chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Oxygen consumption decreased, Renal disorder, SARS-CoV-2 test positive, Thrombosis
Clinical narrative: DIZZINESS; FELL; HURT HIMSELF; SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); SOME DAMAGE TO HIS KIDNEYS IN THE PROCESS (BLOOD CLOT); CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the patient became ill with COVID like symptoms, and got tested for COVID on 22-Mar-2021 and received results that he was COVID positive on 25-Mar-2021 and was running high temperatures (fevers over 103), On 27-MAR-2021, the patient became dizzy, fell and hurt himself, was rushed to the hospital and was admitted same day. He did some damage to his kidneys in the process. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) Over 103. Laboratory data included: Oxygen consumption decreased (NR: not provided) 87.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 positive, dizziness, fell, injury to kidney, hurt himself and blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition) This report was associated with product quality complaint : 90000174591.; Sender's Comments: V0: 20210355610- Covid-19 Vaccine Ad26.Cov2.S-Confirmed Covid-19 Positive. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210355610- Covid-19 Vaccine Ad26.Cov2.S - Dizziness, Fell, Hurt himself, Some damage to his kidneys in the process (blood clot). This events are considered Unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 28-MAR-2021, the patient received vaccine shot and she died on the same day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death and Other Medically Important Condition).; Sender's Comments: 20210356482 - Covid-19 Vaccine Ad26.Cov2.S - Death. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Cold sweat, Fatigue, Feeling hot
Clinical narrative: Cellulitis; Clammy skin and hands; Nauseous; Fatigue; fever; chills/teeth chattering; red rash; red mark on their right arm; hot to the touch; tender; Arm swollen and sore; A spontaneous report was received from consumer, concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chills, fatigue, nausea, fever/pyrexia, red mark on their right arm/ vaccination site erythema clammy skin and hands/cold sweat, red rash/ rash erythematous ,arm swollen and sore/pain in extremity, red rash, hot to touch/ feeling hot and tenderness.  The patient's medical history was not reported. Concomitant medications included bomocriptine, doxycycline, cetirizine hydrochloride, ibuprofen.  On 06-JAN-2021, prior to the onset of the events, the patient received mRNA-1273 intramuscularly in Right arm for prophylaxis of COVID-19 infection.  On 07-JAN-2021, after receiving mRNA-1273, the patient's arm was swollen tender, and sore. The patient reported that the arm felt better the next day, after sleeping and taking it easy. The patient stated that on 08-JAN-2021, she woke up with more energy after sleeping and taking it easy. The injection site was not treated directly, but she may have taken some Advil for symptom relief. On 19-JAN-2021, the patient started not feeling well. On 20-JAN-2021, the patient noticed a red mark on their right arm where they had received the injection. The patient reported that she had a red rash on the right arm, below the injection site, that was hot to the touch. On 21-JAN-2021, she reported seeing a physician. The physician ordered an ultrasound to rule out a blood clot in the patient's arm. The doctor diagnosed the patient with cellulitis and prescribed an antibiotic (Doxycycline) and cetirizine hydrochloride. The event cellulitis was assessed as medically significant as per IME list. The patient reported feeling very nauseous and fatigued. The patient also reported chills and fever, chattering teeth, clammy hands and feet. The patient is still fatigued and nauseous but is starting to feel better today 28-JAN-2021. The treatment included an antibiotic (Doxycycline) and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events cellulitis, chills, fatigue, nausea, fever, red mark on their right arm, clammy skin and hands, red rash, arm swollen and sore, red rash, hot to touch and tenderness was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash erythematous, Tenderness
Clinical narrative: Cellulitis; Clammy skin and hands; Nauseous; Fatigue; fever; chills/teeth chattering; red rash; red mark on their right arm; hot to the touch; tender; Arm swollen and sore; A spontaneous report was received from consumer, concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chills, fatigue, nausea, fever/pyrexia, red mark on their right arm/ vaccination site erythema clammy skin and hands/cold sweat, red rash/ rash erythematous ,arm swollen and sore/pain in extremity, red rash, hot to touch/ feeling hot and tenderness.  The patient's medical history was not reported. Concomitant medications included bomocriptine, doxycycline, cetirizine hydrochloride, ibuprofen.  On 06-JAN-2021, prior to the onset of the events, the patient received mRNA-1273 intramuscularly in Right arm for prophylaxis of COVID-19 infection.  On 07-JAN-2021, after receiving mRNA-1273, the patient's arm was swollen tender, and sore. The patient reported that the arm felt better the next day, after sleeping and taking it easy. The patient stated that on 08-JAN-2021, she woke up with more energy after sleeping and taking it easy. The injection site was not treated directly, but she may have taken some Advil for symptom relief. On 19-JAN-2021, the patient started not feeling well. On 20-JAN-2021, the patient noticed a red mark on their right arm where they had received the injection. The patient reported that she had a red rash on the right arm, below the injection site, that was hot to the touch. On 21-JAN-2021, she reported seeing a physician. The physician ordered an ultrasound to rule out a blood clot in the patient's arm. The doctor diagnosed the patient with cellulitis and prescribed an antibiotic (Doxycycline) and cetirizine hydrochloride. The event cellulitis was assessed as medically significant as per IME list. The patient reported feeling very nauseous and fatigued. The patient also reported chills and fever, chattering teeth, clammy hands and feet. The patient is still fatigued and nauseous but is starting to feel better today 28-JAN-2021. The treatment included an antibiotic (Doxycycline) and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events cellulitis, chills, fatigue, nausea, fever, red mark on their right arm, clammy skin and hands, red rash, arm swollen and sore, red rash, hot to touch and tenderness was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaccination site erythema
Clinical narrative: Cellulitis; Clammy skin and hands; Nauseous; Fatigue; fever; chills/teeth chattering; red rash; red mark on their right arm; hot to the touch; tender; Arm swollen and sore; A spontaneous report was received from consumer, concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chills, fatigue, nausea, fever/pyrexia, red mark on their right arm/ vaccination site erythema clammy skin and hands/cold sweat, red rash/ rash erythematous ,arm swollen and sore/pain in extremity, red rash, hot to touch/ feeling hot and tenderness.  The patient's medical history was not reported. Concomitant medications included bomocriptine, doxycycline, cetirizine hydrochloride, ibuprofen.  On 06-JAN-2021, prior to the onset of the events, the patient received mRNA-1273 intramuscularly in Right arm for prophylaxis of COVID-19 infection.  On 07-JAN-2021, after receiving mRNA-1273, the patient's arm was swollen tender, and sore. The patient reported that the arm felt better the next day, after sleeping and taking it easy. The patient stated that on 08-JAN-2021, she woke up with more energy after sleeping and taking it easy. The injection site was not treated directly, but she may have taken some Advil for symptom relief. On 19-JAN-2021, the patient started not feeling well. On 20-JAN-2021, the patient noticed a red mark on their right arm where they had received the injection. The patient reported that she had a red rash on the right arm, below the injection site, that was hot to the touch. On 21-JAN-2021, she reported seeing a physician. The physician ordered an ultrasound to rule out a blood clot in the patient's arm. The doctor diagnosed the patient with cellulitis and prescribed an antibiotic (Doxycycline) and cetirizine hydrochloride. The event cellulitis was assessed as medically significant as per IME list. The patient reported feeling very nauseous and fatigued. The patient also reported chills and fever, chattering teeth, clammy hands and feet. The patient is still fatigued and nauseous but is starting to feel better today 28-JAN-2021. The treatment included an antibiotic (Doxycycline) and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events cellulitis, chills, fatigue, nausea, fever, red mark on their right arm, clammy skin and hands, red rash, arm swollen and sore, red rash, hot to touch and tenderness was resolving.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Facial paresis, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Right side of mouth dropped; Diagnosed with paresthesia; Numbness in her cheek, tongue, jaw and head on the right side; Slurring; Blood pressure shot up; Bad headache; A spontaneous case was reported by a consumer concerning a 66-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following: diagnosed with paresthesia (paraesthesia),  numbness in her cheek, tongue, jaw and head on the right side (hypaesthesia), right side of mouth dropped (facial paralysis), slurring (dysarthria), blood pressure shot up (hypertension) and bad headache (headache).    The patient's past medical history included stroke (she had stroke about 7 years ago). Concomitant products included blood pressure medication (not otherwise specified).  On 16-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Batch no. 031L20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.     On 16-Feb-2021, within one minute after receiving the vaccine, the  patient experienced numbness in her cheek and tongue on the right side. The numbness moved to her jaw and head and she also had slurring. The right side of her mouth dropped, her blood pressure shot up, and she had a bad headache. The patient was taken to the emergency room (ER) and diagnosed with paresthesia and also treated for stroke symptoms. The patient was in the hospital from about 10:30-5:00 pm.  Treatment included aspirin and IV. The recommendation was made for the patient to take atorvastatin, but the patient was not taking it. The patient went to see her physician on 22-Feb-2021.  At the time of this report, the patient's side effects had not completely resolved.      The action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, diagnosed with paresthesia, numbness in her cheek, tongue, jaw and head on the right side, right side of mouth dropped, slurring, blood pressure shot up, and bad headache, was considered not recovered/not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. The patient's past medical history of stroke and ongoing history of hypertension remains a confounder.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Right side of mouth dropped; Diagnosed with paresthesia; Numbness in her cheek, tongue, jaw and head on the right side; Slurring; Blood pressure shot up; Bad headache; A spontaneous case was reported by a consumer concerning a 66-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following: diagnosed with paresthesia (paraesthesia),  numbness in her cheek, tongue, jaw and head on the right side (hypaesthesia), right side of mouth dropped (facial paralysis), slurring (dysarthria), blood pressure shot up (hypertension) and bad headache (headache).    The patient's past medical history included stroke (she had stroke about 7 years ago). Concomitant products included blood pressure medication (not otherwise specified).  On 16-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Batch no. 031L20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.     On 16-Feb-2021, within one minute after receiving the vaccine, the  patient experienced numbness in her cheek and tongue on the right side. The numbness moved to her jaw and head and she also had slurring. The right side of her mouth dropped, her blood pressure shot up, and she had a bad headache. The patient was taken to the emergency room (ER) and diagnosed with paresthesia and also treated for stroke symptoms. The patient was in the hospital from about 10:30-5:00 pm.  Treatment included aspirin and IV. The recommendation was made for the patient to take atorvastatin, but the patient was not taking it. The patient went to see her physician on 22-Feb-2021.  At the time of this report, the patient's side effects had not completely resolved.      The action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, diagnosed with paresthesia, numbness in her cheek, tongue, jaw and head on the right side, right side of mouth dropped, slurring, blood pressure shot up, and bad headache, was considered not recovered/not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. The patient's past medical history of stroke and ongoing history of hypertension remains a confounder.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cardiac flutter, Diarrhoea, Headache
Clinical narrative: Glare headache; Heart flutters; Severe pain in both shoulders; Fever 102.2; Right arm injection was itchy; Right arm injection site was sore; Diarrhea; A spontaneous case was received from a consumer concerning a 63-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pain at vaccination site itching headache ,pain at both the shoulders ,pyrexia, heart flutters and diarrhea.  .  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 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021,she experienced  her arm was sore and itchy at the injection site. On 12 Feb2021 she developed a 102.2 fever and severe pain in both shoulders. On 13 Feb 2021, patient experienced diarrhea and heart flutters. On 14 Feb,2021 she experienced a glare headache. Treatment for the event included ,Tylenol.  Action taken with mRNA-1273 in response to the event, unknown.   The outcome of the event, pain at vaccination site, itching headache ,pain at both the shoulders ,pyrexia, heart flutters and diarrhea., was considered unknown.; Reporter's Comments: This case concerns a 63 Y/O F with a serious unexpected event of cardiac flutter, and non serious unexpected diarrhea, severe arthralgia and expected pyrexia, headache, vaccination site pruritus, and vaccination site pain.  Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Glare headache; Heart flutters; Severe pain in both shoulders; Fever 102.2; Right arm injection was itchy; Right arm injection site was sore; Diarrhea; A spontaneous case was received from a consumer concerning a 63-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pain at vaccination site itching headache ,pain at both the shoulders ,pyrexia, heart flutters and diarrhea.  .  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 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021,she experienced  her arm was sore and itchy at the injection site. On 12 Feb2021 she developed a 102.2 fever and severe pain in both shoulders. On 13 Feb 2021, patient experienced diarrhea and heart flutters. On 14 Feb,2021 she experienced a glare headache. Treatment for the event included ,Tylenol.  Action taken with mRNA-1273 in response to the event, unknown.   The outcome of the event, pain at vaccination site, itching headache ,pain at both the shoulders ,pyrexia, heart flutters and diarrhea., was considered unknown.; Reporter's Comments: This case concerns a 63 Y/O F with a serious unexpected event of cardiac flutter, and non serious unexpected diarrhea, severe arthralgia and expected pyrexia, headache, vaccination site pruritus, and vaccination site pain.  Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Gait inability, Pyrexia
Clinical narrative: 102.0 now 102.8 F Fever.; Can't walk; Can't form a sentence; Extremely weak; 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 experienced fever/pyrexia, weakness/asthenia, can't walk/gait inability, couldn't form a sentence (aphasia).  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On an unknown date in Jan 2021, patient received their first of two planned doses of mRNA-1273 vaccine (Batch number: Unknown).  On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the mRNA-1273 vaccine, on 16 Feb 2021, the patient experienced a fever of 102-102.8 degrees Fahrenheit.  She was extremely weak, couldn't walk or form a sentence.    Treatment details for events were not reported.  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.  The  outcome of the events, fever/pyrexia, weakness/asthenia, can't walk/gait inability, can't form a sentence/aphasia 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 event (Pyrexia, asthenia) a causal relationship cannot be excluded. Very limited information regarding the event (gait instability, aphasia) has been provided at this time. Noting advance age is a risk factor. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Feeling abnormal, Headache, Illness
Clinical narrative: feels pretty sick; stomach is really bad; foggy in the head; headache; very severe back pain; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very severe backpain/back pain , feels pretty sick/illness, stomach is really bad/abdominal discomfort, foggy in the head/feeling abnormal, headache.  The patient's medical history included sick for 5 month with a novel virus a few years ago. Current condition included asthma. Concomitant medications included gnucola for the lungs, this helped her with her asthma.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events very severe backpain. On an unknown date, the patient experienced the events feels pretty sick, stomach is really bad, foggy in the head, headache.  Treatment details included Charcoal, acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), very severe backpain, feels pretty sick, stomach is really bad, foggy in the head, headache was unknown.; Reporter's Comments: This case concerns a 74 Y/O F with a serious unexpected back pain, illness, feeling abnormal, headache, abdominal discomfort.  Event onset Day 2 after first dose mRNA-1273. Treated with charcoal, acetylsalicylic acid. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Haemorrhage, Pain in extremity, Rash
Clinical narrative: She bled down her arm like she never bled before; Warm to touch; Tender to touch; Red warm 3inches round under the skin; Rash; Pain in arm; This spontaneous case was reported by a 70-years-old female consumer who received first dose of mRNA-1273 and experienced event rash.    The consumer's medical history was not provided.   Relevant concomitant medication was reported as acetylsalicylic acid (aspirin) for an unknown indication.  On 14-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 23-Jan-2021, the consumer experienced the event rash.   Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.   The outcome of event was unknown.   The follow-up was received on 27-Jan-2021 and it included that the consumer had experienced events she bled down her arm like she never bled before, pain in arm, red warm 3inches round under the skin, warm to touch and tender to touch.  On an unknown date, the consumer experienced the event she bled down her arm like she never bled before.  On 14-JAN-2021, the consumer experienced the event pain in arm.  On 23-Jan-2021, the consumer experienced the events red warm 3inches round under the skin, warm to touch and tender to touch.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was unknown.   The outcome of events was unknown.  The follow up information was received on 27 Jan 2021. The outcome of rash (unknown), erythema and pain (recovered) of extremity was updated.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of hemorrhage, and nonserious unexpected pain in extremity, feeling hot, tenderness, and expected erythema, rash.  Event onset on Day 1 after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: She bled down her arm like she never bled before; Warm to touch; Tender to touch; Red warm 3inches round under the skin; Rash; Pain in arm; This spontaneous case was reported by a 70-years-old female consumer who received first dose of mRNA-1273 and experienced event rash.    The consumer's medical history was not provided.   Relevant concomitant medication was reported as acetylsalicylic acid (aspirin) for an unknown indication.  On 14-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 23-Jan-2021, the consumer experienced the event rash.   Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.   The outcome of event was unknown.   The follow-up was received on 27-Jan-2021 and it included that the consumer had experienced events she bled down her arm like she never bled before, pain in arm, red warm 3inches round under the skin, warm to touch and tender to touch.  On an unknown date, the consumer experienced the event she bled down her arm like she never bled before.  On 14-JAN-2021, the consumer experienced the event pain in arm.  On 23-Jan-2021, the consumer experienced the events red warm 3inches round under the skin, warm to touch and tender to touch.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was unknown.   The outcome of events was unknown.  The follow up information was received on 27 Jan 2021. The outcome of rash (unknown), erythema and pain (recovered) of extremity was updated.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of hemorrhage, and nonserious unexpected pain in extremity, feeling hot, tenderness, and expected erythema, rash.  Event onset on Day 1 after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Delirium, Feeling abnormal, Gait disturbance
Clinical narrative: Woke up delirious; Very unsteady, and she had to hold onto the wall to keep upright; She stated that she did some weird things; Had no appetite; Weak; 101.6 degrees fever; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm.  Treatment details included Patient took 3 Tylenols.  Action taken with mRNA-1273 in response to the events was not provided.   On 19 Feb 2021 the outcome of event events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm was 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Woke up delirious; Very unsteady, and she had to hold onto the wall to keep upright; She stated that she did some weird things; Had no appetite; Weak; 101.6 degrees fever; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm.  Treatment details included Patient took 3 Tylenols.  Action taken with mRNA-1273 in response to the events was not provided.   On 19 Feb 2021 the outcome of event events 101.6 degrees fever, it took her forever to write a simple email, woke up delirious, very unsteady, and she had to hold onto the wall to keep upright, she stated that she did some weird things: tried to feed her cat with cat litter, poured all her, had no appetite but was able to eat at around 10pm was 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pulmonary congestion
Clinical narrative: congestion; Coughing; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events coughing, congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Jan 2021, the patient experienced the coughing, congestion. The event congestion was considered to be medically significant.  Treatment details included Amoxicillin, cough medicine, Z-pack.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, coughing, congestion 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 reported events, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Pain in extremity, Syncope
Clinical narrative: syncope/fainted; Dizziness; couldn't eat; Fatigue/ tiredness; Sore arm; A spontaneous report was received from a consumer concerning herself, an 87-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope/fainted, sore arm/pain in extremity, dizziness, fatigue/tiredness, and she couldn't eat (decreased appetite).   The patient's medical history included COVID-19 in December 2020.  Concomitant product use was not provided.   On 11 FEB 2021, 1 day prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 FEB 2021, the patient experienced sore arm.  On 12 FEB 2021, the patient experienced syncope (she fainted), dizziness, fatigue/tiredness, and she couldn't eat.   Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.  The event of syncope/fainted was considered resolved on an unknown date.  The outcome of the events of sore arm, dizziness, fatigue/tiredness, and couldn't eat were 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia
Clinical narrative: heart rate went down to 50 and 49/heart rate was consistently in the low 50s or even below 50; A spontaneous report  was received from a consumer concerning a 71 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low heart rate/bradycardia.  The patient's medical history included allergy to sulfa and latex.  The patient was taking baby aspirin 81 mg, Simvastatin 20 mg, Ethacrynic acid 25 mg, Benicar 20 mg, Synthroid 100 mcg, Potassium, Ciprofloxacin 500 mg as concomitant medication  On 23-Jan-2021, prior to the onset of the events, the patient received their first dose of  planned two doses of mRNA-12 intamuscularly for prophylaxis of COVID-19 infection.   On 23-Jan-2021, the patient got the shot where my heart rate was consistently in the low 50s or even below 50.  No treatment information was given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event low heart was resolved on 23-Jan-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: fractured hip; fallen; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who fell/fall and fractured hip/hip fracture.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient fell and fractured her hip on an unknown date.  Treatment for the event included rehabilitation.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events, fall and hip fracture 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 event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cellulitis, Vaccination site pruritus
Clinical narrative: Burning sensation; Itching; Cellulitis; A spontaneous report was received from a consumer concerning a 79-year-old, female patient, who burning sensation, itching/ Injection site pruritis, and cellulitis.  The patient's medical history was not provided.  Concomitant products known to have bee used by the patient, within two weeks prior to the event, included Synthroid and Metoprolol.  On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 006M20A) via unknown route for COVID-19 infection prophylaxis.   The patient experienced bump like a hard ball, burning sensation, redness, itching, and pain at the injection site after the first dose of vaccine.  On 24 Feb 2021, the patient was referred to a doctor and was diagnosed with cellulitis.  Treatment medication was reported as Antibiotics for eight days.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, burning sensation, itching, and cellulitis were considered 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 events, a causal relationship cannot be excluded
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, COVID-19, Dyspnoea, Fatigue
Clinical narrative: trouble breathing; fever 102.5; Fatigue; Joint pain; headache; Nausea; Vomiting; muscle pain; A spontaneous report was received from a 65-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever 102.5/pyrexia, trouble breathing/dyspnoea, joint and muscle pain/myalgia, joint pain/arthralgia, headache, fatigue nausea and vomiting.  The patient's medical history included autoimmune disease and COVID-19 on an unknown date in Apr 2020. Concomitant medications were not provided.  On 8 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving mRNA-1273, patient developed fatigue, headache, fever off and on especially at night reaching as high as 102.5, joint and muscle pain, nausea, vomiting, and headache. After the vaccine she had trouble breathing and was put on a course of prednisone. She had Covid-19 in Apr 2020 and was feeling as bad as when she had it. Her HCP recommended she have a Covid-19 test and it came back negative.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever 102, 5, trouble breathing, joint and muscle pain, headache, nausea and vomiting was not resolved.; Reporter's Comments: This case concerns a 65 Y/O F with PMH of autoimmune disease COVID-19 had serious unexpected dyspnea and expected pyrexia, fatigue, headache, arthralgia, nausea, vomiting. Treated with prednisone. Events ongoing. after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: trouble breathing; fever 102.5; Fatigue; Joint pain; headache; Nausea; Vomiting; muscle pain; A spontaneous report was received from a 65-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever 102.5/pyrexia, trouble breathing/dyspnoea, joint and muscle pain/myalgia, joint pain/arthralgia, headache, fatigue nausea and vomiting.  The patient's medical history included autoimmune disease and COVID-19 on an unknown date in Apr 2020. Concomitant medications were not provided.  On 8 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving mRNA-1273, patient developed fatigue, headache, fever off and on especially at night reaching as high as 102.5, joint and muscle pain, nausea, vomiting, and headache. After the vaccine she had trouble breathing and was put on a course of prednisone. She had Covid-19 in Apr 2020 and was feeling as bad as when she had it. Her HCP recommended she have a Covid-19 test and it came back negative.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever 102, 5, trouble breathing, joint and muscle pain, headache, nausea and vomiting was not resolved.; Reporter's Comments: This case concerns a 65 Y/O F with PMH of autoimmune disease COVID-19 had serious unexpected dyspnea and expected pyrexia, fatigue, headache, arthralgia, nausea, vomiting. Treated with prednisone. Events ongoing. after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; A spontaneous report was received from a consumer who was a 79-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tested positive for COVID-19.  The patient's medical history was not included . Concomitant products was not included.  On 08 Feb 2021, prior to the onset of event the patient received first dose of their two planned doses of mRNA-1273 (Batch No:unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 09 Feb 2021, the patient experienced tired and breathing labored lasted the whole week. Then got progressively worse. On 16 Feb 2021 she tested positive for COVID-19 and had pneumonia. She was hospitalized for a week.  Treatment information was not included.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, tested positive for COVID-19 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event COVID 19 , a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pruritus, Pulmonary fibrosis, Skin reaction
Clinical narrative: itching on her back, hands and wrists (severe), and behind her ear by her hairline; delayed types of reactions; dizzy whenever she lays down; rash going up her arm.; exhausted, fatigue, and couldn't get out of bed.; pulmonary fibrosis was also exacerbated.; A spontaneous report was received from a consumer, concerning a 78 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions).  The patient's medical history had pulmonary fibrosis.No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the Left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experience exhausted, fatigue, and couldn't get out of bed, pulmonary fibrosis was also exacerbated and On 03 Feb 2021 ,the patient experience itching on her back, hands and wrists (severe), and behind her ear by her hairline,rash going up her arm, dizzy whenever she lays down,delayed types of reactions.  The patient was treated with lidocaine for itchiness on her hands and wrists.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions) were considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The pulmonary fibrosis and dizziness events are probably related to the patient's comorbidities. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site rashes and fatigue, a causal relationship cannot be excluded.