chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site urticaria
Clinical narrative: Local reaction at the Injection site, skin is red; Injection site rash; Tender at the center; Was just a welt; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Local reaction at the Injection site, skin is red), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE PAIN (Tender at the center) and VACCINATION SITE URTICARIA (Was just a welt) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G25L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Local reaction at the Injection site, skin is red), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE PAIN (Tender at the center) and VACCINATION SITE URTICARIA (Was just a welt). At the time of the report, VACCINATION SITE ERYTHEMA (Local reaction at the Injection site, skin is red), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE PAIN (Tender at the center) and VACCINATION SITE URTICARIA (Was just a welt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.    This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Reporter's co-worker
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: diarrhea; queasiness; headache; fever; soreness; chattering teeth; chills; exhausted; A spontaneous report was received from a 51 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and experienced fever, exhaustion, chills, soreness, chattering teeth, diarrhea, headache and queasiness.   The patient's medical history was not provided. Concomitant medications reported included famotidine, atenolol and oxymetazoline hydrochloride.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J2/2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 1 Jan 2020, patient reported fever, exhaustion, chills, soreness and chattering teeth. On 7 Jan 2020, patient started to feel bad again with fever, chills, exhaustion, diarrhea, headache and queasiness.   Treatment for the event included ibuprofen and then paracetamol.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, fever, exhaustion, chills, soreness, chattering teeth, diarrhea, headache and queasiness were considered unknown.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, fever , nausea and chills are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: diarrhea; queasiness; headache; fever; soreness; chattering teeth; chills; exhausted; A spontaneous report was received from a 51 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and experienced fever, exhaustion, chills, soreness, chattering teeth, diarrhea, headache and queasiness.   The patient's medical history was not provided. Concomitant medications reported included famotidine, atenolol and oxymetazoline hydrochloride.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J2/2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 1 Jan 2020, patient reported fever, exhaustion, chills, soreness and chattering teeth. On 7 Jan 2020, patient started to feel bad again with fever, chills, exhaustion, diarrhea, headache and queasiness.   Treatment for the event included ibuprofen and then paracetamol.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, fever, exhaustion, chills, soreness, chattering teeth, diarrhea, headache and queasiness were considered unknown.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, fever , nausea and chills are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue) and PYREXIA (Low grade fever) 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 reported medical history).   On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), FATIGUE (Fatigue) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Fatigue) had resolved and PYREXIA (Low grade fever) outcome was unknown. Not Provided          Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-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 event, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Nasal congestion, Somnolence
Clinical narrative: Very sleepy; 5cm by 7cm diffuse, circular erythema at the injection site; Pain at the injection site; stuffy nose; A spontaneous report was received from a 45 year old female consumer who was participating in the mRNA-1273 Emergency Use Authorization and developed stuffy nose, injection site pain, sleepiness, and circular erythema at the injection site.   The patient's medical history, as provided by the reporter, included food allergies. Concomitant medications were not provided.   On 5 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 026L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 5 Jan 2021, approximately 1.5 hours after the injection, patient states her nose started to feel stuffy which persisted through 6 Jan 2021. On 6 Jan 2021, she experienced pain at the injection site. On 7 Jan 2021, she was very sleepy and developed a 5cm by 7cm diffuse circular erythema at the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, stuffy nose, sleepiness and injection site erythema, were considered resolved. The other event outcome, injection site pain, is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Nausea, Pregnancy test
Clinical narrative: Pregnant; headache; nausea; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Penicillin allergy and Drug allergy (Ceclor).    On 21-Dec-2020 at 12:21 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Aug-2020 and the estimated date of delivery was 27-May-2021. On 21-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's estimated date of conception was 04-Sep-2020. The patient had 2 previous pregnancies including a full term birth on 22-Aug-2017 and spontaneous abortion on 07-Mar-2020.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: TCR received. call received and provided email id; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 32-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Ocular discomfort, Pain in extremity, Pyrexia
Clinical narrative: arm so sore; Running a fever; Headache; pressure behind eyes; very cold; A spontaneous report was received from a consumer concerning a 55-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, fever, headache, pressure behind the eyes and feeling cold.   The patient's medical history was not reported.  Concomitant medications included acetylsalicylic acid, vitamin D3, lisinopril, metoprolol, pravastatin, and an unspecified, over-the-counter heartburn medication.    On an unspecified date, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient received Covid-19 vaccine and developed so sore arm, fever, headache, pressure behind the eyes, and feeling very cold. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown/ not reported.; Reporter's Comments: This report concerns a 55-year old female patient who experienced non-serious events of sore arm, fever, headache, pressure behind the eyes and feeling cold occurring within 2 days of her receiving the mRNA-1273. 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: Urticaria
Clinical narrative: Hives; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hives (urticaria).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, the patient developed hives after receiving the vaccine. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, hives, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the event of urticaria, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: huge rash which is itchy and swelling; huge rash which is itchy and swelling; Fever; Chills; Joint aches; Vertigo; Vomitting; Vision was messed up; Arm hurt so bad; A spontaneous report was received from a consumer who was a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and his arm hurt so bad, he had vertigo, vomiting, vision was messed up, fever, chills, joint aches and later developed huge itchy rash and swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  Later that day (30 Dec 2020), the patient's arm badly hurt.   On 31 Dec 2020, he had vertigo, vomiting, and his vision was messed up.   The next day on 01 Jan 2021 he had fever, chills and joint aches.  On 02 Jan 2021, he developed a huge itchy rash and swelling.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm hurt so bad, vertigo, vomiting, vision messed up, fever, chills, joint aches, huge itchy rash and swelling were not reported.; Reporter's Comments: This case concerns a male subject (age and medical history not provided) who received Moderna's COVID-19 vaccine (unknown Lot #) and experienced  non-serious events of pain in extremity, vertigo, vomiting, vision was messed up, fever, chills, joint aches and later developed huge itchy rash and swelling.  The extremity pain event occurred on the same day after the  first dose of the vaccine administration, while vertigo, and vision problem occurred one day after the vaccine administration. Fever, chills, and joint aches occurred 2 days after, while itchy rash and swelling events occurred 3 days after vaccine administration. The treatment for the events and outcome were not provided. Based on temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vertigo, Visual impairment, Vomiting
Clinical narrative: huge rash which is itchy and swelling; huge rash which is itchy and swelling; Fever; Chills; Joint aches; Vertigo; Vomitting; Vision was messed up; Arm hurt so bad; A spontaneous report was received from a consumer who was a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and his arm hurt so bad, he had vertigo, vomiting, vision was messed up, fever, chills, joint aches and later developed huge itchy rash and swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  Later that day (30 Dec 2020), the patient's arm badly hurt.   On 31 Dec 2020, he had vertigo, vomiting, and his vision was messed up.   The next day on 01 Jan 2021 he had fever, chills and joint aches.  On 02 Jan 2021, he developed a huge itchy rash and swelling.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm hurt so bad, vertigo, vomiting, vision messed up, fever, chills, joint aches, huge itchy rash and swelling were not reported.; Reporter's Comments: This case concerns a male subject (age and medical history not provided) who received Moderna's COVID-19 vaccine (unknown Lot #) and experienced  non-serious events of pain in extremity, vertigo, vomiting, vision was messed up, fever, chills, joint aches and later developed huge itchy rash and swelling.  The extremity pain event occurred on the same day after the  first dose of the vaccine administration, while vertigo, and vision problem occurred one day after the vaccine administration. Fever, chills, and joint aches occurred 2 days after, while itchy rash and swelling events occurred 3 days after vaccine administration. The treatment for the events and outcome were not provided. Based on temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm swollen; Arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE WARMTH (Arm was warm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025LD08) for COVID-19 vaccination.     The patient's past medical history included Broken hip. Concurrent medical conditions included Hypertension (Moderate high blood pressure.), Clotting disorder, Heart disorder and Kidney disorder. Concomitant products included WARFARIN SODIUM (COUMADIN) and HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) for an unknown indication.    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 VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE WARMTH (Arm was warm). On 07-Jan-2021, VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE WARMTH (Arm was warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: symptoms subsided after "a couple days" and then returned along with itching on the arm; chills; headache; arm pain; redness of the arm; arm was hot to the touch; small hard knot on arm; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm) and VACCINATION SITE WARMTH (arm was hot to the touch) in a 63-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.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE BESILATE (NORVASC), LISINOPRIL and IBUPROFEN for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm), VACCINATION SITE WARMTH (arm was hot to the touch) and VACCINATION SITE INDURATION (small hard knot on arm). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (symptoms subsided after "a couple days" and then returned along with itching on the arm). On 28-Dec-2020, CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm), VACCINATION SITE WARMTH (arm was hot to the touch), VACCINATION SITE INDURATION (small hard knot on arm) and VACCINATION SITE PRURITUS (symptoms subsided after "a couple days" and then returned along with itching on the arm) 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.   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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: symptoms subsided after "a couple days" and then returned along with itching on the arm; chills; headache; arm pain; redness of the arm; arm was hot to the touch; small hard knot on arm; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm) and VACCINATION SITE WARMTH (arm was hot to the touch) in a 63-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.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE BESILATE (NORVASC), LISINOPRIL and IBUPROFEN for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm), VACCINATION SITE WARMTH (arm was hot to the touch) and VACCINATION SITE INDURATION (small hard knot on arm). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (symptoms subsided after "a couple days" and then returned along with itching on the arm). On 28-Dec-2020, CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (redness of the arm), VACCINATION SITE WARMTH (arm was hot to the touch), VACCINATION SITE INDURATION (small hard knot on arm) and VACCINATION SITE PRURITUS (symptoms subsided after "a couple days" and then returned along with itching on the arm) 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.   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: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red indurated area at the injection site with some itching; red indurated area at the injection site with some itching; red indurated area at the injection site with some itching; Soreness at the injection site; A spontaneous report was received from a Nurse who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some soreness at the injection site and a red indurated area at the injection site with some itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29-Dec-2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.  Upon receiving the vaccine, the patient experienced some soreness at the injection site and after 8 days, 06-Jan-2021 she continued to experience a red indurated area at the injection the injection site with some itching.   Treatment for the events was not reported.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, soreness at the injection site and indurated area at the injection site with some itching, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Eye swelling, Fatigue, Lacrimation increased, Myalgia
Clinical narrative: Muscle pain; Fatigue; Runny nose; Red eye; Swollen eye; Dryness in throat; watery eyes; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 03 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 03 Jan 2021, the patient experienced muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat. No treatment was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Muscle pain; Fatigue; Runny nose; Red eye; Swollen eye; Dryness in throat; watery eyes; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 03 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 03 Jan 2021, the patient experienced muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat. No treatment was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Dizziness, Erythema, Fatigue
Clinical narrative: Really bad jaw pain; Glands a little bit big; Bodyaches; Redness and burning of her face, chest, neck turned into a full rash; Very exhausted; headache; Rash; Vomiting; Diarrhea; Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".; Redness in area; Blotchy in area; Very very dizzy; Felt like her neck, chest, face were on fire; Couldn't sleep well that night and kind of slept.; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Felt like her neck, chest, face were on fire), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area) and RASH MACULAR (Blotchy in area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.   On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)(batch no: 011J20A). On 04-Jan-2021, the patient experienced HOT FLUSH (Felt like her neck, chest, face were on fire) and INSOMNIA (Couldn't sleep well that night and kind of slept.). On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area), RASH MACULAR (Blotchy in area), DIZZINESS (Very very dizzy), RASH (Rash) and VOMITING (Vomiting). On 06-Jan-2021, the patient experienced PAIN (Bodyaches), BURNING SENSATION (Redness and burning of her face, chest, neck turned into a full rash), FATIGUE (Very exhausted) and HEADACHE (headache). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Glands a little bit big). On an unknown date, the patient experienced PAIN IN JAW (Really bad jaw pain). At the time of the report, HOT FLUSH (Felt like her neck, chest, face were on fire), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area), RASH MACULAR (Blotchy in area), DIZZINESS (Very very dizzy), PAIN (Bodyaches), LYMPHADENOPATHY (Glands a little bit big), INSOMNIA (Couldn't sleep well that night and kind of slept.), PAIN IN JAW (Really bad jaw pain), BURNING SENSATION (Redness and burning of her face, chest, neck turned into a full rash), RASH (Rash), VOMITING (Vomiting), FATIGUE (Very exhausted) and HEADACHE (headache) was resolving.     The patient's past medical history are not reported.  No concomitant medications were provided. Treatment medications include Benadryl 25 mg twice a day every 4-6 hours which was increased to 50 mg on January 7, 2021.           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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Insomnia, Lymphadenopathy, Pain
Clinical narrative: Really bad jaw pain; Glands a little bit big; Bodyaches; Redness and burning of her face, chest, neck turned into a full rash; Very exhausted; headache; Rash; Vomiting; Diarrhea; Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".; Redness in area; Blotchy in area; Very very dizzy; Felt like her neck, chest, face were on fire; Couldn't sleep well that night and kind of slept.; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Felt like her neck, chest, face were on fire), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area) and RASH MACULAR (Blotchy in area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.   On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)(batch no: 011J20A). On 04-Jan-2021, the patient experienced HOT FLUSH (Felt like her neck, chest, face were on fire) and INSOMNIA (Couldn't sleep well that night and kind of slept.). On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area), RASH MACULAR (Blotchy in area), DIZZINESS (Very very dizzy), RASH (Rash) and VOMITING (Vomiting). On 06-Jan-2021, the patient experienced PAIN (Bodyaches), BURNING SENSATION (Redness and burning of her face, chest, neck turned into a full rash), FATIGUE (Very exhausted) and HEADACHE (headache). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Glands a little bit big). On an unknown date, the patient experienced PAIN IN JAW (Really bad jaw pain). At the time of the report, HOT FLUSH (Felt like her neck, chest, face were on fire), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area), RASH MACULAR (Blotchy in area), DIZZINESS (Very very dizzy), PAIN (Bodyaches), LYMPHADENOPATHY (Glands a little bit big), INSOMNIA (Couldn't sleep well that night and kind of slept.), PAIN IN JAW (Really bad jaw pain), BURNING SENSATION (Redness and burning of her face, chest, neck turned into a full rash), RASH (Rash), VOMITING (Vomiting), FATIGUE (Very exhausted) and HEADACHE (headache) was resolving.     The patient's past medical history are not reported.  No concomitant medications were provided. Treatment medications include Benadryl 25 mg twice a day every 4-6 hours which was increased to 50 mg on January 7, 2021.           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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Rash, Rash macular, Swelling face, Vomiting
Clinical narrative: Really bad jaw pain; Glands a little bit big; Bodyaches; Redness and burning of her face, chest, neck turned into a full rash; Very exhausted; headache; Rash; Vomiting; Diarrhea; Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".; Redness in area; Blotchy in area; Very very dizzy; Felt like her neck, chest, face were on fire; Couldn't sleep well that night and kind of slept.; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Felt like her neck, chest, face were on fire), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area) and RASH MACULAR (Blotchy in area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.   On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)(batch no: 011J20A). On 04-Jan-2021, the patient experienced HOT FLUSH (Felt like her neck, chest, face were on fire) and INSOMNIA (Couldn't sleep well that night and kind of slept.). On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area), RASH MACULAR (Blotchy in area), DIZZINESS (Very very dizzy), RASH (Rash) and VOMITING (Vomiting). On 06-Jan-2021, the patient experienced PAIN (Bodyaches), BURNING SENSATION (Redness and burning of her face, chest, neck turned into a full rash), FATIGUE (Very exhausted) and HEADACHE (headache). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Glands a little bit big). On an unknown date, the patient experienced PAIN IN JAW (Really bad jaw pain). At the time of the report, HOT FLUSH (Felt like her neck, chest, face were on fire), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling ear, face, cheek, glands below jaw. "Looked like a chipmunk".), ERYTHEMA (Redness in area), RASH MACULAR (Blotchy in area), DIZZINESS (Very very dizzy), PAIN (Bodyaches), LYMPHADENOPATHY (Glands a little bit big), INSOMNIA (Couldn't sleep well that night and kind of slept.), PAIN IN JAW (Really bad jaw pain), BURNING SENSATION (Redness and burning of her face, chest, neck turned into a full rash), RASH (Rash), VOMITING (Vomiting), FATIGUE (Very exhausted) and HEADACHE (headache) was resolving.     The patient's past medical history are not reported.  No concomitant medications were provided. Treatment medications include Benadryl 25 mg twice a day every 4-6 hours which was increased to 50 mg on January 7, 2021.           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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: itchy at injection site; swollen at injection site; redder at injection site; larger at injection site; A spontaneous report was received from a physician concerning a 42-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy at injection site, swollen at injection site, redder at injection site, and it's getting bigger.  The patient's medical history was not provided. Concomitant medications reported included antidepressant, mineral NOS, vitamins NOS and diphenhydramine hydrochloride.  On 26 Dec 2020, approximately 7 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 25J20/2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient's injection site began to get itchy, swollen, larger and redder. She reported the symptoms were ongoing and it was getting bigger. Treatment for the events included topical hydrocortisone.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events itchy at injection site, swollen at injection site, redder at injection site, and it's getting bigger were not reported.; Reporter's Comments: This case concerns a 42-year old, female patient. The patient's medical history was not provided. The patient experienced NS, expected event of injection site swelling, pruritis, erythema and unexpected event of injection site reaction NOS. The events occurred 8 days after the first dose of mRNA-1273 (Lot number: 25J20/2A) administration. Treatment for the events included topical hydrocortisone. 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Decreased appetite, Fatigue, Pain in extremity
Clinical narrative: Lost his appetite; Feels tightness on his chest; Felt tired; Sore arm; A spontaneous report was received from a physician concerning a 59-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, felt tired/fatigue, lost his appetite/ appetite decreased, feels tightness in his chest/chest discomfort.  The patient's medical history included testing positive for COVID-19 on Mar 2020 which took about 6 months to get over. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection.   On the same day, after vaccination, the patient experienced a sore arm that lasted for 4 days. On 28 Dec 2020, he felt tired and lost his appetite. The patient reported that he got tested for COVID-19 three times between 28 Dec 2020 and 07 Jan 2021, which were all negative. At the time of report, on 07 Jan 2021, the patient had tiredness, appetite was not great and felt tightness in his chest.   Treatment for the event included dexamethasone for couple of days..   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, sore arm was considered resolved on 27 Dec 2020. The outcome of the events felt tired, lost his appetite, feels tightness in his chest, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Eye pain, Fatigue, Vision blurred
Clinical narrative: Blurry vision; Pain in the eyes; Pain in the left breast; Fatigue; A spontaneous report was received from a healthcare professional concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blurry vision, eye pain, fatigue and breast pain.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 02 Jan 2021, the patient reported having blurry vision, pain in the eyes, fatigue and pain in the left breast. Patient had not taken any treatment for the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events, blurry vision, eye pain, fatigue and breast pain was not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in her vaccinated arm, right after the vaccination; A spontaneous report was received from a consumer, who is a caregiver concerning a female patient of un unknown age, who received Moderna's COVID-19 Vaccine and experienced pain in the arm right after the vaccination.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in right arm for prophylaxis of COVID-19 for infection.  On 03 JAN 2021, the patient experienced pain in arm right after the vaccination.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event pain in right arm right after the vaccination was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: A spontaneous report was received from a nurse, concerning a 44 year-old patient of unknown gender, unknown race and ethnicity, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced injection site itchy (injection site pruritus), injection site redness (injection site erythema) and injection site swelling. The patient's medical history and concomitant medications not provided. On Dec 29, 2020, prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (lot# unknown), intramuscularly for prophylaxis of COVID-19 infection. On Jan 5, 2021 (seven days post vaccination), patient experienced injection site redness, swelling and itchy. The treatment for the events included diphenhydramine and unspecified cream. Action taken in response to the events was not provided. The outcome for the events, injection site itchy, injection site redness and injection site swelling not reported. Reporter's comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: the injection side felt warm; redness at injection; A spontaneous report () was received from a nurse, concerning a 43 year-old female patient who received Moderna's COVID-19 Vaccine and experienced redness at injection and the injection side felt warm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, an hour prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot 039K20A) intramuscularly on right deltoid for COVID-19 infection prophylaxis.  The patient had redness at injection about the size of a dime. The redness grew to the size of a quarter, then to the size of 50 cents.   On 04 Jan 2021, the injection side felt warm and the area grew to 3 inches by 3 inches. Treatment for the events included Benadryl (diphenhydramine) on 30 Dec 2020.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, redness at injection, was considered resolved on an unknown date. The outcome of the event, the injection side felt warm, was considered as unknown.; Reporter's Comments: This case concerns a 43-year-old female subject, who experienced a non-serious unexpected event of Vaccination site warmth, and non-serious expected event of Vaccination site erythema. Vaccination site erythema occurred one hour after first dose while Vaccination site warmth occurred after seven days of first dose of the study medication. Vaccination site erythema resolved after treatment with Benadryl (Diphenhydramine). 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: Blood pressure reduced substantially 30 points and it is 106/63; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure reduced substantially 30 points and it is 106/63) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020. Concurrent medical conditions included Hypertension and Chronic kidney disease. Concomitant products included LOSARTAN from 04-Jan-2021 to an unknown date for Hypertension.    On 04-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 HYPOTENSION (Blood pressure reduced substantially 30 points and it is 106/63). At the time of the report, HYPOTENSION (Blood pressure reduced substantially 30 points and it is 106/63) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure measurement: 106/63 Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 69-year-old male, with PMH of COVID-19, hypertension on losartan, and CKD, who experienced NS unexpected event of "blood pressure reduced 30 points to 106/63."  Event onset occurred 4 days after the first dose of mRNA-1273. Treatment not reported. 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.