chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: Weakness; Tiredness, exhaustion; Low grade fever 99-100F; Circumscribed rash at injection site which looked like a cellulitis infection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection) 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 29-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 VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection). At the time of the report, VACCINATION SITE CELLULITIS (Circumscribed rash at injection site which looked like a cellulitis infection) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature increased: 99° to 100° f (High) High. On 11-Jan-2021, SARS-CoV-2 test negative: negative (Negative) Negative.   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.  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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence, Vaccination site pain
Clinical narrative: Urinary incontinence as being unable to make it to restroom before being able to go number 1; Arm has been a little sore which increases if he pushes on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Urinary incontinence as being unable to make it to restroom before being able to go number 1) and VACCINATION SITE PAIN (Arm has been a little sore which increases if he pushes on the injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm has been a little sore which increases if he pushes on the injection site). On 06-Jan-2021, the patient experienced URINARY INCONTINENCE (Urinary incontinence as being unable to make it to restroom before being able to go number 1). At the time of the report, URINARY INCONTINENCE (Urinary incontinence as being unable to make it to restroom before being able to go number 1) and VACCINATION SITE PAIN (Arm has been a little sore which increases if he pushes on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history included diabetes.  Concomitant medications included normal diabetes medication.  Additionally, patient experienced urinary incontinence where he was being unable to make it to the restroom before being able to go number 1. Patient confirmed he didn't experience this before. However, this occurred three to four times on yesterday and once this morning, also two times yesterday it occurred while he was getting out of his car. No treatment information was provided.  This case concerns an 80-year-old male who experienced nonserious events of unexpected urinary incontinence and expected vaccination site pain.  Event onset occurred the same days as the first dose of mRNA-1273. Treatment not reported. Events not resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns an 80-year-old male who experienced nonserious events of unexpected urinary incontinence and expected vaccination site pain.  Event onset occurred the same days as the first dose of mRNA-1273. Treatment not reported. Events not resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Conjunctival hyperaemia, Headache, Nasal congestion
Clinical narrative: Congestion; Vomiting; Mild rash on the face; Pain in the injection arm; My fever has been from 100.6°F to 99°F and now 98°F; Head hurts so bad; Chills; Pink eyes; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever has been from 100.6 ° F to 99 °F and now 98 °F (pyrexia), vomiting, head hurts so bad (headache), pain in the injection arm (vaccination site pain), pink eyes (conjunctival hyperaemia), congestion (nasal congestion), mild rash on face (rash), and chills.  The patient's medical history included COVID-19 infection in Mar 2020. No relevant concomitant medication was provided.  On 05 Jan 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) in the left arm for prophylaxis of COVID-19 infection.   On the night of the same day, the patient experienced vomiting, fever, and headache, arm pain, pink eyes, mild facial rash, and chills. Her temperature was 100.6°F, down to 99°F and later reduced to 98°F. The exact time the temperatures were taken was not reported. The patient started experiencing congestion on 06-Jan-2021.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, vomiting, fever has been from 100.6 ° F to 99 °F and now 98 °, head hurts so bad, pain in the injection arm, pink eyes, congestion, mild rash on face, and chills, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test, Vaccination site pain, Vomiting
Clinical narrative: Congestion; Vomiting; Mild rash on the face; Pain in the injection arm; My fever has been from 100.6°F to 99°F and now 98°F; Head hurts so bad; Chills; Pink eyes; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever has been from 100.6 ° F to 99 °F and now 98 °F (pyrexia), vomiting, head hurts so bad (headache), pain in the injection arm (vaccination site pain), pink eyes (conjunctival hyperaemia), congestion (nasal congestion), mild rash on face (rash), and chills.  The patient's medical history included COVID-19 infection in Mar 2020. No relevant concomitant medication was provided.  On 05 Jan 2021, on the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) in the left arm for prophylaxis of COVID-19 infection.   On the night of the same day, the patient experienced vomiting, fever, and headache, arm pain, pink eyes, mild facial rash, and chills. Her temperature was 100.6°F, down to 99°F and later reduced to 98°F. The exact time the temperatures were taken was not reported. The patient started experiencing congestion on 06-Jan-2021.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, vomiting, fever has been from 100.6 ° F to 99 °F and now 98 °, head hurts so bad, pain in the injection arm, pink eyes, congestion, mild rash on face, and chills, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a series of adverse reactions, many of these symptoms overlap with symptoms of COVID-19; A spontaneous report was received from a consumer who was a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a series of adverse reactions, many of these symptoms overlap with symptoms of COVID-19 (vaccine complication).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of symptoms, the patient received her first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19.  On an unknown date, the patient reported that she had a series of adverse reactions "that have already been reported to the CDC."  She stated that many of these symptoms overlapped with symptoms of COVID-19. She did not specify the symptoms she had.  The patient was "fairly confident" that her symptoms were related to the vaccine.  She had been testing negative on days when she came into the office.    No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, a series of adverse reactions, many of these symptoms overlap with symptoms of COVID-19, 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Dizziness
Clinical narrative: Lost focus; Extremely dizzy; Weak; A spontaneous report was received from a consumer, concerning a 52-year-old female patient, who received Moderna's COVID-19 Vaccine and felt extremely dizzy, weak, and lost focus.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 03 Jan 2021, three hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025J208) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Jan 2021, the patient became extremely dizzy, weak, and lost focus. The patient was taken to the emergency room (ER) and was so weak they had to put her in a wheelchair. Unspecified tests were conducted at the ER but nothing was found and the patient was sent home. Treatment included diazepam, although it was not confirmed.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, extremely dizzy, weak, and lost focus, was unknown.; Reporter's Comments: This report refers to a case of 52- year-old female patient who experienced events of extremely dizzy, weak and lost focus 3 hours after administration of mRNA-1273, lot # 025J208, Expiration date-unknown. Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiological factors, a causal association cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the chest and abdomen; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash on the chest and abdomen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced RASH (Rash on the chest and abdomen). At the time of the report, RASH (Rash on the chest and abdomen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Paraesthesia oral, Urticaria, Vaccination site pain
Clinical narrative: Itchy; Eye swelling; Hives; Tingling upper lip; tenderness near the injection site; injection site swelling; A spontaneous report was received from a consumer who was a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling near injection site (vaccination site swelling), tenderness (vaccination site pain), itchy (eye pruritus), swelling of eyes, hives (urticaria) and tingling of upper lip (paraesthesia  oral).  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced, swelling near injection site and tenderness.  On 02 Jan 2021, the patient developed, itchy, swelling of eyes, hives and tingling of upper lip. The patient checked herself into the emergency room (ER) at this point. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, swelling near injection site, tenderness, itchy, swelling of eyes, hives and tingling of upper lip 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.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itchy; Eye swelling; Hives; Tingling upper lip; tenderness near the injection site; injection site swelling; A spontaneous report was received from a consumer who was a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling near injection site (vaccination site swelling), tenderness (vaccination site pain), itchy (eye pruritus), swelling of eyes, hives (urticaria) and tingling of upper lip (paraesthesia  oral).  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced, swelling near injection site and tenderness.  On 02 Jan 2021, the patient developed, itchy, swelling of eyes, hives and tingling of upper lip. The patient checked herself into the emergency room (ER) at this point. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, swelling near injection site, tenderness, itchy, swelling of eyes, hives and tingling of upper lip 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: A spontaneous report was received from a nurse concerning a 59-year old, female patient who received Moderna's COVID-19 vaccine and experienced a round, indurated, red, and warm to touch injection site/injection site induration, injection site erythema, injection site warmth, sore arm/injection site pain, fatigue and body aches/pain.   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 (lot# 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having a sore arm for a few days. On 07 Jan 2021, the patient woke up to a round, indurated, red, warm-to-touch reaction at the injection site. She also experienced fatigue and body aches.   Treatment of the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, a round, indurated, red, and warm to touch injection site, fatigue and body aches, was unknown.  The event, sore arm, was considered 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A spontaneous report was received from a nurse concerning a 59-year old, female patient who received Moderna's COVID-19 vaccine and experienced a round, indurated, red, and warm to touch injection site/injection site induration, injection site erythema, injection site warmth, sore arm/injection site pain, fatigue and body aches/pain.   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 (lot# 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having a sore arm for a few days. On 07 Jan 2021, the patient woke up to a round, indurated, red, warm-to-touch reaction at the injection site. She also experienced fatigue and body aches.   Treatment of the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, a round, indurated, red, and warm to touch injection site, fatigue and body aches, was unknown.  The event, sore arm, was considered 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Palpitations, Urticaria, Vaccination site erythema, Vaccination site hypoaesthesia
Clinical narrative: More numb; Tender at site of injection; site of injection on right arm started becoming red; Injection site bit swollen; Hardness at injection site; Hives as allergic reaction; Palpitation; Tongue and throat felt numbing; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives as allergic reaction), PALPITATIONS (Palpitation), HYPOAESTHESIA ORAL (Tongue and throat felt numbing), VACCINATION SITE HYPOAESTHESIA (More numb) and VACCINATION SITE INDURATION (Hardness at injection site) in a 37-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.     The patient's past medical history included No adverse event.    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 URTICARIA (Hives as allergic reaction), PALPITATIONS (Palpitation) and HYPOAESTHESIA ORAL (Tongue and throat felt numbing). On 05-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (site of injection on right arm started becoming red) and VACCINATION SITE SWELLING (Injection site bit swollen). On 06-Jan-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (More numb) and VACCINATION SITE PAIN (Tender at site of injection). At the time of the report, URTICARIA (Hives as allergic reaction), VACCINATION SITE HYPOAESTHESIA (More numb), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PAIN (Tender at site of injection), VACCINATION SITE ERYTHEMA (site of injection on right arm started becoming red) and VACCINATION SITE SWELLING (Injection site bit swollen) had not resolved, PALPITATIONS (Palpitation) outcome was unknown and HYPOAESTHESIA ORAL (Tongue and throat felt numbing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included acetaminophen and Benadryl.  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.; 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: More numb; Tender at site of injection; site of injection on right arm started becoming red; Injection site bit swollen; Hardness at injection site; Hives as allergic reaction; Palpitation; Tongue and throat felt numbing; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives as allergic reaction), PALPITATIONS (Palpitation), HYPOAESTHESIA ORAL (Tongue and throat felt numbing), VACCINATION SITE HYPOAESTHESIA (More numb) and VACCINATION SITE INDURATION (Hardness at injection site) in a 37-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.     The patient's past medical history included No adverse event.    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 URTICARIA (Hives as allergic reaction), PALPITATIONS (Palpitation) and HYPOAESTHESIA ORAL (Tongue and throat felt numbing). On 05-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (site of injection on right arm started becoming red) and VACCINATION SITE SWELLING (Injection site bit swollen). On 06-Jan-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (More numb) and VACCINATION SITE PAIN (Tender at site of injection). At the time of the report, URTICARIA (Hives as allergic reaction), VACCINATION SITE HYPOAESTHESIA (More numb), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PAIN (Tender at site of injection), VACCINATION SITE ERYTHEMA (site of injection on right arm started becoming red) and VACCINATION SITE SWELLING (Injection site bit swollen) had not resolved, PALPITATIONS (Palpitation) outcome was unknown and HYPOAESTHESIA ORAL (Tongue and throat felt numbing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included acetaminophen and Benadryl.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: covid-19 exposure; sore arm; A spontaneous report  was received from a healthcare professional concerning a 42 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm and had exposure to Covid-19 through his household.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On 29 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot number 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that he received his first dose on 29 Dec 2020 in his left arm. He reported having a sore arm for one day. He also reported that on 31 Dec 2020 he had a relative living in the household tested positive for Covid-19. The patient planned to also get tested for Covid-19 on 02 Jan 2021. Treatment for the event paracetamol.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The event, sore arm was considered resolved on 30 Dec 2020. The outcome of the event exposure to Covid-19 through his household was unknown.; Reporter's Comments: Very limited information regarding this event Exposure to Covid-19 has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Influenza like illness, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Redness continued to grow...on day 7 it was 5 cm...on day 9, 11 cm; Extremely hard on day 2 and 7; Flu-like symptoms; Soreness; Redness continue to grow; Extremely itchyon day 2 and 7; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Redness continued to grow...on day 7 it was 5 cm...on day 9, 11 cm) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 02-Jan-2021, the patient experienced CONDITION AGGRAVATED (Redness continued to growon day 7 it was 5 cm on day 9, 11 cm). On 27-Dec-2020, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. On 02-Jan-2021, CONDITION AGGRAVATED (Redness continued to growon day 7 it was 5 cm..on day 9, 11 cm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Case 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.   This case was linked to MOD-2021-003438 (Patient Link).; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Redness continued to grow...on day 7 it was 5 cm...on day 9, 11 cm; Extremely hard on day 2 and 7; Flu-like symptoms; Soreness; Redness continue to grow; Extremely itchyon day 2 and 7; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Redness continued to grow...on day 7 it was 5 cm...on day 9, 11 cm) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 02-Jan-2021, the patient experienced CONDITION AGGRAVATED (Redness continued to growon day 7 it was 5 cm on day 9, 11 cm). On 27-Dec-2020, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. On 02-Jan-2021, CONDITION AGGRAVATED (Redness continued to growon day 7 it was 5 cm..on day 9, 11 cm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Case 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.   This case was linked to MOD-2021-003438 (Patient Link).; 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Bad body aches; Headache; Pain in the arm that received the vaccine; This spontaneous case was reported by an other and describes the occurrence of MYALGIA (Bad body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the arm that received the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Bad body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the arm that received the vaccine). At the time of the report, MYALGIA (Bad body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the arm that received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Case comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No new information; 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash, Urticaria, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild muscle soreness; Urticaria; injection site warmness; RASH; Itchiness; injection site redness; injection site sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Urticaria), VACCINATION SITE WARMTH (injection site warmness), RASH (RASH), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 29-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 VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site sore arm). On 04-Jan-2021, the patient experienced URTICARIA (Urticaria), VACCINATION SITE WARMTH (injection site warmness), RASH (RASH) and VACCINATION SITE PRURITUS (Itchiness). On 07-Jan-2021, the patient experienced MYALGIA (Mild muscle soreness). On 31-Dec-2020, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site sore arm) had resolved. On 05-Jan-2021, URTICARIA (Urticaria) and VACCINATION SITE WARMTH (injection site warmness) had resolved. At the time of the report, RASH (RASH), VACCINATION SITE PRURITUS (Itchiness) and MYALGIA (Mild muscle soreness) 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.   He treated the reactions on 30dec2020 with ibuprofen. On 6jan2021 he treated the rash with topical diphenhydramine and the night of 6jan2021 he took diphenhydramine 25 mg.  Company comment: 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Mild muscle soreness; Urticaria; injection site warmness; RASH; Itchiness; injection site redness; injection site sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Urticaria), VACCINATION SITE WARMTH (injection site warmness), RASH (RASH), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 29-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 VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site sore arm). On 04-Jan-2021, the patient experienced URTICARIA (Urticaria), VACCINATION SITE WARMTH (injection site warmness), RASH (RASH) and VACCINATION SITE PRURITUS (Itchiness). On 07-Jan-2021, the patient experienced MYALGIA (Mild muscle soreness). On 31-Dec-2020, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PAIN (injection site sore arm) had resolved. On 05-Jan-2021, URTICARIA (Urticaria) and VACCINATION SITE WARMTH (injection site warmness) had resolved. At the time of the report, RASH (RASH), VACCINATION SITE PRURITUS (Itchiness) and MYALGIA (Mild muscle soreness) 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.   He treated the reactions on 30dec2020 with ibuprofen. On 6jan2021 he treated the rash with topical diphenhydramine and the night of 6jan2021 he took diphenhydramine 25 mg.  Company comment: 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Headache; Really tired; Sore arm; Maternal exposure; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure), HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-3 drinks/week) in November 2004. Concurrent medical conditions included Sulfonamide allergy, Melanoma in January 2017 and Hashimoto's thyroiditis since April 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, LEVOTHYROXINE for Thyroid disorder NOS, PARACETAMOL (TYLENOL) for an unknown indication.    On 05-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 13-Aug-2020 and the estimated date of delivery was 20-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure). On 06-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, Pregnancy test: positive (Positive) Positive. On 21-Dec-2020, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception reported was 25-Aug-2020.  Previous pregnancy was reported as live full term birth as outcome on 26-Feb-2019. No treatment information was reported.; Sender's Comments: .
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Really tired; Sore arm; Maternal exposure; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure), HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-3 drinks/week) in November 2004. Concurrent medical conditions included Sulfonamide allergy, Melanoma in January 2017 and Hashimoto's thyroiditis since April 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, LEVOTHYROXINE for Thyroid disorder NOS, PARACETAMOL (TYLENOL) for an unknown indication.    On 05-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 13-Aug-2020 and the estimated date of delivery was 20-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure). On 06-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, Pregnancy test: positive (Positive) Positive. On 21-Dec-2020, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception reported was 25-Aug-2020.  Previous pregnancy was reported as live full term birth as outcome on 26-Feb-2019. No treatment information was reported.; Sender's Comments: .
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Flushing
Clinical narrative: flushed face; weakness; extremely fatigued until she couldn't move hardly; fever temperature of 101.4; chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed face), ASTHENIA (weakness), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2OA) 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 FLUSHING (flushed face), ASTHENIA (weakness), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills). At the time of the report, FLUSHING (flushed face), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills) had resolved and ASTHENIA (weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 101.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the events included cold compress and drinking a lot of fluids.   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.; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flushed face; weakness; extremely fatigued until she couldn't move hardly; fever temperature of 101.4; chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed face), ASTHENIA (weakness), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2OA) 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 FLUSHING (flushed face), ASTHENIA (weakness), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills). At the time of the report, FLUSHING (flushed face), FATIGUE (extremely fatigued until she couldn't move hardly), PYREXIA (fever temperature of 101.4) and CHILLS (chills) had resolved and ASTHENIA (weakness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 101.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the events included cold compress and drinking a lot of fluids.   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.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pain in extremity
Clinical narrative: Covid-19; Mild chills; a little bit sore Arm; A spontaneous report was received from a health care provider regarding a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, a little bit sore arm and a positive COVID-19 test.  The patient's medical history as provided by the reporter included a positive COVID-19 test. No concomitant medications were reported.    On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient experienced mild chills, a little bit sore arm. A few days later,  on an unknown date, she tested positive for COVID-19.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, chills, a little bit sore arm and a positive COVID-19 test was considered to have an unknown outcome.  The reporter did not provide causality for the 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 events chills and pain arm, a causal relationship cannot be excluded. The causality for the event COVID-19 is assessed as unlikely, based on its known causative agent. It is likely that the patient was already infected with the virus but was asymptomatic before being administered with the mRNA-1273 vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Dyspnoea, Heart rate increased, Heart rate irregular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Mild chest pressure) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spinal cord disorder, Back pain, Muscle pain and Heart attack.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation), CHEST DISCOMFORT (Mild chest pressure) and VACCINATION SITE PAIN (Arm is still a little sore from vaccination). On 10-Jan-2021, the patient experienced BACK PAIN (Backache) and MYALGIA (Muscle aches). On 09-Jan-2021, DYSPNOEA (Mild difficulty breathing), HEART RATE INCREASED (Had a fast hearbeat (strong palpitations)), HEART RATE IRREGULAR (Heart beats irregular), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Mild chest pressure) had resolved. At the time of the report, BACK PAIN (Backache) and MYALGIA (Muscle aches) outcome was unknown and VACCINATION SITE PAIN (Arm is still a little sore from vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.