chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient taken to the ER; Palpitation; Light headedness; Tingling sensation on hand and feet; Rash; Nausea; Fever (low grade); Chills; Server allergic reaction; A spontaneous report was received from a 43 years old female patient concerning her self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, palpitation, light headedness, rash, tingling sensation on hand and feet, fever (low grade), chills, was taken to the ER. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, at around 3:50 pm, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly at unknown anatomical region for prophylaxis of COVID-19 infection.  On 19 Jan 2021, about 7-10min after receiving the first dose of mRNA-1273, the patient experienced had palpitation light headedness and nausea. The patient  was evaluated at vaccination post asked to go home. At home, the Palpitation continue (HR=150b/m in) and had rash and tingling on her hand and feet. The patient was taken to the ER at around 8:30-9:00 pm. At ER the patient was given IV fluids, Ibuprofen and acetaminophen. EKG was done and was normal, the patient was released to go home with a HR of 105 b/min. Since then she had repeated episodes of palpitation, fever (low grade) and chills.  On 26 Jan-2021, the patient experienced the  servere allergic reaction a week later after receiving the Moderna Covid-19.  The Patient consented to be followed up by the safety department. Patient had been advice by her physician not to take the 2nd dose of the vaccine on 28 Jan 21.  Treatment details included IV fluids, Acetaminophen, Ibuprofen Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include nausea, light headedness, rash, tingling sensation on hand and feet was unknown and  Palpitation, fever (low grade) and chill was not 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, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Gastrooesophageal reflux disease, Nausea, Pain in extremity
Clinical narrative: Acid reflex symptoms; Felt his chest and stomach were burning; Felt his chest and stomach were burning; He had pain in his arm; Nauseas; A spontaneous report was received from an consumer concerning a 70 years old, male patient who experienced acid reflex symptoms, stomach burning, chest burning, nausea and pain in arm.    The patient's medical history included chronic obstructive pulmonary disease, high blood pressure and anomality on his heart frequency all since an unknown date.  The concomitant products included blood thinner medicine, Blood pressure medication, nasal spray, salbuterol and omeprazole.  On 29 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) for prophylaxis of COVID-19 infection.    On 24 Feb 2021 patient experienced this acid reflect symptoms but worst than ever, he felt his chest and stomach were burning, nauseas and had pain in his arm. The patient was admitted to emergency room on 24 Feb 2021 due to acid reflect symptoms and was hospitalized on 24 Feb 2021.  Laboratory investigations included tests (not specified) which revealed acid reflex.  Treatment for the event included pill and had a via on his hand for an unknown indication.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events acid reflex symptoms, he felt his chest and stomach were burning, nauseas and had pain in his arm 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.; Sender's Comments:  MOD-2021-026319:same reporter, different patient and event
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lip swelling, Swelling face, Tryptase, Urticaria
Clinical narrative: Swollen face; Swollen lips; Very itchy eyes; Hives on the back; A spontaneous report  was received from a nurse concerning a 36 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen face,  swollen lips, very itchy eyes and hives on the back(Intervention/Medically Important).  The patient's medical history included cataract surgery, bilateral eye surgery and COVID. The patient had giant tear left and buckles in bilateral eyes.  Concomitant medications included seroquel (200mg), zoloft 50mg (50 mg), Topamax (100mg bid), Latuda (80mg), birth control, tylenol, advil and tizanidine (as needed) drugs used for unknown indication.  On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient experienced swollen face, swollen lips, very itchy eyes and hives on the back.  Lab test was performed on 26 Jan 2021, tryptase level was 8.4.  Treatment for the events include Epipen for both legs, pepcid and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, swollen face, swollen lips, very itchy eyes and hives on the back, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Faintness to the point of dropping to floor on her knees; Dizziness; A spontaneous report was received from a Healthcare Professional concerning a female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events faintness to the point of dropping to floor on her knees and dizziness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient experienced the events faintness to the point of dropping to floor on her knees and dizziness.  The event faintness to the point of dropping to floor on her knees was considered serious with criteria of important medical event and dizziness was considered to be non-serious.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The events faintness to the point of dropping to floor on her knees and dizziness were considered recovered/resolved on an unknown date in Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start  of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anxiety, Chest discomfort, Erythema, Eye swelling
Clinical narrative: Vomited; a rash in her vagina area; Vaginal itching; she scratched so much that got abrasions; Chest was red; heart rate was elevated; Eyes were swollen; She scratched so much that she got abrasions; Felt like she was having an anxiety attack; Her arms and legs were itchy/body overall was itchy; Chest felt tight; Allergic reaction; Swelling of her throat; Dose was administered on day 57; Nausea; Strong headache/head hurt; A spontaneous report was received from a consumer, a 36 year-old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) 57 days after receiving first dose and developed an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.   The patient's medical history include severe allergies NOS.  Concomitant product included Benadryl prior to the second dose of the vaccine.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided).   On 22-Feb-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22-Feb-2021 , immediately after receiving vaccine, the patient experienced an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.  Treatment for the events included Phenergan, IV antihistamine, IV steroids, prednisone, hydroxyzine hydrochloride and EpiPen.    The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's prior severe allergy history may have been contributory for the occurrence of the allergic reaction and associated events. Additionally, This report refers to a case of  an inappropriate schedule of product administration for mRNA-1273, lot #011M20A.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Inappropriate schedule of product administration, Nausea
Clinical narrative: Vomited; a rash in her vagina area; Vaginal itching; she scratched so much that got abrasions; Chest was red; heart rate was elevated; Eyes were swollen; She scratched so much that she got abrasions; Felt like she was having an anxiety attack; Her arms and legs were itchy/body overall was itchy; Chest felt tight; Allergic reaction; Swelling of her throat; Dose was administered on day 57; Nausea; Strong headache/head hurt; A spontaneous report was received from a consumer, a 36 year-old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) 57 days after receiving first dose and developed an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.   The patient's medical history include severe allergies NOS.  Concomitant product included Benadryl prior to the second dose of the vaccine.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided).   On 22-Feb-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22-Feb-2021 , immediately after receiving vaccine, the patient experienced an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.  Treatment for the events included Phenergan, IV antihistamine, IV steroids, prednisone, hydroxyzine hydrochloride and EpiPen.    The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's prior severe allergy history may have been contributory for the occurrence of the allergic reaction and associated events. Additionally, This report refers to a case of  an inappropriate schedule of product administration for mRNA-1273, lot #011M20A.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Skin abrasion, Vomiting, Vulvovaginal pruritus
Clinical narrative: Vomited; a rash in her vagina area; Vaginal itching; she scratched so much that got abrasions; Chest was red; heart rate was elevated; Eyes were swollen; She scratched so much that she got abrasions; Felt like she was having an anxiety attack; Her arms and legs were itchy/body overall was itchy; Chest felt tight; Allergic reaction; Swelling of her throat; Dose was administered on day 57; Nausea; Strong headache/head hurt; A spontaneous report was received from a consumer, a 36 year-old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) 57 days after receiving first dose and developed an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.   The patient's medical history include severe allergies NOS.  Concomitant product included Benadryl prior to the second dose of the vaccine.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided).   On 22-Feb-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22-Feb-2021 , immediately after receiving vaccine, the patient experienced an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.  Treatment for the events included Phenergan, IV antihistamine, IV steroids, prednisone, hydroxyzine hydrochloride and EpiPen.    The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's prior severe allergy history may have been contributory for the occurrence of the allergic reaction and associated events. Additionally, This report refers to a case of  an inappropriate schedule of product administration for mRNA-1273, lot #011M20A.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal rash
Clinical narrative: Vomited; a rash in her vagina area; Vaginal itching; she scratched so much that got abrasions; Chest was red; heart rate was elevated; Eyes were swollen; She scratched so much that she got abrasions; Felt like she was having an anxiety attack; Her arms and legs were itchy/body overall was itchy; Chest felt tight; Allergic reaction; Swelling of her throat; Dose was administered on day 57; Nausea; Strong headache/head hurt; A spontaneous report was received from a consumer, a 36 year-old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) 57 days after receiving first dose and developed an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.   The patient's medical history include severe allergies NOS.  Concomitant product included Benadryl prior to the second dose of the vaccine.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided).   On 22-Feb-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22-Feb-2021 , immediately after receiving vaccine, the patient experienced an allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash.  Treatment for the events included Phenergan, IV antihistamine, IV steroids, prednisone, hydroxyzine hydrochloride and EpiPen.    The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, allergic reaction with generalized itching, swollen eyes, skin abrasions, throat swelling, chest tightness, chest erythema, elevated heart rate, nausea, vomiting, headache, anxiety attack and vaginal/vulvar rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's prior severe allergy history may have been contributory for the occurrence of the allergic reaction and associated events. Additionally, This report refers to a case of  an inappropriate schedule of product administration for mRNA-1273, lot #011M20A.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 3rd dose 28 days after the 2nd one; A Spontaneous report was received from a Pharmacist concerning a female patient in her 60s who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced third dose administered 28 days from second dose.  The patient's medical history was not provided. Concomitant medications were not listed.  On unknown date, the patient received their second dose of two planned doses mRNA-1273(Lot number: unknown) for prophylaxis of COVID-19 infection.  On 22 Feb 2021, 28 days after second dose, the patient received third dose of the vaccine.  Treatment information is not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, third dose administered 28 days from second dose was considered as recovered.; Reporter's Comments: This case concerns a female patient who received their third dose of mRNA-1273 (Lot unknown), reporting Extra dose administered without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; A spontaneous report was received from a consumer concerning a male patient of unknown age, who was received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patient's medical history was not provided. No concomitant medications were reported.   On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  It was reported by the patient's wife that the patient died.  She was calling to cancel his second dose of mRNA-1273.  No additional details, including the date of death, were reported.   Treatment information was not provided.  Action taken with the mRNA-1273 was not applicable as the patient died.  The cause of death was not provided.  Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Dizziness
Clinical narrative: Diagnosed with c-diff; Feeling dizzy; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with c-diff(Clostridium difficile infection) and feeling dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced feeling dizzy. On an unknown date, the patient was diagnosed with c-diff(Clostridium difficile infection) and considered medically significant event.  No treatment information was provided for the event feeling dizzy.Treatment for the event c-diff(Clostridium difficile infection) included high dose of antibiotic.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events c-diff (Clostridium difficile infection) and feeling dizzy was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; A spontaneous report was received from a consumer who was also an 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a urinary tract infection (UTI).  The patient's medical history included voice larynx disorder "frozen".  Concomitant product use was not provided.     On 01-Feb-2021, prior to the onset of the event, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24-Feb-2021, the patient developed a UTI. Treatment included antibiotics prescribed, but not taken by the patient.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event of UTI was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: My 16 year old son can participate in your Covid 19; Received the first moderna vaccine by error of pharmacy; A spontaneous report was received from a reporter concerning a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) by error of the pharmacy.  The patient's medication history was not provided. Concomitant medications none.  On 19 Feb2021 2021, the 16 year old patient received the first of the two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly in the anatomical location in the for prophylaxis of COVID-19 infection.  The pharmacy has shared with them that he can no longer receive his second vaccine due to their error.   The patient's mother seems very interested in him getting his second vaccine and has asked to please let her know how this can be resolved Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered as recovered or resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) and vaccination error for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Headache, Heart rate increased, Hypertension
Clinical narrative: blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report  was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia).   The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had "compromised lungs"), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine.     On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection.    On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot.   On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment.   On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours.  Test showed a severe inflammatory reaction.  She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever.  The patient's blood pressure was 289/89 and they "thought she was going to have a stroke or a heart attack" because her blood pressure was so high.    Treatment for the events included steroids and unspecified painkillers.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting.  The outcome of the events of  severe reaction,  swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Laboratory test, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report  was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia).   The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had "compromised lungs"), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine.     On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection.    On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot.   On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment.   On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours.  Test showed a severe inflammatory reaction.  She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever.  The patient's blood pressure was 289/89 and they "thought she was going to have a stroke or a heart attack" because her blood pressure was so high.    Treatment for the events included steroids and unspecified painkillers.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting.  The outcome of the events of  severe reaction,  swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report  was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia).   The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had "compromised lungs"), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine.     On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection.    On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot.   On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment.   On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours.  Test showed a severe inflammatory reaction.  She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever.  The patient's blood pressure was 289/89 and they "thought she was going to have a stroke or a heart attack" because her blood pressure was so high.    Treatment for the events included steroids and unspecified painkillers.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting.  The outcome of the events of  severe reaction,  swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Fatigue, Peripheral swelling, Pruritus, Rash
Clinical narrative: Extreme fatigue; Angioedema on soles of both feet; Itchiness; Rash on lower part of right wrist; Rash on the front part of the arm/anterior part of arm; Feet swelling; Fatigue; A spontaneous report was received from a consumer who is a 47-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema, rash and pruritus.  The patient's medical history was not provided by the reporter. Concomitant medications reported included vitamins.   On 25-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27-Jan-2021, the patient reported having rash on lower part of right wrist and arm, fatigue, feet swelling, itchiness and angioedema itchy (angioedema).  On 22-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25-Feb-2021, the patient reported having rash on the front part of the arm/anterior part of arm, extreme fatigue, itchiness, burning rash (not hives).  No lab details were mentioned.  Treatment for the events included Benadryl as instructed by her health care professional.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, angioedema, rash and pruritus, were considered unknown or not reported.  The event angioedema was deemed medically significant.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Impaired healing, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Bleeding from papercut won't stop.; Till this day it has not healed; delayed healing; Itching in left arm near injection site; Scratched and arm turned orange; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding from papercut won't stop, till this day it has not healed, Itching in left arm near injection site, (arm) turned orange after scratching.  The patient's medical history was not provided. Concomitant medications reported were Crestor, Zetia.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced itching in her left arm near injection site. The patient scratched and her arm  turned orange. On 14 Feb 2021, she got a paper cut which caused bleeding and till this day it had not healed.  No treatment information was provided  Action taken with mRNA-1273 in response to the events was unknown.   The events of bleeding from papercut won't stop , till this day it has not healed were unresolved, while the outcome of the events of Itching in left arm near injection site, (arm) turned orange after scratching were unknown.  The reporter did not provide an assessment for the event bleeding from papercut won't stop, till this day it has not healed, Itching in left arm near injection site, (arm) turned orange after scratching.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Headache, Vaccination site erythema
Clinical narrative: acutely arthritic hands and wrists with swelling, redness, warmth and significant pain and reduced mobility; mild headache; mild injection site reaction/local site reaction (redness); A spontaneous report was received from a retired physician, who was also the husband of a 57 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild headache, mild injection site reaction/local site reaction (redness)/injection site erythema, and arthritic hands and wrists with swelling, redness, warmth and significant pain and reduced mobility/arthritis.  The patient's medical history included gastroesophageal reflux disease. The patient had ongoing condition of multiple sclerosis. The concomitant medications included  interferon beta-1a, esomeprazole magnesium, and escitalopram.  On 16 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly  in left arm for prophylaxis of COVID-19 infection.   The patient had experienced mild headache for first 12 hours post vaccination, local site reaction (redness) for 5 days after vaccination.   On 25 Feb 2021, the patient experienced acute wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal joint pain with swelling, reduced range of motion, redness and warmth in both hands though it started first in left hand. The patient was unable to pick glass of water due to significant pain which worsened in the morning gradually improving throughout the day.  The reporter felt this event was disabling for the patient.  Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The events of mild headache and mild injection site reaction/local site reaction (redness) were resolved.  The event of arthritic hands and wrists with swelling, redness, warmth and significant pain and reduced mobility was not resolved at the time of this report.; Reporter's Comments: This case concerns a 57 year old, female patient, who experienced serious event of acute arthritis and non serious events of headache and vaccination site erythema. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Lip swelling, Pharyngeal swelling, Swelling face
Clinical narrative: Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, was 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 events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Burning; Allergic reaction; Hives all over her body; Face swelled up; Lips welled up; Throat swelled up; A spontaneous report, was received from a consumer (patient's daughter), concerning a 78 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced allergic reaction (hypersensitivity), hives all over her body (urticaria), face swelled up (swelling face), lips swelled up (lip swelling), throat was swelled up (pharyngeal swelling), and burning (burning sensation).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On 06-Feb-2021, approximately 48 hours after vaccination, the patient developed allergic reaction and had hives all over her body. The patient received diphenhydramine for hives. The patient also stated that inside of her was burning, face swelled up, lips swelled up and throat swelled up. The patient rushed to emergency room (ER). They needed to take the patient to an allergist because they wanted to find out if this was related to the vaccine. The allergist told her that they couldn't do an allergy testing. The patient asked if there were any reports on people showing allergic reaction 48 hours later after the vaccine. The patient was scheduled to get the second dose.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events, allergic reaction, hives all over her body, face swelled up, lips swelled up, throat was swelled up, and burning, was 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 events, a causal relationship cannot be excluded.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Headache, Heart rate irregular
Clinical narrative: Hallucinating; Occasional rapid heart beat; Hadache; A spontaneous report was received from a caregiver concerning reporter's mother a 97-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced hallucinating/ hallucination, occasional rapid heartbeat/ heart rate irregular and headache.   The patient's current conditions included chronic urinary tract infection. Products known to have been used by the patient, within two weeks prior to the event, included antibiotics for chronic urinary tract infection.   On 26-Feb-2021, prior to the onset of the symptoms, the patient received their unspecified dose of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route and site for prophylaxis of COVID-19 infection.  On 27-Feb-2021 the patient had headache for 2 days, was hallucinating and had occasional rapid heartbeat.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The Outcome of the events, hallucinating,  occasional Rapid Heartbeat, and headache was unknown.  Company Comment: The reported events, hallucinations, heart rate irregular, and headache,  were considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event and excluding any other etiology, a causal relationship with the event cannot be excluded. Headache is consistent with the vaccine profile
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Muscular weakness
Clinical narrative: He could hardly walk, legs gave out and he fell and could not get up; Can't lift legs; No strength in the legs and arms; A spontaneous report, was received from a consumer (patient), a 78 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced he could hardly walk, legs gave out and he fell and could not get up (monoplegia), can't lift legs (muscular weakness), and no strength in the legs and arms (muscular weakness).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient stated that the morning on 13 Feb 2021, after the vaccine was administered, the patient could hardly walk legs gave out and he fell and could not get up, no strength in the legs and arms, and can't lift legs. The patient was now able to feel everything normal as of this morning on 14 Feb 2021. No treatment details were provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of events he could hardly walk, legs gave out and he fell and could not get up, can't lift legs, and no strength in the legs and arms were considered resolved on 14 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Nonspecific reaction, Rectal haemorrhage
Clinical narrative: Lupus got worse; Lot of bleeding from her womb and rectum; Lot of bleeding from her womb and rectum; COVID positive; Dizzy; Strong reaction; Can't get out of bed; A spontaneous report was received from a consumer who was also a 63-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Lupus got worse, lot of bleeding from her womb and rectum,COVID positive, dizzy, strong reaction and can't get out of bed.  The patient's medical history included lupus. Concomitant medications included prednisone, enoxaparin, folic acid and pain killers.  On 12 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 27 Jan 2021, 15 days later, patient had a "strong reaction" and went to the hospital where patient got diagnosed with COVID. Patient says patient cannot even stand, felt dizzy and had to lay in bed all day. The patient had lupus, which worsened after vaccination. She had a lot of bleeding from womb and rectum.  Patient said she won't get the second dose because it will kill patient. Treatment for the event included tylenol but symptoms did not get better.  The mRNA-1273 was withdrawn in response to the events  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the event -tested positive has been provided at this time.  Further information has been requested. However, based on the mechanism of action of mRNA-1273, the event- COVID-19 is assessed as unlikely related to mRNA-1273.