chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Joint swelling, Lymphadenopathy, Nonspecific reaction
Clinical narrative: VERY BAD REACTION; SWEATS; SWOLLEN LYMPH NODES IN NECK; SWOLLEN HANDS AND WRIST SWOLLEN LIKE ARTHRITIS; SWOLLEN KNUCKLES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid virus. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very bad reaction, sweats, swollen lymph nodes in neck, swollen hands and wrist swollen like arthritis, swollen knuckles, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of the sweats, headache, swollen lymph nodes in neck, swollen hands and wrist swollen like arthritis, swollen knuckles and very bad reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: VERY BAD REACTION; SWEATS; SWOLLEN LYMPH NODES IN NECK; SWOLLEN HANDS AND WRIST SWOLLEN LIKE ARTHRITIS; SWOLLEN KNUCKLES; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid virus. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very bad reaction, sweats, swollen lymph nodes in neck, swollen hands and wrist swollen like arthritis, swollen knuckles, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of the sweats, headache, swollen lymph nodes in neck, swollen hands and wrist swollen like arthritis, swollen knuckles and very bad reaction was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE ACHE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at Right Arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from nausea on 05-APR-2021, was recovering from chills, and had not recovered from fever, muscle ache, and headache. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Lymphadenopathy, Nasal oedema
Clinical narrative: COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Paraesthesia oral, Pyrexia, Rhinorrhoea
Clinical narrative: COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat irritation
Clinical narrative: COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERAL SIDE EFFECTS; This spontaneous report received from a vaccine facility concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On 2021, the subject experienced several side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from several side effects. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache
Clinical narrative: BACK PAIN; CHILLS; HEADACHE; SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin, and batch number were not reported) 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 back pain, chills, headache, and soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, back pain, headache and soreness at the injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: GARGLING/HOARSE VOICE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced gargling/hoarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gargling/hoarse voice was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, Fatigue, Pain in extremity
Clinical narrative: Type 2 Diabetic with levels at 544; Sore arm; A little tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS (Type 2 Diabetic with levels at 544) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Type 2 diabetes mellitus.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIABETES MELLITUS (Type 2 Diabetic with levels at 544) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tired). At the time of the report, DIABETES MELLITUS (Type 2 Diabetic with levels at 544), PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood glucose: upto 544 (High) Type 2 Diabetic - sugar level was up to 544, the highest she's ever been is around 350.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Underlying diabetes mellitus is a confounder.   Reporter did not allow further contact; 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. Underlying diabetes mellitus is a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
Clinical narrative: Pre-heart attack; Invalid dose : deviation of time (delay between both doses more than 42 days); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Pre-heart attack) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MYOCARDIAL INFARCTION (Pre-heart attack) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Invalid dose : deviation of time (delay between both doses more than 42 days)). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Invalid dose : deviation of time (delay between both doses more than 42 days)) had resolved. At the time of the report, MYOCARDIAL INFARCTION (Pre-heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Chest pain
Clinical narrative: sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself.  A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50.  By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe.  Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events.  Follow up needed, further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Near death experience, Pain in extremity
Clinical narrative: sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself.  A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50.  By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe.  Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events.  Follow up needed, further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Tachycardia
Clinical narrative: sinking sense of doom-death; high heart rate; BP is spiking to 165/100; mile fever; sore arm; Severe headache; blood sugar spikes of 200 fasting; Increased tahcycardiaI suffer from that) but it was more frequent and severe; chest pains; This is a spontaneous report received from a contactable consumer (patient) reported for herself.  A 56-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM6199) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 12:00 at a single dose for covid-19 immunisation. Medical history included had covid from 30Jun2020. Concomitant medication patient received within 2 weeks of vaccination included Metoprolol ER 25 mg cyclic, Armour Thyroid 30 mg cyclic. The patient previously took fluoroquinolones and experienced known allergies. The patient reported that on 13Mar2021 on Day 3 of vaccine BP starts to go up. My average is 100/50.  By day 4 BP is spiking to 165/100 with a mile fever and sore arm, and a sinking sense of doom-death). Severe headache and continued blood pressure spikes throughout week along with blood sugar spikes of 200 fasting. I'm not diabetic. Increased tahcycardiaI suffer from that) but it was more frequent and severe.  Blood pressure spiked to 187/167, I took extra BP meds (which was low dose more for my tachycardia)to help with insane BP. Went to hospital and stayed for 2 days. No heart attack, Just insane BP with chest pains and high heart rate. Day 18 after shot and BP is going down and so is blood sugar. Every once in a while, it will spike to 160/100--last for about 1 hour and then drop to my normal BP before the shot. The events were considered serious with seriousness criteria hospitalization and medically significant. The patient was hospitalized for 2 days. Adverse events resulted in Emergency room/department or urgent care, Hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Mar2021. The patient was recovering from all the events.  Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: patient got nerve problems in his face, lips, tongue and then his eye and started drooping/talking like his face was paralyzed; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  Historical vaccine included first dose of bnt162b2 on an unspecified date at single dose for COVID-19 immunization. On Feb2021, the patient got nerve problems in his face, lips, tongue and then his eye and started drooping and stayed like that as of today and was talking like his face was paralyzed. Clinical outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administer an expired Flublok with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (GMI) (Reference number- 00530251).  This case involves a adult female patient who was administered an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ446AA, expiry date: 18-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on 22-Mar-2021 (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX-23) for Immunisation.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Cough, Ear discomfort, Epistaxis, Headache
Clinical narrative: Sore throat,  swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen, so hurts to eat or chew.  Chronic constant headache, swollen glands, ears feel plugged.  Bloody nose.  Lips suddenly extremely chapped and raw.  Hurts to swallow.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Odynophagia, Oral pain, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Sore throat,  swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen, so hurts to eat or chew.  Chronic constant headache, swollen glands, ears feel plugged.  Bloody nose.  Lips suddenly extremely chapped and raw.  Hurts to swallow.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Sore throat,  swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen, so hurts to eat or chew.  Chronic constant headache, swollen glands, ears feel plugged.  Bloody nose.  Lips suddenly extremely chapped and raw.  Hurts to swallow.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Insomnia, Tinnitus
Clinical narrative: Tinnitus. Loud ringing in right ear. It is constant, started just after the vaccine. I am having trouble sleeping and concentrating. Will be making a dr appt but unsure if they can help?
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Fatigue, Headache, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: First day experienced extreme fatigue and could not function.  Have also experienced extreme headaches and unexplainable crying spells.  My arm of injection is still sore, although not all of the time.   The extreme fatigue hits hard and causes me to lay down to sleep.  Headaches are rare for me, but now  are common.  The crying spells are extreme, and are the same as when my endocrine glands stopped working 5 years ago. . Now Day 8 and these symptoms are continuing and waking me up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: First day experienced extreme fatigue and could not function.  Have also experienced extreme headaches and unexplainable crying spells.  My arm of injection is still sore, although not all of the time.   The extreme fatigue hits hard and causes me to lay down to sleep.  Headaches are rare for me, but now  are common.  The crying spells are extreme, and are the same as when my endocrine glands stopped working 5 years ago. . Now Day 8 and these symptoms are continuing and waking me up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I woke up with severe Tinnitus.  I called the Dept of Health hotline and was assured that it was temporary.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Deep vein thrombosis, Pulmonary embolism, Thrombectomy, Thrombosis
Clinical narrative: Blood Clots, Stroke
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Cerebrovascular accident, Chest X-ray, Computerised tomogram head abnormal
Clinical narrative: I experienced a slight headache  sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before.  I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysarthria, Facial paralysis, Headache, Ischaemic stroke
Clinical narrative: I experienced a slight headache  sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before.  I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging head abnormal, Migraine with aura, Muscular weakness, Pain in extremity
Clinical narrative: I experienced a slight headache  sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before.  I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: I experienced a slight headache  sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before.  I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Developed a fever of 100.2, chills, muscle aches and cramps, and a low-grade headache. Took Tylenol for the fever.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Red welt on arm appeared a little over a week after injection. Mild itching.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on APR-2021. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: MILD HEADACHE; MILD PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 11:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced mild pain at injection site. On 03-APR-2021 19:30, the subject experienced mild headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, and mild pain at injection site on 04-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea, sweating, dizziness.  BP 73/50, heart rate 43
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 62 yr old gentleman admitted with COVID-19; vaccinated March 17, 2021 Symptom onset 3/26, date positive test 4/1, started dexamethasone 4/4 and Tocilizumab 4/4. h/o DM tyle 2, htn, chronic CH, got, osa
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, COVID-19, SARS-CoV-2 test positive
Clinical narrative: 77 yr old covid +, symptom onset 2 weeks prior, date positive 4/3, admitted to the hospital on 4/3. Also admitted for acute appendicitis with appendectomy and purulent ascities; DM, HTN,  received first covid vaccine April 1.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Fever, Chills. Muscle Pain, light headedness
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received Janssen COVID-19 vaccine on 3/31/21 and was admitted to the hospital on 4/1/21 with COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received first dose of Pfizer COVID-19 vaccine on 3/18/21 and subsequently admitted to the hospital with COVID-19 on 4/1/21.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received the 1st dose of Pfizer COVID19 vaccine on 3/19/21 and was subsequently admitted to the hospital with COVID19 on 3/30/21.
Age: 26.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Anxiety, Insomnia
Clinical narrative: Onset of anxiety and sleeplessness within weeks which became chronic and continued to present.  Significant relief eventually achieved through chelation of toxic metals including aluminum in 2019.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Autoimmune thyroiditis, Thyroid hormone replacement therapy
Clinical narrative: Onset of Hashimoto's Thyroiditis in 2005 which has continued to present.  Treatment continues through thyroid hormone supplementation.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Pain
Clinical narrative: Muscle and lymph node tenderness and extreme pain and stiffness in right neck, deltoid, trapezius, radiating up back of the right head.  Moving head and neck were very uncomfortable - extremely stiff.  Same location of inflammation as the first shot. Both vaccine shots were given to my left arm - which had no pain. I have a very high pain tolerance.. This pain required me to tap the Norco which I had from two hip replacement surgeries - which I never needed! Same with C sections or broken (hairline fractured) bones.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received 1st dose of Pfizer COVID19 vaccine on 2/10/21, and 2nd dose of Pfizer COVID-19 vaccine on 3/3/2021 and was subsequently admitted to the hospital on 3/11/21 with COVID-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received 1st dose of Pfizer COVID19 vaccine on 3/11/21 and was subsequently admitted to the hospital on 3/20/21 with COVID19
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received 1st dose of Moderna vaccine on 4/1/21, and was subsequently admitted to the hospital on 4/4/21 with COVID19
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever Muscle aches Headaches Nausea (04/10/2021 @ 2000
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dry mouth, Fatigue
Clinical narrative: 9 hrs after injection, felt achey, 12 hrs post chills, increased aching throughout entire body, sweating, fever, very fatigued, dry mouth, soreness in neck and jaw, loss of appetite. These symptoms lasted 36 hours.  Swelling and redness on arm below vaccination site; started within a few hours of vaccine, has continued to progress and worsen. Slight coughing, headache.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Neck pain, Pain
Clinical narrative: 9 hrs after injection, felt achey, 12 hrs post chills, increased aching throughout entire body, sweating, fever, very fatigued, dry mouth, soreness in neck and jaw, loss of appetite. These symptoms lasted 36 hours.  Swelling and redness on arm below vaccination site; started within a few hours of vaccine, has continued to progress and worsen. Slight coughing, headache.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Vaccination site swelling
Clinical narrative: 9 hrs after injection, felt achey, 12 hrs post chills, increased aching throughout entire body, sweating, fever, very fatigued, dry mouth, soreness in neck and jaw, loss of appetite. These symptoms lasted 36 hours.  Swelling and redness on arm below vaccination site; started within a few hours of vaccine, has continued to progress and worsen. Slight coughing, headache.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent tinnitus in both ears.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Limb discomfort, Pain
Clinical narrative: Fever, limb aches on side of injection, headache, lethargy.  Symptoms primarily lasted for 18 hours.  May be still be feeling tired, not certain if related to shot.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, limb aches on side of injection, headache, lethargy.  Symptoms primarily lasted for 18 hours.  May be still be feeling tired, not certain if related to shot.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site muscle soreness lasting around 1 day
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Headache, Pain
Clinical narrative: HEART PALPITATIONS; DIZZINESS; SHOULDER PAIN; HEADACHE; BODY ACHES; BACK PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 or 1808928 (unsure), and  expiry: UNKNOWN) dose was not reported, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced back pain. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, back pain, and shoulder pain, and had not recovered from headache, heart palpitations, and dizziness. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART PALPITATIONS; DIZZINESS; SHOULDER PAIN; HEADACHE; BODY ACHES; BACK PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 or 1808928 (unsure), and  expiry: UNKNOWN) dose was not reported, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced back pain. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, back pain, and shoulder pain, and had not recovered from headache, heart palpitations, and dizziness. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Pt. received first dose of Pfizer COVID19 vaccine on 2/10/21, 2nd dose on 3/3/21, and was subsequently admitted to the hospital on 4/6/21 and found to have COVID-19
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Headache, Laboratory test, Pain in extremity
Clinical narrative: Next day fever mild headache severe redness and aching left arm/during the week left arm itching  under armpits and wrist, went to physician on Friday 4/9/2021
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Next day fever mild headache severe redness and aching left arm/during the week left arm itching  under armpits and wrist, went to physician on Friday 4/9/2021
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Insomnia, Pain, Pain in extremity
Clinical narrative: I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for two days. I missed work the day after receiving the shot (Wednesday). Went to work on Thursday with no sleep. Missed on Friday due to not being able to sleep.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye irritation, Eyelid margin crusting, Eyelid skin dryness, Flank pain
Clinical narrative: Minimum soreness at injection site; however, sometime during that night I awoke with pain down my left side, particularly in the hip, thigh, and calf -- painful enough to take ibuprofen for relief. The pain came back for several subsequent nights before gradually occurring about once a week at this point. Also, two or three days after the vaccination, my left eye developed an irritation that resulted in a crustiness and dryness around the eyelid, the latter which persist. Then, about two weeks following the shot, my left hand, near the thumb and wrist, developed a weakness and extreme pain that came for around 24 hours, departed, and came back a few days later. I had four episodes of this, though that also has not made an appearance since the last week of March.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Minimum soreness at injection site; however, sometime during that night I awoke with pain down my left side, particularly in the hip, thigh, and calf -- painful enough to take ibuprofen for relief. The pain came back for several subsequent nights before gradually occurring about once a week at this point. Also, two or three days after the vaccination, my left eye developed an irritation that resulted in a crustiness and dryness around the eyelid, the latter which persist. Then, about two weeks following the shot, my left hand, near the thumb and wrist, developed a weakness and extreme pain that came for around 24 hours, departed, and came back a few days later. I had four episodes of this, though that also has not made an appearance since the last week of March.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dizziness, Dyshidrotic eczema, Headache, Injection site erythema
Clinical narrative: Day after- intense, persistent headache (no response to tylenol),  fever (highest recorded 104.9), minor muscle aches, dizziness when upright Day 2- headache started to subside, soreness, swelling and redness at injection site, inflamed lymph node on same side, triggered episode of dyshidrotic eczema in both hands and feet (have  had condition 15+ years but have not had an episode in at least 6 months, no other obvious triggers at this time.)  Unusually vivid dreams (but not nightmares) 2nd and 3rd night after. Pain/swelling in arm/lymph node continuing into day 3 (Item 20- I am recovering, but have not recovered completely)