chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: I had COVID-19 arm: extreme itchiness from the top of my arm to the elbow, rash at the injection site, redness and skin was raised (started on 12/28/2021), the day after the injection. This lasted for 3 days. Then in the evening of 1/8/2022, I experienced extreme itchiness and hives on my face, neck, chest, back and hands. I felt the same itchiness in the evening of 1/9/2022.  It is so bad I am unable to sleep. I want to peel my skin off. If it continues after another few days, I will call my doctor.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back disorder, Back pain, Intervertebral disc degeneration, Intervertebral disc protrusion
Clinical narrative: Day of the event: lower back started aching within a couple hours, worsened by the hour so I had to take my laptop to bed by afternoon and stayed there all night.  Next morning, bent down to pick something up and threw my back out entirely, dropped me to the floor and it's never been the same since.   3 weeks after the injection, I started waking up to swollen lips periodically for 2 weeks.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Magnetic resonance imaging, X-ray
Clinical narrative: Day of the event: lower back started aching within a couple hours, worsened by the hour so I had to take my laptop to bed by afternoon and stayed there all night.  Next morning, bent down to pick something up and threw my back out entirely, dropped me to the floor and it's never been the same since.   3 weeks after the injection, I started waking up to swollen lips periodically for 2 weeks.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Swelling
Clinical narrative: swelling and spasm on the left side of the neck, near the collarbone
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitch in the left side of face, just above lip. Twitching continued daily for 5 months and then nearly on the dot stopped and I have yet to have it return.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pain
Clinical narrative: Chills, body aches, nausea, vomiting, passed-out, loss of appetite and fatigue.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Chills, body aches, nausea, vomiting, passed-out, loss of appetite and fatigue.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eyelid pain, Headache, Pain in extremity, Swelling of eyelid
Clinical narrative: Woke up with a very sore arm, severe headache, and swollen, red upper right eyelid. Gave Tylenol for pain. Headache and arm pain resolved within 24 hours.  Eyelid still red, sore and swollen over 72 hours later. Using warm compresses with little relief. Trying Benadryl now, too soon to report outcome.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Felt squeezing in heart; severe headache like a cement block in head; chills and fever 101.4. The next morning, severe fatigue and could hardly get out of bed to use the bathroom. Sensations lasted 36 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: Described previously
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea, Neuropathy peripheral, Vertigo
Clinical narrative: Neuropathy in feet and thighs after 1 week following vaccination. Dizziness, nausea, vertigo, weakness after 2 months following vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Menstrual disorder
Clinical narrative: Pfizer  Hair loss and changes in menstruation
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Approximately seven hours after the time the vaccine was administered, the injection site became swollen and red (~2 inches in diameter). The following day, on January 9th, the injection site also began itching.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Skin itching, multiple hives all over the body - arms, legs, neck, back, waistline, and head.   Consistent rash and itching all over the body with hives - redness, bumps etc.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Lymph node pain, Lymphadenopathy, Mobility decreased, Neck pain
Clinical narrative: Enlarged Lymph nodes at the base of the skull. Extremely painful causing pain in neck making movement difficult.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erectile dysfunction, Paraesthesia
Clinical narrative: I have got erectile dysfunction from the pfizer vaccine I feel less sensitive with a burning tingle feeling . I have found many other with this problem who went to doctor but could not help with this problem all they said was time that help them recouver it been almost 4.5 month for me and still suffer from this problem.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal filler injection, Swelling, Tenderness
Clinical narrative: I received my first two doses of the Moderna covid vaccine in Jan/Feb 2021. On September 24, 2021 I was treated with a hyaluronic acid based dermal filler in my under eye area. The about 22 hours after my Moderna booster vaccine administration,  I noted swelling  of the undereye filler and tenderness to palpate. I contacted my provider and he prescribed a Medrol dose pack, which I took the first dose of on 1/9/22 after no improvement in symptoms.  As of 10:36pm on 1/9/22 there is slight improvement, but still noticeable swelling and tenderness to palpate area of dermal filler injection.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Sleep disorder
Clinical narrative: Both knees begun to ache at night so hard that I could not sleep. After getting up and walking around for half an hour the pain subsided. After another two hours of sleep, I woke up again in knee pain and this repeated through the night. After getting up in the morning the pain did not return as long as I was walking around. The pain returned again the next night in the same manner. This lasted for four days. I began to take Ibuprofin after the second night.  After the fourth night the pain did not reappear and has not reappeared during the rest of the year.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Adenovirus infection, Condition aggravated, Cough, Headache, Lymphadenopathy
Clinical narrative: Day 1-3 headache swollen neck lymph nodes Day 4-10 (and currently) sore throat, congestion, cough, headache  Possible activation of latent adenovirus???
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Day 1-3 headache swollen neck lymph nodes Day 4-10 (and currently) sore throat, congestion, cough, headache  Possible activation of latent adenovirus???
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Alopecia areata, Laboratory test normal, Thyroid function test normal
Clinical narrative: Hair loss, first noticed by my daughter in October in one area on the back of her head.  She was diagnosed with alopecia areata in November.  It has progressed to multiple areas on her head.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Increased appetite, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt. is a 42 y.o. female is here for Leg Pain (Booster vaccine (Pfizer) last Monday - had normal body aches, but on Wednesday - she started having a pain sensation in her upper R leg; it started getting worse on Saturday) Patient coming in for right anterior thigh pain and paresthesia that started on Wednesday.  She did get COVID-19 booster vaccine on Monday.  Noticed a slight discomfort on Wednesday, feels like it is getting worse.  Ibuprofen is effective at relieving her symptoms.  No skin changes, not warm to the touch, not painful to touch.  No limping or painful to walk, no swelling.  No history is happening the past, patient is worried about the possibility of a blood clot. Also she's had significant increase of appetite since Saturday.   **Portions of this note were created using voice recognition technology. Although efforts are made to correct all errors prior to signing please notify us at the following number if any dictation errors are noted**   Family History not pertinent.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Over 1 week arm pain with swelling, decreased ROM
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood disorder, Dyspnoea, Laboratory test
Clinical narrative: - BLOOD CLOT IN LUNG CAUSING A-FIB.  WENT TO WALK IN, IMMEDIATELY SENT TO THE EMERGENCY ROOM AND FROM THERE TO THE HOSPITAL. DIAGNOSIS - A-FIB W/ RAPID VENTRICULAR RESPONSE. SHORTNESS OF BREATH.  CURRENTLY ON APIXABAN, WAS ON ATORVASTATIN AND METOPROLOL UNTIL THIS WEEK.  ECHOCARDIOGRAM SCHEDULED JAN. 18TH TO DETERMINE ANY PERMANENT DAMAGE WITH VISIT TO CARDIOLOGIST ON JANUARY 28TH FOR CONSULTATION REGARDING RESULTS. APPOINTMENT AGAIN WITH DR. FOR LAB WORK ON BLOOD CONDITION RE-CONTINUING APIXABAN) AND AGAIN A CONSULTATION WITH MID-APRIL/MAY REGARDING PERMANENT DAMAGE AS A RESULT OF THIS VACCINE. WAS HEALTHY, ACTIVE 74 YEAR OLD UNTIL TWO WEEKS AFTER SECOND INJECTION.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: - BLOOD CLOT IN LUNG CAUSING A-FIB.  WENT TO WALK IN, IMMEDIATELY SENT TO THE EMERGENCY ROOM AND FROM THERE TO THE HOSPITAL. DIAGNOSIS - A-FIB W/ RAPID VENTRICULAR RESPONSE. SHORTNESS OF BREATH.  CURRENTLY ON APIXABAN, WAS ON ATORVASTATIN AND METOPROLOL UNTIL THIS WEEK.  ECHOCARDIOGRAM SCHEDULED JAN. 18TH TO DETERMINE ANY PERMANENT DAMAGE WITH VISIT TO CARDIOLOGIST ON JANUARY 28TH FOR CONSULTATION REGARDING RESULTS. APPOINTMENT AGAIN WITH DR. FOR LAB WORK ON BLOOD CONDITION RE-CONTINUING APIXABAN) AND AGAIN A CONSULTATION WITH MID-APRIL/MAY REGARDING PERMANENT DAMAGE AS A RESULT OF THIS VACCINE. WAS HEALTHY, ACTIVE 74 YEAR OLD UNTIL TWO WEEKS AFTER SECOND INJECTION.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Same side effects as after the 2nd dose, however, in the evening on 1/8/22 I started to experience extreme itchiness and hives all over my face, neck and chest.  I took Benadryl which provided some relief but I still feel quite itchy.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Fatigue, Feeling cold
Clinical narrative: I had extreme fatigue and cold all the time.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Nausea, SARS-CoV-2 test positive, Ventricular tachycardia
Clinical narrative: Patient is admitted for V tach. He also is COVID-19 positive, and has had a mild nonproductive cough and nausea.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arrhythmia, Arthralgia, COVID-19, Cardiac stress test
Clinical narrative: Patient is admitted for V tach. He also is COVID-19 positive, and has had a mild nonproductive cough and nausea.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: Patient is admitted for V tach. He also is COVID-19 positive, and has had a mild nonproductive cough and nausea.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pain, Palpitations
Clinical narrative: Patient is admitted for V tach. He also is COVID-19 positive, and has had a mild nonproductive cough and nausea.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Tachycardia, Troponin normal, Ventricular tachycardia
Clinical narrative: Patient is admitted for V tach. He also is COVID-19 positive, and has had a mild nonproductive cough and nausea.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, COVID-19, Chest X-ray abnormal, Death, Hypoglycaemia
Clinical narrative: pt brought to ED after being found unresponsive and hypoglycemic; positive for COVID 5 wks prior to this hosp admission; chest x ray showing possible infiltrates and recent COVID infection; started on Zosyn; pancytopenia (neutropenic); pt's condition worsened in the hospital and per death certificate, pt died in the hospital
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Neutropenia, Pancytopenia, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: pt brought to ED after being found unresponsive and hypoglycemic; positive for COVID 5 wks prior to this hosp admission; chest x ray showing possible infiltrates and recent COVID infection; started on Zosyn; pancytopenia (neutropenic); pt's condition worsened in the hospital and per death certificate, pt died in the hospital
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid positive contact through nursing home
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Cardiac imaging procedure abnormal, Cardiac stress test abnormal, Chest pain, Condition aggravated
Clinical narrative: Patient describes experiencing immediate shortness of breath after 2nd dose of vaccine as well as severe recurring headaches and a resurgence of her autoimmune conditions. No immediate emergent medical attention was sought after by patient. Patient describes still experiencing chest pains, exercise intolerance, severe headaches, and tinnitus since the administration of her second dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endocarditis, Exercise tolerance decreased, Headache, Immediate post-injection reaction
Clinical narrative: Patient describes experiencing immediate shortness of breath after 2nd dose of vaccine as well as severe recurring headaches and a resurgence of her autoimmune conditions. No immediate emergent medical attention was sought after by patient. Patient describes still experiencing chest pains, exercise intolerance, severe headaches, and tinnitus since the administration of her second dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Tinnitus
Clinical narrative: Patient describes experiencing immediate shortness of breath after 2nd dose of vaccine as well as severe recurring headaches and a resurgence of her autoimmune conditions. No immediate emergent medical attention was sought after by patient. Patient describes still experiencing chest pains, exercise intolerance, severe headaches, and tinnitus since the administration of her second dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Headache, Pyrexia
Clinical narrative: I received a covid vaccine booster from Pharmacy on Monday 1/03/22 and immediate had an adverse reaction including: high fever, elevated blood pressure, chills, metallic taste, etc. Pharmacy staff called me on Tuesday morning to notify that I had been given the full undiluted vial of vaccine, approximately 6 doses. Pharmacy staff said that a report has been filed with the governing agency and that my doctor had been notified. I was instructed to stay home and monitor my symptoms and to go to the ER if I had heart palpitations. I am continuing to have symptoms that include high blood pressure, headache, nausea, and extreme fatigue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Blood pressure increased, Chills, Dysgeusia, Fatigue
Clinical narrative: I received a covid vaccine booster from Pharmacy on Monday 1/03/22 and immediate had an adverse reaction including: high fever, elevated blood pressure, chills, metallic taste, etc. Pharmacy staff called me on Tuesday morning to notify that I had been given the full undiluted vial of vaccine, approximately 6 doses. Pharmacy staff said that a report has been filed with the governing agency and that my doctor had been notified. I was instructed to stay home and monitor my symptoms and to go to the ER if I had heart palpitations. I am continuing to have symptoms that include high blood pressure, headache, nausea, and extreme fatigue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperpyrexia, Hypertension, Immediate post-injection reaction, Incorrect dose administered
Clinical narrative: I received a covid vaccine booster from Pharmacy on Monday 1/03/22 and immediate had an adverse reaction including: high fever, elevated blood pressure, chills, metallic taste, etc. Pharmacy staff called me on Tuesday morning to notify that I had been given the full undiluted vial of vaccine, approximately 6 doses. Pharmacy staff said that a report has been filed with the governing agency and that my doctor had been notified. I was instructed to stay home and monitor my symptoms and to go to the ER if I had heart palpitations. I am continuing to have symptoms that include high blood pressure, headache, nausea, and extreme fatigue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Product preparation issue
Clinical narrative: I received a covid vaccine booster from Pharmacy on Monday 1/03/22 and immediate had an adverse reaction including: high fever, elevated blood pressure, chills, metallic taste, etc. Pharmacy staff called me on Tuesday morning to notify that I had been given the full undiluted vial of vaccine, approximately 6 doses. Pharmacy staff said that a report has been filed with the governing agency and that my doctor had been notified. I was instructed to stay home and monitor my symptoms and to go to the ER if I had heart palpitations. I am continuing to have symptoms that include high blood pressure, headache, nausea, and extreme fatigue.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Laboratory test normal, Nausea, Rhinorrhoea
Clinical narrative: received Pfizer vaccines on 1/30/21, 2/13/21 tested positive for COVID by PCR on 1/2/22 hospitalized from 1/4 to 1/19/22 d/t COVID pneumonia
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: received Pfizer vaccines on 1/30/21, 2/13/21 tested positive for COVID by PCR on 1/2/22 hospitalized from 1/4 to 1/19/22 d/t COVID pneumonia
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: received Pfizer vaccines on 1/30/21, 2/13/21 tested positive for COVID by PCR on 1/2/22 hospitalized from 1/4 to 1/19/22 d/t COVID pneumonia
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation, Myocarditis, Pericarditis, Troponin increased
Clinical narrative: Myopericarditis treated with colchicine & acetaminophen
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Electrocardiogram ST segment elevation, Myocarditis, Troponin increased
Clinical narrative: Myopericarditis treated with colchicine & acetaminophen
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: adult dose to pediatric patient; adult dose to pediatric patient; This case was reported by a nurse via sales rep and described the occurrence of overdose in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported a mal administration of adult dose to pediatric patient, which led to overdose and adult product administered to child. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Got Shingrix, 2 months later got COVID; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In December 2021, 2 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The patient received Shingrix vaccine mid of October then 2 months later contracted COVID.  They referred to health care professional.  The reporter did not consent to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: Given only the liquid component; Given only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a neonate male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th December 2021, the patient received Menveo. On 30th December 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter reported that a patient was administered only the liquid component of the Menveo vaccine inadvertently, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The recommended age for getting Menveo was at least 2 months of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Purpura
Clinical narrative: broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs; purpura on left knee; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs) and PURPURA (purpura on left knee) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046821A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PETECHIAE (broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs) and PURPURA (purpura on left knee). In May 2021, PURPURA (purpura on left knee) had resolved. At the time of the report, PETECHIAE (broke out in petechiae in shins/ petechiae again, on shins on her skin, not in the upper thigh, just the lower legs, both legs) had not resolved.            Concomitant medications were not provided.  Patient reported that no treatments  was tried. Patient's dermatologist did not prescribe anything.  Patient went to see a dermatologist. It did not go away for a while.  Company Comment: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected AESI events of Petechiae and Purpura. The events occurred on the same month after the second dose of mRNA-1273 Vaccine. At the time of the report, after at least 2 months, the outcome of the events was resolved. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-407959 (Patient Link).; Sender's Comments: This case concerns a 49-year-old female patient, with no medical history reported, who experienced the unexpected AESI events of Petechiae and Purpura. The events occurred on the same month after the second dose of mRNA-1273 Vaccine. At the time of the report, after at least 2 months, the outcome of the events was resolved. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; Diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with COVID) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 007M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with COVID). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive test evening.         No concomitant medication reported. No treatment medication details reported. The patient got vaccinated in February and March and then got a booster November first and get breakthrough infections.The patient was confused cause all this just happened. Diagnosed with COVID. On 25-Dec-2021 evening test the positive.  This is a spontaneous case concerning  a  62-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Drug Ineffective and Covid-19 as an added event. The events occurred approximately 54 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  62-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Drug Ineffective and Covid-19 as an added event. The events occurred approximately 54 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: fever; swollen lymph node in her left armpit; headaches for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), LYMPHADENOPATHY (swollen lymph node in her left armpit) and HEADACHE (headaches for 2 days) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever), LYMPHADENOPATHY (swollen lymph node in her left armpit) and HEADACHE (headaches for 2 days). In April 2021, HEADACHE (headaches for 2 days) had resolved. At the time of the report, PYREXIA (fever) and LYMPHADENOPATHY (swollen lymph node in her left armpit) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-440806, MOD-2022-440720.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: I don't have an appetite / I force myself to eat; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (I don't have an appetite / I force myself to eat) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 026C21A and 026C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot on 09-Dec-2021. Past adverse reactions to the above products included No adverse reaction with Flu shot.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced DECREASED APPETITE (I don't have an appetite / I force myself to eat). At the time of the report, DECREASED APPETITE (I don't have an appetite / I force myself to eat) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had lost sense of smell & taste, before the booster. On 06 Jan 2022, it was informed that the patient still can't taste or smell however can taste honey.   No treatment medications were reported.   This case was linked to MOD-2022-442047 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Non significant information received On 06-Jan-2022: Follow-up received and patient demographics added , vaccination details added , Event added and it was confirmed that loss of taste and loss of smell happened prior to booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I want to get the booster shot but my last shot made me very sick. Is the moderna booster the best to take with less side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I want to get the booster shot but my last shot made me very sick. Is the moderna booster the best to take with less side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I want to get the booster shot but my last shot made me very sick. Is the moderna booster the best to take with less side effects). At the time of the report, ILLNESS (I want to get the booster shot but my last shot made me very sick. Is the moderna booster the best to take with less side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (I want to get the booster shot but my last shot made me very sick. Is the moderna booster the best to take with less side effects) to be related.    No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 19 doses administered past expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 doses administered past expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 doses administered past expiration). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (19 doses administered past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The reporter wanted to know regarding the steps to take when a patient was given an expired Moderna Vaccine. Number of doses/vials: 19 doses: 1 dose was a 2nd primary series dose and 18 doses were booster doses. On 14-Dec-2021, vial was initially stored in the refrigerator.  Treatment information was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral discomfort
Clinical narrative: Since then, mouth is uncomfortable; Numbing in the mouth/around inside my mouth at the beginning of my throat; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Since then, mouth is uncomfortable) and HYPOAESTHESIA ORAL (Numbing in the mouth/around inside my mouth at the beginning of my throat) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISCOMFORT (Since then, mouth is uncomfortable) and HYPOAESTHESIA ORAL (Numbing in the mouth/around inside my mouth at the beginning of my throat). At the time of the report, ORAL DISCOMFORT (Since then, mouth is uncomfortable) and HYPOAESTHESIA ORAL (Numbing in the mouth/around inside my mouth at the beginning of my throat) outcome was unknown.            No concomitant medication were reported.  Patient had her booster shot from Moderna 2 to 3 weeks ago and events started a week after the shot.  Since then, she noticed that in her mouth, it's so uncomfortable, like when you go to the dentist and the numbing medicine is going away. It's around inside her mouth at the beginning of her throat.  Patient visited doctor on 06 Jan 2022.  No treatment medication were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm where the shot was given) and arthralgia (sore shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore arm where the shot was given) and arthralgia (sore shoulder). At the time of the report, vaccination site pain (sore arm where the shot was given) and arthralgia (sore shoulder) outcome: unknown. No concomitant medication or treatment information provided. Patient received 2 Moderna COVID-19 doses in the months before. With the booster, patient had soreness in her shoulder too. Patient was still disoriented and dizzy since Friday. Reporter will make patient an appointment with her local GP. Patient was physically fine, walks, but won't drive now because of adverse event. This case linked to MOD-2022-440044 (patient link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore arm where the shot was; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm where the shot was) and ARTHRALGIA (sore shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm where the shot was) and ARTHRALGIA (sore shoulder). At the time of the report, PAIN IN EXTREMITY (Sore arm where the shot was) and ARTHRALGIA (sore shoulder) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-440044, MOD-2022-443499 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: red botches; she was not able to raise her arm anymore.; It was swollen underneath her arm.; sore arm that was hot and affecting the deltoid area; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (red botches), MOBILITY DECREASED (she was not able to raise her arm anymore.), PERIPHERAL SWELLING (It was swollen underneath her arm.) and PAIN IN EXTREMITY (sore arm that was hot and affecting the deltoid area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ECZEMA (red botches), MOBILITY DECREASED (she was not able to raise her arm anymore.), PERIPHERAL SWELLING (It was swollen underneath her arm.) and PAIN IN EXTREMITY (sore arm that was hot and affecting the deltoid area). At the time of the report, ECZEMA (red botches), PERIPHERAL SWELLING (It was swollen underneath her arm.) and PAIN IN EXTREMITY (sore arm that was hot and affecting the deltoid area) had resolved and MOBILITY DECREASED (she was not able to raise her arm anymore.) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient never had an injury. She had seen a doctor who referred her to an orthopedic but she mentioned it would take a lot to see a doctor.
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Rash, Rash macular
Clinical narrative: Leg had extensive swelling; After a bath had a red blotching pattern on face; Initial information received on 22-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 3 years old female patient who had leg had extensive swelling and after a bath had a red blotching pattern on face while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received an 0.5 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, administration site, lot number and expiry date was unknown) via intramuscular route for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "leg had extensive swelling" (peripheral swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date the patient developed a non-serious event " after a bath had a red blotching pattern on face" (rash macular) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Leg had extensive swelling, After a bath had a red blotching pattern on face).  At time of reporting, the outcome was Unknown for the event leg had extensive swelling and was Unknown for the event after a bath had a red blotching pattern on face.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: getting my flu shots my whole life; had the flu twice in my life; Initial information received on 24-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via global digital media.  This case involves an unknown age and gender patient who reported getting my flu shots my whole life; had the flu twice in my life, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date ,the patient developed a non-serious event "getting my flu shots my whole life; had the flu twice in my life" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" I have been getting my flu shots my whole life I am in my 60s now I have had the flu twice in my life I've had my covid shots and also boosters I've also had overseas medical type of shots depending on what part of the world I was going to and what to look out for in different parts of the world and to be prepared for what possible exposures you might have there."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (getting my flu shots my whole life; had the flu twice in my life).  At time of reporting, the outcome was Unknown for the event getting my flu shots my whole life; had the flu twice in my life.
Sex: U
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: flu shot is wicked...almost killed my son; Initial information received on 24-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had  flu shot is wicked...almost killed my son while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious flu shot is wicked...almost killed my son (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu shot is wicked...almost killed my son).  At time of reporting, the outcome was Unknown for the event flu shot is wicked...almost killed my son.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 27-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination .  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I haven't gotten the flu since I stopped getting it years ago".  INFLUENZA VACCINE was discontinued on an unknown date.  It was not reported if the patient received a corrective treatment for the events (Flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: he is always sick; Initial information received on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 72 years old male patient who was always sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious event "he is always sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "have a friend that is 72. He got the flu shot. And whatever Rona shots they recommend. Now he is always sick. Not sure if this is the best choice for seniors."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (he is always sick).  At time of reporting, the outcome was Unknown for the event he is always sick.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: so sick; Initial information received on 28-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who was so sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown)  in unknown administration site as prophylactic vaccination (flu vaccination).  On an unknown date the patient developed a non-serious event "so sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (so sick).  At time of reporting, the outcome was Unknown for the event so sick.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 27-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination (flu vaccine).  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.