chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: swelling right foot (toe and bottom of foot); Swollen arm; a lot of pain in right foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of pain in right foot), PERIPHERAL SWELLING (swelling right foot (toe and bottom of foot)) and PERIPHERAL SWELLING (Swollen arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (a lot of pain in right foot) and PERIPHERAL SWELLING (Swollen arm). On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling right foot (toe and bottom of foot)). At the time of the report, PAIN IN EXTREMITY (a lot of pain in right foot), PERIPHERAL SWELLING (swelling right foot (toe and bottom of foot)) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Doxycycline and Cortisone). Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that hives became worse on fourth day.  Patient scheduled an appointment with HCP on 29-MAR-2021.  Event outcome was unknown.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Right arm was swollen where she got the shot; Sore where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Right arm was swollen where she got the shot) and VACCINATION SITE PAIN (Sore where she got the shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Right arm was swollen where she got the shot) and VACCINATION SITE PAIN (Sore where she got the shot). At the time of the report, VACCINATION SITE SWELLING (Right arm was swollen where she got the shot) and VACCINATION SITE PAIN (Sore where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment details was not provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Dizziness, Feeling abnormal, Heart rate increased, Pain
Clinical narrative: body ache; heart beat was up; lightheadedness; felt Zombie; "I was calm like some body gave me a bunch of drinks"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), HEART RATE INCREASED (heart beat was up), DIZZINESS (lightheadedness), FEELING ABNORMAL (felt Zombie) and ABNORMAL BEHAVIOUR ("I was calm like some body gave me a bunch of drinks") in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TIZANIDINE, SERTRALINE, CETIRIZINE, PROGESTERONE, ESTRADIOL, Flovent inhaler and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (body ache), HEART RATE INCREASED (heart beat was up), DIZZINESS (lightheadedness), FEELING ABNORMAL (felt Zombie) and ABNORMAL BEHAVIOUR ("I was calm like some body gave me a bunch of drinks"). At the time of the report, FEELING ABNORMAL (felt Zombie) and ABNORMAL BEHAVIOUR ("I was calm like some body gave me a bunch of drinks") 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. Treatment information was not reported.    This case was linked to MOD-2021-029567 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchy arm for over a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm for over a week) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm for over a week). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm for over a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia, Periorbital swelling
Clinical narrative: eyes are puffy and bloodshot was present; left side of his body was numb and tingly; fatigue/tired; left side of his body was numb and tingly; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (eyes are puffy and bloodshot was present), PARAESTHESIA (left side of his body was numb and tingly), FATIGUE (fatigue/tired) and HYPOAESTHESIA (left side of his body was numb and tingly) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PERIORBITAL SWELLING (eyes are puffy and bloodshot was present), PARAESTHESIA (left side of his body was numb and tingly), FATIGUE (fatigue/tired) and HYPOAESTHESIA (left side of his body was numb and tingly). At the time of the report, PERIORBITAL SWELLING (eyes are puffy and bloodshot was present), PARAESTHESIA (left side of his body was numb and tingly), FATIGUE (fatigue/tired) and HYPOAESTHESIA (left side of his body was numb and tingly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided/unknown. Treatment medication included Benadryl and Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Lymphadenopathy/swollen lymph nodes; Fever; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy/swollen lymph nodes), PYREXIA (Fever) and FATIGUE (Fatigue) 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymphadenopathy/swollen lymph nodes), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy/swollen lymph nodes), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058228:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Prenatal screening test, Ultrasound antenatal screen, Ultrasound scan abnormal
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypoglycemia since 05-Jan-2005. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Acid reflux (esophageal), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from an unknown date to 13-Jun-2021 for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 19-Jun-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The vaginal delivery occurred on 13-Jun-2021, which was reported as Full-term. For neonate 1, with an APGAR score of 8 at 1 minute. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, Ultrasound antenatal screen: inconclusive (Inconclusive) Single fetus implanted in uterus, regular heartbeat. On 07-Jan-2021, Prenatal screening test: inconclusive (Inconclusive) Fetus is female, no likelihood of genetic disorders detected.. On 10-Feb-2021, Ultrasound scan abnormal: normal (normal) Anatomy scan-No problems detected.. On 30-Mar-2021, Glucose tolerance test: normal (normal) No gestational diabetes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient date of positive pregnancy was 17-OCT-2021.Patient received prenatal care during pregnancy from a local hospital. Number of fetus was 1.Patient had prior history of alcohol use 4 drinks/ weeks. and stop date is 17-OCT-2020. Treatment information was not provided.   This case was linked to MOD-2021-239414 (Parent-Child Link).   See case MOD-2021-239414 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains significant information.Pregnancy details added. Medical history added. Lab data added. Patient's ethnicity added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Third episode of diarrhea on 21 March 2021; Second episode of diarrhea on 17 March 2021; First episode of diarrhea on 14 March 2021; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (First episode of diarrhea on 14 March 2021), DIARRHOEA (Second episode of diarrhea on 17 March 2021) and DIARRHOEA (Third episode of diarrhea on 21 March 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Osteosarcoma (cancer in right arm).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA (First episode of diarrhea on 14 March 2021). On 17-Mar-2021, the patient experienced DIARRHOEA (Second episode of diarrhea on 17 March 2021). On 21-Mar-2021, the patient experienced DIARRHOEA (Third episode of diarrhea on 21 March 2021). At the time of the report, DIARRHOEA (First episode of diarrhea on 14 March 2021), DIARRHOEA (Second episode of diarrhea on 17 March 2021) and DIARRHOEA (Third episode of diarrhea on 21 March 2021) outcome was unknown.            Treatment drugs were not provided concomitant drugs were not provided   Patient stated that the pharmacist told her that diarrhea can last for a week.
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Liquid dripping down arm  and pant leg wet; Liquid dripping down arm  and pant leg wet; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Liquid dripping down arm  and pant leg wet) and SYRINGE ISSUE (Liquid dripping down arm  and pant leg wet) in a male 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 reported.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced UNDERDOSE (Liquid dripping down arm  and pant leg wet) and SYRINGE ISSUE (Liquid dripping down arm  and pant leg wet). At the time of the report, UNDERDOSE (Liquid dripping down arm  and pant leg wet) and SYRINGE ISSUE (Liquid dripping down arm  and pant leg wet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of Underdose and Syringe Issue, for mRNA-1273, lot # unknown, with no associated AEs.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood bilirubin, Mental fatigue
Clinical narrative: "spaced ouy/like a mental thing"; no energy; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE ("spaced ouy/like a mental thing") and ASTHENIA (no energy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Liver cell carcinoma recurrent. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 10-Feb-2021 to an unknown date for Liver cell carcinoma recurrent.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL FATIGUE ("spaced ouy/like a mental thing") and ASTHENIA (no energy). At the time of the report, MENTAL FATIGUE ("spaced ouy/like a mental thing") and ASTHENIA (no energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood bilirubin: way up (High) way up. one number was high and other was down..         No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021,contains No new Information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pruritus
Clinical narrative: arm itched; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (arm itched) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Lyme disease, Food allergy (carries an Epipen) and Seasonal allergy. Concomitant products included EPINEPHRINE (EPIPEN), ONDANSETRON (ZOFRAN [ONDANSETRON]), PARACETAMOL (TYLENOL), ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (arm itched). On 25-Feb-2021, PRURITUS (arm itched) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5 F.     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 US-MODERNATX, INC.-MOD-2021-058859 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058859:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-058894 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058894:Case for patient 1
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache
Clinical narrative: Chills; Headache; Felt weak; Wanted to go to bed and sleep; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), ASTHENIA (Felt weak) and FATIGUE (Wanted to go to bed and sleep) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), ASTHENIA (Felt weak) and FATIGUE (Wanted to go to bed and sleep). On 19-Mar-2021, CHILLS (Chills), HEADACHE (Headache), ASTHENIA (Felt weak) and FATIGUE (Wanted to go to bed and sleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heart rate increased, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: Terrible pain, pain was awful; Elevated heart rate; Fever 100.7F; Red pin prick marks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Terrible pain, pain was awful), HEART RATE INCREASED (Elevated heart rate), PYREXIA (Fever 100.7F) and VACCINATION SITE ERYTHEMA (Red pin prick marks) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUDESONIDE, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II), CROMOGLICATE SODIUM (NASALCROM), ASPIRIN [ACETYLSALICYLIC ACID], IPRATROPIUM, ALBUTEROL [SALBUTAMOL], EPINEPHRINE (EPIPEN), IRON, VITAMIN D [VITAMIN D NOS], FOLIC ACID, FAMOTIDINE (PEPCID [FAMOTIDINE]) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Terrible pain, pain was awful), HEART RATE INCREASED (Elevated heart rate), PYREXIA (Fever 100.7F) and VACCINATION SITE ERYTHEMA (Red pin prick marks). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Terrible pain, pain was awful), PYREXIA (Fever 100.7F) and VACCINATION SITE ERYTHEMA (Red pin prick marks) had not resolved and HEART RATE INCREASED (Elevated heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: unknown results pending.         Action taken with mRNA-1273 in response to the events was not applicable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Bone , kidney and body pains and headaches; Bone , kidney and body pains and headaches; lack of air and dizziness; Lack of air; headache; Bone , kidney and body pains and headaches; 104°F fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air) and HEADACHE (headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 14-Dec-2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air), HEADACHE (headache), MYALGIA (Bone , kidney and body pains and headaches) and PYREXIA (104°F fever). At the time of the report, BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air), HEADACHE (headache), MYALGIA (Bone , kidney and body pains and headaches) and PYREXIA (104°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 104 (High) 104 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant information received on 06-AUG-2021,Contained No New Information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Renal pain
Clinical narrative: Bone , kidney and body pains and headaches; Bone , kidney and body pains and headaches; lack of air and dizziness; Lack of air; headache; Bone , kidney and body pains and headaches; 104°F fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air) and HEADACHE (headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 14-Dec-2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air), HEADACHE (headache), MYALGIA (Bone , kidney and body pains and headaches) and PYREXIA (104°F fever). At the time of the report, BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air), HEADACHE (headache), MYALGIA (Bone , kidney and body pains and headaches) and PYREXIA (104°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 104 (High) 104 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant information received on 06-AUG-2021,Contained No New Information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: felt like trash; I feel hot; Aches and pain; upset stomach; it has not been fun; been in bed; feel trash; headache; "beat red" face; swollen lips; Swollen neck and chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING HOT (I feel hot) and PAIN (Aches and pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX), ROSUVASTATIN CALCIUM (CRESTOR), FOLIC ACID and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING ABNORMAL (feel trash) and HEADACHE (headache). On 25-Mar-2021, the patient experienced FEELING HOT (I feel hot), PAIN (Aches and pain), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (it has not been fun) and FATIGUE (been in bed). On an unknown date, the patient experienced MALAISE (felt like trash). At the time of the report, ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING HOT (I feel hot), PAIN (Aches and pain) and ABDOMINAL DISCOMFORT (upset stomach) had not resolved and MALAISE (it has not been fun), FEELING ABNORMAL (feel trash), MALAISE (felt like trash), HEADACHE (headache) and FATIGUE (been in bed) 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.   Concomitant product also includes  blood pressure pills and magnesium potassium Treatment information was provided as Prednisone, Benadryl,  Epinephrine from emergency room visit   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on 12-May-2021 and contains Significant information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Malaise, Pain, Swelling
Clinical narrative: felt like trash; I feel hot; Aches and pain; upset stomach; it has not been fun; been in bed; feel trash; headache; "beat red" face; swollen lips; Swollen neck and chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING HOT (I feel hot) and PAIN (Aches and pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX), ROSUVASTATIN CALCIUM (CRESTOR), FOLIC ACID and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING ABNORMAL (feel trash) and HEADACHE (headache). On 25-Mar-2021, the patient experienced FEELING HOT (I feel hot), PAIN (Aches and pain), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (it has not been fun) and FATIGUE (been in bed). On an unknown date, the patient experienced MALAISE (felt like trash). At the time of the report, ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING HOT (I feel hot), PAIN (Aches and pain) and ABDOMINAL DISCOMFORT (upset stomach) had not resolved and MALAISE (it has not been fun), FEELING ABNORMAL (feel trash), MALAISE (felt like trash), HEADACHE (headache) and FATIGUE (been in bed) 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.   Concomitant product also includes  blood pressure pills and magnesium potassium Treatment information was provided as Prednisone, Benadryl,  Epinephrine from emergency room visit   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on 12-May-2021 and contains Significant information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Lymphadenopathy, Myalgia, Nasal congestion
Clinical narrative: body aches; wheezing; Dry cough; coughed up a plug of thick yellow mucus once; nose was running; swollen glands under her right arm and throat; face felt slightly swollen (tight); bone aches; nasal congestion; chills; fever up to 101.5 F; nausea; muscle aches; low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once) and RHINORRHOEA (nose was running) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Lyme disease, Seasonal allergy, Food allergy and Nasal congestion. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), RHINORRHOEA (nose was running), LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (fever up to 101.5 F), NAUSEA (nausea), MYALGIA (muscle aches) and PYREXIA (low grade fever). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Pain, at a dose of 1000 mg; ALBUTEROL [SALBUTAMOL] for Wheezing, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Rhinitis, at an unspecified dose and frequency. On 25-Mar-2021, WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PAIN (body aches), RHINORRHOEA (nose was running) and PYREXIA (fever up to 101.5 F) outcome was unknown and LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), MYALGIA (muscle aches) and PYREXIA (low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Pyrexia: 38.6 celsius (High) 101.5 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea, Swelling face
Clinical narrative: body aches; wheezing; Dry cough; coughed up a plug of thick yellow mucus once; nose was running; swollen glands under her right arm and throat; face felt slightly swollen (tight); bone aches; nasal congestion; chills; fever up to 101.5 F; nausea; muscle aches; low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once) and RHINORRHOEA (nose was running) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Lyme disease, Seasonal allergy, Food allergy and Nasal congestion. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), RHINORRHOEA (nose was running), LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (fever up to 101.5 F), NAUSEA (nausea), MYALGIA (muscle aches) and PYREXIA (low grade fever). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Pain, at a dose of 1000 mg; ALBUTEROL [SALBUTAMOL] for Wheezing, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Rhinitis, at an unspecified dose and frequency. On 25-Mar-2021, WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PAIN (body aches), RHINORRHOEA (nose was running) and PYREXIA (fever up to 101.5 F) outcome was unknown and LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), MYALGIA (muscle aches) and PYREXIA (low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Pyrexia: 38.6 celsius (High) 101.5 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: body aches; wheezing; Dry cough; coughed up a plug of thick yellow mucus once; nose was running; swollen glands under her right arm and throat; face felt slightly swollen (tight); bone aches; nasal congestion; chills; fever up to 101.5 F; nausea; muscle aches; low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once) and RHINORRHOEA (nose was running) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Lyme disease, Seasonal allergy, Food allergy and Nasal congestion. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), RHINORRHOEA (nose was running), LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (fever up to 101.5 F), NAUSEA (nausea), MYALGIA (muscle aches) and PYREXIA (low grade fever). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Pain, at a dose of 1000 mg; ALBUTEROL [SALBUTAMOL] for Wheezing, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Rhinitis, at an unspecified dose and frequency. On 25-Mar-2021, WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PAIN (body aches), RHINORRHOEA (nose was running) and PYREXIA (fever up to 101.5 F) outcome was unknown and LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), MYALGIA (muscle aches) and PYREXIA (low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Pyrexia: 38.6 celsius (High) 101.5 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Believes Wrong vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Believes Wrong vaccine administered) in a male 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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Believes Wrong vaccine administered). At the time of the report, WRONG PRODUCT ADMINISTERED (Believes Wrong vaccine administered) had resolved.       Reporter did not allow further contact; Sender's Comments: This report refers to a case of wrong product administered for mRNA-1273, with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness on the whole left side of body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness on the whole left side of body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation.     The patient's past medical history included Stroke.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on the whole left side of body). At the time of the report, HYPOAESTHESIA (numbness on the whole left side of body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm - slightly more sever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm - slightly more sever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0120M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (Sore arm - slightly more sever). On 16-Jan-2021, MYALGIA (Sore arm - slightly more sever) had resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-056303 (E2B Linked Report). This case was linked to MOD-2021-056303 (Patient Link).; Sender's Comments:  MOD-2021-056303:Case 1 of 2
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: Headache; sore throat; feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and FEELING ABNORMAL (feeling really bad) in a male 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.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and FEELING ABNORMAL (feeling really bad). At the time of the report, HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and FEELING ABNORMAL (feeling really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided No concomitant medications were provided
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Stomach is upset; Arm is swollen; Red; Low grade fever; Very nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach is upset), PERIPHERAL SWELLING (Arm is swollen), FEELING ABNORMAL (Red), PYREXIA (Low grade fever) and NAUSEA (Very nauseated) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ALLERGAN) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, Lizum for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach is upset), PERIPHERAL SWELLING (Arm is swollen), FEELING ABNORMAL (Red), PYREXIA (Low grade fever) and NAUSEA (Very nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach is upset), PERIPHERAL SWELLING (Arm is swollen), FEELING ABNORMAL (Red), PYREXIA (Low grade fever) and NAUSEA (Very nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Pyrexia: 99° to 100° (Low) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the event was not applicable.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the chest) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH (rash on the chest). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash on the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 16-Mar-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 HEADACHE (Severe headaches). At the time of the report, HEADACHE (Severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has no prior history on headaches and migraines. upon the conversation caller confirmed patient has not  visited Primary HCP due to insurance issues, and is going to visit nearest urgent clinic.