chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Impaired healing, Large intestinal stenosis, Myalgia, Nightmare, Pain
Clinical narrative: colon stenosis; unspecified disorder of intestine; dry skin; Laceration; Wound healing delayed; bruise; nightmares; general body pain; Muscle ache; fatigue; fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of LARGE INTESTINAL STENOSIS (colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included Stomach pain, Diarrhea (two to three formed stools per day), Constipation and Surgery (Surgery to remove affected portions of his intestines.) in 1991.   On 23-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, LARGE INTESTINAL STENOSIS (colon stenosis), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            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.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Skin laceration
Clinical narrative: colon stenosis; unspecified disorder of intestine; dry skin; Laceration; Wound healing delayed; bruise; nightmares; general body pain; Muscle ache; fatigue; fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of LARGE INTESTINAL STENOSIS (colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included Stomach pain, Diarrhea (two to three formed stools per day), Constipation and Surgery (Surgery to remove affected portions of his intestines.) in 1991.   On 23-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, LARGE INTESTINAL STENOSIS (colon stenosis), GASTROINTESTINAL DISORDER (unspecified disorder of intestine), DRY SKIN (dry skin), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (bruise), NIGHTMARE (nightmares), PAIN (general body pain), MYALGIA (Muscle ache), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            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.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Transient ischaemic attack
Clinical narrative: Transient ischaemic attack; Flickering lights; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in an 80-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.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criterion medically significant) and PHOTOPSIA (Flickering lights). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and PHOTOPSIA (Flickering lights) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications are not provided. The patient was taken to the emergency room, where the patient was evaluated and released without an overnight stay.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Bone pain, Headache, Myalgia, Near death experience
Clinical narrative: Thought was going to die with first shot; Feeling paralyzed and laid in bed for 3 days; About 7-8 hours her arm was killing; Lot of her previous pain from the accident had come back; Unusual reaction; Every bone and muscle in her body was hurting; Headache; Every bone and muscle in her body was hurting; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Thought was going to die with first shot) and PARALYSIS (Feeling paralyzed and laid in bed for 3 days) in a 72-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 Accident automobile. Concomitant products included ALPRAZOLAM (XANAX), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and MELATONIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Thought was going to die with first shot) (seriousness criterion medically significant), PARALYSIS (Feeling paralyzed and laid in bed for 3 days) (seriousness criterion medically significant), PAIN IN EXTREMITY (About 7-8 hours her arm was killing), PAIN (Lot of her previous pain from the accident had come back), ADVERSE REACTION (Unusual reaction), BONE PAIN (Every bone and muscle in her body was hurting), HEADACHE (Headache) and MYALGIA (Every bone and muscle in her body was hurting). At the time of the report, NEAR DEATH EXPERIENCE (Thought was going to die with first shot), PARALYSIS (Feeling paralyzed and laid in bed for 3 days), PAIN IN EXTREMITY (About 7-8 hours her arm was killing), PAIN (Lot of her previous pain from the accident had come back), ADVERSE REACTION (Unusual reaction), BONE PAIN (Every bone and muscle in her body was hurting), HEADACHE (Headache) and MYALGIA (Every bone and muscle in her body was hurting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.  Company Comment: 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.   This case was linked to MOD-2021-099253 (Patient Link).; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paralysis
Clinical narrative: Thought was going to die with first shot; Feeling paralyzed and laid in bed for 3 days; About 7-8 hours her arm was killing; Lot of her previous pain from the accident had come back; Unusual reaction; Every bone and muscle in her body was hurting; Headache; Every bone and muscle in her body was hurting; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Thought was going to die with first shot) and PARALYSIS (Feeling paralyzed and laid in bed for 3 days) in a 72-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 Accident automobile. Concomitant products included ALPRAZOLAM (XANAX), HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) and MELATONIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Thought was going to die with first shot) (seriousness criterion medically significant), PARALYSIS (Feeling paralyzed and laid in bed for 3 days) (seriousness criterion medically significant), PAIN IN EXTREMITY (About 7-8 hours her arm was killing), PAIN (Lot of her previous pain from the accident had come back), ADVERSE REACTION (Unusual reaction), BONE PAIN (Every bone and muscle in her body was hurting), HEADACHE (Headache) and MYALGIA (Every bone and muscle in her body was hurting). At the time of the report, NEAR DEATH EXPERIENCE (Thought was going to die with first shot), PARALYSIS (Feeling paralyzed and laid in bed for 3 days), PAIN IN EXTREMITY (About 7-8 hours her arm was killing), PAIN (Lot of her previous pain from the accident had come back), ADVERSE REACTION (Unusual reaction), BONE PAIN (Every bone and muscle in her body was hurting), HEADACHE (Headache) and MYALGIA (Every bone and muscle in her body was hurting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.  Company Comment: 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.   This case was linked to MOD-2021-099253 (Patient Link).; 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Apraxia, Attention deficit hyperactivity disorder, Cognitive disorder, Condition aggravated
Clinical narrative: Progressive Limbic Encephalitis; inattention; short term memory loss; apraxia; slow cognitive speeds; Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis), CONDITION AGGRAVATED (Progressive Limbic Encephalitis), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention), AMNESIA (short term memory loss), APRAXIA (apraxia) and COGNITIVE DISORDER (slow cognitive speeds) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MZ0A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Limbic encephalitis in September 2020.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis) (seriousness criteria hospitalization and medically significant), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention) (seriousness criteria hospitalization and medically significant), AMNESIA (short term memory loss) (seriousness criteria hospitalization and medically significant), APRAXIA (apraxia) (seriousness criteria hospitalization and medically significant) and COGNITIVE DISORDER (slow cognitive speeds) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced CONDITION AGGRAVATED (Progressive Limbic Encephalitis) (seriousness criterion hospitalization). At the time of the report, LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis), CONDITION AGGRAVATED (Progressive Limbic Encephalitis), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention), AMNESIA (short term memory loss), APRAXIA (apraxia) and COGNITIVE DISORDER (slow cognitive speeds) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with Plasma Pherisis x7 exchanges plus IV methylprednisolone followed by Prednisone taper.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Limbic encephalitis
Clinical narrative: Progressive Limbic Encephalitis; inattention; short term memory loss; apraxia; slow cognitive speeds; Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis), CONDITION AGGRAVATED (Progressive Limbic Encephalitis), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention), AMNESIA (short term memory loss), APRAXIA (apraxia) and COGNITIVE DISORDER (slow cognitive speeds) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MZ0A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Limbic encephalitis in September 2020.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis) (seriousness criteria hospitalization and medically significant), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention) (seriousness criteria hospitalization and medically significant), AMNESIA (short term memory loss) (seriousness criteria hospitalization and medically significant), APRAXIA (apraxia) (seriousness criteria hospitalization and medically significant) and COGNITIVE DISORDER (slow cognitive speeds) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced CONDITION AGGRAVATED (Progressive Limbic Encephalitis) (seriousness criterion hospitalization). At the time of the report, LIMBIC ENCEPHALITIS (Recurrence of Limbic Encephalitis/Progressive Limbic Encephalitis), CONDITION AGGRAVATED (Progressive Limbic Encephalitis), ATTENTION DEFICIT HYPERACTIVITY DISORDER (inattention), AMNESIA (short term memory loss), APRAXIA (apraxia) and COGNITIVE DISORDER (slow cognitive speeds) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with Plasma Pherisis x7 exchanges plus IV methylprednisolone followed by Prednisone taper.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Haematocrit decreased, Headache, Myalgia
Clinical narrative: Midsternal chest pain, described as sharp and 5 out 10 in severity; a rash on her right thigh going down her leg/ petechia; hematocrit was low; large welt on her arm at the injection site; fever; body aches; headache; no energy; throbbing arm pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity) in a 31-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.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ASTHENIA (no energy), PAIN IN EXTREMITY (throbbing arm pain), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). On 23-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (large welt on her arm at the injection site). On 29-Apr-2021, the patient experienced PETECHIAE (a rash on her right thigh going down her leg/ petechia) and HAEMATOCRIT DECREASED (hematocrit was low). On 03-May-2021 at 2:00 AM, the patient experienced CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity), PETECHIAE (a rash on her right thigh going down her leg/ petechia) and HAEMATOCRIT DECREASED (hematocrit was low) outcome was unknown and ASTHENIA (no energy), PAIN IN EXTREMITY (throbbing arm pain), VACCINATION SITE URTICARIA (large welt on her arm at the injection site), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to ER for treatment of chest pain on 03-May-2021 and was discharged same day.  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.   This case was linked to MOD-2021-099479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received on 03-May-2021: AE of Chest pain added; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Petechiae, Pyrexia, Vaccination site urticaria
Clinical narrative: Midsternal chest pain, described as sharp and 5 out 10 in severity; a rash on her right thigh going down her leg/ petechia; hematocrit was low; large welt on her arm at the injection site; fever; body aches; headache; no energy; throbbing arm pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity) in a 31-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.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ASTHENIA (no energy), PAIN IN EXTREMITY (throbbing arm pain), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). On 23-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (large welt on her arm at the injection site). On 29-Apr-2021, the patient experienced PETECHIAE (a rash on her right thigh going down her leg/ petechia) and HAEMATOCRIT DECREASED (hematocrit was low). On 03-May-2021 at 2:00 AM, the patient experienced CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Midsternal chest pain, described as sharp and 5 out 10 in severity), PETECHIAE (a rash on her right thigh going down her leg/ petechia) and HAEMATOCRIT DECREASED (hematocrit was low) outcome was unknown and ASTHENIA (no energy), PAIN IN EXTREMITY (throbbing arm pain), VACCINATION SITE URTICARIA (large welt on her arm at the injection site), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to ER for treatment of chest pain on 03-May-2021 and was discharged same day.  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.   This case was linked to MOD-2021-099479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received on 03-May-2021: AE of Chest pain added; 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: Blood test, Plasma cell myeloma recurrent
Clinical narrative: Disease (multiple myeloma) exacerbation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLASMA CELL MYELOMA RECURRENT (Disease (multiple myeloma) exacerbation) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma in remission (in remission more than 7 months).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PLASMA CELL MYELOMA RECURRENT (Disease (multiple myeloma) exacerbation) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA RECURRENT (Disease (multiple myeloma) exacerbation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood test: "went in roof," "significant change in blood count (abnormal) "Went in roof," "Significant change in blood counting".         The patient had multiple myeloma and was in remission more than 7 months at the time of the first vaccine dosing on 20-JAN-2021.  Treatment information was not reported.  Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.   This case was linked to MOD-2021-098777 (Patient Link).; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Influenza like illness, Loss of consciousness, Pyrexia
Clinical narrative: In and out of consciousness; feeling faint, fainted briefly/Passed out multiple times; Couldn't stand up; Flu-like symptoms; Fever with a temperature of 103 degress; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (In and out of consciousness) and SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010N120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included AMITRIPTYLINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (In and out of consciousness) (seriousness criteria hospitalization and medically significant), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) (seriousness criteria hospitalization and medically significant), DYSSTASIA (Couldn't stand up) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). 24-Mar-2021, the patient experienced PYREXIA (Fever with a temperature of 103 degress). At the time of the report, LOSS OF CONSCIOUSNESS (In and out of consciousness), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times), DYSSTASIA (Couldn't stand up), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever with a temperature of 103 degress) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 103 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received treatment medication included Tylenol, to alleviate the symptoms.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: In and out of consciousness; feeling faint, fainted briefly/Passed out multiple times; Couldn't stand up; Flu-like symptoms; Fever with a temperature of 103 degress; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (In and out of consciousness) and SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010N120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included AMITRIPTYLINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (In and out of consciousness) (seriousness criteria hospitalization and medically significant), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times) (seriousness criteria hospitalization and medically significant), DYSSTASIA (Couldn't stand up) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). 24-Mar-2021, the patient experienced PYREXIA (Fever with a temperature of 103 degress). At the time of the report, LOSS OF CONSCIOUSNESS (In and out of consciousness), SYNCOPE (feeling faint, fainted briefly/Passed out multiple times), DYSSTASIA (Couldn't stand up), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever with a temperature of 103 degress) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 103 High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received treatment medication included Tylenol, to alleviate the symptoms.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site cellulitis, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Cellulitis; Blisters on left arm and shoulder; hot to the touch; left arm got swelled up; It had red ring all over it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE CELLULITIS (Cellulitis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 007B21A) for COVID-19 vaccination.   Concurrent medical conditions included Idiopathic thrombocytopenic purpura. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LISINOPRIL and BUSPIRONE HCL for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INJECTION SITE CELLULITIS (Cellulitis) (seriousness criterion medically significant) with BLISTER (Blisters on left arm and shoulder), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE SWELLING (left arm got swelled up) and VACCINATION SITE ERYTHEMA (It had red ring all over it). At the time of the report, INJECTION SITE CELLULITIS (Cellulitis) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications reported.  Treatment of these events included Doxycycline for 10days, symptoms stopped about 14 days after taking the Doxycycline.  Company Comment: 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Rheumatoid arthritis, Scleritis
Clinical narrative: BAD FLARE UP IN EYE (SCLERITIS); Rheumatoid arthritis flare up; Cold sores; This spontaneous case was reported by a consumer and describes the occurrence of SCLERITIS (BAD FLARE UP IN EYE (SCLERITIS)) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-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.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In March 2021, the patient experienced SCLERITIS (BAD FLARE UP IN EYE (SCLERITIS)) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and ORAL HERPES (Cold sores). At the time of the report, SCLERITIS (BAD FLARE UP IN EYE (SCLERITIS)), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and ORAL HERPES (Cold sores) outcome was unknown.            No concomitant medication reported. No treatment information provided.  Action taken with respect to mRNA-1273 was not applicable.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Pyrexia, Rib fracture
Clinical narrative: Heart flutter; Fever; Hurt self in the toilet/broken ribs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 57-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.     Concurrent medical conditions included Plaque psoriasis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) from 01-Mar-2021 to an unknown date for Plaque psoriasis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced RIB FRACTURE (Hurt self in the toilet/broken ribs). On an unknown date, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant) and PYREXIA (Fever). At the time of the report, CARDIAC FLUTTER (Heart flutter), RIB FRACTURE (Hurt self in the toilet/broken ribs) and PYREXIA (Fever) outcome was unknown.            The patient reported after started Skyrizi, she hurt herself in the toilet. She went to the emergency room on 18-Apr-2021 as she had broken ribs and physician prescribed medication, but she could not recall name. She reported after receiving Moderna vaccine she experienced heart flutter and fever in 2021.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the pyrexia event.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the pyrexia event.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. The reporter informed there were 2 deaths of those who had received their second dose of Moderna vaccine, same day, same location who died 2 hours after vaccine administration. Treatment information was not provided.  This is a patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unk) and died after he received the second dose of vaccine. No Medical History information was reported. Concomitant product use was not provided by the reporter Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unk) and died after he received the second dose of vaccine. No Medical History information was reported. Concomitant product use was not provided by the reporter Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Diarrhoea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat diarrhea cough chest tightness
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Within two hours spiked a fever too 102.00 degree became really sick pucking ever hours until 6am fever broke around 7am still feel really sick
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever after 12 hours, 101 degrees, ending after 36 hours, at 60 hours below injection upper arm red, hot to touch, sore.  Doctor prescribed cephalexin 500 mg, 3x daily.  90 hours tender still, less red and less hot, other than are feeling much better.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Chest X-ray, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: acute hypoxic respiratory failure, severe sepsis, acute COPD exacerbation, secondary to COVID-19 pneumonia.  remdesivir  Solu-Medrol 40 mg IV
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Sepsis
Clinical narrative: acute hypoxic respiratory failure, severe sepsis, acute COPD exacerbation, secondary to COVID-19 pneumonia.  remdesivir  Solu-Medrol 40 mg IV
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I had a fever blister in my left ear on the inside wall of my ear.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Pulmonary congestion
Clinical narrative: Cough  chest congestion   Tessalon
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: first 2 days, normal side effects (sore arm, fatigue) then day 3 dizziness and nausea all day and still  happening after 15 days. has not gone away yet
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever Cough Sore throat
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient slumped on chair at observation area within 5 minutes of vaccination but quickly regained consciousness when rph attempted to assist patient. Patient did not hit the ground and was unconscious for less than 30 seconds. patient urinated on self. blood pressure reading was 107/75mmhg and temperature was 97. Patient was monitored for more than 30 minutes afterward and left with a family member.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever ? Cough ? Sore Throat ? Generalized Body Aches ? Nasal Congestion  Patient has tried Tylenol.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever ? Cough ? Sore Throat ? Generalized Body Aches ? Nasal Congestion  Patient has tried Tylenol.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: about over a week later, injection site was very swollen and itchy, and had a welt the size of a baseball. temperature of injection site reads about 101.7 f. counseled pt to see doctor if injection site does not get better within 48 to 72 hours
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: about over a week later, injection site was very swollen and itchy, and had a welt the size of a baseball. temperature of injection site reads about 101.7 f. counseled pt to see doctor if injection site does not get better within 48 to 72 hours
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: 18-20 hrs after shot: -fatigue  -fever -soreness of injection site -swollen and red at injection site -armpit pain (left)  Three days after shot: -nausea  -swollen and red at injection site  (about 2-inch diameter) -injection site itching   Four days... -extreme headache  -swollen and red at injection site  -injection site itching  After 7 days... -injection site itching  -swelling decreased
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Nausea, Pyrexia
Clinical narrative: 18-20 hrs after shot: -fatigue  -fever -soreness of injection site -swollen and red at injection site -armpit pain (left)  Three days after shot: -nausea  -swollen and red at injection site  (about 2-inch diameter) -injection site itching   Four days... -extreme headache  -swollen and red at injection site  -injection site itching  After 7 days... -injection site itching  -swelling decreased
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Client of a group home requested to be vaccinated with the Johnson and Johnson (J&J) vaccine. Client was asked if he had ever had an adverse reaction the the Covid-19 vaccine, Client stated no. The J&J vaccine was administered in the client's left deltoid. Client went into observation area and was observed for 15 minutes without incident. When the Community Health Worker was entering the administration of the J&J into the system, the client had previously received 2 doses of Pfizer on dates 3/28 and 4/18. Client was requested to come back to observation. Client was observed for an additional 15 minutes. Client was instructed not to get any more Covid-19 vaccines. Group home administrator was notified of the event.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported feeling lightheaded and dizzy. patient sat in chair, removed mask to get air and drank some water. 911 was called as a precaution. a cool compress was placed on back of pt neck as directed by 911. vitals were within normal limits. pt reported feeling normal and walked to ambulance to sign paperwork as he reported not needing to go to the hospital.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Thyroid function test abnormal
Clinical narrative: 03/11/2021 : Low TSH 03/31/21 : Low TSH, + TPO, + TSO 04/23/21: low TSH, + TPO, + TSI 05/03/21: low TSH, +T3, +TSI  Severe FATIGUE, Continuous headache
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: About 20 minutes after the shot was given to me, I got a bad pain in my lower back. It has been 6 days  since it was given to me & I still have the back pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Joint range of motion decreased, Lethargy
Clinical narrative: From the day before, very sharp arm pain and not able to lift arm above shoulder, despite heavy garden  work the day before (day of vaccine) which is usual for this subject; woke up 050521 with lethargy, low  fever and stiffness. However the strangest was what I found that evening - a large red area NEXT to the  vaccination site all the way to underarm. This area felt bruised, including the underarm, and hurt to  touch, as well as being warm.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: From the day before, very sharp arm pain and not able to lift arm above shoulder, despite heavy garden  work the day before (day of vaccine) which is usual for this subject; woke up 050521 with lethargy, low  fever and stiffness. However the strangest was what I found that evening - a large red area NEXT to the  vaccination site all the way to underarm. This area felt bruised, including the underarm, and hurt to  touch, as well as being warm.
Age: 3.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Delusion, Hallucination, Paranoia, Psychotic disorder, Sleep deficit
Clinical narrative: 3 days after first dose started having Hallucinations sleep deprivation paranoia uncontrolled thoughts of being stalked raped hearing voices talking about her this physcosis escalated after the second dose came night an day out of nowhere she went to medical center ER who then transferred her to hospital where she spent 5 days and was released and is now taking Lexipro and Abilify to ease these delusions.. no history of mental illness prior to receiving Moderna vaccines
Age: 3.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal
Clinical narrative: 3 days after first dose started having Hallucinations sleep deprivation paranoia uncontrolled thoughts of being stalked raped hearing voices talking about her this physcosis escalated after the second dose came night an day out of nowhere she went to medical center ER who then transferred her to hospital where she spent 5 days and was released and is now taking Lexipro and Abilify to ease these delusions.. no history of mental illness prior to receiving Moderna vaccines
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Painful swelling about 5? below injection site. Swelling was large (about 7-8? in a diameter), hot, and painful. It started the size of a quarter the first day. Reaction showed up the day after getting the shot. It is now almost 10 days later and still have mild redness and itchiness. No rash. Seeked medical advice and was told it was normal and to ice it.