the first injection), CHILLS (chills), FATIGUE (extreme fatigue , felt with no energy), VACCINATION SITE RASH (Rash on the left arm (which was the arm of the injection)) and NAUSEA (nausea). At the time of the report, MYALGIA (soreness in the back and pelvic area), VACCINATION SITE PAIN (the second shot was more painful than the first injection), CHILLS (chills), FATIGUE (extreme fatigue , felt with no energy), VACCINATION SITE RASH (Rash on the left arm (which was the arm of the injection)) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm hurts) 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 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 PAIN IN EXTREMITY (arm hurts). The patient was treated with NAPROXEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment information was reported.   Concomitant medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vaccination site pain
Clinical narrative: sore arm; so much energy, she feels good; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (so much energy, she feels good) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (so much energy, she feels good). At the time of the report, PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (so much energy, she feels good) had resolved. Not Provided          No concomitant medications were provided by the reporter.   Treatment was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-046468 (E2B Linked Report). This case was linked to MOD-2021-046468 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046468:1st dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Chills, Myalgia
Clinical narrative: Loss of taste; Loss of smell; Felt very weak; Chills; Fever; Body aches; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     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. On 18-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Loss of taste; Loss of smell; Felt very weak; Chills; Fever; Body aches; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     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. On 18-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), ASTHENIA (Felt very weak), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (severe vertigo) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 11-Mar-2021, the patient experienced VERTIGO (severe vertigo). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 13-Mar-2021, VERTIGO (severe vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: sore arm; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ABDOMINAL DISCOMFORT (upset stomach) 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 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 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, PAIN IN EXTREMITY (sore arm) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information 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 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06-May-2021 included contact information.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: when she sneezed she then became dizzy; developed a headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (when she sneezed she then became dizzy) and HEADACHE (developed a headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus disorder NOS. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SPIRONOLACTONE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and CARVEDILOL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (developed a headache). On 16-Mar-2021, the patient experienced DIZZINESS (when she sneezed she then became dizzy). On 16-Mar-2021, HEADACHE (developed a headache) had resolved. At the time of the report, DIZZINESS (when she sneezed she then became dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HERPES ZOSTER (rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) on 10-Mar-2021 for Shingles, at a dose of 1 gram three times a day. At the time of the report, HERPES ZOSTER (rash on right side, mainly on her neck from her spinal cord to her adams apple; diagnosed with shingles on her right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash around injection site the size of a 50 cent piece; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around injection site the size of a 50 cent piece) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 15-Mar-2021, the patient experienced VACCINATION SITE RASH (rash around injection site the size of a 50 cent piece). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash around injection site the size of a 50 cent piece) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: sore arm; had so much energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (had so much energy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (had so much energy). At the time of the report, PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (had so much energy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications were reported.  No treatment information was provided by the reporter.  Patient took second dose on 15-MAR-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-046458 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046458:2nd dose case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: brain fog; vertigo; could not stand; feeling sick; headache; vomiting; could not open her eyes; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (could not open her eyes), FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand) and MALAISE (feeling sick) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SOMNOLENCE (could not open her eyes) and FATIGUE (fatigue). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand), MALAISE (feeling sick), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) ongoing since an unknown date at a dose of 1 dosage form and CLONAZEPAM (KLONOPIN) ongoing since an unknown date at a dose of 1 dosage form. On 08-Feb-2021, SOMNOLENCE (could not open her eyes) and FATIGUE (fatigue) had resolved. At the time of the report, FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand), MALAISE (feeling sick), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vertigo, Vomiting
Clinical narrative: brain fog; vertigo; could not stand; feeling sick; headache; vomiting; could not open her eyes; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (could not open her eyes), FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand) and MALAISE (feeling sick) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SOMNOLENCE (could not open her eyes) and FATIGUE (fatigue). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand), MALAISE (feeling sick), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) ongoing since an unknown date at a dose of 1 dosage form and CLONAZEPAM (KLONOPIN) ongoing since an unknown date at a dose of 1 dosage form. On 08-Feb-2021, SOMNOLENCE (could not open her eyes) and FATIGUE (fatigue) had resolved. At the time of the report, FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand), MALAISE (feeling sick), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.