chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Lymphadenopathy, Nausea, Pain
Clinical narrative: Immediately I felt flushed, sweaty, dizzy and nauseous. After it passed I was able to drive home. By the evening my injection site was swollen, red and hot. I went to Urgent Care first thing the next morning and they said it was just COVID Arm and I would be fine. By that evening I was in excruciating pain in every inch of my body. Over the next 2 months the pain was excruciating and I was having dizzy spells and vomiting but my late October the spells of vertigo/dizziness, nausea and vomiting, falling, mental confusion, sensitivity in my right ear, headaches and I noticed large swollen lymph nodes up my right side of my neck. The past 3 months I have been incapacitated because of how much pain I?m in and these spells that now last for days instead of a couple minutes. My PCP has diagnosed this as an adverse reaction to the vaccine but wouldn?t file a VARES report. I?m seeing a Neurologist, Endocrinologist, an ENT doctor, I?m having an MRI of my brain, ultrasound of my lymph nodes and nerve testing on my arms and legs. No one knows what is wrong with me or how to help me get better.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vertigo, Vomiting
Clinical narrative: Immediately I felt flushed, sweaty, dizzy and nauseous. After it passed I was able to drive home. By the evening my injection site was swollen, red and hot. I went to Urgent Care first thing the next morning and they said it was just COVID Arm and I would be fine. By that evening I was in excruciating pain in every inch of my body. Over the next 2 months the pain was excruciating and I was having dizzy spells and vomiting but my late October the spells of vertigo/dizziness, nausea and vomiting, falling, mental confusion, sensitivity in my right ear, headaches and I noticed large swollen lymph nodes up my right side of my neck. The past 3 months I have been incapacitated because of how much pain I?m in and these spells that now last for days instead of a couple minutes. My PCP has diagnosed this as an adverse reaction to the vaccine but wouldn?t file a VARES report. I?m seeing a Neurologist, Endocrinologist, an ENT doctor, I?m having an MRI of my brain, ultrasound of my lymph nodes and nerve testing on my arms and legs. No one knows what is wrong with me or how to help me get better.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Heart rate increased, Loss of personal independence in daily activities
Clinical narrative: discomfort in his left chest area; fast abnormal heart beat; shortness of breath involuntary gasp for air; Very Fatigue; unable to complete daily task; This is a spontaneous report received from contactable Consumer (Non-healthcare Professional reporting for a patient).  A 15 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 17:00 (Lot number: 59762-1000-01) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST DISCOMFORT (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "discomfort in his left chest area"; HEART RATE INCREASED (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "fast abnormal heart beat"; DYSPNOEA (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "shortness of breath involuntary gasp for air"; FATIGUE (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "Very Fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "unable to complete daily task". The events "discomfort in his left chest area", "fast abnormal heart beat", "shortness of breath involuntary gasp for air", "very fatigue" and "unable to complete daily task" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were not taken as a result of chest discomfort, heart rate increased, dyspnoea, fatigue, loss of personal independence in daily activities. Clinical course: No other vaccine in four weeks.  No Known allergies. The patient had no covid prior vaccination and has no history of COVID 19 positive test.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: discomfort in his left chest area; fast abnormal heart beat; shortness of breath involuntary gasp for air; Very Fatigue; unable to complete daily task; This is a spontaneous report received from contactable Consumer (Non-healthcare Professional reporting for a patient).  A 15 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 17:00 (Lot number: 59762-1000-01) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST DISCOMFORT (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "discomfort in his left chest area"; HEART RATE INCREASED (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "fast abnormal heart beat"; DYSPNOEA (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "shortness of breath involuntary gasp for air"; FATIGUE (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "Very Fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "unable to complete daily task". The events "discomfort in his left chest area", "fast abnormal heart beat", "shortness of breath involuntary gasp for air", "very fatigue" and "unable to complete daily task" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were not taken as a result of chest discomfort, heart rate increased, dyspnoea, fatigue, loss of personal independence in daily activities. Clinical course: No other vaccine in four weeks.  No Known allergies. The patient had no covid prior vaccination and has no history of COVID 19 positive test.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myocarditis
Clinical narrative: discomfort in his left chest area; fast abnormal heart beat; shortness of breath involuntary gasp for air; Very Fatigue; unable to complete daily task; This is a spontaneous report received from contactable Consumer (Non-healthcare Professional reporting for a patient).  A 15 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Oct2021 17:00 (Lot number: 59762-1000-01) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST DISCOMFORT (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "discomfort in his left chest area"; HEART RATE INCREASED (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "fast abnormal heart beat"; DYSPNOEA (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "shortness of breath involuntary gasp for air"; FATIGUE (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "Very Fatigue"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (life threatening) with onset 15Oct2021 06:00, outcome "not recovered", described as "unable to complete daily task". The events "discomfort in his left chest area", "fast abnormal heart beat", "shortness of breath involuntary gasp for air", "very fatigue" and "unable to complete daily task" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were not taken as a result of chest discomfort, heart rate increased, dyspnoea, fatigue, loss of personal independence in daily activities. Clinical course: No other vaccine in four weeks.  No Known allergies. The patient had no covid prior vaccination and has no history of COVID 19 positive test.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; felt extremely fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I am a heart patient." (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 26Apr2021, outcome "unknown", described as "felt extremely fatigued"; HEADACHE (non-serious) with onset 28Apr2021, outcome "unknown", described as "headache".  Additional information: The patient took first Covid-19 Vaccine on Sunday, 25Apr2021. On Monday, 26Apr2021, the patient felt extremely fatigued and stayed at home to rest. On Wednesday, 28Apr2021, the patient experienced a headache and stayed home again due to the vaccine. The patient was a heart patient.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Chills, Feeling cold
Clinical narrative: 2 weeks post vaccine vomiting and high grade fever. episode lasted 10 hours. then mid grade fever for 1 week.  On january 3, 2022 (week 3) patient presented with abdominal pain, signs of shock, fever of 100 deg F, cold chills, shaking; nausea, ultrasound indicated swollen lymphnodes and swollen appendix.  Appendectomy occurred January 10,2022. Arm pain and extreme weakness developed 12 hours post op.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Lymphadenopathy, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: 2 weeks post vaccine vomiting and high grade fever. episode lasted 10 hours. then mid grade fever for 1 week.  On january 3, 2022 (week 3) patient presented with abdominal pain, signs of shock, fever of 100 deg F, cold chills, shaking; nausea, ultrasound indicated swollen lymphnodes and swollen appendix.  Appendectomy occurred January 10,2022. Arm pain and extreme weakness developed 12 hours post op.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Pathology test, Pyrexia, Shock, Tremor, Ultrasound scan abnormal
Clinical narrative: 2 weeks post vaccine vomiting and high grade fever. episode lasted 10 hours. then mid grade fever for 1 week.  On january 3, 2022 (week 3) patient presented with abdominal pain, signs of shock, fever of 100 deg F, cold chills, shaking; nausea, ultrasound indicated swollen lymphnodes and swollen appendix.  Appendectomy occurred January 10,2022. Arm pain and extreme weakness developed 12 hours post op.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 2 weeks post vaccine vomiting and high grade fever. episode lasted 10 hours. then mid grade fever for 1 week.  On january 3, 2022 (week 3) patient presented with abdominal pain, signs of shock, fever of 100 deg F, cold chills, shaking; nausea, ultrasound indicated swollen lymphnodes and swollen appendix.  Appendectomy occurred January 10,2022. Arm pain and extreme weakness developed 12 hours post op.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Immunisation, Pulmonary embolism, Vaccination site pain
Clinical narrative: Pulmonary Embolism; Upper left arm pain since the vaccine, not just at the site; 3rd Covid vaccine; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 18:00 (Lot number: FF8841) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]), administered in arm right, administration date 18Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: breast cancer 4 years prior; "possible penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; GABAPENTIN; LEVOTHYROXINE; LETROZOLE. Past drug history included: Neosporin, reaction(s): "Allergies: Neosporin"; Bacitracin, reaction(s): "Allergies: Bacitracin". Vaccination history included: Bnt162b2 (dose lot number: ER8732, dose administration time: 04:00PM , dose number: 2, vaccine location: Left arm), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (dose lot number: EN6200, dose administration time: 11:00AM, dose number: 1, vaccine location: Left arm), administration date: 06Mar2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (life threatening) with onset 21Oct2021 18:00, outcome "unknown", described as "3rd Covid vaccine"; PULMONARY EMBOLISM (life threatening) with onset 22Oct2021 21:00, outcome "recovering", described as "Pulmonary Embolism"; VACCINATION SITE PAIN (life threatening) with onset 22Oct2021 21:00, outcome "recovering", described as "Upper left arm pain since the vaccine, not just at the site". The events "pulmonary embolism" and "upper left arm pain since the vaccine, not just at the site" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: pulmonary embolism. Therapeutic measures were taken as a result of pulmonary embolism including Eliquis for anticoagulation. About 27 hours after the 3rd Covid vaccine, the patient developed severe pain in her right chest. The following day this was confirmed by CT with contrast to be a pulmonary embolism. Additionally, the patient had upper left arm pain since the vaccine, not just at the site where the vaccine was given. The patient has no covid-19 prior vaccination has not been tested for covid-19 post vaccination.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Instant numbness in right arm and right side of face. Elevated heart rate followed by dizziness and sweating, almost lost consciousness.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Instant numbness in right arm and right side of face. Elevated heart rate followed by dizziness and sweating, almost lost consciousness.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Flushing, Palpitations, Rash
Clinical narrative: Flush, itchy, difficulty swallowing, palpitations, mild dyspnea, fatigue on exertion.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Skin warm, Tongue disorder
Clinical narrative: Flush, itchy, difficulty swallowing, palpitations, mild dyspnea, fatigue on exertion.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Fatigue, Hot flush, Palpitations
Clinical narrative: Flush, itchy, difficulty swallowing, palpitations, mild dyspnea, fatigue on exertion.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Flush, itchy, difficulty swallowing, palpitations, mild dyspnea, fatigue on exertion.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: After first dose, on February 9th, patient kept passing out. After second dose on March 9th, patient ended up in hospital, had stents and a pace maker put in, may also have a heart murmur.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac pacemaker insertion, Stent placement
Clinical narrative: After first dose, on February 9th, patient kept passing out. After second dose on March 9th, patient ended up in hospital, had stents and a pace maker put in, may also have a heart murmur.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Eye swelling, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Developed swelling around right orbit as well as decreased sensation over the right side of her face. Symptoms are persistent but have shown some signs of starting to improve.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Full blood count normal, Magnetic resonance imaging head normal, Metabolic function test, Orbital swelling
Clinical narrative: Developed swelling around right orbit as well as decreased sensation over the right side of her face. Symptoms are persistent but have shown some signs of starting to improve.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory loss
Clinical narrative: Developed swelling around right orbit as well as decreased sensation over the right side of her face. Symptoms are persistent but have shown some signs of starting to improve.
Age: 8.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Head injury, Incorrect dose administered, Product administered to patient of inappropriate age, Seizure, Syncope
Clinical narrative: About 3-5 minutes after injection she collapsed and was unconscious for 10-15 seconds with seizure like activity. Eyes rolling/ jerking body
Age: 8.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Dyskinesia, Gaze palsy, Loss of consciousness, Seizure, Syncope
Clinical narrative: About 3-5 minutes after injection she collapsed and was unconscious for 10-15 seconds with seizure like activity. Eyes rolling/ jerking body
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: stuffed up nose; Administration date: 30Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Jun2021 13:00 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administrator route: intramuscular, vaccine location: right arm), administration date: 23Jun2021, when the patient was 21 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Jun2021 13:00, outcome "recovered" (30Jun2021 13:00), described as "Administration date: 30Jun2021"; NASAL CONGESTION (non-serious) with onset 22Dec2021, outcome "recovered", described as "stuffed up nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had been tested for COVID-19 since the vaccination. The patient had no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101870698 Same reporter/SD, Different event
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Nasal congestion, SARS-CoV-2 test
Clinical narrative: stuffed up nose; Administration date: 30Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Jun2021 13:00 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administrator route: intramuscular, vaccine location: right arm), administration date: 23Jun2021, when the patient was 21 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Jun2021 13:00, outcome "recovered" (30Jun2021 13:00), described as "Administration date: 30Jun2021"; NASAL CONGESTION (non-serious) with onset 22Dec2021, outcome "recovered", described as "stuffed up nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had been tested for COVID-19 since the vaccination. The patient had no known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101870698 Same reporter/SD, Different event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Muscle spasms
Clinical narrative: experiences flu symptoms; muscle spasm on her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "experiences flu symptoms"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "muscle spasm on her back". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Muscle spasms
Clinical narrative: experiences flu symptoms; muscle spasm on her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "experiences flu symptoms"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "muscle spasm on her back". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Chest pain, Fatigue
Clinical narrative: Same day: headache, fatigue, localized arm tenderness Next day: headache, more fatigue, arm pain,  sharp pain in left arm pit, heart palpitations, spasm in left chest with pain that wrapped from sternum, under left breast to near shoulder.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Pain in extremity, Palpitations, Tenderness
Clinical narrative: Same day: headache, fatigue, localized arm tenderness Next day: headache, more fatigue, arm pain,  sharp pain in left arm pit, heart palpitations, spasm in left chest with pain that wrapped from sternum, under left breast to near shoulder.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laryngitis, Nasal congestion, Nasopharyngitis
Clinical narrative: The next day developed laryngitis, annd stuffy nose/head like a bad cold.   This was following my Booster shot.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Diarrhoea, Headache
Clinical narrative: I got the vaccine on Friday, and was feeling great. No sickness, had the next day planned. Woke up on Saturday with sweats, chills, body aches, muscle aches, and fever. Took my temp, and it was 101.7. My right arm was still sore, and my right lymph nodes were swollen. I had diarrhea, headache, cough, fever, nausea, almost puked a few times, lack of appetite. This morning, I noticed a rash on my legs. I called the pharmacy right away and told them about it. Took some Benadryl to help with the itching. I?m still recuperating from the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lymphadenopathy, Myalgia, Nausea, Pain
Clinical narrative: I got the vaccine on Friday, and was feeling great. No sickness, had the next day planned. Woke up on Saturday with sweats, chills, body aches, muscle aches, and fever. Took my temp, and it was 101.7. My right arm was still sore, and my right lymph nodes were swollen. I had diarrhea, headache, cough, fever, nausea, almost puked a few times, lack of appetite. This morning, I noticed a rash on my legs. I called the pharmacy right away and told them about it. Took some Benadryl to help with the itching. I?m still recuperating from the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: I got the vaccine on Friday, and was feeling great. No sickness, had the next day planned. Woke up on Saturday with sweats, chills, body aches, muscle aches, and fever. Took my temp, and it was 101.7. My right arm was still sore, and my right lymph nodes were swollen. I had diarrhea, headache, cough, fever, nausea, almost puked a few times, lack of appetite. This morning, I noticed a rash on my legs. I called the pharmacy right away and told them about it. Took some Benadryl to help with the itching. I?m still recuperating from the vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Started feeling pain at/near the injection site.  Dull ache to more intense pain needing otc pain reliever. Pain comes and goes. Pain is worse in my left arm. Right arm has the same symptoms, but not as intense. Pain in both arms can last for several hours if not treated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Rash pruritic
Clinical narrative: On the early morning of October 30, 2021 (approximately 36 hours post-vaccination), I had an onset of very heavy bleeding (soaked through a regular maxi pad every 1-2 hours) 10 days earlier than my expected menses to onset. Due to the severity of the heavy bleeding, my gynecologist prescribed Tranex Acid 650mg, SIG: Take 2 tabs PO TID x 3 days. The bleeding stopped 8 days after onset with the help of the medication. This in turn dried up my breastmilk production from my recent pregnancy (delivered twins on August 12, 2021- G4, P5). On November 2, 2021 (approximately 5 days post-vaccination), I had a rash suddenly onset. The rash was very itchy with an internal burning feeling, was warm to touch and progressed into raised welt regions on my body. The rash covered approximately 30-40% of my abdomen, sides, buttocks, legs, arms and face. I took 50mg of Benadryl to stop the allergic reaction and symptoms resolved within approximately 4-6 hours after onset. On November 3, 2021 (approximately 6 days post-vaccination), I had another rash suddenly onset with the same description as the rash the day prior. This time the rash covered approximately 40-50% of my abdomen, sides, buttocks, legs, arms and face. I took 50mg of Benadryl to stop the allergic reaction and symptoms resolved within approximately 4-6 hours after onset. On November 11, 2021, I had an episode of breakthrough bleeding with moderate to heavy flow that lasted approximately 36 hours. I was started on Lo Loestrin OCP on November 11, 2021 to control the breakthrough bleeding. On November 24, 2021, I had bleeding onset with moderate to heavy flow that lasted approximately 4-5 days. My gynecologist ordered a pelvic ultrasound. I completed it on November 26, 2021. It did not show any abnormalities in my uterus or ovaries and could not help determine what could be causing the breakthrough bleeding. On December 9, 2021, I had breakthrough bleeding onset with moderate to heavy flow that lasted approximately 4 days. On December 14, 2021, I had breakthrough bleeding with light spotting lasting approximately 24 hours. On December 21, 2021, I had breakthrough bleeding with light spotting to light flow that lasted approximately 3 days. On December 31, 2021, I had bleeding onset with moderate to heavy bleeding that lasted approximately 7 days. On January 3, 2022, I was switched to a different OCP, Seasonale, to see if it would help with the breakthrough bleeding as the Lo Loestrin OCP did not seem to help. Outcome is still forthcoming.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Urticaria
Clinical narrative: On the early morning of October 30, 2021 (approximately 36 hours post-vaccination), I had an onset of very heavy bleeding (soaked through a regular maxi pad every 1-2 hours) 10 days earlier than my expected menses to onset. Due to the severity of the heavy bleeding, my gynecologist prescribed Tranex Acid 650mg, SIG: Take 2 tabs PO TID x 3 days. The bleeding stopped 8 days after onset with the help of the medication. This in turn dried up my breastmilk production from my recent pregnancy (delivered twins on August 12, 2021- G4, P5). On November 2, 2021 (approximately 5 days post-vaccination), I had a rash suddenly onset. The rash was very itchy with an internal burning feeling, was warm to touch and progressed into raised welt regions on my body. The rash covered approximately 30-40% of my abdomen, sides, buttocks, legs, arms and face. I took 50mg of Benadryl to stop the allergic reaction and symptoms resolved within approximately 4-6 hours after onset. On November 3, 2021 (approximately 6 days post-vaccination), I had another rash suddenly onset with the same description as the rash the day prior. This time the rash covered approximately 40-50% of my abdomen, sides, buttocks, legs, arms and face. I took 50mg of Benadryl to stop the allergic reaction and symptoms resolved within approximately 4-6 hours after onset. On November 11, 2021, I had an episode of breakthrough bleeding with moderate to heavy flow that lasted approximately 36 hours. I was started on Lo Loestrin OCP on November 11, 2021 to control the breakthrough bleeding. On November 24, 2021, I had bleeding onset with moderate to heavy flow that lasted approximately 4-5 days. My gynecologist ordered a pelvic ultrasound. I completed it on November 26, 2021. It did not show any abnormalities in my uterus or ovaries and could not help determine what could be causing the breakthrough bleeding. On December 9, 2021, I had breakthrough bleeding onset with moderate to heavy flow that lasted approximately 4 days. On December 14, 2021, I had breakthrough bleeding with light spotting lasting approximately 24 hours. On December 21, 2021, I had breakthrough bleeding with light spotting to light flow that lasted approximately 3 days. On December 31, 2021, I had bleeding onset with moderate to heavy bleeding that lasted approximately 7 days. On January 3, 2022, I was switched to a different OCP, Seasonale, to see if it would help with the breakthrough bleeding as the Lo Loestrin OCP did not seem to help. Outcome is still forthcoming.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Injection site pain, Insomnia
Clinical narrative: After getting my booster, I started experience chest pain right where my heart is located. I thought it was physiological so I've been ignoring it all day. Now I'm trying to sleep and it is still persistent. My heart hurts. It has not gone away. Additionally, my left arm is very sore where the injection site is. If I still feel pain in my heart tomorrow, I will see a medical professional.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone decreased, Condition aggravated, Hypothyroidism, Loss of personal independence in daily activities
Clinical narrative: Noticed a few days after both the 2nd Moderna Vaccine in March 2021  AND the Booster Moderna Ocotber 2021 that I had all the symptoms of worse hypothyroidism. and it was hard to do gardening or my usual daily activities.  This lasted about 3 months after 2nd covid shot and is now lasting almost 3 months since I had the Booster.  My immune system should go back to normal and my Levethroid should work better. soon
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient arrived with her mother at our community COVID vaccine clinic to receive the first dose of 5-11 Pfizer today between 12-3 pm. The nurse vaccinating patient did provide the appropriate vaccine dose for patient's age. However, the nurse administering the vaccine grabbed the incorrect dosage and then inoculated the child improperly. Although there have been protocols only to have one vaccine type at each table (so not more than one vaccine brand and dose allowed on each table), there was a break in protocol. The pediatric dose 0.2ml and the 0.3ml amount were delivered to the table, thus causing the vaccine administration error. Our data entry staff caught the error approximately 5 minutes post-administration. Immediately upon learning of the error, the mother was advised and provided my contact information. Additionally, I advised her mother to seek medical attention immediately if her daughter developed any adverse reactions. Patients mother was given the "what to expect after vaccine" paperwork that describes common side effects when to call the doctor and things to remember post-vaccine. This document also has the v-safe QR code, and I advised the mother to register her daughter to report any adverse reactions. The mother verbalized her dismay that her daughter received the incorrect vaccine. I acknowledged her frustration, apologized profusely for the clinician's error, and gave mother, the patient, and family relations department to express her concerns.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, SARS-CoV-2 test negative
Clinical narrative: Woke up on Monday Dec 13th 2021 with a headache around left temple head area, took Ibuprofen and it faded for that day. Woke up on Tuesday Dec 14th 2021 with a headache across front of forehead area, took Ibuprofen and it faded for that day. During Wednesday Dec 15th 2021 headache moved to back of head and felt 'inside' of head and increased in intensity. There were no other symptoms. From Wednesday Dec 15th 2021 to Monday Dec 27th 2021 the headache remained around that position and varied in intensity from a base pain level of 1-2 up to worst cases around 7-8. At times during the day the headache would suddenly increase in intensity up to a pain level of about 7. Pain was reduced with regular Tylenol, around 650mg 2-3 times a day reducing over the last 5 days of the symptom remaining. During times of increased pain levels, I was unable to do my normal daily activities. On Tuesday Dec 21st, I visited a walk-in clinic about the condition, the resulted suggested diagnosis was a "stress headache" due to there being no other symptoms than the headache in that location. Two Covid tests during the time of the symptoms were taken and both returned negative results.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever of 101-102, chills, severe swelling of injection site, burning hot, painful and hard to move or rotate right arm. This is still ongoing from 1/8/2022..was told it was an allergic reaction to the shot, this could be ongoing for up to 2 weeks.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Fever of 101-102, chills, severe swelling of injection site, burning hot, painful and hard to move or rotate right arm. This is still ongoing from 1/8/2022..was told it was an allergic reaction to the shot, this could be ongoing for up to 2 weeks.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Chest pain
Clinical narrative: Chest pain and heart fluttering. Constant pressure.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 11 year old patient received adult Pfizer dose (0.3 mL). Both the child (patient) and parent were untruthful about the patient's age and verbally stated that patient was 12 years old. However, upon processing, it was discovered that this patient was actually 11 years old and parents confirmed that after pharmacy called to follow up. Patient is 3 days from turning 12 years old but not 12 yet.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol normal, Blood test normal, Dizziness, Fatigue, Full blood count normal
Clinical narrative: Immediate symptoms were extreme headache, dizziness and nausea.  Prolonged symptoms currently are headache, dizziness, nausea, tiredness and hypersomnia (sleeping 15 hours per night).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Immediate post-injection reaction, Myopia, Nausea
Clinical narrative: Immediate symptoms were extreme headache, dizziness and nausea.  Prolonged symptoms currently are headache, dizziness, nausea, tiredness and hypersomnia (sleeping 15 hours per night).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination abnormal, Thyroid function test normal
Clinical narrative: Immediate symptoms were extreme headache, dizziness and nausea.  Prolonged symptoms currently are headache, dizziness, nausea, tiredness and hypersomnia (sleeping 15 hours per night).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Muscle spasms, Pain, Vaginal haemorrhage
Clinical narrative: Sore arm at injection area. Full body aches, slight headache during the day and while sleeping. Intense lower body cramps from hips down. Woke up shedding 2 maxi pads worth of blood from vaginal area.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Cellulitis, Dermatitis, Eczema, Erythema
Clinical narrative: Interface dermatitis- Small, itchy, fluid filled blisters on middle finger of left hand appeared 12/13/2021. Blisters grew and appeared to become infected. Saw healthcare provider 12/22/2021. Diagnosed either eczema or herpetic whitlow (HSV). Provider took samples for HSV and varicella tests.Finger became red, and blisters crusted over. On 1/3/2022, notice the fluid blisters on both hands, and no improvement to middle finger of left hand. On 1/4/2022, returned to healthcare provider. Learned HSV and varicella tests were negative, and provider diagnosed cellulitis of middle finger of left hand. Prescribed cephalexin. Infection in middle finger of left hand responded quickly, but by 1/6/2022, small, fluid filled blisters had become more numerous on both hands, spreading to palms, the tops of both feet, and the bottoms of both feet. Consulted with physician via telephone on 1/7/2022 and sent photographs by email. He recommended use of triamcinolone acetone 0.5% ointment, which was applied three times daily. By 1/10/2022, blisters had spread past the wrists of both arms, from the shoulders to elbows, and from the feet to both knees. No fever, or symptoms other than itchiness. Sent additional photos to physician. physician. Spoke with physician via telephone. telephone He had consulted with dermatologist who diagnosed interface dermatitis (ID). Prescribed prednisone and additional triamcinolone acetone ointment (as if writing, not yet given).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Laboratory test, Pruritus, Scab, Varicella
Clinical narrative: Interface dermatitis- Small, itchy, fluid filled blisters on middle finger of left hand appeared 12/13/2021. Blisters grew and appeared to become infected. Saw healthcare provider 12/22/2021. Diagnosed either eczema or herpetic whitlow (HSV). Provider took samples for HSV and varicella tests.Finger became red, and blisters crusted over. On 1/3/2022, notice the fluid blisters on both hands, and no improvement to middle finger of left hand. On 1/4/2022, returned to healthcare provider. Learned HSV and varicella tests were negative, and provider diagnosed cellulitis of middle finger of left hand. Prescribed cephalexin. Infection in middle finger of left hand responded quickly, but by 1/6/2022, small, fluid filled blisters had become more numerous on both hands, spreading to palms, the tops of both feet, and the bottoms of both feet. Consulted with physician via telephone on 1/7/2022 and sent photographs by email. He recommended use of triamcinolone acetone 0.5% ointment, which was applied three times daily. By 1/10/2022, blisters had spread past the wrists of both arms, from the shoulders to elbows, and from the feet to both knees. No fever, or symptoms other than itchiness. Sent additional photos to physician. physician. Spoke with physician via telephone. telephone He had consulted with dermatologist who diagnosed interface dermatitis (ID). Prescribed prednisone and additional triamcinolone acetone ointment (as if writing, not yet given).
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Feeling abnormal, Pain
Clinical narrative: Pt reports 3 day hx of Lt sided chest pain that radiates into midsternum. Pt reports pain is constant, feels like a throbbing and sharp pain and that it feels like her heart "is going to burst"
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Ear, nose and throat examination, Specialist consultation, Tinnitus
Clinical narrative: I have had a ringing in my ears since my second dose of the vaccine, apparently known as Tinnitus. I have discussed with my ENT doctor as well as an audiologist that I was referred to. Both mentioned that I was not the only one to come in and report this. I took a hearing test and appeared I had not lost any hearing at the time of the test. However, it?s been about 7 months since the second shot and the ringing is still there. Both ears, all of the time.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, X-ray
Clinical narrative: Pain at injecting site. Currently ongoing. Upon xray, bone island present that was not previously there. PT ordered, as pain is so great no longer can put on jacket or shirt without starting with injured arm. PT is protocol before pursuing additional treatment.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy hives covering body
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Differential white blood cell count, Dizziness
Clinical narrative: Extreme discomfort in chest, going down left arm with tingling in left hand. Fatigue, shortness of breath, dizziness. Patient went to emergency room in case it was a heart attack. Symptoms much less pronounced after 2 hours (started at 6am, up until about 8am). Diagnosis is chest pains. Released from ER after 5 hours. Still experiencing light symptoms two days later.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Full blood count, Hepatitis C antibody
Clinical narrative: Extreme discomfort in chest, going down left arm with tingling in left hand. Fatigue, shortness of breath, dizziness. Patient went to emergency room in case it was a heart attack. Symptoms much less pronounced after 2 hours (started at 6am, up until about 8am). Diagnosis is chest pains. Released from ER after 5 hours. Still experiencing light symptoms two days later.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lipase, Metabolic function test, Paraesthesia, Troponin
Clinical narrative: Extreme discomfort in chest, going down left arm with tingling in left hand. Fatigue, shortness of breath, dizziness. Patient went to emergency room in case it was a heart attack. Symptoms much less pronounced after 2 hours (started at 6am, up until about 8am). Diagnosis is chest pains. Released from ER after 5 hours. Still experiencing light symptoms two days later.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: About 2 days after vaccination, patient reported feeling hot and sweaty; he then felt dizzy and had some nausea with blurring of his vision. He was standing during this episode. fell back onto father, recovered and went to the bathroom and had an episode of vomiting. Felt  better subsequently and has been doing well. Denies loss of consciousness. Likely brief vasovagal episode.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Vision blurred, Vomiting
Clinical narrative: About 2 days after vaccination, patient reported feeling hot and sweaty; he then felt dizzy and had some nausea with blurring of his vision. He was standing during this episode. fell back onto father, recovered and went to the bathroom and had an episode of vomiting. Felt  better subsequently and has been doing well. Denies loss of consciousness. Likely brief vasovagal episode.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Periarthritis
Clinical narrative: severe pain; frozen shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain) and PERIARTHRITIS (frozen shoulders) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIARTHRITIS (frozen shoulders). On an unknown date, the patient experienced PAIN (severe pain). At the time of the report, PAIN (severe pain) and PERIARTHRITIS (frozen shoulders) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is taking diabetic medication and high blood pressure medication No Treatment received by the patient; Sender's Comments: This is a regulatory authority case concerning a  40-year-old female patient  medical history of diabetes, who experienced unexpected events of pain and Periarthritis. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. Patient developed severe pain that required therapy. She doesn't know if its the way she got the vaccine. She has had frozen shoulders since February. She closed her eyes so she is unsure of where they administered the vaccine in her arm. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.