chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Contusion, Hypoaesthesia, Malignant neoplasm removal
Clinical narrative: Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection.  Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by  extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pyrexia, Sensory loss, Squamous cell carcinoma of skin
Clinical narrative: Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection.  Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by  extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon injury
Clinical narrative: Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection.  Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by  extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Peripheral swelling, Weight increased
Clinical narrative: JOINT PAIN  HANDS FEET, KNEES AND ALL OVER, SWELLING IN UPPER AND LOWER EXTREMITIES, FATIGUE, WEIGHT GAIN
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash, headache and fever
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Throat tightness
Clinical narrative: INCREASED HEARTRATE AND SWELLING OF THROAT.  PATIENT CAME TO ME 15 MINUTES AFTER RECEIVING THE VACCINE AT APPROXIMATELY 5:01 PM.   SHE STATED THE THROAT CLOSURE WAS GETTING WORSE AND HEART RATE FELT FAST.  I TOOK BP TO FIND ELEVATION (DON'T REMEMBER THE EXACT VALUE).  HEART RATE WAS 113 BPM AT APROXIMATELY 5:O2.   (EMS WAS CALLED).   5:03 ADMINISTERED EPIPEN 0.3      MEDICS ARRIVED AT 5:05PM.    PT TAKEN TO HOSPITAL BY MEDICS AT 5:10 PM
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Influenza, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Arm pain, swelling at site. Sick feeling for 4-5 days, malice, flu symptoms aches/pains for weeks, now. Swelling on right side= arm, legs, breast pain still continues, also.. no treatment other than aspirin and or Tylenol initially.. swollen right side has still persisted as well as painful breast nipple area.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Arm pain, swelling at site. Sick feeling for 4-5 days, malice, flu symptoms aches/pains for weeks, now. Swelling on right side= arm, legs, breast pain still continues, also.. no treatment other than aspirin and or Tylenol initially.. swollen right side has still persisted as well as painful breast nipple area.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear only. Constant high pitch ringing that never ceases.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Unevaluable event
Clinical narrative: see above
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Barium swallow normal, Blood test, Chest X-ray, Computerised tomogram normal, Cough
Clinical narrative: Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Ear pain, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Throat irritation, Weight decreased
Clinical narrative: Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Blood pressure decreased, Hypotension, Syncope, Vomiting
Clinical narrative: Syncopal episode with syncopal convulsions, monitored and BP checked, low BP, vomiting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chest pain, Erythema, Herpes zoster
Clinical narrative: Severe right sided thoracic  & chest pain. Onset of blister with redness, continued Rt sided pain 11/10.  In first vacation since Covid and got sick, went to urgent care July 4, 2021, Dx with SHINGLES.   Taking prednisone & valtrex but over next few days, blistering, redness spread between chest/breast to thoracic spine.  Still with symptoms, while out of town on vacation!  I am 55yo, healthy female, no underlying autoimmune disease or anything, no family history of shingles, so how did this happen?  Possibly from Covid vaccine?
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Fatigue, Lipoma
Clinical narrative: Hoarseness,  cough, fatigue, lipoma
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Anxiety, Blood test abnormal, Chest discomfort, Crying
Clinical narrative: Started feeling sick (light headed, anxious, felt like he was coming down with illness and chest pressure) on 518, by 6am on 6/19 he woke up crying with massive chest pressure, we took him to urgent care at 12:30p, immediately sent to ER due to abnormal EKG, admitted in ER with more tests & blood work taken(troponin was 1300) so he then was send via ambulance transport to cardiac unit at Hospital where he spent the night and on 5/20 they did a battery of tests to figure out what his diagnosis was. Confirmed a  minor heart attack caused by a cardiac embolism. Echocardiogram showed minor heart damage. He was prescribed a ZIO patch to wear for 2 weeks resulting in no issues. Dr confirmed this event was Covid vaccine related.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram abnormal, Embolism, Hospitalisation, Magnetic resonance imaging heart
Clinical narrative: Started feeling sick (light headed, anxious, felt like he was coming down with illness and chest pressure) on 518, by 6am on 6/19 he woke up crying with massive chest pressure, we took him to urgent care at 12:30p, immediately sent to ER due to abnormal EKG, admitted in ER with more tests & blood work taken(troponin was 1300) so he then was send via ambulance transport to cardiac unit at Hospital where he spent the night and on 5/20 they did a battery of tests to figure out what his diagnosis was. Confirmed a  minor heart attack caused by a cardiac embolism. Echocardiogram showed minor heart damage. He was prescribed a ZIO patch to wear for 2 weeks resulting in no issues. Dr confirmed this event was Covid vaccine related.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myocardial infarction, Troponin increased
Clinical narrative: Started feeling sick (light headed, anxious, felt like he was coming down with illness and chest pressure) on 518, by 6am on 6/19 he woke up crying with massive chest pressure, we took him to urgent care at 12:30p, immediately sent to ER due to abnormal EKG, admitted in ER with more tests & blood work taken(troponin was 1300) so he then was send via ambulance transport to cardiac unit at Hospital where he spent the night and on 5/20 they did a battery of tests to figure out what his diagnosis was. Confirmed a  minor heart attack caused by a cardiac embolism. Echocardiogram showed minor heart damage. He was prescribed a ZIO patch to wear for 2 weeks resulting in no issues. Dr confirmed this event was Covid vaccine related.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Ejection fraction decreased, Gene sequencing, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: VF arrest 1 week after second Moderna vaccination. Successfully resuscitated, good neurologic outcome. Initial ejection fraction was low, 25%, currently improving. MRI with late gadolinium enhancement suggesting myocarditis. Troponin normal. Genetics panel without polymorphism predisposing to cardiomnyopathy.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation, Troponin normal, Ventricular fibrillation
Clinical narrative: VF arrest 1 week after second Moderna vaccination. Successfully resuscitated, good neurologic outcome. Initial ejection fraction was low, 25%, currently improving. MRI with late gadolinium enhancement suggesting myocarditis. Troponin normal. Genetics panel without polymorphism predisposing to cardiomnyopathy.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Diagnosed with high blood pressure after receiving vaccine, even though I have been treated by a cardiologist for close to 12 years and have never had high blood pressure.  My primary care physician has since played down the idea that my condition is vaccine-related.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperventilation
Clinical narrative: sore muscles all over entire arm in pain when used Extreme chills fever mood swings extreme fatigue muscle pains headache dizziness hyperventilating
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mood swings, Myalgia, Pain, Pyrexia
Clinical narrative: sore muscles all over entire arm in pain when used Extreme chills fever mood swings extreme fatigue muscle pains headache dizziness hyperventilating
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: We had a customer who had an appointment today to get a 1st dose Pfizer vaccine. On consent form, she answered "No" to the question, "Have you ever received a dose of COVID-19 vaccine before?" I verified with her before giving vaccine. She did not have any vaccination card with. I administered Pfizer vaccine and gave her the vaccination card. When I processed the vaccine, it returned with this reject: " Patient received a single dose vaccine. Records indicate patient received single dose 20210405." I confirmed she received J&J vaccine on 4/5/2021. I attempted to call the patient multiple times before able to reach her. She confirmed that she did get the J&J vaccine. This is her statement: "I have Non-Hodgkin's Lymphoma, and oncologist is not happy with J&J level of coverage/effectiveness (especially against the Delta variant) and wanted me to get one of the mRNA vaccines to get additional coverage/effectiveness."  I told her that she should have mentioned this on the consent form and in person prior to us administering the vaccine, and she said she misread the question as if it was asking if she had received a 1st dose of Pfizer or Moderna, so she answered "No."
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: started with chronic hives 24 hours after second injection
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pathology test, Placental disorder
Clinical narrative: Missed miscarriage diagnosed at 20 weeks. The baby died 5 days after vaccine dose 2 at 16.5 weeks. No abnormalities in previous scans. Placenta pathology noted inflammation and infection.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurring of vision in left eye 21 days after the first dose of Covid vaccine
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: started approx 12:30 am 7/7/2021, low grade fever ~99°F, accompanied with mild malaise, fatigue, sensitivity around injection site. tylenol taken approx 2 hours after vaccination.  advil pm taken around bed time (3am 7/7/2021)   symptoms continued throughout the day with increased tenderness and soreness in arm that received injection. OTC pain medication taken in morning 11:30am. once more at 3pm.  spiked fever began around 10pm cst (22:00, 7/7/2021) of ~101.7°F, moderate to severe muscle aches, general overall feeling of ?unwell?, lethargic.  ~11:30pm pain in left arm began to spread down towards elbow, painful to move or flex muscles in arm out of normal range, stinging sensation.   ~1am 7/8/2021, noticed a rash approx 1.5inches-2.5inches from injection site on arm. arm is hot to touch, rash is inconsistent in size/shape & pattern, slightly raised, swollen, red & splotchy. mimicking the appearance of possible hives. advil pm taken 2am 7/8/2021, along with 25mg benadryl to help soothe rash.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: started approx 12:30 am 7/7/2021, low grade fever ~99°F, accompanied with mild malaise, fatigue, sensitivity around injection site. tylenol taken approx 2 hours after vaccination.  advil pm taken around bed time (3am 7/7/2021)   symptoms continued throughout the day with increased tenderness and soreness in arm that received injection. OTC pain medication taken in morning 11:30am. once more at 3pm.  spiked fever began around 10pm cst (22:00, 7/7/2021) of ~101.7°F, moderate to severe muscle aches, general overall feeling of ?unwell?, lethargic.  ~11:30pm pain in left arm began to spread down towards elbow, painful to move or flex muscles in arm out of normal range, stinging sensation.   ~1am 7/8/2021, noticed a rash approx 1.5inches-2.5inches from injection site on arm. arm is hot to touch, rash is inconsistent in size/shape & pattern, slightly raised, swollen, red & splotchy. mimicking the appearance of possible hives. advil pm taken 2am 7/8/2021, along with 25mg benadryl to help soothe rash.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: started approx 12:30 am 7/7/2021, low grade fever ~99°F, accompanied with mild malaise, fatigue, sensitivity around injection site. tylenol taken approx 2 hours after vaccination.  advil pm taken around bed time (3am 7/7/2021)   symptoms continued throughout the day with increased tenderness and soreness in arm that received injection. OTC pain medication taken in morning 11:30am. once more at 3pm.  spiked fever began around 10pm cst (22:00, 7/7/2021) of ~101.7°F, moderate to severe muscle aches, general overall feeling of ?unwell?, lethargic.  ~11:30pm pain in left arm began to spread down towards elbow, painful to move or flex muscles in arm out of normal range, stinging sensation.   ~1am 7/8/2021, noticed a rash approx 1.5inches-2.5inches from injection site on arm. arm is hot to touch, rash is inconsistent in size/shape & pattern, slightly raised, swollen, red & splotchy. mimicking the appearance of possible hives. advil pm taken 2am 7/8/2021, along with 25mg benadryl to help soothe rash.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Tearfulness
Clinical narrative: Headaches, cramps in the abdomen were observed. Tears of sadness and sorrow were shed.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had both vaccine doses back in January and Wednesday 01Jul he drew positive to Covid-19 after a molecular PCR test.; had both vaccine doses back in January and Wednesday 01Jul he drew positive to Covid-19 after a molecular PCR test.; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old male patient received bnt162b2, via an unspecified route of administration, administered in right arm on 07Jan2021 13:00 (Lot Number: EL3246) as dose 1, single, and then via an unspecified route of administration, administered in left arm on 28Jan2021 (Lot Number: EL8982) as dose 2, single, all at the age of 31-year-old for covid-19 immunization. The patient had no known allergies and no other medical history. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had both vaccine doses back in January and Wednesday 01Jul2021 (as reported) he drew positive to covid-19 after a molecular PCR test on 28Jun2021 14:00  (as reported). The patient underwent lab tests and procedures which included PCR (Nasal Swab): positive on 30Jun2021. Therapeutic measures were not taken as a result of event. The outcome of event was recovering.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2to the reported vaccination failure / COVID-19 cannot be ruled out.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles or herpes zoster; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 30-JUN-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On 18-JUL-2012, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for the long-term prevention herpes zoster or shingles. Subsequently, to the patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles or herpes zoster.  Then, on an unknown date, the patient was hospitalized due to the event. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not linted to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost 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. At the reporting time, the outcome of herpes zoster was not provided. The reporter considered the event herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; The MMR-II expired on 6/30/2021 and was inadvertently administered on 7/1/2021; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 01-JUL-2021, the patient was inadvertently vaccinated with an expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# S020160, expiration date 30-JUN-2021; dose, strength, frequency and route unknown) for prophylaxis (Expired product administered). The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) had never had any temperature excursions. No additional adverse event (AE) reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Wrong technique in product usage process
Clinical narrative: swelling of the entire upper arm; injection site swelling; pain at the injection site; needle was in his arm for a long period of time longer then any other vaccine he has had; This spontaneous report was received from a male patient of unknown age. The patient stated that he has never had any problems with vaccines in the past. There was no information about the patient's concurrent conditions, allergies and concomitant therapies provided.   On 25-JUN-2021 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one 0.5 milliliter injection into unspecified arm (strength, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient stated that during the vaccination the needle was in his arm for a long period of time, longer than any other vaccine he has had (wrong technique in product usage process).  On the vaccination day, the patient had a reaction to the vaccine. He experienced swelling of the entire upper arm, injection site swelling and pain at the injection site. The patient used ice and heating pad to relieve experienced symptoms. At the time of this report, the patient was recovering from the mentioned events.   The reporter considered all events to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; administered after the expiration date; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 01-JUL-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # s011951 with expiration date on 16-APR-2021, 1 dosage form (route of administration was not reported) for prophylaxis. No adverse event was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site warmth, Neuropathy peripheral
Clinical narrative: Neuropathy peripheral; Hypoaesthesia; Paraesthesia; Injection site warmth; Injection site pruritus; Injection site erythema; This case was received via VAERS (Reference number: 1283744) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy peripheral) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Hypertension (mild). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), IRBESARTAN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy peripheral) (seriousness criterion medically significant), HYPOAESTHESIA (Hypoaesthesia), PARAESTHESIA (Paraesthesia), INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (Injection site pruritus) and INJECTION SITE ERYTHEMA (Injection site erythema). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy peripheral), HYPOAESTHESIA (Hypoaesthesia), PARAESTHESIA (Paraesthesia), INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (Injection site pruritus) and INJECTION SITE ERYTHEMA (Injection site erythema) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Approximately 12 hours post dose patient experienced tingling sensation in legs during sleep. Days 2 to 8 post dose, experienced tingling in feet and slight numbness in feet and lower legs. Slight numbness was noticed in fingertips on days 7 and 8. Diagnosis was peripheral neuropathy due to reaction to 1st Moderna Covid-19 shot. On day 7 post dose developed an itchy red spot at injection site approximately 1 inch diameter. By day 8 reaction, at injection site progressed to intense response: large affected area of 4 inches by 3 inches, redness, itchy, area hot to the touch due to reaction to the 1st Moderna Covid-19 shot. Physician recommends no 2nd Moderna COVID-19 shot, or any other COVID vaccine.  No treatment medication details were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Neuropathy peripheral; Hypoaesthesia; Paraesthesia; Injection site warmth; Injection site pruritus; Injection site erythema; This case was received via VAERS (Reference number: 1283744) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy peripheral) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Hypertension (mild). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), IRBESARTAN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy peripheral) (seriousness criterion medically significant), HYPOAESTHESIA (Hypoaesthesia), PARAESTHESIA (Paraesthesia), INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (Injection site pruritus) and INJECTION SITE ERYTHEMA (Injection site erythema). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy peripheral), HYPOAESTHESIA (Hypoaesthesia), PARAESTHESIA (Paraesthesia), INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE PRURITUS (Injection site pruritus) and INJECTION SITE ERYTHEMA (Injection site erythema) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Approximately 12 hours post dose patient experienced tingling sensation in legs during sleep. Days 2 to 8 post dose, experienced tingling in feet and slight numbness in feet and lower legs. Slight numbness was noticed in fingertips on days 7 and 8. Diagnosis was peripheral neuropathy due to reaction to 1st Moderna Covid-19 shot. On day 7 post dose developed an itchy red spot at injection site approximately 1 inch diameter. By day 8 reaction, at injection site progressed to intense response: large affected area of 4 inches by 3 inches, redness, itchy, area hot to the touch due to reaction to the 1st Moderna Covid-19 shot. Physician recommends no 2nd Moderna COVID-19 shot, or any other COVID vaccine.  No treatment medication details were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Chest X-ray, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Bell's palsy; Pain in extremity; This case was received via FDA VAERS (Reference number: 1284039) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Blood pressure high (under control) and Cholesterol high (under control). Concomitant products included AMLODIPINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), OMEPRAZOLE, SIMVASTATIN, FISH OIL and COENZYME Q10 [UBIDECARENONE] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in extremity). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form and VALACICLOVIR at a dose of 1 dosage form. At the time of the report, BELL'S PALSY (Bell's palsy) and PAIN IN EXTREMITY (Pain in extremity) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 27-Apr-2021, Chest X-ray: inconclusive (Inconclusive) inconclusive. On 27-Apr-2021, Electrocardiogram: inconclusive (Inconclusive) inconclusive. On 27-Apr-2021, Magnetic resonance imaging: inconclusive (Inconclusive) inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included flax. The reporter stated the patient had Bell's palsy on left side of face. Very limited information regarding this events has been provided at this time.; Sender's Comments: Very limited information regarding this events has been provided at this time
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Bell's palsy; Pain in extremity; This case was received via FDA VAERS (Reference number: 1284039) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Blood pressure high (under control) and Cholesterol high (under control). Concomitant products included AMLODIPINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), OMEPRAZOLE, SIMVASTATIN, FISH OIL and COENZYME Q10 [UBIDECARENONE] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in extremity). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form and VALACICLOVIR at a dose of 1 dosage form. At the time of the report, BELL'S PALSY (Bell's palsy) and PAIN IN EXTREMITY (Pain in extremity) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 27-Apr-2021, Chest X-ray: inconclusive (Inconclusive) inconclusive. On 27-Apr-2021, Electrocardiogram: inconclusive (Inconclusive) inconclusive. On 27-Apr-2021, Magnetic resonance imaging: inconclusive (Inconclusive) inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included flax. The reporter stated the patient had Bell's palsy on left side of face. Very limited information regarding this events has been provided at this time.; Sender's Comments: Very limited information regarding this events has been provided at this time
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I had 3 vaccines and I have the shingles/ suspected vaccination failure; I have the shingles; had 3 vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 dose of Shingles vaccines which led to extra dose administered. Post vaccination the patient had shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline/ HCP mixed the adjuvant portion with saline solution; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 4 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 Delated
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline/ HCP mixed the adjuvant portion with saline solution; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 5 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1-deleted
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 6 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1-deleted
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 7 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 deleted