chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Alcohol use and Spontaneous abortion on 22-Nov-2020. Concomitant products included FLUTICASONE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.  On 07-Jan-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-Dec-2020 and the estimated date of delivery was 06-Oct-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the first week of the pregnancy. On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Pregnancy test: positive (Positive) positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site reaction, itchy; Injection site reaction, redness; Warm; Tender; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site reaction, itchy), INJECTION SITE ERYTHEMA (Injection site reaction, redness), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (Tender) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site reaction, itchy), INJECTION SITE ERYTHEMA (Injection site reaction, redness), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (Tender). At the time of the report, VACCINATION SITE PRURITUS (Injection site reaction, itchy), INJECTION SITE ERYTHEMA (Injection site reaction, redness), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (Tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Injection site pain, Maternal exposure during pregnancy
Clinical narrative: soreness at the site of injection; Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INJECTION SITE PAIN (soreness at the site of injection) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness at the site of injection). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (soreness at the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood glucose increased: 20 (High) Blood sugar elevated from 10 to 20 points..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Jul-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects she got after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects she got after receiving the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects she got after receiving the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects she got after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Pain in extremity, Vertigo
Clinical narrative: almost stumbled; dizzy/lightheaded; felt like my head was swimming/loopy on the head; Arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of FALL (almost stumbled) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (almost stumbled). At the time of the report, FALL (almost stumbled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen.  No concomitant medication was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: Pregnancy; Pain at injection site (L); This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at injection site (L)) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included Live birth and Migraine headache (Stable OTC before pregnancy) on 01-Jan-2000. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) from 01-Jan-2020 to 01-Jan-2020 for Migraine, LETROZOLE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was 09-Jun-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Pain at injection site (L)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy. The delivery occurred, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. The patient was treated with PARACETAMOL (TYLENOL) on 06-Jan-2021 for Adverse event, at a dose of UNK, bid. On 07-Jan-2021, VACCINATION SITE PAIN (Pain at injection site (L)) had resolved. On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had ultrasounds in December 2020 and January 2021, results were unknown. Estimated date of conception 18-sept-2021,date of positive pregnancy test 01-oct-2020 and Date of last menstrual period 02-sept-2021 was reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Severe constipation; This spontaneous case was reported by an other caregiver and describes the occurrence of CONSTIPATION (Severe constipation) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CONSTIPATION (Severe constipation). At the time of the report, CONSTIPATION (Severe constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Event assessment updated from not provided to not related.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Real muscle pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of   in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O13LZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational hypertension (Single umblical artery) on 02-Feb-2019, Spontaneous abortion (on an unknown date of April 2018.) in April 2018 and Pregnancy (Live full term birth.) on 02-Feb-2019. Concurrent medical conditions included Alcohol use (3 drinks a year). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), DOCUSATE SODIUM (COLACE), MAGNESIUM and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 05-Jan-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Aug-2020 and the estimated date of delivery was 25-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 3600 grams (7lbs 15oz). The outcome was reported as Term Birth w/o Complications. there was a complication of Complete placenta Previa during this pregnancy. On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unspecified date, lab test also included genetic testing; however, result was normal.  Number of fetus was found to be one.   Patient delivered a live full-term baby on ??-???-2021. Patient had no complications related to pregnancy and the patient gave birth to male baby with no abnormalities.  Treatment information was not provided.   This case was linked to MOD-2021-237477 (Parent-Child Link).   See case MOD-2021-237477 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up document included outcome of pregnancy and patient demographics (gender and weight).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Injection site erythema, Injection site pruritus, Injection site swelling, Joint injury
Clinical narrative: fell; Hurt her wrist; itchy; large round redness; a little bit of swelling and looked like she got hit in the arm with a baseball; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FALL (fell), INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (large round redness), INJECTION SITE SWELLING (a little bit of swelling and looked like she got hit in the arm with a baseball) and JOINT INJURY (Hurt her wrist) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CENTRUM VITAMINTS, VITAMIN D NOS, METOPROLOL, GABAPENTIN, ROSUVASTATIN, WARFARIN, LEVOTHYROXINE and FISH OIL for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (large round redness) and INJECTION SITE SWELLING (a little bit of swelling and looked like she got hit in the arm with a baseball). On an unknown date, the patient experienced FALL (fell) and JOINT INJURY (Hurt her wrist). At the time of the report, FALL (fell), INJECTION SITE PRURITUS (itchy), INJECTION SITE ERYTHEMA (large round redness), INJECTION SITE SWELLING (a little bit of swelling and looked like she got hit in the arm with a baseball) and JOINT INJURY (Hurt her wrist) 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.   Treatment: Medrol for hurting wrist.  No treatment for the rest of the events.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate irregular, Illness, Pain in extremity
Clinical narrative: Heart rate went up and down and was very irregular; Runny nose; Light Cough; Headache; Arm hurt a little bit; Felt a little sick; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm hurt a little bit) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was tested positive on 15-DEC-2020) on 15-Dec-2020.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache), PAIN IN EXTREMITY (Arm hurt a little bit) and ILLNESS (Felt a little sick). On 14-Jan-2021, HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm hurt a little bit) had resolved. At the time of the report, ILLNESS (Felt a little sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Heart rate went up and down and was very irregular; Runny nose; Light Cough; Headache; Arm hurt a little bit; Felt a little sick; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm hurt a little bit) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was tested positive on 15-DEC-2020) on 15-Dec-2020.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache), PAIN IN EXTREMITY (Arm hurt a little bit) and ILLNESS (Felt a little sick). On 14-Jan-2021, HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm hurt a little bit) had resolved. At the time of the report, ILLNESS (Felt a little sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The arm around the area where the shot was red; very warm; there was a bump; It was a rash 6 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The arm around the area where the shot was red), VACCINATION SITE WARMTH (very warm), VACCINATION SITE SWELLING (there was a bump) and VACCINATION SITE RASH (It was a rash 6 inches in diameter) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (The arm around the area where the shot was red), VACCINATION SITE WARMTH (very warm), VACCINATION SITE SWELLING (there was a bump) and VACCINATION SITE RASH (It was a rash 6 inches in diameter). At the time of the report, VACCINATION SITE ERYTHEMA (The arm around the area where the shot was red), VACCINATION SITE WARMTH (very warm), VACCINATION SITE SWELLING (there was a bump) and VACCINATION SITE RASH (It was a rash 6 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 06-Jun-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: redness; swelling; soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol before the injection and Benadryl (2 nights before sleeping) after injection.  No concomitant medication was provided.    This case was linked to MOD21-10243 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Drug start date, patient details, treatment, event updated; Sender's Comments:  MOD21-10243:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: received the 1st Moderna vaccine and is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Oct-2020 and the estimated date of delivery was 30-Jul-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 210120031) for COVID-19 vaccination.     The patient's past medical history included Human papilloma virus infection in November 2020. Previously administered products included for an unreported indication: HPV VACCINE (She had the complete series of the HPV vaccine). Concurrent medical conditions included Pregnancy since 15-Sep-2020. Concomitant products included IRON FERROUS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 22-Jun-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Premature labour
Clinical narrative: Preterm labor; Arm  was a little bit sore; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREMATURE LABOUR (Preterm labor), MYALGIA (Arm  was a little bit sore) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004N20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Sulfa (not sure)). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 23-Mar-2021. On 26-Jan-2021, the patient experienced MYALGIA (Arm  was a little bit sore) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 29-Jan-2021, the patient experienced PREMATURE LABOUR (Preterm labor). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PREMATURE LABOUR (Preterm labor) and MYALGIA (Arm  was a little bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.  Patient 32 weeks pregnant at the time of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: No specific follow-up information recorded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant during both vaccinations) and MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding since) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 05-Dec-2020 to an unknown date and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 8:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-May-2020 and the estimated date of delivery was 24-Feb-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant during both vaccinations). On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding since). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The vaginal delivery occurred on 25-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3560 grams (7lbs 14oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Baby's length was 53.3 cm and head circumference was 33 cm.. There was no fetal abnormalities at the time of delivery or after 1 month pot-partum. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant during both vaccinations) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding since) had resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2020, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Patient stated that she had known pregnancy prior to vaccination. There were no complications with pregnancy, delivery, or infant. She is breast feeding the infant. Patient also stated that that there is no adverse event caused to her child after breastfeeding. This case was linked to MOD-2021-120553 (Parent-Child Link). See case MOD-2021-120553 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 contains significant information. The primary reporter details were updated. The lab data has been added.  New event has been added.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dysarthria, Dyspnoea
Clinical narrative: Difficulty breathing; Slurred speech; Odd chest pain; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA (Slurred speech), CHEST PAIN (Odd chest pain), DIZZINESS (Dizzy) and DYSPNOEA (Difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20a) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DYSARTHRIA (Slurred speech), CHEST PAIN (Odd chest pain) and DIZZINESS (Dizzy). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSARTHRIA (Slurred speech), CHEST PAIN (Odd chest pain), DIZZINESS (Dizzy) and DYSPNOEA (Difficulty breathing) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided. Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Myalgia, Pain in extremity, Pregnancy test
Clinical narrative: arm soreness; muscle aches all over the body; Fatigue; 5 months pregnant;received both doses of Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a paramedic and describes the occurrence of PAIN IN EXTREMITY (arm soreness), MATERNAL EXPOSURE DURING PREGNANCY (5 months pregnant;received both doses of Moderna COVID-19 vaccine), MYALGIA (muscle aches all over the body) and FATIGUE (Fatigue) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Delivery (Patient had Pre-Eclampsia (week 38) Pregnancy outcome: Live, Full-term birth) on 28-Nov-2018. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Sep-2020 and the estimated date of delivery was 17-Jun-2021. On 27-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (5 months pregnant;received both doses of Moderna COVID-19 vaccine). On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), MYALGIA (muscle aches all over the body) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth month of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (5 months pregnant;received both doses of Moderna COVID-19 vaccine) had resolved. On 28-Jan-2021, PAIN IN EXTREMITY (arm soreness), MYALGIA (muscle aches all over the body) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported of having an allergy to dairy products.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Delayed hypersensitivity reaction; About 5 to 8 cm diameter pruritus around the injection site; About 5 to 8 cm diameter redness around the injection site; About 5 to 8 cm diameter swelling around the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), VACCINATION SITE PRURITUS (About 5 to 8 cm diameter pruritus around the injection site), VACCINATION SITE ERYTHEMA (About 5 to 8 cm diameter redness around the injection site) and VACCINATION SITE SWELLING (About 5 to 8 cm diameter swelling around the injection site) 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 TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), VACCINATION SITE PRURITUS (About 5 to 8 cm diameter pruritus around the injection site), VACCINATION SITE ERYTHEMA (About 5 to 8 cm diameter redness around the injection site) and VACCINATION SITE SWELLING (About 5 to 8 cm diameter swelling around the injection site). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), VACCINATION SITE PRURITUS (About 5 to 8 cm diameter pruritus around the injection site), VACCINATION SITE ERYTHEMA (About 5 to 8 cm diameter redness around the injection site) and VACCINATION SITE SWELLING (About 5 to 8 cm diameter swelling around the injection site) 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.   No concomitant medications were reported No treatment medications were reported This was reported by a physician,  who wrote 12 men experienced an 8th day delayed hypersensitivity reaction to the first shot of Moderna COVID vaccine(about 5 to 8 cm diameter redness, swelling and pruritus around the injection site which lasts 4 days to a week).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: fatigue; nausea; low grade fever; unbelievable chills; leftside pain in hip joints/razor sharp joint pains; injection site pain; leftside pain in fingers and toes; swollen tongue; rash; Wild Dizziness; Difficulty breathing; facial swelling; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate) and PAIN IN EXTREMITY (leftside pain in fingers and toes) in a 60-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.     The patient's past medical history included COVID-19 (per patient she had undiagnosed covid-19 for three months in 2020 (from February through April). With it she had  super dry bronchial tubes, the doctor said she had asthma without examining her- over teleconference. She had respiratory and heart symptoms with covid-19. she was fuzzy headed with decreased mental sharpness with the covid-19.  It is better now.) from February 2020 to April 2020.    On 29-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 4:00 PM, the patient experienced DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), SWOLLEN TONGUE (swollen tongue) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (leftside pain in fingers and toes), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain). At the time of the report, DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), PAIN IN EXTREMITY (leftside pain in fingers and toes), SWOLLEN TONGUE (swollen tongue), RASH (rash), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient had no history of allergies. Patient took diphenhydramine to treat her symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fatigue; nausea; low grade fever; unbelievable chills; leftside pain in hip joints/razor sharp joint pains; injection site pain; leftside pain in fingers and toes; swollen tongue; rash; Wild Dizziness; Difficulty breathing; facial swelling; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate) and PAIN IN EXTREMITY (leftside pain in fingers and toes) in a 60-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.     The patient's past medical history included COVID-19 (per patient she had undiagnosed covid-19 for three months in 2020 (from February through April). With it she had  super dry bronchial tubes, the doctor said she had asthma without examining her- over teleconference. She had respiratory and heart symptoms with covid-19. she was fuzzy headed with decreased mental sharpness with the covid-19.  It is better now.) from February 2020 to April 2020.    On 29-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 4:00 PM, the patient experienced DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), SWOLLEN TONGUE (swollen tongue) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (leftside pain in fingers and toes), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain). At the time of the report, DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), PAIN IN EXTREMITY (leftside pain in fingers and toes), SWOLLEN TONGUE (swollen tongue), RASH (rash), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient had no history of allergies. Patient took diphenhydramine to treat her symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Swollen tongue
Clinical narrative: fatigue; nausea; low grade fever; unbelievable chills; leftside pain in hip joints/razor sharp joint pains; injection site pain; leftside pain in fingers and toes; swollen tongue; rash; Wild Dizziness; Difficulty breathing; facial swelling; fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate) and PAIN IN EXTREMITY (leftside pain in fingers and toes) in a 60-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.     The patient's past medical history included COVID-19 (per patient she had undiagnosed covid-19 for three months in 2020 (from February through April). With it she had  super dry bronchial tubes, the doctor said she had asthma without examining her- over teleconference. She had respiratory and heart symptoms with covid-19. she was fuzzy headed with decreased mental sharpness with the covid-19.  It is better now.) from February 2020 to April 2020.    On 29-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 4:00 PM, the patient experienced DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), SWOLLEN TONGUE (swollen tongue) and RASH (rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (leftside pain in fingers and toes), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain). At the time of the report, DIZZINESS (Wild Dizziness), DYSPNOEA (Difficulty breathing), SWELLING FACE (facial swelling), HEART RATE INCREASED (fast heart rate), PAIN IN EXTREMITY (leftside pain in fingers and toes), SWOLLEN TONGUE (swollen tongue), RASH (rash), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (low grade fever), CHILLS (unbelievable chills), ARTHRALGIA (leftside pain in hip joints/razor sharp joint pains) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient had no history of allergies. Patient took diphenhydramine to treat her symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: bad nauseas (which are "driving her crazy"); body aches; Body aches and head aches since Saturday morning; Bad chills since Saturday morning; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (bad nauseas (which are "driving her crazy")), MYALGIA (body aches), HEADACHE (Body aches and head aches since Saturday morning) and CHILLS (Bad chills since Saturday morning) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced NAUSEA (bad nauseas (which are "driving her crazy")), MYALGIA (body aches), HEADACHE (Body aches and head aches since Saturday morning) and CHILLS (Bad chills since Saturday morning). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NAUSEA (bad nauseas (which are "driving her crazy")), MYALGIA (body aches), HEADACHE (Body aches and head aches since Saturday morning) and CHILLS (Bad chills since Saturday morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient took medications to treat nausea.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI On 07-Jun-2021: Event outcome updated and patient declined for further FU.