chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: for shingles, and other zoster-related conditions.; for shingles, and other zoster-related conditions.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  In 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was treated by a physician for shingles, and other zoster-related conditions and due to the events was hospitalized. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent  conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered.  The causality assessment was related.
Age: 56.0
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event, Wrong product administered
Clinical narrative: Received first dose of Heplisav-B, second dose was given with Twinrix; Initial Report Received on 06-Jan-2021  A registered nurse in the reported that a 56 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was administered Twinrix (Hepatitis A and Hepatitis B Recombinant Vaccine) as the second dose for hepatitis B immunization.  Medical history was reported as unknown.    Concomitant medications was reported as unknown.  On 12-Nov-2020, the patient received the first dose of HEPLISAV-B (Lot # 933623, expiration date 22-Aug-2021, NDC #43528-0003-05 and serial number 611405742605) at an unknown facility.  On 16-Dec-2020, 35 days after receiving the first dose of HEPLISAV-B, the patient received Twinrix (Hepatitis A and Hepatitis B Recombinant Vaccine) as the second dose (Lot #, expiration date and NDC # not provided) of hepatitis B vaccination at an unknown facility.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received a third Heplisav-B Injection; Initial Report Received on 14-Jan-2021  A registered pharmacist reported that a 60 year-old female (race and ethnicity not provided) received a third dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.   No concomitant medications were reported.  On 11-Jul-2020, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  On 13-Aug-2020, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  On 13-Jan-2021, 187 days after having received the first injection and 154 days after having received the second injection, the patient received a third dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and serial number 836086802696 not reported) because she did not know she got it at her doctor's office.  At the time of report, the patient reported no adverse reactions to the injections.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Second Dose Given was Engerix; Initial Report Received on 03-Mar-2021  A licensed practical nurse (LPN) reported that a 55 year-old male received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given Engerix [Hepatitis B Vaccine (Recombinant)] as the second dose.  Medical history was reported as hypertension, diabetes, coronary artery disease (CAD). Allergy history was reported as hydrochlorothiazide (reaction of hypokalemia) and lisinopril (reaction of cough).  Medications at the time of vaccination were reported as potassium, glipizide, aspirin, atorvastatin, metformin, atenolol, losartan, and amlodipine.  20-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021 and NDC # 43528-003-01), route and site unknown.   On 21-Dec-2020, 63 days after having been vaccinated with HEPLISAV-B, the second dose given to the patient was Engerix [Hepatitis B Vaccine (Recombinant)].   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of consciousness, Pruritus, Seizure
Clinical narrative: Passed Out; Possible Seizure; Swollen Tongue; itchines; Headache; shivering; shaking really bad; A spontaneous report  was received from a nurse who was a 42- year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness.  The patient's medical history was not reported by the reporter. Concomitant medications were not provided.  On 19-Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-Jan-2021, 24 hours after vaccine administration, the patient reported that she was shivering and shaking really bad and had a headache day afterwards.  On an unknown date, she reported that her tongue was swollen. She also reported that the she passed out and doesn't know if she had a seizure (date unknown). The patient reported that she took ibroprophen for her headache and diphenhydramine for itchiness.  On 28-Jan-2021, she reported that she felt fine.   Treatment for events included ibroprophen and diphenhydramine.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of events, experienced some side effects was unknown, shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness, were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the information provided and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Headache and chills are consistent with the known safety profile of the vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tremor
Clinical narrative: Passed Out; Possible Seizure; Swollen Tongue; itchines; Headache; shivering; shaking really bad; A spontaneous report  was received from a nurse who was a 42- year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness.  The patient's medical history was not reported by the reporter. Concomitant medications were not provided.  On 19-Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-Jan-2021, 24 hours after vaccine administration, the patient reported that she was shivering and shaking really bad and had a headache day afterwards.  On an unknown date, she reported that her tongue was swollen. She also reported that the she passed out and doesn't know if she had a seizure (date unknown). The patient reported that she took ibroprophen for her headache and diphenhydramine for itchiness.  On 28-Jan-2021, she reported that she felt fine.   Treatment for events included ibroprophen and diphenhydramine.  Action taken with mRNA-1273 in response to the events was unknown.   The outcomes of events, experienced some side effects was unknown, shivering, shaking really bad, had a headache day afterwards, tongue was swollen, passed out and doesn't know if she had a seizure and itchiness, were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the information provided and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Headache and chills are consistent with the known safety profile of the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Chills, Hallucination, Headache
Clinical narrative: started hallucinating; I was dreaming but awake; started getting anxious; arm started to hurt really bad; felt a little chilly; minor headache; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a little chilly, minor headache, arm started to hurt really bad, started hallucinating, I  was dreaming but awake,  and started getting anxious.  The patient's medical history was not provided. Concomitant medications reported include baby aspirin and lipitor for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events felt a little chilly and minor headache. On 30 Jan 2021, the patient experienced the events arm started to hurt really bad,  started hallucinating, I was dreaming but awake, and started getting anxious.  On 30 Jan 2021, the patient called 911 and was hospitalized. The results of hospital EEG, CAT scan, and MRI are unknown.   Treatment details were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events felt a little chilly, minor headache, arm started to hurt really bad, started hallucinating, i was dreaming but awake,  and started getting anxious was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: started hallucinating; I was dreaming but awake; started getting anxious; arm started to hurt really bad; felt a little chilly; minor headache; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a little chilly, minor headache, arm started to hurt really bad, started hallucinating, I  was dreaming but awake,  and started getting anxious.  The patient's medical history was not provided. Concomitant medications reported include baby aspirin and lipitor for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events felt a little chilly and minor headache. On 30 Jan 2021, the patient experienced the events arm started to hurt really bad,  started hallucinating, I was dreaming but awake, and started getting anxious.  On 30 Jan 2021, the patient called 911 and was hospitalized. The results of hospital EEG, CAT scan, and MRI are unknown.   Treatment details were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events felt a little chilly, minor headache, arm started to hurt really bad, started hallucinating, i was dreaming but awake,  and started getting anxious was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Dosing Error (Interchangeability with Pfizer Covid-19 vaccine); Inappropriate schedule of vaccine administered; A spontaneous report report was received from a other HCP concerning a  patient (age and gender unknown) was participating in the mRNA-1273 emergency use program and experienced  Dosing Error (Interchangeability with Pfizer Covid-19 vaccine).   The patient's medical history is not included. No relevant concomitant medication were reported.  On 15th Jan 2021, the patient received the 1st dose of Pfizer vaccine and on 28 Jan 2021 the patient received the 1st dose of Moderna vaccine.  Laboratory detail not included.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of wrong vaccine administered and inappropriate schedule of vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Lymphadenopathy, Vaccination site rash
Clinical narrative: Shingles; COVID Arm; Swelling of Lymph Nodes; Fatigue in Arm and Leg; A spontaneous report was received from a consumer concerning a 37-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID Arm, Swelling of Lymph Nodes, Fatigue in Arm and Leg and Shingles.   The patient's medical history was not reported. Concomitant medications reported included daily vitamin and ginger 500 mg.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Jan 2021, a day after the vaccination of first dose the patient experienced COVID Arm, Swelling of Lymph Nodes in the injection arm and Fatigue in Arm and Leg. On 05 Feb 2021, the patient went to urgent care and was diagnosed with Shingles Virus (Shingles). Shingles was medically assessed as serious at urgent care.  Treatment medications for the event Shingles included Valtrex and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, COVID Arm, Swelling of Lymph Nodes and Fatigue in Arm and Leg was reported as unknown. On 05 Feb 2021, the outcome of the event shingles was not recovered/not resolved.; Reporter's Comments: Based on the established safety profile and a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.  The events of COVID arm, swelling of lymph nodes in the injection arm and fatigue in arm and leg are consistent with the known safety profile of the vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial discomfort, Headache, Hypoaesthesia, Mastication disorder
Clinical narrative: Tongue feels funny; Chewing is hard; His left eye and face are changing shape, smiling is hard; Possible Bell's Palsy; Numbness on left side of face; Swelling arm; Painful arm; Headache; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible Bell's Palsy/facial paralysis, numbness on left side of face/hypoaesthesia, tongue felt funny/paraesthesia oral, chewing was hard/mastication disorder, left eye and face were changing shape, smiling was hard/ facial discomfort, sore arm/pain in extremity, arm swelling/peripheral swelling, and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient initially had pain, swelling, sore arm and headache. Patient stated on 15 Feb 2021, he had some numbness on left side of face, chewing and smiling was hard. Patient stated a couple days later, he had numbness and on 01 Mar 2021, his left eye and face were changing shape, tongue felt funny, and it was hard to brush teeth. Patient spoke with doctor and MRI was scheduled on 12 Mar 2021, according to patient there was a possibility for Bell's Palsy.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, facial paralysis, hypoesthesia, paraesthesia oral, mastication disorder, facial discomfort, pain in extremity, peripheral swelling and headache were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Peripheral swelling, Vaccination site pain
Clinical narrative: Tongue feels funny; Chewing is hard; His left eye and face are changing shape, smiling is hard; Possible Bell's Palsy; Numbness on left side of face; Swelling arm; Painful arm; Headache; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible Bell's Palsy/facial paralysis, numbness on left side of face/hypoaesthesia, tongue felt funny/paraesthesia oral, chewing was hard/mastication disorder, left eye and face were changing shape, smiling was hard/ facial discomfort, sore arm/pain in extremity, arm swelling/peripheral swelling, and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient initially had pain, swelling, sore arm and headache. Patient stated on 15 Feb 2021, he had some numbness on left side of face, chewing and smiling was hard. Patient stated a couple days later, he had numbness and on 01 Mar 2021, his left eye and face were changing shape, tongue felt funny, and it was hard to brush teeth. Patient spoke with doctor and MRI was scheduled on 12 Mar 2021, according to patient there was a possibility for Bell's Palsy.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, facial paralysis, hypoesthesia, paraesthesia oral, mastication disorder, facial discomfort, pain in extremity, peripheral swelling and headache were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immobile, Myalgia, Pain, X-ray
Clinical narrative: pain is ramping; Every joint in body/large and small joints were painful/shoulder, neck and hip hurt the most; Deep muscle pain; She was "nonfunctioning"/could not do anything; Was in so much pain; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events she was "nonfunctioning"/could not do anything (immobile), was in so much pain (pain) every joint in body/large and small joints were painful/shoulder, neck and hip hurt the most (arthralgia), deep muscle pain (myalgia), pain is ramping (pain worsened)  The patient's medical history was not provided. Allergies included hay fever. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (lot: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient reported that she was nonfunctioning. She could not do anything. She was in so much pain. She had pain in every joint in her body. She stated that her large and small joints were painful. She had deep muscle pain as well. Her shoulder, neck and hip hurt the most. She took acetaminophen and ibuprofen. The patient went to orthopedist for the pain. The X-rays were normal for age. She was given meloxicam and a steroid pack (methylprednisolone) and she started feeling better. On 25 Jan 2021, a few days later, she reported that the pain came back. The pain was ramping and was still ongoing.  Treatment medications included: acetaminophen, ibuprofen, meloxicam, and methylprednisolone.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events, was in so much pain/pain came back/pain is ramping/pain,"nonfunctioning"/could not do anything, every joint in body/large and small joints were painful/shoulder, neck and hip hurt the most, deep muscle pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032919:Case with first dose
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Haemoptysis, Hallucination, Headache
Clinical narrative: Hallucination; Coughing up blood; Sleepless nights; Rapid heartbeat; Headache; High temperature; Fatigue; A spontaneous report was received from a consumer concerning a 74-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucination, coughing up blood, sleepless nights, rapid heartbeat, headache, high temperature and fatigue.  The patient's medical history was not provided. Concomitant medications included Morphine Sulfate (Long Acting), Antihyperlipidemic, Baby Aspirin and Vitamins.  On 24 Feb 2021, one day, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the same day of vaccination patient experienced hallucination, coughing up blood, sleepless nights, rapid heartbeat, headache, high temperature and fatigue.  Treatment for the events was not reported.    Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Pyrexia
Clinical narrative: Hallucination; Coughing up blood; Sleepless nights; Rapid heartbeat; Headache; High temperature; Fatigue; A spontaneous report was received from a consumer concerning a 74-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucination, coughing up blood, sleepless nights, rapid heartbeat, headache, high temperature and fatigue.  The patient's medical history was not provided. Concomitant medications included Morphine Sulfate (Long Acting), Antihyperlipidemic, Baby Aspirin and Vitamins.  On 24 Feb 2021, one day, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the same day of vaccination patient experienced hallucination, coughing up blood, sleepless nights, rapid heartbeat, headache, high temperature and fatigue.  Treatment for the events was not reported.    Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Neck pain
Clinical narrative: Tremendous pain in neck; I was so weak that I could not pick my head up; Headache; A spontaneous report was received from a consumer who was also a 86 years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced tremendous neck pain, severe headache and weakness.  The patient's medical history and products known to have been used by the patient were not reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) on 22 Jan 2021. On 22 Feb 2021, approximately two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.  On an unspecified date, the patient start to experience tremendous neck pain, severe headache and weakness, later he was admitted to a hospital.  No treatment information was provided.   No relevant laboratory details were included.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events were  not applicable.  The events, were considered  recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Product dose omission issue
Clinical narrative: Suffer a stroke a few weeks after the vaccine; 42 days pasted since his first dose; A spontaneous report was received from a son, concerning a  92 year old male patient, his father, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke a few weeks after the vaccine and it was known that missed the second date, 42 days passed since the first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a stroke and went to nursing home. Th patient had missed the second vaccine dose which was scheduled for 19-Feb-2021. It was known that 42 days have passed since the patient had the initial dose administered. No treatment information was provided.   The outcome of event, 42 days passed since his first dose was recovered.   The outcome of the event, suffer a stroke a few weeks after the vaccine, was unknown.; Reporter's Comments: This report refers to a case of 92- year-old male patient who experienced serious unexpected event of stroke a few weeks after the vaccine and missed the second date (Product dose omission issue) for mRNA-1273. Limited information regarding the event of stroke has been provided at this time. Patients medical history, onset date, clinical details and diagnostic results of the event are lacking. Further information has been requested. The event of product dose omission issue is considered not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cervical spinal stenosis, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness, Paraesthesia
Clinical narrative: excruciating pain in her spinal stenosis, pain is from bottom of her cervical spine to her scapular; Outside of her right arm to the 3rd, 4th, and 5th finger is numb and tingling; Outside of her right arm to the 3rd, 4th, and 5th finger is numb and tingling; Right hand is weak, she has difficulty holding a fork or a pen; A spontaneous report was received from a consumer concerning a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events excruciating pain in her spinal stenosis (spinal stenosis flared up), pain from the bottom of her cervical spine to her scapular, the outside of her right arm to the 3rd, 4th, and 5th finger is numb, the outside of her right arm to the 3rd, 4th, and 5th finger is tingling, right hand is weak, difficulty holding a fork, difficulty holding a pen.  The patient's medical history was spinal stenosis. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events excruciating pain in her spinal stenosis (spinal stenosis flared up), pain from the bottom of her cervical spine to her scapular (medical significant), the outside of her right arm to the 3rd, 4th, and 5th finger is numb, the outside of her right arm to the 3rd, 4th, and 5th finger is tingling, right hand is weak, difficulty holding a fork, difficulty holding a pen.  Laboratory details as reported included magnetic resonance imaging.  Treatment details included arthritis Tylenol, steroid, control drug.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, excruciating pain in her spinal stenosis (spinal stenosis flared up), pain from the bottom of her cervical spine to her scapular, the outside of her right arm to the 3rd,4th,and 5th finger is numb,the outside of her right arm to the 3rd,4th,and 5th finger is tingling,right hand is weak,difficulty holding a fork,difficulty holding a pen was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. An underlying history of spinal stenosis is a strong contributor.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Unresponsive to stimuli
Clinical narrative: Unresponsive; extreme fatigue that is getting worse, not better; A spontaneous report was received from caregiver for an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme fatigue that is getting worse (fatigue), unresponsive (Unresponsive to stimulus) and barely speaks   The patient's medical history was not provided. No concomitant product use was reported.  On 24-Feb- 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 05-MAR-2021, 10 days after receiving the vaccine, the reporter stated that the patient became unresponsive and was taken to the ER (emergency room). She was taken to the ER and discharged twice on the same day. The reporter also stated that his mother had extreme fatigue that was getting worse, not better and that the patient barely speaks. The  The caregiver was headed to emergency room at the time of this report.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, extreme fatigue that is getting worse, unresponsive and barely speaks was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: sinus was very bad; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 13Feb2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the vaccine, the second one, yesterday (13Feb2021), and was doing okay. However, the patient's sinus was very bad. The patient asked if it was okay to take decongestant pseudoephedrine hydrochloride (SUDAFED) or any of that, because he/she was told that you should not take anything except paracetamol (TYLENOL). The clinical outcome of sinus was very bad was unknown.  Information about lot number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: flu shot hurt a lot more than the COVID shot; Initial information was received on 20-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media.  This case involves a patient (unknown demographics) who got hurt a lot more than the COVID shot (vaccination site pain), while he/she received INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got hurt a lot more than the COVID shot (vaccination site pain) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as non-serious.  It was unknown if patient's physician provided consent to be contacted.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  The details of laboratory data were not reported   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information on batch number for this case.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient had general malaise unknown cause. Onsite EMS was called vitals BP 224/100 99%O2  HR 93 Patient treated, transported by the EMS to the hospital.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Chills, fever and lose stools.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness
Clinical narrative: Total loss of hearing in right ear.  Sudden on set.  Went to bed fine.  Woke up total deaf in right ear.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bladder catheterisation, Bladder pain, Blood test, Cystitis interstitial, Full blood count
Clinical narrative: Constant Nausea, Headaches including Migraine, Bladder pain syndrome/interstitial cystitis
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Nausea, Smear cervix, Ultrasound scan
Clinical narrative: Constant Nausea, Headaches including Migraine, Bladder pain syndrome/interstitial cystitis
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Constant Nausea, Headaches including Migraine, Bladder pain syndrome/interstitial cystitis
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Severe rash on neck and some on torso developed 48 hours after the shot. Persistent itching for 2 days thereafter.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER, BODYACHES, CHILLS
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: A day later a rash appeared on my left arm.  It was extremely itchy.  It progressed to the tops of both of my legs, my right arm, chest, stomach and back.  It continued to spread even with Benadryl and Cortizone cream.  I went to the clinic this morning and have been given prednisone.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Chills, Diarrhoea, Fatigue
Clinical narrative: Started with nausea, then chills, unbalanced, tiredness, chest pain, cold arm, rapid heartbeat, muscle fatigue, headache, diarrhea.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Muscle fatigue, Nausea, Peripheral coldness
Clinical narrative: Started with nausea, then chills, unbalanced, tiredness, chest pain, cold arm, rapid heartbeat, muscle fatigue, headache, diarrhea.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever 101.4  headache fatigue chills   Advised continue apap as directed if no resolution of fever greater than 101 degrees seek medical  attention.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling hot
Clinical narrative: 1 minute after administration of vaccine patient experienced warm ness and lightheaded and a little dizzy. She was extremely anxious about receiving the shot prior to.  I asked her to breath and relax and I fanned her. After about 10 minutes she felt better
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Pruritus, Rash, Skin warm
Clinical narrative: The site has been hard and warm to the touch since 3/13.  Today it started itching.  I feel it on my upper arm/deltoid area where I got the shot, around my arm and toward the front shoulder/chest area (all on the left).  I feel bumps that feel like bug bites, close to where the shot was administered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Moderna COVID?19 Vaccine EUA I have a welt at the injection site. It continues to be itchy and warm to the touch
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Initial insomnia, Neck pain, Pain in extremity
Clinical narrative: Near immediate knot pain at neck/shoulder. ~4hr, arm soreness, headache, trouble sleeping. ~20hr, pain in armpit similar to knot pain (swollen lymph node?) And persistent low-grade headache. ~24hr, chills, poss fever, continued armpit pain and headache.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dysgeusia, Electric shock sensation, Head discomfort, Palpitations
Clinical narrative: About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine).  The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic reaction
Clinical narrative: About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine).  The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral disorder, Chest discomfort, Dysgeusia, Pain in extremity, Palpitations
Clinical narrative: About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine).  The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine).  The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash erythematous, Skin warm
Clinical narrative: Red rash, warm to touch, itchy to left arm injection site
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head, Electrocardiogram, Hypoaesthesia, Intensive care
Clinical narrative: 03/12/21 at approx 8 pm I began to have uncontrollable tremors/seizure in both arms, both legs and head. Numbness/weakness in all fingertips and both legs to above the knees. The symptoms continued to increase and at 11:30 pm I was taken to ER. Was transported by ambulance to Hospital. Was admitted to the ICU. Lumbar puncture was done on 03/13/21 to rule out Guillain Barre. Neurologist determined it was a neurological reaction to the COVID vaccine shot. Was released from the hospital 03/15/21. Legs continue to be numb/weak, but I am able to walk carefully unassisted.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Muscular weakness, Neurological symptom, Seizure, Tremor
Clinical narrative: 03/12/21 at approx 8 pm I began to have uncontrollable tremors/seizure in both arms, both legs and head. Numbness/weakness in all fingertips and both legs to above the knees. The symptoms continued to increase and at 11:30 pm I was taken to ER. Was transported by ambulance to Hospital. Was admitted to the ICU. Lumbar puncture was done on 03/13/21 to rule out Guillain Barre. Neurologist determined it was a neurological reaction to the COVID vaccine shot. Was released from the hospital 03/15/21. Legs continue to be numb/weak, but I am able to walk carefully unassisted.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Erythema, Rash
Clinical narrative: I received 2 doses of the Pfizer vaccine 3 weeks apart. I had no adverse effects after the first shot. A day or two after receiving the second dose I observed a rash on both ankles. There was no itch, but my skin became red and very dry. It has been 17 days since receiving the second dose and the rash has not gone away although it is a bit less red. I've had no ill effects from the rash.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Polymerase chain reaction
Clinical narrative: No adverse  symptoms or sign
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Pruritus
Clinical narrative: 26 minutes after receiving the vaccination, the patient developed  over her left forearm, right shoulder, posterior neck, and left scalp. Upon evaluation, she had no hives or rashes. Lungs were clear on auscultation bilaterally. No shortness of breath, nausea, respiratory distress, anaphylaxis. She was given Allegra 60 mg PO times one. Her blood pressure, taking by machine, was 205/117.  No dizziness, chest pain, headaches, or vision changes. Subsequent manual recheck of her blood pressure were in the 160s to 180/ 100s, and after possibly 30 minutes of monitoring with serial your blood pressure checks, her blood pressure  was 172/94 manually.  Her itching resolved, and she developed no other symptoms.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Skin tightness
Clinical narrative: I had a delayed red rash appear on my arm  about 11 days after my vaccine. I first became aware of it as the skin on my arm from the location where I received the vaccine down to about 2" above my elbow began to feel tight and itchy and turn red. It isn't really bothersome, just noticeably red and slightly elevated  so I have not and don't intend to call my doctor. I just thought you may want to include this in your database.  I also saw the news that this kind of delayed skin reaction has been reported, is not serious and not a reason to forego receiving the second dose so I am not concerned about safety.  I have taken a photo of it should it be requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: FEVER, BODYACHES, NAUSEA
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Gait inability, Pyrexia, Sleep disorder
Clinical narrative: Began to feel feverish around or slightly before 9:30, when chills & shivering began.  Could not sleep due to shivering.  Got up around 1 AM to go to bathroom- was VERY weak & needed help.  Also while getting to bathroom began to lose control over kidneys and was urinating involuntarily.   Had urge to to go the bathroom again around 3;  30.  This time could NOT walk at all & was once again urinating involuntarily.  Tried to just go back to bed, but did not seem to have any control over my body.  Around 4:30 I got as comfortable as possible on the floor & slept  off & on until around 8:30.  When I woke up I was able with  help to get back into bed. I had continued to urinate involuntarily during the time I was sleeping prior to 8:30.   The symptoms seemed to gradually subside after this point.  Called Neurologist,  thinking that my radiation induced nerve damage was involved in my reaction and she agreed.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Began to feel feverish around or slightly before 9:30, when chills & shivering began.  Could not sleep due to shivering.  Got up around 1 AM to go to bathroom- was VERY weak & needed help.  Also while getting to bathroom began to lose control over kidneys and was urinating involuntarily.   Had urge to to go the bathroom again around 3;  30.  This time could NOT walk at all & was once again urinating involuntarily.  Tried to just go back to bed, but did not seem to have any control over my body.  Around 4:30 I got as comfortable as possible on the floor & slept  off & on until around 8:30.  When I woke up I was able with  help to get back into bed. I had continued to urinate involuntarily during the time I was sleeping prior to 8:30.   The symptoms seemed to gradually subside after this point.  Called Neurologist,  thinking that my radiation induced nerve damage was involved in my reaction and she agreed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Swelling
Clinical narrative: 24 Hours after receiving the vaccine my arm was sore from my bicep all the way up to my lower neck.  I noticed two bumps near my clavicle, as well that area is swollen.