chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Pulmonary mass
Clinical narrative: I received a Pfizer booster shot followed by senior Fluad shot, both left arm sane time. Which pharmacist saud shouldn't be a problem. Five days later very bad pain in left armpit lymph nodes which then moved  to include left clavicle area. Lasted over a week. Used heat and took pain reliever. Made breathing uncomfortable  as lung pressed against rib and thus against lymph nodes. After that pain subsided i had right rib pain. A CT showed a healing fracture AND multiple lung nodules. I'll be seeing a pulmonologist soon. I believe its possible the lung issue is related to the lymph node reaction.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Lymphadenopathy, Nasal congestion
Clinical narrative: Swollen lymph node. Extremely sore throat. Sweating. Fatigue. Headache. Stuffy and runny nose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Swollen lymph node. Extremely sore throat. Sweating. Fatigue. Headache. Stuffy and runny nose.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms, Nausea
Clinical narrative: Muscles around heart rapidly spasmed for approximately an hour. I felt a sense of dread and nausea. Spasms stopped and started during the hour I was affected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Sharp chest pain
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Mild angioedema. No urticaria, no resp distress, no anaphylaxis.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Urticaria
Clinical narrative: Back of hands, back of next and back covered in hives and chills within 4 hours of receiving  the vaccine. The chills I brushed off as I get cold easily to begin with, but this has been ongoing throughout the night now.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure a day after getting the Pfizer booster. Got booster Tuesday 11/23 around 12:00 PM and seizure occured Wednesday at around 1:30 PM
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: double pneumonia in the both lungs, they were fully vaccinated and still got a  Delta variant; double pneumonia in the both lungs, they were fully vaccinated and still got a  Delta variant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "double pneumonia in the both lungs, they were fully vaccinated and still got a  Delta variant". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: like for 2 weeks). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101587753 same reporter/drug/event, different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Many bruises on both legs with no prior history of easily bruising. Still present and not resolving.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Sudden Death
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Rash all over torso within 24 hours, in addition to soreness on arm ?and all over? (the last part was according to the child)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, vomiting, joint pain, back pain, headache
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever, chills, vomiting, joint pain, back pain, headache
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram, Echocardiogram, Electrocardiogram, Fibrin D dimer
Clinical narrative: Pulmonary thrombus embolism in the left main pulmonary artery .  I am on blood thinner(xarelto). The dosage keeps being changed because the blood clots keep reoccurring.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary thrombus embolism in the left main pulmonary artery .  I am on blood thinner(xarelto). The dosage keeps being changed because the blood clots keep reoccurring.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Dizziness, Full blood count, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Menorrhagia,  worse starting early October.  In November saw Dr. Hgb was 7.6, was irritated, dizzy, syncope,   Now taking iron pills 3 times daily, had pelvic ultrasound that showed no changes since 2008.  Bleeding slowed and stopped, after 3-4 weeks. No history of severe anemia, no history of abnormal bleeding.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Irritability, Ovarian cyst, Platelet count increased, Syncope
Clinical narrative: Menorrhagia,  worse starting early October.  In November saw Dr. Hgb was 7.6, was irritated, dizzy, syncope,   Now taking iron pills 3 times daily, had pelvic ultrasound that showed no changes since 2008.  Bleeding slowed and stopped, after 3-4 weeks. No history of severe anemia, no history of abnormal bleeding.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound pelvis normal, White blood cell count normal
Clinical narrative: Menorrhagia,  worse starting early October.  In November saw Dr. Hgb was 7.6, was irritated, dizzy, syncope,   Now taking iron pills 3 times daily, had pelvic ultrasound that showed no changes since 2008.  Bleeding slowed and stopped, after 3-4 weeks. No history of severe anemia, no history of abnormal bleeding.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Condition aggravated, Tinnitus
Clinical narrative: My tinnitus got much louder and has not subsided since May.   Along with my tinnitus getting worse I have had a continual Ulcerative Colitis flare up unlike any flare up  since May as well.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Vertigo
Clinical narrative: 1) Sudden strong dizziness and vertigo approximately two hours after receiving the vaccine. Had to lay down for a few hours. After a few hours feel much better but still somewhat dizzy.  I did not have anything like this after the 1st and 2nd doses of the same vaccine, and I am not sure if I ever experienced anything similar.  2) Mild pain at the injection site - started about the same time as dizziness.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Urticaria, Wheezing
Clinical narrative: Hives began 2 weeks after the booster. They are worst in the morning and evening. Benedryl helps relieve them but then they reappear again at the same times each day moving to different places on my body. I?ve had wheezing that goes with the hives.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, C-reactive protein increased, Chest pain, Computerised tomogram thorax abnormal, Dysphagia
Clinical narrative: In the fifth day after my second dose , I got severe chest pain ( stabbing pain in nature) which was localized in the beginning of the pain then started to radiate to all chest specially right side ( anterior and posterior). shortness of the breathing started with the progression of the pain , I was fainting twice because of the pain which now in the whole chest. I cannot sleep at all and even I have difficulty in breathing and even swallowing. I had severe headache since these symptoms started. the pain makes my movements limited. I have elevated temperature 39.2 c. yesterday I started medications like Paracetamol, NSAIDs and Colchicine ( as prescribed by the doctor)
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Headache, Mobility decreased, Pain
Clinical narrative: In the fifth day after my second dose , I got severe chest pain ( stabbing pain in nature) which was localized in the beginning of the pain then started to radiate to all chest specially right side ( anterior and posterior). shortness of the breathing started with the progression of the pain , I was fainting twice because of the pain which now in the whole chest. I cannot sleep at all and even I have difficulty in breathing and even swallowing. I had severe headache since these symptoms started. the pain makes my movements limited. I have elevated temperature 39.2 c. yesterday I started medications like Paracetamol, NSAIDs and Colchicine ( as prescribed by the doctor)
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pleural effusion, Sleep disorder, Syncope, Ultrasound scan abnormal
Clinical narrative: In the fifth day after my second dose , I got severe chest pain ( stabbing pain in nature) which was localized in the beginning of the pain then started to radiate to all chest specially right side ( anterior and posterior). shortness of the breathing started with the progression of the pain , I was fainting twice because of the pain which now in the whole chest. I cannot sleep at all and even I have difficulty in breathing and even swallowing. I had severe headache since these symptoms started. the pain makes my movements limited. I have elevated temperature 39.2 c. yesterday I started medications like Paracetamol, NSAIDs and Colchicine ( as prescribed by the doctor)
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Booster injection; Contracted COVID four weeks after having our booster injection; Contracted COVID four weeks after having our booster injection; This is a spontaneous report received from a contactable Consumer for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster injection"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID four weeks after having our booster injection". The patient thought the vaccine was effective, since he only had moderate symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101590502 same reporter and drug, different patient and event
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Immunisation
Clinical narrative: as dose 3 (booster), single; Severe chest discomfort; cold chills; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old male patient third dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 32030bd, Expiry date: unknown), via an unspecified route of administration, administered in left arm on an unspecified date as dose 3 (booster), single for covid-19 immunisation at Pharmacy or Drug store. Medical history included heart bypass, diabetes mellitus, cholesterol, blood pressure. The concomitant medications were not reported. No other vaccine received in four weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Er8727, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 17Mar2021 at 17:00 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Er8727, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 07Apr2021 at 17:00 as dose 2, single both for covid-19 immunisation at Pharmacy or Drug store. Known allergies to Vancomycin was reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination. The patient had not been tested for COVID-19 post vaccination. On an unspecified date the patient received DOSE 3 (booster) and experienced severe chest discomfort on 13Nov2021 at 14:00 and cold chills on 13Nov2021 approximately at 21:00. Patient took nitro to relieve some discomfort. No treatment was taken for cold chills. The outcome of the event severe chest discomfort and cold chills was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US313487 (Novartis).  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got Covid".His nose has continued to run since his second shot.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received one dose of Pfizer Covid-19 vaccine and then later was diagnosed with Covid-19 before receiving second Pfizer Covid-19 vaccine; Patient received one dose of Pfizer Covid-19 vaccine and then later was diagnosed with Covid-19 before receiving second Pfizer Covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Physician) for a Pfizer sponsored program (170972). A female patient received bnt162b2 (COMIRNATY) (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient received one dose of Pfizer Covid-19 vaccine and then later was diagnosed with Covid-19 before receiving second Pfizer Covid-19 vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: then later was diagnosed with covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Death, Immunisation
Clinical narrative: BOOSTER; suddenly dies in his sleep 2 weeks after 3rd covid jab; This is a spontaneous report received from non-contactable Consumer. A 52-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The prominent (Institution) Cardiologist suddenly died in his sleep just two weeks after getting his 3rd covid jab. The cardiologist who said he 'won't cry at funeral' for "selfish" unvaccinated people. The following information was reported: IMMUNISATION (death), outcome "fatal", described as "BOOSTER"; DEATH (death), outcome "fatal", described as "suddenly dies in his sleep 2 weeks after 3rd covid jab". The patient date of death was unknown. The reported cause of death was "suddenly dies in his sleep 2 weeks after 3rd covid jab", immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: BOOSTER; suddenly dies in his sleep 2 weeks after 3rd covid jab
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia
Clinical narrative: Covid; Covid; pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 16Aug2021 12:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid"; PNEUMONIA (medically significant), outcome "unknown", described as "pneumonia". The patient took shot and got Covid, Pneumonia 1 week later.  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: COVID-19, Cough, Dry mouth, Headache, Myalgia
Clinical narrative: Nasal congestion; dry mouth; non-productive cough; mild headache; mild muscle aches; Diagnosed with Covid-19; Diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)via Pfizer sales representative. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: ER8733) at the age of 57 years as dose 2, single and administration date 13Apr2021 (Lot number: EW0158) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "Diagnosed with Covid-19"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Nasal congestion"; DRY MOUTH (non-serious), outcome "unknown", described as "dry mouth"; COUGH (non-serious), outcome "unknown", described as "non-productive cough"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; MYALGIA (non-serious), outcome "unknown", described as "mild muscle aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) unknown results. Clinical course:Diagnosed with Covid-19 with Pfizer provided self-test, and confirmed by separate HCP test on Monday, 15Nov2021. Nasal congestion, dry mouth, non-productive cough, mild headache, mild muscle aches. No fever.   Follow-Up (24Nov2021):Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal congestion; dry mouth; non-productive cough; mild headache; mild muscle aches; Diagnosed with Covid-19; Diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)via Pfizer sales representative. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: ER8733) at the age of 57 years as dose 2, single and administration date 13Apr2021 (Lot number: EW0158) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2021, outcome "unknown" and all described as "Diagnosed with Covid-19"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Nasal congestion"; DRY MOUTH (non-serious), outcome "unknown", described as "dry mouth"; COUGH (non-serious), outcome "unknown", described as "non-productive cough"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; MYALGIA (non-serious), outcome "unknown", described as "mild muscle aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) unknown results. Clinical course:Diagnosed with Covid-19 with Pfizer provided self-test, and confirmed by separate HCP test on Monday, 15Nov2021. Nasal congestion, dry mouth, non-productive cough, mild headache, mild muscle aches. No fever.   Follow-Up (24Nov2021):Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Nov2021 (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: CHEST PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "Chest pain". The event "chest pain" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of chest pain. Additional information: Ibuprophen was received for treatment of adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a Pfizer-sponsored program. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis. Reporter called in regards to CEO withheld and spreading misinformation on the covid-19 vaccine, and they are criminals. Also paid 2.3 billion in fraudulent marketing in 2009. Complaints of kids being killed from having the covid-19 vaccine and will not inject his children with chemicals. Also stated that we should be killed for doing that. States that he knows people that have died from the Pfizer covid-19 vaccine and has a friend that was treated for myocarditis after the vaccine. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: severe restless leg syndrome has completely disappeared; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: GL9267, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 66-years-old) as Dose 1, Single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6200, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 as Dose 2, Single and third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FJ1611, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 16Nov2021 as Dose 3 (Booster), Single for covid-19 immunisation at Pharmacy/drug store. Medical history included Restless legs syndrome (Verbatim: Restless leg syndrome Developed the restless leg 10-12 years ago) from an unknown date and unknown if ongoing. Concomitant medication(s) included ropinirole (ROPINIROLE) was taken for an unspecified indication, start and stop date were not reported. On 16Nov2021, patient experienced severe restless leg syndrome has completely disappeared. The event was reported as non-serious. It was reported that developed the restless leg 10-12 years ago. Warm transfer of a caller explaining that he had received all 3 Pfizer Covid vaccines was very happy as they are working to his benefit. He reports that since getting his Covid shots, his severe restless leg syndrome has completely disappeared. The age was captured as stated by the caller, though discrepant. Primary Healthcare was decline. He explained that he was taking Ropinirole four times a day and if he doesn't take it his legs go absolutely crazy. The caller stated that had the shot tuesday morning, so he was supposed to take his next pill about 3pm in the afternoon but realized he didn't need it. He said to himself that he was going to see how far he can push it. It was explained that he did not need it at 3, not at 9, or all day yesterday. This was not normal as normally if he doesn't take that product his leg would be shaking so bad, he couldn't even drive a car. He has still not had to take his Ropinirole. He developed the restless leg 10-12 years ago, but it wasn't as bad then, over the last 3 years it has gotten really back. His doctor tried everything but only the Ropinirole worked. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none other than the previous Covid doses. Vaccinations prior 4 weeks was reported as none. The outcome of the event was not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Pain assessment, Palpitations, SARS-CoV-2 test
Clinical narrative: Burning of my heart; Chest pain, after the second shot, it was an 8/10 on the pain scale; Accompanied by palpitations and pounding heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 13:30 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Plantar fasciitis" (unspecified if ongoing); "gelatin" (unspecified if ongoing); "MSG allergy" (unspecified if ongoing); "xanthan gum allergy" (unspecified if ongoing); "acacia gum allergy" (unspecified if ongoing); "artificial flavors" (unspecified if ongoing); "carag allergy" (unspecified if ongoing). Concomitant medication(s) included: TYROSINE; GTA FORTE II; SELENIUM. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim"; Z-pak, reaction(s): "known allergies: Z-pak"; Codeine, reaction(s): "known allergies:codeine"; Phenergan, reaction(s): "known allergies: Phenergan". Vaccination history included: Bnt162b2 (1st Dose, administration date=20Aug2021,, administration time=15:00 , vaccine location=Left arm), administration date: 20Aug2021, when the patient was 43 years old, for Covid-19 Immunization, reaction(s): "Burning of my heart", "chest pain". The following information was reported: BURNING SENSATION (non-serious) with onset 10Sep2021, outcome "recovered" (2021), described as "Burning of my heart"; CHEST PAIN (non-serious) with onset 10Sep2021, outcome "recovered" (15Sep2021), described as "Chest pain, after the second shot, it was an 8/10 on the pain scale"; PALPITATIONS (non-serious) with onset 10Sep2021, outcome "recovered" (Sep2021), described as "Accompanied by palpitations and pounding heartbeat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation, chest pain, palpitations.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, patient was not diagnosed with COVID-19. Patient received other medications within 2 weeks of vaccination included Pro. Burning of her heart and chest pain. she had it more mildly after the first shot for about 2 days after the shot. After the second shot, it was an 8/10 on the pain scale and lasted from Friday 10Sep21 to Wednesday 15Sep21. It was accompanied by palpitations and pounding heartbeat at times. The patient received treatment for the adverse reactions with ibuprofen for every 4 hours. Since the vaccination, patient had been tested for COVID-19 on 04Oct2021 via nasal swab test, result was negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Nerve injury, Scar
Clinical narrative: severe case of shingles on her head and face; nerve damage; facial scaring; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "contracted COVID" (unspecified if ongoing), notes: contracted COVID on unk date in late 2020 or early 2021. The patient's concomitant medications were not reported. Vaccination history included: Shingrix vaccine (1st dose), administration date: 24Jun2020, when the patient was 53 years old, for Immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: HERPES ZOSTER (disability) with onset Apr2021, outcome "recovered with sequelae", described as "severe case of shingles on her head and face"; NERVE INJURY (disability) with onset Apr2021, outcome "recovered with sequelae", described as "nerve damage"; SCAR (disability) with onset Apr2021, outcome "recovered with sequelae", described as "facial scaring". In Apr2021, she developed severe case of shingles on her head and face. She had nerve damage and facial scaring from the shingles outbreak that may be permanent. She was unsure if she developed shingles due to the COVID vaccine. She was afraid to get the (3rd) booster for fear that she may have another shingles flare. The events "severe case of shingles on her head and face", "nerve damage" and "facial scaring" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster, nerve injury, scar. Patient was treated at hospital on or around 07Apr2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal, Pain
Clinical narrative: brain fog; Body soreness; extreme tiredness; confusion; This is a spontaneous report from a non-contactable consumer (patient reported for self). A 27-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown; lot unknown reason: unable to locate or read the details), via an unspecified route of administration, administered in arm Left on 11Oct2021 11:30 (at the age of 27 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Known allergies were reported, depression. Concomitant medication(s) included influenza vaccine (FLU) on 01Nov2021 for immunisation. Other medications received in two weeks included Birth control, allergy medication, and anti-depress. Other medications received in 4 weeks included Flu shot. The patient received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced brain fog, body soreness, extreme tiredness, confusion on 11Oct2021. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the events. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown; lot unknown reason: unable to locate or read the details), via an unspecified route of administration, administered in arm Left on 01Nov2021 12:30 (at the age of 27 years old) as dose 2, single for covid-19 immunisation. The outcome of the events (brain fog, body soreness, extreme tiredness, confusion) was reported as recovered (on an unspecified date in 2021).  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Immunisation
Clinical narrative: High Blood Pressure 2 hour's after booster 164/107; High Blood Pressure 2 hour's after booster 164/107; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Oct2021 11:00 (Lot number: EW0181) at the age of 66 year as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Inflammation of shoulder" (unspecified if ongoing). Family history included: "A-Flutter", start date: 11Mar2021 (unspecified if ongoing), notes: 08Apr2021 had ablation to correct atrial  flutter. Concomitant medication(s) included: IBUPROFEN [IBUPROFEN SODIUM] taken for inflammation (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Date/Time (24hr): 10Feb2021 and time: 15:00 GMT, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9265), administration date: 10Feb2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "BP 194/110", "I felt extremely unwell", "no appetite", "felt sick", "No energy", "double vision"; Bnt162b2 (Dose: 2, Date/Time (24hr): 03Mar2021 and time: 15:00 GMT, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EN6202), administration date: 03Mar2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "High blood pressure". The following information was reported: IMMUNISATION (non-serious) with onset 19Oct2021 11:00, outcome "unknown", HYPERTENSION (non-serious) with onset 19Oct2021 13:00, outcome "recovered" (02Nov2021) and all described as "High Blood Pressure 2 hour's after booster 164/107". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Pyrexia
Clinical narrative: Aches; fatigue; Chills; fever; dose received: 3/dose number = 3; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Nov2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Jan2021 (at the age of 25-years-old)  and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Feb2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 18Nov2021 at 17:00, the patient experienced aches, fatigue, chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with diphenhydramine citrate, ibuprofen (IBUPROFEN PM). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, fatigue, chills and fever were resolved on an unknown date in Nov2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Arm soreness; Dose number 3 received; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via intramuscular route of administration in the left arm on 22Nov2021 at 09:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Nov2021 at 14:00, the patient experienced arm soreness. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable other health care professional and a non-contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation and the patient also received palbociclib (IBRANCE, Film-coated tablet) via an unspecified route of administration on 12Nov2021 at a dose of 125 mg for an unspecified indication. It was reported that the patient felt really tired last week, but she also got her COVID 19 vaccine so she does not know if it was from that or the Ibrance. The action taken with IBRANCE was unknown. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain in extremity
Clinical narrative: The next morning feeling tired and headache; The next morning feeling tired and headache; My left arm feeling sore after 10 hours of injection; dose received 3/dose number = 3; This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via intramuscular route of administration in the left arm on 22Nov2021 at 11:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications with 2 weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Other vaccines  within 4 weeks prior to COVID vaccine included influenza vaccine (FLU) on15Nov2021 for immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration in the left arm on 18Mar2021 at 10:15 (at the age of 30-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an intramuscular route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 22Nov2021 at 22:00, (also reported as after10 hours of injection, the patient experienced left arm feeling sore; the next morning on 23Nov2021, the patient was feeling tired and had headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm feeling sore after 10 hours of injection, the next morning feeling tired and headache were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urinary tract infection
Clinical narrative: UTI; Patient had received third/booster dose 3, BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 08Nov2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. The patient had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 53-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 09Nov2021, the patient experienced urinary tract infection (UTI) after taking the booster vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event which included treatment with an OTC AZO product and cranberry juice. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event UTI after taking booster vaccine was not recovered at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Vaccination site pain
Clinical narrative: Menstruated cycle that was not scheduled to occur for another 1.5 weeks; Menstrual cycle is accompanied with heavy bleeding and intense cramps; Menstrual cycle is accompanied with heavy bleeding and intense cramps; Vaginal spotting; Soreness at the injection site; Soreness at the injection site and in the shoulder of the arm that was injected; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3303080 [as reported]) via an unspecified route of administration in the left arm on 17Nov2021 at 18:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient experienced vaginal spotting for five days beginning on 18Nov2021, the day after immunization followed by a menstrual cycle on 23Nov2021 that was not scheduled to occur for another 1.5 weeks. Menstrual cycle was accompanied with heavy bleeding and intense cramps, more than normal. The patient also experienced soreness at the injection site and in the shoulder of the arm that was injected on an unknown date in Nov2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal spotting was resolved on 23Nov2021; while that of the events menstruated cycle that was not scheduled to occur for another 1.5 weeks, menstrual cycle was accompanied with heavy bleeding and intense cramps, more than normal was not resolved; soreness at the injection site and in the shoulder of the arm that was injected was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.