chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Arm sore) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.  On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm sore). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-056485 (Patient Link).
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and PRURITUS (itching) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.     On 04-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 RASH (rash) and PRURITUS (itching). At the time of the report, RASH (rash) and PRURITUS (itching) 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Oct-2020 and the estimated date of delivery was date. On 13-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by an other and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Depression and Anxiety. Concurrent medical conditions included Drug allergy (drug-cefprozil) and Drug allergy (cefprozil). Concomitant products included ZINGIBER OFFICINALE (GINGERPRO) from 01-Jan-2020 to an unknown date for Nausea and Digestion impaired, DOXYLAMINE from 27-Jul-2020 to 09-Mar-2021 for Nausea and Insomnia, MAGNESIUM from 01-Jan-2019 to an unknown date for Sleeplessness and Constipation, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-May-2020 to an unknown date for Vitamin supplementation, DOCOSAHEXAENOIC ACID (OMEGA 3 DHA [DOCOSAHEXAENOIC ACID]) from 01-May-2020 to an unknown date for an unknown indication.    On 11-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Jun-2020 and the estimated date of delivery was 19-Mar-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The vaginal delivery occurred on 10-Mar-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, the birth weight was 1388 grams (3lbs 1oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Ultrasound antenatal screen normal: normal (normal) Normal, no abnormalities founds. On 18-Dec-2020, Glucose tolerance test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's reported last menstrual period was 12-Jun-2020, date of positive pregnancy test was on 06-Jun-2020.  Meconium stained amniotic fluid without complications was reported. No infant abnormalities were reported during pregnancy and 1 month post-partum.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Initial additional - pregnancy outcome form : Added revised patient initial, updated lab data, delivery details and concomitant medications drug information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelling on two fingers on her right hand; Itching; Red spots; A spontaneous report was received from a consumer concerning a 68-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling on two fingers on her right hand / peripheral swelling, red spots / erythema and itching / pruritus.  The patient's medical history and concomitant product use was not provided by the reporter.  On 15 Feb 2021, approximately one day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, patient experienced the events, swelling on two fingers on her right hand, red spots and itching.  Treatment for the events included naproxen and cortisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, swelling on two fingers on her right hand, red spots and itching was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: Body aches; Body pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN (Body pain) and DIARRHOEA (Diarrhea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included TRAMADOL, Diazepam as needed and DULOXETINE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Body aches), PAIN (Body pain) and DIARRHOEA (Diarrhea). At the time of the report, PAIN (Body aches), PAIN (Body pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient didn't receive any treatment her symptoms subsided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Birth Control . Treatment details were not provided.; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: term a little bit of tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (term a little bit of tenderness) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03IL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, ATORVASTATIN, METFORMIN, LEVOTHYROXINE and FISH OIL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced TENDERNESS (term a little bit of tenderness). At the time of the report, TENDERNESS (term a little bit of tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment given
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Night sweats
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite), FATIGUE (tiredness) and NIGHT SWEATS (night sweats) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness). On 15-Feb-2021, the patient experienced NIGHT SWEATS (night sweats). On 18-Feb-2021, HEADACHE (light headache), DIZZINESS (dizziness), DECREASED APPETITE (loss of appetite), FATIGUE (tiredness) and NIGHT SWEATS (night sweats) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient has taken Tylenol which subsided the adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L202A and 205J202A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Leiomyosarcoma (cancer) and Infertility. Concurrent medical conditions included Pregnancy since 11-Feb-2021 and Kidney absent (since birth). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation, ESTROGEN NOS and VITAMIN D NOS (VITAMIN D NOS 3000 iu) for an unknown indication, PROGESTERONE.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Jan-2021 and the estimated date of delivery was 20-Oct-2021. On 25-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, Estimated date of conception-02-02-2021. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pregnancy test positive: positive positive positive.         no treatment given  no concomitant provide
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site arm spots that are itchy; Injection site slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site arm spots that are itchy) and VACCINATION SITE SWELLING (Injection site slightly swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site arm spots that are itchy) and VACCINATION SITE SWELLING (Injection site slightly swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site arm spots that are itchy) and VACCINATION SITE SWELLING (Injection site slightly swollen) outcome was unknown.            no concomitant medication provided no treatment given
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Headache, Injection site erythema, Injection site pain
Clinical narrative: muddled feeling; chills that come and go; nausea; injection site painful; injection site itchy; injection site is red; weird headache; arm pain; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (muddled feeling), CHILLS (chills that come and go), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful) and INJECTION SITE PRURITUS (injection site itchy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. patient will call back to add) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no history provided).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (muddled feeling), CHILLS (chills that come and go), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful), INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site is red), HEADACHE (weird headache) and LIMB DISCOMFORT (arm pain). At the time of the report, CONFUSIONAL STATE (muddled feeling), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful), INJECTION SITE ERYTHEMA (injection site is red), HEADACHE (weird headache) and LIMB DISCOMFORT (arm pain) outcome was unknown and CHILLS (chills that come and go) had resolved.            no concomitant medication provided patient has taken treatment ibuprofen
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Lethargy, Limb discomfort, Nausea
Clinical narrative: muddled feeling; chills that come and go; nausea; injection site painful; injection site itchy; injection site is red; weird headache; arm pain; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (muddled feeling), CHILLS (chills that come and go), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful) and INJECTION SITE PRURITUS (injection site itchy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. patient will call back to add) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no history provided).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (muddled feeling), CHILLS (chills that come and go), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful), INJECTION SITE PRURITUS (injection site itchy), INJECTION SITE ERYTHEMA (injection site is red), HEADACHE (weird headache) and LIMB DISCOMFORT (arm pain). At the time of the report, CONFUSIONAL STATE (muddled feeling), NAUSEA (nausea), INJECTION SITE PAIN (injection site painful), INJECTION SITE ERYTHEMA (injection site is red), HEADACHE (weird headache) and LIMB DISCOMFORT (arm pain) outcome was unknown and CHILLS (chills that come and go) had resolved.            no concomitant medication provided patient has taken treatment ibuprofen
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting; muscle soreness; lymph nodes are tender; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting), MYALGIA (muscle soreness), LYMPH NODE PAIN (lymph nodes are tender), CHILLS (chills) and PAIN (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting), MYALGIA (muscle soreness), LYMPH NODE PAIN (lymph nodes are tender), CHILLS (chills) and PAIN (body aches). At the time of the report, LYMPHADENOPATHY (Lymph nodes around the base of her neck, base of her skull and around her clavicle are hurting), MYALGIA (muscle soreness), LYMPH NODE PAIN (lymph nodes are tender), CHILLS (chills) and PAIN (body aches) outcome was unknown.            no concomitant medication Patient has taken treatment tylenol
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pregnant Received 2 doses of vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant Received 2 doses of vaccine) in a 38-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Obesity in 2011. Concurrent medical conditions included Asthma, Hypertension since 2016, Hypothyroidism since 2015 and Pregnancy (Due date-01-09-2021) since 31-Dec-2020. Concomitant products included LEVOTHYROXINE, VITAMIN D NOS, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT inhaler), NIFEDIPINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA) and HYDRALAZINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 25-Nov-2020 and the estimated date of delivery was 01-Sep-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant Received 2 doses of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant Received 2 doses of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Pregnancy test positive: positive (Positive) positive.         no treatment provided.  Estimated date of conception was 07 Dec 2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound foetal
Clinical narrative: exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 29-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 10-Dec-2020 and the estimated date of delivery was 16-Sep-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Ultrasound foetal: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included ALBUTEROL SULFATE (ALBUTEROL SULFATE Inhalation  When needed) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT inhaler) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient has given Inhaler and Usenix
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Glucose tolerance test, Myalgia, Pain in extremity
Clinical narrative: Aches; Sore arm; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), MYALGIA (Sore arm) and CHILLS (Chills) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (No complications and live, full-term birth.) on 28-Feb-2018. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Aches), MYALGIA (Sore arm) and CHILLS (Chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred  on 28-Feb-2018, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. Live, full-term birth. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches), MYALGIA (Sore arm) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-018518 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Internal review conducted on 23-Jul-2021 resulted in updates to pregnancy information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Aches; Sore arm; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches), EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), MYALGIA (Sore arm) and CHILLS (Chills) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (No complications and live, full-term birth.) on 28-Feb-2018. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Aches), MYALGIA (Sore arm) and CHILLS (Chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The delivery occurred  on 28-Feb-2018, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. Live, full-term birth. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches), MYALGIA (Sore arm) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-018518 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Internal review conducted on 23-Jul-2021 resulted in updates to pregnancy information.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Sinusitis
Clinical narrative: loss of taste; loss of smell; symptoms similar to a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection). At the time of the report, AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SINUSITIS (symptoms similar to a sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment has provided no concomitant medication has given   This case was linked to MOD-2021-016500 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Pain in extremity, Rash
Clinical narrative: Burning shoulder; stiff neck; A rash at the right side of the chest; aching arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (aching arm), MUSCULOSKELETAL DISCOMFORT (Burning shoulder), MUSCULOSKELETAL STIFFNESS (stiff neck) and RASH (A rash at the right side of the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history found).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (aching arm). On 12-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Burning shoulder), MUSCULOSKELETAL STIFFNESS (stiff neck) and RASH (A rash at the right side of the chest). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (aching arm), MUSCULOSKELETAL DISCOMFORT (Burning shoulder) and MUSCULOSKELETAL STIFFNESS (stiff neck) was resolving and RASH (A rash at the right side of the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitation) in a female patient of an unknown age 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 provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitation). At the time of the report, PALPITATIONS (heart palpitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment provided  no concomitant medication given
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-1 test positive
Clinical narrative: She took a COVID-19 test and tested positive; fever; coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PYREXIA (fever) and COVID-19 (She took a COVID-19 test and tested positive) in a 69-year-old female patient 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 provided).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COUGH (coughing). On 12-Feb-2021, the patient experienced PYREXIA (fever). On 13-Feb-2021, the patient experienced COVID-19 (She took a COVID-19 test and tested positive). At the time of the report, COUGH (coughing), PYREXIA (fever) and COVID-19 (She took a COVID-19 test and tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Pyrexia: 12-feb-21 (High) 100.4. On 13-Feb-2021, SARS-CoV-1 test positive: positive positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided. Schedule for 2 dose 18-feb-2021, she tested positive and pharmacist has said to finish her quarantine before she gets 2 dose.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in the muscle area where she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle area where she got the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included BUSPIRONE, DULOXETINE, LAMOTRIGINE, TOPIRAMATE, c-Dextro HBR, IBUPROFEN, METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN), GABAPENTIN, METOLAZONE, BUMETANIDE (BUMEX), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), L-METHYLFOLATE, LURASIDONE, LEVOTHYROXINE, SPIRONOLACTONE, SUVOREXANT (BELSOMRA), TRIAMCINOLONE ACETONIDE (NASACORT), MACROGOL 3350 (DULCOLAX BALANCE), GUAIFENESIN (MUCINEX) and MECOBALAMIN (B12 SHOT) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (pain in the muscle area where she got the vaccine). At the time of the report, MYALGIA (pain in the muscle area where she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment given
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red injection site that's getting bigger) in a female patient of an unknown age 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 provided). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red injection site that's getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red injection site that's getting bigger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication and treatment provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Mild side effects) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Mild side effects). At the time of the report, ADVERSE DRUG REACTION (Mild side effects) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Vaccination site pain
Clinical narrative: alot of pain in right arm; pain when breathing, especially on right side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (alot of pain in right arm) and PAINFUL RESPIRATION (pain when breathing, especially on right side) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 12-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 VACCINATION SITE PAIN (alot of pain in right arm) and PAINFUL RESPIRATION (pain when breathing, especially on right side). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (alot of pain in right arm) and PAINFUL RESPIRATION (pain when breathing, especially on right side) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site itching; Vaccination site swollen; Vaccination site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE SWELLING (Vaccination site swollen) and VACCINATION SITE ERYTHEMA (Vaccination site red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY PROVIDED).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE SWELLING (Vaccination site swollen) and VACCINATION SITE ERYTHEMA (Vaccination site red). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE SWELLING (Vaccination site swollen) and VACCINATION SITE ERYTHEMA (Vaccination site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication and treatment provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: aching in neck; aching in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aching in his arm) and NECK PAIN (aching in neck) in a 70-year-old male 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 (no adverse events).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (aching in his arm). On an unknown date, the patient experienced NECK PAIN (aching in neck). At the time of the report, PAIN IN EXTREMITY (aching in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Nausea
Clinical narrative: Big round red itchy circle at injection site; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Big round red itchy circle at injection site) and NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COPD.    On 11-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 INJECTION SITE ERYTHEMA (Big round red itchy circle at injection site) and NAUSEA (nauseous). At the time of the report, INJECTION SITE ERYTHEMA (Big round red itchy circle at injection site) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment and concomitant medication provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: Itchiness; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and FATIGUE (Fatigue extreme) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SUCRALFATE (CARAFATE), CARVEDILOL (COREG), ARIPIPRAZOLE (ABILIFY), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), ALPRAZOLAM (XANAX), FLUTICASONE PROPIONATE (FLOVENT HFA) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (Itchiness) and FATIGUE (Fatigue extreme). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency and VITAMINS NOS at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness) and FATIGUE (Fatigue extreme) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Swelling, Swelling face
Clinical narrative: swelling on her face, ears and across the bridge of her nose; ear swelling; swelling on her face, ears and across the bridge of her nose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on her face, ears and across the bridge of her nose) and SWELLING (swelling on her face, ears and across the bridge of her nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS for an unknown indication.    The patient's past medical history included No adverse event (no medical history found). Concomitant products included MACROGOL 3350 (MIRALAX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and VITAMINS NOS (unknown route) at an unspecified dose. On an unknown date, the patient experienced SWELLING FACE (swelling on her face, ears and across the bridge of her nose) and SWELLING (swelling on her face, ears and across the bridge of her nose). At the time of the report, SWELLING FACE (swelling on her face, ears and across the bridge of her nose) and SWELLING (swelling on her face, ears and across the bridge of her nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient using blood pressure medication no treatment provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: CHILLS; MUSCLE ACHES; SWEATING; FEVER; HOT FLASHES; STOMACH PAINS; DIARRHEA; HEADACHES; EXTREME WEAKNESS AND FATIGUE; UNABLE TO DO ANYTHING AT ALL EXCEPT STAY IN BED ALL DAY; BODY ACHES; COULD BARELY EAT ANYTHING EXCEPT DRINK WATER AND SOUPS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (CHILLS), MYALGIA (MUSCLE ACHES), HYPERHIDROSIS (SWEATING), PYREXIA (FEVER) and HOT FLUSH (HOT FLASHES) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (CHILLS), MYALGIA (MUSCLE ACHES), HYPERHIDROSIS (SWEATING), PYREXIA (FEVER), HOT FLUSH (HOT FLASHES), ABDOMINAL PAIN UPPER (STOMACH PAINS), DIARRHOEA (DIARRHEA), HEADACHE (HEADACHES), ASTHENIA (EXTREME WEAKNESS AND FATIGUE), MALAISE (UNABLE TO DO ANYTHING AT ALL EXCEPT STAY IN BED ALL DAY), PAIN (BODY ACHES) and DECREASED APPETITE (COULD BARELY EAT ANYTHING EXCEPT DRINK WATER AND SOUPS). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHILLS (CHILLS), MYALGIA (MUSCLE ACHES), HYPERHIDROSIS (SWEATING), PYREXIA (FEVER), HOT FLUSH (HOT FLASHES), ABDOMINAL PAIN UPPER (STOMACH PAINS), DIARRHOEA (DIARRHEA), HEADACHE (HEADACHES), ASTHENIA (EXTREME WEAKNESS AND FATIGUE), MALAISE (UNABLE TO DO ANYTHING AT ALL EXCEPT STAY IN BED ALL DAY), PAIN (BODY ACHES) and DECREASED APPETITE (COULD BARELY EAT ANYTHING EXCEPT DRINK WATER AND SOUPS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided patient felling better after taking treatment