chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Injection site warm; Injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) 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 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy). At the time of the report, INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment for the event is not provided.   This case was linked to MOD-2021-008434 (Patient Link).; 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: Erythema, Thermal burn, Vaccination site pain
Clinical narrative: Arm hurt at injection site; Face was on fire; Face was red; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Face was on fire), ERYTHEMA (Face was red) and VACCINATION SITE PAIN (Arm hurt at injection site) in a 67-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced THERMAL BURN (Face was on fire) and ERYTHEMA (Face was red). On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, THERMAL BURN (Face was on fire), ERYTHEMA (Face was red) and VACCINATION SITE PAIN (Arm hurt at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus, Vertigo
Clinical narrative: warm to the touch at injection site; redness; significant itching; vertigo-like, head rush, like going down a roller coaster; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo-like, head rush, like going down a roller coaster), INJECTION SITE WARMTH (warm to the touch at injection site), ERYTHEMA (redness) and PRURITUS (significant itching) in a 59-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 No adverse event (No reported medical history.).    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 VERTIGO (vertigo-like, head rush, like going down a roller coaster). On an unknown date, the patient experienced INJECTION SITE WARMTH (warm to the touch at injection site), ERYTHEMA (redness) and PRURITUS (significant itching). On 09-Jan-2021, VERTIGO (vertigo-like, head rush, like going down a roller coaster) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to the touch at injection site), ERYTHEMA (redness) and PRURITUS (significant itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in all over the hand; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash in all over the hand) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced RASH (Rash in all over the hand). On 25-Dec-2020, RASH (Rash in all over the hand) 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 product use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: fever 102F; chills; body aches; sore arm; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 102F), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore arm) and FATIGUE (general fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Dec-2020.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (fever 102F), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore arm) and FATIGUE (general fatigue). At the time of the report, PYREXIA (fever 102F), CHILLS (chills), MYALGIA (body aches), VACCINATION SITE PAIN (sore arm) and FATIGUE (general fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details were not reported.; 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: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red Rash around the injection site; Injection site itching; Red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Rash around the injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Red rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red Rash around the injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Red rash around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red Rash around the injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Red rash around the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The patient stated that she I had her second shot and did not have any reactions to that shot.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Information of dose 2 was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy since 22-May-1991, Drug allergy (Keflex) since 22-May-1991 and Allergy to antibiotic (minocycline and Clarithromycin) since 22-May-1991.    On 31-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 an unknown date and the estimated date of delivery was 25-Jan-2021. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 01-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on her second pregnancy.First pregnancy due date was 4 Dec 2019 with resulted in live birth.  No concomitants or treatment medications were reported. Estimated date of conception was 05 May 2020.; Sender's Comments: This is a case of product exposure during pregnancy with associated AE for this 29-year-old female.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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Colour blindness acquired, Pain in extremity, SARS-CoV-2 test, Vision blurred, Visual impairment
Clinical narrative: She couldn't identify a green light from a red light and went through a red light; Eyes were extra blurry; Couldn't read her texts; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jan-2021. The most recent information was received on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of COLOUR BLINDNESS ACQUIRED (She couldn't identify a green light from a red light and went through a red light), VISION BLURRED (Eyes were extra blurry), PAIN IN EXTREMITY (Sore arm) and VISUAL IMPAIRMENT (Couldn't read her texts) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2DA) for COVID-19 vaccination.     The patient's past medical history included Blind right eye and COVID-19 in October 2020. Concurrent medical conditions included Optic neuritis and Multiple sclerosis.   On 06-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLOUR BLINDNESS ACQUIRED (She couldn't identify a green light from a red light and went through a red light) and VISION BLURRED (Eyes were extra blurry). 07-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Couldn't read her texts). On 07-Jan-2021, COLOUR BLINDNESS ACQUIRED (She couldn't identify a green light from a red light and went through a red light), VISION BLURRED (Eyes were extra blurry), PAIN IN EXTREMITY (Sore arm) and VISUAL IMPAIRMENT (Couldn't read her texts) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: unknown (Positive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided    This case was linked to MOD-2021-208218, MOD-2021-208218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received and contains significant information about past medical history, second dose of vaccination and adverse event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) in 2000 and Penicillin allergy.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Jun-2020 and the estimated date of delivery was 11-Mar-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) normal. On an unknown date, Ultrasound antenatal screen normal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that she was feeling well and that she did not experience any complications.  No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  The estimated date of conception was reported as Jun. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: follow-up received on 29-Jan-2021 included patient information, medical history, due date, and product lot number; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 40-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid 19 positive after getting vaccine; A spontaneous report was received from a consumer concerning a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID-19 Virus.   The patient's medical history was not provided by the reporter. Concomitant medications reported included ESOMEPRAZOLE, LISINOPRIL, METOPROLOL, ATORVASTATIN, 83MG BABY ASPIRIN, VITAMIN D3, VITAMIN C with ZINC.   On 12 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.   On 13 Jan 2021, after receiving mRNA-1273, the patient tested positive for COVID-19 Virus. Treatment for the event is unknown at this time.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event Positive COVID-19, was considered to be unknown 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 event, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    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 NAUSEA (Nausea), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea). At the time of the report, NAUSEA (Nausea), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhea) 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Tremor
Clinical narrative: flu like symptoms: pain, chills, pyrexia, headache; shaking; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms: pain, chills, pyrexia, headache) and TREMOR (shaking) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Moderna 011) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included IBUPROFEN for an unknown indication.    On 07-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 INFLUENZA LIKE ILLNESS (flu like symptoms: pain, chills, pyrexia, headache) and TREMOR (shaking). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms: pain, chills, pyrexia, headache) and TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes:blood pressure medication and cholesterol medication. She has been taking ibuprofen since yesterday and has been doing the same today.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Abdominal pain; Headache; Redness at site of injection; Swelling at site of injection; Pain at the site of injection; A spontaneous report was received from a consumer concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at site of injection, swelling at site of injection, pain at the site of injection, abdominal pain and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient experienced redness at site of injection, swelling at site of injection, pain at the site of injection. These side effects reduced after few days.  On 07 Jan 2021, the patient experienced abdominal pain and headache.   Treatment for the events included ibuprofen (400 mg), tylenol (1000mg) and simethicone.  The patient was still having the symptoms at the time of this report.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, redness at site of injection, swelling at site of injection, pain at the site of injection, abdominal pain and headache was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Does not have an appetite; Lymph node is sore; Arm pit was swollen; Arm hurts; Headache that went around the whole head; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Does not have an appetite), LYMPH NODE PAIN (Lymph node is sore), LYMPHADENOPATHY (Arm pit was swollen), VACCINATION SITE PAIN (Arm hurts) and HEADACHE (Headache that went around the whole head) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included OMEPRAZOLE for an unknown indication.    On 07-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 HEADACHE (Headache that went around the whole head). On 08-Jan-2021, the patient experienced DECREASED APPETITE (Does not have an appetite), LYMPH NODE PAIN (Lymph node is sore), LYMPHADENOPATHY (Arm pit was swollen) and VACCINATION SITE PAIN (Arm hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Does not have an appetite), LYMPH NODE PAIN (Lymph node is sore), LYMPHADENOPATHY (Arm pit was swollen), VACCINATION SITE PAIN (Arm hurts) and HEADACHE (Headache that went around the whole head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus, Skin warm
Clinical narrative: Got a lump; Turned hot; Really itchy; A spontaneous report was received from a consumer concerning a 35-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lump/mas, turned hot/skin warm, and really itchy/pruritus.   The patient's medical history was not provided by the reporter. No concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the event, the patient received their doses of mRNA-1273 (Lot number: unknown ) in an unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient got a lump, turned hot, really itchy for 3 days.  Treatment for the events included none. No consultation with Healthcare professional done.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events got a lump, turned hot, really itchy were reported to be resolved on an unknown date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe Vertigo; A spontaneous report was received from a physician concerning a 65-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe vertigo.  The patient's medical history, was not reported. Concomitant medications reported included aspirin 81 mg.  On 04 jan 2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced severe vertigo.   No laboratory details was provided. Treatment for the event included meclizine.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vertigo, was considered as resolved on 07 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Photopsia, Vaccination site pain
Clinical narrative: Saw lights emitting from blanket; Pain when she moved her arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (Saw lights emitting from blanket), VACCINATION SITE PAIN (Pain when she moved her arm) and CHILLS (Chills) in a 79-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 Cataracts (Cataract surgery 5 years ago), Corneal implant (Partial cornea implants 5 years ago) and Eye laser surgery (2 years ago).    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 VACCINATION SITE PAIN (Pain when she moved her arm) and CHILLS (Chills). On 13-Jan-2021, the patient experienced PHOTOPSIA (Saw lights emitting from blanket). At the time of the report, PHOTOPSIA (Saw lights emitting from blanket), VACCINATION SITE PAIN (Pain when she moved her arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash like a circle at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Rash like a circle at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash like a circle at the injection site). At the time of the report, VACCINATION SITE RASH (Rash like a circle at the injection site) 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.   This case concerns a 43-year-old female who experienced nonserious expected event of vaccination site rash.  Event onset occurred day 10 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 43-year-old female who experienced nonserious expected event of vaccination site rash.  Event onset occurred day 10 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic, Vaccination site erythema
Clinical narrative: red spot then it stated to feel Itchy; injection site area was smooth; red about 2 inch circular diameter around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red spot then it stated to feel Itchy), INJECTION SITE REACTION (injection site area was smooth) and VACCINATION SITE ERYTHEMA (red about 2 inch circular diameter around the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced RASH PRURITIC (red spot then it stated to feel Itchy), INJECTION SITE REACTION (injection site area was smooth) and VACCINATION SITE ERYTHEMA (red about 2 inch circular diameter around the injection site). At the time of the report, RASH PRURITIC (red spot then it stated to feel Itchy), INJECTION SITE REACTION (injection site area was smooth) and VACCINATION SITE ERYTHEMA (red about 2 inch circular diameter around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The relevant concomitant medications were also not provided. No treatment information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I got the moderna vaccine at 8 weeks and 5 days; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I got the moderna vaccine at 8 weeks and 5 days) 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 (I got the moderna vaccine at 8 weeks and 5 days). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I got the moderna vaccine at 8 weeks and 5 days) had 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.   concomitant and Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2021: follow up received and contains no new information.; Sender's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Baseball sized rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Baseball sized rash) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and RASH (Baseball sized rash). At the time of the report, URTICARIA (Hives) had resolved and RASH (Baseball sized rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment included topical Benadryl (diphenhydramine) cream for hives.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter'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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Soft tissue mass
Clinical narrative: small lump on shoulder and base of the neck; This spontaneous case was reported by a consumer and describes the occurrence of SOFT TISSUE MASS (small lump on shoulder and base of the neck) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EL3246) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SOFT TISSUE MASS (small lump on shoulder and base of the neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOFT TISSUE MASS (small lump on shoulder and base of the neck) 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.   No concomitant medications reported by investigator; Sender's Comments: This case concerns a 57-year-old male who experienced a nonserious unexpected event of soft tissue mass.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included Tylenol. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Migraine, Vaccination site pain
Clinical narrative: Back pain; Horrible migraine; no energy to get up; Arm really sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MIGRAINE (Horrible migraine), ASTHENIA (no energy to get up) and VACCINATION SITE PAIN (Arm really sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE, ETHINYLESTRADIOL, LEVONORGESTREL (TRIVORA) and PARACETAMOL (TYLENOL) for an unknown indication.    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 BACK PAIN (Back pain), MIGRAINE (Horrible migraine), ASTHENIA (no energy to get up) and VACCINATION SITE PAIN (Arm really sore). At the time of the report, BACK PAIN (Back pain), MIGRAINE (Horrible migraine), ASTHENIA (no energy to get up) and VACCINATION SITE PAIN (Arm really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-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 start date of the events, a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Soreness at the injection site; Redness at the injection site-size of a quarter; Bumps/hardness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Bumps/hardness around the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site-size of a quarter) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril, metformin HCL, tessalenpark.). Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), GLIMEPIRIDE, EMPAGLIFLOZIN (JARDIANCE), ESCITALOPRAM, CICLOSPORIN (RESTASIS), LOSARTAN, INSULIN DEGLUDEC (TRESIBA), HYDROXYCHLOROQUINE, BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), MACROGOL 3350 (MIRALAX), CYAMOPSIS TETRAGONOLOBA GUM (BENEFIBER FIBER SUPPLEMENT), FUROSEMIDE, CALCIUM, METOPROLOL TARTRATE, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE and NYSTATIN for an unknown indication.    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 VACCINATION SITE INDURATION (Bumps/hardness around the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site-size of a quarter). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE INDURATION (Bumps/hardness around the injection site) had resolved and VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site-size of a quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Big red spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red spot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced ERYTHEMA (Big red spot). At the time of the report, ERYTHEMA (Big red spot) 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: Based on the information provided, a temporal association between the reported events and administration of mRNA-1273 vaccine, and excluding any other etiology, a causal association cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash started from day 7 to day 12 and is getting bigger; A spontaneous report (United States) was received from a consumer (age and gender unknown) who received Moderna's COVID-19 vaccine and experienced rash which started from day 7 to day 12 and is getting bigger.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, patient started to experience rash from day 7 to 12 and it got bigger. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events of rash which started from day 7 to day 12 and is getting bigger was not recovered.; Reporter's Comments: This case concerns a 72-year-old female who experienced the nonserious unexpected event of RASH.  Event onset 7-12 days after the first dose of mRNA-1273. Treatment not reported. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Pyrexia, Swelling face
Clinical narrative: Cheeks were swelling; Eyes were swelling; Low grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Cheeks were swelling), EYE SWELLING (Eyes were swelling) and PYREXIA (Low grade fever) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020 and Dermal filler injection in 2020.    On 06-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 SWELLING FACE (Cheeks were swelling), EYE SWELLING (Eyes were swelling) and PYREXIA (Low grade fever). At the time of the report, SWELLING FACE (Cheeks were swelling), EYE SWELLING (Eyes were swelling) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol around the clock on 07-Jan-2021 for the event low grade fever.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 99 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99 degrees) 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 reported medical history.).    On 09-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 PYREXIA (Fever of 99 degrees). At the time of the report, PYREXIA (Fever of 99 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Body temperature: 99 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pyrexia, 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 onset date of the reported event of pyrexia, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Chills, Fatigue, Malaise
Clinical narrative: Loss of taste; Not doing well; Extreme fatigue; Muscle aches; Joint pain; Chills; A spontaneous report was received from a 74 year old male, patient ,who administered first dose of Moderna Covid-19 Vaccine and have experienced loss of taste, malaise, fatigue, muscle aches, joint pains and chills.  The patient's medical history was not provided. His concomitant medications were Purinethol, Losartan, Omeprazole, Metoprolol, Singulair, Metformin, Amaryl, Norvasc, Pioglitazone, Trulicity 0. No information on allergies.  On 28 Dec 2020, prior to onset of events, patient received first of two planned doses of Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot: 039K20A).   Since then patient has been not doing well(malaise) and experiencing loss of taste, muscle aches, joint pains, chills and fatigue. It is not known whether he seek treatment for the events.  Action taken with 2nd dose of vaccine is not reported.  The outcome of the events loss of taste, malaise, muscle aches, joint pains, chills, and fatigue were not recovered at the time of report.; 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Loss of taste; Not doing well; Extreme fatigue; Muscle aches; Joint pain; Chills; A spontaneous report was received from a 74 year old male, patient ,who administered first dose of Moderna Covid-19 Vaccine and have experienced loss of taste, malaise, fatigue, muscle aches, joint pains and chills.  The patient's medical history was not provided. His concomitant medications were Purinethol, Losartan, Omeprazole, Metoprolol, Singulair, Metformin, Amaryl, Norvasc, Pioglitazone, Trulicity 0. No information on allergies.  On 28 Dec 2020, prior to onset of events, patient received first of two planned doses of Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot: 039K20A).   Since then patient has been not doing well(malaise) and experiencing loss of taste, muscle aches, joint pains, chills and fatigue. It is not known whether he seek treatment for the events.  Action taken with 2nd dose of vaccine is not reported.  The outcome of the events loss of taste, malaise, muscle aches, joint pains, chills, and fatigue were not recovered at the time of report.; 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.