chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: body aches; arm is so painful; diarrhea little bit.; chills; fever of 99 degree; nausea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (arm is so painful), DIARRHOEA (diarrhea little bit.), CHILLS (chills) and PYREXIA (fever of 99 degree) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (arm is so painful), DIARRHOEA (diarrhea little bit.), CHILLS (chills), PYREXIA (fever of 99 degree), NAUSEA (nausea) and VOMITING (throwing up). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (arm is so painful), DIARRHOEA (diarrhea little bit.), CHILLS (chills), PYREXIA (fever of 99 degree), NAUSEA (nausea) and VOMITING (throwing up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Pyrexia: 99 (Inconclusive) patient reports fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient asked whether she can take Tylenol and Advil for her body aches.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Cough, Dizziness postural, Dyspnoea
Clinical narrative: Right arm pain / can't lay on right arm; Right arm feels like it is on fire; Hurting everywhere; Feels horrible; Dizzy when standing; Cant walk  very good; Shortness of breath; Ill; Cough; Right arm  heavy; Throwing up; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible) and DIZZINESS POSTURAL (Dizzy when standing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003821A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-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 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain / can't lay on right arm) and LIMB DISCOMFORT (Right arm  heavy). 22-Apr-2021, the patient experienced BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 21-Apr-2021 at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) on 21-Apr-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), LIMB DISCOMFORT (Right arm  heavy), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Motrin and Zofran .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Limb discomfort, Malaise, Pain
Clinical narrative: Right arm pain / can't lay on right arm; Right arm feels like it is on fire; Hurting everywhere; Feels horrible; Dizzy when standing; Cant walk  very good; Shortness of breath; Ill; Cough; Right arm  heavy; Throwing up; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible) and DIZZINESS POSTURAL (Dizzy when standing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003821A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-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 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain / can't lay on right arm) and LIMB DISCOMFORT (Right arm  heavy). 22-Apr-2021, the patient experienced BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 21-Apr-2021 at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) on 21-Apr-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), LIMB DISCOMFORT (Right arm  heavy), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Motrin and Zofran .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Right arm pain / can't lay on right arm; Right arm feels like it is on fire; Hurting everywhere; Feels horrible; Dizzy when standing; Cant walk  very good; Shortness of breath; Ill; Cough; Right arm  heavy; Throwing up; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible) and DIZZINESS POSTURAL (Dizzy when standing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003821A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-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 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain / can't lay on right arm) and LIMB DISCOMFORT (Right arm  heavy). 22-Apr-2021, the patient experienced BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 21-Apr-2021 at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) on 21-Apr-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), LIMB DISCOMFORT (Right arm  heavy), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Motrin and Zofran .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: unable to raise left arm; he had sore left arm; had sore in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (unable to raise left arm), MYALGIA (he had sore left arm) and ARTHRALGIA (had sore in shoulder) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced MOBILITY DECREASED (unable to raise left arm), MYALGIA (he had sore left arm) and ARTHRALGIA (had sore in shoulder). On 21-Apr-2021, MOBILITY DECREASED (unable to raise left arm), MYALGIA (he had sore left arm) and ARTHRALGIA (had sore in shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non significant follow up received on 26-MAY-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) 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 20-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 PAIN IN EXTREMITY (arm was really sore). At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs included no treatment drugs included
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Malaise, Pain, Paraesthesia
Clinical narrative: Very sick; Injection site soreness; Flu like; Temperature of 101.6; Soreness; Tingling from the left shoulder down to my hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PARAESTHESIA (Tingling from the left shoulder down to my hand), INFLUENZA LIKE ILLNESS (Flu like), MALAISE (Very sick) and PYREXIA (Temperature of 101.6) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO INFORMATION WAS ADDED.  Concurrent medical conditions included Lung cancer since 08-Feb-2016. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for Diabetes mellitus, HYDROCODONE for Pain, PEMBROLIZUMAB (KEYTRUDA), ZOLEDRONIC ACID (ZOMETA LIVI) and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) 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 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On 19-Mar-2021, the patient experienced PAIN (Soreness) and PARAESTHESIA (Tingling from the left shoulder down to my hand). On 20-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like) and PYREXIA (Temperature of 101.6). On an unknown date, the patient experienced MALAISE (Very sick) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, PAIN (Soreness), PARAESTHESIA (Tingling from the left shoulder down to my hand), MALAISE (Very sick) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like) and PYREXIA (Temperature of 101.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: 101.6 (Inconclusive) Temperature of 101.6 was reported..         No treatment information was provided.   This case was linked to MOD-2021-085755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information included, medical history, laboratory data, concomitant product with indications, new event ( fever, tingling arm, feeling sick, flu like symptoms) were updated. On 26-May-2021: significant follow up
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Very sick; Injection site soreness; Flu like; Temperature of 101.6; Soreness; Tingling from the left shoulder down to my hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PARAESTHESIA (Tingling from the left shoulder down to my hand), INFLUENZA LIKE ILLNESS (Flu like), MALAISE (Very sick) and PYREXIA (Temperature of 101.6) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO INFORMATION WAS ADDED.  Concurrent medical conditions included Lung cancer since 08-Feb-2016. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for Diabetes mellitus, HYDROCODONE for Pain, PEMBROLIZUMAB (KEYTRUDA), ZOLEDRONIC ACID (ZOMETA LIVI) and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) 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 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On 19-Mar-2021, the patient experienced PAIN (Soreness) and PARAESTHESIA (Tingling from the left shoulder down to my hand). On 20-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like) and PYREXIA (Temperature of 101.6). On an unknown date, the patient experienced MALAISE (Very sick) and VACCINATION SITE PAIN (Injection site soreness). At the time of the report, PAIN (Soreness), PARAESTHESIA (Tingling from the left shoulder down to my hand), MALAISE (Very sick) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like) and PYREXIA (Temperature of 101.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Body temperature: 101.6 (Inconclusive) Temperature of 101.6 was reported..         No treatment information was provided.   This case was linked to MOD-2021-085755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information included, medical history, laboratory data, concomitant product with indications, new event ( fever, tingling arm, feeling sick, flu like symptoms) were updated. On 26-May-2021: significant follow up
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: headache; hot rash on chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and RASH (hot rash on chest and neck) 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 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (headache) and RASH (hot rash on chest and neck). The patient was treated with PARACETAMOL (TYNELOL) on 19-Apr-2021 for Headache, at a dose of 1 dosage form. On 20-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, RASH (hot rash on chest and neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant was provided
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Yesterday early in the morning, she started with high fever; Nausea; Headache; She also started vomiting; She started with diarrhea yesterday afternoon; Patient started with sore arm in afternoon after receiving 2nd dose; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose), PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (She also started vomiting) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM (ATIVAN) and COPD inhaler for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose). On 21-Apr-2021, the patient experienced PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache), VOMITING (She also started vomiting) and DIARRHOEA (She started with diarrhea yesterday afternoon). The patient was treated with NUTRIENTS NOS (ENSURE [NUTRIENTS NOS]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose), PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache), VOMITING (She also started vomiting) and DIARRHOEA (She started with diarrhea yesterday afternoon) outcome was unknown. Not Provided
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Yesterday early in the morning, she started with high fever; Nausea; Headache; She also started vomiting; She started with diarrhea yesterday afternoon; Patient started with sore arm in afternoon after receiving 2nd dose; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose), PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (She also started vomiting) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM (ATIVAN) and COPD inhaler for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose). On 21-Apr-2021, the patient experienced PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache), VOMITING (She also started vomiting) and DIARRHOEA (She started with diarrhea yesterday afternoon). The patient was treated with NUTRIENTS NOS (ENSURE [NUTRIENTS NOS]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Patient started with sore arm in afternoon after receiving 2nd dose), PYREXIA (Yesterday early in the morning, she started with high fever), NAUSEA (Nausea), HEADACHE (Headache), VOMITING (She also started vomiting) and DIARRHOEA (She started with diarrhea yesterday afternoon) outcome was unknown. Not Provided
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Morning sickness
Clinical narrative: Exposure during Pregnancy; Morning sickness all day; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) and MORNING SICKNESS (Morning sickness all day) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 031AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (DICLEGIS) for Morning sickness, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and VITAMIN B12 [VITAMIN B12 NOS] 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 22-Apr-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 18-Nov-2021. In April 2021, the patient experienced MORNING SICKNESS (Morning sickness all day). On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Exposure during Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 22-Apr-2021, EXPOSURE DURING PREGNANCY (Exposure during Pregnancy) had resolved. At the time of the report, MORNING SICKNESS (Morning sickness all day) outcome was unknown. Not Provided          Patient described she had a history of having morning sickness with previous pregnancy which lasted up until birth. Action taken with mRNA 1273 in response to the Events is not applicable. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Vomiting, Weight decreased
Clinical narrative: Has lost 15 pounds; Unable to eat; Either has diarrhea or vomits right away; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Has lost 15 pounds), FEEDING DISORDER (Unable to eat) and VOMITING (Either has diarrhea or vomits right away) 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 WEIGHT DECREASED (Has lost 15 pounds), FEEDING DISORDER (Unable to eat) and VOMITING (Either has diarrhea or vomits right away). At the time of the report, WEIGHT DECREASED (Has lost 15 pounds), FEEDING DISORDER (Unable to eat) and VOMITING (Either has diarrhea or vomits right away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Action taken with mRNA-1273 in response to the event was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-086413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086413:Case for Daughter
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Back pain, Chills
Clinical narrative: red hot blotch on his arm; bloated, extended stomach and gas; Gas after 2nd dose; stomach hurt; couldn't eat; couldn't get out of bed because he didn't have any muscle/muscle pain; fatigue; joint pain/pains in wrists, shoulder; chills; vomiting; fever; sweating; shaking; Pains in neck; pains in lower back; lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt) and FEEDING DISORDER (couldn't eat) in a 73-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.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeding disorder, Flatulence, Hyperhidrosis
Clinical narrative: red hot blotch on his arm; bloated, extended stomach and gas; Gas after 2nd dose; stomach hurt; couldn't eat; couldn't get out of bed because he didn't have any muscle/muscle pain; fatigue; joint pain/pains in wrists, shoulder; chills; vomiting; fever; sweating; shaking; Pains in neck; pains in lower back; lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt) and FEEDING DISORDER (couldn't eat) in a 73-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.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pyrexia, Tremor, Vomiting
Clinical narrative: red hot blotch on his arm; bloated, extended stomach and gas; Gas after 2nd dose; stomach hurt; couldn't eat; couldn't get out of bed because he didn't have any muscle/muscle pain; fatigue; joint pain/pains in wrists, shoulder; chills; vomiting; fever; sweating; shaking; Pains in neck; pains in lower back; lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt) and FEEDING DISORDER (couldn't eat) in a 73-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.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: red hot blotch on his arm; bloated, extended stomach and gas; Gas after 2nd dose; stomach hurt; couldn't eat; couldn't get out of bed because he didn't have any muscle/muscle pain; fatigue; joint pain/pains in wrists, shoulder; chills; vomiting; fever; sweating; shaking; Pains in neck; pains in lower back; lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt) and FEEDING DISORDER (couldn't eat) in a 73-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.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No concomitant medications reported.  The patient's past medical history included COVID-19.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headaches) outcome was unknown. Not Provided          No concomitant drugs reported. She was experiencing headaches after 10 days. Symptoms are ongoing.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: ricked twice by the same needle - there are 2 holes next to each other; ricked twice by the same needle - there are 2 holes next to each other; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (ricked twice by the same needle - there are 2 holes next to each other) and PRODUCT ADMINISTRATION ERROR (ricked twice by the same needle - there are 2 holes next to each other) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (ricked twice by the same needle - there are 2 holes next to each other) and PRODUCT ADMINISTRATION ERROR (ricked twice by the same needle - there are 2 holes next to each other). At the time of the report, INCORRECT DOSE ADMINISTERED (ricked twice by the same needle - there are 2 holes next to each other) and PRODUCT ADMINISTRATION ERROR (ricked twice by the same needle - there are 2 holes next to each other) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: hives; left foot was sore; swelling of feet; Itching of the area of rash; Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh; Ring like rash at the injection site; Headaches in the morning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PAIN IN EXTREMITY (left foot was sore), PERIPHERAL SWELLING (swelling of feet), RASH PRURITIC (Itching of the area of rash) and RASH (Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN and PIOGLITAZONE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (Itching of the area of rash), RASH (Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh), VACCINATION SITE RASH (Ring like rash at the injection site) and HEADACHE (Headaches in the morning). On an unknown date, the patient experienced URTICARIA (hives), PAIN IN EXTREMITY (left foot was sore) and PERIPHERAL SWELLING (swelling of feet). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), PAIN IN EXTREMITY (left foot was sore), PERIPHERAL SWELLING (swelling of feet), RASH PRURITIC (Itching of the area of rash), RASH (Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh) and VACCINATION SITE RASH (Ring like rash at the injection site) outcome was unknown and HEADACHE (Headaches in the morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow-up. Events added urticaria, pain in extremity and peripheral swelling.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site rash
Clinical narrative: hives; left foot was sore; swelling of feet; Itching of the area of rash; Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh; Ring like rash at the injection site; Headaches in the morning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PAIN IN EXTREMITY (left foot was sore), PERIPHERAL SWELLING (swelling of feet), RASH PRURITIC (Itching of the area of rash) and RASH (Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN and PIOGLITAZONE for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (Itching of the area of rash), RASH (Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh), VACCINATION SITE RASH (Ring like rash at the injection site) and HEADACHE (Headaches in the morning). On an unknown date, the patient experienced URTICARIA (hives), PAIN IN EXTREMITY (left foot was sore) and PERIPHERAL SWELLING (swelling of feet). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), PAIN IN EXTREMITY (left foot was sore), PERIPHERAL SWELLING (swelling of feet), RASH PRURITIC (Itching of the area of rash), RASH (Rash on the armpit, upper arm, side of abdomen, buttocks and upper thigh) and VACCINATION SITE RASH (Ring like rash at the injection site) outcome was unknown and HEADACHE (Headaches in the morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant follow-up. Events added urticaria, pain in extremity and peripheral swelling.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Peripheral swelling
Clinical narrative: sweats; swellon arm; Headache; fever; nausea; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), PERIPHERAL SWELLING (swellon arm), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Drug allergy (Allergic to codeine).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), PERIPHERAL SWELLING (swellon arm), HEADACHE (Headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats), PERIPHERAL SWELLING (swellon arm), HEADACHE (Headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment products were not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sweats; swellon arm; Headache; fever; nausea; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), PERIPHERAL SWELLING (swellon arm), HEADACHE (Headache), PYREXIA (fever) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome. Concurrent medical conditions included Drug allergy (Allergic to codeine).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), PERIPHERAL SWELLING (swellon arm), HEADACHE (Headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (sweats), PERIPHERAL SWELLING (swellon arm), HEADACHE (Headache), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment products were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: take a lot of meds, then one thing leads to another, it drives me crazy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (take a lot of meds, then one thing leads to another, it drives me crazy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PREGABALIN (LYRICA) for an unknown indication.    No relevant medical history was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form and PREGABALIN (LYRICA) (unknown route) dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (take a lot of meds, then one thing leads to another, it drives me crazy). At the time of the report, FEELING ABNORMAL (take a lot of meds, then one thing leads to another, it drives me crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Urticaria
Clinical narrative: killer headache; chills; full body hives; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (killer headache), CHILLS (chills) and URTICARIA (full body hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product sopelapram for an unknown indication.    Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), rasuvastatin and alandronate for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and sopelapram (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (killer headache), CHILLS (chills) and URTICARIA (full body hives). At the time of the report, HEADACHE (killer headache), CHILLS (chills) and URTICARIA (full body hives) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.