chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Crying, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Crying for no apparent reason; Dead to the world; Felt nauseous; Tired; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Crying for no apparent reason), FEELING ABNORMAL (Dead to the world), NAUSEA (Felt nauseous) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced CRYING (Crying for no apparent reason), FEELING ABNORMAL (Dead to the world), NAUSEA (Felt nauseous) and FATIGUE (Tired). In January 2021, CRYING (Crying for no apparent reason), FEELING ABNORMAL (Dead to the world), NAUSEA (Felt nauseous) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up email was received and outcome was updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Pyrexia, Vaccination complication
Clinical narrative: Normal expected reactions all weekend; Excruciating joint pain; Fever; Extremely Dizzy- can hardly stand; Extremely Dizzy- can hardly stand; A spontaneous report was received from a female HCP,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced normal expected reactions all weekend, extremely dizzy-can hardly stand, excruciating joint pain and fever.   The patient's medical history, as provided by the reporter, included COVID-19 (November 2020) . No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient received the Moderna vaccine and experienced the normal expected reactions the following entire weekend. She was sick all weekend with everything except the loss of sense of smell. She also had excruciating joint pain and a fever that broke on 03 Jan 2021. On 04 Jan 2021 around 4:00am, the patient was extremely dizzy and could hardly stand. She stated that she knows it sounds like an inner ear issue but she has never had an inner ear issue before. The patient would like to know if this is one of the side effects. No treatment information was provided.  Action taken with mRNA-1273 in response to the events is not applicable.   Outcome of the events, normal expected reactions all weekend, extremely dizzy-can hardly stand, and excruciating joint pain, were not reported. The event, fever, resolved on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Shortness of breath; Higher heart rate; Dizziness; Nausea; Fatigue; Full body ache; Shivers and chills; Arm pain; Soreness; A spontaneous report was received from a 40 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, higher heart rate, dizziness, nausea, fatigue, full body ache, shivers, chills, arm pain and soreness.  The patient's medical history included asymptomatic asthma and TRAPS (autoinmune condition). Concomitant medications reported was cetirizine hydrochloride.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection .   On 04 Jan 2021, 1-3 hours administration, the patient experienced higher heart rate, shortness of breath, dizziness, nausea. She stated that fatigue started 5 to 6 hours after administration. She reported full body ache, shivers and chills. All of them except nausea stopped before going to sleep that day. The patient was still experiencing arm pain and soreness at the time of report. Treatment for some of the symptoms include ibuprofen.  Action taken with mRNA-1273 vaccine was unknown.  The outcome of events, higher heart rate, shortness of breath, dizziness, fatigue, full body ache, shivers and chills, were resolved on 04 Jan 2021. The outcome of events, arm pain and soreness were ongoing.   The outcome of events, arm pain soreness and nausea were ongoing.; Reporter's Comments: This report refers to a case of 40-year-old female patient who experienced same day onset of unexpected events of higher heart rate, shortness of breath, dizziness, nausea, fatigue, full body ache, shivers, chills and arm pain soreness for mRNA-1273. De-challenge and re-challenge are not applicable. Based on the information provided which includes evidence of temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Shortness of breath; Higher heart rate; Dizziness; Nausea; Fatigue; Full body ache; Shivers and chills; Arm pain; Soreness; A spontaneous report was received from a 40 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, higher heart rate, dizziness, nausea, fatigue, full body ache, shivers, chills, arm pain and soreness.  The patient's medical history included asymptomatic asthma and TRAPS (autoinmune condition). Concomitant medications reported was cetirizine hydrochloride.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection .   On 04 Jan 2021, 1-3 hours administration, the patient experienced higher heart rate, shortness of breath, dizziness, nausea. She stated that fatigue started 5 to 6 hours after administration. She reported full body ache, shivers and chills. All of them except nausea stopped before going to sleep that day. The patient was still experiencing arm pain and soreness at the time of report. Treatment for some of the symptoms include ibuprofen.  Action taken with mRNA-1273 vaccine was unknown.  The outcome of events, higher heart rate, shortness of breath, dizziness, fatigue, full body ache, shivers and chills, were resolved on 04 Jan 2021. The outcome of events, arm pain and soreness were ongoing.   The outcome of events, arm pain soreness and nausea were ongoing.; Reporter's Comments: This report refers to a case of 40-year-old female patient who experienced same day onset of unexpected events of higher heart rate, shortness of breath, dizziness, nausea, fatigue, full body ache, shivers, chills and arm pain soreness for mRNA-1273. De-challenge and re-challenge are not applicable. Based on the information provided which includes evidence of temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pruritus, Vaccination site erythema, Vaccination site hypoaesthesia, Vaccination site rash
Clinical narrative: Itching this morning and Red and blotchy on cheeks; Left arm red; Swollen; area is also warm to touch; upper outer left arm has red rash; reports a numb feelling in area of shot on left deltoid; axillary tenderness; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (area is also warm to touch), VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid), PRURITUS (Itching this morning and Red and blotchy on cheeks), VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI. Concomitant products included AMOXICILLIN for Stye, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 05-Jan-2021 to an unknown date for UTI.   On 29-Dec-2020 at 4:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid) and AXILLARY PAIN (axillary tenderness). On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (area is also warm to touch) and VACCINATION SITE RASH (upper outer left arm has red rash). On 06-Jan-2021 at 7:45 AM, the patient experienced PRURITUS (Itching this morning and Red and blotchy on cheeks). 06-Jan-2021 at 7:45 AM, the patient experienced VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (area is also warm to touch), VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid), AXILLARY PAIN (axillary tenderness) and VACCINATION SITE RASH (upper outer left arm has red rash) outcome was unknown, PRURITUS (Itching this morning and Red and blotchy on cheeks) had not resolved and VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen) was resolving.      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 of these events included cool compresses.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. However a temporal association cannot be denied and a causal relationship cannot be excluded'.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itching this morning and Red and blotchy on cheeks; Left arm red; Swollen; area is also warm to touch; upper outer left arm has red rash; reports a numb feelling in area of shot on left deltoid; axillary tenderness; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (area is also warm to touch), VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid), PRURITUS (Itching this morning and Red and blotchy on cheeks), VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included UTI. Concomitant products included AMOXICILLIN for Stye, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 05-Jan-2021 to an unknown date for UTI.   On 29-Dec-2020 at 4:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid) and AXILLARY PAIN (axillary tenderness). On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (area is also warm to touch) and VACCINATION SITE RASH (upper outer left arm has red rash). On 06-Jan-2021 at 7:45 AM, the patient experienced PRURITUS (Itching this morning and Red and blotchy on cheeks). 06-Jan-2021 at 7:45 AM, the patient experienced VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (area is also warm to touch), VACCINATION SITE HYPOAESTHESIA (reports a numb feelling in area of shot on left deltoid), AXILLARY PAIN (axillary tenderness) and VACCINATION SITE RASH (upper outer left arm has red rash) outcome was unknown, PRURITUS (Itching this morning and Red and blotchy on cheeks) had not resolved and VACCINATION SITE ERYTHEMA (Left arm red) and VACCINATION SITE SWELLING (Swollen) was resolving.      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 of these events included cool compresses.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. However a temporal association cannot be denied and a causal relationship cannot be excluded'.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Rash, Tenderness
Clinical narrative: tenderness; redness; Grew a hive in the point on her shoulder where she received the vaccine that continued to spread; injection site rash which continued to spread; Rash and hives covering the majority of her left arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), INJECTION SITE ERYTHEMA (redness), INJECTION SITE URTICARIA (Grew a hive in the point on her shoulder where she received the vaccine that continued to spread), INJECTION SITE RASH (injection site rash which continued to spread) and RASH (Rash and hives covering the majority of her left arm) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced TENDERNESS (tenderness), INJECTION SITE ERYTHEMA (redness), INJECTION SITE URTICARIA (Grew a hive in the point on her shoulder where she received the vaccine that continued to spread), INJECTION SITE RASH (injection site rash which continued to spread) and RASH (Rash and hives covering the majority of her left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness), INJECTION SITE ERYTHEMA (redness), INJECTION SITE URTICARIA (Grew a hive in the point on her shoulder where she received the vaccine that continued to spread), INJECTION SITE RASH (injection site rash which continued to spread) and RASH (Rash and hives covering the majority of her left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Throat tightness
Clinical narrative: Extremely high blood pressure; Tightness in chest; Tightness in throat; A spontaneous report was received from a consumer who was a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extremely high blood pressure, tightness in chest, and tightness in throat.  The patient's medical history was not provided. Concomitant product use included an unspecified medication used for thyroid.   On 07 Jan at 1:30 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Jan 2021, less than five minutes after receiving the vaccine,  the patient experienced severe symptoms. Symptoms included, extremely high blood pressure, tightness in chest, and tightness in throat. The person in charge of monitoring reactions after the vaccine, took the patient's blood pressure and had to call an ambulance. The patient was taken to the hospital and remained there for hours. At the hospital, she was seen by her cardiologist and had unspecified laboratory and diagnostic work done. The patient was sent home on the same day and symptoms did not continue. Treatment for the events included acetylsalicylic acid and an unspecified medication that was placed under the patient's tongue.   Action taken with mRNA-1273 in response to the events was not provided.   The events, extremely high blood pressure, tightness in chest, and tightness in throat, were considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), and who experienced the non-serious unlisted events of high blood pressure, tightness in chest and tightness in throat.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: little sore arm; A spontaneous report was received from a 66-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced just a little sore arm.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included acetylsalicylic acid, rosuvastatin, metoprolol, vitamin D, ascorbic acid, and vitamin B12.   On 04 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced her arm being just a little sore. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, just a little sore arm, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Disorientation, Dizziness, Dyspnoea
Clinical narrative: So out of it; Feel like I am going to fall on my face; Extremely dizzy; Eyes burning; Ringing in ears; Hot and swollen; Hot and swollen; Chills; Temperature went up to 100.3; Headache; Out of breath; A spontaneous report was received from a healthcare professional concerning a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, being so out of it, hot and swollen at injection site, headache, temperature went up to 100.3 F, ringing in ears, eyes burning, out of breath, extremely dizzy, chills, and feel like I am going to fall on my face.    The patient's medical history included a positive COVID-19 diagnosis in April 2020. Products known to have been used by the patient, within two weeks prior to the event, included baclofen, duloxetine, two blood pressure medications, one medication for anxiety, potassium, meloxicam, and nortriptyline.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, following vaccine administration, the patient was so out of it and felt like she was going to fall on her face.  On  06 Jan 2021, the patient's injection site was hot and swollen.  She reported that she had a headache and fever and there was ringing in her ears.  Her eyes burned, she was extremely dizzy, and had chills. Treatment for the event included paracetamol and sumatriptan.   Action taken with mRNA-1273 in response to the events was not provided.   The events, being so out of it, hot and swollen at injection site, headache, temperature went up to 100.3 F, ringing in ears, eyes burning, out of breath, extremely dizzy, chills and feel like I am going to fall on my face, were considered resolving.; Reporter's Comments: This case concerns a 60-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious listed events of Injection site swelling, Chills, Pyrexia, and Headache, and the non-serious unlisted events of Dyspnoea, Disorientation, Balance disorder, Dizziness, Eye irritation, Tinnitus, and Injections site warmth.  Very limited information regarding the events has been provided at this time.  Based on the current available information and temporal association between vaccination and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: So out of it; Feel like I am going to fall on my face; Extremely dizzy; Eyes burning; Ringing in ears; Hot and swollen; Hot and swollen; Chills; Temperature went up to 100.3; Headache; Out of breath; A spontaneous report was received from a healthcare professional concerning a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, being so out of it, hot and swollen at injection site, headache, temperature went up to 100.3 F, ringing in ears, eyes burning, out of breath, extremely dizzy, chills, and feel like I am going to fall on my face.    The patient's medical history included a positive COVID-19 diagnosis in April 2020. Products known to have been used by the patient, within two weeks prior to the event, included baclofen, duloxetine, two blood pressure medications, one medication for anxiety, potassium, meloxicam, and nortriptyline.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, following vaccine administration, the patient was so out of it and felt like she was going to fall on her face.  On  06 Jan 2021, the patient's injection site was hot and swollen.  She reported that she had a headache and fever and there was ringing in her ears.  Her eyes burned, she was extremely dizzy, and had chills. Treatment for the event included paracetamol and sumatriptan.   Action taken with mRNA-1273 in response to the events was not provided.   The events, being so out of it, hot and swollen at injection site, headache, temperature went up to 100.3 F, ringing in ears, eyes burning, out of breath, extremely dizzy, chills and feel like I am going to fall on my face, were considered resolving.; Reporter's Comments: This case concerns a 60-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious listed events of Injection site swelling, Chills, Pyrexia, and Headache, and the non-serious unlisted events of Dyspnoea, Disorientation, Balance disorder, Dizziness, Eye irritation, Tinnitus, and Injections site warmth.  Very limited information regarding the events has been provided at this time.  Based on the current available information and temporal association between vaccination and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: So out of it; Feel like I am going to fall on my face; Extremely dizzy; Eyes burning; Ringing in ears; Hot and swollen; Hot and swollen; Chills; Temperature went up to 100.3; Headache; Out of breath; A spontaneous report was received from a healthcare professional concerning a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, being so out of it, hot and swollen at injection site, headache, temperature went up to 100.3 F, ringing in ears, eyes burning, out of breath, extremely dizzy, chills, and feel like I am going to fall on my face.    The patient's medical history included a positive COVID-19 diagnosis in April 2020. Products known to have been used by the patient, within two weeks prior to the event, included baclofen, duloxetine, two blood pressure medications, one medication for anxiety, potassium, meloxicam, and nortriptyline.   On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, following vaccine administration, the patient was so out of it and felt like she was going to fall on her face.  On  06 Jan 2021, the patient's injection site was hot and swollen.  She reported that she had a headache and fever and there was ringing in her ears.  Her eyes burned, she was extremely dizzy, and had chills. Treatment for the event included paracetamol and sumatriptan.   Action taken with mRNA-1273 in response to the events was not provided.   The events, being so out of it, hot and swollen at injection site, headache, temperature went up to 100.3 F, ringing in ears, eyes burning, out of breath, extremely dizzy, chills and feel like I am going to fall on my face, were considered resolving.; Reporter's Comments: This case concerns a 60-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious listed events of Injection site swelling, Chills, Pyrexia, and Headache, and the non-serious unlisted events of Dyspnoea, Disorientation, Balance disorder, Dizziness, Eye irritation, Tinnitus, and Injections site warmth.  Very limited information regarding the events has been provided at this time.  Based on the current available information and temporal association between vaccination and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Feeling fatigued; Achy from head to shoulders/whole body aches; Headache; fever up to 96 F; Shoulder pain; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, achy from head to shoulders, shoulder pain, headache, and fever up to 96F.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Patient was feeling fatigued and achy from head to shoulders, and not feeling generally well. On 04 Jan 2021 after taking the vaccine, the patient experienced, achy from head to shoulders, shoulder pain, headache, and fever up to 96°F.  She took Tylenol which helped her fever briefly.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fatigue, achy from head to shoulders, shoulder pain, headache, and fever up to 96F, was considered not 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling fatigued; Achy from head to shoulders/whole body aches; Headache; fever up to 96 F; Shoulder pain; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, achy from head to shoulders, shoulder pain, headache, and fever up to 96F.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Patient was feeling fatigued and achy from head to shoulders, and not feeling generally well. On 04 Jan 2021 after taking the vaccine, the patient experienced, achy from head to shoulders, shoulder pain, headache, and fever up to 96°F.  She took Tylenol which helped her fever briefly.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fatigue, achy from head to shoulders, shoulder pain, headache, and fever up to 96F, was considered not 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach cramping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLAPARIB (LYNPARZA).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach cramping). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up via telephone, patient reported she received second dose with no adverse events. No email or address to send ADR form.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive for Covid after 1st vaccine injection; Lost my sense of smell; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sense of smell and positive for COVID-19 after first vaccine injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 Dec 2020, the patient stated that she had a few symptoms of Covid-19 and got tested, it was negative.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the day after administration, the patient experienced lost sense of smell. On the same day, she took a Covid-19 test, which was positive. No treatment was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for events, lost sense of smell and positive for COVID-19 after 1st vaccine injection, were unknown.; Reporter's Comments: very limited information regarding this event has been provided. However, the events of (anosmia, Covid-19) is Unlikely related to mRNA-1273 and Further information has been requested
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; A spontaneous report was received from a Healthcare professional concerning a 67-year-old, female who received Moderna's COVID-19 vaccine and experienced cough.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021 she experienced cough.    On 05 Jan 2021 she woke up feeling better. Treatment for the event including inhaler.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event cough was resolved on 05 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site warmth, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (area is a little warm to touch), INJECTION SITE REACTION (Injection site reaction), SKIN REACTION (Delayed skin reaction), VACCINATION SITE INDURATION (induration) and VACCINATION SITE PRURITUS (itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K2A and 039K0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atopy. Concurrent medical conditions included Drug allergy (Allergic to mangoes). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 27-Dec-2020, the patient experienced INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE INDURATION (induration) and VACCINATION SITE ERYTHEMA (area of redness 4-5 cm). On 02-Jan-2021, the patient experienced SKIN REACTION (Delayed skin reaction). On 03-Jan-2021, the patient experienced INJECTION SITE WARMTH (area is a little warm to touch) and VACCINATION SITE PRURITUS (itchy). On 28-Dec-2020, INJECTION SITE REACTION (Injection site reaction) had resolved. On 04-Jan-2021, VACCINATION SITE INDURATION (induration) had resolved. On 11-Jan-2021, SKIN REACTION (Delayed skin reaction) had resolved. At the time of the report, INJECTION SITE WARMTH (area is a little warm to touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown and VACCINATION SITE ERYTHEMA (area of redness 4-5 cm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: additional SD received On 28-Apr-2021: Follow up received on 28APR2021, added information on reporter details (address, email), patient demographics (height, weight and race), patient medical history and also report additional events for 1st dose ( Injection site reaction, delayed skin reaction) and reports 2nd dose details and events.; 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.; 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye swelling, Pain in extremity, Paraesthesia oral, Urticaria
Clinical narrative: Hives allover the body; Left eye swollen; Left upper lip tingling; Sore arm; Trouble lifting arm; A spontaneous report was received from physician, concerning a 23 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, had trouble lifting it, left swollen eye, left upper lip tingling and hives all over her 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 (lot number 11220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, around 09: 00 pm, the patient experienced a sore arm and had trouble lifting it. On 02 Jan 2021, the patient experienced a left swollen eye, left upper lip tingling and hives all over her body. The patient went to the emergency room where she was treated with Benadryl intravenously. The symptoms subsided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, a sore arm, had trouble lifting it was unknown. The outcome of events, left swollen eye, left upper lip tingling and hives all over her body was resolving.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy; Red; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red and itchy.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 309K209) in right arm for prophylaxis of COVID-19 infection.   On 4-JAN-2021, the patient experienced injection site redness and itchiness.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, red and itchy was considered not 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Around the area of injection there is a lump; Area of injection is warm; Big red circle around the area of injection; Around the area of injection is painful; Arm kind of sore; Arm kind of red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm kind of red), VACCINATION SITE ERYTHEMA (Big red circle around the area of injection) and VACCINATION SITE PAIN (Around the area of injection is painful) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ERYTHEMA (Arm kind of red). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle around the area of injection) and VACCINATION SITE PAIN (Around the area of injection is painful). On 06-Jan-2021, ERYTHEMA (Arm kind of red) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Big red circle around the area of injection) and VACCINATION SITE PAIN (Around the area of injection is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Around the area of injection there is a lump; Area of injection is warm; Big red circle around the area of injection; Around the area of injection is painful; Arm kind of sore; Arm kind of red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm kind of red), VACCINATION SITE ERYTHEMA (Big red circle around the area of injection) and VACCINATION SITE PAIN (Around the area of injection is painful) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ERYTHEMA (Arm kind of red). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle around the area of injection) and VACCINATION SITE PAIN (Around the area of injection is painful). On 06-Jan-2021, ERYTHEMA (Arm kind of red) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Big red circle around the area of injection) and VACCINATION SITE PAIN (Around the area of injection is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Vaccine taken during 6 weeks of pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine taken during 6 weeks of pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 13-Oct-2020. Concurrent medical conditions included Hypothyroidism and Graves' disease (Treated with l-131 @15 y/o, takes levothyroxine 112 mcg 9 pills a week) since May 2003. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D NOS for an unknown indication.   On 04-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 25-Oct-2020 and the estimated date of delivery was 27-Aug-2021. On 04-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine taken during 6 weeks of pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, 6 weeks pregnant. On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine taken during 6 weeks of pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Dec-2020, Blood test: Inconclusive. On 12-Dec-2020, Pregnancy test: Positive. On 28-Dec-2020, Ultrasound foetal: ultrasound for viability, size outside dating range. On 11-Jan-2021, Ultrasound foetal: Ultrasound for viability, GS and YS visualized 3.6mm, embryo visualized 12.1 mm, FHR 166 bpm. On 19-Feb-2021, Blood test: results not provided. On 19-Feb-2021, Ultrasound foetal: Sex determined: Boy NIPT low risk for T21, T18, T13 and turner. Nasal bone present, 154bpm, NT 2.1mm, CRL 71.8, Z36.82.     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 treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Initial pregnancy report filled and submitted. Updated the medical history, pregnancy details, con meds and prior history.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Pain
Clinical narrative: Breast swelling; Severe R breast pain; Side pain; severe pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (Severe R breast pain), PAIN (Side pain; severe pain) and BREAST SWELLING (Breast swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced BREAST PAIN (Severe R breast pain) and PAIN (Side pain; severe pain). On 07-Jan-2021, the patient experienced BREAST SWELLING (Breast swelling). At the time of the report, BREAST PAIN (Severe R breast pain), PAIN (Side pain; severe pain) and BREAST SWELLING (Breast swelling) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided  by the reporter. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow up information was received onv31 Mar 2021: included information about second dose.; 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: Body temperature, Pyrexia
Clinical narrative: Fever temperature of 99.9; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced a fever temperature of 99.9.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30-dec-2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient began to experience a fever temperature of 99.9.   Laboratory information included body temperature of 99.9 F.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was unknown.   The event fever temperature of 99.9 was 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 event, a causal relationship cannot be excluded.