chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach ache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of Pfizer Covid 19 Vaccine on an unknown date. The patient experienced stomach ache in Apr2021. It was reported that the patient had the second dose last Thursday 22Apr2021. She is currently experiencing stomach ache after the dose. She wants to know if this is an adverse event of the vaccine. Outcome of the event was not recovered.                    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash underneath her armpit; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age 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 as single dose for covid-19 immunisation. The 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 27Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a rash underneath her armpit on 25Apr2021. so she wanted to know if the rash may still be related to the vaccine even if it started to appear days before she got her 2nd dose. She said that aside from that, she felt okay and had no temperature. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in his lower extremities; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in his lower extremities on 29Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cholangiogram, Impaired driving ability, Magnetic resonance imaging, Vertigo, Vestibular function test
Clinical narrative: vertigo; haven't been able to drive my car in 36 days; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Un-known), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced vertigo and haven't been able to drive my car in 36 days on an unspecified date. Patient asked are you getting calls from people who experience vertigo from the Pfizer BioNTech covid vaccine. I've already called in about this. I am a fairly healthy person. I've been sent for an MRI, MRA and vestibular testing. I found on (site name) 128 people who reporting experiencing vertigo after getting either the Pfizer or Moderna covid vaccine. I haven't been able to drive my car in 36 days. Caller confirmed receiving the Pfizer BioNTech covid vaccine. Response was no information available on the topic of vertigo within current information. Patient underwent lab test and procedures included MRI, MRA and vestibular testing showed unknown result. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received first dose April 6th and tested positive for Covid-19.; This is a spontaneous report from a Pfizer sponsored program COVAX US support via contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 06Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's first vaccination was on 06Apr2021 and immediately on the same day, the patient was tested positive for COVID-19. She was supposed to receive second dose on 04May2021 however she was required to quarantine tile 03May2021. She wanted to know if she should still receive the vaccine or what was the protocol for testing positive after receiving the vaccine. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: "frozen" shoulder after the shot; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 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. The patient fears that he may had received the vaccine in his shoulder capsule rather than muscle because he ended up with a frozen shoulder after the shot. Antibody testing was not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing had not been established. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the assessment of immune response in vaccinated people. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; Gets winded while talking; headache; feeling like she has a cold; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patent).  A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0150 ), dose 2 intramuscular, administered in Arm Right on 26Apr2021 10:30 as single dose  for covid-19 immunisation.  First dose was given 05Apr2021, 10:00 Pfizer COVID vaccine, Lot ER8733, Expiration was unknown. Injected intramuscularly in left arm. The patients concomitant medications were not reported. The patient did not had any prior vaccination before to this vaccine. On 26Apr2021 21:00 patient had  joint pain and achiness , On 28Apr2021 19:00 the patient experienced headache, on 28Apr2021 12:00 she was  feeling like she has a cold, On 29April2021 12:00, she has  sore throat, on 29Apr2021 12:00  she reported she gets winded while talking. The events were worsened. The patient was recovering from joint pain. The patient had a queried that she had first and second doses of Pfizer COVID Vaccines but is having some symptoms and is not sure if she has gotten COVID or not, she was not sure whether should get tested or not.  The outcome of the rest of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Brain natriuretic peptide normal, Dyspnoea, Dyspnoea exertional, Fibrin D dimer
Clinical narrative: Acute onset of dyspnea, predominantly with exertion over 1-2 days. Diagnosed with unprovoked pulmonary embolism diagnosed 2 months after vaccine. No family or personal history, no tobacco use. Up to date on cancer screenings.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial strain, Platelet count normal, Pulmonary embolism, Troponin
Clinical narrative: Acute onset of dyspnea, predominantly with exertion over 1-2 days. Diagnosed with unprovoked pulmonary embolism diagnosed 2 months after vaccine. No family or personal history, no tobacco use. Up to date on cancer screenings.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness postural, Gait disturbance, Headache
Clinical narrative: I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe headaches at the front of my head and at the back starting in less than 24 hours after the vaccine. On the next day I had a fever added to these headaches. I couldn't open eyes and light hurt my eyes. I had a loss of appetite and huge weakeness. I couldn't walk and had literally to crawl to the bathroom. When I stood up from my bed I almost fainted.  After 96 hours after vaccine I still have nausea and headaches that diminished a bit. Fever disappeared only after 96 hours. Still I'm very weak, have nausea and can't really do anything except being in bed.  I have never had anything like that in my life after a vaccine. and I'm in perfect health and don't smoke, don't drink any alcohol, doing regular gym and my BMI is normal
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Photophobia, Pyrexia
Clinical narrative: I have had 4 terrible days after the vaccine that I had to spend in bed. I had horrific severe headaches at the front of my head and at the back starting in less than 24 hours after the vaccine. On the next day I had a fever added to these headaches. I couldn't open eyes and light hurt my eyes. I had a loss of appetite and huge weakeness. I couldn't walk and had literally to crawl to the bathroom. When I stood up from my bed I almost fainted.  After 96 hours after vaccine I still have nausea and headaches that diminished a bit. Fever disappeared only after 96 hours. Still I'm very weak, have nausea and can't really do anything except being in bed.  I have never had anything like that in my life after a vaccine. and I'm in perfect health and don't smoke, don't drink any alcohol, doing regular gym and my BMI is normal
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Urticaria
Clinical narrative: urticarial of hands and neck, subjective swelling of throat
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: Rash on face, lower face on chin, chin line and around mouth. Rash also on different parts of body including chest, back, inner thighs and scalp.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Influenza like illness, Lethargy
Clinical narrative: Elevated resting heart rate (102 bpm), accompanied by flu-like symptoms (moderate chills, fever, headache, lethargy)
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Elevated resting heart rate (102 bpm), accompanied by flu-like symptoms (moderate chills, fever, headache, lethargy)
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. But I did not throw up.  Ate a little, took some alive (two tablets). Was tired but not overly fatigued. My arm really hurt at injection site, pain traveled up to my neck. Unable to lay on arm at all. Then I just felt buzzing in waves. I went to bed (no chills) but couldn't go to sleep.  Body felt wired and tired. Finally fell asleep at 8:30 am.  Day after shot: Arm still sore but not as much. Still experience nausea but not as strong. Tired but not overly so. Later in evening (around 12:30 pm) developed some chills and had four sneezes in a row causing me to have a stuffy head. Not sure if that is allergies or a cold coming on.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Injection site pain, Nausea, Neck pain, Sneezing
Clinical narrative: About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. But I did not throw up.  Ate a little, took some alive (two tablets). Was tired but not overly fatigued. My arm really hurt at injection site, pain traveled up to my neck. Unable to lay on arm at all. Then I just felt buzzing in waves. I went to bed (no chills) but couldn't go to sleep.  Body felt wired and tired. Finally fell asleep at 8:30 am.  Day after shot: Arm still sore but not as much. Still experience nausea but not as strong. Tired but not overly so. Later in evening (around 12:30 pm) developed some chills and had four sneezes in a row causing me to have a stuffy head. Not sure if that is allergies or a cold coming on.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: My arm still has pain in the local area where I received the shot.  It is a dull ache about a 2-3 on scale and persistent.  It feels deep as if in the bone.  There is no rash or swelling and never was a rash or swelling. This persistent ache is over a month now and has not diminished.  I did have mild fever and felt puny 2 days after the shot which is fine/expected and that went away.  The arm pain concerns me.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Nausea, Pyrexia
Clinical narrative: feeling freezing cold; chills; fever; headache; nausea; This is a spontaneous report from a contactable consumer (patient herself) via Medical Team. A 69-year-old female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 28Apr2021 as single dose and had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration as single dose for COVID-19 immunization. 10 hours later the patient started feeling "freezing" cold, chills, fever, headache, and nausea. The patient still had these symptoms and wanted to know if it's ok to take ibuprofen. The patient also stated she had called someone earlier at Pfizer to report her side effects and was cold transferred to MI for her question. Outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: She states her Left arm has started swelling and is red; She states her Left arm has started swelling and is red; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received both doses of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot number was not reported)  via an unspecified route of administration, administered in the left arm on the 05Apr2021 and 26Apr2021 as single dose for COVID-19 immunization. Medical history included history of surgeries in her left arm on unknown dates. The patient's concomitant medications were not reported. Clinical course reported as: She stated that her Left arm started swelling and was red.  She has a history of surgeries in her left arm and has had 4 total bouts of melanoma on her left side: 1 in the left leg, 2 in her arm, and 1 on her left back. Lymph nodes for both arms are gone due to being removed. She doesn't know if she should be placing an ice pack on the arm to help with inflammation and redness or if it will interfere with the vaccine. The Health Department where she got the vaccine advised her to call Pfizer. The outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Miliaria
Clinical narrative: heat rash; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heat rash. heat rash a week on one side later following sun exposure. Sitting in the car with capirs on, has since resolved. Related it to a heat rash following use of tetracycline 15 years ago. The outcome of the events was recovered on an unspecified date.  PQC Details:  Request Name: REQ-275831 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller was on hold trying to reach. Reports first dose 21Apr2021, heat rash a week on one side later following sun exposure. Sitting in the car with capirs on, has since resolved. Related it to a heat rash following use of tetracycline 15 years ago. Granddaughter hung up phone. Callback @ 1541. Response: Spoke from attached.  Warm transfer to Reference #za2wis1t.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Real tightness in her arm; This is a spontaneous report from a contactable consumer (patient) self-reported. A 48-year-old Female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, on 29Apr2021 at 10:10, as single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On 29Apr2021, the patient experienced real tightness in her arm, describing it as her arm had tied up in a knot. It started a couple of hours after the shot. Patient stated she took a shower when she got home, and it did seem to ease it up and again described her arm as tight and wound up but no pain. Outcome of the event were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dyspnoea
Clinical narrative: shortness of breath has gotten to the point of her gasping for air"; appetite is gone; bad cough; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number/Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number/Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. it was reported that patient experiencing shortness of breath that lasted a few days after receiving both doses. Caller states her shortness of breath has gotten to the point of her gasping for air. Caller states her appetite is gone and she has a bad cough. The outcome of the event was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.  .
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: diagnosed with COVID-19; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Apr2021, the patient was diagnosed with covid-19. patient states that she was re-tested on Monday 26Apr2021 which came back negative. Patient also reported that her husband, who received his first dose the same day as her, already had COVID-19 before receiving the vaccine. Patient would like to know if she and her husband are okay to receive their second doses of the vaccine tomorrow. The patient underwent lab tests and procedures on 26Apr2021, sars-cov-2 antibody test negative. No PQC present. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, SARS-CoV-2 test negative, Skin reaction
Clinical narrative: red mark at the injection site; Patient believed she got the covid vaccine subcutaneous instead of intramuscular; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received dose 1 of bnt162b2 (BNT162B2, solution for injection), (Batch/Lot Number: unknown) on 15 Apr 2021 as single dose for covid-19 immunisation. The medical history and concomitant medication were not reported. Patient reported that she had red mark at the injection site after 2 weeks. Further patient reported that on 15Apr2021 the nurse pulled her skin and injected not into the main part of the muscle but more on the side. Patient believed she got the covid vaccine subcutaneous instead of intramuscular. Years ago, patient had a flu vaccine as well that didn't go all the way into her arm, where she developed a red mark on her skin. She never got the same red mark on subsequent vaccinations. It was reported that participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis. Patient would like to know the impact of receiving the covid vaccine subcutaneously rather than intramuscularly. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vision blurred
Clinical narrative: Pain in the arm; Headache; Blurred vision / He can see big letters but has difficulty reading small letters.; This is a spontaneous report from a contactable consumer (Patient).   A male patient of unspecified age received second dose of BNT162b2 (Pfizer-Biontech Covid19 vaccine, Lot number not reported), via an unspecified route of administration on 28Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: Not reported) on unknown date for covid-19 immunisation. On an unknown date in Apr2021, the patient developed, pain in the arm, headache and blurred vision. The patient can see big letters but has difficulty reading small letters. He lifts heavy stuff in his job. Patient wanted to know if he can take medications for pain (he is currently taking tylenol) to treat some of the side effects that he was presenting. At the time of this report event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: section at injection site same day was sore; red; arm pit was really sore; swollen; This is a spontaneous case received from a contactable female consumer (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced section at injection site same day was sore, red, also her arm pit left side (side she got the shot is on left) was sore and still is and the next morning when she notices her arm pit was really sore which is a size of pinky finger, like a vein swollen and two weeks later it's still like this. The outcome of section at injection site same day was sore was unknown while other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Rash
Clinical narrative: face is real red; rash on her cheeks and neck; Caller describes the rash as raised like pimples; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 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. Since she received the vaccine her face was real red and she had a rash on her cheeks and neck. The rash as raised like pimples. The events assessed as non-serious with outcome of event unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Vaccination site pain
Clinical narrative: pain in her right arm; there is pain in her right breast and under arm.; there is pain in her right breast breast and under arm; there is pain in her right breast breast and under arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for 60-year-old female patient (reporter wife) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) On 07Apr2021 administered at right arm as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. On 07Apr2021, patient had experienced pain in her right arm where she received the vaccine. Patient  reported that she could hardly lift up the arm because of the pain, there is pain in her right breast breast and under arm. The patients second dose was due today 29Apr2021 but she did not want to get it because of the pain. Patient  is going to see an MD tomorrow for treatment. The clinical outcome for the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: she is experiencing swelling and had rashes all over the body; she is experiencing swelling and had rashes all over the body; This is a spontaneous report received from a contactable female consumer (patient). A female patient (unknown age) received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 22Apr2021 at a single dose for Covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, after receiving vaccine the patient experienced swelling and had rashes all over the body. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Product use issue
Clinical narrative: swollen lymph nodes on right side, opposite of vaccination site; Stated she had Sars-COV-2 in October; Stated she had Sars-COV-2 in October; This is a spontaneous report received from a contactable consumer (patient self-reported). A 60-year-old female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date in Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included Sars-COV-2 in October which anticipated an adverse event. Concomitant medications were not reported. The patient reported that she received first dose a week ago, and had swollen lymph nodes on right side, opposite of vaccination site. She had a difficulty reaching HCP. Contact pharmacy where received, indicated to call MI and asked for treatment recommendation of hot or ice. She felt better with "hot", husband stated cold. She asked that if should receive second dose. It was also reported that the decision to receive the second dose for any other reason cannot be made by Pfizer. The patient referred to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knew her health situation and was access to information that can better help inform this decision. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Fatigue, Feeling abnormal, Feeling of body temperature change
Clinical narrative: sore arm; feeling hot and cold; stomach pain; fatigue; rash; headache; upset stomach; feeling horrible/feel like run over by a truck; This is a spontaneous report received from a contactable consumer (patient herself). A 53 (unit: unspecified) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included compromised immune system, due to the stress; she has history of PCOS and IBS. The patient historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization and experienced the rash after the dose. The patient's concomitant medications were not reported. Consumer received her second dose of the Pfizer covid vaccine yesterday. She stated that she regards it, she was feeling horrible, has sore arm, feel like run over by a truck, feeling hot and cold, stomach pain. She stated that she was going to get the autoimmune disease from this vaccine in 5 years, consumer questioned was she going to die, vaccine is misleading and should not be given. She feels like she has full blown covid. she also experienced fatigue, rash, headache and upset stomach. Consumer wanted to know if that vaccine would give her autoimmune disease. Consumer questioned and wanted to know if she could get covid from the vaccine. On an unspecified date, the patient experienced sore arm, feeling hot and cold, stomach pain, fatigue, rash, headache, upset stomach, feeling horrible/ feel like run over by a truck. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: sore arm; feeling hot and cold; stomach pain; fatigue; rash; headache; upset stomach; feeling horrible/feel like run over by a truck; This is a spontaneous report received from a contactable consumer (patient herself). A 53 (unit: unspecified) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included compromised immune system, due to the stress; she has history of PCOS and IBS. The patient historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization and experienced the rash after the dose. The patient's concomitant medications were not reported. Consumer received her second dose of the Pfizer covid vaccine yesterday. She stated that she regards it, she was feeling horrible, has sore arm, feel like run over by a truck, feeling hot and cold, stomach pain. She stated that she was going to get the autoimmune disease from this vaccine in 5 years, consumer questioned was she going to die, vaccine is misleading and should not be given. She feels like she has full blown covid. she also experienced fatigue, rash, headache and upset stomach. Consumer wanted to know if that vaccine would give her autoimmune disease. Consumer questioned and wanted to know if she could get covid from the vaccine. On an unspecified date, the patient experienced sore arm, feeling hot and cold, stomach pain, fatigue, rash, headache, upset stomach, feeling horrible/ feel like run over by a truck. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: tiredness and weakness in his legs and arms; tiredness and weakness in his legs and arms; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 91-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 09Apr2021 (at the age of 91-years-old) as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date (about 3-4 days after the vaccine) patient experienced tiredness and weakness in his legs and arms (that continues). Reporter wanted to know that for how long the symptoms might last and if her husband should receive the second Pfizer Covid 19 Vaccine. Reporter also wanted to know if Lipitor, Lisinopril, Metoprolol, Nexium and Aspirin might interfere with Pfizer Covid 19 Vaccine. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for coronavirus; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program COVAX support. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, the patient tested positive for coronavirus. The patient underwent lab test which included SARS-CoV-2 test: Positive on 14Apr2021. The second dose of the vaccine was scheduled on 05May2021 and patient was asking if this was okay. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After the shot all of my inflammation subsided; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included motion sickness for 45 years. Concomitant medications were not reported. Patient stated that I had a bad flare up right before having my second Pfizer shot. 24 hours after the shot all of my inflammation subsided. I would like to report this wonderful finding in hopes that other people with autoimmune illness might benefit. I think my response was similar to people who have "long-haulers" syndrome following COVID 19 exposure. I have a background in science and would be happy to talk with anyone who is interested in understanding more. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Fatigue, Investigation
Clinical narrative: he started having "really bad" abdominal cramping and pain; these symptoms made him "so tired"; This is a spontaneous report from a contactable (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Apr2021 (at 70-years age) as single dose for covid-19 immunisatio and patient 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 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included polymyositis but states that came back negative. After receiving second dose patient started having really bad abdominal cramping and pain. Patient reported that these symptoms made him so tired that he had to leave work one day and his side effects are better now that his doctor took him off of work. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: he started having "really bad" abdominal cramping and pain; these symptoms made him "so tired"; This is a spontaneous report from a contactable (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Apr2021 (at 70-years age) as single dose for covid-19 immunisatio and patient 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 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included polymyositis but states that came back negative. After receiving second dose patient started having really bad abdominal cramping and pain. Patient reported that these symptoms made him so tired that he had to leave work one day and his side effects are better now that his doctor took him off of work. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Fatigue, Investigation
Clinical narrative: Caller also mentions that after his first dose, he was tired and "weak in my back" but reports these symptoms went away after 3 days; Caller also mentions that after his first dose, he was tired and "weak in my back" but reports these symptoms went away after 3 days; This is a spontaneous report from the contactable consumer (Patient, self-reported). A 70-year-old male patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced he was tired and week in his back, but repots these symptoms went away after 3 days. The patient did not report of abdominal cramping or pain specifically. Outcome of the events recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Caller also mentions that after his first dose, he was tired and "weak in my back" but reports these symptoms went away after 3 days; Caller also mentions that after his first dose, he was tired and "weak in my back" but reports these symptoms went away after 3 days; This is a spontaneous report from the contactable consumer (Patient, self-reported). A 70-year-old male patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced he was tired and week in his back, but repots these symptoms went away after 3 days. The patient did not report of abdominal cramping or pain specifically. Outcome of the events recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site dryness, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site got swollen and red for a couple of days; it becomes itchy, dry; injection site got swollen and red for a couple of days; it becomes itchy, dry; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (patient) reported.   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and medications were not reported.  She got the first dose on 11Apr2021. On an unspecified date, patient experienced the injection site got swollen and red for a couple of days. The mark remained on her arm for two weeks. Now, it became itchy, dry and it looks strange. She was scheduled to get the second dose on 2nd May. She wanted to know about this concern before getting the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Dry skin, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: injection site got swollen and red for a couple of days; it becomes itchy, dry; injection site got swollen and red for a couple of days; it becomes itchy, dry; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (patient) reported.   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and medications were not reported.  She got the first dose on 11Apr2021. On an unspecified date, patient experienced the injection site got swollen and red for a couple of days. The mark remained on her arm for two weeks. Now, it became itchy, dry and it looks strange. She was scheduled to get the second dose on 2nd May. She wanted to know about this concern before getting the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site got swollen and red for a couple of days; it becomes itchy, dry; injection site got swollen and red for a couple of days; it becomes itchy, dry; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (patient) reported.   A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and medications were not reported.  She got the first dose on 11Apr2021. On an unspecified date, patient experienced the injection site got swollen and red for a couple of days. The mark remained on her arm for two weeks. Now, it became itchy, dry and it looks strange. She was scheduled to get the second dose on 2nd May. She wanted to know about this concern before getting the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; fever not up to 100 but was 100.2 at one point; headache; This is a spontaneous report from a contactable consumer (patient). via. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration, on an unknown date on Tuesday (at the age of 64-year-old), as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, wednesday evening, patient had chills. Early Thursday morning, patient got fever, headache, but had fever, not up to 100 but was 100.2 at one point. The patient's laboratory test and procedure performed on an unknown date included body temperature: 100.2. The patient asked whether she will infect her husband with fever, whether she can go back work if the temperature is 99.8 and should she quarantine and how long will the events last. The clinical outcome of all events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Malaise
Clinical narrative: chills; fever like symptoms like sweats and hot but no fever; fever like symptoms like sweats and hot but no fever; headache; nausea; not feeling well; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 21Apr2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced chills, fever like symptoms like sweats and hot but no fever, headache and nausea. Caller stated she is continuing on day 8 of side effects. She reported that her daughter experienced chills, fever like symptoms like sweats and hot but no fever, headache and nausea. She stated that tylenol takes the headache away for about 3 to 4 hours. Reporter stated she gave her daughter zofran in the mornings for nausea. Reporter stated ibuprofen does not help much. She stated her daughter tested negative for covid. She stated her daughter has missed some school and athletic events and reports not feeling well. Reporter stated her daughter had better days on days 2 and 3 and her worst days were yesterday and today. She reported tylenol did not help much, only for a limited time. She was concerned that the side effects are not going away and not alleviating. She asked is this common for there to be this many side effects this many days after the first dose. Reporter asked does she move forward with the second dose. She stated the pediatrician told her to ask Pfizer. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.