chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle discomfort, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm warm to the touch; Feels like the muscle has hardened; A hard, red lump that is 10 cm in diameter out from the injection site; Itchy arm; Swollen arm; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Swollen arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A/011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included an ice pack.  Based on the current available information and temporal association between the use of the product and the start dates of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events a causal relationship cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Arm warm to the touch; Feels like the muscle has hardened; A hard, red lump that is 10 cm in diameter out from the injection site; Itchy arm; Swollen arm; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Swollen arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A/011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included an ice pack.  Based on the current available information and temporal association between the use of the product and the start dates of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received Moderna vaccine and pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna vaccine and pregnant) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna vaccine and pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna vaccine and pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm is really sore now; Fever; Arm became sore; A spontaneous report was received consumer concerning a from a 85-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and a fever of 101.5°F.  The patient's medical history included COVID-19. Concomitant medications reported included two blood pressure pills, blood thinner, statin and vitamins.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient had a sore arm.   On 31 Dec 2020, patient developed a really sore arm and a fever of 101.5°F.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome event(s) sore arm and fever of 101.5°F, were unknown.; Reporter's Comments: This case concerns an 85-year-old female with PMH of OCIVD-19, who experienced NS unexpected events of pain in extremity and pain aggravated along with NS expected fever.  Event onset occurred the same day as first dose of mRNA-1273. Treated with "baby aspirin" not reported. Event outcome unknown.  Based on the current available information and temporal association between the use of the product and the start date of the event of sore arm and fever of 101.5F,  a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
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 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Felt all I have eaten was coming out of my ears; Temperature was 104.7 F; Shoulder really sore; A spontaneous report was received from a consumer concerning a 78-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder really sore(shoulder soreness), running at temperature(fever) and felt eaten was coming out of ears (feeling abnormal).  The patient's medical history was not provided. Concomitant medications included Metoprolol and Losartan.   On 30 Dec 2020, the patient received their dose of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced shoulder really sore and temperature was 100.7 F. On 31 Dec 2020, next morning patient administered Tylenol and temperature went down to 99.7 F followed by felt eaten was coming out of ears (feeling abnormal). On the same day 31 Dec 2020, patient's temperature was at 104.7 F. The patient was running at temperature.  Treatment details for temperature(fever) included paracetamol. No treatment information was provided for shoulder soreness and feeling abnormal.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, shoulder really sore was not reported. The outcome of the event, temperature 104.7 F was not resolved.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Dizziness while sitting; Arm feeling painful; Large red ring around injection site; Itching; injection site the size of a golf ball; A spontaneous report  was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine and experienced arm feeling painful, large red ring around injection site, injection site the size of a golf ball, itching, dizziness while sitting.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020 around 4:00 to 5:00 pm, the patient received the first of two planned doses of mRNA-1273 for COVID-19 infection prophylaxis.   On 31 Dec 2020, the patient reported that her arm was feeling painful, and that there was a large red ring around injection site the size of a golf ball, redness, itching, and dizziness while sitting. No treatment for the events was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, arm feeling painful, large red ring around injection site, injection site the size of a golf ball, itching, dizziness while sitting, was considered 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion on 03-Sep-2020. Family history included Psoriasis. Concurrent medical conditions included Graves' disease since August 2017. Concomitant products included LEVOTHYROXINE for Hypothyroidism, 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], VITAMIN D [VITAMIN D NOS] and VITAMIN B6 for an unknown indication.    On 31-Dec-2020 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Nov-2020 and the estimated date of delivery was 06-Sep-2021. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 31-Dec-2020, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-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. Previous pregnancy end date was 3 Sep 2021 and outcome was spontaneous abortion. Patient was not taking Alcohol, Nicotine, Marijuana and Other illicit substance use.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Severe headache; Fever; Fatigue; A spontaneous report was received from a consumer concerning a 63-year-old female patient who received Moderna's COVID-19 vaccine and experienced severe headache/headache, body aches pain, fever/pyrexia, and fatigue.  The patient's medical history and concomitant product use were not provided by the reporter.  On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 011J20A) via Intramuscular route in the left arm for COVID-19 infection prophylaxis.  On 30 Dec 2020 the patient experienced severe headache, body aches, fever, and fatigue.  The events were treated with Tylenol and after two days the events resolved.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was recovered on 02 Jan 2021.   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 reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and wanted to be put on the registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and wanted to be put on the registry) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, 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 06-Jan-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and wanted to be put on the registry). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and wanted to be put on the registry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2020: Internal review on 26-Jul-2021 resulted in updates to the pregnancy details.; 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: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm swollen; Painful, red, swollen lump on injection site; Painful, red, swollen lump on injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed injection site mass, injection site erythema, arm swollen, arm hard to move and injection site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) on 22 Dec 2020 in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, same day post vaccination, the right arm was achy and hard to move and subsided same day. On day 9 the pain came back with swelling and redness about 3 inches at the vaccine site, after treating with Tylenol, Brufen and ice pack they were resolved by day12.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome for the events were considered 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numb lips; A spontaneous report was received from a consumer concerning a female patient who experienced numb lips.  The patient's medical history and concomitant product use were not provided by the reporter.  On 23-Dec-2020, the same day as onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23-Dec-2020 the patient developed numb lips 30 minutes after receiving the vaccine which lasted for a half an hour.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was recovered.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Little bit of headache; A spontaneous report was received from a consumer concerning an unknown age, female patient, who received Moderna's COVID-19 Vaccine and experienced little bit of headache and sore throat.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of events, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced had a little bit of a headache and sore throat.  No treatment information was provided  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events headache and sore throat was not reported.; Reporter's Comments: Very limited information regarding these events have been provided at this time. at therapy date and onset of the events is lacking.  No further information is expected as reported denied additional information. Headache is consistent with the known safety profile of mRNA-1273.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: very uncomfortable; Headache; Chills; Fatigue; Coughing; sore throat; No appetite; A spontaneous report  was received from a consumer, concerning a 42 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced headache, chills, very uncomfortable, coughing, fatigue, no appetite, and sore throat.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly for COVID-19 infection prophylaxis.   On an unknown date, the patient started having a headache, chills, and was very uncomfortable. The reporter stated that as days went by, the patient had more and more symptoms.   On 31 Dec 2020, the patient was coughing, had fatigue, no appetite, and had a sore throat. Treatment for the events included acetaminophen/doxylamine succinate/dextromethorphan and ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a 42-year-old, male patient. The patient's medical history was not provided. The patient experienced unexpected event of cough, sore throat, malaise, decreased appetite and expected event of chills, fatigue and headache. The event of headache, chills, malaise occurred on unspecified date and event of cough, fatigue, decreased appetite and sore throat occurred 3 days after the first dose of mRNA-1273 (batch number: 025L20A) administration. 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: very uncomfortable; Headache; Chills; Fatigue; Coughing; sore throat; No appetite; A spontaneous report  was received from a consumer, concerning a 42 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced headache, chills, very uncomfortable, coughing, fatigue, no appetite, and sore throat.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly for COVID-19 infection prophylaxis.   On an unknown date, the patient started having a headache, chills, and was very uncomfortable. The reporter stated that as days went by, the patient had more and more symptoms.   On 31 Dec 2020, the patient was coughing, had fatigue, no appetite, and had a sore throat. Treatment for the events included acetaminophen/doxylamine succinate/dextromethorphan and ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a 42-year-old, male patient. The patient's medical history was not provided. The patient experienced unexpected event of cough, sore throat, malaise, decreased appetite and expected event of chills, fatigue and headache. The event of headache, chills, malaise occurred on unspecified date and event of cough, fatigue, decreased appetite and sore throat occurred 3 days after the first dose of mRNA-1273 (batch number: 025L20A) administration. 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Little bit pain/body pain; Rednesss on arm; Pain on the arm; Muscle pain; Swelling; A spontaneous report was received from a 38-year-old female consumer who developed redness on the arm/vaccination site erythema, pain on the arm/vaccination site pain, muscle pain/myalgia, little bit pain/body pain'/pain and swelling/vaccination site swelling after receiving Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history or concomitant product use was not reported.  On 29 Dec 2020, the patient received her planned doses of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection. She developed redness and pain on the arm, muscle pain, little bit pain, body pain and swelling.   She did not take any treatment in response to the events.  Action taken with mRNA-1273 in the response to the events redness on the arm, pain on the arm, muscle pain, little bit pain/body pain and swelling was not known.  The outcome of the events redness on the arm, pain on the arm, muscle pain, little bit pain/body pain and swelling was considered as resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 38-year-old female who had nonserious events of unexpected pain and expected vaccination site pain, vaccination site erythema, vaccination site swelling and myalgia.  Event onset 2 days after the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-002099:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced COVID-19 (Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Tested positive for COVID two days after receiving the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, SARS-CoV-2 test positive: 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.   Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of tested positive for COVID-19  and mRNA-1273 use is assessed as unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up included updated medical history of COVID-19 which the patient reported as retroactive.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of tested positive for COVID-19  and mRNA-1273 use is assessed as unlikely.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Individual little pink dots at Injection site; Injection site Red; Hurt for 2 days/felt pain in right arm; Swelling around the site of injection; Dots around the site of injection; Injection site  Warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE WARMTH (Injection site  Warm), VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm) and VACCINATION SITE SWELLING (Swelling around the site of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2020, the patient experienced VACCINATION SITE WARMTH (Injection site  Warm). On 29-Dec-2020, the patient experienced VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm) and VACCINATION SITE SWELLING (Swelling around the site of injection). On 06-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site) and VACCINATION SITE ERYTHEMA (Injection site Red). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE WARMTH (Injection site  Warm), VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm), VACCINATION SITE SWELLING (Swelling around the site of injection) and VACCINATION SITE ERYTHEMA (Injection site Red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient reported the events lasted for around 1 week.  Patient took ice as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and event outcome updated.; Sender's Comments: This case concerns a 58-year-old female with a nonserious unexpected event of pain in extremity, vaccination site reaction, vaccination site warmth, vaccination site discoloration and expected vaccination site erythema and vaccination site swelling. Event onset the same day as first dose mRNA-1273. Events resolved. Based on 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Individual little pink dots at Injection site; Injection site Red; Hurt for 2 days/felt pain in right arm; Swelling around the site of injection; Dots around the site of injection; Injection site  Warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE WARMTH (Injection site  Warm), VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm) and VACCINATION SITE SWELLING (Swelling around the site of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2020, the patient experienced VACCINATION SITE WARMTH (Injection site  Warm). On 29-Dec-2020, the patient experienced VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm) and VACCINATION SITE SWELLING (Swelling around the site of injection). On 06-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site) and VACCINATION SITE ERYTHEMA (Injection site Red). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Dots around the site of injection), VACCINATION SITE WARMTH (Injection site  Warm), VACCINATION SITE DISCOLOURATION (Individual little pink dots at Injection site), VACCINATION SITE PAIN (Hurt for 2 days/felt pain in right arm), VACCINATION SITE SWELLING (Swelling around the site of injection) and VACCINATION SITE ERYTHEMA (Injection site Red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient reported the events lasted for around 1 week.  Patient took ice as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and event outcome updated.; Sender's Comments: This case concerns a 58-year-old female with a nonserious unexpected event of pain in extremity, vaccination site reaction, vaccination site warmth, vaccination site discoloration and expected vaccination site erythema and vaccination site swelling. Event onset the same day as first dose mRNA-1273. Events resolved. Based on 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: Asthenia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Weight loss; Weakness; Things didn't taste right; Fever; Vomiting; Fatigue; Muscle aches; Nausea; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jun-2020 to 21-Jun-2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.3-100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: Non Significant information was received.Upon internal review, change the outcome of the events from unknown to recovered.; 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
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Taste disorder, Vomiting, Weight decreased
Clinical narrative: Weight loss; Weakness; Things didn't taste right; Fever; Vomiting; Fatigue; Muscle aches; Nausea; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 01-Jun-2020 to 21-Jun-2020.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 99.3-100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: Non Significant information was received.Upon internal review, change the outcome of the events from unknown to recovered.; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site warm to touch; injection site is swollen to the size of a 50 cent piece; injection site itching; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warm to touch), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE SWELLING (injection site is swollen to the size of a 50 cent piece) and INJECTION SITE ERYTHEMA (injection site red) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (injection site red). On 07-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching). On 08-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warm to touch) and INJECTION SITE SWELLING (injection site is swollen to the size of a 50 cent piece). At the time of the report, INJECTION SITE WARMTH (injection site warm to touch), INJECTION SITE PRURITUS (injection site itching), INJECTION SITE SWELLING (injection site is swollen to the size of a 50 cent piece) and INJECTION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Sender's Comment 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.; 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: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Once a week prior to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 07-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 20-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 07-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2020, Pregnancy test: positive (Positive) Positive. On 14-Dec-2020, Ultrasound scan: normal (normal) normal.     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.   Contact information was updated   No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up accepted, confirmed email. No new information; 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.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Maternal exposure during pregnancy, Pain, Pain in extremity
Clinical narrative: Pregnant and received vaccine; Arm soreness; Body aches; chills; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine), PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and CHILLS (chills) in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 28-Feb-2016.    On 05-Jan-2021 at 11:15 AM, 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 01-Jul-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine), PAIN IN EXTREMITY (Arm soreness) and PAIN (Body aches). 05-Jan-2021, the patient experienced CHILLS (chills). On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine) had resolved. On 06-Jan-2021, PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and CHILLS (chills) 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 relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine administered to a pregnant woman; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to a pregnant woman) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jun-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to a pregnant woman). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to a pregnant woman) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 38-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Muscle twitching, Pain in extremity, Peripheral swelling
Clinical narrative: Arm twitching where the vaccine was given; Swelling of arm; Pain in extremity; Vaccine exposure during Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy), MUSCLE TWITCHING (Arm twitching where the vaccine was given), PERIPHERAL SWELLING (Swelling of arm) and PAIN IN EXTREMITY (Pain in extremity) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy). On an unknown date, the patient experienced MUSCLE TWITCHING (Arm twitching where the vaccine was given), PERIPHERAL SWELLING (Swelling of arm) and PAIN IN EXTREMITY (Pain in extremity). On 26-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during Pregnancy) had resolved. At the time of the report, MUSCLE TWITCHING (Arm twitching where the vaccine was given), PERIPHERAL SWELLING (Swelling of arm) and PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.        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.   Company Comment   This is a case of product exposure during pregnancy with  associated AEs of pain in extremity, peripheral swelling and muscle twitching  for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events of pain in extremity, peripheral swelling, and muscle twitching, a causal relationship cannot be excluded.; Sender's Comments: This is a case of product exposure during pregnancy with  associated AEs of pain in extremity, peripheral swelling and muscle twitching  for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The event of exposure during pregnancy is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events of pain in extremity, peripheral swelling, and muscle twitching, a causal relationship cannot be excluded.