chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Bled a lot; Bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled a lot) and VACCINATION SITE BRUISING (Bruising) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bled a lot) and VACCINATION SITE BRUISING (Bruising). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bled a lot) and VACCINATION SITE BRUISING (Bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Nauseating feeling; Dizziness that is not severe; Injection site pain; A spontaneous report was received from a 77-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced injection site pain, dizziness that is not severe and nauseated feeling.  The patient's medical history was not provided. Concomitant medications were amlodipine, losartan HCl, carvedilol, fenofibrate and thyroid medication.  On 02 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A; Exp. date: 20 June 2021)  intramuscularly in his left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, after receiving the vaccine, the patient experienced injection site pain.  On 04 Jan 2021, the patient experienced dizziness that is not severe which is ongoing.   On 05 Jan 2021, the patient had a nauseating feeling. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, injection site pain, is recovered on 04 Jan 2021.   The outcome for the events, dizziness and nausea is not recovered.; Reporter's Comments: This case concerns a 77-year-old, male patient. The patient's medical history was not provided. The patient experienced NS expected events of injection site pain and nausea and unexpected event of dizziness.  The event of injection site pain occurred the same day, dizziness occurred 3 days and nausea occurred 4 days after the first dose of mRNA-1273 (Lot number: 039K20A; Exp. date: 20 June 2021). No treatment was taken. 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: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over body; A spontaneous report was received from a consumer who is an unidentified patient who experienced itching all over the body.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient began itching all over the body.  Patient denied breathing issues or the need to call for emergency help.   Treatment included Benadryl.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, itching all over, was recovered/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 event, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: Today I woke up with blood on my pillow and on my pajamas; A spontaneous report was received from a consumer who was an 82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, today I woke up with blood on my pillow and on my pajamas.   The patient's medical history was not provided.  Concomitant medications included acetylsalicylic acid.  On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02FL0A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient woke up with blood on her pillow and her pajamas.  She removed the Band-Aid from the injection site, and it was full of blood, but her arm was not bleeding. The event resolved on the same day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, today I woke up with blood on my pillow and on my pajamas, was considered resolved on 06 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case an 82-year-old, female patient who experienced the event of woke up with blood on her pillow and her pajamas (injection site hemorrhage) for mRNA-1273 (Lot number 02FL0A, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the event of injection site hemorrhage and vaccine administration cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: feeling as if had not slept for 4 weeks, extremely tired; arm is extremely sore; feels like crap as if had flu; diarrhea; fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF); A spontaneous report was received from a other health care professional (reporting on self), concerning a 41-year-old, female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling as if had not slept for 4 weeks, extremely tired, arm is extremely sore, running a fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF at 5 o clock), feels like crap as if had flu and diarrhea.   The patient's medical history included anxiety. Concomitant medications reported included lorazepam and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (LOT number 039K20-2A) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 06 Jan 2021, approximately 0 days prior to the onset of the event, the patient was running a fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF at 5 o clock) and 1 day prior to the onset of the events, feeling as if had not slept for 4 weeks, extremely tired, arm  is extremely sore, feels like crap as if had flu, and diarrhea,  Action taken with mRNA-1273 in response to the events was not reported.  The event, diarrhea, was considered resolved on 07 Jan 2021. The outcomes of the events, feeling as if had not slept for 4 weeks, extremely tired, arm is extremely sore, running a fever (lowest was 99.8 ºF yesterday and today it was 101.1 ºF at 5 o clock), and feels like crap as if had flu, 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site swelling, Injection site warmth
Clinical narrative: Armpit pain; Injection site swelling; Injection site warmth; A spontaneous report was received from a nurse who is a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site swelling, hot to touch at the injection site and pain in her arm that radiate to her armpit.  The patient's medical history was not provided. Concomitant medications reported included citalopram and levonorgestrel.  On 31 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient experienced injection site swelling, hot to touch at the injection site and pain in her arm radiating to her armpit. Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, injection site swelling, hot to touch at the injection site and pain in her arm radiating to her armpit was unknown.  Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling
Clinical narrative: swelling at injection site; headache; A spontaneous report was received from a female consumer who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed swelling at injection site and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J-20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After the vaccine, the patient noticed swelling at injection site and headache.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, swelling at injection site and headache, 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: reaction at the injection site, skin rash; skin tender in center; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (reaction at the injection site, skin rash) and VACCINATION SITE PAIN (skin tender in center) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE RASH (reaction at the injection site, skin rash) and VACCINATION SITE PAIN (skin tender in center). At the time of the report, VACCINATION SITE RASH (reaction at the injection site, skin rash) and VACCINATION SITE PAIN (skin tender in center) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications provided by the reporter.   This case was linked to MOD-2021-002584 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-002584:Reporter's case
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm got numb, could not feel anything with it but could move it.; Soreness of arm; A spontaneous case report was received from Consumer concerning a 24-year female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm got numb, could not feel anything with it but could move it and it lasted like one hour. Also experienced soreness.  The patient's medical history was not reported. The concomitant medication included, meloxica.   On an unknown date prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 025L20A), Expiration date: not provided) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after administration of vaccine patient experienced arm got numb, could not feel anything with it but could move it and it lasted like one hour. Also experienced soreness.   Action taken with vaccine was unknown.  On 05 Jan 2021, the arm got numb, could not feel anything with it but could move was recovered on an unknown date the outcome for soreness was unknown.; Reporter's Comments: This case concerns a 24-year-old female who experienced NS expected events of Hypoaesthesia and Pain in extremity.  Event onset occurred on Day 1 after the first dose of mRNA-1273. Treatment not reported. Hypoaesthesia resolved, but pain in extremity 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Musculoskeletal discomfort, Myalgia, Uterine pain
Clinical narrative: Hip thing, a heat in the underback of her hip; Little pain down in her uterus; heat on top of head; muscle sore; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Hip thing, a heat in the underback of her hip), UTERINE PAIN (Little pain down in her uterus), FEELING HOT (heat on top of head), MYALGIA (muscle sore) and HEADACHE (Severe 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 reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Hip thing, a heat in the underback of her hip), UTERINE PAIN (Little pain down in her uterus), FEELING HOT (heat on top of head), MYALGIA (muscle sore) and HEADACHE (Severe headache). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Hip thing, a heat in the underback of her hip), UTERINE PAIN (Little pain down in her uterus), FEELING HOT (heat on top of head), MYALGIA (muscle sore) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness; Redness; Burning; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Burning) and VACCINATION SITE SWELLING (Swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Blood pressure high and Potassium abnormal.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Burning) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Burning) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Benadryl and alcohol to the vaccine injection site.  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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Large Hive appeared around the area of vaccination; Itchy; Tender to touch; Normal redness; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (Large Hive appeared around the area of vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Tender to touch) and VACCINATION SITE ERYTHEMA (Normal redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Large Hive appeared around the area of vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Tender to touch) and VACCINATION SITE ERYTHEMA (Normal redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (Large Hive appeared around the area of vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Tender to touch) and VACCINATION SITE ERYTHEMA (Normal redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Benadryl and Ice used as a Treatment medication   This case concerns a female of unknown age who experienced NS expected events of vaccination site erythema followed by vaccination site urticaria, vaccination site pruritus, and vaccination site pain.  Event onset occurred a few days after the first dose of mRNA-1273. Treatment included Benadryl and ice. Events resolving. 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.
Sex: U
Vaccine: COVID19
Symptoms: Mastication disorder, Pain, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: swelling on right side of face and jaw; swelling on right side of tongue; swelling on right side of throat; It is affecting eating mechanically; Soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on right side of face and jaw), SWOLLEN TONGUE (swelling on right side of tongue), PHARYNGEAL SWELLING (swelling on right side of throat), MASTICATION DISORDER (It is affecting eating mechanically) and PAIN (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 SWELLING FACE (swelling on right side of face and jaw), SWOLLEN TONGUE (swelling on right side of tongue), PHARYNGEAL SWELLING (swelling on right side of throat), MASTICATION DISORDER (It is affecting eating mechanically) and PAIN (Soreness). At the time of the report, SWELLING FACE (swelling on right side of face and jaw), SWOLLEN TONGUE (swelling on right side of tongue), PHARYNGEAL SWELLING (swelling on right side of throat), MASTICATION DISORDER (It is affecting eating mechanically) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Heart rate, Heart rate increased
Clinical narrative: Fatigue; Rash on the chest; Facial flushing; Headache; Hot flashes; Rapid heartbeat; This spontaneous case was reported by an other health care professional and describes the occurrence of HOT FLUSH (Hot flashes), HEART RATE INCREASED (Rapid heartbeat), RASH (Rash on the chest), FLUSHING (Facial flushing) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HOT FLUSH (Hot flashes), HEART RATE INCREASED (Rapid heartbeat), FLUSHING (Facial flushing) and HEADACHE (Headache). On 07-Jan-2021 at 2:30 PM, the patient experienced RASH (Rash on the chest). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK, qd and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, qd. At the time of the report, HOT FLUSH (Hot flashes), HEART RATE INCREASED (Rapid heartbeat), RASH (Rash on the chest), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and FLUSHING (Facial flushing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Heart rate: rapid.     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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Rash
Clinical narrative: Fatigue; Rash on the chest; Facial flushing; Headache; Hot flashes; Rapid heartbeat; This spontaneous case was reported by an other health care professional and describes the occurrence of HOT FLUSH (Hot flashes), HEART RATE INCREASED (Rapid heartbeat), RASH (Rash on the chest), FLUSHING (Facial flushing) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HOT FLUSH (Hot flashes), HEART RATE INCREASED (Rapid heartbeat), FLUSHING (Facial flushing) and HEADACHE (Headache). On 07-Jan-2021 at 2:30 PM, the patient experienced RASH (Rash on the chest). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK, qd and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, qd. At the time of the report, HOT FLUSH (Hot flashes), HEART RATE INCREASED (Rapid heartbeat), RASH (Rash on the chest), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and FLUSHING (Facial flushing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Heart rate: rapid.     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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: Chills; Cough; Feeling miserable; Headache; Shoulder pain; Thirst; Tiredness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Is feeling nasty) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse effect (No reported medical history.).   On 06-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 FEELING ABNORMAL (Is feeling nasty). At the time of the report, FEELING ABNORMAL (Is feeling nasty) had not resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications reported by investigator o No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Thirst, Vomiting
Clinical narrative: Chills; Cough; Feeling miserable; Headache; Shoulder pain; Thirst; Tiredness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Is feeling nasty) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse effect (No reported medical history.).   On 06-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 FEELING ABNORMAL (Is feeling nasty). At the time of the report, FEELING ABNORMAL (Is feeling nasty) had not resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications reported by investigator o No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ageusia, COVID-19, Cough, Decreased appetite
Clinical narrative: Her doctor asked to wait 90 days to get her 2nd dose; Shaking and shaking; Sick at my stomach; Gagging; Myalgia; Head was hurting so bad; Got Covid after getting 1st dose of vaccine; Coughing; Couldn't walk; Did not have appetite; Didn't taste nothing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose), COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk) and TREMOR (Shaking and shaking) in a 77-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.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad). On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick at my stomach) and RETCHING (Gagging). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) and TREMOR (Shaking and shaking). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) outcome was unknown and COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), TREMOR (Shaking and shaking), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), ABDOMINAL DISCOMFORT (Sick at my stomach), RETCHING (Gagging), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: TCR  is non-significant
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Inappropriate schedule of product administration, Myalgia, Retching
Clinical narrative: Her doctor asked to wait 90 days to get her 2nd dose; Shaking and shaking; Sick at my stomach; Gagging; Myalgia; Head was hurting so bad; Got Covid after getting 1st dose of vaccine; Coughing; Couldn't walk; Did not have appetite; Didn't taste nothing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose), COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk) and TREMOR (Shaking and shaking) in a 77-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.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad). On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick at my stomach) and RETCHING (Gagging). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) and TREMOR (Shaking and shaking). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) outcome was unknown and COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), TREMOR (Shaking and shaking), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), ABDOMINAL DISCOMFORT (Sick at my stomach), RETCHING (Gagging), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: TCR  is non-significant
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Her doctor asked to wait 90 days to get her 2nd dose; Shaking and shaking; Sick at my stomach; Gagging; Myalgia; Head was hurting so bad; Got Covid after getting 1st dose of vaccine; Coughing; Couldn't walk; Did not have appetite; Didn't taste nothing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose), COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk) and TREMOR (Shaking and shaking) in a 77-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.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad). On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick at my stomach) and RETCHING (Gagging). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) and TREMOR (Shaking and shaking). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) outcome was unknown and COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), TREMOR (Shaking and shaking), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), ABDOMINAL DISCOMFORT (Sick at my stomach), RETCHING (Gagging), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: TCR  is non-significant
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (on weekends) and Marijuana use (Occasional). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 31-Jan-2020 to an unknown date for Pregnancy.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 14-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, Ultrasound scan: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 34 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving mRNA-1273 vaccine approximately 2 months after she had a positive pregnancy test. No adverse events were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, Pain
Clinical narrative: Cough; Pressure in his chest; Shortness of breath; Fatigue; Body aches; A spontaneous report was received from a consumer who was a 54-year old, male patient, who received Moderna's COVID-19 vaccine and experienced fatigue, body aches, cough, pressure in his chest, and shortness of breath.   The patient's medical history was not reported.  No relevant concomitant medications were reported.   On 03 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient developed fatigue and body aches, especially in his back. He provided self-treatment and the events resolved on 05 Jan 2021. On 05 Jan 2021, he began to develop a cough, pressure in his chest, and shortness of breath. Treatment for the events included paracetamol, dextromethorphan hydrobromide/paracetamol/ phenylephrine hydrochloride, and dextromethorphan hydrobromide/mepyramine maleate/paracetamol/ phenylephrine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fatigue and body aches, was considered recovered/resolved on 05 Jan 2021.  The outcome of the events, pressure in chest and shortness of breath, was considered recovering/resolving on 08 Jan 2021.  The outcome of the event, cough, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 54- year-old male patient, who experienced non-serious uexpected event of Fatigue and non-serious unexpected events of Pain, Chest discomfort, Cough, and Dyspnea. The events of Fatigue and Pain occurred on the same day after first dose of mRNA-1273, lot # unknown. The events of Chest discomfort, Cough, and Dyspnea occurred approximately 2 days after first dose of mRNA-1273, lot # unknown.Treatment for the events included paracetamol, dextromethorphan hydrobromide/paracetamol/ phenylephrine hydrochloride, and dextromethorphan hydrobromide/mepyramine maleate/paracetamol/ phenylephrine hydrochloride. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster reactivation, Paraesthesia
Clinical narrative: A spontaneous report was received from a health care professional concerning a 67-year-old female patient who experienced backpain going down her spine, swollen along the spine, paresthesia  in her neck and upper spine, spots shape like the pox, light red colour, and numbness through out her upper and lower extremities after receiving the Moderna COVID-19 vaccine. The patient's medical history included an episode of herpes zoster infection that occurred about 3 years prior, diabetes, and high cholesterol. Concomitant medications reported included "cholesterol", metformin, and omeprazole. On 02 Jan 2021 the patient received the first of two planned doses of mRNA-1273 (lot number 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Jan 2021, day2 after vaccination, she had rash with pain and swelling of the upper spine and shoulder area (which was similar to the rash of herpes zoster infection 3 years ago) and generalized paresthesia (tingling and numbness) of all extremities. From day 5 after vaccination all the symptoms started alleviating. There is no report of any treatment given to the patient for her symptoms. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was reported as resolving.; 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: Lymph node pain, Lymphadenopathy
Clinical narrative: Left Axillary lymph nodes swollen; Left Axillary lymph node tender; A spontaneous report was received from a female consumer of an unknown age who received Moderna's COVID-19 Vaccine, and who developed left axillary lymphs are swollen and tender.   The patient's medical history was not provided.  Concomitant medications were not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on an unspecified date intramuscularly  for prophylaxis of COVID-19 infection.   The patient reported a week or so after she received the Moderna vaccine her left axillary lymphs are swollen and tender.  Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The events of left axillary lymphs are swollen and tender were considered not recovered/not resolved.; 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Arm was itchy; Swollen arm; Rash; Experiencing pain, spreading through arm; Feeling poorly; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling poorly), INJECTION SITE PRURITUS (Arm was itchy), INJECTION SITE SWELLING (Swollen arm), INJECTION SITE RASH (Rash) and INJECTION SITE PAIN (Experiencing pain, spreading through arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371920A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FEELING ABNORMAL (Feeling poorly). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Arm was itchy), INJECTION SITE SWELLING (Swollen arm), INJECTION SITE RASH (Rash) and INJECTION SITE PAIN (Experiencing pain, spreading through arm). On 01-Jan-2021, FEELING ABNORMAL (Feeling poorly) had resolved. At the time of the report, INJECTION SITE PRURITUS (Arm was itchy), INJECTION SITE SWELLING (Swollen arm), INJECTION SITE RASH (Rash) and INJECTION SITE PAIN (Experiencing pain, spreading through 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.   No relevant concomitant medications were reported. No treatment information was 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.; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site itchy; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 immunization.     The patient's past medical history included No adverse event (No reported medical history.).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; 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. Further information has been requested
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal discomfort
Clinical narrative: Back trouble; Woke up feeling tired; Joints hurt, Ache in her joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Back trouble), FATIGUE (Woke up feeling tired) and ARTHRALGIA (Joints hurt, Ache in her joints) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Back trouble), FATIGUE (Woke up feeling tired) and ARTHRALGIA (Joints hurt, Ache in her joints). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. On 07-Jan-2021, MUSCULOSKELETAL DISCOMFORT (Back trouble) had resolved. At the time of the report, FATIGUE (Woke up feeling tired) and ARTHRALGIA (Joints hurt, Ache in her joints) had resolved.            Concomitant product use was not provided by the reporter.   Follow-up received on 17-Mar-2021 indicated, the patient was fine and the symptoms she had reported were from her diabetes and not the vaccine. The patient has since had her second dose of vaccine and had no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Updated event outcome, suspect product details and case details.