chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Influenza like illness, Malaise, Pain
Clinical narrative: felt sick; high fever; chills; flu like symptoms; trouble breathing; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), MALAISE (felt sick), PYREXIA (high fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), PYREXIA (high fever), CHILLS (chills) and PAIN (aches). On 09-Jan-2021 at 4:00 PM, the patient experienced MALAISE (felt sick). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), MALAISE (felt sick), PYREXIA (high fever), CHILLS (chills) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt sick; high fever; chills; flu like symptoms; trouble breathing; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), MALAISE (felt sick), PYREXIA (high fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), PYREXIA (high fever), CHILLS (chills) and PAIN (aches). On 09-Jan-2021 at 4:00 PM, the patient experienced MALAISE (felt sick). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (trouble breathing), MALAISE (felt sick), PYREXIA (high fever), CHILLS (chills) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Very sore; Very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Very sore) and VACCINATION SITE ERYTHEMA (Very red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Very sore) and VACCINATION SITE ERYTHEMA (Very red). At the time of the report, VACCINATION SITE PAIN (Very sore) and VACCINATION SITE ERYTHEMA (Very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow received on 14-jun-2021 contains No new information.; 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity
Clinical narrative: Allergic reaction on injection site; A report was received from a nurse concerning a 62-year-old female patient who received her first of two planned doses of mRNA-1273 vaccine and experienced allergic reaction on the injection site.  The patient's medical history was not provided. Concomitant products reportedly used by the patient included, fish oil and black seeds.  On 23 DEC 2020, the patient received her first of two planned doses of mRNA-1273 vaccine (batch# 011J20A) in the left arm for prophylaxis of COVID-19 infection.  On 01 JAN 2021, the patient developed  an allergic reaction on the injection site. The reporter mentioned It was uncomfortable; the site was swelling and red, looking like a rash.  Treatment for the event included Diphenhydramine and cold compression with ice packs.   Any action taken regarding the vaccine as a result of the event was not reported.  The outcome of the event was considered 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Myalgia, Pruritus, Vaccination site erythema
Clinical narrative: Altered mental state; Itchiness of injection site; Muscle pain; Redness of the injection site; A spontaneous report was received from reporter concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain/ Myalgia, itchiness, redness of the injection site/ Vaccination site erythema and altered mental state/ Mental disorder.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) via unknown route in left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the day after administration, the patient experienced muscle pain, itchiness, redness of the injection site and an altered mental state. The patient was getting better now, after taking metoprolol and azithromycin.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events were resolving.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Feeling hot, Vomiting
Clinical narrative: high blood pressure of around 188/99; feeling warm; vomiting; chills on an off; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure of around 188/99), FEELING HOT (feeling warm), VOMITING (vomiting) and CHILLS (chills on an off) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure of around 188/99), FEELING HOT (feeling warm), VOMITING (vomiting) and CHILLS (chills on an off). On 09-Jan-2021, FEELING HOT (feeling warm), VOMITING (vomiting) and CHILLS (chills on an off) had resolved. On 11-Jan-2021, BLOOD PRESSURE INCREASED (high blood pressure of around 188/99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, Blood pressure measurement: 188/99 (High) high.     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.; Sender's Comments: This case concerns a 72-year-old female who experienced NS unexpected events of blood pressure increased, feeling hot and NS expected events of vomiting, chills.  Event onset occurred 4 days after the first dose of mRNA-1273. Treatment not reported. Events 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.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood glucose, Headache, Hunger
Clinical narrative: feeling hungry; on off random aches and pains; 101 fever; vomited; got sick to my stomach; joint pain; Headache; elevated blood sugar; sharp arm pain; couldn't move his arm; shoulder pain; A spontaneous report was received from a consumer concerning a 32-year old, male patient who received Moderna's COVID-19 vaccine and experienced sharp arm pain, shoulder pain, inability to move arm, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever, joint pain, headache and random aches and pains.   The patient's medical history, as provided by the reporter, included Type-1 Diabetes.  No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient had sharp arm pain, shoulder pain and could not move his arm. He also reported a blood sugar reading of 417. After treating with insulin, it returned to normal. On an unknown date, the patient felt hungry around 4 am, with no relief by lunch time. On 02 Jan 2021, the patient got sick to his stomach and vomited. He also reported a temperature of 101 degrees Fahrenheit, joint pain, headache, and elevated blood sugar (390). Symptoms resolved that night. On 03 Jan 2021, the patient reports having a headache and on/off random aches and pains. Treatment for the event included an unspecified insulin.   Action taken with mRNA-1273 in response to the events was not reported.   The events sharp arm pain, shoulder pain, inability to move arm, headache, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever were considered recovered on 02 Jan 2021.  The outcome of headache and random aches and pains were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. These events could also be confounded by the type 2 diabetes history in the patient.
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia, Limb discomfort, Pain, Pain in extremity, Pyrexia
Clinical narrative: feeling hungry; on off random aches and pains; 101 fever; vomited; got sick to my stomach; joint pain; Headache; elevated blood sugar; sharp arm pain; couldn't move his arm; shoulder pain; A spontaneous report was received from a consumer concerning a 32-year old, male patient who received Moderna's COVID-19 vaccine and experienced sharp arm pain, shoulder pain, inability to move arm, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever, joint pain, headache and random aches and pains.   The patient's medical history, as provided by the reporter, included Type-1 Diabetes.  No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient had sharp arm pain, shoulder pain and could not move his arm. He also reported a blood sugar reading of 417. After treating with insulin, it returned to normal. On an unknown date, the patient felt hungry around 4 am, with no relief by lunch time. On 02 Jan 2021, the patient got sick to his stomach and vomited. He also reported a temperature of 101 degrees Fahrenheit, joint pain, headache, and elevated blood sugar (390). Symptoms resolved that night. On 03 Jan 2021, the patient reports having a headache and on/off random aches and pains. Treatment for the event included an unspecified insulin.   Action taken with mRNA-1273 in response to the events was not reported.   The events sharp arm pain, shoulder pain, inability to move arm, headache, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever were considered recovered on 02 Jan 2021.  The outcome of headache and random aches and pains were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. These events could also be confounded by the type 2 diabetes history in the patient.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feeling hungry; on off random aches and pains; 101 fever; vomited; got sick to my stomach; joint pain; Headache; elevated blood sugar; sharp arm pain; couldn't move his arm; shoulder pain; A spontaneous report was received from a consumer concerning a 32-year old, male patient who received Moderna's COVID-19 vaccine and experienced sharp arm pain, shoulder pain, inability to move arm, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever, joint pain, headache and random aches and pains.   The patient's medical history, as provided by the reporter, included Type-1 Diabetes.  No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient had sharp arm pain, shoulder pain and could not move his arm. He also reported a blood sugar reading of 417. After treating with insulin, it returned to normal. On an unknown date, the patient felt hungry around 4 am, with no relief by lunch time. On 02 Jan 2021, the patient got sick to his stomach and vomited. He also reported a temperature of 101 degrees Fahrenheit, joint pain, headache, and elevated blood sugar (390). Symptoms resolved that night. On 03 Jan 2021, the patient reports having a headache and on/off random aches and pains. Treatment for the event included an unspecified insulin.   Action taken with mRNA-1273 in response to the events was not reported.   The events sharp arm pain, shoulder pain, inability to move arm, headache, increased blood sugar, feeling hungry, getting sick to his stomach, vomiting, fever were considered recovered on 02 Jan 2021.  The outcome of headache and random aches and pains were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. These events could also be confounded by the type 2 diabetes history in the patient.
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters on her fingers and on the palm of her hand; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on her fingers and on the palm of her hand) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025M208A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-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 BLISTER (Blisters on her fingers and on the palm of her hand). At the time of the report, BLISTER (Blisters on her fingers and on the palm of her hand) had not resolved.        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 were reported.   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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 1990 and Hypertension since 2010. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, NIFEDIPINE for Hypertension, ASPIRIN [ACETYLSALICYLIC ACID] and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for Thrombosis.    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 22-Aug-2020 and the estimated date of delivery was 29-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) She had routine blood works and tests for pregnancy and the results were normal. On an unknown date, Pregnancy test: positive (Positive) Positive, 6 weeks after the last menstrual period.     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.   Patient Medical history includes Blood clot .   Treatment information was not reported .  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Delayed fatigue; A spontaneous report was received from a daughter, concerning about her mother (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced delayed fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after receiving the vaccine, the patient experienced delayed fatigue. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, Delayed fatigue is Unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Headache, Illness
Clinical narrative: Feeling very ill; Extreme diarrhea; Weak; Congestion; Really sick; Fever of 101; Headache; Muscle pain, Terrible aches and pain; A spontaneous report, was received from a consumer (patient's daughter), concerning her mother who was an 88-year-old white female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling very ill (malaise), extreme diarrhea (diarrhea),  weak (asthenia), congestion (nasal congestion), really sick (illness), fever of 101 (pyrexia), headaches, and muscle pain/terrible aches and pain (myalgia).  The patient's medical history included COVID-19 infection and heart valve replacement. Concomitant medication reported included unspecified blood thinners.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, 05 Jan 2021 at home, the patient experienced very ill, extreme diarrhea, terrible aches and pain, running a fever of 101-degree Fahrenheit (F) and really sick. It took seven hours and 20 minutes sitting in the car for the shot. The patient fever was now down to 100 F. The patient's diarrhea had stopped and just weak with headaches, congestion and muscle pains. The consumer stated that the symptoms were similar to COVID-19 symptoms, which the patient had before, but not as bad. It was noted that the patient was sick for two weeks and took a couple more weeks to recover. The patient was not hospitalized and only a few weeks ago, she felt strong enough to stop using her walker and cane as her muscles were very week from COVID. The patient was up all night long sick. The treatment for the events included gatorade and acetaminophen. The patient finally got to eat a little bit slowly.  Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome for the events, feeling very ill, extreme diarrhea, terrible aches and pain, weak, congestion, really sick, fever of 101, headaches, and muscle pains was considered as 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.  The patient's advanced age and previous COVID infection are contributing factors for general illness and weakness.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Feeling very ill; Extreme diarrhea; Weak; Congestion; Really sick; Fever of 101; Headache; Muscle pain, Terrible aches and pain; A spontaneous report, was received from a consumer (patient's daughter), concerning her mother who was an 88-year-old white female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling very ill (malaise), extreme diarrhea (diarrhea),  weak (asthenia), congestion (nasal congestion), really sick (illness), fever of 101 (pyrexia), headaches, and muscle pain/terrible aches and pain (myalgia).  The patient's medical history included COVID-19 infection and heart valve replacement. Concomitant medication reported included unspecified blood thinners.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On the same day, 05 Jan 2021 at home, the patient experienced very ill, extreme diarrhea, terrible aches and pain, running a fever of 101-degree Fahrenheit (F) and really sick. It took seven hours and 20 minutes sitting in the car for the shot. The patient fever was now down to 100 F. The patient's diarrhea had stopped and just weak with headaches, congestion and muscle pains. The consumer stated that the symptoms were similar to COVID-19 symptoms, which the patient had before, but not as bad. It was noted that the patient was sick for two weeks and took a couple more weeks to recover. The patient was not hospitalized and only a few weeks ago, she felt strong enough to stop using her walker and cane as her muscles were very week from COVID. The patient was up all night long sick. The treatment for the events included gatorade and acetaminophen. The patient finally got to eat a little bit slowly.  Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome for the events, feeling very ill, extreme diarrhea, terrible aches and pain, weak, congestion, really sick, fever of 101, headaches, and muscle pains was considered as 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.  The patient's advanced age and previous COVID infection are contributing factors for general illness and weakness.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus, Vomiting
Clinical narrative: Ringing/Buzzing in her head like a Machine; Intense Headaches; Vomiting; A spontaneous report was received from a nurse who was a, female patient who experienced ringing/buzzing in her head, intense headaches and vomiting.  The patient's medical history was not provided. No concomitant medications were reported.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. Within minutes of receiving the vaccine, the patient experienced ringing/buzzing in her head, intense headaches and vomiting. The patient stated that she did not report the symptoms to the healthcare professionals providing the vaccine to avoid causing a scene. The patient tried some topical ointment/gel (pennsaid) to get the ringing to stop that was used for plantar fasciitis. However, the off-label medication did not help.  On 04 Jan 2021, the patient went to the emergency room (ER). The patient was treated with dextroamphetamine, toradol, fluids and ondansetron for the events.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, ringing/buzzing in her head, intense headaches and vomiting 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye pruritus, Eye swelling, Faeces discoloured, Flatulence
Clinical narrative: Weight decreased from 132 to 130 pounds; Loose bowels with red tint; Loose bowels with red tint; Gas; Itchy eyes; Right eye was swollen; Look like she had the flu; A spontaneous report was received from a consumer concerning a 83 year old female patient, who  experienced itchy eyes (eye pruritus), right eye was swollen (eye swelling), looked like she had the flu (flu like symptoms), loose bowels with red tint (diarrhea and faeces discoloured), gas (flatulence), and weight decreased from 132 to 130 pounds (weight decreased).  The patient's medical history included bowel resection.  Products known to have been used by the patient, within two weeks prior to the events, included plantago ovata.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 in her left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, after receiving the vaccine, the patient experienced uncontrollable itching in both eyes and her right eye getting swollen.  It looked like she had the flu.    On 05 Jan 2021, the patient began having loose bowels with a red tint that lasted through the night (3-4 times).  She had a lot of gas which began last night (05 Jan 2021) that continued into the morning. The patient reported that the itching and swollen eye was improved.  On 06 Jan 2021, the patient stated that her weight decreased from 132 to 130 pounds.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome, itchy eyes (eye pruritus) and right eye was swollen (eye swelling), were considered recovering.  The outcome for the events of looked like she had the flu (flu like symptoms), loose bowels with red tint (diarrhea and faeces discoloured), gas (flatulence), and weight decreased from 132 to 130 pounds (weight decreased) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Weight decreased
Clinical narrative: Weight decreased from 132 to 130 pounds; Loose bowels with red tint; Loose bowels with red tint; Gas; Itchy eyes; Right eye was swollen; Look like she had the flu; A spontaneous report was received from a consumer concerning a 83 year old female patient, who  experienced itchy eyes (eye pruritus), right eye was swollen (eye swelling), looked like she had the flu (flu like symptoms), loose bowels with red tint (diarrhea and faeces discoloured), gas (flatulence), and weight decreased from 132 to 130 pounds (weight decreased).  The patient's medical history included bowel resection.  Products known to have been used by the patient, within two weeks prior to the events, included plantago ovata.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 in her left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, after receiving the vaccine, the patient experienced uncontrollable itching in both eyes and her right eye getting swollen.  It looked like she had the flu.    On 05 Jan 2021, the patient began having loose bowels with a red tint that lasted through the night (3-4 times).  She had a lot of gas which began last night (05 Jan 2021) that continued into the morning. The patient reported that the itching and swollen eye was improved.  On 06 Jan 2021, the patient stated that her weight decreased from 132 to 130 pounds.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome, itchy eyes (eye pruritus) and right eye was swollen (eye swelling), were considered recovering.  The outcome for the events of looked like she had the flu (flu like symptoms), loose bowels with red tint (diarrhea and faeces discoloured), gas (flatulence), and weight decreased from 132 to 130 pounds (weight decreased) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: pregnancy; arm pain at injection site; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (arm pain at injection site) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 15-Mar-2013 and Pregnancy on 05-Jul-2017. Concurrent medical conditions included GERD. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for GERD, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Supplementation therapy.    On 28-Dec-2020 at 2:19 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Aug-2020 and the estimated date of delivery was 12-May-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) and VACCINATION SITE PAIN (arm pain at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. On 29-Dec-2020, VACCINATION SITE PAIN (arm pain at injection site) 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.   No treatment information was provided.; Reporter's Comments: This is a case of product exposure during pregnancy with  an associated Adverse event of vaccination site pain for this 39-year-old female. The Adverse event of vaccination site pain is assessed as possible. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: experiencing side effects from the Moderna vaccine; A spontaneous report was received from a consumer concerning a patient (age and gender unspecified) who received Moderna's Covid-19 vaccine (mRNA-1273) and was experiencing side effects from the Moderna vaccine.  The patient's medical history was not provided. Concomitant product use was not provided.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) through an unknown route in an unknown arm , for prophylaxis of COVID-19 infection.   On an unspecified date, the patient was experiencing side effects after receiving the Moderna COVID-19 Vaccine.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the event of experiencing side effects from the Moderna vaccine was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Injection site is red, swollen; injection site swollen; Itching; Warm to touch; A spontaneous report was received from a pharmacist concerning a thirty-eight year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced injection site is red, swollen, itching, and warm to touch.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (LOT number 025J20A) on 27 Dec 2020 intramuscularly in the left arm deltoid muscle for prophylaxis of COVID-19 infection.   Patient received the vaccine 27 Dec 2020 and stated everything seemed fine but during the weekend on 03Jan2021 the patient noticed that the injection site was red, swollen (described a 3 inch radius like a hamburger patty), itching and warm to touch.   Treatment for the events included hydrocortisone (03 Jan 2020 and 04 Jan 2020), diphenhydramine, ibuprofen and acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The event outcomes for injection site is red, swollen, itching, and warm to touch are considered unknown.; Reporter's Comments: This case concerns a 38 year old female patient who experienced the non-serious expected events of  Injection site redness and Injection site swelling, and non-serious unexpected events of pruritis and feeling of warmth. The events occurred 8 days after the first dose of mRNA-1273. Very limited information regarding these events has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout; A spontaneous report was received from a consumer concerning a 91-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed gout.  The patient's medical history was not provided. Current condition included deafness. The concomitant medications reported included metoprolol, allopurinol, colesevelam hcl, gabapentin, rivaroxaban, levothyroxine and nateglinide for unspecified indications.   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 right arm for prophylaxis of COVID-19 infection. On the same day, the patient developed gout.   Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event gout 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 gout, a causal relationship cannot be excluded.  However, considering this elderly patient takes concomitant allopurinol, the underlying condition may have been contributory. Follow-up information on medical history is requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Limb discomfort, Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph nodes red; Lymph nodes swollen; Right underarm was little swollen at injection site; Right underarm sore at injection site; Right underarm warm at injection site; Right arm hurt; Right arm was heavy (getting worse) and whole right arm also felt more heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy), SKIN WARM (Right underarm warm at injection site), PAIN IN EXTREMITY (Right arm hurt), ERYTHEMA (Lymph nodes red) and LYMPHADENOPATHY (Lymph nodes swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy) and PAIN IN EXTREMITY (Right arm hurt). On 11-Jan-2021, the patient experienced SKIN WARM (Right underarm warm at injection site), ERYTHEMA (Lymph nodes red), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Right underarm was little swollen at injection site) and AXILLARY PAIN (Right underarm sore at injection site). On 07-Jan-2021, PAIN IN EXTREMITY (Right arm hurt) had resolved. At the time of the report, LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy), SKIN WARM (Right underarm warm at injection site), ERYTHEMA (Lymph nodes red), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Right underarm was little swollen at injection site) and AXILLARY PAIN (Right underarm sore at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site swelling
Clinical narrative: Lymph nodes red; Lymph nodes swollen; Right underarm was little swollen at injection site; Right underarm sore at injection site; Right underarm warm at injection site; Right arm hurt; Right arm was heavy (getting worse) and whole right arm also felt more heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy), SKIN WARM (Right underarm warm at injection site), PAIN IN EXTREMITY (Right arm hurt), ERYTHEMA (Lymph nodes red) and LYMPHADENOPATHY (Lymph nodes swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy) and PAIN IN EXTREMITY (Right arm hurt). On 11-Jan-2021, the patient experienced SKIN WARM (Right underarm warm at injection site), ERYTHEMA (Lymph nodes red), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Right underarm was little swollen at injection site) and AXILLARY PAIN (Right underarm sore at injection site). On 07-Jan-2021, PAIN IN EXTREMITY (Right arm hurt) had resolved. At the time of the report, LIMB DISCOMFORT (Right arm was heavy (getting worse) and whole right arm also felt more heavy), SKIN WARM (Right underarm warm at injection site), ERYTHEMA (Lymph nodes red), LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Right underarm was little swollen at injection site) and AXILLARY PAIN (Right underarm sore at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate increased, Pain in extremity, Palpitations
Clinical narrative: Sore arm; Tiredness; Injection site pain; Dizziness; Rapid heartbeat; Heart racing; A spontaneous report was received on from a physician concerning a 73 year old, female patient who experienced dizziness, rapid heartbeat, tired, palpitations and pain at the injection site.   The patient's medical history included Thyroid Gland. The concomitant medication included as Synthroid, Potassium and Vitamin D.  On 03 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Batch number:037K20A for prophylaxis of Covid -19 infection in their left arm approximately.  On the same day night the patient experienced dizziness, rapid heartbeat and pain at the injection site.   The day of vaccination, the patient stated she felt really tired, felt her heart racing and went to bed right away.   The next morning day 2 after vaccination the patient woke up with a sore arm and later that night felt palpitations again. She stated she took Tylenol and Benadryl as treatment.   She was worried because symptoms come and go and stated she feels her heartbeat when going to bed.  Action taken with second dose of mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of dizziness, rapid heartbeat, pain at the injection site, palpitations, sore limb, fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events palpitations, rapid heartbeat, and tiredness could be explained by the patient's history of thyroid gland condition.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; Tiredness; Injection site pain; Dizziness; Rapid heartbeat; Heart racing; A spontaneous report was received on from a physician concerning a 73 year old, female patient who experienced dizziness, rapid heartbeat, tired, palpitations and pain at the injection site.   The patient's medical history included Thyroid Gland. The concomitant medication included as Synthroid, Potassium and Vitamin D.  On 03 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Batch number:037K20A for prophylaxis of Covid -19 infection in their left arm approximately.  On the same day night the patient experienced dizziness, rapid heartbeat and pain at the injection site.   The day of vaccination, the patient stated she felt really tired, felt her heart racing and went to bed right away.   The next morning day 2 after vaccination the patient woke up with a sore arm and later that night felt palpitations again. She stated she took Tylenol and Benadryl as treatment.   She was worried because symptoms come and go and stated she feels her heartbeat when going to bed.  Action taken with second dose of mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of dizziness, rapid heartbeat, pain at the injection site, palpitations, sore limb, fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events palpitations, rapid heartbeat, and tiredness could be explained by the patient's history of thyroid gland condition.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Soreness of the arm; injection site is blushed, pinkish-red; Injection site is swollen; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site is blushed, pinkish-red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.  No Medical History information was reported.   On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the arm), VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site is blushed, pinkish-red). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown and VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (injection site is blushed, pinkish-red) 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 medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Patient details, outcome of the events injection site swollen and blushed, pinkish-red were updated.  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: Exposure during pregnancy
Clinical narrative: Pregnant physician that received the vaccine; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant physician that received the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant physician that received the vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant physician that received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided. This is a case of product exposure during pregnancy with no associated AEs for this unknown aged female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown aged female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.