chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear disorder, Tinnitus
Clinical narrative: Significant hearing problem in left ear / loss of hearing in left ear; Gets loud ringing in the ear; Amplified sounds after taking first dose; A spontaneous report was received from a consumer concerning himself, 79-year-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced significant hearing problem in left ear, loss of hearing in left ear/deafness unilateral, gets loud ringing in the ear/tinnitus, amplified sounds after taking the first dose of the moderna vaccine/ ear disorder.  The patient's medical history was not provided. Concomitant medications reported included acetylsalicylic acid, simvastatin, vitamin D, multivitamin and levothyroxine for product use for unknown indication.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) via unknown route for prophylaxis of COVID-19 infection. Patient reports that he was scheduled for a brain scan.  On 28 Jan 2021, the patient experienced significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine.   Treatment information was not provided.  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) was not applicable.   The outcome of the event(s), significant hearing problem in left ear, loss of hearing in left ear, gets loud ringing in the ear, amplified sounds after taking the first dose of the moderna vaccine was 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Meniere's disease, Oropharyngeal discomfort, Paranasal sinus discomfort, Productive cough
Clinical narrative: A spontaneous report was received from a consumer [United States] concerning 60 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced worsening of meniere's disease symptoms/meniere's disease, scratchy throat/oropharyngeal discomfort, sinus pressure/paranasal sinus discomfort, dry cough/cough, phlegm/productive cough, vomiting.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 046A21A) on 18 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.    On 18 Mar 2021 the patient developed a dry cough, scratchy throat, sinus pressure, phlegm, vomiting x1, and worsening of her Meniere's disease symptoms. The medically significant event is meniere's disease. Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events worsening of meniere's disease symptoms, scratchy throat, sinus pressure, dry cough, phlegm, and vomiting was not reported.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Vomiting is consistent with the product known safety profile.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: A spontaneous report was received from a consumer [United States] concerning 60 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced worsening of meniere's disease symptoms/meniere's disease, scratchy throat/oropharyngeal discomfort, sinus pressure/paranasal sinus discomfort, dry cough/cough, phlegm/productive cough, vomiting.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 046A21A) on 18 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.    On 18 Mar 2021 the patient developed a dry cough, scratchy throat, sinus pressure, phlegm, vomiting x1, and worsening of her Meniere's disease symptoms. The medically significant event is meniere's disease. Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events worsening of meniere's disease symptoms, scratchy throat, sinus pressure, dry cough, phlegm, and vomiting was not reported.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Vomiting is consistent with the product known safety profile.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hyperpyrexia, Hypothermia
Clinical narrative: feel freezing; temperature which read 104 degrees Fahrenheit; feel cold; she felt hot inside; A spontaneous report was received from a consumer, concerning  a 69 years adult female patient, who received Moderna COVID-19 Vaccine and experienced feel freezing/ Hypothermia, temperature which read 104 degrees Fahrenheit/ Hyperpyrexia, feel cold/ Chills, she felt hot inside/ Feeling hot.  The patient's medical history was not provided.  On 08Feb2021, prior to the onset of events, the patient received their first of two planned  A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event(s) feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit was unknown.  doses of mRNA-1273 (batch number: 031L20A) via unknown route for COVID-19 infection prophylaxis. On 08Mar2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 027A21A) via unknown route for COVID-19 infection prophylaxis.  On 09Mar2021, patient began to feel cold then went to the supermarket where she began to feel freezing and left, at  home although the heat was on, she still felt cold and resorted to wearing a winter jacket and two blankets still feeling freezing but oddly enough, she felt hot inside so she took her temperature which read 104 degrees Fahrenheit. She then proceeded to drink 1.5 cups of cold sparkling water and gradually these symptoms subsided.  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 (Cold,Hyperthermia,Feeling hot, Chills) was considered to be not unknown at the time of this report.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Major depression, Suicidal ideation
Clinical narrative: A Spontaneous report was received from a consumer concerning a male patient of an unknown age, who received Modern's COVID-19 vaccine (mRNA-1273) and experienced suicidal ideation and severe depression (Major Depression). The patient's medical history is unknown. Concomitant medications is unknown. On unknown date, 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 unknown date the patient experienced suicidal Ideation and depression after taking the vaccine. The treatment details were unknown. Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events suicidal Ideation and depression after taking the vaccine 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 reported events, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Erythema, Eye haemorrhage, Nasal discomfort, Product dose omission issue
Clinical narrative: A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive 2nd dose within recommended time frame/product dose omission issue and experienced 2 busted blood vessel in left eye/eye hemorrhage, throat burning sensation/throat irritation, nasal irritation/nasal discomfort, breast burning/breast pain and red spots on face and face turned bright red randomly/erythema. The patient's medical history included cataract surgery. Products known to have been used by the patient, within two weeks prior to the event, include Loteprednol etabonate, Bromfenac Sodium, and Gentamicin Sulfate. On 05Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch: 041120A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient did not receive 2nd dose within recommended time frame. On 02 Feb 2021, patient had red spots on face and on 04 Feb 2021, her face turned bright red randomly, throat, nose and breast were burning and on 10 Feb 2021, she had 2 busted blood vessel in left eye. The event 2 busted blood vessel in left eye was considered as medically significant. Treatment medication for the event included Diphenhydramine, unspecified steroid and Cortisone cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event did not receive 2nd dose within recommended time frame was resolved on an unspecified date, throat, nose, breast burning was resolved on 11 Feb 2021, 2 busted blood vessel in left eye was resolved on 15 Feb 2021 and red spots on face and face turned bright red randomly was not resolved at the time of this report. Reporter's Comments: Based on the HCP reporter's assessment  the events are assessed as unlikely related to mRNA-1273.The patient had eye surgery and was on medications causing the reported events as side effects.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: A spontaneous report was received from a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive 2nd dose within recommended time frame/product dose omission issue and experienced 2 busted blood vessel in left eye/eye hemorrhage, throat burning sensation/throat irritation, nasal irritation/nasal discomfort, breast burning/breast pain and red spots on face and face turned bright red randomly/erythema. The patient's medical history included cataract surgery. Products known to have been used by the patient, within two weeks prior to the event, include Loteprednol etabonate, Bromfenac Sodium, and Gentamicin Sulfate. On 05Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch: 041120A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient did not receive 2nd dose within recommended time frame. On 02 Feb 2021, patient had red spots on face and on 04 Feb 2021, her face turned bright red randomly, throat, nose and breast were burning and on 10 Feb 2021, she had 2 busted blood vessel in left eye. The event 2 busted blood vessel in left eye was considered as medically significant. Treatment medication for the event included Diphenhydramine, unspecified steroid and Cortisone cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event did not receive 2nd dose within recommended time frame was resolved on an unspecified date, throat, nose, breast burning was resolved on 11 Feb 2021, 2 busted blood vessel in left eye was resolved on 15 Feb 2021 and red spots on face and face turned bright red randomly was not resolved at the time of this report. Reporter's Comments: Based on the HCP reporter's assessment  the events are assessed as unlikely related to mRNA-1273.The patient had eye surgery and was on medications causing the reported events as side effects.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Mood swings, Suicidal ideation
Clinical narrative: Suicidal thoughts; Mood swings; Depression; A spontaneous report was received from a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced suicidal thoughts, mood swings and depression   The patient's medical history was not provided. Concomitant medications were not reported.  On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced mood swings, depression, and suicidal thoughts after getting the shot. The patient provided limited information before ending the call   Action taken with second dose mRNA-1273 in response to the events was not reported.   The outcome of the events, suicidal shots, mood swings, depression and patient got violent were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure increased, Heart rate increased, Lethargy
Clinical narrative: Anaphylactic reaction/Shortness of breath/ Trouble swallowing; Weakness; Sore throat; Night sweats; Elevated blood pressure; Heart rate in 120s; feel lethargic; A spontaneous report was received from a consumer concerning for a 73 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylactic reaction, shortness of breath/ dyspnoea, trouble swallowing/ dysphagia, feel lethargic/lethargy, weakness/asthenia, night sweats and sore throat/ oropharyngeal pain, elevated blood pressure and heart rate in 120s.  The patient's medical history was not provided. The concomitant medications on use were 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 (lot number: 024M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (lot number: 032M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 12 Mar 2021, within 10 minutes of second dose, patient experienced anaphylactic reaction. She experienced flushing and shortness of breath and was given oxygen, benadryl 50 mg and depomedrol intramuscularly by an EMT on site. Patient was taken to the ER for evaluation and discharged on medrol dose pak, tagamet BID and benadryl. As of today 12 days later, patient still has  he following side effects: flushing beet red, trouble swallowing feels like throat is closing in, night sweats, feels lethargic, weakness, elevated blood pressure and heart rate in 120s and a sore throat. She has consulted with three HCPs since discharge and all have said to continue on her medications.  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 events anaphylactic reaction, shortness of breath, trouble swallowing, feel lethargic, weakness, night sweats and sore throat blood pressure and heart rate in 120s were not recovered 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Oropharyngeal pain
Clinical narrative: Anaphylactic reaction/Shortness of breath/ Trouble swallowing; Weakness; Sore throat; Night sweats; Elevated blood pressure; Heart rate in 120s; feel lethargic; A spontaneous report was received from a consumer concerning for a 73 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylactic reaction, shortness of breath/ dyspnoea, trouble swallowing/ dysphagia, feel lethargic/lethargy, weakness/asthenia, night sweats and sore throat/ oropharyngeal pain, elevated blood pressure and heart rate in 120s.  The patient's medical history was not provided. The concomitant medications on use were 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 (lot number: 024M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (lot number: 032M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 12 Mar 2021, within 10 minutes of second dose, patient experienced anaphylactic reaction. She experienced flushing and shortness of breath and was given oxygen, benadryl 50 mg and depomedrol intramuscularly by an EMT on site. Patient was taken to the ER for evaluation and discharged on medrol dose pak, tagamet BID and benadryl. As of today 12 days later, patient still has  he following side effects: flushing beet red, trouble swallowing feels like throat is closing in, night sweats, feels lethargic, weakness, elevated blood pressure and heart rate in 120s and a sore throat. She has consulted with three HCPs since discharge and all have said to continue on her medications.  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 events anaphylactic reaction, shortness of breath, trouble swallowing, feel lethargic, weakness, night sweats and sore throat blood pressure and heart rate in 120s were not recovered 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.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chest X-ray, Computerised tomogram, Electrocardiogram, Hypertension
Clinical narrative: blood pressure was high; mild stroke; transient global amnesia; sore arm; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/cerebrovascular accident, transient global amnesia, sore arm and high blood pressure.  The patient's medical history was unknown. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, prior to the onset of event, the patient received their second of two planned dose of mRNA-1273 (Lot number: 010A21A) vaccine in the left arm for prophylaxis of COVID-19 infection.  On the same day as the second dose, the patient experienced a sore arm later in the day.  On 21 Mar 2021, she had mild stroke. It shocked her because she did not have medical issues that would have lead to a stroke. She did not immediately go to hospital. She followed up with her doctor who then asked her to go to the urgent care or emergency room (ER). She went to the urgent care first and they said she needed to go to the ER because of the symptoms she was having. She then went to the ER. She was there for 6 hours. She asked the nurse if they were going to admit her but nurse said no because she was not having the symptoms at that time. In the ER, she had an MRI, CAT scan, EKG, chest x-ray done and also had blood drawn.  The patient had high blood pressure noted while in the ER.  The ER doctor said she had transient global amnesia which they said was precursor to the stroke. The event was also considered to be medically significant. Treatment information was not provided.   Action taken with the mRNA-1273 in response to the event was not applicable.  The outcome of the events, mild stroke, transient global amnesia, sore arm and high blood pressure, 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.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, Transient global amnesia
Clinical narrative: blood pressure was high; mild stroke; transient global amnesia; sore arm; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/cerebrovascular accident, transient global amnesia, sore arm and high blood pressure.  The patient's medical history was unknown. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, prior to the onset of event, the patient received their second of two planned dose of mRNA-1273 (Lot number: 010A21A) vaccine in the left arm for prophylaxis of COVID-19 infection.  On the same day as the second dose, the patient experienced a sore arm later in the day.  On 21 Mar 2021, she had mild stroke. It shocked her because she did not have medical issues that would have lead to a stroke. She did not immediately go to hospital. She followed up with her doctor who then asked her to go to the urgent care or emergency room (ER). She went to the urgent care first and they said she needed to go to the ER because of the symptoms she was having. She then went to the ER. She was there for 6 hours. She asked the nurse if they were going to admit her but nurse said no because she was not having the symptoms at that time. In the ER, she had an MRI, CAT scan, EKG, chest x-ray done and also had blood drawn.  The patient had high blood pressure noted while in the ER.  The ER doctor said she had transient global amnesia which they said was precursor to the stroke. The event was also considered to be medically significant. Treatment information was not provided.   Action taken with the mRNA-1273 in response to the event was not applicable.  The outcome of the events, mild stroke, transient global amnesia, sore arm and high blood pressure, 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Escherichia infection, Food poisoning
Clinical narrative: E.Coli Infection; Food Poisoning; A spontaneous report was received from a consumer, concerning a 71-year-old male patient who received Modern's COVID-19 vaccine (mRNA-1273) and developed E. coli Infection and food poisoning.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 25 Feb 2021, approximately three weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch number:02A21A) in the left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, the patient was diagnosed with E-coli infection which was considered as serious (medically significant) and food poisoning.   Treatment medication included unknown antibiotics for the events.   Action taken with mRNA-1273 in response to events were unknown.  The outcome of the events E. coli Infection and food poisoning were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Fatigue, Headache, Myocarditis
Clinical narrative: A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt like a needle in her kidney/renal pain, feve/pyrexiar, fatigue, tiredness/fatigue, chest pain, upset heart/cardiac disorder, headache and inflammation of heart muscle/myocarditis.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, metformin, glimepiride, simvastatin, losartan.  On 16 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 001B21A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Mar 2021, 5 minutes later she experienced felt like a needle in her kidney. On 17 Mar 2021, she had fever. On an unknown date in Mar 2021, she had fatigue and tiredness. On 20 Dec 2021, she had chest pain and upset heart. On 21 Mar 2021, she had a headache and fever. On 22 Mar 2021 she had chest pain and went to the doctor and was diagnosed inflammation of the heart muscle. The event inflammation of the heart muscle was assessed medically significant.  Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.  The events felt like a needle in her kidney was resolved on 16 Mar 2021.  The events fever and headache were resolved on 21 Mar 2021.  The outcome of the evens fatigue, tiredness, chest pain, upset heart and inflammation of heart muscle were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal pain
Clinical narrative: A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt like a needle in her kidney/renal pain, feve/pyrexiar, fatigue, tiredness/fatigue, chest pain, upset heart/cardiac disorder, headache and inflammation of heart muscle/myocarditis.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, metformin, glimepiride, simvastatin, losartan.  On 16 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 001B21A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Mar 2021, 5 minutes later she experienced felt like a needle in her kidney. On 17 Mar 2021, she had fever. On an unknown date in Mar 2021, she had fatigue and tiredness. On 20 Dec 2021, she had chest pain and upset heart. On 21 Mar 2021, she had a headache and fever. On 22 Mar 2021 she had chest pain and went to the doctor and was diagnosed inflammation of the heart muscle. The event inflammation of the heart muscle was assessed medically significant.  Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.  The events felt like a needle in her kidney was resolved on 16 Mar 2021.  The events fever and headache were resolved on 21 Mar 2021.  The outcome of the evens fatigue, tiredness, chest pain, upset heart and inflammation of heart muscle were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hypoxia, Nausea, Pain, Palpitations
Clinical narrative: Oxygen drop; Shingles on her forehead; Heart Racing; Aches/pain; Rash; Sore arm; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Oxygen drop) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOXIA (Oxygen drop) (seriousness criterion hospitalization), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was hospitalized on 20-Feb-2021 due to HYPOXIA. At the time of the report, HYPOXIA (Oxygen drop), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: 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: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: Oxygen drop; Shingles on her forehead; Heart Racing; Aches/pain; Rash; Sore arm; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Oxygen drop) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HYPOXIA (Oxygen drop) (seriousness criterion hospitalization), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was hospitalized on 20-Feb-2021 due to HYPOXIA. At the time of the report, HYPOXIA (Oxygen drop), HERPES ZOSTER (Shingles on her forehead), PALPITATIONS (Heart Racing), PAIN (Aches/pain), RASH (Rash), VACCINATION SITE PAIN (Sore arm), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; 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 heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough.   The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone.   On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue.   On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious.  On 25 Mar 2021, he coughed up some yellow mucus.  Treatment for the events reported included pacemaker and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia, Pain in extremity, Productive cough
Clinical narrative: Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; 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 heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough.   The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone.   On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue.   On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious.  On 25 Mar 2021, he coughed up some yellow mucus.  Treatment for the events reported included pacemaker and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; 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 heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough.   The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone.   On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue.   On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious.  On 25 Mar 2021, he coughed up some yellow mucus.  Treatment for the events reported included pacemaker and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Mental impairment
Clinical narrative: stroke-like symptoms, reacting like he "had a stroke" following their vaccine; Feels like a vegetable; A spontaneous report  was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of stroke-like symptoms, reacting like he "had a stroke" following his vaccine and current condition is "like a vegetable" which lead to the hospitalization of the patient.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On unknown date, prior to the onset of the events, the patient received their dose of mRNA (Batch/Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On unknown date, patient experienced event reacting like he "had a stroke" following their vaccine. Following severe symptoms, patient was subsequently hospitalized and had been transferred twice since. Reporter said their current status is "like a vegetable". The events are medically significant.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) stroke-like symptoms, reacting like he "had a stroke" following their vaccine and current condition is "like a vegetable" were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Depression, Emotional disorder
Clinical narrative: Severe depression; Emotional reaction; Severe anger; A spontaneous report was received from a consumer concerning a 37 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced emotional reaction, severe depression and severe anger.  The patient's medical history included hysterectomy. Products known to have been used by the patient, within two weeks prior to the event included ondansetron, pantoprazole, vitamin B complex, probiotics.  On 26 Mar 2021, approximately one day prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 019B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Mar 2021, the patient experienced severe depression and severe anger, had emotional reaction and no physical reaction. The patient reported that it was not normal for her as she experience this when she has PMS (Premenstrual syndrome) and after taking steroids. However, the patient does not have PMS and did not take any steroids. The patient felt better later. The event severe depression was considered medically significant. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events emotional reaction, severe depression and severe anger 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. Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; A spontaneous report was received from a consumer concerning reporter's husband a 79-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed pneumonia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 02 Mar 2021, approximately 13 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 001A21A) via an unknown route for prophylaxis of COVID-19 infection.  On 14 Mar 2021 the patient was hospitalized for pneumonia and was discharged on 16 Mar 2021. The reporter stated that her husband has "previously been prone to pneumonia".  Treatment information included unspecified antibiotics.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event pneumonia 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 event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Delusional perception, Dizziness, Dysstasia, Fall
Clinical narrative: very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection arm]; itched; Could not stand up staright; had 17 or 18 falls in 2 days; slept so much after the vaccination; A spontaneous report was received from a pharmacist concerning a 70-year-old age female patient who received mRNA-1273 vaccine and experienced very frantic/delirium, episode of psychosis/psychotic disorder, Delusions/delusional perception, dizziness, Headache, malaise, knot on injection arm/vaccination site mass, itch/pruritis, could not stand up straight/dysstasia, 17 or 18 falls for 2 days, slept so much/Hypersomnia.  The medical history was anaphylactic reaction like iodine. Concomitant medications were not provided by the reporter.  On 17 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: 045A21A) via Intramuscular route in the right deltoid for prophylaxis of COVID-19 infection.   After the first dose of vaccination, on an unspecified date, the experienced delusional, dizzy, and go through an episode of psychosis and was very frantic and got better and patient never had this before, had headaches and malaise, slept so much, had a big knot in her arm, itched, hard, could not stand up straight, 17 or 18 falls in 2 days. The event delirium worried about was medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event frantic was resolved. The outcome of the events episode of psychosis, delusions, dizziness, headache, malaise, knot on injection arm, itch, could not stand up straight, 17 or 18 falls for 2 days, slept so much 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Malaise, Pruritus, Psychotic disorder
Clinical narrative: very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection arm]; itched; Could not stand up staright; had 17 or 18 falls in 2 days; slept so much after the vaccination; A spontaneous report was received from a pharmacist concerning a 70-year-old age female patient who received mRNA-1273 vaccine and experienced very frantic/delirium, episode of psychosis/psychotic disorder, Delusions/delusional perception, dizziness, Headache, malaise, knot on injection arm/vaccination site mass, itch/pruritis, could not stand up straight/dysstasia, 17 or 18 falls for 2 days, slept so much/Hypersomnia.  The medical history was anaphylactic reaction like iodine. Concomitant medications were not provided by the reporter.  On 17 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: 045A21A) via Intramuscular route in the right deltoid for prophylaxis of COVID-19 infection.   After the first dose of vaccination, on an unspecified date, the experienced delusional, dizzy, and go through an episode of psychosis and was very frantic and got better and patient never had this before, had headaches and malaise, slept so much, had a big knot in her arm, itched, hard, could not stand up straight, 17 or 18 falls in 2 days. The event delirium worried about was medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event frantic was resolved. The outcome of the events episode of psychosis, delusions, dizziness, headache, malaise, knot on injection arm, itch, could not stand up straight, 17 or 18 falls for 2 days, slept so much 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.