chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea
Clinical narrative: Shortness of breath; Congested heart failure; A spontaneous report received from a consumer concerning a female patient of unknown age, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced shortness of breath and congested heart failure.  The patients medical history was not provided. No relevant concomitant medications were reported.   On 08 Mar 2021, prior  to onset of events, the patient  received their first of two planned doses of mRNA-1273 (lot# unknown) of vaccine for prophylaxis of COVID-19 infection.  On 10 Mar 2021, patient developed shortness of breath, and congested heart failure which resulted in hospitalization for 3 days.Treatment for the events included Lasix.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, shortness of breath and congested heart failure, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Mobility decreased, Pulmonary oedema, Vomiting
Clinical narrative: Lungs filling up with fluid; Cannot move; Uncontrolled diarrhea and uncontrolled bowel movements; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lungs filling up with fluid/pulmonary edema, uncontrolled diarrhea/diarrhea, vomiting, cannot move/mobility decreased, uncontrolled bowel movements/bowel movement irregularity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 16 Mar 2021, prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:unknown) for prophylaxis of COVID-19 infection.  On 16 Mar 2021, within 12 hours of vaccination, the patient experienced lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events, lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements, were unknown.; Sender'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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Facial paralysis, Hyperaesthesia teeth, Impaired driving ability
Clinical narrative: Felt like something poking her face /almost like paralyzed face; Teeth became sensitive to cold and hot; Worst bodyaches she has ever had; Fever; Disoriented; Nauseous; Felt confused; Could not even drive herself home; A Spontaneous report was received from a consumer, concerning a 29-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced confusion, disorientation, could not drive herself/impaired driving ability, nausea, fever/pyrexia, body aches/general body pain, sensitive teeth/hyperaesthesia teeth, poking in face/facial paralysis.   The patient's medical history included unspecified teeth work on Dec 2020. Concomitant product used by the patient medroxy progesterone acetate for an unknown indication.   On 15 Feb 2021, the patient received the first dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On 15 Mar 2021, prior to the onset of events the patients received second dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On 15 Mar 2021, on the day of her second dose, the patient felt confused, disoriented and could not even drive herself back to home. On 16 Mar 2021, the patient developed fever and the worst body aches ever she had. The patient noticed that her teeth became sensitive to both cold and hot. The patient stated that her teeth were shocking in the whole mouth and the two teeth which had some work was hurting. The patient felt like something was poking her face almost like her face was paralyzed and felt nauseous. The event facial paralysis was considered medically significant and serious.  The patient tried acetaminophen which did not work and then took ibuprofen which was effective.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events confusion, disorientation, could not drive herself/impaired driving ability, nausea, fever/pyrexia, body aches/general body pain, sensitive teeth/hyperaesthesia teeth, poking in face/facial paralysis were unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded.  Nausea and fever are consistent with the vaccine safety profile.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Felt like something poking her face /almost like paralyzed face; Teeth became sensitive to cold and hot; Worst bodyaches she has ever had; Fever; Disoriented; Nauseous; Felt confused; Could not even drive herself home; A Spontaneous report was received from a consumer, concerning a 29-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced confusion, disorientation, could not drive herself/impaired driving ability, nausea, fever/pyrexia, body aches/general body pain, sensitive teeth/hyperaesthesia teeth, poking in face/facial paralysis.   The patient's medical history included unspecified teeth work on Dec 2020. Concomitant product used by the patient medroxy progesterone acetate for an unknown indication.   On 15 Feb 2021, the patient received the first dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On 15 Mar 2021, prior to the onset of events the patients received second dose of their two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID 19 infection.  On 15 Mar 2021, on the day of her second dose, the patient felt confused, disoriented and could not even drive herself back to home. On 16 Mar 2021, the patient developed fever and the worst body aches ever she had. The patient noticed that her teeth became sensitive to both cold and hot. The patient stated that her teeth were shocking in the whole mouth and the two teeth which had some work was hurting. The patient felt like something was poking her face almost like her face was paralyzed and felt nauseous. The event facial paralysis was considered medically significant and serious.  The patient tried acetaminophen which did not work and then took ibuprofen which was effective.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events confusion, disorientation, could not drive herself/impaired driving ability, nausea, fever/pyrexia, body aches/general body pain, sensitive teeth/hyperaesthesia teeth, poking in face/facial paralysis were unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded.  Nausea and fever are consistent with the vaccine safety profile.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial discomfort, Insomnia, Neuropathy peripheral, Pain
Clinical narrative: Rushed to ER and diagnosed with neuropathy; Pain; Skin sensitivity; Occasionally face feels like water is being splashed on it; not able to sleep for 11 days because of her symptoms; Chills; A spontaneous report was received from a consumer concerning for herself, a 44-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Rushed to ER and diagnosed with neuropathy(/neuropathy peripheral), chills (chills), pain (pain), Skin sensitivity/(skin sensation), Unable to sleep for 11 days because of her symptoms (Insomnia) and Occasionally face feels like water is being splashed on it /(Facial discomfort).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Feb 2021, prior to the onset of the events, the patient received hertheir first of the two planned vaccine doses of mRNA-1273 (Batch/Lot number: 001A21A) via intramuscularly for the prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient was rushed to ER for tingling and numbness she developed in her feet, up to  the leg and on her hand and got diagnosed as Neuropathy which was medically significant. The patient experienced chills, pain, skin sensitivity and numbness in feet/legs, sometimes in hands. Occasionally face "feels like water is being splashed on it". These symptoms have occurred for 11 days. Patient was rushed to ER for tingling and numbness she developed in her feet, up to the leg and on her hand and got diagnosed as Neuropathy. She was not able to sleep for 11 days because of her symptoms. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, Rushed to ER and diagnosed with neuropathy, chills, pain, Skin sensitivity, unable to sleep for 11 because of her symptoms and occasionally face feels like water is being splashed on it, 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Skin sensitisation
Clinical narrative: Rushed to ER and diagnosed with neuropathy; Pain; Skin sensitivity; Occasionally face feels like water is being splashed on it; not able to sleep for 11 days because of her symptoms; Chills; A spontaneous report was received from a consumer concerning for herself, a 44-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Rushed to ER and diagnosed with neuropathy(/neuropathy peripheral), chills (chills), pain (pain), Skin sensitivity/(skin sensation), Unable to sleep for 11 days because of her symptoms (Insomnia) and Occasionally face feels like water is being splashed on it /(Facial discomfort).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Feb 2021, prior to the onset of the events, the patient received hertheir first of the two planned vaccine doses of mRNA-1273 (Batch/Lot number: 001A21A) via intramuscularly for the prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient was rushed to ER for tingling and numbness she developed in her feet, up to  the leg and on her hand and got diagnosed as Neuropathy which was medically significant. The patient experienced chills, pain, skin sensitivity and numbness in feet/legs, sometimes in hands. Occasionally face "feels like water is being splashed on it". These symptoms have occurred for 11 days. Patient was rushed to ER for tingling and numbness she developed in her feet, up to the leg and on her hand and got diagnosed as Neuropathy. She was not able to sleep for 11 days because of her symptoms. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, Rushed to ER and diagnosed with neuropathy, chills, pain, Skin sensitivity, unable to sleep for 11 because of her symptoms and occasionally face feels like water is being splashed on it, 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Nasopharyngitis, Vomiting
Clinical narrative: Throwing up; Colds; Bowel movement was not going anywhere; A spontaneous report was received from a consumer concerning an 80-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced cold/nasopharyngitis, throwing up/vomiting and bowel movement was not going anywhere/constipation.  The patient's medical history was not provided. No Relevant concomitant medications were reported.  On 23 Feb 2021, approximately two weeks prior to the onset of symptoms, the patient received their first of the two planned vaccine doses of mRNA-1273 (Lot number: 010T00A21A), on an unspecified arm with unknown dose and route of administration, for prophylaxis of COVID-19 infection.   On 9 March 2021, the patient was hospitalized for colds.   On 12 Mar 2021, the patient was discharged.   On 13 Mar 2021, the patient was throwing up and was again brought back to the hospital. The patient was told that their "bowel movement was not going anywhere."   On 17 Mar 2021, Diagnostic procedure, Endoscopy was performed on the patient and the result was normal.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On 12 March 2021, the outcome of the event, cold was considered resolved.  On an unknown date, the outcome of the events, throwing up and bowel movement was not going anywhere were 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, Constipation and vomiting, a causal relationship cannot be excluded.  The event of Nasopharyngitis was assessed as Unlikely Related to study drug, as this could be due to spread of virus droplets.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Loss of consciousness, Pain in extremity
Clinical narrative: Passed out; Zero appetite; Arm was very painful; Fatigued; Major chills; Fever; A Spontaneous report was received on 16 Mar 2021 concerning a female patient of unspecified age.  On unspecified date she had her first Moderna COVID-19 vaccine and developed events include Fever, Major chills, Zero Appetite, Severe Fatigue which resulted in passing out, Painful Arm.  On the next day morning or after 24 hours she was said to be completely all right.  Patient age, pregnancy information, concomitant medications, other relevant history, current condition or lab data is not specified as this report was taken up from the social media source.  The outcome of the above listed events were said to be 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Passed out; Zero appetite; Arm was very painful; Fatigued; Major chills; Fever; A Spontaneous report was received on 16 Mar 2021 concerning a female patient of unspecified age.  On unspecified date she had her first Moderna COVID-19 vaccine and developed events include Fever, Major chills, Zero Appetite, Severe Fatigue which resulted in passing out, Painful Arm.  On the next day morning or after 24 hours she was said to be completely all right.  Patient age, pregnancy information, concomitant medications, other relevant history, current condition or lab data is not specified as this report was taken up from the social media source.  The outcome of the above listed events were said to be 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 events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Neurological symptom
Clinical narrative: lingering neurologic issue; 102°F fever; Chills; Headaches; Loss of appetite; fatigue; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 102 °f fever, chills, headaches, loss of appetite, fatigue, lingering neurologic issue/pyrexia, chills, headaches, decreased appetite, fatigue, and neurological symptoms.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Mar 2021, prior to the onset of the events the patient received second dose of two planned doses of mRNA-1273 (lot/batch: 001B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced the event(s) 102 °f fever, chills, headaches, loss of appetite, fatigue, and lingering neurologic issue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events 102 °f fever, chills, headaches, loss of appetite, fatigue, and lingering neurologic issue was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lingering neurologic issue; 102°F fever; Chills; Headaches; Loss of appetite; fatigue; A spontaneous report was received from a consumer concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 102 °f fever, chills, headaches, loss of appetite, fatigue, lingering neurologic issue/pyrexia, chills, headaches, decreased appetite, fatigue, and neurological symptoms.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Mar 2021, prior to the onset of the events the patient received second dose of two planned doses of mRNA-1273 (lot/batch: 001B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced the event(s) 102 °f fever, chills, headaches, loss of appetite, fatigue, and lingering neurologic issue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events 102 °f fever, chills, headaches, loss of appetite, fatigue, and lingering neurologic issue was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy on same side as vaccine; A spontaneous report was received from a consumer concerning 69-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial palsy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 13 Jan 2021,the patient received his first of the two planned vaccine doses of mRNA-1273 (Batch number: 039K20A).    On 10 Feb 2021, approximately 28 days after the first vaccine dose, prior to the onset of the symptoms, the patient received his second of the two planned vaccine doses of mRNA-1273 (Batch number: 028L20A), intramuscularly, in the left arm, for prophylaxis of COVID-19 infection.   On an unknown date, after 2.5 weeks of the second dose of vaccination, the patient experienced bell's palsy on the same side he received  the vaccine and was reported as ongoing at the time of report.    Treatment for the event included steroid, antiviral and eyedrops.  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, facial paralysis and cerebrovascular accident, were considered not resolved at the time of 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 event, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Diplopia, Hemiparaesthesia, Magnetic resonance imaging
Clinical narrative: MRI showed acute injury to brain; Had double vision; paraesthesia on one side of the body/tingling on one side of body; A spontaneous report was received from a physician concerning a 29-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paresthesia on one side of body/tingling on one side of body /hemiparaesthesia, had double vision and MRI showed acute brain injury.  The patient's medical history, as provided by the reporter, included some neurological issues but all the tests were reported as normal prior to vaccine administration. Concomitant medications were not provided.  On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced tingling and paraesthesia on one side of body. After a few days on an unknown date the patient had double vision and magnetic resonance imaging was done which showed acute brain injury. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), paresthesia on one side of body/tingling on one side of body /hemiparaesthesia, had double vision and MRI showed acute brain injurywas unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; A spontaneous report was received from consumer, who is 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.  The patient's medical history was not provided. No relevant Concomitant medications were reported.  On 20-FEB-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15-mar-2021 the patient was diagnosed with pneumonia by primary physician. The event is considered as medically significant.  Treatment medication included Levaquin.  Action taken with mRNA-1273 in response to the events was unknown   The event pneumonia was not recovered .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's advance age may remain a risk factor. Further information has been requested.; Sender'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. However, patient's advance age may remain a risk factor. Further information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis perforated, Computerised tomogram, Diarrhoea, Nausea
Clinical narrative: Ruptured appendicitis; Upper stomach pain; Severe diarrhea; Nausea; Throwing up; Sore arm; A spontaneous report was received from a consumer concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ruptured appendicitis, sore arm/pain in extremity, abdominal pain upper, diarrhea, nausea, vomiting.   The patient's medical history was not provided by the reporter. Concomitant medications were not provided.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M02A) in left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced soreness in her left arm which lasted 2 days before resolving. On 19 Feb 2021, she experienced some abdominal pain, nausea, throwing up, and severe diarrhea. On 25 Feb 2021, she was admitted to the hospital. She received 4 CT scans then had surgery for appendicitis. With the surgery they found the appendix was ruptured and they did not remove her appendix. While admitted she was given IV antibiotics and anti nausea medication. She was discharged and continued to have abdominal pain. She was taking Norco, nausea medication, and an oral antibiotic since discharge. She was told by her doctors to wait 2 weeks before receiving the second dose of the vaccine at discharge. They did not want to cause a fever with the vaccine in addition to her appendicitis. She was scheduled to take the second on 03 Mar 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The event sore arm/pain in extremity was resolved after 2 days. The event ruptured appendicitis is unknown. The events abdominal pain upper, diarrhea, nausea, and vomiting were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Ruptured appendicitis; Upper stomach pain; Severe diarrhea; Nausea; Throwing up; Sore arm; A spontaneous report was received from a consumer concerning a 28-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ruptured appendicitis, sore arm/pain in extremity, abdominal pain upper, diarrhea, nausea, vomiting.   The patient's medical history was not provided by the reporter. Concomitant medications were not provided.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M02A) in left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine the patient experienced soreness in her left arm which lasted 2 days before resolving. On 19 Feb 2021, she experienced some abdominal pain, nausea, throwing up, and severe diarrhea. On 25 Feb 2021, she was admitted to the hospital. She received 4 CT scans then had surgery for appendicitis. With the surgery they found the appendix was ruptured and they did not remove her appendix. While admitted she was given IV antibiotics and anti nausea medication. She was discharged and continued to have abdominal pain. She was taking Norco, nausea medication, and an oral antibiotic since discharge. She was told by her doctors to wait 2 weeks before receiving the second dose of the vaccine at discharge. They did not want to cause a fever with the vaccine in addition to her appendicitis. She was scheduled to take the second on 03 Mar 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The event sore arm/pain in extremity was resolved after 2 days. The event ruptured appendicitis is unknown. The events abdominal pain upper, diarrhea, nausea, and vomiting were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Diarrhoea, Hyperhidrosis, Rectal haemorrhage, Vomiting
Clinical narrative: Rectal bleeding; Colitis attack; Diarrhea; Sweats; Vomiting; A spontaneous report  was received from a consumer concerning a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  colitis attack/colitis, diarrhea/diarrhoea, vomiting, rectal bleeding/rectal hemorrhage and sweats/hyperhidrosis.  The patient's medical history was not provided. Concomitant medications list was also not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030MZ0A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 11 Mar 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273 (batch number: 032M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 11 Mar 2021, after receiving the second dose of mRNA-1273, the patient had a terrible gastrointestinal situation. She had an emergency CAT (computerized axial tomography) scan from her gastro doctor which brought on a colitis attack which she normally does not have. She experienced diarrhea, vomiting, sweats and rectal bleeding.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events,  colitis attack, diarrhea, vomiting, rectal bleeding and sweats, were considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information cannot be obtained since the patient has declined.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling hot, Headache
Clinical narrative: Bad cold; Sneezing; Coughing; Chest cold; Dull headache; Felt hot; Shaky; Temperature of 102F/ Fever 100F; Body was sore; Queasy; Chills; Tired; A spontaneous report was received from a consumer who's experienced chills, felt hot, temperature of 102F, feeling queasy,shaky, body was sore, and felt tired after vaccination.  There is no patients medical history was provided. No concomitant medications were provided.  On 14-feb-2021   a prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (unknown Lot number) through unknown route in the arm for prophylaxis of COVID-19 infection.   On 14-MAR-2021, she received her second dose at 11 am. By 5pmshe was feeling queasy. She took a Motrin around 5pm. By 8pm, she had chills, felt hot, temperature of 102F, shaky, body was sore, and felt tired  Action taken with mRNA-1273 in response to the events was not applicable as she completed both the doses.  The outcome of events, feeling queasy, chills, felt hot, temperature 102F, shaky, body was sore and felt tired was not resolved.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported events and excluding any other etiology, a causal relationship with the event cannot be excluded. Nausea, myalgia, headache, fatigue, chills and fever are consistent with the safety profile of the product.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Myalgia, Nasopharyngitis, Nausea, Nervousness
Clinical narrative: Bad cold; Sneezing; Coughing; Chest cold; Dull headache; Felt hot; Shaky; Temperature of 102F/ Fever 100F; Body was sore; Queasy; Chills; Tired; A spontaneous report was received from a consumer who's experienced chills, felt hot, temperature of 102F, feeling queasy,shaky, body was sore, and felt tired after vaccination.  There is no patients medical history was provided. No concomitant medications were provided.  On 14-feb-2021   a prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (unknown Lot number) through unknown route in the arm for prophylaxis of COVID-19 infection.   On 14-MAR-2021, she received her second dose at 11 am. By 5pmshe was feeling queasy. She took a Motrin around 5pm. By 8pm, she had chills, felt hot, temperature of 102F, shaky, body was sore, and felt tired  Action taken with mRNA-1273 in response to the events was not applicable as she completed both the doses.  The outcome of events, feeling queasy, chills, felt hot, temperature 102F, shaky, body was sore and felt tired was not resolved.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported events and excluding any other etiology, a causal relationship with the event cannot be excluded. Nausea, myalgia, headache, fatigue, chills and fever are consistent with the safety profile of the product.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: Bad cold; Sneezing; Coughing; Chest cold; Dull headache; Felt hot; Shaky; Temperature of 102F/ Fever 100F; Body was sore; Queasy; Chills; Tired; A spontaneous report was received from a consumer who's experienced chills, felt hot, temperature of 102F, feeling queasy,shaky, body was sore, and felt tired after vaccination.  There is no patients medical history was provided. No concomitant medications were provided.  On 14-feb-2021   a prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (unknown Lot number) through unknown route in the arm for prophylaxis of COVID-19 infection.   On 14-MAR-2021, she received her second dose at 11 am. By 5pmshe was feeling queasy. She took a Motrin around 5pm. By 8pm, she had chills, felt hot, temperature of 102F, shaky, body was sore, and felt tired  Action taken with mRNA-1273 in response to the events was not applicable as she completed both the doses.  The outcome of events, feeling queasy, chills, felt hot, temperature 102F, shaky, body was sore and felt tired was not resolved.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the product and the start date of the reported events and excluding any other etiology, a causal relationship with the event cannot be excluded. Nausea, myalgia, headache, fatigue, chills and fever are consistent with the safety profile of the product.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Computerised tomogram
Clinical narrative: appendicitis; A spontaneous report was received from a consumer (reporting on self) concerning a 52-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal pain. which was diagnosed as  appendicitis.   The patient's medical history was not provided. Concomitant medications included hydroxychloroquine sulfate.  On 04 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 23M20A) in the right arm  for prophylaxis of COVID-19 infection.  On 07 Mar 2021, the patient had abdominal pain. In the morning of 08 Mar 2021, patient went to urgent care as she thought the pain was due to UTI (urinary tract infection) but urgent care said it was not UTI and they referred  to go to ER (emergency room). The patient went to ER on 08 Mar 2021, where they did CAT scan and found out that she had appendicitis, hence at 7 pm on 08 Mar 2021 they operated the patient and removed appendix.   Action taken with mRNA-1273 in response to the event not applicable   The outcome of the event of appendicitis  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, a causal relationship cannot be excluded
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis, Arthralgia, Arthritis, Coccydynia
Clinical narrative: appendicitis; A spontaneous report was received from a consumer (reporting on self) concerning a 52-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal pain. which was diagnosed as  appendicitis.   The patient's medical history was not provided. Concomitant medications included hydroxychloroquine sulfate.  On 04 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 23M20A) in the right arm  for prophylaxis of COVID-19 infection.  On 07 Mar 2021, the patient had abdominal pain. In the morning of 08 Mar 2021, patient went to urgent care as she thought the pain was due to UTI (urinary tract infection) but urgent care said it was not UTI and they referred  to go to ER (emergency room). The patient went to ER on 08 Mar 2021, where they did CAT scan and found out that she had appendicitis, hence at 7 pm on 08 Mar 2021 they operated the patient and removed appendix.   Action taken with mRNA-1273 in response to the event not applicable   The outcome of the event of appendicitis  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, a causal relationship cannot be excluded
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Condition aggravated, Neck pain, Urine analysis normal
Clinical narrative: appendicitis; A spontaneous report was received from a consumer (reporting on self) concerning a 52-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced abdominal pain. which was diagnosed as  appendicitis.   The patient's medical history was not provided. Concomitant medications included hydroxychloroquine sulfate.  On 04 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the left arm for prophylaxis of COVID-19 infection.  On 04 Mar 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 23M20A) in the right arm  for prophylaxis of COVID-19 infection.  On 07 Mar 2021, the patient had abdominal pain. In the morning of 08 Mar 2021, patient went to urgent care as she thought the pain was due to UTI (urinary tract infection) but urgent care said it was not UTI and they referred  to go to ER (emergency room). The patient went to ER on 08 Mar 2021, where they did CAT scan and found out that she had appendicitis, hence at 7 pm on 08 Mar 2021 they operated the patient and removed appendix.   Action taken with mRNA-1273 in response to the event not applicable   The outcome of the event of appendicitis  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, a causal relationship cannot be excluded
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Apallic syndrome
Clinical narrative: Became vegetative; A spontaneous report  was received from a consumer concerning, a 73-years old, female patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event became vegetative/apallic syndrome.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On an unknown date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On an unknown date, the patient became vegetative. The event became vegetative is considered as medically significant.No treatment details were provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, became vegetative, was unknown.; Reporter's Comments: This case concerns a 73-years old, female patient,  who experienced the event of became vegetative. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism
Clinical narrative: Pulmonary embolism; Shortness of breath; A spontaneous report was received from a physician, concerning a 67 years old female patient, who received Moderna's COVID-19 vaccine and experienced shortness of breath and pulmonary embolism.  The patient's medical history was not provided. Concomitant product details were not provided by the reporter.  On 15-Feb-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. On 15-Mar-2021, after the recovery from the events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 18-Feb-2021, after first dose of vaccine, the patient experienced shortness of breath and required 2 days hospitalization for pulmonary embolism. Treatment using Enoxaparin was reported. The shortness of breath was gone once being discharged  from the hospital. Rivaroxaban was prescribed as the discharge medication.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events shortness of breath was considered resolved and of event pulmonary embolism was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error, Respiratory failure
Clinical narrative: Respiratory failure; Messed up with medication; A spontaneous report was received from a Consumer concerning himself, a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure and messed up with medication/ Medication error.   The patient's medical history was not reported. Concomitant medication was not reported.  On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273  mRNA-1273 (Lot number: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, after receiving mRNA-1273, the patient experienced respiratory failure and messed up with medication. He was hospitalized in ICU from 27 Feb 2021 till 08 Mar 2021 due to his medication messed up and had a respiratory failure.  Action taken with mRNA-1273 in response to the events was not reported.  The events respiratory failure and messed up with medication were reported considered resolved on 08 Mar 2021.; Reporter's Comments: There is insufficient details to assess the event of medication error as the specific drug and error was not ddescribed as well as the condition leading to error. In addition, limited information has been provide about the event of respiratory failure but for the fact that  it was due to medication error.  Hence assessed as unlikely due to  mRNA-1273
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Blood pressure spiked; Dizzy spell; A spontaneous report was received from a consumer concerning an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy spell and blood pressure spiked.  The patient's medical history was not reported. No relevant concomitant medication were reported.  On 16 Feb 2021, approximately one month and one day prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: C1215 ) in the left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, the patient experienced dizzy spell, blood pressure spiked to almost 200 to before second dose that was scheduled on the 16Mar2021 and the patient was hospitalized. No treatment information was provided.  Action taken with mRNA-1273 in response to events was not reported.  The outcome of the events dizzy spell and blood pressure spiked was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Loss of consciousness, Pain in extremity
Clinical narrative: passed out; feeling strange; started sweating; sore arm; A spontaneous report was received from a consumer concerning a 78-year-old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and tender right arm, feeling strange, started sweating and passed out.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 16-MAR-2021 the patient received their second dose of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 16-MAR-2021 patient had a sore and tender right arm. On 19-MAR-2021, she started feeling strange, started sweating and passed out. The adverse event of passed out was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  Outcome of the events of sore and tender right arm, feeling strange, started sweating and passed out was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary embolism
Clinical narrative: Blood clots in his lungs (After second dose); A spontaneous report was received from consumer, concerning himself, a 71-year -old elderly, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clots in lungs (Pulmonary embolism).  The patient's medical history was reported as unknown. Concomitants reported included Metoprolol, Tamsulosin, Gabapentin, Metformin, Fenofibrate and Losartan for unknown indication.  On 8 Mar 2021 patient received second of two planned doses of mRNA-1273 (Lot number: 040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 18 Mar 2021 patient went to doctor and after some studies that included a CT scan they discovered he had blood clots in his lungs. The event blood clots in lungs (Pulmonary embolism) was medically significant. It was reported that, he was prescribed with a blood thinner for treatment purpose.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, blood clots in lungs 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, a causal relationship cannot be excluded.