chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Pain in extremity, Pallor, Raynaud's phenomenon, Skin discolouration
Clinical narrative: I received the 1st dose of the Moderna Vaccine on January 6, 2021 at 01:49 pm. Approximately 4.5 hours later on January 6, 2021, I went outside in the cold temperatures. Upon returning inside to warmer air, the bilateral fingertips of both hands were pale white, numb, and painful. The time was 06:30 pm on January 6, 2021. At 06:47 pm, I felt a different feeling in the bilateral tips of my fingertips, and could see the color changing from pale white to a mixture of purple/black.  January 6, 2021 at 06:32 pm was the first time I have ever had my hands respond in this manner to cold temperatures. I have felt one fingertip go numb and turn white for a split second, only one time in my life but it was not a repeat occurrence, and it only lasted for about a second when it occurred. This experience and reaction I currently have lasts from 15-30 minutes of bilateral fingertip numbness and discoloration with pain. The bilateral fingertips of both hands now respond in this manner every time they are exposed to cold temperatures. I signed up for V-Safe and did state that I was having this symptom through the Vaccine reporting system on V-Safe under ?other'' multiple times. Treatment I received from a health provider are as follows; I had a telemedicine visit on January 14, 2021 at 12:51 pm to address my concern of ?reaction to Covid vaccine, fingertips were numb, lasting 30 mins?. On 1/14/2021, I received a primary diagnosis of Raynaud's Syndrome by my Primary Care Provider.  On 1/28/2021, I was seen in person by my Primary Care Provider for a Well Visit to complete a physical with my primary care provider. I was provided with a referral to a Rheumatologist for further advice about receiving the additional second Covid vaccination in the series. I also was ordered to do lab work. On 2/2/2021, I was seen by a Rheumatologist for new diagnosis of Raynaud?s Syndrome, and advised that risk outweighed the benefits in regards to receiving the second vaccination in the Moderna Covid-19 series.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urine analysis, Urine protein/creatinine ratio, White blood cell count
Clinical narrative: I received the 1st dose of the Moderna Vaccine on January 6, 2021 at 01:49 pm. Approximately 4.5 hours later on January 6, 2021, I went outside in the cold temperatures. Upon returning inside to warmer air, the bilateral fingertips of both hands were pale white, numb, and painful. The time was 06:30 pm on January 6, 2021. At 06:47 pm, I felt a different feeling in the bilateral tips of my fingertips, and could see the color changing from pale white to a mixture of purple/black.  January 6, 2021 at 06:32 pm was the first time I have ever had my hands respond in this manner to cold temperatures. I have felt one fingertip go numb and turn white for a split second, only one time in my life but it was not a repeat occurrence, and it only lasted for about a second when it occurred. This experience and reaction I currently have lasts from 15-30 minutes of bilateral fingertip numbness and discoloration with pain. The bilateral fingertips of both hands now respond in this manner every time they are exposed to cold temperatures. I signed up for V-Safe and did state that I was having this symptom through the Vaccine reporting system on V-Safe under ?other'' multiple times. Treatment I received from a health provider are as follows; I had a telemedicine visit on January 14, 2021 at 12:51 pm to address my concern of ?reaction to Covid vaccine, fingertips were numb, lasting 30 mins?. On 1/14/2021, I received a primary diagnosis of Raynaud's Syndrome by my Primary Care Provider.  On 1/28/2021, I was seen in person by my Primary Care Provider for a Well Visit to complete a physical with my primary care provider. I was provided with a referral to a Rheumatologist for further advice about receiving the additional second Covid vaccination in the series. I also was ordered to do lab work. On 2/2/2021, I was seen by a Rheumatologist for new diagnosis of Raynaud?s Syndrome, and advised that risk outweighed the benefits in regards to receiving the second vaccination in the Moderna Covid-19 series.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: I received the 1st dose of the Moderna Vaccine on January 6, 2021 at 01:49 pm. Approximately 4.5 hours later on January 6, 2021, I went outside in the cold temperatures. Upon returning inside to warmer air, the bilateral fingertips of both hands were pale white, numb, and painful. The time was 06:30 pm on January 6, 2021. At 06:47 pm, I felt a different feeling in the bilateral tips of my fingertips, and could see the color changing from pale white to a mixture of purple/black.  January 6, 2021 at 06:32 pm was the first time I have ever had my hands respond in this manner to cold temperatures. I have felt one fingertip go numb and turn white for a split second, only one time in my life but it was not a repeat occurrence, and it only lasted for about a second when it occurred. This experience and reaction I currently have lasts from 15-30 minutes of bilateral fingertip numbness and discoloration with pain. The bilateral fingertips of both hands now respond in this manner every time they are exposed to cold temperatures. I signed up for V-Safe and did state that I was having this symptom through the Vaccine reporting system on V-Safe under ?other'' multiple times. Treatment I received from a health provider are as follows; I had a telemedicine visit on January 14, 2021 at 12:51 pm to address my concern of ?reaction to Covid vaccine, fingertips were numb, lasting 30 mins?. On 1/14/2021, I received a primary diagnosis of Raynaud's Syndrome by my Primary Care Provider.  On 1/28/2021, I was seen in person by my Primary Care Provider for a Well Visit to complete a physical with my primary care provider. I was provided with a referral to a Rheumatologist for further advice about receiving the additional second Covid vaccination in the series. I also was ordered to do lab work. On 2/2/2021, I was seen by a Rheumatologist for new diagnosis of Raynaud?s Syndrome, and advised that risk outweighed the benefits in regards to receiving the second vaccination in the Moderna Covid-19 series.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Erythema, Flushing, Oropharyngeal pain
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Erythema, Feeling hot, Flushing
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypersensitivity, Immediate post-injection reaction, Paraesthesia, Paraesthesia oral
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Blood pressure increased, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Flushing, Heart rate increased, Palpitations, Paraesthesia
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs.  The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Left side of face swelled and is numb, tongue started to feel numb, arm numb
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Hypoaesthesia, Hypoaesthesia oral, Swelling face
Clinical narrative: Left side of face swelled and is numb, tongue started to feel numb, arm numb
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: patient reported that he started to experiance: vomiting, diarrhea, difficulty breathing, muscle sorness, difficulty swallowing, and headache on 03/03/2021 @2230.. patient reported that today 03/07/2021 he is doing fine and all his symptoms are getting better.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dysphagia, Dyspnoea, Headache, Myalgia
Clinical narrative: patient reported that he started to experiance: vomiting, diarrhea, difficulty breathing, muscle sorness, difficulty swallowing, and headache on 03/03/2021 @2230.. patient reported that today 03/07/2021 he is doing fine and all his symptoms are getting better.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: patient reported that he started to experiance: vomiting, diarrhea, difficulty breathing, muscle sorness, difficulty swallowing, and headache on 03/03/2021 @2230.. patient reported that today 03/07/2021 he is doing fine and all his symptoms are getting better.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, C-reactive protein increased, Confusional state, Delirium, Disorientation
Clinical narrative: PATIENT FELT SLEEPY AND THE NEXT MORNING COULD NOT CONSTRUCTIONS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Red blood cell sedimentation rate increased
Clinical narrative: PATIENT FELT SLEEPY AND THE NEXT MORNING COULD NOT CONSTRUCTIONS
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: PATIENT FELT SLEEPY AND THE NEXT MORNING COULD NOT CONSTRUCTIONS
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Lip swelling, Palpitations, Pharyngeal swelling
Clinical narrative: Throat felt scratchy gave 50mg/mL IM benadryl.  Face swelled up and turned red and her chest hurt.  Gave 0.3mg epipen vastus lateralis.  Brought patient to ER via wheelchair
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Erythema, Swelling face, Throat irritation
Clinical narrative: Throat felt scratchy gave 50mg/mL IM benadryl.  Face swelled up and turned red and her chest hurt.  Gave 0.3mg epipen vastus lateralis.  Brought patient to ER via wheelchair
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Palpitations, Paraesthesia oral
Clinical narrative: within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Feeling hot, Palpitations, Paraesthesia oral
Clinical narrative: within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: we have a 17 year old patient who received her first and second dose of GARDASIL 9; This spontaneous report has been received from a physician referring to a 17 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unspecified date in 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (strength, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Then, on an unspecified date in 2016, the patient received the second dose. It was reported that the third dose will be administered on an unknown date (inappropriate schedule of product administration).
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced severe allergic reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an unknown date, approximately 15 minutes prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a severe allergic reaction. The symptoms were discovered during the 15 minute, post-vaccination observation period. The patient had no prior history of anaphylactic reactions. The patient was not hospitalized. Treatment information was not provided.   The second dose of mRNA-1273 was discontinued in response to the event.   The event severe allergic reaction was considered Recovered/Resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Hypersensitivity is considered listed.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Moderna COVID-19 Vaccine to a 17 year old patient; A spontaneous report was received from a healthcare facility staff member, concerning a 17-year-old, who was administered Moderna's COVID-19 vaccine (mRNA-1273) (PT: Product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)intramuscularly for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the 17-year-old patient was administered their first dose of vaccine. No additional information was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, administered Moderna COVID-19 Vaccine to a 17-year-old patient, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting Product administered to patient of inappropriate age without any associated adverse events. Event considered resolved.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Cellulitis; Heat from injection site; Swelling; became red; Injection site pain; A spontaneous report was received from a Consumer concerning a 37-years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Erythema, Injection site warmth, Swelling, Cellulitis and Injection site pain.  The patient's medical history was not provided.  Relevant concomitant medications were reported as Monopost, Multivitamins, Lisinopril.  On 29 DEC 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Erythema, Injection site joint discomfort, Swelling, Cellulitis.   On 29 DEC 2020, the patient experienced Injection site pain. His arm began to hurt the day of injection and continued for about a week after the injection. Arm pain began to subside for a day or two. After a few days arm swelled again and became red or started generating heat. Patient went to the Emergency Room for treatment and was diagnosed with Cellulitis.   No Laboratory details were provided.  Treatment information was provided as Tylenol and Antibiotics.  Action taken with mRNA-1273 in response to the events was unknown.   On an unknown date, the outcome of the events was recovered.; Reporter's Comments: This case concerns a 37-year-old male who experienced serious unexpected cellulitis, serious expected swelling, NS unexpected injection site warmth and NS expected injection site pain and erythema.  Event onset was the same day as the first dose of mRNA-1273. Treatment with Tylenol and antibiotics. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 2 uncapped vials thawed out in room  temperature placed back in the refrigerator and administered to 22 patients next day; 2 uncapped vials thawed out in room  temperature placed back in the refrigerator and administered to 22 patients next day; A spontaneous report, was received from a nurse concerning, 22 patients who received Moderna's COVID-19 Vaccine and who experienced two uncapped vials thawed out in room temperature, and placed back in the refrigerator and administered to 22 patients the next day/Product temperature excursion issue and Out of specifications product use.  The patients medical history's were not provided. concomitant product use was not provided.  On 17-Feb-2021, prior to the onset of events, a Healthcare Provider had 2 uncapped vials of mRNA-1273 (Batch numbers unknown) thawed out in room temperature (around 70 degrees Fahrenheit) for approximately two hours. These vials were placed back in the refrigerator (4-5 degrees Centigrade) for approximately 24 hours.  On 18-Feb-2021, 22 patients received a dose of mRNA-1273 intramuscularly for COVID-19 prophylaxis and were administered vaccine from the previously thawed vials.  Action taken with mRNA-1273 in response to the event was unknown.  The reported event, Two uncapped vials thawed out in room temperature, placed back in the refrigerator and administered to 22 patients the next day, outcome was considered resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of product storage error and out of specification product use for mRNA-1273 administered to 22 patients, (lot # not provided) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial palsy reaction; A spontaneous report was received from a consumer (patients wife) concerning an male patient of unknown age who experienced the event facial paralysis.   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 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event facial palsy. Information about treatment was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event facial palsy was unknown. ; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Flushing, Hypotension, Nausea
Clinical narrative: Anaphylaxis; low blood pressure; experienced flushing; nausea; A spontaneous report was received from a consumer concerning a 39-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylaxis, flushing, nausea, and low blood pressure.  The patient's medical history included allergy to medications (information not reported). Concomittent meds included Xyrem  (for narcolepsy/cataplexy) and Adderall (narcolepsy)   On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, 20 minutes after the vaccine the patient experienced flushing. nausea, low blood pressure (reading unknown). Patient was premedicated with Benadryl and Xyzal because of known history of allergy to medications. Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were reported as resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Mobility decreased
Clinical narrative: difficulty talking; unable to move his arm or leg; Massively sick; body pain; Nausea; headaches; fatigue; muscle aches and pains; chills; A spontaneous report was received from a 79-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "unable to move his arm or leg", massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.  The patient's medical history included Covid-19 positive on 17-OCT-2020. Concomitant product included metformin, metoprolol and rivaroxaban.  On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04-FEB-2021, one day after receiving the vaccine, the patient felt "crummy", "massively sick", nausea, headaches, fatigue, chills, muscle aches and pains and other pains. On 05-FEB-2021, the patient reported that he believed he was having a stroke. The patient was unable to move his arm or leg and had difficulty talking. The patient was taken to the emergency room for treatment. Computerized tomogram (CT) scan and magnetic resonance imaging (MRI) were taken. Later that night, after receiving treatment all his side effects subsided and none were present at the time of this report. The patient would like to know if he should get the second dose of vaccine.  Treatment information included heparin, acetaminophen and magnesium.  Action taken with mRNA-1273 was unknown.  The outcome of the events, unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills, was resolved.  The reporter did not provide the assessment for the events unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Speech disorder
Clinical narrative: difficulty talking; unable to move his arm or leg; Massively sick; body pain; Nausea; headaches; fatigue; muscle aches and pains; chills; A spontaneous report was received from a 79-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "unable to move his arm or leg", massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.  The patient's medical history included Covid-19 positive on 17-OCT-2020. Concomitant product included metformin, metoprolol and rivaroxaban.  On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04-FEB-2021, one day after receiving the vaccine, the patient felt "crummy", "massively sick", nausea, headaches, fatigue, chills, muscle aches and pains and other pains. On 05-FEB-2021, the patient reported that he believed he was having a stroke. The patient was unable to move his arm or leg and had difficulty talking. The patient was taken to the emergency room for treatment. Computerized tomogram (CT) scan and magnetic resonance imaging (MRI) were taken. Later that night, after receiving treatment all his side effects subsided and none were present at the time of this report. The patient would like to know if he should get the second dose of vaccine.  Treatment information included heparin, acetaminophen and magnesium.  Action taken with mRNA-1273 was unknown.  The outcome of the events, unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills, was resolved.  The reporter did not provide the assessment for the events unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.; 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: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Paraesthesia
Clinical narrative: abnormal heart beat; felt a tingling in her chest; A spontaneous report was received from a consumer concerning an 88-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt a tingling in her chest (paraesthesia), and abnormal heart beat (arrhythmia).  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 3 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 arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient felt a tingling in her chest. Three weeks later, on 14 Feb 2021, the patient was admitted to the hospital for an abnormal heart beat. No treatment information was provided. At the time of this report, the patient was still suffering from the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, felt a tingling in her chest and abnormal heartbeat, were not recovered/not resolved.; Reporter's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of the vaccine 28 days after the second one; A spontaneous report was received from a health professional concerning a male patient in his 60s who received extra dose administered.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their third dose of mRNA-1273 (Batch number: Batch number not provided) for prophylaxis of COVID-19 infection.  On 22 Feb 2021, five patients received third dose of the mRNA-1273 vaccine, 28 days after the second one.  Action taken with the drug in response to the event was not applicable.  The outcome of the event was recovered/resolved.; Reporter's Comments: This case concerns a male patient of unknown gender and age who received their third dose of mRNA-1273 (Lot unknown), reporting Extra dose administered without any associated adverse events.
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 and a consumer concerning a female patient, (5 patients, all of the patients were in their 60's according to the reporter), who received third dose 28 days after the second dose of Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not reported by the reporter. Concomitant medication was not reported.  On an unknown date, prior to the onset of the event, all the five patients received their first and second doses of mRNA-1273 (Lot number: unknown) through an unknown route at an unspecified site for prophylaxis of COVID-19 infection.  On 22 Feb 2021 at 2:22 pm, these five patients received their third dose of mRNA-1273 (Lot number: unknown) through an unknown route at an unspecified site for prophylaxis of COVID-19 infection. The third dose was 28 days after the second one, which had also been given 28 days after the first dose in all five cases. The nurse obviously gave the 3 doses 28 days apart from each other.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event, received third dose 28 days after the second dose of Moderna's COVID-19 vaccine (mRNA-1273) was resolved; 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia in left lung; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pneumonia in the left lung/pneumonia.  The patient's medical history included a heart transplant and diabetes. No concomitant product use was reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, post vaccination, the patient developed pneumonia in the left lung and was hospitalized.   Treatment information included an unspecified antibiotic.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, pneumonia in the left lung/pneumonia, was considered unknown.; 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: COVID-19, Chills, Erythema, Fatigue, Headache
Clinical narrative: Covid-19 Positive; low oxygen level; Chills; Headache; Fatigue; Redness; A spontaneous report was received from a consumer concerning a female patient of 79 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and tested positive for covid-19 and experienced low oxygen level, chills, headache, fatigue and redness.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 05 Feb 2021, prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 030L20A ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 06 Feb 2021, one day after vaccination, patient experienced chills, headache, fatigue and redness.  On an unknown date, patient experienced low oxygen level and tested positive for covid-19, patient was hospitalized. No Treatment information for the event was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events covid-19 positive, low oxygen level, chills, headache, fatigue and redness was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of a Covid-19 Positive test after vaccination, this event is as unlikely related to mRNA-1273. However,  the events of chills, headache, fatigue and redness are  possibly related to mRNA-1273 administered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: Covid-19 Positive; low oxygen level; Chills; Headache; Fatigue; Redness; A spontaneous report was received from a consumer concerning a female patient of 79 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and tested positive for covid-19 and experienced low oxygen level, chills, headache, fatigue and redness.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 05 Feb 2021, prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 030L20A ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 06 Feb 2021, one day after vaccination, patient experienced chills, headache, fatigue and redness.  On an unknown date, patient experienced low oxygen level and tested positive for covid-19, patient was hospitalized. No Treatment information for the event was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events covid-19 positive, low oxygen level, chills, headache, fatigue and redness was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of a Covid-19 Positive test after vaccination, this event is as unlikely related to mRNA-1273. However,  the events of chills, headache, fatigue and redness are  possibly related to mRNA-1273 administered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain
Clinical narrative: Fainting episode; Arm soreness; A spontaneous report was received from a Consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainting episode, arm soreness.  The patient's medical history was not provided. Concomitant medications reported were Tysabri for drug use 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 batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events arm soreness. On 27 Jan 2021, the patient experienced fainting episode.  No treatment medication was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021, the outcome of events fainting episode was resolved. The outcome of events arm soreness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aphasia, COVID-19, Cough, Delirium
Clinical narrative: potential pneumonia; COVID-19 positive; shortness of breath; cough; fever; delirious; taking pants off; couldn't speak; incoherent; would not eat or drink; would not eat; A spontaneous report was received from a consumer concerning a 83-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed shortness of breath, cough, fever, delirious, taking pants,off, couldn't speak, incoherent, would not eat or drink.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 28 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 30 Jan 2021, the patient developed shortness of breath, cough, fever, delirious, taking pants, off, couldn't speak, incoherent, would not eat or drink.    02 Feb 2021 Patient was admitted into the hospital. Patient tested positive for COVID-19. Patient was on a respirator with potential pneumonia.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However , the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 positive test after vaccination, the event of Covid -19 is unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Food refusal, Incoherent, Pneumonia
Clinical narrative: potential pneumonia; COVID-19 positive; shortness of breath; cough; fever; delirious; taking pants off; couldn't speak; incoherent; would not eat or drink; would not eat; A spontaneous report was received from a consumer concerning a 83-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed shortness of breath, cough, fever, delirious, taking pants,off, couldn't speak, incoherent, would not eat or drink.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 28 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 30 Jan 2021, the patient developed shortness of breath, cough, fever, delirious, taking pants, off, couldn't speak, incoherent, would not eat or drink.    02 Feb 2021 Patient was admitted into the hospital. Patient tested positive for COVID-19. Patient was on a respirator with potential pneumonia.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However , the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 positive test after vaccination, the event of Covid -19 is unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: potential pneumonia; COVID-19 positive; shortness of breath; cough; fever; delirious; taking pants off; couldn't speak; incoherent; would not eat or drink; would not eat; A spontaneous report was received from a consumer concerning a 83-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed shortness of breath, cough, fever, delirious, taking pants,off, couldn't speak, incoherent, would not eat or drink.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 28 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 30 Jan 2021, the patient developed shortness of breath, cough, fever, delirious, taking pants, off, couldn't speak, incoherent, would not eat or drink.    02 Feb 2021 Patient was admitted into the hospital. Patient tested positive for COVID-19. Patient was on a respirator with potential pneumonia.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However , the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 positive test after vaccination, the event of Covid -19 is unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Pneumothorax
Clinical narrative: Collapsed lung; A spontaneous report was received from a consumer concerning herself, a 79 year old patient who received Moderna's COVID-19 vaccine and experienced collapsed lung.  The patient's medical history included COPD.   On 8 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:025L20A) and on 5 Feb 2021, the second dose of mRNA-1273 (Batch number:032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The event collapsed lung was experienced in Feb 2021 that lead to hospitalization for about 3 days. The patient reported that she has performed a biopsy on Feb 2021. Treatment for the event included IV steroids and oral prednisone.  The reporter has also mentioned that the event, collapsed lung is not related to the vaccine.  Action taken with mRNA-1273 in response to the event(s) was unknown.   The outcome of the event collapsed lung was not recovered/resolved.; Reporter's Comments: Based on the current available information, which includes a pre-existing history of COPD and the time to event onset from vaccine administration, a causal relationship between the event and product use is assessed as unlikely.