chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Musculoskeletal stiffness, Oral discomfort
Clinical narrative: bell's pausy; strange feeling in my lip; stiff neck; A spontaneous report was received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  developed Bell's Palsy (facial paralysis), stiff neck (musculoskeletal stiffness), and a strange feeling in her lip (oral discomfort).    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 vitamins, atorvastatin calcium and calcium   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient developed a very stiff neck and had a restless sleep. On 06 Feb 2021, the patient reported awaking with a strange feeling in her lip. She was advised by her primary care physician. On 07 Feb 2021, the symptoms had worsened, and her facial muscle had twisted. Treatment for the event included prednisone and valacyclovir.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The events, Bell's Palsy, stiff neck and strange feeling in lip, was considered not recovered/not resolved.; Reporter's Comments: Although a temporal relationship exists, there is not enough information to assess the causal relationship of the reported events with the administration of mRNA-1273 (Batch number: 038K20A).  Critical details such as patient's medical history and relevant diagnostic test are lacking. Additional information have been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Product administered to patient of inappropriate age
Clinical narrative: Hot flashes; Tired; 17-year old inadvertently given the first dose of the vaccine; A spontaneous report was received from a parent whose 17-year-old, female daughter received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in hot flashes, and tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Feb 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient's father reported his daughter was given the Moderna vaccine in error as she is only 17. The patient experienced hot flashes and was tired after receiving 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, vaccine given to a 17-year old, was considered resolved on 06 Feb 2021. The outcomes for events, hot flashes and tired, were not reported.; Reporter's Comments: This report refers to a 17-year old female patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection with reported events of hot flashes and was tired. Based temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Headache, Product administered at inappropriate site, Vaccination site joint movement impairment, Vaccination site joint pain
Clinical narrative: I can't raise my arm to a horizontal position; Pain is starting to go to my back; Pain is starting to go to my head; Instead of going into the side of my arm, they put it almost vertically down into the joint; joint  is hurting like crazy; A spontaneous report was received from a consumer concerning a patient, of unknown gender and age, who was administered Covid-19 vaccine as follows: instead of going into the side of his arm, they put it almost vertically down into joint/ MedDRA PT: product administered at inappropriate site and experienced it is hurting like crazy/ MedDRA PT: vaccination site joint pain, can't raise my arm to a horizontal position/ MedDRA PT: vaccination site joint movement impairment, pain is starting to go to my back/ MedDRA PT: back pain, and pain is starting to go to my head/ MedDRA PT: headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of Covid-19 infection.   The patient reported that instead of going into the side of their arm, they put it almost vertically down into joint and it is hurting like crazy. Two days later, it is getting worse, and the patient can't raise their arm to a horizontal position. The patient also stated that pain is starting to go to their back and their head.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events of it is hurting like crazy, can't raise my arm to a horizontal position, pain is starting to go to my back, and pain is starting to go to my head, was considered as unknown. The event, vaccine instead of going into the side of his arm, they put it almost vertically down into joint, was considered recovered.; Reporter's Comments: The events of vaccination site joint pain, vaccination site joint movement impairment, backpain and headache developed after first dose of mRNA-1372. 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: Cerebrovascular accident, Hypoaesthesia, Paraesthesia
Clinical narrative: Mini stroke; Tingling sensation; Numbness at the right side of the body from face down to foot; A spontaneous report was received from a HCP concerning a male patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient's medical history was reported as diabetic and was taking medications for diabetes but did not provide exact name of the medication. No relevant concomitant medications were reported.     24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.   On 29 Dec 2020, 5 days after the dose of injection, the patient experienced and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient was taken to ER and patient was diagnosed with mini stroke at the ER. No Laboratory details provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events experienced tingling sensation and numbness at the right side of the body from face down to the foot was Unknown.; Reporter's Comments: The events developed on five day after first dose of mRNA-1372. Paresthesia, and hypoesthesia were consistent with increased risk of cerebrovascular accidents associated with history of diabetes. 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: Anaphylactic reaction, Erythema
Clinical narrative: Early sing of anaphylactic reaction; Face was bright orange; A spontaneous report was received from a consumer concerning a 71 years old, male patient who experienced early sign of anaphylactic reaction (anaphylactic reaction), and face was bright orange (erythema).   The patient's medical history included anaphylactic reaction since an unknown date, high blood pressure since an unknown date, anxiety since an unknown date and pain since an unknown date. Products known to have been used by the patient, within two weeks prior to the event, included High blood pressure medication, Pain medication, Anxiety medication and Vitamins all since an unknown date at unknown dose, frequency, route and formulation.   On 10-Feb-2021, approximately 20 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.   The patient experienced anaphylactic reaction and face was bright orange on 10-Feb-2021 after receiving the vaccine. Patient was treated in the ER and stayed there for four hours while the symptoms slowly resolved. Patient indicated face was 75% back to normal while in ER. Treatment for the event included steroid injection, Zicam and steroid tablets.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), early sign of anaphylactic reaction, and face was bright orange were considered resolved or recovered.; 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 (within 20 minutes after receiving the vaccine), a causal relationship cannot be excluded. Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Bell's Palsy.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021 he patient received their first of two planned doses of mRNA-1273 (BATCH # 042C20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   Consumer was a 70-year-old male that received the first dose of the Moderna COVID-19 vaccine on 09 Feb 2021, in the left upper arm. The patient experienced Bell's Palsy after the first dose on 09 Feb 2021.  No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the event Bell's Palsy was unknown.  The reporter did not provide an assessment for the event, Bell's Palsy.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Diarrhoea, Headache
Clinical narrative: diarrhea; chills; headache; she had no use of the right arm; extreme pain down my arm (right), pain was like a stabbing with knife on my arm; extreme pain up my jaw (right side); extreme pain in back (right side); didn't sleep much at all; her arm was sore by 2pm and felt really weak by the )time evening came; felt really weak; arm was sore; Neck pain; A spontaneous report was received from a 72-year-old female patient, who experienced sore arm, felt weak, extreme pain in right arm, right jaw and back, and neck, did not sleep much at all, pain was like stabbing with knife on arm, no use of right arm, diarrhea, and chills.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) on 05 Feb 2021 at 10:45 AM in right arm for the prophylaxis of COVID-19 infection.  On 05 Feb 2021 at 2:00 PM, her arm was sore, felt really week by the evening, extreme pain down her arm, up my jaw, neck and back, did not sleep much. She took acetaminophen which dulled the pain.  On 06 Feb 2021, pain was like a "stabbing with knife on arm." She stated that the pain was worse at night and she had no se of the right arm.  On 07 Feb 2021, she had diarrhea, chills, and headache.  On 08 Feb 2021, she had no pain in neck and jaw, and her arm was still mildly sore, had dull headache.  Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, felt weak, extreme pain in right arm, and back was not resolved; outcome of the events, extreme pain in jaw, back, neck was resolved on 08 Feb 2021; outcome of the events, did not sleep much, pain was like a "stabbing with knife on my arm", no use of right arm, diarrhea, chills, and headache was not resolved.; Reporter's Comments: This case concerns a 72-year-old female with a serious unexpected event of LLT Paralysis arm with NS unexpected arm pain, jaw pain, neck pain, back pain, asthenia, diarrhea, difficulty sleeping and NS expected vaccination site pain, headache, chills.  The events occurred 2 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Monoplegia, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: diarrhea; chills; headache; she had no use of the right arm; extreme pain down my arm (right), pain was like a stabbing with knife on my arm; extreme pain up my jaw (right side); extreme pain in back (right side); didn't sleep much at all; her arm was sore by 2pm and felt really weak by the )time evening came; felt really weak; arm was sore; Neck pain; A spontaneous report was received from a 72-year-old female patient, who experienced sore arm, felt weak, extreme pain in right arm, right jaw and back, and neck, did not sleep much at all, pain was like stabbing with knife on arm, no use of right arm, diarrhea, and chills.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) on 05 Feb 2021 at 10:45 AM in right arm for the prophylaxis of COVID-19 infection.  On 05 Feb 2021 at 2:00 PM, her arm was sore, felt really week by the evening, extreme pain down her arm, up my jaw, neck and back, did not sleep much. She took acetaminophen which dulled the pain.  On 06 Feb 2021, pain was like a "stabbing with knife on arm." She stated that the pain was worse at night and she had no se of the right arm.  On 07 Feb 2021, she had diarrhea, chills, and headache.  On 08 Feb 2021, she had no pain in neck and jaw, and her arm was still mildly sore, had dull headache.  Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, felt weak, extreme pain in right arm, and back was not resolved; outcome of the events, extreme pain in jaw, back, neck was resolved on 08 Feb 2021; outcome of the events, did not sleep much, pain was like a "stabbing with knife on my arm", no use of right arm, diarrhea, chills, and headache was not resolved.; Reporter's Comments: This case concerns a 72-year-old female with a serious unexpected event of LLT Paralysis arm with NS unexpected arm pain, jaw pain, neck pain, back pain, asthenia, diarrhea, difficulty sleeping and NS expected vaccination site pain, headache, chills.  The events occurred 2 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Vaccination site pain
Clinical narrative: diarrhea; chills; headache; she had no use of the right arm; extreme pain down my arm (right), pain was like a stabbing with knife on my arm; extreme pain up my jaw (right side); extreme pain in back (right side); didn't sleep much at all; her arm was sore by 2pm and felt really weak by the )time evening came; felt really weak; arm was sore; Neck pain; A spontaneous report was received from a 72-year-old female patient, who experienced sore arm, felt weak, extreme pain in right arm, right jaw and back, and neck, did not sleep much at all, pain was like stabbing with knife on arm, no use of right arm, diarrhea, and chills.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) on 05 Feb 2021 at 10:45 AM in right arm for the prophylaxis of COVID-19 infection.  On 05 Feb 2021 at 2:00 PM, her arm was sore, felt really week by the evening, extreme pain down her arm, up my jaw, neck and back, did not sleep much. She took acetaminophen which dulled the pain.  On 06 Feb 2021, pain was like a "stabbing with knife on arm." She stated that the pain was worse at night and she had no se of the right arm.  On 07 Feb 2021, she had diarrhea, chills, and headache.  On 08 Feb 2021, she had no pain in neck and jaw, and her arm was still mildly sore, had dull headache.  Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, felt weak, extreme pain in right arm, and back was not resolved; outcome of the events, extreme pain in jaw, back, neck was resolved on 08 Feb 2021; outcome of the events, did not sleep much, pain was like a "stabbing with knife on my arm", no use of right arm, diarrhea, chills, and headache was not resolved.; Reporter's Comments: This case concerns a 72-year-old female with a serious unexpected event of LLT Paralysis arm with NS unexpected arm pain, jaw pain, neck pain, back pain, asthenia, diarrhea, difficulty sleeping and NS expected vaccination site pain, headache, chills.  The events occurred 2 days after the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Loss of consciousness, Pain
Clinical narrative: Fell; Blurred vision; Very weak; Passed out; A lot of pain; Chills; A spontaneous report  was received from a 66-year- old female patient who experienced a lot of pain, chills, fell, blurred vision, very weak and passed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 08 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced pain at injection site, chills.   On 09 Feb 2021, the patient fell, had blurred vision, very weak and passed out. She spoke to her doctor who recommended rest.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event passed out was resolved; outcome of the events, pain at injection site, chills, fell, blurred vision, and very weak, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Fell; Blurred vision; Very weak; Passed out; A lot of pain; Chills; A spontaneous report  was received from a 66-year- old female patient who experienced a lot of pain, chills, fell, blurred vision, very weak and passed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 08 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced pain at injection site, chills.   On 09 Feb 2021, the patient fell, had blurred vision, very weak and passed out. She spoke to her doctor who recommended rest.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event passed out was resolved; outcome of the events, pain at injection site, chills, fell, blurred vision, and very weak, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Fatigue, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs.  Treatment details were unknown.  Action taken with mRNA-1273 was unknown.  The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 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.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs.  Treatment details were unknown.  Action taken with mRNA-1273 was unknown.  The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Dysgeusia, Flushing
Clinical narrative: Hypersensitivity reaction; Mild metallic taste; Flushing; Heart palpitations; Tightness in chest; Lightheadedness; Weakness; A spontaneous report was received from a consumer who is a physician concerning herself, a 50 year old female patient who recived Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 26Dec2020, the patient received the first of their first of two planned doses of mRNA-1273 (lot number 025H20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26Dec2020, shortly after receiving the injection, the patient experienced a hypersensitivity reaction with a mild metallic taste, flushing heart palpitations, tightness in chest, lightheadedness, and weakness.  No treatment was reported and the symptoms did not last past the day.  Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia  was considered resolved.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Hypersensitivity after receiving first dose of mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Palpitations
Clinical narrative: Hypersensitivity reaction; Mild metallic taste; Flushing; Heart palpitations; Tightness in chest; Lightheadedness; Weakness; A spontaneous report was received from a consumer who is a physician concerning herself, a 50 year old female patient who recived Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 26Dec2020, the patient received the first of their first of two planned doses of mRNA-1273 (lot number 025H20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26Dec2020, shortly after receiving the injection, the patient experienced a hypersensitivity reaction with a mild metallic taste, flushing heart palpitations, tightness in chest, lightheadedness, and weakness.  No treatment was reported and the symptoms did not last past the day.  Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of hypersensitivity reaction, dysgeusia, flushing, palpitations, chest discomfort, dizziness and asthenia  was considered resolved.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Hypersensitivity after receiving first dose of mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Diarrhoea, Dysphagia, Heart rate increased, Injection site erythema
Clinical narrative: Anaphylactic Shock; rapid heart rate; injection site redness; injection site soreness; body ache; troble swallowing; diarrhea; A Spontaneous report was received from a consumer concerning a 40- year-old , female patient, who received Moderna's COVID-19 vaccine (mRNA)and experienced Anaphylatic shock, diarrhea, injection site soreness and redness.  The patient's medical history was not provided and allergies included allergic to latex. No concomitant medication was reported.  On 21 Jan 2021, approximately 25 minutes prior to the onset of events, the patient received their first  of two planned dose of mRNA-1273(lot number-012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, prior to receiving mRNA-1273, after 25 minutes the patient experienced anaphylactic shock and the symptoms during shock include rapid heart rate, trouble swallowing and passing out. The patient was rushed to hospital and was intervened with Epinephrine and Benadryl.  The action taken with mRNA-1273 in response to the events was unknown.  The events anaphylactic shock, body ache , diarrhea, injection site soreness and redness are not resolved.; Reporter's Comments: This report concerns a 40--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273) (Lot #012L20A) and experienced anaphylactic shock, diarrhea, injection site soreness and redness. 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: Injection site pain, Pain
Clinical narrative: Anaphylactic Shock; rapid heart rate; injection site redness; injection site soreness; body ache; troble swallowing; diarrhea; A Spontaneous report was received from a consumer concerning a 40- year-old , female patient, who received Moderna's COVID-19 vaccine (mRNA)and experienced Anaphylatic shock, diarrhea, injection site soreness and redness.  The patient's medical history was not provided and allergies included allergic to latex. No concomitant medication was reported.  On 21 Jan 2021, approximately 25 minutes prior to the onset of events, the patient received their first  of two planned dose of mRNA-1273(lot number-012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, prior to receiving mRNA-1273, after 25 minutes the patient experienced anaphylactic shock and the symptoms during shock include rapid heart rate, trouble swallowing and passing out. The patient was rushed to hospital and was intervened with Epinephrine and Benadryl.  The action taken with mRNA-1273 in response to the events was unknown.  The events anaphylactic shock, body ache , diarrhea, injection site soreness and redness are not resolved.; Reporter's Comments: This report concerns a 40--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273) (Lot #012L20A) and experienced anaphylactic shock, diarrhea, injection site soreness and redness. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial disorder, Corneal oedema, Eye disorder, Headache, Pain in extremity
Clinical narrative: severe headache; blurriness; liquid behind her cornea; 2 leaks in the eye; extended artery in left side of head; hearing loss in left ear; arm pain; A spontaneous report received from a Consumer concerning, 65-year-old female patient who has received both doses of the Moderna COVID-19 vaccine and experiencing arm pain, sever headache, blurriness, liquid behind her cornea, 2 leaks in the eye, extended artery in left side of head and hearing loss in her left ear/MedDRA PT: [Sever Headache].   The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch #: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 11-FEB-2021 Patient Husband reported, that his wife received the Moderna COVID-19 vaccine on 14JAN2021 in her left arm and on the same day experienced arm pain that lasted for 3 days. On 16JAN2021 the patient reported that she had a severe headache and shortly after experienced blurriness. The patient got medical attention and it was reported that she has liquid behind her cornea and 2 leaks in the eye, extended artery in left side of head and hearing loss in her left ear. Symptoms are ongoing and HCP consent was obtained. Patient was not hospitalized.  Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss, Vision blurred
Clinical narrative: severe headache; blurriness; liquid behind her cornea; 2 leaks in the eye; extended artery in left side of head; hearing loss in left ear; arm pain; A spontaneous report received from a Consumer concerning, 65-year-old female patient who has received both doses of the Moderna COVID-19 vaccine and experiencing arm pain, sever headache, blurriness, liquid behind her cornea, 2 leaks in the eye, extended artery in left side of head and hearing loss in her left ear/MedDRA PT: [Sever Headache].   The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch #: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 11-FEB-2021 Patient Husband reported, that his wife received the Moderna COVID-19 vaccine on 14JAN2021 in her left arm and on the same day experienced arm pain that lasted for 3 days. On 16JAN2021 the patient reported that she had a severe headache and shortly after experienced blurriness. The patient got medical attention and it was reported that she has liquid behind her cornea and 2 leaks in the eye, extended artery in left side of head and hearing loss in her left ear. Symptoms are ongoing and HCP consent was obtained. Patient was not hospitalized.  Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Vaccine dripped out while the pharmacist was injecting her arm, did not get the full dose; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not get the full dose, some of the vaccine dripped out while the pharmacist was injecting her arm, and about ninety percent of the vaccine got into arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported that she did not get the full dose of the vaccine when she received her first shot. She also reported that some of the vaccine dripped out, while the pharmacist was injecting her arm. The patient is not sure how much dripped out but reports about ninety percent of the vaccine got into arm.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, did not get the full dose, some of the vaccine dripped out while the pharmacist was injecting her arm, and about ninety percent of the vaccine got into arm were resolved.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273. There were no reported AEs associated with this case.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Vision blurred
Clinical narrative: Facial drooping; blurred vision; A spontaneous report was received from a healthcare professional  concerning a 73 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial drooping/facial paralysis and blurred vision/vision blurred.     The patient's medical history included hypertension.  Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, metoprolol, HCTZ, calcium, and multivitamin.   On 25 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient began experienced facial drooping with blurred vision on 09 Feb 2021.  The patient presented to the hospital and was treated with prednisone and acyclovir.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events facial drooping with blurred vision were not recovered.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Hypothermia
Clinical narrative: temperature has been dropping today over the last 30 minutes and is now at 91.2 degrees; Diarrhea; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature dropping and diarrhea.   The patient's medical history was not provided. Concomitant medications known to have been used by the patient included amlodipine, losartan, apixaban, and docusate sodium.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient temperature had been dropping over the last 30 minutes and was at 91.2 degrees and she experienced diarrhea.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events were resolved on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Not sure any liquid administered; A spontaneous report was received from a consumer regarding himself, a 75-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced possible vaccine underdose.  The patient's medical history was not provided. Products known to have been used by the patient were not included.  On 05 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 05 Feb 2021, as the patient received the vaccine, he noted that the nurse was fiddling with the vial for a long time. Patient stated that on the news it was said to go quicker, like 2 seconds and it took at least 10 seconds for this dose. Patient reported that the skin was punctured but is unsure if any liquid was administered. Patient reports always having a vaccine reaction and this time there was none. Due to the patient having zero side effects, they assume that they did not receive the vaccination.   Treatment information was not provided.   Action taken with mRNA-1273 was not provided.  The outcome of the events, vaccine underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Vaccine underdose for mRNA-1273, lot 016M20A with no associated AEs.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Did not get the full dose; Syringe and needles did not connect correctly; A spontaneous report  was received from a nurse, concerning a male patient of unknown age, who experienced a medication error where he did not get the full dose/MedDRA PT: underdose, and syringe and needles did not connect correctly/MedDRA PT: device connection issue.  The patient's medical history was not provided.  No concomitant medications were reported.   On an unknown date, 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.   Nurse reported that the equipment came in from the state and some of the syringes and needles did not connect correctly.  The patient did not get the full dose because where the syringe and needles did not connect right and during administration, the majority of the vaccine came out of the connection and not into the patient's muscle.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.  The event, medication error of underdose and device connection issue,  was considered as resolved.  The nurse reported the same event for two different patients so an additional case created for each of the 2 separate reports, one for each patient.; Reporter's Comments: This case concerns a 77-year-old male who experienced NS unexpected events of Incomplete dose administered and Device connection issue without associated adverse events.  The events occurred the same day as the first dose of mRNA-1273 (lot # unknown).  Events resolved. Further information requested.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014294:same reporter, different patient
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product administered to patient of inappropriate age
Clinical narrative: Administered first dose of the Moderna Covid-19 to a 17 year old patient.; Dizziness; A spontaneous report was received from a healthcare provider (HCP) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness and inappropriate age at vaccine administration.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 21 JAN 2021, the patient received her first of two doses of mRNA-1273 (lot number 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The HCP reported that in order to not waste any doses, the facility calls on family and friends to get the vaccine for no shows.  The HCP reported that the patient experienced dizziness a few minutes after the injection.  The patient hadn't eaten for 16 hours prior to taking the shot.  The patient was monitored, and it resolved within the hour.    Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, dizziness and inappropriate age at vaccine administration was recovered.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 042L20A (inappropriate age at vaccine administration) and experienced dizziness. The event of dizziness is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Majority of the vaccine came out of the connection; Did not get the full dose; A spontaneous report was received from a healthcare professional concerning a 77-year-old, male patient who received a first dose of Moderna's COVID-19 vaccine, and some of the syringes and needles did not connect correctly, patient might have not gotten the full dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) Intramuscularly for prophylaxis of COVID-19 infection.   On 22-Jan-2021, reporter HCP (RN) stated that equipment for vaccination came from the state, and some of the syringes and needles did not connect correctly and due to that during administration, in two different patients, the majority of the vaccine came out of the connection and not into the patient's muscle. Reporter was concerned about that two patients might not gotten the full dose, and should they continue schedule and consider the vaccine legitimate or should they restart the series after 28 days. No treatment information was provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The events, some of the syringes and needles did not connect correctly, patient might have not gotten the full dose were considered recovered/resolved.; Reporter's Comments: This report refers to a case of device connection issue and underdose for mRNA-1273, lot # unknown, with no associated AEs; Sender's Comments:  MOD-2021-014288:same reporter, different patient
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 yo accidentally given Moderna vaccine; A spontaneous report was received from a healthcare professional concerning a 16 year old who received Moderna's COVID-19 Vaccine (mRNA-1273) and a 16 year old was accidentally given the Moderna vaccine/product administered to patient of inappropriate age.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 29 Jan 2021, the physician called to report that a 16 year old patient was accidentally given the Moderna vaccine. The patient was "clinically fine". No treatment information was provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event, 16 year old was accidentally given the Moderna vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273. There was no associated AEs with this case of inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: During injection the needle broke; Felt the vaccine leaking on her arm; A spontaneous report was received from a consumer regarding her mother, a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that the needle broke during injection, and felt the vaccine leak down her arm.  The patient's medical history was not provided. Concomitant product use was not provided.   On  19 Jan 2021,  prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.    On 19 Jan 2021, when the patient was receiving her first dose, the needle was broken and felt like some of the vaccine  leaked down her arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to events were not reported.  The outcome of the events, during injection the needle broke and felt the vaccine leaking on her arm were considered resolved on 19 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.