chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nauseous; unable to sleep last night due to the pain; right arm has been hurting all day; fever; throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep last night due to the pain), VACCINATION SITE PAIN (right arm has been hurting all day), PYREXIA (fever), VOMITING (throwing up) and CHILLS (chills) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 provided).    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 INSOMNIA (unable to sleep last night due to the pain), VACCINATION SITE PAIN (right arm has been hurting all day), PYREXIA (fever), VOMITING (throwing up) and CHILLS (chills). On 13-Jan-2021, the patient experienced NAUSEA (nauseous). At the time of the report, INSOMNIA (unable to sleep last night due to the pain), VACCINATION SITE PAIN (right arm has been hurting all day), PYREXIA (fever), VOMITING (throwing up), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, Dyspnoea, Headache
Clinical narrative: Loss of taste in the left side of the mouth; Weakness; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Lungs felt heavy and Pain in the lungs; Body Ache; Headache; Join Pain; Nausea; A spontaneous report was received from a consumer concerning a 62-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, loss of taste in the left side of her mouth/ageusia, shakiness only the left side/tremor,  fast heartbeat/heart rate increased, shortness of breath/dyspnoea, weakness/asthenia, lungs felt heavy(pain the lungs)/pulmonary pain, headache/ headache, joint pain/arthralgia, body aches/pain and nausea/nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received the vaccine and experienced loss of taste in the left side of her mouth, shakiness only the left side fast heartbeat, shortness of breath, weakness, lungs felt heavy, pain the lungs,  headache, joint pain, body aches and nausea. Treatment for the events included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, loss of taste in the left side of her mouth, shakiness only the left side fast heartbeat, shortness of breath, weakness, headache and nausea were not resolved. The events, lungs felt heavy, pain the lungs, joint pain and body aches were resolving.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain, Pulmonary pain, Tremor
Clinical narrative: Loss of taste in the left side of the mouth; Weakness; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Lungs felt heavy and Pain in the lungs; Body Ache; Headache; Join Pain; Nausea; A spontaneous report was received from a consumer concerning a 62-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, loss of taste in the left side of her mouth/ageusia, shakiness only the left side/tremor,  fast heartbeat/heart rate increased, shortness of breath/dyspnoea, weakness/asthenia, lungs felt heavy(pain the lungs)/pulmonary pain, headache/ headache, joint pain/arthralgia, body aches/pain and nausea/nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received the vaccine and experienced loss of taste in the left side of her mouth, shakiness only the left side fast heartbeat, shortness of breath, weakness, lungs felt heavy, pain the lungs,  headache, joint pain, body aches and nausea. Treatment for the events included naproxen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, loss of taste in the left side of her mouth, shakiness only the left side fast heartbeat, shortness of breath, weakness, headache and nausea were not resolved. The events, lungs felt heavy, pain the lungs, joint pain and body aches were resolving.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Flu-like symptoms, including mild fever of 98-99 F; Lightheaded; Flu-like symptoms, including mild fever of 98-99 F; Redness at the injection site; Consistent headache; My injection site swelled up and was raised 2 cm into my shoulder; It hurts to raise my arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (It hurts to raise my arm), INFLUENZA LIKE ILLNESS (Flu-like symptoms, including mild fever of 98-99 F), DIZZINESS (Lightheaded), VACCINATION SITE SWELLING (My injection site swelled up and was raised 2 cm into my shoulder) and PYREXIA (Flu-like symptoms, including mild fever of 98-99 F) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .     On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (It hurts to raise my arm), VACCINATION SITE SWELLING (My injection site swelled up and was raised 2 cm into my shoulder), VACCINATION SITE ERYTHEMA (Redness at the injection site) and HEADACHE (Consistent headache). On 09-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms, including mild fever of 98-99 F), DIZZINESS (Lightheaded) and PYREXIA (Flu-like symptoms, including mild fever of 98-99 F). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 11-Jan-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms, including mild fever of 98-99 F) and PYREXIA (Flu-like symptoms, including mild fever of 98-99 F) had resolved. At the time of the report, PAIN IN EXTREMITY (It hurts to raise my arm), DIZZINESS (Lightheaded), VACCINATION SITE ERYTHEMA (Redness at the injection site) and HEADACHE (Consistent headache) outcome was unknown and VACCINATION SITE SWELLING (My injection site swelled up and was raised 2 cm into my shoulder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Inconclusive) 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 Concomitant medications were provided Treatment information provided as ice packs,; 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: SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Flu-like symptoms, including mild fever of 98-99 F; Lightheaded; Flu-like symptoms, including mild fever of 98-99 F; Redness at the injection site; Consistent headache; My injection site swelled up and was raised 2 cm into my shoulder; It hurts to raise my arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (It hurts to raise my arm), INFLUENZA LIKE ILLNESS (Flu-like symptoms, including mild fever of 98-99 F), DIZZINESS (Lightheaded), VACCINATION SITE SWELLING (My injection site swelled up and was raised 2 cm into my shoulder) and PYREXIA (Flu-like symptoms, including mild fever of 98-99 F) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .     On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced PAIN IN EXTREMITY (It hurts to raise my arm), VACCINATION SITE SWELLING (My injection site swelled up and was raised 2 cm into my shoulder), VACCINATION SITE ERYTHEMA (Redness at the injection site) and HEADACHE (Consistent headache). On 09-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms, including mild fever of 98-99 F), DIZZINESS (Lightheaded) and PYREXIA (Flu-like symptoms, including mild fever of 98-99 F). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 11-Jan-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms, including mild fever of 98-99 F) and PYREXIA (Flu-like symptoms, including mild fever of 98-99 F) had resolved. At the time of the report, PAIN IN EXTREMITY (It hurts to raise my arm), DIZZINESS (Lightheaded), VACCINATION SITE ERYTHEMA (Redness at the injection site) and HEADACHE (Consistent headache) outcome was unknown and VACCINATION SITE SWELLING (My injection site swelled up and was raised 2 cm into my shoulder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Inconclusive) 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 Concomitant medications were provided Treatment information provided as ice packs,; 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Rash macular, Vaccination site pain
Clinical narrative: cannot move arm without having pain; Blotchy Skin Injection Site 2" across; Red Injection Site 2" across; A spontaneous report was received from a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and cannot move arm with out having pain , injection site on arm is red and blotchy about 2" across.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 10 Jan 2021, at 2pm, the patient received his first of two planned doses of mRNA-1273 (Lot: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Jan 2021, since administration, the patient can not move his arm without having pain. He stated, when he takes ibuprofen, movement is possible and better. He also mentioned his injection site on the arm is red and blotchy about 2" across. He stated that his sister, who is an emergency room physician, suggested he take diphenhydramine hydrochloride and use a warm compress.   The outcome of the events, cannot move arm without having pain, injection site on arm is red and blotchy about 2" across, were 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.            Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm is extremely swollen / tuffy and  swollen 8.6 centimeters wide and 7.5 cm long; Red, its like welted up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm is extremely swollen / tuffy and  swollen 8.6 centimeters wide and 7.5 cm long) and ERYTHEMA (Red, its like welted up) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PERIPHERAL SWELLING (Left arm is extremely swollen / tuffy and  swollen 8.6 centimeters wide and 7.5 cm long) and ERYTHEMA (Red, its like welted up). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (Left arm is extremely swollen / tuffy and  swollen 8.6 centimeters wide and 7.5 cm long) and ERYTHEMA (Red, its like welted up) had not resolved.        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.; 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: Chills, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Vomiting
Clinical narrative: bad fever; bad chills; throwing up; A spontaneous report (United States) was received from a consumer, a female patient (age not reported), who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced bad fever (pyrexia), bad chills, and was throwing up (vomiting).  The patient's medical history, as provided by the reporter, included she tested positive for COVID in approximately November 2020 (reported as about a month and a half ago from the time of this report) at which time she quarantined for two weeks and then her test came back negative on an unknown date.  The reporter spoke to her healthcare professional, who told her it was okay for her to receive the vaccine.  Concomitant product use was not provided.  On 09 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection. On 10 Jan 2021, the patient experienced bad fever, bad chills, and she was throwing up.  No treatment information was provided  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, bad fever, bad chills, and throwing up, 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Pain in her armpit of the same arm she got the vaccine administered; Swollen lymph node; Tenderness from the injection site is gone; This spontaneous case was reported by an other health care professional and describes the occurrence of AXILLARY PAIN (Pain in her armpit of the same arm she got the vaccine administered), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) and VACCINATION SITE PAIN (Tenderness from the injection site is gone) 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 No adverse event. Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control.  On 08-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 AXILLARY PAIN (Pain in her armpit of the same arm she got the vaccine administered), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) and VACCINATION SITE PAIN (Tenderness from the injection site is gone). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, AXILLARY PAIN (Pain in her armpit of the same arm she got the vaccine administered) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) had not resolved and VACCINATION SITE PAIN (Tenderness from the injection site is gone) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash
Clinical narrative: rash itchy; Throat started to swell; Bad rash from head to toe; This spontaneous case was reported by a nurse and describes the occurrence of PHARYNGEAL SWELLING (Throat started to swell), PRURITUS (rash itchy) and RASH (Bad rash from head to toe) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RASH (Bad rash from head to toe). On 10-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat started to swell). On 12-Jan-2021, the patient experienced PRURITUS (rash itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat started to swell), PRURITUS (rash itchy) and RASH (Bad rash from head to toe) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Intrauterine Fetal Death. On 07-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccinated while pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccinated while pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccinated while pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Musculoskeletal stiffness, Nausea, Pain, Vaccination site movement impairment
Clinical narrative: Hot heated feeling from her ears to her wrist; Pain that also radiates from her ears to her wrist; Stiff neck to the right side; Cannot lift her right arm up to her chest; Nausea; A spontaneous report was received from a non-healthcare professional concerning a 25 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hot heated feeling from her ears to her wrist, pain that also radiates from her ears to her wrist, stiff neck to the right side, nausea, cannot lift her right arm up to her chest.  No medical history was reported.  No concomitant medication was reported.  On 12-Jan-2021, prior to the onset of the events hot heated feeling from her ears to her wrist, pain that also radiates from her ears to her wrist, stiff neck to the right side, nausea, cannot lift her right arm up to her chest, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) via an intramuscular route in right arm for prophylaxis of COVID-19 infection.  On 12-Jan-2021, the patient experienced hot heated feeling from her ears to her wrist, pain that also radiates from her ears to her wrist, stiff neck to the right side, nausea, cannot lift her right arm up to her chest.  Laboratory details was not provided.  Treatment medication included Benadryl at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events hot heated feeling from her ears to her wrist, pain that also radiates from her ears to her wrist, stiff neck to the right side, nausea, cannot lift her right arm up to her chest was not provided.  The outcome of the events hot heated feeling from her ears to her wrist, pain that also radiates from her ears to her wrist, stiff neck to the right side, nausea, cannot lift her right arm up to her chest was not provided.  The reporter did not provide the assessment of the events hot heated feeling from her ears to her wrist, pain that also radiates from her ears to her wrist, stiff neck to the right side, nausea, cannot lift her right arm up to her chest to study drug.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Neck pain, Odynophagia
Clinical narrative: severe headache; neck pain/Speaking or eating hurts the neck; Any kind of movement such as swallowing; Any kind of movement such as swallowing and breathing is painful; A spontaneous report was received from a non-healthcare professional concerning a 48 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful. No medical history was reported.  No concomitant medication was reported.  On 07-Jan-2021, prior to the onset of the events severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an intramuscular route in right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful.  Laboratory details was not provided.  Treatment medication included ibuprofen at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful was not provided.  The outcome of the severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful was not provided.  The reporter did not provide the assessment of the events severe headache, any kind of movement such as swallowing and any kind of movement such as swallowing and breathing is painful to study drug.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nervousness
Clinical narrative: Dizziness; Feel shaky; Numb almost like I took a Lortab; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NERVOUSNESS (Feel shaky) and HYPOAESTHESIA (Numb almost like I took a Lortab) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Dizziness), NERVOUSNESS (Feel shaky) and HYPOAESTHESIA (Numb almost like I took a Lortab). At the time of the report, DIZZINESS (Dizziness), NERVOUSNESS (Feel shaky) and HYPOAESTHESIA (Numb almost like I took a Lortab) 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. No treatment was received by the patient.  She got the Moderna COVID-19 vaccine at 9am this morning.  Two hours later she started to feel dizziness and shaky.  The same day she started to feel numb stating that it "almost felt like I took a Lortab."  Reporter allowed further contact with her and consent for Safety to follow-up with her health care provider was denied  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; 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: Body temperature, Body temperature decreased, Feeling cold, Temperature intolerance
Clinical narrative: Cannot warm up; temperature 96.2 ºF; is cold to touch/has been freezing all day; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (Cannot warm up), BODY TEMPERATURE DECREASED (temperature 96.2 ºF) and FEELING COLD (is cold to touch/has been freezing all day) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety, High cholesterol, Chronic migraine and Vitamin D deficiency.    On 11-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 TEMPERATURE INTOLERANCE (Cannot warm up), BODY TEMPERATURE DECREASED (temperature 96.2 ºF) and FEELING COLD (is cold to touch/has been freezing all day). At the time of the report, TEMPERATURE INTOLERANCE (Cannot warm up), BODY TEMPERATURE DECREASED (temperature 96.2 ºF) and FEELING COLD (is cold to touch/has been freezing all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 96.2f (Low) 96.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received other medications for depression, anxiety, high cholesterol, chronic migraines and vitamin D deficiency. The patient did not receive any treatment medications.; 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. Further information has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: symptoms of COVID/ positive result from the COVID test after first dose; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (symptoms of COVID/ positive result from the COVID test after first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and ENALAPRIL MALEATE (VASOTEC [ENALAPRIL MALEATE]) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2020, the patient experienced COVID-19 (symptoms of COVID/ positive result from the COVID test after first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (symptoms of COVID/ positive result from the COVID test after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-1 test: 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.   Treatment included paracetamol maybe once or twice.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain and soreness in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain and soreness in the right arm) 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 11-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 VACCINATION SITE PAIN (Pain and soreness in the right arm). At the time of the report, VACCINATION SITE PAIN (Pain and soreness in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information 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: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: Fever of 101; Extremely fatigued; Extreme lethargy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101), FATIGUE (Extremely fatigued) and LETHARGY (Extreme lethargy) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101), FATIGUE (Extremely fatigued) and LETHARGY (Extreme lethargy). At the time of the report, PYREXIA (Fever of 101), FATIGUE (Extremely fatigued) and LETHARGY (Extreme lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.    Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for coronavirus) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for coronavirus). At the time of the report, COVID-19 (Tested positive for coronavirus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm warm to touch; Hard arm; Swollen arm; Red arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm to touch), VACCINATION SITE INDURATION (Hard arm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 VACCINATION SITE WARMTH (Arm warm to touch), VACCINATION SITE INDURATION (Hard arm), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Sore arm). On 13-Jan-2021, VACCINATION SITE WARMTH (Arm warm to touch), VACCINATION SITE INDURATION (Hard arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen arm) 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.   Treatment for the event included paracetamol.  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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE ERYTHEMA (developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.) in a 56-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.). At the time of the report, INJECTION SITE ERYTHEMA (developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injection.) outcome was unknown.    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.     Reporter did not allow further contact.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Influenza like illness, Palpitations
Clinical narrative: Tightness in chest; A racing heart; Dizziness; Still feel a little off; Flu like symptoms; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), PALPITATIONS (A racing heart), DIZZINESS (Dizziness), FEELING ABNORMAL (Still feel a little off) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), PALPITATIONS (A racing heart), DIZZINESS (Dizziness), FEELING ABNORMAL (Still feel a little off) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, CHEST DISCOMFORT (Tightness in chest), PALPITATIONS (A racing heart), DIZZINESS (Dizziness), FEELING ABNORMAL (Still feel a little off) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided. Treatment activities for event was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Dizziness; Weakness; Fatigue; Headache; Muscle pain; Joint pain; Fever; Chills; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fatigue, Headache, Myalgia, Arthralgia, Pyrexia, Chills, Asthenia and Dizziness.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Jan 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, The patient experienced Fatigue, Headache, Muscle pain, Joint pain, Fever, Chills, Weakness and Dizziness.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 13 Jan 2021, the outcome of the event(s) Fatigue, Headache, Myalgia, Arthralgia, Pyrexia, Chills, Asthenia and Dizziness were resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Dizziness; Weakness; Fatigue; Headache; Muscle pain; Joint pain; Fever; Chills; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fatigue, Headache, Myalgia, Arthralgia, Pyrexia, Chills, Asthenia and Dizziness.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Jan 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, The patient experienced Fatigue, Headache, Muscle pain, Joint pain, Fever, Chills, Weakness and Dizziness.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 13 Jan 2021, the outcome of the event(s) Fatigue, Headache, Myalgia, Arthralgia, Pyrexia, Chills, Asthenia and Dizziness were resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: Drippy nose; Temperature was recorded at 99.4 degrees considers a low grade fever; Soreness in the left deltoid; Fatigue; A spontaneous report was received from a consumer, concerning a 66 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in the left deltoid, fatigue, temperature was recorded at 99.4 degrees considers a "low grade fever" and drippy nose.  The patient's medical history reported, included immune/colitis disease. Concomitant medications reported, included Humair.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(batch/lot:011L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient experienced soreness in the left deltoid and fatigue. On 12 Jan 2021, the patient experienced temperature was recorded at 99.4 degrees considers a "low grade fever" and drippy nose.  Treatment medications included Dayquil and Nightquil.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events soreness in the left deltoid and fatigue were recovered on 12 Jan 2021. Outcome of the events temperature was recorded at 99.4 degrees considers a "low grade fever" and drippy nose was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Hyperhidrosis
Clinical narrative: headache; vomiting; dry heaved; stomach still kind of hurts; chills; fever; sweating profusely; sickest he has felt for as long as he can remember; A spontaneous report was received from a consumer, a 21 year-old male patient, who received Moderna's COVID-19 Vaccine and experienced headache, chills, fever, sweating profusely, vomiting, dry heaved, sickest he has felt for as long as he can remember, and stomach still kind of hurts.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch 011L20A) intramuscularly in the left arm for COVID-19 infection prophylaxis.   That evening, the patient started getting a headache and chills. He stated that the chills got worse and he started running a fever, but he didn't measure his temperature at that time. The patient reported that he was sweating profusely at night.   On 13 Jan 2021, the patient woke up around 1:00 am and vomited. He reported that he fell back asleep and woke up with a pounding headache, where his entire head was throbbing. The patient stated that he vomited, then dry heaved for about an hour, and was not able to keep anything down. He reported that his temperature that morning was 100.1 Fahrenheit. The patient stated that was the sickest he felt for as long as he could remember. He reported that he was finally able to keep liquids down and he was a little better. The patient stated that his stomach still kind of hurt. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, vomiting, sickest he has felt for as long as he can remember, and stomach still kind of hurts, was considered resolving. The outcome of the events, chills, fever, sweating profusely, and dry heaved, was considered resolved on 13 Jan 2021.; 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