chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm was sore; This is a spontaneous report received from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced his arm was sore. The outcome of event was unknown. He had his Pfizer vaccine and his arm was sore but he did not get a lump or have redness.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dyskinesia, Electrocardiogram
Clinical narrative: I got this involuntary movement of my neck and shuttering while seating; I got this involuntary movement of my neck and shuttering while seating; I was so tired; sleeping all the time; heaviness of my forehead; I can't seat properly; I can't talk properly.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 13Jul2021 12:07 as dose 1, single for COVID-19 immunization. Medical history included bronchial asthma, scoliosis, unstable angina, kidney stone in 2019 and dye contrast allergy. The patient's concomitant medications were not reported. The patient experienced involuntary movement of neck and shuttering while seating, almost 20 minutes after vaccination, on 13Jul2021. The patient was rushed to the hospital (emergency room) for these events and was administered medicines. The patient could not talk or sit properly on 13Jul2021. After 7 hours in emergency room, the patient was back to normal. On 18Jul2021, 5 days after vaccination, the patient was tired, sleeping all the time and felt heaviness of forehead. The patient underwent lab tests and procedures at hospital on 13Jul2021 which included CT scan, ECG, Chest x-ray and other blood test and all the results were normal. The patient was given a shot of medicines as treatment for involuntary movement of neck and shuttering while seating and the events caused hospitalization of the patient. The patient was scheduled to have an MRI (at the time of report). The outcome of the events involuntary movement of neck and shuttering while seating, could not talk or sit properly was recovered on 13Jul2021. The outcome of events tired and sleeping all the time was unknown. The outcome of events heaviness of forehead was not recovered.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Hypersomnia, Sitting disability, Speech disorder
Clinical narrative: I got this involuntary movement of my neck and shuttering while seating; I got this involuntary movement of my neck and shuttering while seating; I was so tired; sleeping all the time; heaviness of my forehead; I can't seat properly; I can't talk properly.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 13Jul2021 12:07 as dose 1, single for COVID-19 immunization. Medical history included bronchial asthma, scoliosis, unstable angina, kidney stone in 2019 and dye contrast allergy. The patient's concomitant medications were not reported. The patient experienced involuntary movement of neck and shuttering while seating, almost 20 minutes after vaccination, on 13Jul2021. The patient was rushed to the hospital (emergency room) for these events and was administered medicines. The patient could not talk or sit properly on 13Jul2021. After 7 hours in emergency room, the patient was back to normal. On 18Jul2021, 5 days after vaccination, the patient was tired, sleeping all the time and felt heaviness of forehead. The patient underwent lab tests and procedures at hospital on 13Jul2021 which included CT scan, ECG, Chest x-ray and other blood test and all the results were normal. The patient was given a shot of medicines as treatment for involuntary movement of neck and shuttering while seating and the events caused hospitalization of the patient. The patient was scheduled to have an MRI (at the time of report). The outcome of the events involuntary movement of neck and shuttering while seating, could not talk or sit properly was recovered on 13Jul2021. The outcome of events tired and sleeping all the time was unknown. The outcome of events heaviness of forehead was not recovered.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I got this involuntary movement of my neck and shuttering while seating; I got this involuntary movement of my neck and shuttering while seating; I was so tired; sleeping all the time; heaviness of my forehead; I can't seat properly; I can't talk properly.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 13Jul2021 12:07 as dose 1, single for COVID-19 immunization. Medical history included bronchial asthma, scoliosis, unstable angina, kidney stone in 2019 and dye contrast allergy. The patient's concomitant medications were not reported. The patient experienced involuntary movement of neck and shuttering while seating, almost 20 minutes after vaccination, on 13Jul2021. The patient was rushed to the hospital (emergency room) for these events and was administered medicines. The patient could not talk or sit properly on 13Jul2021. After 7 hours in emergency room, the patient was back to normal. On 18Jul2021, 5 days after vaccination, the patient was tired, sleeping all the time and felt heaviness of forehead. The patient underwent lab tests and procedures at hospital on 13Jul2021 which included CT scan, ECG, Chest x-ray and other blood test and all the results were normal. The patient was given a shot of medicines as treatment for involuntary movement of neck and shuttering while seating and the events caused hospitalization of the patient. The patient was scheduled to have an MRI (at the time of report). The outcome of the events involuntary movement of neck and shuttering while seating, could not talk or sit properly was recovered on 13Jul2021. The outcome of events tired and sleeping all the time was unknown. The outcome of events heaviness of forehead was not recovered.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Insomnia, Limb discomfort, Pyrexia
Clinical narrative: Arm felt like bones were cracking; Could not sleep for 24 hours; Fever; Feels tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced that her arm felt like bones were cracking, could not sleep for 24 hours, fever and felt tired. The patient underwent lab tests and procedures which included body temperature unknown result on an unknown date. As therapeutic measure paracetamol (TYLENOL) was taken for fever and diazepam (VALIUM) was taken for insomnia. The outcome was unknown for the reported events.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: PPV
Symptoms: Exposure to communicable disease, Pain
Clinical narrative: he had a little pain; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "Pfizer flu shot", "pneumococcal shot" also reported as "Pulmonary Flu Shot"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for imminization. The patient medical history included "exposed to that flu". Concomitant medications were not reported. He said one of the things he did before anything else was he took the pneumococcal thing, the over 65 flu type, he took that, then after 3-4 weeks from there took he took the Pfizer flu shot and he was wondering if he should wait a bit longer than three months or three weeks for the second. He says after the pneumococcal shot he had a little pain, he thought before that he must have been exposed to that flu, he didn't know have it now, it had subsided. The outcome of the event was unknown.  The lot number for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Back pain, Investigation, Musculoskeletal stiffness, Pain
Clinical narrative: The vaccine activated an autoimmune condition spondyloarthritis; pulled back; cracked rib; night stiffness; crippled pain in feet; crippled pain in back; crippled pain in soft tissues around bone joints; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 52-year-old via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (Lot Number: Ek8737) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure (hbp), high cholesterol but under control with meds and had Covid-19 early Jan2021 to an unknown date. The patient has no known allergies. Concomitant medications included atorvastatin calcium (ATORVASTATIN) and lisinopril, both unspecified indications, start and stop date were not reported. The patient did not receive other vaccine in four weeks. It was reported that the patient had a vaccine activated an autoimmune condition, spondyloarthritis on an unspecified date in 2021. The patient mentioned that the second shot made it so much worse. He did not realize what was happening. He mentioned that though pulled back, cracked rib, etc. got worse and worse. He had night stiffness, etc. He was "almost crippled pain in feet, back and in soft tissues around bone joints." He finally got into a doctor and was placed on Enbrel and Celebrex which made him feel 99% back to normal. He mentioned that the shot crippled him and activated an autoimmune. He mentioned that he does test positive for hlab27 (2021) as he found out. He also had Covid early Jan2021. So, he had antibodies most likely already. No one believes the shot caused it but there is no doubt it did based on timeline and symptoms. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient considered the events as serious since it resulted in disability or permanent damage. The patient has not been Covid tested post vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rib fracture, SARS-CoV-2 test, Spondylitis
Clinical narrative: The vaccine activated an autoimmune condition spondyloarthritis; pulled back; cracked rib; night stiffness; crippled pain in feet; crippled pain in back; crippled pain in soft tissues around bone joints; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 52-year-old via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (Lot Number: Ek8737) as dose 1, single for covid-19 immunisation. Medical history included high blood pressure (hbp), high cholesterol but under control with meds and had Covid-19 early Jan2021 to an unknown date. The patient has no known allergies. Concomitant medications included atorvastatin calcium (ATORVASTATIN) and lisinopril, both unspecified indications, start and stop date were not reported. The patient did not receive other vaccine in four weeks. It was reported that the patient had a vaccine activated an autoimmune condition, spondyloarthritis on an unspecified date in 2021. The patient mentioned that the second shot made it so much worse. He did not realize what was happening. He mentioned that though pulled back, cracked rib, etc. got worse and worse. He had night stiffness, etc. He was "almost crippled pain in feet, back and in soft tissues around bone joints." He finally got into a doctor and was placed on Enbrel and Celebrex which made him feel 99% back to normal. He mentioned that the shot crippled him and activated an autoimmune. He mentioned that he does test positive for hlab27 (2021) as he found out. He also had Covid early Jan2021. So, he had antibodies most likely already. No one believes the shot caused it but there is no doubt it did based on timeline and symptoms. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient considered the events as serious since it resulted in disability or permanent damage. The patient has not been Covid tested post vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Pain in extremity, Pruritus
Clinical narrative: left arm hurt; felt burning and itching mainly on my chest pretty severe; felt burning and itching mainly on my chest pretty severe and a randomly itching sensation through my entire body; explain that would be that it felt like a bunch of fleas attacked me and bit me in random order; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 25May2021 as dose 2, single for covid-19 immunisation. Medical history included varicella. There were no concomitant medications. Historical vaccine included bnt162b2 (BNT162B2, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 as dose 1, single for covid-19 immunisation. About 8 hours after the vaccination left arm hurt for about 2 days and that was all the patient experienced after first dose and received Shingrix on an unspecified date for an unspecified indication. The patient experienced about 8 hours after left arm hurt, and 2 hours after that felt burning and itching mainly on chest pretty severe, and a randomly itching sensation through entire body, it felt like a bunch of fleas attacked and bit in random order. The patient stated once again about 8 hours later my left arm hurt and 2 hours after that felt burning and itching mainly on chest. Pretty severe and a randomly itching sensation through my entire body. The best way to explain that would be that it felt like a bunch of fleas attacked me and bit me in random order. The patient scratched the "attacked" spot lightly and it stopped itching but would pop up on other parts of my body. The first day was very intense, the second day not too bad the third day it faded out and that was It certainly was not the worst experience after the vaccination but a very uncomfortable one. Saturday, 24July2021 this scenario repeated itself in the same order. For no reason, The patient went through the same ordeal severe itching on the chest throughout the body for almost 3 days, and then it disappeared. And nothing triggered it. No vaccination or any other outside influence. The patient discovered a very unique comparison in my health history which may shed some light on this situation. At the tender age of 40, the patient was diagnosed with chickenpox. The symptoms experienced were very similar to what described above. Itching and discomfort at the same body parts. Ca. 20 years later heard about shingle shots. As the pharmacist gave the injection, the patient felt a brief itching sensation, exactly the same location where had the chickenpox, mainly on the chest and all over the body. That lasted only a few minutes and then disappeared. It almost felt as if the body "remembered" where the virus was located. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: her fever still at 102.4; Ache in the body; Chills; This is a spontaneous report from a contactable consumer or other non hcp (Parent) reported for patient (Daughter). A female patient of an unspecified age (Age:12, Unit: Unknown as reported) received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 26Jul2021 as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The reporter stated her daughter just turned twelve she had her COVID vaccine, Pfizer just the few days after she turned twelve, previous night she had her second shot because it was three weeks already and the first dose she did not have no problem. She cannot get her fever and chills to stop. That morning they started around like 1 or 2 o'clock in the morning and her fever still at 102.4. The reporter asked should I take it to the ER. Because the Motrin and the ice pack on her head and washing her down with cold water is not doing that. Is that a side effect like the Covid vaccine. The chills, the ache in the body because the reporter did not have the Pfizer, she did not have the same symptoms like her. The patient underwent lab tests and procedures which included body temperature: 102.4 fahrenheit on 27Jul2021. The outcome of all the events was reported as not resolved.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 26Jul2021 12:30 (at the age of 24-years-old) (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included colitis and covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 26Jul2021 17:30 patient experienced fever, muscle pain. patient received treatment as Tylenol. Patient had no other vaccine in four weeks, and no other medications in two weeks, patient has no allergy. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient diagnosed with COVID-19, Since the vaccination, patient not been tested for COVID-19. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She had an allergic reaction or a bad reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she had an allergic reaction or a bad reaction on an unspecified date. patient was actually calling because she took the Pfizer vaccine for COVID and she had a couple of questions, where she's going to send the medical bills to because she had an allergic reaction or a bad reaction. The outcome for event was unknown.   The lot number for the vaccine, [enter generic Pfizer vaccine name], was not provided and will be requested during follow up
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Oropharyngeal discomfort, Peripheral swelling, Rash
Clinical narrative: Welts on face about 4-5 hours later; red line under right arm; rash over body; hand and elbows swelled up; hand and elbows swelled up; face swollen; throat started feeling strange; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Jul2021 16:15 (Batch/Lot Number: EW0196P, age at vaccination was 56-year-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccaination. Medical history included known allergies: Penicillin and sulfa drugs. Concomitant medications was not reported. The patient previously took Penicilin and Sulfa drugs. The patient had no other medical history. The patient was not tested for COVID prior vaccination. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had welts on face about 4-5 hours later. Took Antihistamine and they went down and in the AM not as bad. A few days later welts and a red line under right arm. A few days later a rash over body. The next day my hand and elbows swelled up. Took a bunch of antihistamine and it started to get better then another rash all over hands and face swollen, throat started feeling strange so she took a shot of epipen into her leg. It has been 2 days since that and the rash was subsiding. The second time, as per ED notes "adverse effect of vaccine". The events occurred on 09Jul2021 9:00 AM. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Jul2021 Nasal Swab. Therapeutic measures were taken as a result of welts on face about 4-5 hours later (urticaria), rash (rash). Outcome of rash was recovering and other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face, Urticaria
Clinical narrative: Welts on face about 4-5 hours later; red line under right arm; rash over body; hand and elbows swelled up; hand and elbows swelled up; face swollen; throat started feeling strange; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 09Jul2021 16:15 (Batch/Lot Number: EW0196P, age at vaccination was 56-year-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccaination. Medical history included known allergies: Penicillin and sulfa drugs. Concomitant medications was not reported. The patient previously took Penicilin and Sulfa drugs. The patient had no other medical history. The patient was not tested for COVID prior vaccination. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had welts on face about 4-5 hours later. Took Antihistamine and they went down and in the AM not as bad. A few days later welts and a red line under right arm. A few days later a rash over body. The next day my hand and elbows swelled up. Took a bunch of antihistamine and it started to get better then another rash all over hands and face swollen, throat started feeling strange so she took a shot of epipen into her leg. It has been 2 days since that and the rash was subsiding. The second time, as per ED notes "adverse effect of vaccine". The events occurred on 09Jul2021 9:00 AM. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Jul2021 Nasal Swab. Therapeutic measures were taken as a result of welts on face about 4-5 hours later (urticaria), rash (rash). Outcome of rash was recovering and other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a non-contactable nurse, the patient. A 30-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration on 26Jun2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jul2021, a few days after receiving the COVID vaccine, the patient experienced tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: an extended period; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an extended period on an unspecified date. Patient stated to know information on irregular menses, lymphadenopathy whether vaccine can be received through oral route of administration and whether there was an improved version of vaccine that wouldn't cause any adverse reactions. The outcome of the event oligomenorrhea was unknown.  Information on lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myofascial pain syndrome
Clinical narrative: diagnosed with myofascial; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 68-year-old), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she was diagnosed with myofascial and she wants to try this new medication because it has something to do with the nerves and muscles and just started taking it last week. Patient also stated, she had to be off of the Xeljanz for two weeks because of the COVID vaccine and started back on its last night and she could feel the difference. Outcome of event was unknown.  Information about Lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pulmonary mass, SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo, symptoms off and on when waking, looking down or to the side; Node on lungs; Unable to drive long distance by myself; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in left arm on 06Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hysterectomy in 1991 due to endometriosis, high MCV and MCH count at over 100 (as reported). The patient had no allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7534) via an unspecified route of administration in left arm on 16Mar2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation.  On 01May2021, the patient had experienced vertigo and a node on lungs which was revealed in a CT scan of her right abdomen. This scan was unrelated to COVID but the patient's doctor saw the node and ordered a CT scan of the patient's lung as a result which was pending. Vertigo symptoms were off and on when waking, looking down or to the side. Also occurred on other occasions. The patient was unable to drive long distance by herself and was not sure when it will happen. No therapeutic measures were taken as a result of adverse events. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) on 19Jul2021,  23Jul2021, and on 26Jul2021, all which tested negative.  Since the vaccination, the patient had been tested for COVID-19. The events had resulted in a visit to the doctors or other healthcare professional office/clinic visit.  The clinical outcome of the events, vertigo, node on lungs and unable to drive long distance by herself was not recovered at the time of report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Bruxism, Diarrhoea, Dizziness
Clinical narrative: Dizziness; Headaches; Calf weakness; Legs, arms, back tingling; Disequilibrium; Diarrhea; Period cycle change - heavy bleeding; Sinus pressure; Nausea; Skin scab; Vibration in calf; Heart palpitations; Extreme anxiety; Neck muscle tightness / Jaw muscle tightness; Uterine tenderness; Weight loss; Mouth weakness; Clenching; Random sweating; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 09:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included hashimotos. Concomitant medication included levothyroxine, trigonella foenum-graecum seed (FENUGREEK [TRIGONELLA FOENUM-GRAECUM SEED]) both taken for unknown indications from an unknown date. Patient did not receive any other vaccine in four weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 17Mar2021 09:00am the patient experienced dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The patient underwent lab tests and procedures which included weight: loss on 17Mar2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Steroids were received as treatment. Therapeutic measures were taken as a result of dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change - heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness / jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Headache, Heavy menstrual bleeding, Hyperhidrosis, Muscle tightness
Clinical narrative: Dizziness; Headaches; Calf weakness; Legs, arms, back tingling; Disequilibrium; Diarrhea; Period cycle change - heavy bleeding; Sinus pressure; Nausea; Skin scab; Vibration in calf; Heart palpitations; Extreme anxiety; Neck muscle tightness / Jaw muscle tightness; Uterine tenderness; Weight loss; Mouth weakness; Clenching; Random sweating; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 09:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included hashimotos. Concomitant medication included levothyroxine, trigonella foenum-graecum seed (FENUGREEK [TRIGONELLA FOENUM-GRAECUM SEED]) both taken for unknown indications from an unknown date. Patient did not receive any other vaccine in four weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 17Mar2021 09:00am the patient experienced dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The patient underwent lab tests and procedures which included weight: loss on 17Mar2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Steroids were received as treatment. Therapeutic measures were taken as a result of dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change - heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness / jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Nausea, Palpitations, Paraesthesia
Clinical narrative: Dizziness; Headaches; Calf weakness; Legs, arms, back tingling; Disequilibrium; Diarrhea; Period cycle change - heavy bleeding; Sinus pressure; Nausea; Skin scab; Vibration in calf; Heart palpitations; Extreme anxiety; Neck muscle tightness / Jaw muscle tightness; Uterine tenderness; Weight loss; Mouth weakness; Clenching; Random sweating; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 09:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included hashimotos. Concomitant medication included levothyroxine, trigonella foenum-graecum seed (FENUGREEK [TRIGONELLA FOENUM-GRAECUM SEED]) both taken for unknown indications from an unknown date. Patient did not receive any other vaccine in four weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 17Mar2021 09:00am the patient experienced dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The patient underwent lab tests and procedures which included weight: loss on 17Mar2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Steroids were received as treatment. Therapeutic measures were taken as a result of dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change - heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness / jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Scab, Uterine tenderness, Weight, Weight decreased
Clinical narrative: Dizziness; Headaches; Calf weakness; Legs, arms, back tingling; Disequilibrium; Diarrhea; Period cycle change - heavy bleeding; Sinus pressure; Nausea; Skin scab; Vibration in calf; Heart palpitations; Extreme anxiety; Neck muscle tightness / Jaw muscle tightness; Uterine tenderness; Weight loss; Mouth weakness; Clenching; Random sweating; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 09:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug Store. The patient medical history included hashimotos. Concomitant medication included levothyroxine, trigonella foenum-graecum seed (FENUGREEK [TRIGONELLA FOENUM-GRAECUM SEED]) both taken for unknown indications from an unknown date. Patient did not receive any other vaccine in four weeks. The patient does not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 17Mar2021 09:00am the patient experienced dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The patient underwent lab tests and procedures which included weight: loss on 17Mar2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Steroids were received as treatment. Therapeutic measures were taken as a result of dizziness, headaches, calf weakness, legs, arms, back tingling, disequilibrium, diarrhea, period cycle change - heavy bleeding, sinus pressure, nausea, skin scab, vibration in calf, heart palpitations, extreme anxiety, neck muscle tightness / jaw muscle tightness, uterine tenderness, weight loss, mouth weakness, clenching, random sweating. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Diagnosed with transverse myelitis; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ewo182 and expiration date not provided), via an unspecified route of administration, in left arm, on 03May2021 (at the age of 33-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no COVID prior vaccination, no COVID tested post vaccination. Patient had no known allergies, no other medical history. No other vaccine in four weeks. No other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ewo158 and expiration date not provided), via an unspecified route of administration, in left arm, on 12Apr2021 (at the age of 33-year-old), at single dose, for COVID-19 immunization. Patient was diagnosed with transverse myelitis on 08Jul2021. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. Patient was hospitalized for 4 days. Therapeutic measures were taken as a result of event and included treatment with 3 days of IV steroids.  The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Deafness / Hearing was gone; ringing my left ear; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jun2021 18:30 (Batch/Lot number was not reported) (at age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No COVID prior vaccination, not tested COVID post vaccination. No known allergies. Medical history included Obese. Concomitant medications included ibuprofen; buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE); alprazolam; zolpidem tartrate (AMBIEN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced deafness / hearing was gone (disability) on 26Jun2021 08:15 with outcome of unknown, ringing my left ear (disability) on 26Jun2021 08:15 with outcome of unknown. Patient stated deafness and ringing left ear that didn't go away for weeks and patient had to go to the hospital. Two days or less than two days after shot. Hearing was gone the Saturday morning. The adverse events treatment included Doctor tried nose spray, decongestants. The adverse events resulted in Emergency room/department or urgent care, Disability or permanent damage.   Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vomiting
Clinical narrative: Serve headache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Jul2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have any known allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Feb2021, the patient underwent nasal swab (COVID-19 virus test) and the result was negative. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Jul2021 at 18:00 the patient experienced severe headache and vomiting. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Jul2021, patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the events severe headache and vomiting was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Diarrhoea, Fatigue, Loss of personal independence in daily activities
Clinical narrative: tiredness; patient was so tired; Muscle pain; swelling throat and lymph nodes.; Diarrhea/ having diarrhea for three years but it was now worse; Joint pain; she can't do any of the domestic housekeeping chores she usually did; swelling throat and lymph nodes; has lost 20 pounds since getting the shot; Patient can't do anything, can't even walk; These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200) via an unspecified route of administration, in the left arm, on 24Feb2021 (at the age of 77-year-old) (in the morning), as single dose, for COVID-19 immunization. The patient's medical history diarrhea, crohn's disease, kidney cancer with removal of her kidney two years ago and colonoscopy.  Patient's concomitant medications were not reported. The Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9299, expiry date: Unknown) via an unspecified route of administration, in the left arm, on 03Feb2021 (in the morning), as single dose, for COVID-19 immunization. Patient had the vaccination in Feb2021 (both doses). Patient had a lot joint pain, muscle pain, some trouble swallowing. Patient had some dental work done and they thought maybe that was it because her jaw has been sore but the dentist said no, her jaw checked out good, adds this dentist was like oral facial pain. Patient was still experiencing tiredness; patient was so tired she can't do any of the domestic housekeeping chores she usually did, swelling in her throat and lymph nodes. These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse. Patient can't do anything, can't even walk, can't do nothing. Patient has also been having diarrhea. Patient has been having diarrhea for three years but it was now worse. Mentioned patient has lost 20 pounds since getting the shot. Mentioned that the doctor who did the colonoscopy, was treating her for diarrhea with a prescription of Kreon and Citron, but she still has diarrhea, but not like she had it before. Patient is having blood work tomorrow (unspecified date) because her doctor thinks this might be serious. No Emergency Room visit. Patient visited physician office, gone to the regular doctor for diarrhea. They have been treating her for diarrhea before the vaccine but now it was worse. The patient underwent lab tests and procedure which included the body weight and result was lost 20 pounds on an unknown date in Mar2021.  The outcome of the events was not recovered.   Information on the lot/batch number has been requested.