chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Myalgia, Vaccination site pruritus
Clinical narrative: arm is red , sore, itchy, warm to touch. muscle is hard; arm is red , sore, itchy, warm to touch. muscle is hard; arm is red , sore, itchy, warm to touch. muscle is hard; arm is very red, sore, itchy, warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is red , sore, itchy, warm to touch. muscle is hard), MYALGIA (arm is red , sore, itchy, warm to touch. muscle is hard), VACCINATION SITE PRURITUS (arm is red , sore, itchy, warm to touch. muscle is hard) and ERYTHEMA (arm is very red, sore, itchy, warm to touch) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is red , sore, itchy, warm to touch. muscle is hard), MYALGIA (arm is red , sore, itchy, warm to touch. muscle is hard), VACCINATION SITE PRURITUS (arm is red , sore, itchy, warm to touch. muscle is hard) and ERYTHEMA (arm is very red, sore, itchy, warm to touch). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is red , sore, itchy, warm to touch. muscle is hard), MYALGIA (arm is red , sore, itchy, warm to touch. muscle is hard), VACCINATION SITE PRURITUS (arm is red , sore, itchy, warm to touch. muscle is hard) and ERYTHEMA (arm is very red, sore, itchy, warm to touch) had not 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.   Concomitant medications were not reported. No treatment information was provided.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: muscle or body ache; Fever; Chills; Fatigue; Headache; Joint pain; Nausea; Vomited once; arm stiffness; felt pain bearable; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm stiffness), VACCINATION SITE PAIN (felt pain bearable), MYALGIA (muscle or body ache), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (felt pain bearable). On 30-Dec-2020, the patient experienced MUSCULOSKELETAL STIFFNESS (arm stiffness), MYALGIA (muscle or body ache), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and VOMITING (Vomited once). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm stiffness), VACCINATION SITE PAIN (felt pain bearable), MYALGIA (muscle or body ache), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and VOMITING (Vomited once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided. Company 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12 Apr 2021 included no new information; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: muscle or body ache; Fever; Chills; Fatigue; Headache; Joint pain; Nausea; Vomited once; arm stiffness; felt pain bearable; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm stiffness), VACCINATION SITE PAIN (felt pain bearable), MYALGIA (muscle or body ache), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (felt pain bearable). On 30-Dec-2020, the patient experienced MUSCULOSKELETAL STIFFNESS (arm stiffness), MYALGIA (muscle or body ache), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and VOMITING (Vomited once). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm stiffness), VACCINATION SITE PAIN (felt pain bearable), MYALGIA (muscle or body ache), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and VOMITING (Vomited once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided. Company 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12 Apr 2021 included no new information; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Contusion, Skin tightness, Tenderness, Vaccination site pain
Clinical narrative: soreness at the injection site; tender lump on her L armpit; tender lump on her L armpit; tightness around L arm (as if there was a rubber band around it); bruising on her L arm which extended to her L breast; This spontaneous case was reported by a consumer and describes the occurrence of SKIN TIGHTNESS (tightness around L arm (as if there was a rubber band around it)), CONTUSION (bruising on her L arm which extended to her L breast), VACCINATION SITE PAIN (soreness at the injection site), TENDERNESS (tender lump on her L armpit) and AXILLARY MASS (tender lump on her L armpit) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced SKIN TIGHTNESS (tightness around L arm (as if there was a rubber band around it)), CONTUSION (bruising on her L arm which extended to her L breast), TENDERNESS (tender lump on her L armpit) and AXILLARY MASS (tender lump on her L armpit). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, SKIN TIGHTNESS (tightness around L arm (as if there was a rubber band around it)) had not resolved, CONTUSION (bruising on her L arm which extended to her L breast), VACCINATION SITE PAIN (soreness at the injection site) and TENDERNESS (tender lump on her L armpit) had resolved and AXILLARY MASS (tender lump on her L armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included paracetamol, diphenhydramine and ibuprofen.   Company Comment: This case concerns a 31 Y/O F with nonserious events of unexpected contusion and skin tightness, and expected vaccination site pain, tenderness and axillary mass.  Event onset Day 3 after first dose mRNA-1273. Events resolved, but skin tightness ongoing. 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.; Reporter's Comments: This case concerns a 31 Y/O F with nonserious events of unexpected contusion and skin tightness, and expected vaccination site pain, tenderness and axillary mass.  Event onset Day 3 after first dose mRNA-1273. Events resolved, but skin tightness ongoing. 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Vaccination site is pink; Vaccination site is worm; Vaccination site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site is pink), VACCINATION SITE WARMTH (Vaccination site is worm) and VACCINATION SITE PRURITUS (Vaccination site itching) in an 87-year-old 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 medical reported history).    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site itching). On 13-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Vaccination site is pink) and VACCINATION SITE WARMTH (Vaccination site is worm). At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site is pink), VACCINATION SITE WARMTH (Vaccination site is worm) and VACCINATION SITE PRURITUS (Vaccination site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment was received.  Based on the current available information and temporal association between the use of the product and the start date of these 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 date of these events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Feeling cold, Heart rate
Clinical narrative: Body aches; High Heart rate; Coughing; Sore arm after injection that got worse; Fever; Felt fatigued; Hard to lift; Couldn't get warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), HEART RATE INCREASED (High Heart rate), COUGH (Coughing) and VACCINATION SITE PAIN (Sore arm after injection that got worse) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 01-Dec-2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), VACCINATION SITE PAIN (Sore arm after injection that got worse), PYREXIA (Fever) and FATIGUE (Felt fatigued). On 13-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart rate) and COUGH (Coughing). On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), HEART RATE INCREASED (High Heart rate), COUGH (Coughing), VACCINATION SITE PAIN (Sore arm after injection that got worse), PYREXIA (Fever) and FATIGUE (Felt fatigued) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.3 (High) Fahrenheit. On 13-Jan-2021, Body temperature: 99.7 (High) Fahrenheit. On 13-Jan-2021, Heart rate (Unknown-80s): 125-130 (High) BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Pyrexia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Body aches; High Heart rate; Coughing; Sore arm after injection that got worse; Fever; Felt fatigued; Hard to lift; Couldn't get warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), HEART RATE INCREASED (High Heart rate), COUGH (Coughing) and VACCINATION SITE PAIN (Sore arm after injection that got worse) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 01-Dec-2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), VACCINATION SITE PAIN (Sore arm after injection that got worse), PYREXIA (Fever) and FATIGUE (Felt fatigued). On 13-Jan-2021, the patient experienced HEART RATE INCREASED (High Heart rate) and COUGH (Coughing). On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift), FEELING COLD (Couldn't get warm), HEART RATE INCREASED (High Heart rate), COUGH (Coughing), VACCINATION SITE PAIN (Sore arm after injection that got worse), PYREXIA (Fever) and FATIGUE (Felt fatigued) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 100.3 (High) Fahrenheit. On 13-Jan-2021, Body temperature: 99.7 (High) Fahrenheit. On 13-Jan-2021, Heart rate (Unknown-80s): 125-130 (High) BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; 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: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: lymphadenopathy in axillary nodes same side as where vaccine was given; lymphadenopathy in axillary nodes same side as where vaccine was given - 10% larger now; lymphadenopathy in axillary nodes same side as where vaccine was given - palpable; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymphadenopathy in axillary nodes same side as where vaccine was given 4 to 5 days after receiving the vaccine. It was painful and palpable. The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26-12-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscular in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced lymphadenopathy in axillary nodes same side as where vaccine was given  painful, lymphadenopathy in axillary nodes same side as where vaccine was given  palpable, lymphadenopathy in axillary nodes same side as where vaccine was given - 10% larger now.    Laboratory details was not provided.  The patient was given ibuprofen as treatment medication.  Action taken with mRNA-1273 in response to the events was not reported.   On 14-01-2021, The outcome of the event lymphadenopathy in axillary nodes same side as where vaccine was given  painful was resolved. The outcome of the events lymphadenopathy in axillary nodes same side as where vaccine was given  palpable, lymphadenopathy in axillary nodes same side as where vaccine was given - 10% larger now.; Sender'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: Pruritus
Clinical narrative: Itch in many parts of my body, feet, legs, ear; A spontaneous report was received from a consumer concerning a 82 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itch in many parts of my body, feet, legs, ear.  The patient's medical history was not provided.    The patient was not taking any concomitant medication.  On 13-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 Batch no: 041LZ08 for prophylaxis of COVID-19 infection.  On 14-01-2021, The patient experienced the events Itch in many parts of my body, feet, legs, ear.  Laboratory details was not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Sender'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: Pregnancy
Clinical narrative: Pregnancy; This spontaneous pregnancy case was reported by an other and describes the occurrence of PREGNANCY (Pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnancy). At the time of the report, PREGNANCY (Pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19) 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 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 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.; Reporter's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site bruising, Vaccination site erythema
Clinical narrative: Looks like bruise; Spot where got the injection was very red and was swollen up a little bit; Spot where got the injection was very red and was swollen up a little bit; Some fever; Felt very tired; Normal muscle pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Looks like bruise), MYALGIA (Normal muscle pain in the arm), VACCINATION SITE ERYTHEMA (Spot where got the injection was very red and was swollen up a little bit), VACCINATION SITE SWELLING (Spot where got the injection was very red and was swollen up a little bit) and PYREXIA (Some fever) in a 24-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.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (Normal muscle pain in the arm). On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Spot where got the injection was very red and was swollen up a little bit), VACCINATION SITE SWELLING (Spot where got the injection was very red and was swollen up a little bit), PYREXIA (Some fever) and FATIGUE (Felt very tired). On 14-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Looks like bruise). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Looks like bruise), MYALGIA (Normal muscle pain in the arm), VACCINATION SITE ERYTHEMA (Spot where got the injection was very red and was swollen up a little bit), VACCINATION SITE SWELLING (Spot where got the injection was very red and was swollen up a little bit) and FATIGUE (Felt very tired) outcome was unknown and PYREXIA (Some fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided/unknown by the reporter.   Reporter did not allow further contact; 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Looks like bruise; Spot where got the injection was very red and was swollen up a little bit; Spot where got the injection was very red and was swollen up a little bit; Some fever; Felt very tired; Normal muscle pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Looks like bruise), MYALGIA (Normal muscle pain in the arm), VACCINATION SITE ERYTHEMA (Spot where got the injection was very red and was swollen up a little bit), VACCINATION SITE SWELLING (Spot where got the injection was very red and was swollen up a little bit) and PYREXIA (Some fever) in a 24-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.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (Normal muscle pain in the arm). On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Spot where got the injection was very red and was swollen up a little bit), VACCINATION SITE SWELLING (Spot where got the injection was very red and was swollen up a little bit), PYREXIA (Some fever) and FATIGUE (Felt very tired). On 14-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Looks like bruise). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Looks like bruise), MYALGIA (Normal muscle pain in the arm), VACCINATION SITE ERYTHEMA (Spot where got the injection was very red and was swollen up a little bit), VACCINATION SITE SWELLING (Spot where got the injection was very red and was swollen up a little bit) and FATIGUE (Felt very tired) outcome was unknown and PYREXIA (Some fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided/unknown by the reporter.   Reporter did not allow further contact; 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: COVID-19 Vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 Vaccination during pregnancy) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes (Pregnancy end date: 29-AUG-2002: gestational diabetes was managed by diet 07-MAY-2018: gestational diabetes was uncontrolled by diet and insulin Placenta shut down the day before scheduled C-section asthma). Concurrent medical conditions included Asthma (Patient experiences asthma when she is around allergens like animals with hair/fur/dander) since 1989. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and IRON for Vitamin supplementation.    On 14-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 01-Apr-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 Vaccination during pregnancy). On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (COVID-19 Vaccination during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2020, Pregnancy test: positive (Positive) Positive. On 06-Nov-2020, Ultrasound foetal: normal (normal) normal. On 07-Jan-2021, Blood glucose: abnormal (abnormal) Possibly gestational diabetes, results come back today 15-Jan-2021. On 14-Jan-2021, Blood glucose: abnormal (abnormal) Possibly gestational diabetes, results come back today 15-Jan-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.  The estimated date of conception was reported as 22 to 26-Jun-2020. Date of LMP was reported as  22 to 26-Jun-2020. The patient had no maternal history of subfertility and had established prenatal care. Number of fetuses was reported as 1. The patient had 3 previous live, full term birth on 29-Aug-2002, 30-Jan-2004 and 07-May-2018. The patient had no history of substance abuse.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Pain in extremity, Rash, Vaccination site warmth
Clinical narrative: Malaise; One episode of diarrhea; Rash; Pain in arm; Heat in arm; A spontaneous report was received from a consumer, concerning a 32-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm, heat in arm, malaise and one episode of diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: O26L20A) for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced pain in arm and heat in arm. On an unknown date, the patient experienced malaise, rash, and one episode of diarrhea.   The patient was treated with Ibuprufen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the 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: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: it started itching; redness at the injection site, half a dollar size; swelling at the injection site, half a dollar size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site, half a dollar size), VACCINATION SITE SWELLING (swelling at the injection site, half a dollar size) and PRURITUS (it started itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site, half a dollar size) and VACCINATION SITE SWELLING (swelling at the injection site, half a dollar size). On 18-Jan-2021, the patient experienced PRURITUS (it started itching). On 17-Jan-2021, VACCINATION SITE SWELLING (swelling at the injection site, half a dollar size) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site, half a dollar size) and PRURITUS (it started itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 33.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, Asthenia, Chills, Headache, Nausea
Clinical narrative: chill; feel nausea; arm sore; high fever; headache; lying in the bed the whole day; body really sore; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day), ARTHRALGIA (body really sore) and NAUSEA (feel nausea) in a 33-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.    Co-suspect products included non-company products PARACETAMOL (TYLENOL) for an unknown indication and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENYLIN 1 COLD AND FLU) for an unknown indication.    Concomitant products included Steroid hormones for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENYLIN 1 COLD AND FLU) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day) and ARTHRALGIA (body really sore). On 18-Jan-2021, the patient experienced NAUSEA (feel nausea) and PAIN IN EXTREMITY (arm sore). On an unknown date, the patient experienced CHILLS (chill). At the time of the report, PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day), ARTHRALGIA (body really sore) and NAUSEA (feel nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: chill; feel nausea; arm sore; high fever; headache; lying in the bed the whole day; body really sore; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day), ARTHRALGIA (body really sore) and NAUSEA (feel nausea) in a 33-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.    Co-suspect products included non-company products PARACETAMOL (TYLENOL) for an unknown indication and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENYLIN 1 COLD AND FLU) for an unknown indication.    Concomitant products included Steroid hormones for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENYLIN 1 COLD AND FLU) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day) and ARTHRALGIA (body really sore). On 18-Jan-2021, the patient experienced NAUSEA (feel nausea) and PAIN IN EXTREMITY (arm sore). On an unknown date, the patient experienced CHILLS (chill). At the time of the report, PYREXIA (high fever), HEADACHE (headache), ASTHENIA (lying in the bed the whole day), ARTHRALGIA (body really sore) and NAUSEA (feel nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site movement impairment, Pyrexia
Clinical narrative: shivering; having a low grade fever; a bit tired; stiffness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), PYREXIA (having a low grade fever), FATIGUE (a bit tired) and INJECTION SITE MOVEMENT IMPAIRMENT (stiffness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Jan-2021, the patient experienced INJECTION SITE MOVEMENT IMPAIRMENT (stiffness at the injection site). On 19-Jan-2021, the patient experienced CHILLS (shivering), PYREXIA (having a low grade fever) and FATIGUE (a bit tired). At the time of the report, CHILLS (shivering), PYREXIA (having a low grade fever), FATIGUE (a bit tired) and INJECTION SITE MOVEMENT IMPAIRMENT (stiffness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: Injection site erythema, Injection site pruritus
Clinical narrative: The injection site had developed this big redness around it; it itches a little bit; Patient states she received the first dose of the Moderna Covid-19 vaccine 6 days ago, and noticed yesterday the injection site had developed this big redness around it. Patient states it is not painful but it itches a little bit and the redness is starting to go down her arm Patient has not taken anything for this symptom. She is a 71 year old female who received the vaccine on her left arm. She takes Pantoprazole, Triamterene/hydrochlorothiazide, vitamins. Patient wants to know if this is normal, or a cause for reaction. Consent for safety to follow-up was received and consent to have this call documented was received.; 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: High red spot in the site of the injection; Arm hard as a rock; Arm hurts at touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (High red spot in the site of the injection), VACCINATION SITE INDURATION (Arm hard as a rock) and PAIN IN EXTREMITY (Arm hurts at touch) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (High red spot in the site of the injection), VACCINATION SITE INDURATION (Arm hard as a rock) and PAIN IN EXTREMITY (Arm hurts at touch). At the time of the report, VACCINATION SITE ERYTHEMA (High red spot in the site of the injection), VACCINATION SITE INDURATION (Arm hard as a rock) and PAIN IN EXTREMITY (Arm hurts at touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment was not reported.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: non responder; IgM and IgG (S1/S2 assay) were both negative; A spontaneous report was received from a physician concerning himself, a 69-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was a non responder who had IgM and IgG (S1/S2 assay) were both negative.   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 04 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, the patient checked his antibody level; he reported that the test was from Abbott. He reported that he was a non responder and that his IgM and IgG (S1/S2 assay) were both negative. He stated that "perhaps the antibody tests from the trials were different from the one he took because there are different amino acids." No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events non responder and IgM and IgG (S1/S2 assay) were both negative were not reported.; Reporter's Comments: This case concerns a 69 year old male patient who received his  first of two planned doses of mRNA-1273 (lot number 011J20A) intramuscularly for prophylaxis of COVID-19 infection and reported that he was a non responder and that his IgM and IgG (S1/S2 assay) were both negative. There were no reported adverse events after the vaccine was administered. Based on the current available information, a causal relationship cannot be excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Full blood count, Headache, Hepatic enzyme increased
Clinical narrative: Fever; Fatigue; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011QJ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: negative. On an unknown date, Hepatic enzyme increased: negativve. On an unknown date, X-ray: negative.  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 provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, X-ray
Clinical narrative: Fever; Fatigue; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011QJ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: negative. On an unknown date, Hepatic enzyme increased: negativve. On an unknown date, X-ray: negative.  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 provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; A spontaneous report was received from a consumer concerning a female patient of unknown age who received?Moderna's?COVID-19 vaccine?(mRNA-1273). She was breast feeding.  The patient's medical history, was not provided by the reporter. No relevant Concomitant medications were reported.   Patient received 1st dose of Moderna COVID-19 vaccine mRNA- 1273, batch number and route of administration was not mentioned in the report by the reporter.   Treatment for the events were not included.   Action taken with mRNA-1273 in response to the events was not reported.??   The outcome of the event was recovered and resolved.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Ultrasound foetal
Clinical narrative: Pregnant while receiving vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant while receiving vaccine) in a 36-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M204 and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Stillbirth (loss at 32 weeks, cause unknown but baby did have a knot in the cord and around neck) on 12-May-2015, Pregnant on 10-Mar-2017 and Pregnant on 04-Apr-2019. Concurrent medical conditions included Penicillin allergy.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. The patient's last menstrual period was on 13-Sep-2020 and the estimated date of delivery was 20-Jun-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant while receiving vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 29-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant while receiving vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal (normal) within range. On an unknown date, Ultrasound foetal: normal (normal) all normal.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Pregnancy form initial Received on 23 Apr 2021 included information of patient height, weight, prior pregnancy details, medical history and second vaccine dose.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Vaccination site erythema
Clinical narrative: been really tired all day; upset stomach; develop like a red welt in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (develop like a red welt in the arm), FATIGUE (been really tired all day) and ABDOMINAL DISCOMFORT (upset stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (develop like a red welt in the arm). On an unknown date, the patient experienced FATIGUE (been really tired all day) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, VACCINATION SITE ERYTHEMA (develop like a red welt in the arm), FATIGUE (been really tired all day) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported. Treatment information was not provided.