chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Pain
Clinical narrative: the glands in her neck and under her arms have started to bother me; I felt achy; chills; headache; fever; soreness in my arm like the flu shot; fatigued; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in my arm like the flu shot, fatigued, i felt achy, chills, headache, fever, the glands in her neck and under her arms have started to bother me.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A, 023M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) soreness in my arm like the flu shot, fatigued. On 19 Feb 2021, the patient experienced the event(s) i felt achy, chills, headache, fever. On an unknown date, the patient experienced the event(s) the glands in her neck and under her arms have started to bother me.  Treatment details included Tylenol, Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness in my arm like the flu shot, fatigued, i felt achy, chills, headache, fever, the glands in her neck and under her arms have started to bother me was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: the glands in her neck and under her arms have started to bother me; I felt achy; chills; headache; fever; soreness in my arm like the flu shot; fatigued; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in my arm like the flu shot, fatigued, i felt achy, chills, headache, fever, the glands in her neck and under her arms have started to bother me.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A, 023M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) soreness in my arm like the flu shot, fatigued. On 19 Feb 2021, the patient experienced the event(s) i felt achy, chills, headache, fever. On an unknown date, the patient experienced the event(s) the glands in her neck and under her arms have started to bother me.  Treatment details included Tylenol, Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness in my arm like the flu shot, fatigued, i felt achy, chills, headache, fever, the glands in her neck and under her arms have started to bother me was unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nervousness
Clinical narrative: Felt nervous; Chills; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NERVOUSNESS (Felt nervous), CHILLS (Chills) and FATIGUE (Tired) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure and Poor peripheral circulation. Concomitant products included LEVOTHYROXINE, NIFEDIPINE, METOPROLOL, ATORVASTATIN, HYDRALAZINE, OXYCODONE, ZOLPIDEM, FUROSEMIDE and CLOPIDOGREL for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NERVOUSNESS (Felt nervous), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with ASCORBIC ACID (VITAMIN C ACID) for Adverse event, at a dose of 1 dosage form and VITAMIN D NOS for Adverse event, at a dose of 1 dosage form. On 28-Jan-2021, NERVOUSNESS (Felt nervous), CHILLS (Chills) and FATIGUE (Tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient visited the Emergency Room (dates not reported) where he was recommended to take Vitamin C , Vitamin D and chicken soup. The doctor also advised to reschedule the second dose of the vaccine from 01-Feb-21 to 09-Feb-21.   This case was linked to US-MODERNATX, INC.-MOD-2021-139099 (E2B Linked Report). This case was linked to MOD-2021-139099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up information received on 17 May 2021 will be submitted with initial report.  Follow-up information indicated stop date for events and from the first dose, the patient visited the Emergency Room three times, but was not hospitalized. On 06-Jul-2021: Follow-up received: Events continuing will be reported with Dose 2.; 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. US-MODERNATX, INC.-MOD-2021-139099:Dose 1 case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: aches; couldn't move her neck; chills; fever; A spontaneous report was received from a healthcare facility staff member concerning, a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, aches/pain, fever/pyrexia and couldn't move their neck/musculoskeletal stiffness.  The patient's medical history provided included rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event, included prednisone, hydroxychloroquine, paracetamol for rheumatoid arthritis.  On 02 Feb 2021, approximately 8 to 10 hours prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On the same day, 02 Feb 2021, the patient experienced chills, aches, fever and couldn't move their neck.   The patient was scheduled for their second dose on 03 Mar 2021 and wanted to know if it was dangerous for the patient to get it as they heard the second one was going to be worse.  Treatment for the event included Paracetamol which the patient took just more than the usual (4 daily to 6 daily) to treat their symptoms.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events chills, aches, fever and couldn't move their neck were considered resolving at the time of this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: Swollen on the Injection Site; Feels Heavy Entire Left Arm and Hand; Numb Entire Left Arm; Pain in Chest to neck and to waist Moving to the legs; Hot Injection Site; Shooting pain; Big Red Blotch 3" Injection Site; Tender Left Arm Injection Site; Every muscle in her body hurts; Headache; Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site) and LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2016, the patient experienced FATIGUE (Exhausted). On 16-Feb-2021, the patient experienced PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE PAIN (Tender Left Arm Injection Site), MYALGIA (Every muscle in her body hurts), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body). On 21-Feb-2021, the patient experienced PAIN (Pain in Chest to neck and to waist Moving to the legs). On 22-Feb-2021, the patient experienced LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) and HYPOAESTHESIA (Numb Entire Left Arm). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen on the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site), LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand), HYPOAESTHESIA (Numb Entire Left Arm), VACCINATION SITE PAIN (Tender Left Arm Injection Site), VACCINATION SITE SWELLING (Swollen on the Injection Site), MYALGIA (Every muscle in her body hurts), FATIGUE (Exhausted), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data included all tests were normal.  No concomitant medications are reported.  Treatment medications included Ice.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Rash macular, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen on the Injection Site; Feels Heavy Entire Left Arm and Hand; Numb Entire Left Arm; Pain in Chest to neck and to waist Moving to the legs; Hot Injection Site; Shooting pain; Big Red Blotch 3" Injection Site; Tender Left Arm Injection Site; Every muscle in her body hurts; Headache; Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site) and LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2016, the patient experienced FATIGUE (Exhausted). On 16-Feb-2021, the patient experienced PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE PAIN (Tender Left Arm Injection Site), MYALGIA (Every muscle in her body hurts), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body). On 21-Feb-2021, the patient experienced PAIN (Pain in Chest to neck and to waist Moving to the legs). On 22-Feb-2021, the patient experienced LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) and HYPOAESTHESIA (Numb Entire Left Arm). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen on the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site), LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand), HYPOAESTHESIA (Numb Entire Left Arm), VACCINATION SITE PAIN (Tender Left Arm Injection Site), VACCINATION SITE SWELLING (Swollen on the Injection Site), MYALGIA (Every muscle in her body hurts), FATIGUE (Exhausted), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data included all tests were normal.  No concomitant medications are reported.  Treatment medications included Ice.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Swollen on the Injection Site; Feels Heavy Entire Left Arm and Hand; Numb Entire Left Arm; Pain in Chest to neck and to waist Moving to the legs; Hot Injection Site; Shooting pain; Big Red Blotch 3" Injection Site; Tender Left Arm Injection Site; Every muscle in her body hurts; Headache; Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site) and LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2016, the patient experienced FATIGUE (Exhausted). On 16-Feb-2021, the patient experienced PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), VACCINATION SITE WARMTH (Hot Injection Site), VACCINATION SITE PAIN (Tender Left Arm Injection Site), MYALGIA (Every muscle in her body hurts), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body). On 21-Feb-2021, the patient experienced PAIN (Pain in Chest to neck and to waist Moving to the legs). On 22-Feb-2021, the patient experienced LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand) and HYPOAESTHESIA (Numb Entire Left Arm). On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen on the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Shooting pain), RASH MACULAR (Big Red Blotch 3" Injection Site), PAIN (Pain in Chest to neck and to waist Moving to the legs), VACCINATION SITE WARMTH (Hot Injection Site), LIMB DISCOMFORT (Feels Heavy Entire Left Arm and Hand), HYPOAESTHESIA (Numb Entire Left Arm), VACCINATION SITE PAIN (Tender Left Arm Injection Site), VACCINATION SITE SWELLING (Swollen on the Injection Site), MYALGIA (Every muscle in her body hurts), FATIGUE (Exhausted), HEADACHE (Headache) and ARTHRALGIA (Shooting pain (rated 9 on a scale of 1-10) from base of skull to joints of entire body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data included all tests were normal.  No concomitant medications are reported.  Treatment medications included Ice.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Body Ache; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Ache), FATIGUE (Fatigue) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (Body Ache), FATIGUE (Fatigue) and HEADACHE (Headache). On 29-Jan-2021, MYALGIA (Body Ache) and FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever of 101.6; Headache; Fatigue; A spontaneous report () was received from a consumer concerning a 60 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 101.6/pyrexia, headache and fatigue.  The patient's medical history was not provided. Concomitant medications reported were mometasone furoate, omeprazole, metformin, rosuvastatin calcium, acetylsalicylic acid, atenolol.  The patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) on an unknown date.  On 23 Jan 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in 2021, the patient experienced the events Fever of 101.6, Headache, Fatigue.  Treatment details included Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever of 101, 6, headache, fatigue was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Pyrexia
Clinical narrative: Diarrhea; Fever; Pain at Injecttion site (Right); A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection (right), diarrhea, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) pain at injection (right). On 24 Feb 2021, the patient experienced the event(s) diarrhea, fever.  Treatment details included History Allergy, Caller took Imodium.  Action taken with mRNA-1273 in response to the events was not reported.  On 24 Feb 2021 the outcome of event(s), pain at injection (right) was resolved. The outcome of event(s), diarrhea, fever was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Sore arm; feverish; Mild headache that can get very bad; Tossed and turned all night; A spontaneous report was received from a consumer concerning a 31-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, feverish, tossed and turned all night, mild headache that can get very bad.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) sore arm, feverish, tossed and turned all night, mild headache that can get very bad.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 23 Feb 2021 the outcome of event(s), tossed and turned all night was resolved. The outcome of event(s), sore arm, feverish, mild headache that can get very bad was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: blood glucose levels are increasing (231); This spontaneous case was reported by a physician and describes the occurrence of BLOOD GLUCOSE INCREASED (blood glucose levels are increasing (231)) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00182TA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood glucose levels are increasing (231)). At the time of the report, BLOOD GLUCOSE INCREASED (blood glucose levels are increasing (231)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No new information.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Pyrexia
Clinical narrative: dizzy; feels llike she has a fever; chills; sick to the stomach; A spontaneous report was received from a consumer concerning 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizzy, feels like she has a fever, chills, sick to the stomach.  The patient's medical history was not provided. Concomitant medications reported were Blood pressure pills, Thyroid meds for drug use for unknown indication.  On Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) dizzy, feels like she has a fever, chills, sick to the stomach.  Treatment details included Nothing yet. Thinking about Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizzy, feels like she has a fever, chills, sick to the stomach was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: delayed reaction arm redness; delayed reaction arm swelling; delayed reaction arm itching; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed reaction arm redness, delayed reaction arm swelling, delayed reaction arm itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 020M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) delayed reaction arm redness, delayed reaction arm swelling, delayed reaction arm itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), delayed reaction arm redness, delayed reaction arm swelling, delayed reaction arm itching was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Nausea, Skin discolouration, Tinnitus
Clinical narrative: ringing ears; nausea; loss of balance; blotting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ringing ears, blotting, nausea, loss of balance.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029K20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) ringing ears, blotting, nausea, loss of balance.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), ringing ears, blotting, nausea, loss of balance was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Macule, Pain in extremity, Pruritus
Clinical narrative: Red bumpy dot; Inflammation; Red rings; Itchiness; Hives all over his body; Rash; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), ERYTHEMA (Red rings), PRURITUS (Itchiness), URTICARIA (Hives all over his body) and RASH (Rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 30-Jan-2021, the patient experienced ERYTHEMA (Red rings), PRURITUS (Itchiness), URTICARIA (Hives all over his body) and RASH (Rash). On an unknown date, the patient experienced MACULE (Red bumpy dot) and INFLAMMATION (Inflammation). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYTREC) (oral) ongoing from 30-Jan-2021 for Hives, Itching and Redness, at a dose of 1 dosage form once a day; METHYLPREDNISOLONE for Rash, Erythema, Itching all over and Hives, at an unspecified dose and frequency; CETIRIZINE for Rash, Redness, Itching all over and Hives, at an unspecified dose and frequency and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Inflammation, at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, ERYTHEMA (Red rings), URTICARIA (Hives all over his body), RASH (Rash) and MACULE (Red bumpy dot) had not resolved, PRURITUS (Itchiness) was resolving and INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up added 30-Apr-2021 had information regarding reporter details, patient demographics, vaccination facility information, event added, outcome of event and treatment added to the case. On 11-Jun-2021: Follow up added on 11-Jun-2021 had outcome of the hives as continuing.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Red bumpy dot; Inflammation; Red rings; Itchiness; Hives all over his body; Rash; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), ERYTHEMA (Red rings), PRURITUS (Itchiness), URTICARIA (Hives all over his body) and RASH (Rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 30-Jan-2021, the patient experienced ERYTHEMA (Red rings), PRURITUS (Itchiness), URTICARIA (Hives all over his body) and RASH (Rash). On an unknown date, the patient experienced MACULE (Red bumpy dot) and INFLAMMATION (Inflammation). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYTREC) (oral) ongoing from 30-Jan-2021 for Hives, Itching and Redness, at a dose of 1 dosage form once a day; METHYLPREDNISOLONE for Rash, Erythema, Itching all over and Hives, at an unspecified dose and frequency; CETIRIZINE for Rash, Redness, Itching all over and Hives, at an unspecified dose and frequency and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Inflammation, at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, ERYTHEMA (Red rings), URTICARIA (Hives all over his body), RASH (Rash) and MACULE (Red bumpy dot) had not resolved, PRURITUS (Itchiness) was resolving and INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up added 30-Apr-2021 had information regarding reporter details, patient demographics, vaccination facility information, event added, outcome of event and treatment added to the case. On 11-Jun-2021: Follow up added on 11-Jun-2021 had outcome of the hives as continuing.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dizziness, Rash erythematous, Speech disorder, Thinking abnormal
Clinical narrative: Severe reaction in the injection arm; Red raw rash around the injection site; Covid arm; Felt dizzy; Fuzzy thinking; Talked a little bit strange; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy / dizziness, speech disorder/ speech impairment, thinking abnormal, vaccination site reaction, adverse reaction, rash erythematous.  The patient's medical history was  provided. as blood pressure. Concomitant medications reported were unknown medications for blood pressure.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced  felt dizzy, fuzzy thinking, talked a little bit strange. Approximately after a week on 5 Feb 2021, the patient experienced severe reaction in the injection arm, red raw rash around the injection site and covid arm.  The treatment informations  included  diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   On 29 Jan 2021, the outcome of events felt dizzy, fuzzy thinking, talked a little bit strange were considered as  resolved. On 7 Feb 2021, the outcome of events, severe reaction in the injection arm, red raw rash around the injection site, covid arm were considered  resolved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Severe reaction in the injection arm; Red raw rash around the injection site; Covid arm; Felt dizzy; Fuzzy thinking; Talked a little bit strange; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy / dizziness, speech disorder/ speech impairment, thinking abnormal, vaccination site reaction, adverse reaction, rash erythematous.  The patient's medical history was  provided. as blood pressure. Concomitant medications reported were unknown medications for blood pressure.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced  felt dizzy, fuzzy thinking, talked a little bit strange. Approximately after a week on 5 Feb 2021, the patient experienced severe reaction in the injection arm, red raw rash around the injection site and covid arm.  The treatment informations  included  diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   On 29 Jan 2021, the outcome of events felt dizzy, fuzzy thinking, talked a little bit strange were considered as  resolved. On 7 Feb 2021, the outcome of events, severe reaction in the injection arm, red raw rash around the injection site, covid arm were considered  resolved.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Circle rash on arm,forehead,leg,elbow; A spontaneous report was received from a consumer concerning a female patient (Unspecified age) who experienced circle rash on the arm, forehead, leg, and elbow/rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date in Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date in Feb 2021, the patient experienced circle rash on the arm, forehead, leg, and elbow.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event circle rash on the arm, forehead, leg, and elbow was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Pyrexia, Tremor, Vomiting
Clinical narrative: Shaking; Diarrhea; Fever; Vomiting; Weakness; A spontaneous report was received from a consumer concerning 84 years old male patient developed shaking/tremor, diarrhoea, fever/pyrexia, vomiting.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Insulin.   The patients received their unknown of two planned doses of mRNA-1273 (Batch number: 029L20A) on 22 Jan 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.   On 22 Jan 2021 the patient experienced side effects for a two-hour time between 2:30 and 4:30 he experienced shaking, diarrhea, fever, vomiting, and weakness. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events shaking, diarrhoea, fever, and vomiting was considered resolved on 22 Jan 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Migraine, Nasal congestion, Oropharyngeal pain
Clinical narrative: Migraine; Stuffy Nose; Sore throat; Fever - Temperature of 99.0F; Chills; joint pain; A spontaneous report was received from a consumer concerning, a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (99.0°F)/pyrexia, migraine, chills, sore throat/oropharyngeal pain, stuffy nose/nasal congestion, and joint pain/arthralgia.  The patient's medical history included high blood pressure, osteoarthritis, irritational bowel syndrome, osteopenia, and carpal tunnel syndrome.   Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medicine for high blood pressure and paracetamol for osteoarthritis, irritational bowel syndrome, osteopenia, and carpal tunnel syndrome.  On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20M) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient a fever (99.0°F), migraine, chills, sore throat, stuffy nose, and joint pain.  The patient self-medicated to alleviate the symptoms which included paracetamol, ibuprofen, calming Lotion and body wash.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.  The outcome of the events Fever (99.0°F), migraine, chills, sore throat, stuffy nose, and joint pain were considered unknown at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Migraine; Stuffy Nose; Sore throat; Fever - Temperature of 99.0F; Chills; joint pain; A spontaneous report was received from a consumer concerning, a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (99.0°F)/pyrexia, migraine, chills, sore throat/oropharyngeal pain, stuffy nose/nasal congestion, and joint pain/arthralgia.  The patient's medical history included high blood pressure, osteoarthritis, irritational bowel syndrome, osteopenia, and carpal tunnel syndrome.   Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medicine for high blood pressure and paracetamol for osteoarthritis, irritational bowel syndrome, osteopenia, and carpal tunnel syndrome.  On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20M) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient a fever (99.0°F), migraine, chills, sore throat, stuffy nose, and joint pain.  The patient self-medicated to alleviate the symptoms which included paracetamol, ibuprofen, calming Lotion and body wash.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) was not applicable.  The outcome of the events Fever (99.0°F), migraine, chills, sore throat, stuffy nose, and joint pain were considered unknown at the time of this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; A spontaneous report () was received from a consumer concerning her husband, a 77-year-old male patient who received Moderna (mRNA-1273) vaccine and experienced a sore arm..  The patient's medical history was not provided. Concomitant product use was unknown by the reporter.  On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On the same day 27 Jan 2021, the patient experienced a sore arm.  Treatment information was unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event, a sore arm was considered resolved at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm was sore; Itchy; Swollen to the size of a golf ball / swollen to size of tennis ball; Red; A spontaneous report  was received from a nurse concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, arm was sore / pain in extremity, red / erythema, itchy / pruritus, swollen to the size of a golf ball, swollen to the size of a tennis ball / peripheral swelling.  The patient's medical history was not provided. Concomitant medications reported were atenolol, lisinopril- HCTZ, conjugated estrogens for drug use for unknown indication, oxycodone hydrochloride - paracetamol for pain from back surgery, gabapentin for fibromyalgia, and vitamin D for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) arm was sore, red, itchy, swollen to the size of a golf ball. The events were fading but it later got worsen. On an unknown date, the patient experienced the event swollen to the size of a tennis ball.  Treatment details included diphenhydramine HCl but was not effective.  Action taken with mRNA-1273 in response to the events was not reported.   On 13 Feb 2021 the event, sore arm got resolved. The outcome of event(s), red, itchy, swollen to the size of a golf ball, swollen to the size of a tennis ball was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Discomfort, Nausea
Clinical narrative: feeling nauseated; she can't eat anything; she threw up; A spontaneous report () was received from a consumer concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling nauseated, she can't eat anything, she threw up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not available) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) feeling nauseated, she can't eat anything, she threw up.  Treatment details included Promethazine 0.5mg.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), feeling nauseated, she can't eat anything, she threw up was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza like illness, Limb discomfort
Clinical narrative: achy; flu like symptoms; fatigue; nausea; had no energy; feel crappy; they threw up; sore arm; headache; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, headache, achy, had flu-like symptoms, fatigue, nausea, had no energy, they threw up, feel crappy.  The patient's medical history was not provided. Concomitant medications reported were omeprazole 20 mg once a day, levothyroxin 50 mcg, lovastatin 20 mg for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the event(s) sore arm, headache. On 21 Feb 2021, the patient experienced the event(s) achy, had flu-like symptoms, fatigue, nausea, had no energy, they threw up, feel crappy.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 14 Jan 2021 the outcome of event(s), sore arm, headache was resolved. On21 Feb 2021 the outcome of event(s), they threw up was resolved. The outcome of event(s), achy, had flu-like symptoms, fatigue, nausea, had no energy, feel crappy was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Vomiting
Clinical narrative: achy; flu like symptoms; fatigue; nausea; had no energy; feel crappy; they threw up; sore arm; headache; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, headache, achy, had flu-like symptoms, fatigue, nausea, had no energy, they threw up, feel crappy.  The patient's medical history was not provided. Concomitant medications reported were omeprazole 20 mg once a day, levothyroxin 50 mcg, lovastatin 20 mg for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the event(s) sore arm, headache. On 21 Feb 2021, the patient experienced the event(s) achy, had flu-like symptoms, fatigue, nausea, had no energy, they threw up, feel crappy.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 14 Jan 2021 the outcome of event(s), sore arm, headache was resolved. On21 Feb 2021 the outcome of event(s), they threw up was resolved. The outcome of event(s), achy, had flu-like symptoms, fatigue, nausea, had no energy, feel crappy was unknown.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: Fever; Chills; Body Aches; Tiredness; Fever; Body Ache; A spontaneous report () was received from a healthcare professional concerning a 59-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, body ache, chills, body aches, tiredness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) fever, body ache. On 22 Feb 2021, the patient experienced the event(s) chills, body aches, tiredness.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever, body ache, chills, body aches, tiredness was unknown.; Sender's Comments:  .-MOD-2021-049866:1st dose
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash on the arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Rash on the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE and ATORVASTATIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced RASH (Rash on the arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and RASH (Rash on the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information were not provided.  Patient took second dose on 20-FEB-2021.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Pain in arm; Itching; A spontaneous report was received from a consumer concerning a female patient (Unspecified age) who experienced pain in arm/pain in extremity and itching/pruritus.   The patient's medical history included osteoporosis. Products known to have been used by the patient, within two weeks prior to the event, included denosumab.  On 11 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route in arm for prophylaxis of COVID-19 infection.   On an unknown date in Feb 2021, the patient experienced pain in arm and itching.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event pain in arm and itching was unknown.