chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Non significant follow up received on 27-MAY-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus after the 1st dose; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus after the 1st dose) and TINNITUS (Ringing in ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (she has had it off and on over the last 8 years) since an unknown date.    On 06-Apr-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 TINNITUS (Tinnitus after the 1st dose) and TINNITUS (Ringing in ears). The patient was treated with CLONAZEPAM (KLONOPIN) for Anxiety, at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus after the 1st dose) and TINNITUS (Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided.
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: Abscessed tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (Abscessed tooth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTH ABSCESS (Abscessed tooth). At the time of the report, TOOTH ABSCESS (Abscessed tooth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported. patient will not get her second injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Paraesthesia oral, Swollen tongue, Tongue thrust
Clinical narrative: I felt my tongue was still swollen with like ridges where the teeth are touching my tongue; I had anxiety; My tongue is pushing my teeth; Tongue felt really weird; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue felt really weird), SWOLLEN TONGUE (I felt my tongue was still swollen with like ridges where the teeth are touching my tongue), ANXIETY (I had anxiety) and TONGUE THRUST (My tongue is pushing my teeth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M02A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, OMEPRAZOLE, ESTRADIOL, CHORIONIC GONADOTROPHIN (PROVIGIL [CHORIONIC GONADOTROPHIN]), ATORVASTATIN, CALCIUM, COLECALCIFEROL, MAGNESIUM (CALCIUM MAGNESIUM + VITAMIN D3), LORATADINE, ALPHA LIPOIC ACID, MACROGOL 3350 (MIRALAX) and VITAMINS NOS for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tongue felt really weird). On 27-Feb-2021, the patient experienced SWOLLEN TONGUE (I felt my tongue was still swollen with like ridges where the teeth are touching my tongue), ANXIETY (I had anxiety) and TONGUE THRUST (My tongue is pushing my teeth). On 05-Apr-2021, SWOLLEN TONGUE (I felt my tongue was still swollen with like ridges where the teeth are touching my tongue) had resolved. At the time of the report, PARAESTHESIA ORAL (Tongue felt really weird), ANXIETY (I had anxiety) and TONGUE THRUST (My tongue is pushing my teeth) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included steroids (prednisone), 6 tablets to take by mouth, 1 tablet three times a day for two days, and was asked to take Zyrtec (Cetirizine HCL) 10 mg by mouth twice a day, doctor provided patient with an EpiPen, Medrol Dosepack (Methylprednisolone). No lab data was provided by the reporter.   This case was linked to MOD-2021-089433 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Fatigue, Feeling abnormal
Clinical narrative: Foggy mind; Fast heart beat; High BP; Chills; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Apr-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 FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/100 (High) BP150/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089068:Case for husband
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased
Clinical narrative: Foggy mind; Fast heart beat; High BP; Chills; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Apr-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 FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Foggy mind), HEART RATE INCREASED (Fast heart beat), BLOOD PRESSURE INCREASED (High BP), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 150/100 (High) BP150/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089068:Case for husband
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Oropharyngeal discomfort, Vomiting
Clinical narrative: patient back of throat is rough and rigid; Chills; Fatigue; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (patient back of throat is rough and rigid), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autistic disorder.   On 20-Apr-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 21-Apr-2021, the patient experienced VOMITING (vomiting). On 22-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (patient back of throat is rough and rigid), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL DISCOMFORT (patient back of throat is rough and rigid), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported. Patient did not have any adverse events from the first dose.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got 2nd dose greater than 42 days interval; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose greater than 42 days interval) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose greater than 42 days interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose greater than 42 days interval) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Rash, Rash pruritic
Clinical narrative: rash is itching and stings; chills; sore muscles; tired; Severe rash all over my body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Apr-2021 and was forwarded to Moderna on 24-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (sore muscles), FATIGUE (tired), RASH (Severe rash all over my body) and RASH PRURITIC (rash is itching and stings) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (chills), MYALGIA (sore muscles), FATIGUE (tired) and RASH (Severe rash all over my body). On 24-Apr-2021, the patient experienced RASH PRURITIC (rash is itching and stings). At the time of the report, CHILLS (chills), MYALGIA (sore muscles), FATIGUE (tired), RASH (Severe rash all over my body) and RASH PRURITIC (rash is itching and stings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age patient inadvertently received 1st dose of the Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient inadvertently received 1st dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient inadvertently received 1st dose of the Moderna vaccine). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient inadvertently received 1st dose of the Moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to MOD-2021-089422 (E2B Linked Report).; Sender's Comments:  MOD-2021-089422:Crosslinked case of same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: side effects for her neighbor who is pregnant and due in June; arm was sore; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY and PAIN IN EXTREMITY in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY and PAIN IN EXTREMITY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved and PAIN IN EXTREMITY outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was due in June.  No treatment information was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Headache, Malaise, Vaccination site pain
Clinical narrative: Lack of eating; Pounding headache; Stomach upset; Not feeling well; Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), MALAISE (Not feeling well), DECREASED APPETITE (Lack of eating), HEADACHE (Pounding headache) and VACCINATION SITE PAIN (Injection arm soreness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, SERTRALINE and LINAGLIPTIN (TRAJENTA) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). On 23-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), MALAISE (Not feeling well) and HEADACHE (Pounding headache). On an unknown date, the patient experienced DECREASED APPETITE (Lack of eating). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), MALAISE (Not feeling well), DECREASED APPETITE (Lack of eating), HEADACHE (Pounding headache) and VACCINATION SITE PAIN (Injection arm soreness) was resolving.        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.   Additional concomitant medications included Pre-plus for weak bone. Patient did not receive any treatment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow up received on 3-AUG-2021,contains new information. Outcome of events were updated to Recovering from unknown. Narrative updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Joint swelling, Pyrexia
Clinical narrative: swollen joints, mainly ankles, knees, elbows, and wrists; sore joints, mainly ankles, knees, elbows, and wrists; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swollen joints, mainly ankles, knees, elbows, and wrists), ARTHRALGIA (sore joints, mainly ankles, knees, elbows, and wrists), CHILLS (chills) and PYREXIA (fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced JOINT SWELLING (swollen joints, mainly ankles, knees, elbows, and wrists), ARTHRALGIA (sore joints, mainly ankles, knees, elbows, and wrists), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swollen joints, mainly ankles, knees, elbows, and wrists) and ARTHRALGIA (sore joints, mainly ankles, knees, elbows, and wrists) had not resolved and CHILLS (chills) and PYREXIA (fever) was resolving.            No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-jun-2021 contains second dose has no side effects and maladies was unrelated to the dose 1.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: She is breastfeeding and she was fine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (She is breastfeeding and she was fine) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (She is breastfeeding and she was fine). At the time of the report, EXPOSURE VIA BREAST MILK (She is breastfeeding and she was fine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chills, Dyspnoea, Headache
Clinical narrative: Rash, rough to the touch, from head to toe; Developed a fever; Chills; Headache; Chest was hurting (clarified as pressure on his chest); Hard to breathe; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), RASH (Rash, rough to the touch, from head to toe) and PYREXIA (Developed a fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), PYREXIA (Developed a fever), CHILLS (Chills) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced RASH (Rash, rough to the touch, from head to toe). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Apr-2021, CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), PYREXIA (Developed a fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, RASH (Rash, rough to the touch, from head to toe) was resolving.            No concomitant medications were reported.  At the time of follow up report, patient was doing fine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received and updated the outcome of event (rash) from unknown to recovering and updated narrative.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, rough to the touch, from head to toe; Developed a fever; Chills; Headache; Chest was hurting (clarified as pressure on his chest); Hard to breathe; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), RASH (Rash, rough to the touch, from head to toe) and PYREXIA (Developed a fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), PYREXIA (Developed a fever), CHILLS (Chills) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced RASH (Rash, rough to the touch, from head to toe). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Apr-2021, CHEST DISCOMFORT (Chest was hurting (clarified as pressure on his chest)), DYSPNOEA (Hard to breathe), BACK PAIN (Back pain), PYREXIA (Developed a fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, RASH (Rash, rough to the touch, from head to toe) was resolving.            No concomitant medications were reported.  At the time of follow up report, patient was doing fine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information received and updated the outcome of event (rash) from unknown to recovering and updated narrative.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: feverish; feeling like I do not want to do anything; low grade fever 88-99; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), FEELING ABNORMAL (feeling like I do not want to do anything) and PYREXIA (low grade fever 88-99) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included NIFEDIPINE, LISINOPRIL, FUROSEMIDE, COLECALCIFEROL (VITAMIN D 3), TURMERIC [CURCUMA LONGA RHIZOME], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and MOVE FREE ADVANCED for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (feverish), FEELING ABNORMAL (feeling like I do not want to do anything) and PYREXIA (low grade fever 88-99). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BAYERS ASPIRIN) at a dose of UNK, bid. At the time of the report, PYREXIA (feverish), FEELING ABNORMAL (feeling like I do not want to do anything) and PYREXIA (low grade fever 88-99) was resolving. Not Provided      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.   additional concomitant medications include multi vitamin , calcium magnesium  zinc, fish oil.
Sex: U
Vaccine: COVID19
Symptoms: Intentional product use issue, SARS-CoV-2 test positive
Clinical narrative: Positive result for covid-19; deferred vaccination for 90 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive result for covid-19) and INTENTIONAL PRODUCT USE ISSUE (deferred vaccination for 90 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive result for covid-19) and INTENTIONAL PRODUCT USE ISSUE (deferred vaccination for 90 days). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive result for covid-19) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (deferred vaccination for 90 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  medications provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Influenza like illness, Myalgia, Thinking abnormal
Clinical narrative: hot and cold flashes; he is feeling like he is coming down with the flu; couldn't think straight; fatigue; his muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), INFLUENZA LIKE ILLNESS (he is feeling like he is coming down with the flu), THINKING ABNORMAL (couldn't think straight), FATIGUE (fatigue) and MYALGIA (his muscles hurt) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Sep-2020.    On 21-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), INFLUENZA LIKE ILLNESS (he is feeling like he is coming down with the flu), THINKING ABNORMAL (couldn't think straight), FATIGUE (fatigue) and MYALGIA (his muscles hurt). On 23-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), INFLUENZA LIKE ILLNESS (he is feeling like he is coming down with the flu), THINKING ABNORMAL (couldn't think straight) and MYALGIA (his muscles hurt) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were taken.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site warmth
Clinical narrative: sore arm; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm to touch). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (warm to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Left foot cramping; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Left foot cramping) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Cramps calf in February 2021.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE SPASMS (Left foot cramping). At the time of the report, MUSCLE SPASMS (Left foot cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Breast discomfort, Breast pain, Nausea, Pyrexia
Clinical narrative: All the Moderna Vaccine side effects literally; Left breast feel weird; Lefct breast pain; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (All the Moderna Vaccine side effects literally), BREAST DISCOMFORT (Left breast feel weird), BREAST PAIN (Lefct breast pain), NAUSEA (nausea) and VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026b1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ADVERSE REACTION (All the Moderna Vaccine side effects literally), BREAST DISCOMFORT (Left breast feel weird), BREAST PAIN (Lefct breast pain), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). On 02-Apr-2021, ADVERSE REACTION (All the Moderna Vaccine side effects literally), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) had resolved. At the time of the report, BREAST DISCOMFORT (Left breast feel weird) and BREAST PAIN (Lefct breast pain) 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.   The concomitant medications information was not reported.  Treatment include pain pills.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: All the Moderna Vaccine side effects literally; Left breast feel weird; Lefct breast pain; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (All the Moderna Vaccine side effects literally), BREAST DISCOMFORT (Left breast feel weird), BREAST PAIN (Lefct breast pain), NAUSEA (nausea) and VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026b1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ADVERSE REACTION (All the Moderna Vaccine side effects literally), BREAST DISCOMFORT (Left breast feel weird), BREAST PAIN (Lefct breast pain), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). On 02-Apr-2021, ADVERSE REACTION (All the Moderna Vaccine side effects literally), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) had resolved. At the time of the report, BREAST DISCOMFORT (Left breast feel weird) and BREAST PAIN (Lefct breast pain) 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.   The concomitant medications information was not reported.  Treatment include pain pills.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Heart rate, Nasal congestion, Pain in extremity
Clinical narrative: arm got sore; Worsening cough; Worsening Chest Congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Worsening cough), NASAL CONGESTION (Worsening Chest Congestion) and PAIN IN EXTREMITY (arm got sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Congestion nasal (Prior to both doses, patient had chest congestion.). Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COUGH (Worsening cough) and NASAL CONGESTION (Worsening Chest Congestion). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm got sore). At the time of the report, COUGH (Worsening cough), NASAL CONGESTION (Worsening Chest Congestion) and PAIN IN EXTREMITY (arm got sore) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) heart rate was kind of fast.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included steroids for wheezing and shortness of breath. No treatment information was provided.   This case was linked to MOD-2021-089446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26-May-2021 and updated reporter information, laboratory information,concomitant medication, new events
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm After the First Shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm After the First Shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01B21A and 048B21A) 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 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm After the First Shot). On 25-Mar-2021, PAIN IN EXTREMITY (Sore Arm After the First Shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported. patient not experienced any side effects after second dose.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dizziness, Ear discomfort, Fatigue, Ocular discomfort
Clinical narrative: Pressure in ear and ears are popping; Pressure in eye; Sinuses draining; Herpes inner lip; Opposite arm that received the injection hurts; Tinnitus; Immediately Dizzy; Allergic reaction; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction), TINNITUS (Tinnitus), EAR DISCOMFORT (Pressure in ear and ears are popping) and OCULAR DISCOMFORT (Pressure in eye) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction) and FATIGUE (Tired). On 19-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced EAR DISCOMFORT (Pressure in ear and ears are popping), OCULAR DISCOMFORT (Pressure in eye), SINUSITIS (Sinuses draining), ORAL HERPES (Herpes inner lip) and VACCINATION SITE PAIN (Opposite arm that received the injection hurts). At the time of the report, DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction), TINNITUS (Tinnitus), EAR DISCOMFORT (Pressure in ear and ears are popping), OCULAR DISCOMFORT (Pressure in eye), SINUSITIS (Sinuses draining), ORAL HERPES (Herpes inner lip), FATIGUE (Tired) and VACCINATION SITE PAIN (Opposite arm that received the injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-May-2021 contains non-significant information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Sinusitis, Tinnitus, Vaccination site pain
Clinical narrative: Pressure in ear and ears are popping; Pressure in eye; Sinuses draining; Herpes inner lip; Opposite arm that received the injection hurts; Tinnitus; Immediately Dizzy; Allergic reaction; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction), TINNITUS (Tinnitus), EAR DISCOMFORT (Pressure in ear and ears are popping) and OCULAR DISCOMFORT (Pressure in eye) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction) and FATIGUE (Tired). On 19-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced EAR DISCOMFORT (Pressure in ear and ears are popping), OCULAR DISCOMFORT (Pressure in eye), SINUSITIS (Sinuses draining), ORAL HERPES (Herpes inner lip) and VACCINATION SITE PAIN (Opposite arm that received the injection hurts). At the time of the report, DIZZINESS (Immediately Dizzy), ALLERGY TO VACCINE (Allergic reaction), TINNITUS (Tinnitus), EAR DISCOMFORT (Pressure in ear and ears are popping), OCULAR DISCOMFORT (Pressure in eye), SINUSITIS (Sinuses draining), ORAL HERPES (Herpes inner lip), FATIGUE (Tired) and VACCINATION SITE PAIN (Opposite arm that received the injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-May-2021 contains non-significant information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Dizziness, Fear
Clinical narrative: blood pressure went from 120/70 to 130/100 to 180/110; felt lightheaded; frightened; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure went from 120/70 to 130/100 to 180/110), DIZZINESS (felt lightheaded) and FEAR (frightened) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure went from 120/70 to 130/100 to 180/110), DIZZINESS (felt lightheaded) and FEAR (frightened). At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure went from 120/70 to 130/100 to 180/110), DIZZINESS (felt lightheaded) and FEAR (frightened) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 120/70 normal and 180/110 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Event outcome and reporter's mail ID were updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping; This spontaneous case was reported by a consumer and describes the occurrence of MENORRHAGIA (Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced MENORRHAGIA (Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping). At the time of the report, MENORRHAGIA (Menstrual cycle is abnormal, continued for 7 days instead of 3 days with blood clots / Does not appear to be stopping) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications or medical history provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia, Visual impairment
Clinical narrative: Vision was distorted for about a half hour to an hour; Vision had changed and she wasn't able to see very far; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Vision was distorted for about a half hour to an hour) and VISUAL IMPAIRMENT (Vision had changed and she wasn't able to see very far) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0153) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced METAMORPHOPSIA (Vision was distorted for about a half hour to an hour) and VISUAL IMPAIRMENT (Vision had changed and she wasn't able to see very far). On 10-Apr-2021, METAMORPHOPSIA (Vision was distorted for about a half hour to an hour) and VISUAL IMPAIRMENT (Vision had changed and she wasn't able to see very far) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Skin burning sensation, Tremor
Clinical narrative: burning skin; tremors; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (tremors), SKIN BURNING SENSATION (burning skin) and NAUSEA (nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Mar-2021, the patient experienced NAUSEA (nausea). On 28-Mar-2021, the patient experienced TREMOR (tremors). On 04-Apr-2021, the patient experienced SKIN BURNING SENSATION (burning skin). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Symptomatic treatment, at an unspecified dose and frequency. On 11-Apr-2021, TREMOR (tremors) had resolved. At the time of the report, SKIN BURNING SENSATION (burning skin) outcome was unknown and NAUSEA (nausea) had resolved.            Treatment medications also included steroids.   This case was linked to MOD-2021-089502 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Retching
Clinical narrative: dry heaves; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETCHING (dry heaves) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RETCHING (dry heaves) and CHILLS (chills). At the time of the report, RETCHING (dry heaves) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.