chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Fully vaccinated and tested positive for COVID; Fully vaccinated and tested positive for COVID/Congestion, headache, low grade fever for one day; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021, as single dose(Lot Number: EL3247) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021, as single dose (Lot Number: EL3247) for covid-19 immunisation. Medical history included RA(rheumatoid arthritis). Concomitant medications included abatacept (ORENCIA), methotrexate and folic acid taken for RA. The patient experienced fully vaccinated and tested positive for covid on an unspecified date in 2021. The patient had congestion, headache and low grade fever for one day. The outcome of all events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID case after 2 PFE vaccinations; Breakthrough COVID case after 2 PFE vaccinations; This is a spontaneous report from a contactable Consumer or other non-HCP reported for a patient. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced breakthrough covid case after 2 PFE vaccinations. Event took place after use of product. It was reported that the second dose was given around mid Feb2021. The patient outcome of the event was unknown at the time of this report.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Breakthrough bleeding 30 years after having last period; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in May2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced breakthrough bleeding 30 years after having last period on 18Aug2021. The patient reported that 3 months after receiving the first dose and 30 years after her last period, she had breakthrough bleeding and had to go to the gynecologist. The clinical outcome of breakthrough bleeding 30 years after having last period was recovering.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Blood test, Breast mass, Breast pain, Chest X-ray
Clinical narrative: My back is very tender it feels as if it has been bnuised; Continued breast pain; lump in my right breast. I have a history of lumps and bumps that came and go. Several of them have enlarged since taking the vaccines; My clothes hurt and the bottom of my feet hurt and so did my shoes and socks.; Tonight pain in my ribs/right side and back.; Tonight pain in my ribs/right side and back.; Neck pain back of head pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0196, Expiry date: unknown, at the age of 69-year-old), dose 2 via an unspecified route of administration, administered in Arm Left (Vaccination Facility Type: Pharmacy or Drug Store, Vaccine Administered at Military Facility: No) on 19Jun2021 17:00 as dose 2, single for covid-19 immunization. Medical history included ongoing migraine since childhood migraine IBS, muscle spasms from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, breast mass from an unknown date and unknown if ongoing (lump in my right breast). Patient had a history of lumps and bumps that came and go. Concomitant medications included zolpidem tartrate (AMBIEN) taken for migraine from 2020 and ongoing; cefixime (FLEXERIL [CEFIXIME]) taken for muscle spasms, migraine from 2004 and ongoing; ibuprofen (ADVIL [IBUPROFEN]) taken for pain from an unspecified start date and ongoing. The patient experienced neck pain back of head pain (medically significant) on 06Aug2021. AE required visit to the event neck pain: could not move head. No treatment received for neck pain. The patient experienced tonight pain in my ribs/right side and back on 20Aug2021. The patient experienced my back was very tender it feels as if it had been bnuised (tenderness), continued breast pain, lump in my right breast. Patient had a history of lumps and bumps that came and go, several of them have enlarged since taking the vaccines, my clothes hurt and the bottom of my feet hurt and so did my shoes and socks on an unspecified date. The patient underwent lab tests and procedures which included blood test, chest x-ray and electrocardiogram with unknown results on 23Jun2021 yes, it seemed to reveal nothing unusual. The clinical outcome of neck pain was not recovered and clinical outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Musculoskeletal chest pain, Neck pain, Pain in extremity, Tenderness
Clinical narrative: My back is very tender it feels as if it has been bnuised; Continued breast pain; lump in my right breast. I have a history of lumps and bumps that came and go. Several of them have enlarged since taking the vaccines; My clothes hurt and the bottom of my feet hurt and so did my shoes and socks.; Tonight pain in my ribs/right side and back.; Tonight pain in my ribs/right side and back.; Neck pain back of head pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0196, Expiry date: unknown, at the age of 69-year-old), dose 2 via an unspecified route of administration, administered in Arm Left (Vaccination Facility Type: Pharmacy or Drug Store, Vaccine Administered at Military Facility: No) on 19Jun2021 17:00 as dose 2, single for covid-19 immunization. Medical history included ongoing migraine since childhood migraine IBS, muscle spasms from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, breast mass from an unknown date and unknown if ongoing (lump in my right breast). Patient had a history of lumps and bumps that came and go. Concomitant medications included zolpidem tartrate (AMBIEN) taken for migraine from 2020 and ongoing; cefixime (FLEXERIL [CEFIXIME]) taken for muscle spasms, migraine from 2004 and ongoing; ibuprofen (ADVIL [IBUPROFEN]) taken for pain from an unspecified start date and ongoing. The patient experienced neck pain back of head pain (medically significant) on 06Aug2021. AE required visit to the event neck pain: could not move head. No treatment received for neck pain. The patient experienced tonight pain in my ribs/right side and back on 20Aug2021. The patient experienced my back was very tender it feels as if it had been bnuised (tenderness), continued breast pain, lump in my right breast. Patient had a history of lumps and bumps that came and go, several of them have enlarged since taking the vaccines, my clothes hurt and the bottom of my feet hurt and so did my shoes and socks on an unspecified date. The patient underwent lab tests and procedures which included blood test, chest x-ray and electrocardiogram with unknown results on 23Jun2021 yes, it seemed to reveal nothing unusual. The clinical outcome of neck pain was not recovered and clinical outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: his first shot, it hurt for about an hour and a half and it was more intense in the second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself) from a Pfizer sponsored program. A 66-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included, ongoing cervical stenosis, ongoing RA, ongoing COPD, ongoing emphysema. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunization and experienced first shot it hurt. On an unspecified date in May2021, the patient experienced his first shot, it hurt for about an hour and a half and it was more intense in the second shot. Verbatim and Event Description: Patient had both doses of the vaccine last 10Apr2021 and 01May2021. Patient mentioned that he has some health issues like cervical stenosis, RA, COPD and emphysema. He mentioned that when he got his first shot, it hurt for about an hour and a half and it was more intense in the second shot. Patient called in to know and get some advice when to take the follow up shot or booster shot. Outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral discomfort, Polymerase chain reaction, Taste disorder, Throat irritation
Clinical narrative: my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; sense of metallic taste; sense of taste is altered; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Lot Number: EL 3249) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included very healthy (take no medicines, except topical vaginal estrogen), penicillin allergy, shellfish allergy. Concomitant medication included estradiol (ESTROGEN). The patient previously took Botox and levofloxacin (LEVAQUIN) and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient got the vaccine at on 20Jan2021 11 am. On 20Jan2021 at 2 pm, her tongue started burning, and progressed to her entire tongue, roof of her mouth and back of her throat. Patient told her doctor who said to take diphenhydramine hydrochloride (BENADRYL). Her tongue felt like it was on fire and that someone spilled no vaccine on it (also reported as someone spilled novocaine on it). Patient was diagnosed with burning tongue syndrome, and as of 23Aug2021, she still has a burning tongue with a sense of metallic taste in her mouth, and her sense of taste is altered. Some food makes it worse like salty foods and acidic foods. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was treated for all the events, she used a calming mouth wash, such as Closys. Patient was tested for COVID via nasal swab PCR post vaccination on 08Apr2021 with negative result. Patient had not recovered from the events, at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; sense of metallic taste; sense of taste is altered; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Lot Number: EL 3249) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included very healthy (take no medicines, except topical vaginal estrogen), penicillin allergy, shellfish allergy. Concomitant medication included estradiol (ESTROGEN). The patient previously took Botox and levofloxacin (LEVAQUIN) and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient got the vaccine at on 20Jan2021 11 am. On 20Jan2021 at 2 pm, her tongue started burning, and progressed to her entire tongue, roof of her mouth and back of her throat. Patient told her doctor who said to take diphenhydramine hydrochloride (BENADRYL). Her tongue felt like it was on fire and that someone spilled no vaccine on it (also reported as someone spilled novocaine on it). Patient was diagnosed with burning tongue syndrome, and as of 23Aug2021, she still has a burning tongue with a sense of metallic taste in her mouth, and her sense of taste is altered. Some food makes it worse like salty foods and acidic foods. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was treated for all the events, she used a calming mouth wash, such as Closys. Patient was tested for COVID via nasal swab PCR post vaccination on 08Apr2021 with negative result. Patient had not recovered from the events, at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Ear pruritus, Erythema, Eye pruritus, Hypersensitivity
Clinical narrative: Progressed to symptoms of angioedema.; Systemic " itching "- head, arms, upper anterior  thighs bilaterally, vaguely within about 20-30 minutes.; Facial swelling; red face; blotchy red patches arms, back, legs face; severe itchy (10) inside of ears (deep), eyes; severe itchy (10) inside of ears (deep), eyes; scratchy throat; Next morning, allergic reaction covered by medication; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Aug2021 19:00 (Lot Number: fc3181) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included migraine headache (h/a), hypothyroid, latex allergy, penicillin (PCN) allergy. Concomitant medications included methylphenidate hydrochloride (CONCERTA); duloxetine hydrochloride (CYMBALTA); thyroid (ARMOUR THYROID). Facility type vaccine: Pharmacy or Drug Store. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. On 16Aug2021 patient experienced progressed to symptoms of angioedema, systemic " itching "- head, arms, upper anterior  thighs bilaterally, vaguely within about 20-30 minutes, facial swelling, red face, blotchy red patches arms, back, legs face, severe itchy (10) inside of ears (deep), eyes, scratchy throat, next morning, allergic reaction covered by medication. Events resulted in Doctor or other healthcare professional office/clinic visit. Clinical course was reported as follows: Systemic "itching "- head, arms, upper anterior thighs bilaterally, vaguely within about 20-30 minutes. Progressed to symptoms of angioedema. Facial swelling, red face, blotchy red patches arms, back, legs face, although much more severe itchy (10) inside of ears (deep), eyes, and scratchy throat. Patient had no food or anything else but water after the vaccination. These symptoms evolved over two hours, increasing in intensity. Patient had Benadryl and prednisone in her medicine box and took 75 mg Benadryl, (liquid) 50 ng prednisone at 10:00 pm. Was up until 12:00 midnight; symptoms quelled 80% by 12:30 am. Next morning, allergic reaction covered by medication. General practitioner (GP), notified and was documented. Patient was treated for the events. Patient was recovering from all the events, at the time of the report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Swelling face, Throat irritation
Clinical narrative: Progressed to symptoms of angioedema.; Systemic " itching "- head, arms, upper anterior  thighs bilaterally, vaguely within about 20-30 minutes.; Facial swelling; red face; blotchy red patches arms, back, legs face; severe itchy (10) inside of ears (deep), eyes; severe itchy (10) inside of ears (deep), eyes; scratchy throat; Next morning, allergic reaction covered by medication; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Aug2021 19:00 (Lot Number: fc3181) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included migraine headache (h/a), hypothyroid, latex allergy, penicillin (PCN) allergy. Concomitant medications included methylphenidate hydrochloride (CONCERTA); duloxetine hydrochloride (CYMBALTA); thyroid (ARMOUR THYROID). Facility type vaccine: Pharmacy or Drug Store. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. On 16Aug2021 patient experienced progressed to symptoms of angioedema, systemic " itching "- head, arms, upper anterior  thighs bilaterally, vaguely within about 20-30 minutes, facial swelling, red face, blotchy red patches arms, back, legs face, severe itchy (10) inside of ears (deep), eyes, scratchy throat, next morning, allergic reaction covered by medication. Events resulted in Doctor or other healthcare professional office/clinic visit. Clinical course was reported as follows: Systemic "itching "- head, arms, upper anterior thighs bilaterally, vaguely within about 20-30 minutes. Progressed to symptoms of angioedema. Facial swelling, red face, blotchy red patches arms, back, legs face, although much more severe itchy (10) inside of ears (deep), eyes, and scratchy throat. Patient had no food or anything else but water after the vaccination. These symptoms evolved over two hours, increasing in intensity. Patient had Benadryl and prednisone in her medicine box and took 75 mg Benadryl, (liquid) 50 ng prednisone at 10:00 pm. Was up until 12:00 midnight; symptoms quelled 80% by 12:30 am. Next morning, allergic reaction covered by medication. General practitioner (GP), notified and was documented. Patient was treated for the events. Patient was recovering from all the events, at the time of the report.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: needed heart surgery; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, three weeks after the shot, the patient needed heart surgery. At the time of the report the event outcome was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Had a seizure; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. Forwarded as an Adverse Event by the Escalation team on 23Aug2021.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, patient had a seizure shortly after getting the second dose of your vaccine. To date, doctors have found nothing, and all tests continue to result in negative and normal results. Patient was healthy up until got this crap put into body. Just more big pharma making money hand over fist. Are gullible and stupid sorry, but for one, would not put another Pfizer vaccine in body. The outcome of event seizure was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Renal failure, SARS-CoV-2 test
Clinical narrative: Damage to my kidneys; itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Medical history included, patient had COVID-19 virus on an unspecified date in Jul2020, about 2 weeks after patient stooped having symptoms on an unspecified date in 2020, and started to get itching on arms and other parts of body. Long story short, several months later doctor and patient determined that the virus damaged the kidneys. Patient was in stage 3 of kidney failure. Concomitant medications were not reported. In late Mar2021, Patient got the first dose of Pfizer vaccine. After a couple of days of vaccination on an unspecified date in 2021, Patient got more intense itching and also determined that the vaccine caused more damage to kidneys. Patient questioned how can patient help determine why it caused damage. The event damage to my kidneys was assessed as serious - Medically Significant. The patient underwent lab test and procedure which included COVID-19 test resulted as COVID-19 Virus on an unspecified date in Jul2020. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Fatigue, Muscle spasms
Clinical narrative: started feeling fatigue, tired; dizziness; pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; She usually gets spasms but now they are more intense.; This is a spontaneous report from a contactable consumer or other non-health care professional (pa-tient), from a Pfizer-sponsored program. A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspeci-fied route of administration on 10Aug2021 as dose 2, single for COVID-19 immunization. Medical history included covid-19 from May2021 to an unknown date she had COVID in May2021 and recovered fi-ne, but was treated in the hospital because she had COVID Pneumonia , cushing's syndrome, pre-diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date, and then out of the blue about 3 weeks ago the patient experi-enced started feeling fatigue, tired, dizziness, pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes, a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes and she usually gets spasms but now they are more intense. It was fur-ther stated that Caller was not sure if her symptoms that she has been having over the past two weeks now almost a month are almost a repeat of COVID. She does go to the Doctors because she does have Cushing's syndrome and is a pre-diabetic and on medication for that. She stated she was just trying to marrow a few things down, Had a sudden onset did not have these symptoms all along, just does not feel the same. She usually gets spasms but now they are more intense. And now why did this red bump appear a week later after getting the second vaccine and the itchiness at the site, like she just got the vaccine, is this a possible side effect? Stated she does have an appointment with her neurologist et up and her Cardiologist mentioned to her that she might be experiencing COVID long hauler. The patient underwent lab tests and procedures which included blood test: fine, comput-erised tomogram: fine, ultrasound scan: fine on an unspecified date. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory disturbance, Ultrasound scan
Clinical narrative: started feeling fatigue, tired; dizziness; pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; She usually gets spasms but now they are more intense.; This is a spontaneous report from a contactable consumer or other non-health care professional (pa-tient), from a Pfizer-sponsored program. A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspeci-fied route of administration on 10Aug2021 as dose 2, single for COVID-19 immunization. Medical history included covid-19 from May2021 to an unknown date she had COVID in May2021 and recovered fi-ne, but was treated in the hospital because she had COVID Pneumonia , cushing's syndrome, pre-diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date, and then out of the blue about 3 weeks ago the patient experi-enced started feeling fatigue, tired, dizziness, pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes, a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes and she usually gets spasms but now they are more intense. It was fur-ther stated that Caller was not sure if her symptoms that she has been having over the past two weeks now almost a month are almost a repeat of COVID. She does go to the Doctors because she does have Cushing's syndrome and is a pre-diabetic and on medication for that. She stated she was just trying to marrow a few things down, Had a sudden onset did not have these symptoms all along, just does not feel the same. She usually gets spasms but now they are more intense. And now why did this red bump appear a week later after getting the second vaccine and the itchiness at the site, like she just got the vaccine, is this a possible side effect? Stated she does have an appointment with her neurologist et up and her Cardiologist mentioned to her that she might be experiencing COVID long hauler. The patient underwent lab tests and procedures which included blood test: fine, comput-erised tomogram: fine, ultrasound scan: fine on an unspecified date. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: She was experiencing chest pain and pressure; She was experiencing chest pain and pressure; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the dose 1 of BNT162B2 for Covid-19 Immunization on an unknown date and no events reported. On an unspecified date, patient was experiencing chest pain and pressure, so her pediatrician recommended a trip to the emergency room (ER). The patient advocate mentioned that Pfizer may want to further study these cases and/or enroll these patients in a clinical study (possibly with some compensation). 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear infection, Magnetic resonance imaging, Tinnitus
Clinical narrative: had ringing in his ears; ear infection; clogged ears; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for 51-year-old patient.  A 51-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 17Apr2021 (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced ringing in his ears 4 days later that turned into clogged ears and asks if people have experienced this. Caller states that this has been going on since the end of April until now. Caller states her husband is on his fourth ear infection and went to his primary care and second ENT in (city name withheld) today and has a MRI on Thursday and they don't know. Caller asks if there is something set up to record data. The patient lab data includes MRI on an unspecified date with unknown results. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: nausea; headache; weakness; muscle pain; stiff neck; difficulty moving left arm (injection site Left deltoid); received her first dose of the Pfizer BioNTech Covid-19 Vaccine in April and her second dose in July; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left deltoid on an unknown date in April2021 as DOSE 1, SINGLE; dose 2 via an unspecified route of administration, administered in left deltoid on an unknown date in July2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced nausea, headache, weakness, muscle pain, stiff neck, difficulty moving left arm (injection site Left deltoid) for 3 weeks, received her first dose of the pfizer biontech covid-19 vaccine in april and her second dose in july (inappropriate schedule of product administration). The outcome of all the events was unknown. There was no product quality complaint (PQC) present.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: nausea; headache; weakness; muscle pain; stiff neck; difficulty moving left arm (injection site Left deltoid); received her first dose of the Pfizer BioNTech Covid-19 Vaccine in April and her second dose in July; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left deltoid on an unknown date in April2021 as DOSE 1, SINGLE; dose 2 via an unspecified route of administration, administered in left deltoid on an unknown date in July2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced nausea, headache, weakness, muscle pain, stiff neck, difficulty moving left arm (injection site Left deltoid) for 3 weeks, received her first dose of the pfizer biontech covid-19 vaccine in april and her second dose in july (inappropriate schedule of product administration). The outcome of all the events was unknown. There was no product quality complaint (PQC) present.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Dysgeusia, Erythema, Irritability, Lip blister
Clinical narrative: diarrhea lasted 4-5 days was bloody towards the end; funny feeling in her brain, felt like a pulling sensation; metallic taste in mouth; oral inflammation; bottom lip white spot that looked like blister; both kidneys hurting bad; Raw red and very irritated; Raw red and very irritated; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN). Patient stated that receiving her first dose of the Pfizer BioNTech Covid-19 vaccine experienced some normal side effects and others she would like to know if they are normal and if others have reported these- metallic taste in mouth, oral inflammation, raw red and very irritated, bottom lip white spot that looked like blister, both kidneys hurting bad, diarrhoea lasted 4-5 days was bloody towards the end funny feeling in her brain, felt like a pulling sensation. Patient stated that she saw her HCP for treatment, and he told her to stop taking baby aspirin, take Pepto Bismol and delay her second dose by a week. The Pepto Bismol stopped the diarrhea. The outcome of the events diarrhoea lasted 4-5 days was bloody towards the end was resolved on unspecified date in 2021, remaining events it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Sensory disturbance, Stomatitis
Clinical narrative: diarrhea lasted 4-5 days was bloody towards the end; funny feeling in her brain, felt like a pulling sensation; metallic taste in mouth; oral inflammation; bottom lip white spot that looked like blister; both kidneys hurting bad; Raw red and very irritated; Raw red and very irritated; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN). Patient stated that receiving her first dose of the Pfizer BioNTech Covid-19 vaccine experienced some normal side effects and others she would like to know if they are normal and if others have reported these- metallic taste in mouth, oral inflammation, raw red and very irritated, bottom lip white spot that looked like blister, both kidneys hurting bad, diarrhoea lasted 4-5 days was bloody towards the end funny feeling in her brain, felt like a pulling sensation. Patient stated that she saw her HCP for treatment, and he told her to stop taking baby aspirin, take Pepto Bismol and delay her second dose by a week. The Pepto Bismol stopped the diarrhea. The outcome of the events diarrhoea lasted 4-5 days was bloody towards the end was resolved on unspecified date in 2021, remaining events it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Musculoskeletal chest pain
Clinical narrative: Muscle pain and ache; Fever; Bad chills; Injection site pain; Fatigue all throughout that led her to sleep a lot; Fatigue all throughout that led her to sleep a lot; Pain all over her body and ribcage; Pain all over her body and ribcage; Headache including the muscles on it (the one that connects to the bone).; This is a spontaneous report received from a non-contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced muscle pain and ache, fever, bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, pain all over her body and ribcage and headache including the muscles on it. Patient got both doses of the COMIRNATY vaccine and had her 2nd dose 19Aug2021 (Thursday). Post vaccination up until today (5 days to date), she reported experiencing muscle pain and ache. Patient had alongside muscle ache, she also experienced fever and bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, headache including the muscles on it (the one that connects to the bone). She generally reported being down all weekend that led her not to be able to come to work. Additionally, she reported she called urgent care to check if someone has reported to come in with the same AEs that she had. She was also concerned that AEs were because the dose she got was contaminated. The outcome of event was unknown   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Muscle pain and ache; Fever; Bad chills; Injection site pain; Fatigue all throughout that led her to sleep a lot; Fatigue all throughout that led her to sleep a lot; Pain all over her body and ribcage; Pain all over her body and ribcage; Headache including the muscles on it (the one that connects to the bone).; This is a spontaneous report received from a non-contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced muscle pain and ache, fever, bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, pain all over her body and ribcage and headache including the muscles on it. Patient got both doses of the COMIRNATY vaccine and had her 2nd dose 19Aug2021 (Thursday). Post vaccination up until today (5 days to date), she reported experiencing muscle pain and ache. Patient had alongside muscle ache, she also experienced fever and bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, headache including the muscles on it (the one that connects to the bone). She generally reported being down all weekend that led her not to be able to come to work. Additionally, she reported she called urgent care to check if someone has reported to come in with the same AEs that she had. She was also concerned that AEs were because the dose she got was contaminated. The outcome of event was unknown   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: heart rate quickening; skin tingling; facial numbness; This is a spontaneous report from contactable consumer. This 44-year-old male consumer (patient) reported that: A 44-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is a 44-year-old male who received his first dose of the Pfizer BioNtech covid 19 vaccine and 17 minutes later experienced side effects of heart rate quickening, skin tingling, facial numbness. He stated this went on and off for about 15 minutes. Patient reported he has had side effects since. The patient underwent lab tests and procedures which included heart rate: quickening on an unspecified date heart rate quickening. The outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a solicited report from a non-Pfizer sponsored program entitled (marketing program name from a contactable consumer (patient), based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3898481-00). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 vaccination; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing at "Citrate Free" (as reported), for Moderate to severe rhematoid arthiritis and Moderate to severe chronic plaque psoriasis. The patient's medical history, other relevant history, concomitant drugs were Not Reported. It was unknown if patient was enrolled in a covid-19 Vaccine Trial. On an unspecified date, the patient experienced non-serious covid-19. The patient underwent lab tests and procedures which included covid-19 test: Positive on an unknown date. The action taken in response to the events for adalimumab was Dose Not Changed. The outcome of the event covid-19 was resolved on an unknown date. The reporter's causality for the event of covid-19 with adalimumab and bnt162b2 was not reported.   The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective and Covid 19  cannot be completely excluded.