chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain).   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got "so sick, she couldn't breathe", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt.  On 17 Jan 2021, her temperature was 95 F.  On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea.  On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain.  On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was "sent/admitted" to the hospital. No treatment information was provided.  The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between 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: Headache, Hyperhidrosis, Illness, Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain).   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got "so sick, she couldn't breathe", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt.  On 17 Jan 2021, her temperature was 95 F.  On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea.  On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain.  On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was "sent/admitted" to the hospital. No treatment information was provided.  The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between 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
Clinical narrative: Lymph nodes swelled up; Couldn't breathe; Diarrhea; Stomach hurt; Profusely sweat; Arm was sore; Fatigue; Chills; Fever; Headache; Teeth chattering; Joints hurt; Coughing; Chest tightness; Back hurt; Got so sick; A spontaneous report (United States) was received from a consumer, a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced lymph nodes swelled up (lymphadenopathy), couldn't breathe (dyspnoea), chest tightness (chest discomfort), got so sick (illness), arm was sore (pain in extremity), headache, fever (pyrexia), chills, fatigue, teeth chattering (chills), coughing (cough), joints hurt (arthralgia), profusely sweat (hyperhidrosis), back hurt (back pain), diarrhea (diarrhoea), and stomach hurt (stomach pain).   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Around 6:30 pm on the same day, the patient's arm was sore. She also started getting a headache, fever up to 103 Fahrenheit (F), and chills. She got "so sick, she couldn't breathe", so she used her continuous positive airway pressure machine (CPAP), but it didn't help. She felt fatigued and was coughing. Her joints hurt that night until the next day. Her teeth were chattering until the next day. She had a fever and started to profusely sweat for a couple of hours. She had chest tightness and her back hurt.  On 17 Jan 2021, her temperature was 95 F.  On 18 Jan 2021, the patient's stomach hurt and stopped later that day. The she had diarrhea.  On 19 Jan 2021, she reported that she still had a temperature of 95 F, coughing, fatigue, arm soreness, diarrhea, chest tightness, and back pain.  On 20 Jan 2021, the patient's lymph nodes swelled up and she was having difficulty breathing. She went to an urgent care and from there she was "sent/admitted" to the hospital. No treatment information was provided.  The events, teeth chattering and arthralgia, profusely sweat, were considered resolved on 17 Jan 2021. The event, stomach hurt, resolved on 18 Jan 2021. The events, chest tightness, arm was sore, fever, fatigue, coughing, diarrhea, back hurt, were considered not resolved. The events, lymph nodes swelled up, couldn't breathe, headache, chills, got so sick, were considered unknown.; Reporter's Comments: This case concerns a 53-year-old female with serious unexpected lymphadenopathy and dyspnea and NS unexpected cough, chest tightness, arm pain, back pain, stomach pain, sickness, diarrhea, hyperhidrosis and NS expected headache, fatigue, fever, chills, teeth chattering, arthralgia. Event onset the same day as first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphemia, Headache, Hypertensive crisis, Myalgia
Clinical narrative: 200/100 high blood pressure; stammering problems; uncontrolled shaking at my right hand; cold feet; dry mouth; Headaches; body aches; A spontaneous report was received from a 31-year old, female patient who experienced headaches, body aches, dry mouth, cold feet, uncontrolled shaking in right hand, stammering problems, and 200/100 high blood pressure.  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 (Batch number not provided). On 21 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient was taken to the emergency room (ER) approximately four hours after receiving the second dose of the Moderna COVID vaccine. She was experiencing headaches, body aches, dry mouth, cold feet, uncontrollable shaking in her right hand, speech impairment, and her blood pressure was 200/100. The patient tested negative for all stroke tests performed in the ER.. The patient reported she received a medication that "knocked me out" and relieved the symptoms. Treatment information was not provided. On 23 Jan 2021, the patient still had shaking and stammering problems.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events headaches, body aches, dry mouth, cold feet, and 200/100 high blood pressure were unknown. The outcome of events uncontrolled shaking in right hand and stammering problems were not recovered/ not resolved.  Follow up: Follow-up received on 29 Jan 2021 included the patient's report that her adverse events have been sustained and not improved. On 27 Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.; Reporter's Comments: The follow-up received reports that on 27Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.  Based on this information, the event of hypertensive crisis, dysphemia, tremors, is assessed as unlikely related to mRNA-1273.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Tremor
Clinical narrative: 200/100 high blood pressure; stammering problems; uncontrolled shaking at my right hand; cold feet; dry mouth; Headaches; body aches; A spontaneous report was received from a 31-year old, female patient who experienced headaches, body aches, dry mouth, cold feet, uncontrolled shaking in right hand, stammering problems, and 200/100 high blood pressure.  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 (Batch number not provided). On 21 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient was taken to the emergency room (ER) approximately four hours after receiving the second dose of the Moderna COVID vaccine. She was experiencing headaches, body aches, dry mouth, cold feet, uncontrollable shaking in her right hand, speech impairment, and her blood pressure was 200/100. The patient tested negative for all stroke tests performed in the ER.. The patient reported she received a medication that "knocked me out" and relieved the symptoms. Treatment information was not provided. On 23 Jan 2021, the patient still had shaking and stammering problems.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events headaches, body aches, dry mouth, cold feet, and 200/100 high blood pressure were unknown. The outcome of events uncontrolled shaking in right hand and stammering problems were not recovered/ not resolved.  Follow up: Follow-up received on 29 Jan 2021 included the patient's report that her adverse events have been sustained and not improved. On 27 Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.; Reporter's Comments: The follow-up received reports that on 27Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.  Based on this information, the event of hypertensive crisis, dysphemia, tremors, is assessed as unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Allowed 4 patients to be vaccinated with the vaccines that experienced a temperature excursion; A spontaneous report  was received from a physician regarding product storage error.   On 05 FEB 2021, a physician contacted the safety team regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) that had a temperature excursion of less than 12 hours at maximum of 50 degrees Fahrenheit. It was moved to a refrigerator that was within the acceptable range immediately.  She stated that she exercised clinical judgement and allowed 4 patients to be vaccinated with those vials.; Reporter's Comments: This report refers to a case of product storage error regarding five (5) vials of Moderna's COVID-19 vaccine (mRNA-1273) (Lot # unknown) with no reported adverse events. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Not able to walk; A spontaneous report was received from a [consumer/physician/nurse/pharmacist/healthcare facility staff member/regulatory authority report]  concerning a [age/gender] patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and became unable to walk/gait disturbance.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified psychiatric medications.   On 19 Jan 2021, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient lost the ability to walk on 21 Jan 2021 and was hospitalized.  He was entered into a rehabilitation facility where he was to start treatment with a physical therapist to walk again.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events fatigue, body aches, loss of taste, chills, and temperature of 99 degrees were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Company assessed the event to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Haemorrhage in pregnancy
Clinical narrative: had some bleedings this week; Pregnant; A spontaneous report was received from a nurse concerning a female patient who experienced had some bleedings this week (haemorrhage in pregnancy) and pregnant.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient found out she was pregnant after the vaccination. Patient also reported that she had some bleedings this week. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events had some bleedings this week and pregnant were unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with an adverse event of bleeding during pregnancy for this female of an unknown age. Patient will continue to be contacted for further monitoring of the AE during the pregnancy. Very limited information regarding the event of Bleeding during Pregnancy has been provided at this time and further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; A spontaneous report was received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heart attack (myocardial infarction).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an undisclosed date after receiving mRNA-1273, the patient had a heart attack. The patient stated that Moderna should have told her "about the montelukast allergy".  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, heart attack, was unknown.; Reporter's Comments: Very limited information regarding this event of heart attack has been provided at this time. Patient's age, medical history, list of concomitant medications, onset date and clinical details of the event is lacking. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Loss of consciousness
Clinical narrative: felt temporary black out; loss of memory; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt temporary black out and temporary loss of memory.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient experienced a possible adverse event after the first dose of the vaccine.   It was reported that on the night of receiving the vaccine the patient felt temporary blackout and temporary loss of memory. She mentioned that "she wake up fine the next morning". No treatment information provided.    The outcome of the events felt temporary black out and temporary loss of memory 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.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Heart rate, Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: Racing heart; Fever; Pain at injection site; cough; A spontaneous report was received from a consumer concerning a  67 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like racing heart, cough, fever and pain at injection site.  The patient had a history of heart disease.  On 24-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 028L20A ) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 24-JAN-2021, The patient experienced the events like racing heart, cough, fever and pain at injection site with hospitalization as seriousness criteria.    The Patient is taking atenolol ½ every other day. The patient was also advised to take Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 24- JAN-2021, the outcome of the events like tachycardia, cough, pyrexia, pain at injection site was  not resolved. At the time of this report, the outcome of the event tachycardia was resolved and cough, pyrexia , pain at injection site was not 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 medical history of heart disease remains a confounder for causality.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report  was received from a health care professional (HCP) concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) inadvertently from a vial that was punctured a day before/expired vaccine used.  The patients' medical history was not provided. Concomitant medication history was not provided.  On 13 FEB 2021, the patient received his dose of mRNA-1273 (Lot number 016M20A) intramuscularly for prophylaxis of COVID-19 infection.   The HCP stated that this patient was inadvertently given the vaccine from a vial that was punctured a day before.  A single dose was taken out of that vial and put back outside the six-hour window.    Treatment for this event was not provided.  The outcome of the event, expired vaccine used, was recovered on 13 Feb 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, Lot number 016M20A with no associated adverse events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013964:same reorter, different patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Device connection issue, Erythema, Exposure via skin contact, Extra dose administered
Clinical narrative: Spot on forearm where vaccine dripped turned red; facility chose to administer another dose; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; (spot) blistered; A spontaneous report was received from a consumer concerning a 71-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  the syringe not tightly screwed on and the vaccine leaked down the patient's arm, received another dose of the vaccine, a red spot developed on her forearm where the vaccine dripped, and later blistered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05-Feb-2021, during vaccine administration the syringe was not tightly screwed on, and the vaccine leaked down the patient's arm. The facility chose to administer another dose and the patient received two doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID -19 infection.  On 07-Feb-2021, two days later, a spot developed on her forearm where the vaccine dripped, turned red, and later blistered.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events, the syringe was not screwed tightly on and the vaccine leaked down her arm was considered resolved.  The events of a spot developed on her forearm where vaccine dripped, turned red, and later blistered were reported as unknown.; Reporter's Comments: This report refers to a case of syringe that was not tightly screwed on and the vaccine leaked down the patient's arm, and the facility chose to administer another dose for mRNA-1273, lot # unknown, with associated AEs. 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Spot on forearm where vaccine dripped turned red; facility chose to administer another dose; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; the syringe wasn't screwed in tight enough and the vaccine leaked down her arm; (spot) blistered; A spontaneous report was received from a consumer concerning a 71-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  the syringe not tightly screwed on and the vaccine leaked down the patient's arm, received another dose of the vaccine, a red spot developed on her forearm where the vaccine dripped, and later blistered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05-Feb-2021, during vaccine administration the syringe was not tightly screwed on, and the vaccine leaked down the patient's arm. The facility chose to administer another dose and the patient received two doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID -19 infection.  On 07-Feb-2021, two days later, a spot developed on her forearm where the vaccine dripped, turned red, and later blistered.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The events, the syringe was not screwed tightly on and the vaccine leaked down her arm was considered resolved.  The events of a spot developed on her forearm where vaccine dripped, turned red, and later blistered were reported as unknown.; Reporter's Comments: This report refers to a case of syringe that was not tightly screwed on and the vaccine leaked down the patient's arm, and the facility chose to administer another dose for mRNA-1273, lot # unknown, with associated AEs. 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: some solution leaked out of the syringe; the patient may not have received the recommended .5ml; A spontaneous report was received from a pharmacist concerning a 31-year old, male patient who was scheduled to receive Moderna's COVID-19 vaccine but during the administration the patient may have received an invalid first dose as some solution leaked out of the syringe (syringe leak and underdose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient presented to the clinic for their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  The pharmacist stated that, during attempted administration, the consumer may have received an invalid first dose as some solution leaked out of the syringe and the patient may not have received the recommended 0.5ml.    No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the events, syringe leak and underdose were considered recovered.; Reporter's Comments: This report refers to a case of syringe issue and underdose for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave the last two doses after the six hours of vaccine viability time; A spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the person that was giving the doses gave the last two doses after the six hours of vaccine viability time (expired product administered).   The patients' medical history was not provided. Concomitant product use was not provided.  On an undisclosed date, the patient received a dose of mRNA-1273 (batch number unknown) for prophylaxis of COVID-19 infection.   The reporter stated that they punctured the vial but the person that was giving the doses gave the last two doses after the six hours of vaccine viability time.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The event, gave the last two doses after the six hours of vaccine viability time, was considered recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (batch number unknown) with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave the last 2 doses after the 6hs punctured vial lifespan; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine who received (mRNA-1273) and the person that was administering the doses gave the last two doses after the six hour of vaccine viability time (expired product administered).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received a dose of mRNA-1273 (lot number not provided) for prophylaxis of COVID-19 infection.  It was reported that the person that was administering the doses gave the last two doses after the six hour of vaccine viability time.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event gave the last two doses after the six hour of vaccine viability time was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Expired product administered without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose given to a patient 6 hours and 15 minutes after the first puncture; A spontaneous report was received from a pharmacist concerning a patient, age and gender unknown, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, dose given to a patient 6 hours and 15 minutes after the first puncture.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient 6 hours and 15 minutes after the first puncture of vial. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, dose given to a patient 6 hours and 15 minutes after the first puncture, was considered resolved on 14 Feb 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Expired product administered without any associated adverse events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Vaccination site rash
Clinical narrative: Anaphylactic reaction; rash 3.5 x 5 inches below the injection site; A spontaneous report was received from a consumer concerning a 65-year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction and a vaccination site rash.    The patient's medical history included diabetes since an unknown date.  Relevant concomitant medications included an unspecified diabetes medication.   On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 18-Jan-2021, the patient experienced the event anaphylactic reaction and a vaccination site rash 3.5 x 5 inches.  Laboratory details were not provided. Treatment information included fexofenadine and diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   On 23-Jan-2021, the outcome of the events, anaphylactic reaction and vaccination site rash, was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; A spontaneous was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine and who died.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23-Jan-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:013620A) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Jan-2021, approximately 2 days after injection, patient Died. On 26-Jan-2021, neighbor Reporter called in to report a potential AE death. She shared that she lives in a condo building with other elderly. She shared that she and 2 other neighbors went to a vaccination site in Miami at a fire department. She shared that she is fine but that her neighbor died two days after shot. She shared that she didn't know if he had symptoms and that she knows that he had a lot of medical issues and was on about 15 medicines. She shared that she didn't know his age but guessed 70. She said we can contact his wife, but it must be a Spanish speaking agent because she speaks little English. She is concerned because they all received the vaccine at the same time. She wanted to reiterate that she was fine but believed we should know about the neighbor's death. No treatment information was provided.    Action taken with the second dose of mRNA-1273 in response to the event death is not applicable.   The patient died on 26-Jan-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The cause of death was not provided.; Reported Cause(s) of Death: Unknown
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Not Administered in the Deltoid; Itchy Sensation - Near Elbow; Rash - Near Elbow; Redness - Near Elbow; Swelling - Near Elbow; A spontaneous report was received from a consumer concerning a 31-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) at the incorrect injection site and experienced rash, redness, swelling, and an Itchy sensation near her elbow.    The patient's medical history, is not provided by the reporter. Concomitant medications were not reported.   On 21 Jan 2021, the patient received their first of two planned dose of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.    On 21 Jan 2021, the patient began to experienced rash, redness, a lot of swelling, and an Itchy sensation near her elbow where the vaccine was administered. Treatment for the events included ibuprofen    Action taken with mRNA-1273 in response to the events was unknown.    The outcome of event, incorrect injection site, was considered recovered/resolved on 21 Jan 2021.   The outcome of the events, rash, redness, swelling, and an Itchy sensation, was unknown/not 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 event, a causal relationship cannot be excluded.  The causality of the event of vaccine administered at inappropriate site is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Flushing, Pyrexia, Rash, Skin warm
Clinical narrative: Face and neck all hot; rash had spread throughout her body; Face was really flushed; tachycardia; fever 99.9-102F; A spontaneous report was received from a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f.  Medical history was not reported. Concomitant medication was not reported.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in left arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia with seriousness criteria life threatening and fever 99.9-102f.  Treatment medication included Benadryl at a dose of 50 milligram.  Action taken with mRNA-1273 in response to the face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was not provided.  The outcome of the events face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of severe allergic reaction, tachycardia, rash, flushing, and skin warm, and NS expected event of fever. The events occurred the same day as the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Face and neck all hot; rash had spread throughout her body; Face was really flushed; tachycardia; fever 99.9-102F; A spontaneous report was received from a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f.  Medical history was not reported. Concomitant medication was not reported.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in left arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia with seriousness criteria life threatening and fever 99.9-102f.  Treatment medication included Benadryl at a dose of 50 milligram.  Action taken with mRNA-1273 in response to the face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was not provided.  The outcome of the events face and neck all hot, rash had spread throughout her body, face was really flushed, tachycardia and fever 99.9-102f was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected events of severe allergic reaction, tachycardia, rash, flushing, and skin warm, and NS expected event of fever. The events occurred the same day as the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: had COVID (double Covid pneumonia); A spontaneous report (United States) was received from an Other Health Care Professional concerning a female patient age not provided who developed COVID (double Covid pneumonia)   The patient's medical history was not provided. Concomitant product use was not provided.  On 22-Jan-2021, prior to the onset of events, the patient had the first of two planned doses of mRNA-1273, (Batch number was not provided) (route and site was not provided) for prophylaxis of Covid-19 infection.  The patient left a voicemail message reporting adverse reactions to the Moderna mRNA-1273 vaccine. The patient reported having "Covid".  She reported being hospitalized with, " double Covid pneumonia". No treatment information or hospitalization details were provided.  Agent called the patient back on 26-Jan-2021 and was unable to reach her for more information.  Action taken with mRNA-2021 in response to the events was not reported.  Outcome of the event had COVID (double Covid pneumonia) was unknown.; Reporter's Comments: This case concerns a female of unknown age who was hospitalized with a serious unexpected event of COVID-19 pneumonia.  The event occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Syringe and/or needle broke; Did not receive intended dosage volume; A spontaneous report was received from a consumer concerning a 36 year old, white, male patient who received   Moderna's  Covid 19 vaccine (mRNA1273) and experienced a syringe issue and incorrect dose administration.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    ON 29-JAN-2021, the patient received first of two planned dose of mRNA-1273 (Batch Number 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, during administration of the vaccine, the syringe plastic broke and patient did not receive the intended dosing volume of 0.5 mL.   Treatment  information was not provided/unknown.  Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, syringe issue and incorrect dose administration, were considered recovered/resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and Device connection issue for mRNA-1273 (Batch Number 012M20A) with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Part of the dose leaked out through the connection of the needle to the syringe; Part of the dose leaked out through the connection of the needle to the syringe; A spontaneous report was received from a healthcare professional (pharmacist) concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced the event part of the dose leaked out through the connection of the needle to the syringe (syringe issue) (underdose).  The patient's medical history was not provided. No Relevant concomitant medications was provided.  On unknown date, patient received their second of two planned dose of mRNA-1273 (Lot/Batch: unknown) vaccine for prophylaxis of COVID-19 infection.  On an undisclosed date, patient experienced the event part of the dose leaked out through the connection of the needle to the syringe. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of events experienced for event part of the dose leaked out through the connection of the needle to the syringe was resolved.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Herpes zoster, Musculoskeletal chest pain, Pruritus
Clinical narrative: Pain under right breast; Itching; Shingles right abdomen dermatone; Pain in abdomen; A spontaneous report was received from a consumer concerning a 72, year old, female patient who developed pain under right breast, itching, shingles, and pain in abdomen.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 30-12-2020, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 02-JAN-2021 the patient went to an urgent care for pain under the right breast, itching, shingles, and abdominal pain.  On 03-JAN-2021 the patient went to the hospital for pain under the right breast, itching, shingles, and abdominal pain. The patient was discharged the same day 03-JAN-2021. Treatment for the event included Lyrica twice daily, Valtrex twice daily, Tramadol and two rounds of Prednisone.  The patient self -administered Advil and Tylenol.   There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and was administered on 27-JAN-2021    The outcome of the event(s) not reported.     Follow up: No follow up provided.; Reporter's Comments: This case concerns a 72, year old, female patient who developed pain under right breast, itching, shingles, and pain in abdomen. Very limited information of this event has been provided at this time. Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Vaccination site pain
Clinical narrative: Rapid heart beat at 110bpm and today was 120bpm; Sore left arm at injection site; A spontaneous report was received from a consumer, concerning herself, a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rapid heartbeat at 110bpm and today was 120bpm and sore left arm at injection site.  The patient's medical history was not provided. Patient had no relevant concomitant medications.  On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (010M2A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, after the second dose of vaccine, the patient experienced sore left arm at injection site and rapid heartbeat at 110bpm. On 29 Jan 2021, the patient's heartbeat was about 120bpm, hence she went to emergency room. Patient had no treatment and co-morbidities.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event's rapid heartbeat at 110bpm and today was 120bpm and sore left arm at injection site were not reported.; Reporter's Comments: This case concerns a 30-year-old female who experienced a serious unexpected event of Heart rate increase along with a nonserious expected event of Vaccination site pain. The events occurred the same day as the second dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.