chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation, Vaccination site warmth
Clinical narrative: Irritation at injection site; Redness at injection site; Warm to touch at injection site; A spontaneous report was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events irritation at injection site, redness at injection site, warm to touch at injection site.  The patient's medical history was not provided. Concomitant medications reported were birth control (unspecified) used for unknown indication.  On 30 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M0A) via unknown route for prophylaxis of COVID-19 infection.  On 6 Feb 2021, after receiving the first dose of mRNA-1273, the patient experienced the event(s) irritation at injection site, redness at injection site, warm to touch at injection site.  Treatment details included methylprednisolone, diphenhydramine.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), irritation at injection site, redness at injection site, warm to touch at injection site 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: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant medication details were provided. Treatment details included Tylenol(paracetamol) and caffeine.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Urticaria
Clinical narrative: Hives on his neck and mostly his face; Headache; Fatigue; Soreness, and body aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on his neck and mostly his face), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Soreness, and body aches) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (Hives on his neck and mostly his face), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Soreness, and body aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 milligram. At the time of the report, URTICARIA (Hives on his neck and mostly his face), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Soreness, and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23-Apr-2021 contains non-significant information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Neck pain, Pyrexia, Vaccination complication
Clinical narrative: Felt sick; Had a horrible neck pain; Chills; Vomiting; Fever; Felt down for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt down for two days), ILLNESS (Felt sick), NECK PAIN (Had a horrible neck pain), CHILLS (Chills) and VOMITING (Vomiting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 COMPLICATION (Felt down for two days), ILLNESS (Felt sick), NECK PAIN (Had a horrible neck pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with HYDROCODONE for Neck pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt down for two days), ILLNESS (Felt sick), NECK PAIN (Had a horrible neck pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received and No New Information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt sick; Had a horrible neck pain; Chills; Vomiting; Fever; Felt down for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt down for two days), ILLNESS (Felt sick), NECK PAIN (Had a horrible neck pain), CHILLS (Chills) and VOMITING (Vomiting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 COMPLICATION (Felt down for two days), ILLNESS (Felt sick), NECK PAIN (Had a horrible neck pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with HYDROCODONE for Neck pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt down for two days), ILLNESS (Felt sick), NECK PAIN (Had a horrible neck pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received and No New Information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site warmth, Vaccination site erythema, Vaccination site swelling
Clinical narrative: flu like symptoms; The swelled area was warm to the touch; redness was about 3 inches in diameter; swelling; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE WARMTH (The swelled area was warm to the touch), VACCINATION SITE ERYTHEMA (redness was about 3 inches in diameter), VACCINATION SITE SWELLING (swelling) and FATIGUE (Very fatigued) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-Jun-1982, High cholesterol since 01-Jan-2017, Depression since 01-Jan-1996 and Allergy to antibiotic (ZPack). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 01-Jan-1996 to an unknown date for Depression, ATORVASTATIN CALCIUM (LIPITOR) from 01-Jan-2018 to an unknown date and EZETIMIBE (ZETIA) from 01-Jan-2020 to an unknown date for High cholesterol, LEVOTHYROXINE from 01-Jun-1982 to an unknown date for Hypothyroidism.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE WARMTH (The swelled area was warm to the touch), VACCINATION SITE ERYTHEMA (redness was about 3 inches in diameter), VACCINATION SITE SWELLING (swelling) and FATIGUE (Very fatigued). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE SWELLING (swelling) and FATIGUE (Very fatigued) outcome was unknown and INJECTION SITE WARMTH (The swelled area was warm to the touch) and VACCINATION SITE ERYTHEMA (redness was about 3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use include censoroid. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-JUN-2021. Reporter details was reported. Patient details was reported. Medical history was reported. Concomitant product was reported. Adverse event was reported. Event outcome was updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Vaccination site pain
Clinical narrative: became raised (bumps) again; injection site became red; Redness at site of Injection; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (became raised (bumps) again), INJECTION SITE ERYTHEMA (Redness at site of Injection), VACCINATION SITE PAIN (Soreness of arm) and INJECTION SITE ERYTHEMA (injection site became red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of Injection) and VACCINATION SITE PAIN (Soreness of arm). On 04-Feb-2021, the patient experienced INJECTION SITE MASS (became raised (bumps) again) and INJECTION SITE ERYTHEMA (injection site became red). At the time of the report, INJECTION SITE MASS (became raised (bumps) again), INJECTION SITE ERYTHEMA (Redness at site of Injection), VACCINATION SITE PAIN (Soreness of arm) and INJECTION SITE ERYTHEMA (injection site became red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Events were resolved and patient denied further follow-up
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache
Clinical narrative: stomach problems like hard bowel movements; stomach cramps; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach problems like hard bowel movements), ABDOMINAL PAIN UPPER (stomach cramps) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.    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 ABDOMINAL DISCOMFORT (stomach problems like hard bowel movements), ABDOMINAL PAIN UPPER (stomach cramps) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach problems like hard bowel movements) and HEADACHE (headache) outcome was unknown and ABDOMINAL PAIN UPPER (stomach cramps) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that headache was better, but stomach still hurts. Treatment details included Imitrex.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced COVID-19 (Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Diagnosed positive of COVID-19 after receiving the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication not reported.  Treatment medication not reported.  Patient received the 1st dose of Moderna COVID-19 vaccine on 22 Jan 2021. A week later was diagnosed positive of COVID-19.   This case was linked to MOD-2021-264483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received contains updated information on action taken from Unknown to No change and the event coding updated from COVID-19 virus test positive to COVID-19. The event start date and  dose 2 information added in the case.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Vaccination site pain
Clinical narrative: It was hard for her to breathe for a day; Her arm around her injection site she started to get a burning sensation; A spontaneous report was received from a consumer concerning a female patient  of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning sensation on injection site and breathing difficulty.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, a week prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, a week after receiving the mRNA-1273 vaccine, the patient started to get burning sensation around the injection site, which was on and off for two weeks. On unknown date two weeks after the vaccine she reported that it was hard to breathe for a day.   She had since realized that she was allergic to two of the ingredients in the vaccine.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of burning sensation on injection site was recovered and breathing difficulty was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Patient indicated was allergic to two of the ingredients in the vaccine. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 diagnosis after the first dose; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid-19 diagnosis/covid-19  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) COVID-19 diagnosis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), covid-19 diagnosis 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 event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Hard knot; Itchiness; Slight swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard knot), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure since 2004, Cardiomyopathy since 2004, Lactose intolerance (causes gas and diarrhea  .) since 1988 and Egg allergy (Egg yolk-causes gas and diarrhea .) since 2003. Concomitant products included SIMVASTATIN, LISINOPRIL, NITROGLYCERIN, FUROSEMIDE (LASIX [FUROSEMIDE]) and METOPROLOL for an unknown indication.    On 03-Feb-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard knot), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE ERYTHEMA (Redness). On 20-Feb-2021, VACCINATION SITE INDURATION (Hard knot), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated patient demographic details (Height, weight), other relevant history ( current conditions and allergy), Negative re-challenge and date of re-challenge. Added vaccine facility information, concomitant medications, event end date, intensity and causality as reported was changed to Possible. Site of injection was Left shoulder.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was in pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was in pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (her lymph nodes were removed from right side).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was in pain). On 10-Feb-2021, VACCINATION SITE PAIN (Arm was in pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided no treatment given
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history was reported.  The patient's past medical history included No adverse event (no medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant product was reported patient has diarrhea on 11,feb-2021
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm has really sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm has really sore) in an 82-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).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm has really sore). At the time of the report, VACCINATION SITE PAIN (arm has really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided no treatment was reported
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vomiting
Clinical narrative: Headache; Fatigue; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Upon internal review on 21-May-2021, the age was corrected to unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pyrexia, Vaccination site pain
Clinical narrative: sore arm; chest was tight; fever of 99.5; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), CHEST DISCOMFORT (chest was tight) and PYREXIA (fever of 99.5) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date and Angioplasty (Stent in his heart.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm), CHEST DISCOMFORT (chest was tight) and PYREXIA (fever of 99.5). At the time of the report, VACCINATION SITE PAIN (sore arm), CHEST DISCOMFORT (chest was tight) and PYREXIA (fever of 99.5) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       patient is taking blood pressure and blood thinner medication as conmeds. no treatment proivided
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chest pain, Headache, Hypoaesthesia, Vision blurred
Clinical narrative: Heart pain; Blurry vision; Head numbness; Has arthritis and noticed the pain in their legs has worsen.; Headache; A spontaneous report was received from a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart pain, numbness in head, headaches, blurry vision and worsening of arthritis.  The patient's medical history was not provided. The concurrent condition included arthritis. No concomitant product use was reported   On 27-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date after receiving the vaccine, the patient had experienced heart pain, numbness in head, headaches, blurry vision worsening of leg pain due to ongoing arthritis.  Treatment information included tylenol and ibuprofen.  Action taken with mRNA-1273 was unknown..  The outcome of the events, heart pain, numbness in their head, headaches, blurry vision and worsening of arthritis, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: slight swelling; Red rash spreading in the right arm/starting to get dark; Red rash spreading in the right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash spreading in the right arm/starting to get dark), VACCINATION SITE RASH (Red rash spreading in the right arm) and VACCINATION SITE SWELLING (slight swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST and METOPROLOL for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash spreading in the right arm/starting to get dark) and VACCINATION SITE RASH (Red rash spreading in the right arm). On an unknown date, the patient experienced VACCINATION SITE SWELLING (slight swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Red rash spreading in the right arm/starting to get dark), VACCINATION SITE RASH (Red rash spreading in the right arm) and VACCINATION SITE SWELLING (slight swelling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first). At the time of the report, SARS-COV-2 TEST POSITIVE (5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided   This case was linked to US-MODERNATX, INC.-MOD-2021-023205 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023205:Case crosslinked with MOD21-021925 , MOD21-021934 , MOD21-021935 , MOD21-021937 ,
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site swelling
Clinical narrative: injection site swelling, pain, and redness; injection site swelling, pain, and redness; injection site swelling, pain, and redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (injection site swelling, pain, and redness), ERYTHEMA (injection site swelling, pain, and redness) and VACCINATION SITE SWELLING (injection site swelling, pain, and redness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (injection site swelling, pain, and redness), ERYTHEMA (injection site swelling, pain, and redness) and VACCINATION SITE SWELLING (injection site swelling, pain, and redness). At the time of the report, PAIN (injection site swelling, pain, and redness), ERYTHEMA (injection site swelling, pain, and redness) and VACCINATION SITE SWELLING (injection site swelling, pain, and redness) 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
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site bruising
Clinical narrative: Bruise at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site) and FATIGUE (Fatigue). On 24-Jan-2021, FATIGUE (Fatigue) had resolved. On 28-Jan-2021, VACCINATION SITE BRUISING (Bruise at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm pain Near Injection Site; arm swelling near Injection site; Redness Near the Injection Site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain Near Injection Site), VACCINATION SITE SWELLING (arm swelling near Injection site), VACCINATION SITE ERYTHEMA (Redness Near the Injection Site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm pain Near Injection Site), VACCINATION SITE SWELLING (arm swelling near Injection site), VACCINATION SITE ERYTHEMA (Redness Near the Injection Site) and HEADACHE (Headache). On 12-Feb-2021, VACCINATION SITE PAIN (Arm pain Near Injection Site), VACCINATION SITE SWELLING (arm swelling near Injection site), VACCINATION SITE ERYTHEMA (Redness Near the Injection Site) and HEADACHE (Headache) had resolved.            No concomitant medication provided. no treatmen taken.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: dizziness; headache; Nausea; vomiting; fatigue; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anemic and Cyclic vomiting syndrome (CVS(Cyclic vomiting syndrome)).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting), FATIGUE (fatigue), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting), FATIGUE (fatigue), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided. no treatment taken
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: dizziness; headache; Nausea; vomiting; fatigue; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anemic and Cyclic vomiting syndrome (CVS(Cyclic vomiting syndrome)).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting), FATIGUE (fatigue), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting), FATIGUE (fatigue), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided. no treatment taken
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Vaccination site itcy; injection site was firm; rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site itcy), VACCINATION SITE INDURATION (injection site was firm) and VACCINATION SITE RASH (rash) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site itcy), VACCINATION SITE INDURATION (injection site was firm) and VACCINATION SITE RASH (rash). The patient was treated with PHENOXYMETHYLPENICILLIN POTASSIUM (PENCILLIN) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Vaccination site itcy), VACCINATION SITE INDURATION (injection site was firm) and VACCINATION SITE RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: red rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash at the site of the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (red rash at the site of the injection). At the time of the report, VACCINATION SITE RASH (red rash at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.     Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Vaccination site pain
Clinical narrative: Arm was very sore and patient can still feel some light aching that is annoying; annoying; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was very sore and patient can still feel some light aching that is annoying) and IRRITABILITY (annoying) 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.    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 VACCINATION SITE PAIN (Arm was very sore and patient can still feel some light aching that is annoying) and IRRITABILITY (annoying). At the time of the report, VACCINATION SITE PAIN (Arm was very sore and patient can still feel some light aching that is annoying) and IRRITABILITY (annoying) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: chills; fever; real bad headaches (severe headaches); her arm still hurts; side effects; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (real bad headaches (severe headaches)), VACCINATION SITE PAIN (her arm still hurts) and ADVERSE REACTION (side effects) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (real bad headaches (severe headaches)), VACCINATION SITE PAIN (her arm still hurts) and ADVERSE REACTION (side effects). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PYREXIA (fever), HEADACHE (real bad headaches (severe headaches)), VACCINATION SITE PAIN (her arm still hurts) and ADVERSE REACTION (side effects) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash macular, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Red Blotchy Patches Like a Round Ring around Injection Site; Hot to the touch Injection Site post first vaccine; Tingling Injection Site / Tingling Fingers; Redness below the injection site; Soreness; This spontaneous case was reported by a nurse and describes the occurrence of RASH MACULAR (Red Blotchy Patches Like a Round Ring around Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site post first vaccine), PARAESTHESIA (Tingling Injection Site / Tingling Fingers), VACCINATION SITE ERYTHEMA (Redness below the injection site) and VACCINATION SITE PAIN (Soreness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH MACULAR (Red Blotchy Patches Like a Round Ring around Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site post first vaccine), PARAESTHESIA (Tingling Injection Site / Tingling Fingers), VACCINATION SITE ERYTHEMA (Redness below the injection site) and VACCINATION SITE PAIN (Soreness). On 30-Jan-2021, RASH MACULAR (Red Blotchy Patches Like a Round Ring around Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site post first vaccine), PARAESTHESIA (Tingling Injection Site / Tingling Fingers), VACCINATION SITE ERYTHEMA (Redness below the injection site) and VACCINATION SITE PAIN (Soreness) 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.   Treatment information was not provided.  Concomitant medication was not provided.   This case was linked to MOD-2021-056348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on Jun 30 2021 contains no significant information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nausea, Pain in extremity, Paraesthesia oral
Clinical narrative: soreness on the left arm; metallic taste in mouth; slight tingling on top of her tongue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on the left arm), DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (slight tingling on top of her tongue) and NAUSEA (Nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness on the left arm), DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (slight tingling on top of her tongue) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (soreness on the left arm), DYSGEUSIA (metallic taste in mouth), PARAESTHESIA ORAL (slight tingling on top of her tongue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Arm was just a little sore; Has been tired since then; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was just a little sore) and FATIGUE (Has been tired since then) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, CALCIUM, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (Has been tired since then). On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was just a little sore). At the time of the report, VACCINATION SITE PAIN (Arm was just a little sore) and FATIGUE (Has been tired since then) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included vitamins. The patient did not receive any treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 07 Feb 2021 date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event Sore arm for the first dose and on 07 Feb 2021,experienced fever and chills and it is worse than first one. Patient gave consent to safety follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, fever and chills were resolved on 09 Feb 2021.