chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: REALLY BAD CHILLS; FELT A BIT RUN DOWN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced really bad chills, and felt a bit run down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad chills, and felt a bit run down. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Paraesthesia
Clinical narrative: SHARP CHEST PAIN; TINGLING SENSATION ON THE VACCINATED ARM; NUMBNESS ON THE VACCINATED ARM; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pinch spinal nerves.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced sharp chest pain. On JUN-2021, the subject experienced tingling sensation on the vaccinated arm. On JUN-2021, the subject experienced numbness on the vaccinated arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the vaccinated arm, and tingling sensation on the vaccinated arm, and the outcome of sharp chest pain was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Injection site pain, Pyrexia, Tachycardia
Clinical narrative: TACHYCARDIA; LOW GRADE FEVER; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the subject experienced tachycardia. On 31-JUL-2021, the subject experienced low grade fever. On 31-JUL-2021, the subject experienced injection site soreness. Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) greater than 110 beats per minute (BPM). On 01-AUG-2021 14:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, and had not recovered from low grade fever, and tachycardia. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: NUMBNESS IN ELBOW DOWN, FOREARM, HANDS AND FEET; TINGLING SENSATION FROM ELBOW DOWN FOREARM,HANDS AND FEET/PRICKLY FEELING AFTER GET FROM STANDING ON FEET FOR LONG TIME BUT FEELING FROM THE ELBOW DOWN; FEELS ACHY; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known drug allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced numbness in elbow down, forearm, hands and feet. On JUL-2021, the subject experienced tingling sensation from elbow down forearm, hands and feet/prickly feeling after get from standing on feet for long time but feeling from the elbow down. On JUL-2021, the subject experienced feels achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in elbow down, forearm, hands and feet, tingling sensation from elbow down forearm,hands and feet/prickly feeling after get from standing on feet for long time but feeling from the elbow down and feels achy was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: PERSISTENT TINGLING SENSATION ON BOTH SIDES OF FACE (MORE ON RIGHT SIDE) AND ON BOTH ARMS (MORE ON RIGHT ARM) GOING UP AND DOWN AND GETTING WORSE; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and knee replacement surgery, and concurrent conditions included arthritis, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 210A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the subject experienced persistent tingling sensation on both sides of face (more on right side) and on both arms (more on right arm) going up and down and getting worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent tingling sensation on both sides of face (more on right side) and on both arms (more on right arm) going up and down and getting worse. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: ADMINISTERED SOME OF THE VACCINE (PARTIALLY ADMINISTERED); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administered some of the vaccine (partially administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered some of the vaccine (partially administered) was not reported. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness, Malaise, Rash
Clinical narrative: Some sort of blood formation in his ankle/Like a blood clot; Not feeling well; Rash on his arm; Felt tired; Bleeding at the back of his neck at his cervical area of his spine; Back of his neck at his cervical area of spine has laceration; Dizzy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not provided.  Concomitant products included LORAZEPAM and MIRTAZAPINE for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash on his arm) and FATIGUE (Felt tired). On an unknown date, the patient experienced THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) (seriousness criterion medically significant) and MALAISE (Not feeling well). The patient was treated with Wound care (Bandage) for Skin haemorrhage and Wound care (Bandage) for Skin laceration. At the time of the report, THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot), SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Not feeling well), RASH (Rash on his arm) and FATIGUE (Felt tired) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received include the new adverse events (Not feeling well and blood clot).; Sender's Comments: 81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Skin haemorrhage, Skin laceration, Thrombosis
Clinical narrative: Some sort of blood formation in his ankle/Like a blood clot; Not feeling well; Rash on his arm; Felt tired; Bleeding at the back of his neck at his cervical area of his spine; Back of his neck at his cervical area of spine has laceration; Dizzy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not provided.  Concomitant products included LORAZEPAM and MIRTAZAPINE for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash on his arm) and FATIGUE (Felt tired). On an unknown date, the patient experienced THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) (seriousness criterion medically significant) and MALAISE (Not feeling well). The patient was treated with Wound care (Bandage) for Skin haemorrhage and Wound care (Bandage) for Skin laceration. At the time of the report, THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot), SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Not feeling well), RASH (Rash on his arm) and FATIGUE (Felt tired) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received include the new adverse events (Not feeling well and blood clot).; Sender's Comments: 81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest scan, Hypoaesthesia, Illness, Limb discomfort, Magnetic resonance imaging
Clinical narrative: Could not use Left Hand; numbness to their left arm and hand, and their left foot.; Heart Palpitations; Feel Sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Could not use Left Hand) and HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy and Mitral valve prolapse (Heart) since 1993. Concomitant products included CARVEDILOL, LOSARTAN POTASSIUM and ALPRAZOLAM (XANAX) for an unknown indication.    On 02-Jun-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) (seriousness criterion hospitalization) and ILLNESS (Feel Sick). On 07-Jun-2021, the patient experienced PALPITATIONS (Heart Palpitations). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not use Left Hand) (seriousness criterion hospitalization). On 10-Jun-2021, PALPITATIONS (Heart Palpitations) had resolved. At the time of the report, LIMB DISCOMFORT (Could not use Left Hand) had not resolved and HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) and ILLNESS (Feel Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Magnetic resonance imaging: unknown Inconclusive. On an unknown date, Chest scan: unknown Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: the follow up document received contains no significant information(NNI).; Reporter's Comments: Patient took water pills as treatment medication. On day 5 the patient felt sick on 02 Jun 2021, she went to emergency room with her chest hunting and left side numbness of the body. She also had Magnetic resonance imaging (MRI) and shown to several doctors. Then went to post-exposure prophylaxis (PEP)on 10 Jun 2021. On 10 Jun 2021 she took off work on medical leave for a week. She could not able to use her left hand good and still waiting to see neurologist. The patient had not ever tested positive for COVID-19, and had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination. The patient had not experienced similar adverse event in the past and other potential causes for the event was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Could not use Left Hand; numbness to their left arm and hand, and their left foot.; Heart Palpitations; Feel Sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Could not use Left Hand) and HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy and Mitral valve prolapse (Heart) since 1993. Concomitant products included CARVEDILOL, LOSARTAN POTASSIUM and ALPRAZOLAM (XANAX) for an unknown indication.    On 02-Jun-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) (seriousness criterion hospitalization) and ILLNESS (Feel Sick). On 07-Jun-2021, the patient experienced PALPITATIONS (Heart Palpitations). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not use Left Hand) (seriousness criterion hospitalization). On 10-Jun-2021, PALPITATIONS (Heart Palpitations) had resolved. At the time of the report, LIMB DISCOMFORT (Could not use Left Hand) had not resolved and HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) and ILLNESS (Feel Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Magnetic resonance imaging: unknown Inconclusive. On an unknown date, Chest scan: unknown Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: the follow up document received contains no significant information(NNI).; Reporter's Comments: Patient took water pills as treatment medication. On day 5 the patient felt sick on 02 Jun 2021, she went to emergency room with her chest hunting and left side numbness of the body. She also had Magnetic resonance imaging (MRI) and shown to several doctors. Then went to post-exposure prophylaxis (PEP)on 10 Jun 2021. On 10 Jun 2021 she took off work on medical leave for a week. She could not able to use her left hand good and still waiting to see neurologist. The patient had not ever tested positive for COVID-19, and had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination. The patient had not experienced similar adverse event in the past and other potential causes for the event was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract, Therapeutic response unexpected, Vitamin B12 deficiency
Clinical narrative: catarac in r eye; Deficiency in vitamin B12; leg started to heal and look so much better and the last scab was finally gone; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (catarac in r eye) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Have skin cancer and had two surgeries in the past to help. It has been a few years since the last surgery.). Concurrent medical conditions included Skin cancer and Wound oozing (3-4 inch bumpy non-healing area in right knee constantly oozing a bloody to pinkish fluid.). Concomitant products included METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN B12 NOS for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CATARACT (catarac in r eye) (seriousness criterion medically significant), VITAMIN B12 DEFICIENCY (Deficiency in vitamin B12) and THERAPEUTIC RESPONSE UNEXPECTED (leg started to heal and look so much better and the last scab was finally gone). The patient was treated with IBUPROFEN for Throbbing pain, at a dose of 400 mg three times a day. At the time of the report, CATARACT (catarac in r eye) and VITAMIN B12 DEFICIENCY (Deficiency in vitamin B12) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (leg started to heal and look so much better and the last scab was finally gone) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  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.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant follow up was received. New event- cataract added. Case was upgraded to serious.; 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
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesterolemia.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy) had not resolved.            The patient was given steroids as treatment medication.  The patient was on blood pressure and cholesterol medicine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Thrombosis
Clinical narrative: Strokes; Blood clots; Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died), CEREBROVASCULAR ACCIDENT (Strokes) and THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Aneurysm.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Strokes) (seriousness criteria death and medically significant) and THROMBOSIS (Blood clots) (seriousness criteria death and medically significant). The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter  Patient had multiple medical issues , got vaccine after and aneurysm.   Very limited information regarding this events has been provided at this time.  Further information can't be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Myocardial infarction
Clinical narrative: modernashotgivemeheartattack; Modernashotgivemeashortofbreath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (modernashotgivemeheartattack) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (modernashotgivemeheartattack) (seriousness criterion medically significant) and DYSPNOEA (Modernashotgivemeashortofbreath). At the time of the report, MYOCARDIAL INFARCTION (modernashotgivemeheartattack) and DYSPNOEA (Modernashotgivemeashortofbreath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Very limited information regarding the events has been provided at this time.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Regulatory Authority follow up received. On 28-Jul-2021:Regulatory Authority follow up received.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Sleep disorder, Tinnitus
Clinical narrative: Developed moderate tinnitus about 10 days after my 2nd Pfizer vaccination.  Almost 5 months later,  the tinnitus persists and disrupts my daily life and sleep.    I saw an Ear, Nose, Throat doctor who said they have seen multiple patients who developed tinnitus from the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Non stop Tinnitus in both ears
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dermatitis acneiform, Rash erythematous, Rash papular, Rhinorrhoea, Scab
Clinical narrative: Patient in for red pimple like lesions on his abdomen and back noticed since 4 days now.  Parents state the older papular rashes are drying up but new ones are noted on the face, left shoulder, left axilla, right arm, 3 on the right thigh and one on the right leg. Rashes start as red papules which become crusted. He had his Varicella Vaccine #1 given on July 12, 2021.  No new soap, lotion used. No new food eaten. They have dogs outside the house. Nobody else has it at home.  He also has a runny nose with clear nasal discharges but is getting better.   No fever or cough. No fast or labored breathing.  He is active and eating well.  No sick contacts at home but goes day care.   DIAGNOSIS: Parents were advised since he was noted with new red papules over the weekend  and had old ones which are drying up now with history of Varicella vaccine on 7/12/2021, rashes likely from the Varicella vaccine. he has no exposure to active Tuberculosis, none reproted from daycare and nobody at home has it. Parents were advised not to bring him back to daycare until all the lesions are dried up. Advised he is contagious too though it is from the vaccine.  Will report to VAERS.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood loss assessment, Blood test, Colonoscopy, Dyspnoea, Haemoglobin decreased
Clinical narrative: I began to hemorrhage severely and lost 6 pints of blood. This was 3 days after a colonoscopy where two polyps were removed. There was no bleeding after this, it started three days later after I had received the vaccine  I also was severely short of breath for two weeks afterwards
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Polypectomy
Clinical narrative: I began to hemorrhage severely and lost 6 pints of blood. This was 3 days after a colonoscopy where two polyps were removed. There was no bleeding after this, it started three days later after I had received the vaccine  I also was severely short of breath for two weeks afterwards
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine spasm, Vaginal haemorrhage
Clinical narrative: Uterine cramping, intense vaginal bleeding similar to a menstrual period. Soaking pads every 2 hours for first 2 days, then moderate bleeding for the next 3 days. Completely unexpected, not listed on the vaccine data sheet as a possible side effect. It was not my normal time for menstruation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood immunoglobulin G, Blood test, Chillblains, SARS-CoV-2 test
Clinical narrative: The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.; This literature-non-study case was reported in a literature article and describes the occurrence of CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) (seriousness criterion hospitalization). The patient was treated with CORTICOSTEROIDS (oral) for Chilblains, at an unspecified dose and frequency. At the time of the report, CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy skin: superficial and mid-dermal perivascular cuffed lym (Inconclusive) Superficial and mid-dermal perivascular cuffed lymphocytic infiltrate. Mild superficial dermal edema is present. No interface changes are present. There is no evidence of vasculitis or vasculopathy. Initial and multiple deeper sections were examined. Direct immunofluorescence of the skin showed no specific immunoreactants detected. In 2021, Blood immunoglobulin G: positive (Positive) Present one month post-vaccine. In 2021, Blood test: normal (normal) normal. negative inflammatory markers and autoimmune serologies. In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) to be possibly related.    It was reported that the patient will not get the second COVID-19 vaccine dose.  Furthermore, it was made known that the chilblains-like lesions suggest an antibody response from either 1 vaccine dose or a previous PCR-negative COVID-19 infection.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Laryngomalacia
Clinical narrative: Laryngal malacia; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGOMALACIA (Laryngal malacia) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): 17-Dec-2020- Hypothyrodism.     MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.   On 08-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The mother's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 22-May-2021. On an unknown date, the patient was diagnosed with LARYNGOMALACIA (Laryngal malacia) (seriousness criterion medically significant). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. At the time of the report, LARYNGOMALACIA (Laryngal malacia) outcome was unknown.            No concomitant and treatment medications were provided.  Company comment: This is a child case whose mother was a case of maternal exposure during pregnancy and with associated adverse event of Laryngomalacia on the child. Very limited information regarding these events have been provided at this time. Further information has been requested.   This case was linked to MOD-2021-052207 (Parent-Child Link).   See case MOD-2021-052207 for details regarding the Parent case.; Sender's Comments: This is a child case whose mother was a case of maternal exposure during pregnancy and with associated adverse event of Laryngomalacia on the child. Very limited information regarding these events have been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: Neuropathy in arm for 3 weeks; pins and needles sensation; This spontaneous case was reported by a non-health professional and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) (seriousness criterion medically significant) and PARAESTHESIA (pins and needles sensation). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) and PARAESTHESIA (pins and needles sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided by reporter. No treatment information was provided.  Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Lost her mother after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Lost her mother after getting the vaccine) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No treatment information was provided. No relevant concomitant medications were reported.  Very limited information regarding the events has been provided at this time; Sender's Comments: Very limited information regarding the events has been provided at this time; Reported Cause(s) of Death: unknown cause of death
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypertension, Hypokinesia, Seizure
Clinical narrative: Seizures; High blood pressure; Patient was not strong enough to take the phone; Patient couldn't use hands and arms; Patient didn't speak coherently; Violent chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills). At the time of the report, SEIZURE (Seizures), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills) outcome was unknown.            No adverse events were experienced after the first dose of COVID-19 vaccine, which was "all ok". No information provided about the first dose of the vaccine.  No concomitant medication, treatment received or medical history was provided.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Seizures; High blood pressure; Patient was not strong enough to take the phone; Patient couldn't use hands and arms; Patient didn't speak coherently; Violent chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills). At the time of the report, SEIZURE (Seizures), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills) outcome was unknown.            No adverse events were experienced after the first dose of COVID-19 vaccine, which was "all ok". No information provided about the first dose of the vaccine.  No concomitant medication, treatment received or medical history was provided.  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: Gait inability
Clinical narrative: Could not walk, hospitalized for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk, hospitalized for 4 days) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Could not walk, hospitalized for 4 days) (seriousness criterion hospitalization). The patient was hospitalized for 4 days due to GAIT INABILITY. At the time of the report, GAIT INABILITY (Could not walk, hospitalized for 4 days) had resolved.            No concomitant medication was reported.  It was reported the patient could not walk after receiving the second vaccine dose.  He was hospitalized 4 days, treated with steroids and got better.  Company Comment  Very limited information regarding this event has been provided at this time. Further information has been requested.  Cross linked with case MOD21-124652; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: They have vials in a regular freezer which will be 4 weeks in a couple of days; The case was considered invalid as other info, not qualifying for reporting- CEP. It was not confirmed if patient was administered the vaccination or not.  This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that:  Is the Reporter a Healthcare Professional (HCP)?: Yes; Occupation/ Specialty: Pharmacist Is the reporter the prescribing HCP?: No; Name: Unknown, Address; Unknown; Occupation/ Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party?: Unknown  Suspect Product(s): Pfizer Covid-19 Vaccine Start date: Unknown  Stop date: Unknown  Verbatim and Event Description: The Caller, Withheld is a Pharmacist, asking regarding the storage of the Pfizer Covid-19 vaccine. They have vials in a regular freezer which will be 4 weeks in a couple of days. Asked if they can still use the vaccine. Provided PMI contact number and HOO. Warm transferred to PMI (Withheld) and created Manual PC form. Created and submitted CITI form #.  Medical Information: Were any medical questions addressed by this program forwarded/referred to Medical Information: Yes  Information on lot/batch number has been requested.  Amendment: This follow up is being submitted to amend previously reported information: event recoded to no adverse effect.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary function test, SARS-CoV-2 test
Clinical narrative: Having trouble breathing when talking; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 65-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in right arm on 17Mar2021 13:15 as dose 1, single (at the age of 64-years-old) for COVID-19 immunization and received unspecified Pfizer vaccine (Lot Number- Er8737) via an unspecified route of administration in left arm on 17Mar2021 as dose 2, single for unspecified indication. Patient did not receive any other vaccine in four weeks. Patient did not had COVID-19, prior to vaccination. Patient underwent COVID-19 (nasal swab) test with result as negative. Patient medical history included Multiple Sclerosis. The concomitant medications were not reported. On 30Apr2021, the patient experienced trouble breathing when talking. The pulmonologist inhaler prescriptions did not alleviate any symptoms. The adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient received treatment as pulmonologist tests with unknown results and medications. The outcome of the event was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Heart rate, Oropharyngeal discomfort, Paraesthesia oral
Clinical narrative: Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; This is a spontaneous report from a contactable consumer. This 30-year-old female consumer (patient). A 30-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date: unknown), via unspecified route, administered in arm right on 16Jul2021 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history includes Penicillin allergy and covid-19. Concomitant medications include vitamin e, cyanocobalamin (VITAMIN B-12), folic acid, omeprazole (PROTONIX). No other vaccines received 4 weeks prior to vaccination. Prior to vaccination patient was diagnosed with covid and since the vaccination the patient has been tested for covid. On 16Jul2021 12 :45 AM, after the vaccination, the patient throat started to feel "funny" her mouth and throat had a tingling sensation and a metallic taste in her mouth. Within 5 minutes her throat began to feel tight. It progressively got tighter. she went straight to the ER. her blood pressure was 160/95 and heart rate was 150. her throat did not close all the way off thankfully but closed enough for her to not be able to swallow. Patient received steroid pack and steroid shot as treatment for the observed events. The patient underwent lab tests and procedures on 16Jul2021 which include Blood pressure 160/95, heart rate 150 and SARS-CoV-2 test which showed a negative result. The outcome of the events are recovering.  No follow-up attempts possible. No further information expected