chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Paraesthesia, Peripheral coldness, SARS-CoV-2 test
Clinical narrative: Not feeling well; Tingling in her hands and feet; Fatigue; Nausea; Chills; Confusion; Brain fogginess; Cold hands; Very anxious about having; A spontaneous report was received from a nurse concerning a 56-year-old female patient who experienced confusion [confusion], brain fogginess [foggy feeling in head], not feeling well [malaise], cold hands, are intermittent or waxing and waning, and mostly noticed when going to bed [cold hands], very anxious about having received the vaccine [anxiety], tingling in her hands and feet [tingling feet/hands], fatigue [fatigue], nausea [nausea] and chills [chills].  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 29-Dec-2020, approximately one day prior to the onset of symptoms, the patient received one of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   Since 30-Dec-2020 she has been experiencing fatigue, confusion, brain fogginess, "not feeling well," nausea, chills, and tingling in her hands and feet. The tingling in her hands and feet are accompanied by cold hands, are intermittent and mostly noticed when the patient is going to bed. The caller believes the recipient is also very anxious about having received the vaccine and experiences these symptoms most noticeably before bed due the anxiety. Fatigue has improved somewhat but her other symptoms continue to occur every night. She received negative covid-19 test results on 01-Jan-2021.   Treatment for the events was unknown.    Action taken with mRNA-1273 in response to the events was not applicable.   The event, fatigue, was resolving. The outcomes of the remaining events were 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pyrexia, Vaccination site pain
Clinical narrative: very weak; A little dizzy; High fever; headache; In the injection arm, a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), DIZZINESS (A little dizzy), PYREXIA (High fever), HEADACHE (headache) and VACCINATION SITE PAIN (In the injection arm, a lot of pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L2DA) for COVID-19 vaccination.     No medical history reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ASTHENIA (very weak), DIZZINESS (A little dizzy), PYREXIA (High fever), HEADACHE (headache) and VACCINATION SITE PAIN (In the injection arm, a lot of pain). At the time of the report, ASTHENIA (very weak), DIZZINESS (A little dizzy), PYREXIA (High fever), HEADACHE (headache) and VACCINATION SITE PAIN (In the injection arm, a lot of pain) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment for the pain included ibuprofen.; 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.  The events of pyrexia, headache and vaccination site pain are listed.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore on her left arm; A spontaneous report was received from a consumer, concerning herself, a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore on her left arm/ vaccination site pain.  The patient's medical history reported included heart disease and pacemaker. Concomitant medications reported included oxycodone.  On 29 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 DEC 2020, the patient experienced sore on her left arm for the first couple of days, within 3 or 4 days, which went away. Treatment details were not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event sore on her left arm was considered resolved on 02 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: aches; fatigue; fever of 100.4-100.2 range; cough; A spontaneous report was received from a female nurse  concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced cough, fever, aches and fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020 the patient developed a cough. On 1 Jan 2021, the patient developed a fever 100.2-100.4°F and on an unknown date patient experienced aches and fatigue. Treatment for the event included paracetamol and ibuprofen.   Laboratory details included patient's body temperature which ranged between 100.4 to 100.2 degree Fahrenheit on 1-JAN-2021 and 100.3 degree Fahrenheit.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed a cough, fever, aches and fatigue, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: suspects a possible AE situation; A Spontaneous report was received from Consumer concerning an unknown age, an unknown gender patient, who suspects a possible AE situation  The patient's medical history was not reported. Concomitant Medicines were not reported  On an unknown date, the patient received their first of two planned doses of mRNA-1273.  It was reported that the patient suspects a possible AE situation.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, was considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Dysgeusia, Fatigue, Migraine
Clinical narrative: tingling of forearm; migraine; eyes pain/Pressure in the eyes; dizzy; sore throat; bad taste in her mouth; running nose; loosing balance; very cold hands, very cold feet; nausea; Extreme fatigue; muscle pain; Site of shot is red; Site of shot is hot; Site of shot swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.  Further information has been requested.; 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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Ocular discomfort, Oropharyngeal pain, Paraesthesia
Clinical narrative: tingling of forearm; migraine; eyes pain/Pressure in the eyes; dizzy; sore throat; bad taste in her mouth; running nose; loosing balance; very cold hands, very cold feet; nausea; Extreme fatigue; muscle pain; Site of shot is red; Site of shot is hot; Site of shot swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.  Further information has been requested.; 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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Rhinorrhoea, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: tingling of forearm; migraine; eyes pain/Pressure in the eyes; dizzy; sore throat; bad taste in her mouth; running nose; loosing balance; very cold hands, very cold feet; nausea; Extreme fatigue; muscle pain; Site of shot is red; Site of shot is hot; Site of shot swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.  Further information has been requested.; 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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Body ache; Temperature of 102°F; Chills; This spontaneous case was reported by a dental hygienist (subsequently medically confirmed) and describes the occurrence of PAIN (Body ache), PYREXIA (Temperature of 102°F) and CHILLS (Chills) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previously had COVID-19).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), PYREXIA (Temperature of 102°F) and CHILLS (Chills). At the time of the report, PAIN (Body ache), PYREXIA (Temperature of 102°F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102 °F.     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.   Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of the vaccine.   This case was linked to MOD-2021-003029 (Patient Link).   Reporter did not allow further contact; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: red area hurts when she touches it; redness is about 2inch x 2inch in a circular pattern; area around injection site is very red; Injection site mass; A spontaneous report was received from a physician concerning a 64-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced little bit of soreness, big lump formed under the injection site, area around injection site is very red. redness has evolved and gotten bigger and rounder. Redness is about 2inch x 2inch in a circular pattern and red area hurts when she touches it.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, patient reported she experienced a little bit of soreness right after being vaccinated, but otherwise felt perfectly fine. A big lump formed under the injection site that has not gone away. She reported that the injection site was initially not red. A couple days ago (4Jan2021), she stated the area around the injection site was very red and has evolved and gotten bigger and rounder (about 2inch x 2inch in a circular pattern on 6Jan2021), which hurts when she touches it.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events little bit of soreness, big lump formed under the injection site, area around injection site is very red. redness has evolved and gotten bigger and rounder. Redness is about 2inch x 2inch in a circular pattern and red area hurts when she touches it was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: arm in that area go very red and itchy; arm in that area got very red and itchy; A spontaneous report was received from a female consumer, age unknown. The patient stated on 05-Jan-2021 which was a week after receiving the vaccine her arm in that area got very red and itchy.  The patient's medical history was not provided. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (lot # 011J20A) on 28-Dec-2020 for prophylaxis of Covid-19 infection. The patient reported experiencing the events described in the paragraph above and below about a week after receiving the vaccine.   On 05-Jan-2021 a voice mail was received from the patient, a consumer who reported the following events after receiving the first dose of mRNA-1273 1273 on 28-Dec-2020. The patient stated that on 05-Jan-2021 her arm in that area got very red and itchy. She stated she hadn't had any symptoms since the 2nd day until that point. She did not describe any previous symptoms. She further stated that she thought that seemed strange, so she talked to employee health who told her" they didn't think it was a big deal and that the vaccine was most likely injected into the subcutaneous tissue instead of the muscle". The patient was told to call and report her symptoms and stated we could call her back if we want.  Attempted to contact the patient on 07-Jan-2021 at 9:05 am with no answer. Left voicemail for patient.  Action taken with the second dose of mRNA-1273 in response to the events was not provided/unknown.  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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: Itchiness on her left arm; Skin went dark; Skin went red; Swollen left arm; A report was received from a physician concerning a 76 year old female patient who was participating in a trial and developed itchiness on her left arm, swelling on her left arm, skin went dark and red on her left arm, and swollen left arm.   The patient's medical history, as provided by the reporter, included heart disease and pacemaker placement. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot : 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021 the patient began experiencing reactions on her left arm including itchiness, swelling, dark and red skin, and swelling. The events were treated with prednisone.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of itchiness on her left arm, swelling on her left arm, skin went dark and red on her left arm and swollen left arm were not 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Headache, Nausea
Clinical narrative: Feeling thirsty, unable to quench it; Coughing a lot; High fever of 102F; Feeling chills; Nauseous; Severe headache; A Spontaneous report was received from a consumer (reporting on self), concerning a male patient (age unspecified), who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed a high fever of 102° F, coughing a lot, severe headache, feeling chills, nauseous, and feeling thirsty, unable to quench it.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   The patient woke up at 2:30 AM on 06 Jan 2021 experiencing high fever of 102° F and feeling chills.  At 8:30 AM the patient's fever reduced to 100°F and he was feeling nauseous, coughing a lot, had a severe headache, and was felling thirsty, unable to quench it. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of high fever of 102° F, coughing a lot, severe headache, feeling chills, nauseous, and feeling thirsty, unable to quench it 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Feeling thirsty, unable to quench it; Coughing a lot; High fever of 102F; Feeling chills; Nauseous; Severe headache; A Spontaneous report was received from a consumer (reporting on self), concerning a male patient (age unspecified), who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed a high fever of 102° F, coughing a lot, severe headache, feeling chills, nauseous, and feeling thirsty, unable to quench it.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   The patient woke up at 2:30 AM on 06 Jan 2021 experiencing high fever of 102° F and feeling chills.  At 8:30 AM the patient's fever reduced to 100°F and he was feeling nauseous, coughing a lot, had a severe headache, and was felling thirsty, unable to quench it. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of high fever of 102° F, coughing a lot, severe headache, feeling chills, nauseous, and feeling thirsty, unable to quench it 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 events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Inappropriate affect, Paranoia, Thinking abnormal
Clinical narrative: acting strange behavior wise; thought process not being the same; Not acting normal; Giggling inappropriately; A spontaneous report was received from a Other Health Professional concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced acting strange behavior wise, thought process not being the same, not acting normal, giggling inappropriately.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 06-JAN-2021, the patient's experienced acting strange behavior wise, thought process not being the same, not acting normal, giggling inappropriately.  Treatment medications were not reported.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events was considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Diarrhoea, Fatigue, Heart rate increased
Clinical narrative: heart rate increased about 20 beats; high blood pressure; vomitting; anxiety attack; diarrhea; nausea; arm hurt; tired; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxiety attack), DIARRHOEA (diarrhea), HEART RATE INCREASED (heart rate increased about 20 beats), VOMITING (vomitting) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (nausea), VACCINATION SITE PAIN (arm hurt) and FATIGUE (tired). On 01-Jan-2021, the patient experienced ANXIETY (anxiety attack), DIARRHOEA (diarrhea) and VOMITING (vomitting). On 02-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate increased about 20 beats). On 03-Jan-2021, HEART RATE INCREASED (heart rate increased about 20 beats) had resolved. At the time of the report, ANXIETY (anxiety attack), DIARRHOEA (diarrhea), VOMITING (vomitting), NAUSEA (nausea), VACCINATION SITE PAIN (arm hurt) and FATIGUE (tired) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  Treatment included Zofran, magnesium and probiotics  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.; 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: Nausea, Vaccination site pain, Vomiting
Clinical narrative: heart rate increased about 20 beats; high blood pressure; vomitting; anxiety attack; diarrhea; nausea; arm hurt; tired; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (anxiety attack), DIARRHOEA (diarrhea), HEART RATE INCREASED (heart rate increased about 20 beats), VOMITING (vomitting) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (nausea), VACCINATION SITE PAIN (arm hurt) and FATIGUE (tired). On 01-Jan-2021, the patient experienced ANXIETY (anxiety attack), DIARRHOEA (diarrhea) and VOMITING (vomitting). On 02-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate increased about 20 beats). On 03-Jan-2021, HEART RATE INCREASED (heart rate increased about 20 beats) had resolved. At the time of the report, ANXIETY (anxiety attack), DIARRHOEA (diarrhea), VOMITING (vomitting), NAUSEA (nausea), VACCINATION SITE PAIN (arm hurt) and FATIGUE (tired) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  Treatment included Zofran, magnesium and probiotics  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.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; body aches; cough; tired; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (body aches), COUGH (cough), FATIGUE (tired) and SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 60-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.    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 PAIN (body aches), COUGH (cough) and FATIGUE (tired). On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). On 03-Jan-2021, PAIN (body aches), COUGH (cough) and FATIGUE (tired) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 antibody test: Tested positive for COVID-19.     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. Treatment of the events included that she used an inhaler, and took Tylenol.  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. The causality for the event Covid-19 virus test positive is assessed as unlikely and further information has been requested.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.The causality for the event Covid-19 virus test positive is assessed as unlikely and further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Vaccination site pain
Clinical narrative: felt warm; headache; Arm discomfort; body ache; A spontaneous report was received from a consumer concerning a 30 year old, female who experienced sore arm, headache, body ache, felt warm., after receiving mRNA-1273.   The medical history was not provided. Concomitant product use was not provided.  The consumer received the Moderna COVID-19 Vaccine on 4Jan2021 possible Lot Batch number 025L20A in her left arm. On Tuesday 5Jan2021 around 11AM the she started experience side effects that included sore arm, headache, body ache, felt warm. The consumers temperature she mentioned is usually 98.4 degrees. She mentioned she felt warm and her temperature registered at 98.8 degrees.   The consumer did take Tylenol as treatment. Also mentioned she tested positive for COVID-19 on 06Dec2020. The symptoms of her COVID-19 experience was that she was "sleepy" had a really bad sore throat, cough, lost sense of taste and smell for two days.  Treatment for the event included Tylenol 600mg just one dose has been taken. Consumer also taking an antibiotic for a tooth ache/ Cephalexin 500 mg. QTID.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events was not 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: Body temperature, Cough, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid-19; Cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19), COUGH (Cough) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No past medical history reported.). Concomitant products included VALSARTAN, LEVOTHYROXINE, APIXABAN (ELIQUIS) and SOTALOL for an unknown indication.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (Fever). On 30-Dec-2020, the patient experienced COUGH (Cough). On 03-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19), COUGH (Cough) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 100.8 °F. On 03-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was 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.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy injection site; Redness at the injection site; Swollen injection site the size of a softball; A spontaneous report  was received from a 57-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced itchiness, redness and swelling like the size of a softball at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) in the right arm for prophylaxis of COVID-19 infection.   On 3 Jan 2021, after receiving the vaccine, the patient experienced itchiness, redness and swelling at the injection site. Treatment for the events is Benadryl.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events is Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever of 105°F; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 105°F) and FATIGUE (Tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2UA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PYREXIA (Fever of 105°F) and FATIGUE (Tired). At the time of the report, PYREXIA (Fever of 105°F) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 105.0 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fever ad fatigue are consistent with the known safety profile of the vaccine.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fever ad fatigue are consistent with the known safety profile of the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness; Body aches; Headache; Extreme fatigue; Nausea; Muscle pain; High fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (High fever), CHILLS (Chills), PAIN (Body aches) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced PYREXIA (High fever), CHILLS (Chills), MYALGIA (Muscle pain) and NAUSEA (Nausea). On 04-Jan-2021, the patient experienced FATIGUE (Extreme fatigue). On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Body aches) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), PYREXIA (High fever), CHILLS (Chills), PAIN (Body aches), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Extreme fatigue) and NAUSEA (Nausea) was resolving.        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.   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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Dizziness; Body aches; Headache; Extreme fatigue; Nausea; Muscle pain; High fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (High fever), CHILLS (Chills), PAIN (Body aches) and MYALGIA (Muscle pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced PYREXIA (High fever), CHILLS (Chills), MYALGIA (Muscle pain) and NAUSEA (Nausea). On 04-Jan-2021, the patient experienced FATIGUE (Extreme fatigue). On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Body aches) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), PYREXIA (High fever), CHILLS (Chills), PAIN (Body aches), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Extreme fatigue) and NAUSEA (Nausea) was resolving.        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.   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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse side effects). At the time of the report, VACCINATION COMPLICATION (Adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse side effects). At the time of the report, VACCINATION COMPLICATION (Adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: 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.; 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: Arthralgia, Neck pain, Vaccination site pain
Clinical narrative: Pain across the shoulders/ pain bilaterally on both shoulders; Pain in the neck; Pain at the injection site; A spontaneous report was received from consumer concerning, female, of unknown age, who was administered Moderna COVID-19 vaccine and experienced pain across the shoulders/ pain bilaterally on both shoulders, pain in the neck and pain at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on 04-Jan-2021.   Patient reported that she was having pain across the shoulders. The symptoms started at night-10 hours after receiving the shot. She claimed that pain in the injection site was normal but it was happening bilaterally on both her shoulders and back in the neck. Patient wanted to know if she could take Tylenol and Multrim.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events pain across the shoulders/ pain bilaterally on both shoulders, pain in the neck and pain at the injection site was unknown.; 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-3 drinks per week) in August 2020. Concurrent medical conditions included Asthma since 1992. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) 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.    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 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, Ultrasound scan: normal (normal) normal. On 11-Nov-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.   The patient had previous 2 pregnancies. First pregnancy was full term birth on 22-Nov-2015 and second pregnancy was full term birth as well on 26-Jul-2018.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Diarrhoea, Feeling abnormal
Clinical narrative: feeling bad; taste is gone; can't eat; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), AGEUSIA (taste is gone), DECREASED APPETITE (can't eat) and DIARRHOEA (diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included PANTOPRAZOLE, SERTRALINE, ESTRADIOL (ESTROGEN), GABAPENTIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3, FOLIC ACID, ATORVASTATIN, DONEPEZIL, FESOTERODINE FUMARATE (TOVIAZ), QUETIAPINE FUMARATE, METFORMIN, ISOSORBIDE, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), SPIRONOLACTONE and MODAFINIL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (feeling bad), AGEUSIA (taste is gone), DECREASED APPETITE (can't eat) and DIARRHOEA (diarrhea). At the time of the report, FEELING ABNORMAL (feeling bad), AGEUSIA (taste is gone), DECREASED APPETITE (can't eat) and DIARRHOEA (diarrhea) had not resolved. 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.   No treatment medications provided by the reporter   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.