chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Headache; Fever temperature of 99.3 F; exhaustion; swollen lymph nodes; tenderness under armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes), AXILLARY PAIN (tenderness under armpit), HEADACHE (Headache), PYREXIA (Fever temperature of 99.3 F) and FATIGUE (exhaustion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and AXILLARY PAIN (tenderness under armpit). On 12-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever temperature of 99.3 F) and FATIGUE (exhaustion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) was resolving and AXILLARY PAIN (tenderness under armpit), HEADACHE (Headache), PYREXIA (Fever temperature of 99.3 F) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included vitamins and Birth control; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: It was raised; Injection Site Red Edematous Rash; Red edematous rash; slight itchiness at the injection site; A spontaneous report was received from a health care professional concerning a 24-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced slight itchiness at the injection site and red edematous rash, slightly raised.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 037K20A) intramuscularly in her left arm for prophylaxis of COVID-19.  On 02 Jan 2021, the patient experienced a slight itchiness at the injection site.   On 03 Jan 2021, the patient woke up with a red edematous rash, slightly raised.  The patient stated that the redness was less in the center, but the area had spread to 110 mm. c, red, not itchy, not painful. Treatment included diphenhydramine hydrochloride, taken three times.   The outcome for the events, slight itchiness at the injection site, red edematous rash, slightly raised, were unknown.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events of slight itchiness at the injection site, red edematous rash, slightly raised, and administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of injection site pruritus, injection site induration , injection site rash and injection site erythema are consistent with the product safety profile.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling hot, Heart rate, Hypertension, Injection site pain
Clinical narrative: Ache at injection site; Tingling at injection site; sensation up arm and heart; Tachycardia; Hypertension; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension) 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 adverse events reported.). Concurrent medical conditions included No adverse event (No adverse events reported.) and No adverse event (no adverse event reported.).    On 31-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 PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension). At the time of the report, INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Blood pressure measurement: 143/74 143/74. On 31-Dec-2020, Heart rate: 94 94. On 31-Dec-2020, Hypertension: 160-180 160- 180. On 31-Dec-2020, Tachycardia: 110-120 110 -120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication not provided.  Treatment included emergency department visit.; 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: U
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site paraesthesia
Clinical narrative: Ache at injection site; Tingling at injection site; sensation up arm and heart; Tachycardia; Hypertension; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension) 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 adverse events reported.). Concurrent medical conditions included No adverse event (No adverse events reported.) and No adverse event (no adverse event reported.).    On 31-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 PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension). At the time of the report, INJECTION SITE PAIN (Ache at injection site), VACCINATION SITE PARAESTHESIA (Tingling at injection site), FEELING HOT (sensation up arm and heart), TACHYCARDIA (Tachycardia) and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Blood pressure measurement: 143/74 143/74. On 31-Dec-2020, Heart rate: 94 94. On 31-Dec-2020, Hypertension: 160-180 160- 180. On 31-Dec-2020, Tachycardia: 110-120 110 -120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication not provided.  Treatment included emergency department visit.; 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: Maternal exposure during pregnancy
Clinical narrative: Pregnant patient (She knew she was pregnant) receive her first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient (She knew she was pregnant) receive her first dose of the vaccine) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma and Heart disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) and FOLIC ACID for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Nov-2020 and the estimated date of delivery was 10-Aug-2021. On 21-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient (She knew she was pregnant) receive her first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 21-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient (She knew she was pregnant) receive her first dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  This is a case of product exposure during pregnancy with no associated AEs for this 24-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Internal review on 23-Jul-2021 resulted in updates to the pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 24-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Knocked on butt; Intense headache; 100 fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 21-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Knocked on butt), HEADACHE (Intense headache), PYREXIA (100 fever) and CHILLS (Chills) in a male patient of an unknown age 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MALAISE (Knocked on butt), HEADACHE (Intense headache), PYREXIA (100 fever) and CHILLS (Chills). At the time of the report, MALAISE (Knocked on butt), HEADACHE (Intense headache), PYREXIA (100 fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pyrexia: 100 100.     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 medication not provided. Treatment included Advil.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of headache, fever and chills, and the non-serious unlisted event of Malaise.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Feels weak; Diarrhea; Swollen glands on both sides of face and neck; Muscle soreness and aches; Nausea; chills; Headache; Extreme fatigue and exhaustion; Injection site soreness; Soreness to touch in left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness to touch in left arm), ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck) and FATIGUE (Extreme fatigue and exhaustion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L217A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal disease (May start the Dialysis soon.) since an unknown date.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness to touch in left arm), FATIGUE (Extreme fatigue and exhaustion) and VACCINATION SITE PAIN (Injection site soreness). On 18-Jan-2021, the patient experienced ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck), MYALGIA (Muscle soreness and aches), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Muscle ache and Ache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness to touch in left arm), ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck), FATIGUE (Extreme fatigue and exhaustion), VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle soreness and aches), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (Headache) 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 concomitant medication provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Feels weak; Diarrhea; Swollen glands on both sides of face and neck; Muscle soreness and aches; Nausea; chills; Headache; Extreme fatigue and exhaustion; Injection site soreness; Soreness to touch in left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness to touch in left arm), ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck) and FATIGUE (Extreme fatigue and exhaustion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L217A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Renal disease (May start the Dialysis soon.) since an unknown date.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness to touch in left arm), FATIGUE (Extreme fatigue and exhaustion) and VACCINATION SITE PAIN (Injection site soreness). On 18-Jan-2021, the patient experienced ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck), MYALGIA (Muscle soreness and aches), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Muscle ache and Ache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness to touch in left arm), ASTHENIA (Feels weak), DIARRHOEA (Diarrhea), LYMPHADENOPATHY (Swollen glands on both sides of face and neck), FATIGUE (Extreme fatigue and exhaustion), VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle soreness and aches), NAUSEA (Nausea), CHILLS (chills) and HEADACHE (Headache) 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 concomitant medication provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Itching; Painful; Vaccination site erythema; Vaccination site swelling; redness below the injection site; swelling 2 inches below the injections site; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching), PAIN (Painful), VACCINATION SITE ERYTHEMA (redness below the injection site), VACCINATION SITE SWELLING (swelling 2 inches below the injections site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (swelling 2 inches below the injections site). On 12-Jan-2021, the patient experienced PRURITUS (Itching), PAIN (Painful), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 09-Jan-2021, VACCINATION SITE ERYTHEMA (redness below the injection site) and VACCINATION SITE SWELLING (swelling 2 inches below the injections site) was resolving. At the time of the report, PRURITUS (Itching), PAIN (Painful), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Induration, Rash, Rash erythematous, Rash vesicular
Clinical narrative: knot-like structure on her right hip/bump; rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body; Shingles; Rash is red; Rash is blistery; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (Rash is red), RASH VESICULAR (Rash is blistery), INDURATION (knot-like structure on her right hip/bump) and RASH (rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011LZ0A and 01OMZOA) for COVID-19 vaccination.     The patient's past medical history included Kidney stone and Incontinence. Concurrent medical conditions included Thyroid disorder, Anxiety, Alzheimer's disease and Blood pressure management. Concomitant products included DONEPEZIL for Alzheimer's disease, HYDROXYZINE for Anxiety, LISINOPRIL for Blood pressure management, MIRABEGRON (MYRBETRIC) for Incontinence, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3 for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (Rash is red), RASH VESICULAR (Rash is blistery) and RASH (rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body). On 08-Jan-2021, the patient experienced INDURATION (knot-like structure on her right hip/bump). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Allergy, at an unspecified dose and frequency; LATANOPROST at a dose of .005 percent twice a day and TIMOLOL at a dose of .5 percent once a day. At the time of the report, HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (Rash is red), RASH VESICULAR (Rash is blistery), INDURATION (knot-like structure on her right hip/bump) and RASH (rash on her buttocks/spread to groin area, les, and between her legs/the rash is only on the lower part of the body) had not resolved.            Patient had a stroke on 01 Mar 2021   This case was linked to MOD-2021-255918.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13 Jul 2021 contains medical history.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysarthria, Feeding disorder, Gait inability, Nausea
Clinical narrative: slurred speech; Nausea; unable to eat; painful arm; couldn't walk; Chills; Shakes; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes) and VOMITING (Throwing up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes) and VOMITING (Throwing up). On 12-Jan-2021, the patient experienced NAUSEA (Nausea) and FEEDING DISORDER (unable to eat). On 13-Jan-2021, the patient experienced DYSARTHRIA (slurred speech). On 13-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes), FEEDING DISORDER (unable to eat) and DYSARTHRIA (slurred speech) outcome was unknown and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol and Advil. No concomitant medications were provided by reporter.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor, Vomiting
Clinical narrative: slurred speech; Nausea; unable to eat; painful arm; couldn't walk; Chills; Shakes; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes) and VOMITING (Throwing up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes) and VOMITING (Throwing up). On 12-Jan-2021, the patient experienced NAUSEA (Nausea) and FEEDING DISORDER (unable to eat). On 13-Jan-2021, the patient experienced DYSARTHRIA (slurred speech). On 13-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), GAIT INABILITY (couldn't walk), CHILLS (Chills), TREMOR (Shakes), FEEDING DISORDER (unable to eat) and DYSARTHRIA (slurred speech) outcome was unknown and VOMITING (Throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol and Advil. No concomitant medications were provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test
Clinical narrative: Pregnanacy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnanacy) in a 38-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth). Concurrent medical conditions included Hypothyroidism since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 28-Dec-2020, 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 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnanacy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnanacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive. On an unknown date, Prenatal screening test: 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.   Treatment medication was not reported. Good prenatal checkup was done.  Previous pregnancy included live full-term birth as outcome on 09-Nov-2017.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Sleep disorder
Clinical narrative: kept waking up every hour; pain in arm; Feverish; Nausea; vomited; Body aches; Chills; This spontaneous case was reported by a physical therapist (subsequently medically confirmed) and describes the occurrence of SLEEP DISORDER (kept waking up every hour), VACCINATION SITE PAIN (pain in arm), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Feverish) in a 53-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 included Vertigo in January 2020, Influenza B virus infection in February 2020, Influenza A virus infection in February 2020 and COVID-19 in May 2020. Concomitant products included MAGNESIUM and PROBIOTICS NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). On 14-Jan-2021, the patient experienced PYREXIA (Feverish), NAUSEA (Nausea) and VOMITING (vomited). On an unknown date, the patient experienced SLEEP DISORDER (kept waking up every hour) and VACCINATION SITE PAIN (pain in arm). At the time of the report, SLEEP DISORDER (kept waking up every hour) and VACCINATION SITE PAIN (pain in arm) outcome was unknown and MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Feverish), NAUSEA (Nausea) and VOMITING (vomited) 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.   Patient used herbal remedy for sleeping in concomitant   No treatment medications provided by the reporter.; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: kept waking up every hour; pain in arm; Feverish; Nausea; vomited; Body aches; Chills; This spontaneous case was reported by a physical therapist (subsequently medically confirmed) and describes the occurrence of SLEEP DISORDER (kept waking up every hour), VACCINATION SITE PAIN (pain in arm), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Feverish) in a 53-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 included Vertigo in January 2020, Influenza B virus infection in February 2020, Influenza A virus infection in February 2020 and COVID-19 in May 2020. Concomitant products included MAGNESIUM and PROBIOTICS NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). On 14-Jan-2021, the patient experienced PYREXIA (Feverish), NAUSEA (Nausea) and VOMITING (vomited). On an unknown date, the patient experienced SLEEP DISORDER (kept waking up every hour) and VACCINATION SITE PAIN (pain in arm). At the time of the report, SLEEP DISORDER (kept waking up every hour) and VACCINATION SITE PAIN (pain in arm) outcome was unknown and MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Feverish), NAUSEA (Nausea) and VOMITING (vomited) 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.   Patient used herbal remedy for sleeping in concomitant   No treatment medications provided by the reporter.; 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: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: diarrhea; loss their appetite; all over his body fatigue/feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (loss their appetite) and FATIGUE (all over his body fatigue/feeling very tired) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (loss their appetite) and FATIGUE (all over his body fatigue/feeling very tired). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. On 12-Jan-2021, DIARRHOEA (diarrhea), DECREASED APPETITE (loss their appetite) and FATIGUE (all over his body fatigue/feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included: Blood pressure, Blood thinner, & Cholesterol medications.   This case was linked to MOD-2021-006466 (Patient Link).; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Injection site redness; Injection site warmth; Rash; A spontaneous report was received from a nurse, concerning a 45 years of female patient who received Moderna's COVID-19 vaccine and experienced injection site (redness, warmth, rash). She received intramuscular injection on her left arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27thDec2020, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (lot number 025J20A) via intramuscular route for COVID-19 infection prophylaxis.   On 27 Dec 2020 she received the first dose of vaccine. Two weeks later, she got antibiotics and steroid cream for her injection site reaction (redness that was spreading, warmth). Patient states that her reaction is now gone. Her primary care doctor wasn't sure if it was cellulitis or an allergic reaction, so on 05Jan2021 she took Keflex. On 09Jan2021, she used a steroid cream triamcinolone 0.1% since it hadn't gotten better and Benadryl on 09-11Jan2021 for treatment .She states that the rash was lower than where she remembers the injection being.  No treatment information provided. Action taken with mRNA-1273 in response to the events was not unknown.  The outcome of the events was injection site (redness, warmth, rash) was recovered and resolved at the time of this report.; 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; rash; Fatigue; headache; Muscle Pain; Joint Pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH (rash), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (Muscle Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2oa) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (Dizziness), RASH (rash), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (chills). At the time of the report, DIZZINESS (Dizziness), RASH (rash), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow-up  received on 18-JUN-2021 Included TCR : AE outcome and Gender, Initials was updated; 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Dizziness; rash; Fatigue; headache; Muscle Pain; Joint Pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), RASH (rash), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (Muscle Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2oa) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (Dizziness), RASH (rash), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (chills). At the time of the report, DIZZINESS (Dizziness), RASH (rash), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow-up  received on 18-JUN-2021 Included TCR : AE outcome and Gender, Initials was updated; 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: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site cellulitis, Vaccination site pain
Clinical narrative: cellulitis; pain in armpit; had a pain at injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), AXILLARY PAIN (pain in armpit) and VACCINATION SITE PAIN (had a pain at injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K0-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    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 AXILLARY PAIN (pain in armpit) and VACCINATION SITE PAIN (had a pain at injection site). On 13-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (cellulitis). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis) outcome was unknown and AXILLARY PAIN (pain in armpit) and VACCINATION SITE PAIN (had a pain at injection site) 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.   The concomitant medications reported was meds for high blood pressure. The treatment reported was patient was prescribed antibiotics - Bactrim  for cellulitis.  on 13-Jan-2021, the symptoms returned, patient was having redness and warmth to the touch in the injection site. Also, patient's arm was swollen and hot.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 14-Jan-2021, DIARRHOEA (Diarrhea) 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: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: swollen lymph nodes in armpit; swelling is sore also; muscle was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (muscle was sore), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in armpit) and AXILLARY PAIN (swelling is sore also) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 VACCINATION SITE PAIN (muscle was sore). On 13-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in armpit) and AXILLARY PAIN (swelling is sore also). On 11-Jan-2021, VACCINATION SITE PAIN (muscle was sore) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in armpit) and AXILLARY PAIN (swelling is sore also) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment for the events are not reported but she used heating pad; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      The patient's past medical history included No adverse event (No medical reported history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HERPES ZOSTER (developed shingles). At the time of the report, HERPES ZOSTER (developed shingles) 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.; 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 of Herpes Zoster, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: rash; itchy; A spontaneous report was received from a consumer concerning herself, a 69-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a rash that was itchy in the right arm.  The patient's medical history was not provided. Patient reported that she took allergy medicine for the rash. No concomitant medication information provided.  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02820A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unreported date, patient experienced rash that was itchy on her right arm.   She stated that she took allergy medicine. No other treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, arm had a rash and was itchy, was not reported.; Reporter's Comments: This case concerns a 69-years-old female patient, who experienced non-serious events of Injection site pruritus and Injection site erythema. The events occurred on an unspecified date after first dose of mRNA-1273, lot # 02820A. Treatment included allergy medicine. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sinusitis, Vaccination site pain
Clinical narrative: Arm hurt; Sinusitis; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE PAIN (Arm hurt) and SINUSITIS (Sinusitis) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sinusitis.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever). On 11-Jan-2021, the patient experienced SINUSITIS (Sinusitis). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt). The patient was treated with GUAIFENESIN (MUCINEX) ongoing since an unknown date for Sinusitis, at a dose of 1 dosage form and PREDNISONE ongoing since an unknown date for Sinusitis, at a dose of 1 dosage form. On 09-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown and SINUSITIS (Sinusitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Existing current sinus disorder prior to vaccination is considered a confounder for the event of sinusitis.