chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Ultrasound scan
Clinical narrative: Exposure to vaccine during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Exposure to vaccine during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE (PULMICORT), LEVOTHYROXINE SODIUM (SYNTHROID), BUDESONIDE and LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 24-Aug-2020 and the estimated date of delivery was 05-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Exposure to vaccine during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week 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 30-Dec-2020, MATERNAL EXPOSURE BEFORE PREGNANCY (Exposure to vaccine during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2020, Ultrasound scan: anatomy scan-wm (Inconclusive) Anatomy scan-WM. On 15-Oct-2020, Ultrasound scan: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   27-SEP-2020, Pregnancy test was Positive.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: This follow-up was received by safety on 09-APR-2021 which reported dose 2 details (date of administration, route of administration and anatomical location), lab test details (Ultrasound), date of LMP, date of conception, best doctor details, ethnicity and race.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site warm to touch; Feeling a little itch on the injection site; Half dollar size flatly swollen injection site; Injection site redness; A spontaneous report  was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program and experienced Injection site itching, then she noticed  a half dollar size, flatly swollen Injection site ,Injection site redness and Injection site warmth.  The patient's medical history and concomitant medications not reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Jan 2021,  the patient developed Injection site itching, then she noticed  a half dollar size, flatly swollen Injection site ,Injection site redness and,Injection site warmth.   The patient did not have her vaccine administration card with her so she was unable to provide her vaccine Lot number, or the name of the provider who administered the vaccine.  The patient reported that she did not take any medication or notify her doctor of the symptoms at the time of the report.  Action taken with Moderna mRNA-1273 was not applicable.  The outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Feeling weak; Body ache; When walking feeling a litle light headed; Really tired; Left arm got sore; Left arm swelling; Chills; Muscle ache; A spontaneous report was received from a healthcare professional concerning a 42-year old, female patient who received Moderna's COVID-19 vaccine and experienced a sore arm, swelling, lightheadedness, chills, muscle ache, feeling tired, feeling weak, and body ache.     The patient's medical history included Covid-19 in December 2020. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient's left arm became sore and swollen. That night, she started to feel lightheaded, chills, and muscle ache. At the time of report, the patient reported feeling tired, feeling weak, chills, body aches and lightheadedness.  Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The events of feeling really tired, feeling weak, chills, body ache, and when walking feeling a little light- headed were ongoing at the time of this report. The outcome of the remaining events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Feeling weak; Body ache; When walking feeling a litle light headed; Really tired; Left arm got sore; Left arm swelling; Chills; Muscle ache; A spontaneous report was received from a healthcare professional concerning a 42-year old, female patient who received Moderna's COVID-19 vaccine and experienced a sore arm, swelling, lightheadedness, chills, muscle ache, feeling tired, feeling weak, and body ache.     The patient's medical history included Covid-19 in December 2020. No relevant concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient's left arm became sore and swollen. That night, she started to feel lightheaded, chills, and muscle ache. At the time of report, the patient reported feeling tired, feeling weak, chills, body aches and lightheadedness.  Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The events of feeling really tired, feeling weak, chills, body ache, and when walking feeling a little light- headed were ongoing at the time of this report. The outcome of the remaining events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in jaw
Clinical narrative: pain travelled to jaw; injection site pain; A spontaneous report was received from a consumer concerning herself, who was an 80-year-old, female patient who received Moderna's COVID-19 vaccine and experienced pain in the place she got the shot and it traveled up to her jaw.  The patient's medical history was not provided. Concomitant products known to have been used by the patient included Clonazepam, Furosemide, Gabapentin, Tramadol And HFA inhaler.  On 04 Jan 2021 at approximately 17:52, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 0251J20A) for prophylaxis of COVID-19 infection.    On 04 Jan 2021 at approximately 22:00, about 4 hours after she received the mRNA-1273 vaccination, the patient experienced Pain in the place she got the shot and it traveled up to her jaw. Patient stated that the shot itself was very simple. Treatment information as stated by the patient included Tramadol and used Marijuana but that did not help the pain.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, pain in the place she got the shot and it traveling up to her jaw, was considered unknown.  The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site was swollen; Rectangle hard lump like; Headache; Hot around the injection/injection site was hot; Red spot aound the injection/little red spot at the injection site again and it's gotten bigger each day/injection site was red; Hurt around the injection; A spontaneous report was received from a consumer, concerning her husband, a 65-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the same day after vaccination, the patient had a red spot that was hot and hurting around the injection, which seemed healing for the first 2 days but worsened after 8 days and turned to hard lump like  a small bump, very itchy and round without pain by 11th day. Patient also had headache on the 5th day and resolved on the same day.Treatment details were not reported.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events around the injection site were not resolved at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site was swollen; Rectangle hard lump like; Headache; Hot around the injection/injection site was hot; Red spot aound the injection/little red spot at the injection site again and it's gotten bigger each day/injection site was red; Hurt around the injection; A spontaneous report was received from a consumer, concerning her husband, a 65-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the same day after vaccination, the patient had a red spot that was hot and hurting around the injection, which seemed healing for the first 2 days but worsened after 8 days and turned to hard lump like  a small bump, very itchy and round without pain by 11th day. Patient also had headache on the 5th day and resolved on the same day.Treatment details were not reported.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events around the injection site were not resolved at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025220A) for COVID-19 vaccination.     The patient's past medical history included Insomnia and Subfertility (female) (Not ovulating so was given IVF.). Concomitant products included TRAZODONE for Insomnia, PROGESTERONE (ENDOMETRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-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 an unknown date and the estimated date of delivery was 03-Sep-2021. On 04-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 04-Jan-2021, EXPOSURE DURING 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.   No treatment information was provided by the reporter. Patient had reported previous pregnancy with live birth having no issues Jun-2017.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female with age unknown. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
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 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025O20A) for COVID-19 vaccination.     The patient's past medical history included Social alcohol drinker (couple drinks a week) and Pregnancy (No complications reported, live, full term birth). Concurrent medical conditions included Drug allergy. Concomitant products included FISH OIL and CIMETIDINE HYDROCHLORIDE (TAGAMET [CIMETIDINE HYDROCHLORIDE]) for an unknown indication, 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].    On 02-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 an unknown date and the estimated date of delivery was 14-Feb-2021. On 02-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 02-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Glucose tolerance test: unknown Did not provide test results.. In June 2020, Pregnancy test: positive (Positive) positive. In June 2020, Ultrasound foetal: unknown Did not provide results of "ultrasonds" but stated she had 3 some were around June 2020..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Previous pregnancy end date was 06 Jun 2021 and outcome of the pregnancy was live birth without complications.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Headache; pain and aches; A spontaneous report was received from a 77 year old female consumer concerning who was participating in the mRNA-1273 Emergency Use Program and experienced flu like symptoms, headache and myalgia.  The patient's medical history was not provided. Concomitant medications reported included pravastatin.  On 2 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 011620A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 2 Jan 2021, after the administration of vaccine, the patient experienced flu like symptoms, headache, pain and aches. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, flu like symptoms, headache and myalgia were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The events of headache and myalgia are listed in CCDS.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site reaction
Clinical narrative: Fatigue; Delayed arm reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delayed arm reaction/injection site muscle reaction and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, 7-9 days post-injection, the patient experienced some sort of reaction including delayed arm reaction and fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events delayed arm reaction and fatigue was not reported.  The outcome of the events, delayed arm reaction and fatigue was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms, fingers, chest, and thighs; A spontaneous report was received from a healthcare professional concerning a 37-year old, male patient who received Moderna's COVID-19 vaccine and developed a rash on his arms, fingers, chest and thighs.    The patient's medical history, as provided by the reporter, included hypertension.  Concomitant medications reported included an unknown hypertension medication.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient got a rash on his arms, fingers, chest, and thighs.  Treatment for the event included diphenhydramine hydrochloride, methylprednisolone, and a third, unknown, medication.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event 11 days after vaccination , a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time.  Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pain, Rhinorrhoea
Clinical narrative: Felt weird; Sore; Runny nose; Massive headache; Body aches; A spontaneous report was received from a male patient of unknown age concerning himself received first dose of mRNA-1273 experienced feeling weird (Feeling abnormal), sore (Pain), had a runny nose (Rhinorrhea), a massive headache (Headache) and body aches (Myalgia).   The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 29-Dec-2020, approximately 3 days prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   One 01-Jan-2021, three days after receiving first dose of mRNA-1273, the patient reported that he felt weird, sore, had a runny nose, a massive headache and body aches.    Treatment for the events was not provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Runny nose; Congestion; Sneezing; A spontaneous report was received from a consumer who is a female patient of unknown age that received Moderna's COVID-19 vaccine (mRNA-1273) and developed a runny nose, nasal congestion, and sneezing.   The patient's medical history and relevant concomitant medications were not reported.   On an unspecified day, in Dec 2020, approximately one week prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) unknown route and unknown arm for prophylaxis of COVID-19 infection.   The patient began experiencing a runny nose, nasal congestion, and sneezing on an unspecified date.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events a runny nose, nasal congestion, and sneezing was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to erythromycin...).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-Jun-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient would like to enroll into the pregnancy registry for the mRNA-1273 vaccine.  The patient's date of positive pregnancy, last menstrual period date and conception date were all not provided. No treatment information was reported. Internal review conducted on 23jul2021 resulted in updates to pregnancy information  This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: delayed hypersensitivity reactions; A spontaneous report was received from physician concerning delayed hypersensitivity reactions in patient of unknown age who had received Moderna's COVID-19 Vaccine.  Medical history and concomitant medications for the patients were not provided by the reporter.   The patients received their first of two planned doses of mRNA-1273 (Lot numbers not provided) on unspecified dates for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced delayed hypersensitivity reactions.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Vomiting; Tiredness; Soreness at site of injection; Muscle pain, body ache; Fever; Chills; A spontaneous report was received from a consumer concerning a 29-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, vomiting, body ache/pain, tiredness/fatigue, soreness at site of injection/vaccination site pain, fatigue and muscle pain/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021 at 3:00 am, the patient developed a fever and chills. Two hours later, his side effects progressed to vomiting, body ache, tiredness, soreness at injection site, fatigue and muscle pain. His fever went from 104 degrees to 101 degrees after taking paracetamol. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events,  experienced fever, chills, vomiting, body ache, tiredness, soreness at site of injection, fatigue and muscle pain was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Tiredness; Soreness at site of injection; Muscle pain, body ache; Fever; Chills; A spontaneous report was received from a consumer concerning a 29-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, vomiting, body ache/pain, tiredness/fatigue, soreness at site of injection/vaccination site pain, fatigue and muscle pain/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021 at 3:00 am, the patient developed a fever and chills. Two hours later, his side effects progressed to vomiting, body ache, tiredness, soreness at injection site, fatigue and muscle pain. His fever went from 104 degrees to 101 degrees after taking paracetamol. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events,  experienced fever, chills, vomiting, body ache, tiredness, soreness at site of injection, fatigue and muscle pain was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: Pregnant; Slight Soreness at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Slight Soreness at injection site) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J-20A) for COVID-19 vaccination.     The patient's past medical history included UTI. Concurrent medical conditions included Depression, Anxiety, Eating disorder and Asthma. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE for Pregnancy, OMEPRAZOLE, BUPROPION, LAMOTRIGINE and IRON for an unknown indication.    On 05-Jan-2021 at 9:15 AM, 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 08-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight Soreness at injection site). On 05-Jan-2021 at 9:15 AM, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 05-Jan-2021 at 9:15 AM, EXPOSURE DURING PREGNANCY (Pregnant) had not resolved. At the time of the report, VACCINATION SITE PAIN (Slight Soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Prenatal screening test: results not provided. In 2020, Prenatal screening test: results not provided. On 04-Jul-2020, Pregnancy test: Positive. On 25-Nov-2020, Glucose tolerance test: results not provided. On 21-Dec-2020, Ultrasound scan: results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the vaccination site pain, a causal relationship cannot be excluded. This case also involves the product exposure during pregnancy with no additional  AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pregnant; Slight Soreness at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Slight Soreness at injection site) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J-20A) for COVID-19 vaccination.     The patient's past medical history included UTI. Concurrent medical conditions included Depression, Anxiety, Eating disorder and Asthma. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE for Pregnancy, OMEPRAZOLE, BUPROPION, LAMOTRIGINE and IRON for an unknown indication.    On 05-Jan-2021 at 9:15 AM, 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 08-Jun-2020 and the estimated date of delivery was 15-Mar-2021. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight Soreness at injection site). On 05-Jan-2021 at 9:15 AM, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 05-Jan-2021 at 9:15 AM, EXPOSURE DURING PREGNANCY (Pregnant) had not resolved. At the time of the report, VACCINATION SITE PAIN (Slight Soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Prenatal screening test: results not provided. In 2020, Prenatal screening test: results not provided. On 04-Jul-2020, Pregnancy test: Positive. On 25-Nov-2020, Glucose tolerance test: results not provided. On 21-Dec-2020, Ultrasound scan: results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the vaccination site pain, a causal relationship cannot be excluded. This case also involves the product exposure during pregnancy with no additional  AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: area is warm to the touch; arm started itching; redness started to expand; A Spontaneous report was received from a physician's assistant concerning a 43 year old female patient and developed itching, redness, and warmth at the injection site on her arm.   The patient's medical history and relevant concomitant medications were not reported.   On 23 Dec 2020, approximately eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her arm for prophylaxis of COVID-19 infection.   The patient experienced itching, redness, and warmth at the injection site on her arm beginning on 01 Jan 2021.  The affected area measured approximately 6 cm by 10 cm.  A steroid was prescribed to treat the events.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itching was reported as recovered on 04 Jan 2021 and redness and warmth at the injection site on her arm were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: Tested positive for covid; Dry cough; Chills; fever of 100.3; headache; Fatigue; arm soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for covid), PAIN IN EXTREMITY (arm soreness), COUGH (Dry cough), CHILLS (Chills) and PYREXIA (fever of 100.3) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Amoxicillin). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), CHILLS (Chills), PYREXIA (fever of 100.3), HEADACHE (headache) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced COUGH (Dry cough). On 07-Jan-2021, the patient experienced COVID-19 (Tested positive for covid). On 05-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, COVID-19 (Tested positive for covid), COUGH (Dry cough), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (arm soreness) and PYREXIA (fever of 100.3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: 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 provided. The patient received the second dose of mRNA-1273 on 30-Jan-2021 in left arm.   Based on the current available information and temporal association between the use of the product and the start date of the events- pain in extremity, cough, chills, and pyrexia, , a causal relationship cannot be excluded.  based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: no new information was reported On 07-Jan-2021: no new information was updated On 09-Apr-2021: Added new event(s).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site pain, chills, pyrexia, headache, fatigues and cough,  a causal relationship cannot be excluded.   Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for covid; Dry cough; Chills; fever of 100.3; headache; Fatigue; arm soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for covid), PAIN IN EXTREMITY (arm soreness), COUGH (Dry cough), CHILLS (Chills) and PYREXIA (fever of 100.3) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Amoxicillin). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), CHILLS (Chills), PYREXIA (fever of 100.3), HEADACHE (headache) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced COUGH (Dry cough). On 07-Jan-2021, the patient experienced COVID-19 (Tested positive for covid). On 05-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, COVID-19 (Tested positive for covid), COUGH (Dry cough), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (arm soreness) and PYREXIA (fever of 100.3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: 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 provided. The patient received the second dose of mRNA-1273 on 30-Jan-2021 in left arm.   Based on the current available information and temporal association between the use of the product and the start date of the events- pain in extremity, cough, chills, and pyrexia, , a causal relationship cannot be excluded.  based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: no new information was reported On 07-Jan-2021: no new information was updated On 09-Apr-2021: Added new event(s).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site pain, chills, pyrexia, headache, fatigues and cough,  a causal relationship cannot be excluded.   Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Vaccination site pain
Clinical narrative: blood sugar levels went out of range; injection site tenderness; difficulty with glucose control; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (injection site tenderness), BLOOD GLUCOSE ABNORMAL (difficulty with glucose control) and BLOOD GLUCOSE INCREASED (blood sugar levels went out of range) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (LISPRO INSULIN), INSULIN DEGLUDEC (TRESIBA), LEVOTHYROXINE SODIUM (LEVOXYL), AMLODIPINE, OLMESARTAN MEDOXOMIL (BENICAR), SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site tenderness) and BLOOD GLUCOSE ABNORMAL (difficulty with glucose control). On 28-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar levels went out of range). On 01-Jan-2021, VACCINATION SITE PAIN (injection site tenderness) had resolved. On 02-Feb-2021, BLOOD GLUCOSE INCREASED (blood sugar levels went out of range) had resolved. At the time of the report, BLOOD GLUCOSE ABNORMAL (difficulty with glucose control) 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Urticaria
Clinical narrative: Felt tiredness; headache; Arm, neck and shoulder pain (where she received shot); Could not sleep well; Hives on forehead and cheek; Felt chills; This spontaneous case was reported by a health care professional and describes the occurrence of INSOMNIA (Could not sleep well), URTICARIA (Hives on forehead and cheek), CHILLS (Felt chills), FATIGUE (Felt tiredness) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia since 10-Oct-2020. Concomitant products included IRON from 01-Jan-2021 to an unknown date for Anemia.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INSOMNIA (Could not sleep well), URTICARIA (Hives on forehead and cheek), CHILLS (Felt chills) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)). On 04-Jan-2021 at 4:00 PM, the patient experienced HEADACHE (headache). On 04-Jan-2021 at 6:00 PM, the patient experienced FATIGUE (Felt tiredness). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Jan-2021, URTICARIA (Hives on forehead and cheek) had resolved. On 05-Jan-2021, INSOMNIA (Could not sleep well) and FATIGUE (Felt tiredness) had resolved. On 06-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, CHILLS (Felt chills) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: follow up received on 24-Mar-2021, medical history added, concomitant medications added, events added, treatment information updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt tiredness; headache; Arm, neck and shoulder pain (where she received shot); Could not sleep well; Hives on forehead and cheek; Felt chills; This spontaneous case was reported by a health care professional and describes the occurrence of INSOMNIA (Could not sleep well), URTICARIA (Hives on forehead and cheek), CHILLS (Felt chills), FATIGUE (Felt tiredness) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia since 10-Oct-2020. Concomitant products included IRON from 01-Jan-2021 to an unknown date for Anemia.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INSOMNIA (Could not sleep well), URTICARIA (Hives on forehead and cheek), CHILLS (Felt chills) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)). On 04-Jan-2021 at 4:00 PM, the patient experienced HEADACHE (headache). On 04-Jan-2021 at 6:00 PM, the patient experienced FATIGUE (Felt tiredness). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Jan-2021, URTICARIA (Hives on forehead and cheek) had resolved. On 05-Jan-2021, INSOMNIA (Could not sleep well) and FATIGUE (Felt tiredness) had resolved. On 06-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, CHILLS (Felt chills) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: follow up received on 24-Mar-2021, medical history added, concomitant medications added, events added, treatment information updated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.