chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram T wave normal, Electrocardiogram abnormal, Haematocrit decreased, Haemoglobin normal, Influenza A virus test negative
Clinical narrative: Per hospital records, on 12/24/2021, "Patient is a 19 year old male who presented to the ED with complaints of sore throat and chest discomfort. He had a Pfizer COVID booster vaccination 4 days ago then developed some body aches the following day. Those symptoms improved over the next day but today he began having some burning in his throat and chest area. The burning sensation began at about 7 am when he first woke up and was still present around 10 am. The sensation did not radiate and was not associated with any nausea, vomiting, dyspnea, palpitations, edema or dizziness. He denies recent heavy physical exertion. He has a history of depression. He denies smoking, vaping, ETOH or drug use. He denied fever, chills, cough, shortness of breath, abdominal pain, nausea vomiting or diarrhea. Currently he is not having any chest pain, burning, cough, or shortness of breath. In the ED, his temperature was 98.4 F, pulse 97, respirations 18, blood pressure 130/81, oxygen saturation 97% on room air. Labs revealed a white count of 7400, hemoglobin 14.3, hematocrit 41.8, platelets 215, high sensitive troponin I was elevated at 5790.9. Throat culture was negative for group A strep. SARS-CoV-2 PCR was negative. Influenza PCR negative and RSV PCR was negative. A 12 lead EKG revealed sinus tachycardia with a rate of 101. Normal AST T-wave  as read by the ER physician. He received some IV fluids and Cardiology was notified. As soon as the the patient was transferred to medical floor, patient had no chest pain, shortness of breath or palpitations. Troponin went up to 7610 and then trended down to 3554. Echocardiogram was done that showed normal ejection fraction with no valvular disease and wall motion abnormality. Repeated EKG is also negative for acute ischemic changes and showed normal sinus rhythm. Cardiology evaluated the patient again today and did recommend that patient could be discharged to home but he needs to have a follow-up echocardiogram. Discharge plan is discussed with the patient and he agrees with the plan".
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Platelet count normal, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Per hospital records, on 12/24/2021, "Patient is a 19 year old male who presented to the ED with complaints of sore throat and chest discomfort. He had a Pfizer COVID booster vaccination 4 days ago then developed some body aches the following day. Those symptoms improved over the next day but today he began having some burning in his throat and chest area. The burning sensation began at about 7 am when he first woke up and was still present around 10 am. The sensation did not radiate and was not associated with any nausea, vomiting, dyspnea, palpitations, edema or dizziness. He denies recent heavy physical exertion. He has a history of depression. He denies smoking, vaping, ETOH or drug use. He denied fever, chills, cough, shortness of breath, abdominal pain, nausea vomiting or diarrhea. Currently he is not having any chest pain, burning, cough, or shortness of breath. In the ED, his temperature was 98.4 F, pulse 97, respirations 18, blood pressure 130/81, oxygen saturation 97% on room air. Labs revealed a white count of 7400, hemoglobin 14.3, hematocrit 41.8, platelets 215, high sensitive troponin I was elevated at 5790.9. Throat culture was negative for group A strep. SARS-CoV-2 PCR was negative. Influenza PCR negative and RSV PCR was negative. A 12 lead EKG revealed sinus tachycardia with a rate of 101. Normal AST T-wave  as read by the ER physician. He received some IV fluids and Cardiology was notified. As soon as the the patient was transferred to medical floor, patient had no chest pain, shortness of breath or palpitations. Troponin went up to 7610 and then trended down to 3554. Echocardiogram was done that showed normal ejection fraction with no valvular disease and wall motion abnormality. Repeated EKG is also negative for acute ischemic changes and showed normal sinus rhythm. Cardiology evaluated the patient again today and did recommend that patient could be discharged to home but he needs to have a follow-up echocardiogram. Discharge plan is discussed with the patient and he agrees with the plan".
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Streptococcus test negative, Throat irritation, Troponin I, Troponin increased
Clinical narrative: Per hospital records, on 12/24/2021, "Patient is a 19 year old male who presented to the ED with complaints of sore throat and chest discomfort. He had a Pfizer COVID booster vaccination 4 days ago then developed some body aches the following day. Those symptoms improved over the next day but today he began having some burning in his throat and chest area. The burning sensation began at about 7 am when he first woke up and was still present around 10 am. The sensation did not radiate and was not associated with any nausea, vomiting, dyspnea, palpitations, edema or dizziness. He denies recent heavy physical exertion. He has a history of depression. He denies smoking, vaping, ETOH or drug use. He denied fever, chills, cough, shortness of breath, abdominal pain, nausea vomiting or diarrhea. Currently he is not having any chest pain, burning, cough, or shortness of breath. In the ED, his temperature was 98.4 F, pulse 97, respirations 18, blood pressure 130/81, oxygen saturation 97% on room air. Labs revealed a white count of 7400, hemoglobin 14.3, hematocrit 41.8, platelets 215, high sensitive troponin I was elevated at 5790.9. Throat culture was negative for group A strep. SARS-CoV-2 PCR was negative. Influenza PCR negative and RSV PCR was negative. A 12 lead EKG revealed sinus tachycardia with a rate of 101. Normal AST T-wave  as read by the ER physician. He received some IV fluids and Cardiology was notified. As soon as the the patient was transferred to medical floor, patient had no chest pain, shortness of breath or palpitations. Troponin went up to 7610 and then trended down to 3554. Echocardiogram was done that showed normal ejection fraction with no valvular disease and wall motion abnormality. Repeated EKG is also negative for acute ischemic changes and showed normal sinus rhythm. Cardiology evaluated the patient again today and did recommend that patient could be discharged to home but he needs to have a follow-up echocardiogram. Discharge plan is discussed with the patient and he agrees with the plan".
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: Per hospital records, on 12/24/2021, "Patient is a 19 year old male who presented to the ED with complaints of sore throat and chest discomfort. He had a Pfizer COVID booster vaccination 4 days ago then developed some body aches the following day. Those symptoms improved over the next day but today he began having some burning in his throat and chest area. The burning sensation began at about 7 am when he first woke up and was still present around 10 am. The sensation did not radiate and was not associated with any nausea, vomiting, dyspnea, palpitations, edema or dizziness. He denies recent heavy physical exertion. He has a history of depression. He denies smoking, vaping, ETOH or drug use. He denied fever, chills, cough, shortness of breath, abdominal pain, nausea vomiting or diarrhea. Currently he is not having any chest pain, burning, cough, or shortness of breath. In the ED, his temperature was 98.4 F, pulse 97, respirations 18, blood pressure 130/81, oxygen saturation 97% on room air. Labs revealed a white count of 7400, hemoglobin 14.3, hematocrit 41.8, platelets 215, high sensitive troponin I was elevated at 5790.9. Throat culture was negative for group A strep. SARS-CoV-2 PCR was negative. Influenza PCR negative and RSV PCR was negative. A 12 lead EKG revealed sinus tachycardia with a rate of 101. Normal AST T-wave  as read by the ER physician. He received some IV fluids and Cardiology was notified. As soon as the the patient was transferred to medical floor, patient had no chest pain, shortness of breath or palpitations. Troponin went up to 7610 and then trended down to 3554. Echocardiogram was done that showed normal ejection fraction with no valvular disease and wall motion abnormality. Repeated EKG is also negative for acute ischemic changes and showed normal sinus rhythm. Cardiology evaluated the patient again today and did recommend that patient could be discharged to home but he needs to have a follow-up echocardiogram. Discharge plan is discussed with the patient and he agrees with the plan".
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: I asked for a Flu vacine and was given COVID vacine in error at Pharmacy.  I have now had 2, COVID boosters.    Pharmacy would not add the second booster onto my Vacaine Card.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: I asked for a Flu vacine and was given COVID vacine in error at Pharmacy.  I have now had 2, COVID boosters.    Pharmacy would not add the second booster onto my Vacaine Card.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chest X-ray, Chills, Dizziness
Clinical narrative: Patient developed bilateral leg weakness, foot numbness, urinary retention, and abdominal hyperesthesia.  MRI showed findings consistent with Guillan Barre Syndrome / transverse myelitis.  He is currently being admitted to the hospital for further work up.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Neuralgia, Pruritus
Clinical narrative: Patient developed bilateral leg weakness, foot numbness, urinary retention, and abdominal hyperesthesia.  MRI showed findings consistent with Guillan Barre Syndrome / transverse myelitis.  He is currently being admitted to the hospital for further work up.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Sensitive skin
Clinical narrative: Patient developed bilateral leg weakness, foot numbness, urinary retention, and abdominal hyperesthesia.  MRI showed findings consistent with Guillan Barre Syndrome / transverse myelitis.  He is currently being admitted to the hospital for further work up.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hyperaesthesia, Hypoaesthesia, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: Patient developed bilateral leg weakness, foot numbness, urinary retention, and abdominal hyperesthesia.  MRI showed findings consistent with Guillan Barre Syndrome / transverse myelitis.  He is currently being admitted to the hospital for further work up.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myelitis transverse, Spinal cord disorder, Urinary retention
Clinical narrative: Patient developed bilateral leg weakness, foot numbness, urinary retention, and abdominal hyperesthesia.  MRI showed findings consistent with Guillan Barre Syndrome / transverse myelitis.  He is currently being admitted to the hospital for further work up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick on both of them; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (got sick on both of them) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick on both of them). At the time of the report, ILLNESS (got sick on both of them) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-428271 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2CA) for COVID-19 vaccination.     The patient's past medical history included Clot blood. Concurrent medical conditions included Diabetes, Ovarian cancer ((20 years ago)) and Glaucoma. Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, METFORMIN, PRASUGREL HYDROCHLORIDE (EFFIENT), GLIPIZIDE, FENOFIBRATE, LOSARTAN, TRAZODONE, ATORVASTATIN, LINAGLIPTIN (TRADJENTA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), MECLIZINE [MECLOZINE], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], FOLIC ACID, ZINC, CALCIUM and MAGNESIUM for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the site). At the time of the report, VACCINATION SITE PAIN (Sore at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's conmeds includes Sulfate.  No treatment medication were provided.  Patient mentioned that her doctor experienced the same thing as she did after receiving Moderna vaccine.  Patient wanted to confirm the dose of the booster because a person at the pharmacy stated that it was the  full dose and she was confused whether it was the full dose or the half dose.  Additionally, patient asked about side effects of the 50 mcg booster dose and if they would the same as the primary series or different.   This case was linked to MOD-2021-400476, MOD-2021-400304 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: got a booster dose from a vaccine after Use by date 30; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Nov-2021 and was forwarded to Moderna on 01-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date(s) of administration of vaccine from 15Oct2021 on: 05Nov2021, 12Nov2021, 19NOv2021 and  26Nov2021   This case was linked to MOD-2021-402666 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect dose administered
Clinical narrative: patient received expired dose; patient received .5ml for booster; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and INCORRECT DOSE ADMINISTERED (patient received .5ml for booster) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A, 004C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 05-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and INCORRECT DOSE ADMINISTERED (patient received .5ml for booster). On 05-Apr-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and INCORRECT DOSE ADMINISTERED (patient received .5ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-402877 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: past the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past the expiration date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (past the expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fear of death, Illness, Myalgia, Pain
Clinical narrative: I got so sick from this one, I though I was dying /horrible 2nd dose; Terrible aches 2nd dose/pains from head to toe 2nd dose; It doesn't make sense a vaccine can make you that sick; chills 2nd dose; Fever 2nd dose/ Burning up of fever 2nd dose; Body ache 2nd dose / pains form head to toe 2nd dose; got so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got so sick), FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick) and CHILLS (chills 2nd dose) in a 51-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 COVID-19 from February 2020 to 2020 and COVID-19 from April 2020 to 2020.    On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced ILLNESS (got so sick). On 19-Nov-2021, the patient experienced FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick), CHILLS (chills 2nd dose), PYREXIA (Fever 2nd dose/ Burning up of fever 2nd dose) and MYALGIA (Body ache 2nd dose / pains form head to toe 2nd dose). On 22-Nov-2021, FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick), CHILLS (chills 2nd dose), PYREXIA (Fever 2nd dose/ Burning up of fever 2nd dose) and MYALGIA (Body ache 2nd dose / pains form head to toe 2nd dose) had resolved. At the time of the report, ILLNESS (got so sick) outcome was unknown.            Symptoms included: fever, pains, chills, body ache, terrible aches, pains form head to toe and said it was worst than worst flu or a virus; was in bed for 3 days. Symptoms started at 1:00 am the day after getting the vaccine (19Nov2021) and subsided on 22Nov2021.  Also got sick but it seems it was more severe this time.   This case was linked to MOD-2021-402874 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I got so sick from this one, I though I was dying /horrible 2nd dose; Terrible aches 2nd dose/pains from head to toe 2nd dose; It doesn't make sense a vaccine can make you that sick; chills 2nd dose; Fever 2nd dose/ Burning up of fever 2nd dose; Body ache 2nd dose / pains form head to toe 2nd dose; got so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got so sick), FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick) and CHILLS (chills 2nd dose) in a 51-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 COVID-19 from February 2020 to 2020 and COVID-19 from April 2020 to 2020.    On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced ILLNESS (got so sick). On 19-Nov-2021, the patient experienced FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick), CHILLS (chills 2nd dose), PYREXIA (Fever 2nd dose/ Burning up of fever 2nd dose) and MYALGIA (Body ache 2nd dose / pains form head to toe 2nd dose). On 22-Nov-2021, FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick), CHILLS (chills 2nd dose), PYREXIA (Fever 2nd dose/ Burning up of fever 2nd dose) and MYALGIA (Body ache 2nd dose / pains form head to toe 2nd dose) had resolved. At the time of the report, ILLNESS (got so sick) outcome was unknown.            Symptoms included: fever, pains, chills, body ache, terrible aches, pains form head to toe and said it was worst than worst flu or a virus; was in bed for 3 days. Symptoms started at 1:00 am the day after getting the vaccine (19Nov2021) and subsided on 22Nov2021.  Also got sick but it seems it was more severe this time.   This case was linked to MOD-2021-402874 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: weak/"savvy"; not able to do those activities; legs felt super weak; and unsteady; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs felt super weak), GAIT DISTURBANCE (and unsteady), ASTHENIA (weak/"savvy") and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do those activities) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 008B21A and 044B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced MUSCULAR WEAKNESS (legs felt super weak) and GAIT DISTURBANCE (and unsteady). On an unknown date, the patient experienced ASTHENIA (weak/"savvy") and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do those activities). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 UNK. On 30-Nov-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do those activities) had resolved. At the time of the report, MUSCULAR WEAKNESS (legs felt super weak), GAIT DISTURBANCE (and unsteady) and ASTHENIA (weak/"savvy") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer stated on 06Nov2021 she started she had side effects after getting a booster dose on 03Nov2021. Consumer stated on 06Nov2021 her legs felt super wear and unsteady. It continued to be like than but seem like it was getting better. Sometimes she felt weak and savvy. She also added she felt better on somedays and then on somedays she did not, with AEs reported above. Consumer stated she was physically active and was not able to do those activities. But she was able to do her activities on 30Nov2021   This case was linked to MOD-2021-402868, MOD-2021-402797 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Guillain-Barre syndrome
Clinical narrative: suspected Guerre barre syndrome; droopy lip; This spontaneous case was reported by a pharmacist and describes the occurrence of GUILLAIN-BARRE SYNDROME (suspected Guerre barre syndrome) and FACIAL PARALYSIS (droopy lip) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 045B21A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Communication disorder.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced GUILLAIN-BARRE SYNDROME (suspected Guerre barre syndrome) (seriousness criterion medically significant) and FACIAL PARALYSIS (droopy lip) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (suspected Guerre barre syndrome) and FACIAL PARALYSIS (droopy lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient was fine Tuesday night but when she woke up on the 15Dec2021, it started to get worse, the patient could not walk, lift a spoon/fork and needed assistance walking (needed husbands to help). The Pharmacist suspected Guerre barre syndrome and instructed the caller to go the hospital. The Pharmacist indicated that according to the patient's license, she has a droopy lip and may have other neurological issues. Company Comment This case concerns a 91-year-old, female patient with relevant medical history of dementia and troubling communicating, who experienced the unexpected events of Guillain-Barre syndrome and facial paralysis. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-416025, MOD-2021-416026 (Patient Link).; Sender's Comments: This case concerns a 91-year-old, female patient with relevant medical history of dementia and troubling communicating, who experienced the unexpected events of Guillain-Barre syndrome and facial paralysis. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Decreased appetite, Disturbance in attention, Fatigue, Headache
Clinical narrative: Headache, nausea, fatigue, difficulty with balance, difficulty with concentration, loss of appetite. Time - whole week.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Headache, nausea, fatigue, difficulty with balance, difficulty with concentration, loss of appetite. Time - whole week.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Aphasia, Balance disorder, Cholecystectomy, Coordination abnormal
Clinical narrative: Neuralgia shooting down right arm amd leg (not resolved); neuropathy in right hand (not resolved); loss of balance and coordination (resolved); anomic aphasia and word finding difficulties (partially resolved); diplopia (resolved); left sided ophthalmalgia (resolved); difficulty with short term memory (not resolved); severe GI distress (resolved); breakout of pityriasis rosea (resolved); near constant gallbladder attacks that left me unable to eat anything but bread and pretzels and required a cholecystectomy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Eye pain, Feeding disorder, Gallbladder disorder, Memory impairment
Clinical narrative: Neuralgia shooting down right arm amd leg (not resolved); neuropathy in right hand (not resolved); loss of balance and coordination (resolved); anomic aphasia and word finding difficulties (partially resolved); diplopia (resolved); left sided ophthalmalgia (resolved); difficulty with short term memory (not resolved); severe GI distress (resolved); breakout of pityriasis rosea (resolved); near constant gallbladder attacks that left me unable to eat anything but bread and pretzels and required a cholecystectomy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Neuropathy peripheral, Pityriasis rosea, Speech disorder
Clinical narrative: Neuralgia shooting down right arm amd leg (not resolved); neuropathy in right hand (not resolved); loss of balance and coordination (resolved); anomic aphasia and word finding difficulties (partially resolved); diplopia (resolved); left sided ophthalmalgia (resolved); difficulty with short term memory (not resolved); severe GI distress (resolved); breakout of pityriasis rosea (resolved); near constant gallbladder attacks that left me unable to eat anything but bread and pretzels and required a cholecystectomy.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, increased heart rate
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Blood calcium increased, Blood test abnormal, Condition aggravated, Ear pain
Clinical narrative: No side effects right after the shot other than just feeling tired and a little off. But it seems to have reactivated the rare eczema herpeticum in my system. I had it under control for a year. Following the vaccine - Terrible neck pain - didn't realize it was due to herpeticum - once realized, responded to high doses of L-lysine - diagnosis - Herpetic meningitis, heart beating abnormally, increasingly worsening. Bed rest, taking large doses of L-lysine to try to get it under control and other immune enhancing vitamins - D, C, K, zinc - - meningitis under control, but neck and right rear lobe still low level pain. Increased cold sores on lips and inside nose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema herpeticum, Electrocardiogram abnormal, Fatigue, Feeling abnormal, Heart rate irregular
Clinical narrative: No side effects right after the shot other than just feeling tired and a little off. But it seems to have reactivated the rare eczema herpeticum in my system. I had it under control for a year. Following the vaccine - Terrible neck pain - didn't realize it was due to herpeticum - once realized, responded to high doses of L-lysine - diagnosis - Herpetic meningitis, heart beating abnormally, increasingly worsening. Bed rest, taking large doses of L-lysine to try to get it under control and other immune enhancing vitamins - D, C, K, zinc - - meningitis under control, but neck and right rear lobe still low level pain. Increased cold sores on lips and inside nose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Meningitis, Nasal herpes, Neck pain, Oral herpes, Ultrasound scan normal
Clinical narrative: No side effects right after the shot other than just feeling tired and a little off. But it seems to have reactivated the rare eczema herpeticum in my system. I had it under control for a year. Following the vaccine - Terrible neck pain - didn't realize it was due to herpeticum - once realized, responded to high doses of L-lysine - diagnosis - Herpetic meningitis, heart beating abnormally, increasingly worsening. Bed rest, taking large doses of L-lysine to try to get it under control and other immune enhancing vitamins - D, C, K, zinc - - meningitis under control, but neck and right rear lobe still low level pain. Increased cold sores on lips and inside nose.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Demyelination, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: Unclear exact onset, approximately 2 weeks after first Covid vaccine or 1 week after 2nd Covid vaccine (2nd dose 1/17/21, Lot number EL3248) had sudden transient right leg weakness. Right leg gave out while walking, almost tripped. happed total of 3 times over course of 1 week, lasted approximately 10-30 seconds each time. about one week later began having severe paresthesias of bilateral upper extremities, worse on right arm. Would wake me up from sleep. Have had transient attacks of paresthesia in upper extremities since then. Pattern of paresthesia, burning, tingling sometimes numbness didn't follow a specific nerve distribution.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Magnetic resonance imaging spinal normal, Multiple sclerosis, Muscular weakness, Paraesthesia
Clinical narrative: Unclear exact onset, approximately 2 weeks after first Covid vaccine or 1 week after 2nd Covid vaccine (2nd dose 1/17/21, Lot number EL3248) had sudden transient right leg weakness. Right leg gave out while walking, almost tripped. happed total of 3 times over course of 1 week, lasted approximately 10-30 seconds each time. about one week later began having severe paresthesias of bilateral upper extremities, worse on right arm. Would wake me up from sleep. Have had transient attacks of paresthesia in upper extremities since then. Pattern of paresthesia, burning, tingling sometimes numbness didn't follow a specific nerve distribution.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Sleep disorder, Vaccination complication
Clinical narrative: Unclear exact onset, approximately 2 weeks after first Covid vaccine or 1 week after 2nd Covid vaccine (2nd dose 1/17/21, Lot number EL3248) had sudden transient right leg weakness. Right leg gave out while walking, almost tripped. happed total of 3 times over course of 1 week, lasted approximately 10-30 seconds each time. about one week later began having severe paresthesias of bilateral upper extremities, worse on right arm. Would wake me up from sleep. Have had transient attacks of paresthesia in upper extremities since then. Pattern of paresthesia, burning, tingling sometimes numbness didn't follow a specific nerve distribution.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Vaccination error, Wrong product administered
Clinical narrative: Patient received a pfizer covid vaccine versus a shingles vaccine. Miscommunication between pharmacy staff members and between administering pharmacy staff member and patient lead to an incorrect vaccine to be administered. Patient had previously received 3 pfizer covid vaccines 3/10/21, 3/31/21, 11/14/21 and was accompanying her minor daughter to received a pfizer booster vaccine as well as patient requesting a shingles vaccine. Multiple patients requesting and receiving vaccines at the same time, multiple pharmacy staff members processing, preparing and administering vaccines and miscommunication between patient and administering staff member lead to vaccine error. Within minutes of vaccine being administered, patient was notified of error, possible side effects which she will monitor and call pharmacy with any concerns in the morning and pharmacist will contact pfizer to receive any additional info to relay to patient during a follow up conversation on 12/29/21.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: All for right arm, at injection site: Cannot raise arm, arm pain, arm weakness, limited mobility
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Muscle spasms, Myalgia
Clinical narrative: Started after 30 minutes. Bulging veins, light headedness, sore arm, pain that jumps around body in muscles, chest pain, baby bump discomfort, cramping
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vasodilatation
Clinical narrative: Started after 30 minutes. Bulging veins, light headedness, sore arm, pain that jumps around body in muscles, chest pain, baby bump discomfort, cramping
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Food poisoning, Nausea
Clinical narrative: Explosive gut wrenching diarrhea 5 times within the last hour.  This is very comparable to food poisoning.  I did feel slightly nauseous about 4 hours prior to this but it never got to the point of vomiting.  Hopefully the diarrhea subsides by early morning or I will go to the emergency room for intravenous fluids.  The previous two vaccines only resulted in 2 days of chills for me which was manageable.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: A few days after vaccine, my left lymph node in my armpit hurt and was swollen. Then the week of 12/27 my left lymph node in my neck began to swell
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Urticaria with dermatographia
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin swelling, Urticaria
Clinical narrative: Full body hives. Skin is red, swollen, itchy in patches. Psychiatrist ruled out Lexipro as cause. Went off Lexipro for one week and hives continued. Hives are present everyday and are relieved by taking Zyrtec. Hives return immediately when Zyrtec wears off.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles a week after second shot
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chills, Dyspnoea, Hypoxia
Clinical narrative: Breakthrough COVID-19 case requiring hospitalization:  Patient is a 73-year-old male presents with shortness of breath, fevers and chills and myalgias.  Diagnosed with Covid on 11/29, underwent ab infusion outpatient.  Still progressing and came to the emergency department with hypoxia.  Patient was vaccinated in February 2021 but did not get his booster.  He was found to have Covid pneumonia as well as possible concurrent bacterial pneumonia as well as significant hypoxia.  Patient started on supportive care, IV antibiotics, steroids and remdesivir.  He completed a course of antibiotics as well as remdesivir.  He had slow improvement of his oxygen status and was requiring 2 L at time of discharge.  He will discharge on 2 L home oxygen as well as complete a course of steroids.  He is given follow-up for pulmonology.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 case requiring hospitalization:  Patient is a 73-year-old male presents with shortness of breath, fevers and chills and myalgias.  Diagnosed with Covid on 11/29, underwent ab infusion outpatient.  Still progressing and came to the emergency department with hypoxia.  Patient was vaccinated in February 2021 but did not get his booster.  He was found to have Covid pneumonia as well as possible concurrent bacterial pneumonia as well as significant hypoxia.  Patient started on supportive care, IV antibiotics, steroids and remdesivir.  He completed a course of antibiotics as well as remdesivir.  He had slow improvement of his oxygen status and was requiring 2 L at time of discharge.  He will discharge on 2 L home oxygen as well as complete a course of steroids.  He is given follow-up for pulmonology.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Muscle twitching, Vaccination site discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (muscles feeling weird), MUSCLE TWITCHING (arm was twitching) and VACCINATION SITE DISCOMFORT (muscles in her arm were she had the injection jumping) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced MUSCLE DISCOMFORT (muscles feeling weird), MUSCLE TWITCHING (arm was twitching) and VACCINATION SITE DISCOMFORT (muscles in her arm were she had the injection jumping). In October 2021, MUSCLE DISCOMFORT (muscles feeling weird), MUSCLE TWITCHING (arm was twitching) and VACCINATION SITE DISCOMFORT (muscles in her arm were she had the injection jumping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: extended time between both doses/First Moderna shot in March & second dose in November; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended time between both doses/First Moderna shot in March & second dose in November) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended time between both doses/First Moderna shot in March & second dose in November). In November 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (extended time between both doses/First Moderna shot in March & second dose in November) had resolved.            No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Illness
Clinical narrative: I feel disgusted; She says that she cannot sleep at night due to the pain; She says that she was sick for a day; knees have been very painful; wasn't able to do anything on Sunday, hard time getting in and out of bathtub; started having flu-like symptoms; sore throat; aches and pains; headache; very fatigued; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub) and FEELING ABNORMAL (I feel disgusted) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever). On 07-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub). On an unknown date, the patient experienced FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful). On 08-Nov-2021, INFLUENZA LIKE ILLNESS (started having flu-like symptoms), OROPHARYNGEAL PAIN (sore throat), PAIN (aches and pains), HEADACHE (headache), FATIGUE (very fatigued) and PYREXIA (fever) outcome was unknown. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (wasn't able to do anything on Sunday, hard time getting in and out of bathtub), FEELING ABNORMAL (I feel disgusted), SLEEP DISORDER (She says that she cannot sleep at night due to the pain), ILLNESS (She says that she was sick for a day) and ARTHRALGIA (knees have been very painful) outcome was unknown.            No treatment medication reported. Concomitant medication contains Allergy shot   This case was linked to MOD-2021-242526, MOD-2021-242504 (Patient Link).