chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin discolouration, Swelling, Urticaria
Clinical narrative: Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock   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 tumeric, multivitamin, vitamin d, lexapro and adderall.          On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection.   On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock.   Treatment for the event included was given steroids, benadryl, and prescription antihistamine.    Action taken with mrna-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Never seen anyone bleed this much; Numbness in her fingertips and toes; Tingling in finguretips and toes; Throat closed up; Eyes swollen; Swollen itchy hives; Felt a little dizzy; Discoloration in her skin pattern; Full body rash head to toes; Rash; Swollen itchy hives; Ungodly itch open sores; Hives so large and severe; Low grade fever; Headache; Vomiting; Diarrhea; They were able to stop her from going into anaphylactic shock; A spontaneous report was received from a consumer concerning 41-year old, female patient who received Moderna's covid-19 vaccine (mRNA-1273) and developed felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much, they were able to stop her going into anaphylactic shock   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 tumeric, multivitamin, vitamin d, lexapro and adderall.          On 22 Jan 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mrna-1273 (batch number: 039k20a) intramuscularly in the left deltoid for prophylaxis of covid-19 infection.   On 23 Jan 2021 the patient had experienced felt a little dizzy, diarrhoea, vomiting, headache, low grade fever, full body rash head to toes, hives so large and severe, throat closed up, eyes swollen, discoloration in her skin pattern, numbness in her fingertips and toes, tingling in fingertips and toes, swollen itchy hives, swollen itchy hives, ungodly itch open sores, rash and never seen anyone bleed this much and they were able to stop her going into anaphylactic shock.   Treatment for the event included was given steroids, benadryl, and prescription antihistamine.    Action taken with mrna-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: This case concerns a 41 Y/O F with serious unexpected dizziness, urticaria, diarrhea, vomiting, pharyngitis, eye swelling, skin discoloration, hypoesthesia, paresthesia, pruritus, swelling, rash, hemorrhage, pyrexia, headache. Event onset Day 2 after first dose mRNA-1273. Treatment prevented anaphylactic shock. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; A spontaneous report was received from a Consumer concerning a patient where age and gender unspecified who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event Death.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the Anatomical location unspecified  for prophylaxis of COVID-19 infection.  On unknown date, The patient experienced the event Death.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was Fatal.  The reporter assessed the event Death related to the study drug was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiovascular disorder, Dizziness, Fatigue, Heart rate irregular
Clinical narrative: was black in front of the eyes; feeling weak; Pulse around 15:50 instead of 15:70 as normal; fever; don't feel well; dizziness when standing up; circulatory disturbance; tired; A spontaneous report was received from a Consumer concerning himself, 78 Years old male patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced, fever, Feeling unwell/ Malaise, dizziness when standing up, circulatory disturbance, was black in front of the eyes/ Eye disorder, feeling weak/ Asthenia, Pulse irregular.  The patient's medical history was not provided.   The relevant concomitant medications are amiodarone hydrochloride half a tablet a day, cholesterol against sugar.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the upper arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 03 Mar 2021, with onset latency of two days, the patient experienced fever, did not feel well and felt dizzy on standing and had circulatory disturbance. Next day, the patient reported that it was black in front of his eyes. After checking his pulse, the patient called up emergency and was hospitalized. The patient was still feeling very weak and was still in care.  No Laboratory investigations were provided. No Treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  At the time of this report, the outcome of the events were unknown and for weakness 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047206:case for first dose events.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: was black in front of the eyes; feeling weak; Pulse around 15:50 instead of 15:70 as normal; fever; don't feel well; dizziness when standing up; circulatory disturbance; tired; A spontaneous report was received from a Consumer concerning himself, 78 Years old male patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced, fever, Feeling unwell/ Malaise, dizziness when standing up, circulatory disturbance, was black in front of the eyes/ Eye disorder, feeling weak/ Asthenia, Pulse irregular.  The patient's medical history was not provided.   The relevant concomitant medications are amiodarone hydrochloride half a tablet a day, cholesterol against sugar.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the upper arm for prophylaxis of COVID-19 infection.  On 02 Mar 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 03 Mar 2021, with onset latency of two days, the patient experienced fever, did not feel well and felt dizzy on standing and had circulatory disturbance. Next day, the patient reported that it was black in front of his eyes. After checking his pulse, the patient called up emergency and was hospitalized. The patient was still feeling very weak and was still in care.  No Laboratory investigations were provided. No Treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  At the time of this report, the outcome of the events were unknown and for weakness 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047206:case for first dose events.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Eye irritation, Fatigue, Heart rate increased
Clinical narrative: his body is fainted; weakness; his eyes are burning; swollen arm; accelerated heart; nose congestion; fatigue; his body feels hot; chills; A spontaneous report  was received from a consumer (reporting on self), concerning male patient (age unspecified) who received Moderna's COVID-19 Vaccine (mRNA-1273) and fainted along with  chills, fatigue, hot, burning eyes, weakness, swollen arm, accelerated heart and nose congestion.  The patient's medical history was not provided.   Concomitant medications included metoprolol and acetylsalicylic acid.  On 16 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 17 Mar 2021, the patient developed chills, fatigue,  hot, burning eyes, weakness, swollen arm, accelerated heart and nose congestion and eventually fainted, details were not provided. Treatment included Tylenol (paracetamol).  The adverse event of his body is fainted was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Peripheral swelling, Pyrexia, Syncope
Clinical narrative: his body is fainted; weakness; his eyes are burning; swollen arm; accelerated heart; nose congestion; fatigue; his body feels hot; chills; A spontaneous report  was received from a consumer (reporting on self), concerning male patient (age unspecified) who received Moderna's COVID-19 Vaccine (mRNA-1273) and fainted along with  chills, fatigue, hot, burning eyes, weakness, swollen arm, accelerated heart and nose congestion.  The patient's medical history was not provided.   Concomitant medications included metoprolol and acetylsalicylic acid.  On 16 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 17 Mar 2021, the patient developed chills, fatigue,  hot, burning eyes, weakness, swollen arm, accelerated heart and nose congestion and eventually fainted, details were not provided. Treatment included Tylenol (paracetamol).  The adverse event of his body is fainted was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Pain in extremity, Throat tightness
Clinical narrative: Throat closing up; Severe neck ache; Arm sore; Really bad ache; Head is pounding; A spontaneous report  was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe neck ache/neck pain, head is pounding/headache, arm sore/pain in extremity, really bad ache/pain, throat closing up/throat tightness.  The patient's medical history was included cortisone shot in 2010 and almost lost her foot, asthma, severe celiac disease, irritable bowel syndrome, myalgia, being seen at clinic for stomach issues, nerve pain, muscle pain, two discs in neck, fibromyalgia, anxiety, post-traumatic stress syndrome and had been in the emergency room five times in four and a half months. Concomitant medications were included nortriptyline, sertraline hydrochloride, fluticasone propionate, salmeterol xinafoate, inhalers for drug use for unknown indication and the patient was on gluten diet.  On 18 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced severe neck ache, head is pounding, arm sore, bad ache and throat closing which has a risk of death (life threatening).   No treatment information was provided. Laboratory exams were not performed.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, severe neck ache, head is pounding, arm sore, bad ache, throat closing up was unknown at the time of this report.; 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Contusion, Dermatitis contact, Rash pruritic
Clinical narrative: contact dermatitis; significant rash which is very itchy; bruise; Afibrillation; A Spontaneous report  was received from Consumer concerning 49-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and afibrillation, noticed a significant rash which was very itchy on his hips where he got a bruise, stated his wife thought it was contact dermatitis.  The patient's medical history was not reported. The concomitant medication included Zoloft, Aspirin, Fish oil and Vitamins.  On 11 Mar 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 038A21A, Expiration date: not provided) via intramuscular route in the right arm for prophylaxis of COVID-19 infection.  On same day, patient experienced afibrillation which was resolved on 13 Mar 2021.  On 15 Mar 2021 he noticed a significant rash which was very itchy on his hips where he got a bruise and he stated his wife thought it was contact dermatitis.  Action taken was unknown with respect to events.  The outcome of other events 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohn's disease flared up; A spontaneous report was received from a consumer, concerning a 20 year old male patient, who received Moderna's COVID-19 vaccine and experienced Crohn's disease flared up.  The patient's medical history included Crohn's disease. Concomitant medications included ustekinumab.  On an unspecified day in Mar-2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 014M20A) via intramuscular route on his left arm for prophylaxis of COVID-19 infection.   After the first dose of vaccine patient experienced Crohn's disease flared up. Treatment medication included steroids.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events Crohn's disease flared up was not recovered at the time of this report.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Passed out/passing out; Vertigo; Uncontrollable muscle twitching all over body; Dizziness/lightheadedness; Clammy hands/feet; Diarrhea; Gas; Rapid heart rate; Tingling in both feet/Tingling in bilateral feet; Liquid in both ears; Tiredness/fatigue; Nausea; Chills; A spontaneous report was received from a consumer, concerning a 24- year-old female who received Moderna's COVID vaccine and passed out and developed vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet/cold sweat, tingling in bilateral feet/paresthesia, fatigue ,nausea, liquid in the ears/ear discharge, diarrhea and gas/flatulence.  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event was reported as multivitamins (ascorbic acid, colecalciferaol, cyanocobalamin, pyridine hydrochloride, retinol palmitate, tocopherols mixed).  On 04 March 2021 , prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot number:13A21A) intramuscularly for prophylaxis of COVID 19 infection.  On an unknown date after receiving the first dose of the vaccine the patient passed out which was considered as serious event (medically significant). The patient also experienced vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet ,tingling in bilateral feet, fatigue ,nausea, liquid in the ears, diarrhea, gas and tiredness. The patient reported that she passed out 30 seconds later after getting injection and it was not due to vasovagal reaction. As per patient, tingling started when she woke up early in the morning but in feet only.  Treatment medications include dimenhydrinate and paracetamol. The patient took water and electrolytes for hydration.  Action taken with mRNA-1273 in response to events was considered as unknown.  The outcome of the events passed out and developed vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet/cold sweat, tingling in bilateral feet/paresthesia, fatigue ,nausea, liquid in the ears/ear discharge, diarrhea and gas/flatulence was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Heart rate increased, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: Passed out/passing out; Vertigo; Uncontrollable muscle twitching all over body; Dizziness/lightheadedness; Clammy hands/feet; Diarrhea; Gas; Rapid heart rate; Tingling in both feet/Tingling in bilateral feet; Liquid in both ears; Tiredness/fatigue; Nausea; Chills; A spontaneous report was received from a consumer, concerning a 24- year-old female who received Moderna's COVID vaccine and passed out and developed vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet/cold sweat, tingling in bilateral feet/paresthesia, fatigue ,nausea, liquid in the ears/ear discharge, diarrhea and gas/flatulence.  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event was reported as multivitamins (ascorbic acid, colecalciferaol, cyanocobalamin, pyridine hydrochloride, retinol palmitate, tocopherols mixed).  On 04 March 2021 , prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot number:13A21A) intramuscularly for prophylaxis of COVID 19 infection.  On an unknown date after receiving the first dose of the vaccine the patient passed out which was considered as serious event (medically significant). The patient also experienced vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet ,tingling in bilateral feet, fatigue ,nausea, liquid in the ears, diarrhea, gas and tiredness. The patient reported that she passed out 30 seconds later after getting injection and it was not due to vasovagal reaction. As per patient, tingling started when she woke up early in the morning but in feet only.  Treatment medications include dimenhydrinate and paracetamol. The patient took water and electrolytes for hydration.  Action taken with mRNA-1273 in response to events was considered as unknown.  The outcome of the events passed out and developed vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet/cold sweat, tingling in bilateral feet/paresthesia, fatigue ,nausea, liquid in the ears/ear discharge, diarrhea and gas/flatulence was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Otorrhoea, Paraesthesia, Vertigo
Clinical narrative: Passed out/passing out; Vertigo; Uncontrollable muscle twitching all over body; Dizziness/lightheadedness; Clammy hands/feet; Diarrhea; Gas; Rapid heart rate; Tingling in both feet/Tingling in bilateral feet; Liquid in both ears; Tiredness/fatigue; Nausea; Chills; A spontaneous report was received from a consumer, concerning a 24- year-old female who received Moderna's COVID vaccine and passed out and developed vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet/cold sweat, tingling in bilateral feet/paresthesia, fatigue ,nausea, liquid in the ears/ear discharge, diarrhea and gas/flatulence.  The patient's past medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event was reported as multivitamins (ascorbic acid, colecalciferaol, cyanocobalamin, pyridine hydrochloride, retinol palmitate, tocopherols mixed).  On 04 March 2021 , prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot number:13A21A) intramuscularly for prophylaxis of COVID 19 infection.  On an unknown date after receiving the first dose of the vaccine the patient passed out which was considered as serious event (medically significant). The patient also experienced vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet ,tingling in bilateral feet, fatigue ,nausea, liquid in the ears, diarrhea, gas and tiredness. The patient reported that she passed out 30 seconds later after getting injection and it was not due to vasovagal reaction. As per patient, tingling started when she woke up early in the morning but in feet only.  Treatment medications include dimenhydrinate and paracetamol. The patient took water and electrolytes for hydration.  Action taken with mRNA-1273 in response to events was considered as unknown.  The outcome of the events passed out and developed vertigo, dizziness, lightheadedness, uncontrollable muscle twitching, chills, clammy hands/feet/cold sweat, tingling in bilateral feet/paresthesia, fatigue ,nausea, liquid in the ears/ear discharge, diarrhea and gas/flatulence was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Mental disorder, Seizure
Clinical narrative: Infections; Patient is having a fit; Patient is having nervous breakdown; A Spontaneous  report  was received from a consumer concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fit/seizure, nervous breakdown/mental disorder and infection.  The patient's medical history was provided as "allergic to all things". No concomitant medications were reported.   On 26 Feb 2021, approximately 11 days  prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown location for prophylaxis of COVID-19 infection.   On 09 Mar 2021,patient developed fit and nervous breakdown for three days. After three days ,On 12 Mar 2021,patient was admitted in emergency room and was diagnosed with infection. Also the reporter inquired if it is safe to go for the second dose.  The event fit /seizure was considered as important medical event term.  The treatment medication was reported as antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events patient developed fit and nervous breakdown was considered as resolved on 12 Mar 2021.The outcome of the event infection was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; A spontaneous report (United States) was received from a consumer concerning about a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medically significant event pneumonia.  The patient's medical history was not reported. Concomitant medications were not reported.  On an unknown date in 2021, the patient received their first planned doses of mRNA-1273 (Batch number: unknown) via intramuscular for the prophylaxis of COVID-19 infection.  Later, the patient experienced pneumonia.  Laboratory details was not mentioned.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the event, pneumonia, remains unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Syncope
Clinical narrative: blacked out/ didn't know what was going on; light headed; fever; A spontaneous report was received from a consumer concerning herself, a 69 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blacked out and didn't know what was going on/syncope, fever/pyrexia, light headed/dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Mar 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch number: 040A21A) intramuscularly for prophylaxis of covid 19 infection.  On an unspecified day in Mar 2021, the patient experienced blacked out and didn't know what was going on. She did not lose consciousness. The patient had developed fever and felt light headed. Patient was hospitalized on 13 Mar 2021 due to the events.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, blacked out and didn't know what was going on/syncope, fever/pyrexia, light headed/dizziness 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 these events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Dizziness, Tinnitus
Clinical narrative: Potential hearing loss; Dizziness about one week after receiving which lasted about 3 hours; More intense tinnitus symptoms than usual; More intense tinnitus symptoms than usual; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9629), via an unspecified route of administration, administered in left arm on 08Mar2021 13:00 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Medical history included tinnitus, allergy to PCN and "Thygeson's Disease". Concomitant medication included ciclosporin (RESTASIS). The reported adverse events were dizziness about one week after receiving which lasted about 3 hours; more intense tinnitus symptoms than usual and potential hearing loss, all on 15Mar2021 at 17:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Confusional state, Dementia Alzheimer's type, Disorientation, Dysarthria
Clinical narrative: Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased
Clinical narrative: Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Crying, Depression, Emotional disorder, Energy increased
Clinical narrative: having thoughts of suicide; I Instantly became very emotional, I thought it was relief but my emotions have been off the chart for two weeks.; I had an abundance of energy the first week into to try to get rid of some of the energy I went for a very long walk.; I've been very argumentative; have been crying a lot; high depression; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration administered in arm left on 01Mar2021 11:45 at single dose for covid-19 immunisation.  Medical history included high blood pressure. Concomitant medications included lisinopril; pseudoephedrine; chloramphenicol (UNISON). There was no other vaccine in four weeks. The patient previously took codeine and experienced reaction to codeine.  The patient instantly became very emotional, she thought it was relief but her emotions had been off the chart for two weeks. She had an abundance of energy the first week into to try to get rid of some of the energy she went for a very long walk. Since then been very argumentative, having thoughts of suicide, and had been crying a lot. Before the vaccine she did not have thoughts of suicide or high depression. Adverse event start date was 01Mar2021 at time of 11:45 am. No treatment received. No Covid prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: having thoughts of suicide; I Instantly became very emotional, I thought it was relief but my emotions have been off the chart for two weeks.; I had an abundance of energy the first week into to try to get rid of some of the energy I went for a very long walk.; I've been very argumentative; have been crying a lot; high depression; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration administered in arm left on 01Mar2021 11:45 at single dose for covid-19 immunisation.  Medical history included high blood pressure. Concomitant medications included lisinopril; pseudoephedrine; chloramphenicol (UNISON). There was no other vaccine in four weeks. The patient previously took codeine and experienced reaction to codeine.  The patient instantly became very emotional, she thought it was relief but her emotions had been off the chart for two weeks. She had an abundance of energy the first week into to try to get rid of some of the energy she went for a very long walk. Since then been very argumentative, having thoughts of suicide, and had been crying a lot. Before the vaccine she did not have thoughts of suicide or high depression. Adverse event start date was 01Mar2021 at time of 11:45 am. No treatment received. No Covid prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tumour marker abnormal, Tumour marker test
Clinical narrative: My cancer marker in Oct2020 was 25. In Jan2021 it was 8.  And in Mar2021 was 24. cancer marker go up and down; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 70-year-old female patient received the first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), both via an unspecified route of administration on an unspecified date (at the age of 70-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included cancer of the womb from 1983 (I started out with cancer of the womb which was removed in 1983), lumpectomy from 2003, cancer: outside of the vulva from 2011, right breast removed from 20Dec2017, and chemotherapy from 2003. Concomitant medications included letrozole (FEMARA) from Jan2018 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); diclofenac (VOLTAREN [DICLOFENAC]); ergocalciferol; furosemide (LASIX [FUROSEMIDE]); irbesartan (AVAPRO); levothyroxine sodium (SYNTHROID); omeprazole (PRILOSEC [OMEPRAZOLE]); potassium chloride; rosuvastatin calcium (CRESTOR); hydrochlorothiazide, triamterene (MAXZIDE); and valaciclovir hydrochloride (VALTREX). The patient stated, "My cancer marker in Oct2020 was 25. In Jan2021 it was 8. And in Mar2021 was 24. My heart doctor put me rosuvastatin 10mg at end of 2020 which may have had an impact on my cancer marker going down to an 8. My understanding is that Letrozole is made by Pfizer and the covid vaccine is made by Pfizer. I would like understanding how this medicine works that made my cancer marker go up and down. I would like for you to speak with my cancer doctor or her administrator because these numbers are important to me." Per patient, she will be obtaining her current lab values from the office today and will follow up with her doctor on 19Apr2021. The reporter considered the event as serious medically significant. The outcome of the event was unknown.  Information about lot and batch number was requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood test, Myocardial infarction
Clinical narrative: Heart attack; Asthma attacks; This is a spontaneous report from a contactable consumer (the patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Left Arm on 16Mar2021 10:00 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date (she has had Asthma for about 14-15 years), broke back from an unknown date (she broke her back about 3 years ago); stent placement from an unknown date (she had 2 heart stents placed about 2 years ago), and then she said she was allergic to a couple of fairly common medicines (statins and NSAIDs) from an unknown date. There were no concomitant medications. The patient received her first Pfizer COVID-19 Vaccine on 16Mar2021. She said she would really like to know if the COVID-19 Vaccine possibly caused her to have the worse asthma attack she ever had in her life on 17Mar2021. She clarified she was talking to her friend on the telephone when she had her asthma attack at 3:30PM. She said that on 18Mar2021 at 5:00AM, she had a second asthma attack. She said her second asthma attack was not as bad as the one she had on 17Mar2021. For her first asthma attack on 17Mar2021, she took 2 puffs from her inhaler, and then an additional 2 puffs (4 puffs total). She said her doctor told her if she had a bad asthma attack, she could take 2 more puffs from the inhaler. She said she normally takes 2 puffs from her inhaler. She said for her second asthma attack on 18Mar2021 she took only 2 puffs from her inhaler. After she took her 2 puffs from her ProAir HFA Albuterol Sulfate inhaler, she flopped back into her bed. She reported she normally has 3-4 asthma attacks a year. She reported that her doctor did a complete blood workup on 03Mar2021 and told her she was doing just lovely. The patient also reported she had a very mild heart attack and she can't even take low dose aspirin. The patient also reported she had another question about the COVID-19 Vaccine. She said she was allergic to a couple of fairly common medicines (statins and NSAIDs) and wanted to know if anything in the list of the COVID-19 Vaccine ingredients would indicate her having a possible allergy to the vaccine. The events did not require a visit to Emergency Room and/or Physician Office. The outcome of the event asthma attack was recovering, and for the heart attack was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Laboratory test
Clinical narrative: appendicitis/abdominal pain; This is a spontaneous report from a contactable consumer (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 09:00 as a single dose (at the age of 27-years-old) for covid-19 immunization. The vaccine was administered at the clinic. The patient's medical history and concomitant medications were not reported. On 12Mar2021 at 6:00 pm, she started with abdominal pain that continued through Saturday (13Mar2021), and Sunday (14Mar2021) morning she went to clinic, they told her that she had appendicitis and she should go to hospital for a test. She went to the hospital, they ran a contrast test and she was diagnosed with appendicitis on Mar2021. She had the operation on Monday (15Mar2021) and she was recovering. The reported event resulted in doctor or other healthcare professional office/clinic visit and  emergency room/department or urgent care. The patient needed operation. The patient was hospitalized on Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as after about 9 days), patient began getting symptoms of Bell's Palsy. It got worse and he went to the doctor on an unspecified date and they did confirm that he has bell's palsy and they believe it came from the COVID vaccine. Patient would like to know should he get his second dose on 23Mar2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Syncope
Clinical narrative: fainted two times; felt very tired after the vaccine for several days; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Mar2021 11:45 (Lot Number: EN6206) as single dose for Covid-19 immunisation at age 20 years old. Medical history included allergies to penicillin. The patient is not pregnant. The patient had no covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patient previously received amoxicillin and experienced allergies. The patient reported that she felt very tired after the vaccine for several days. Four days after she received the vaccine, she took a bath and when she got out of the bath, she fainted two times. She stated that she has never fainted before and she has taken several baths. Onset of the events was on 11Mar2021 21:00. No treatment given for the events. The patient had a covid test (saliva) post vaccination on 15Mar2021 with negative result. The patient recovered from the events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Vomiting
Clinical narrative: intractable vomiting; severe unusual for her headache; This is a spontaneous report from a contactable physician. A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot number was not reported), at the age of 46-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included   from an unknown date and unknown if ongoing.     There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. On 11Mar2021, patient developed intractable vomiting and was not able to keep any fluid down for 24h. She had no any other symptoms at that time and no fever or headache. After her vomiting was stopped with high dose of Zofran, she developed severe unusual for her headache that lasted 2 days. The events required physician office visit. The events were assessed as life-threatening by the physician. MRI was done and it was normal. The patient has fully recovered and has no any residual symptoms. Interesting, that patient has a physically and mentally disable son that developed encephalitis at age 4month unclear etiology. No reason for his encephalitis was ever found and no virus was ever recovered. One of the versions of his encephalitis from infection disease team was post vaccinated encephalitis.  The outcome of the event was recovered. The patient was not tested for COVID post vaccination.  Information on lot/batch has been requested.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021301884 Same reporter, different patient/event
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Three weeks after my vaccine shot I was dx with bilateral pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. None Known allergies. Patient was not pregnant. No other vaccine in four weeks. Historical vaccine included BNT162B2 (product=COVID 19, brand=Pfizer, lot number=EL9261) first dose administered in Left arm on 23Jan2021 01:15 PM. The patient experienced three weeks after her vaccine shot she was dx with bilateral pulmonary embolism on 16Mar2021 06:00 AM with outcome of not recovered. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 4 days.  The patient's hospitalization was prolonged as a result of this event. The patient underwent lab tests which included Nasal Swab (sars-cov-2 test): negative on 17Mar2021. No covid prior vaccination. The treatment received included anti-coagulative therapy.