chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fall, Feeling abnormal, Gait inability, Incoherent
Clinical narrative: stroke; was found unconscious; after about an hour or two he started feeling funny, and that evening he hit the floor, was found unconscious; after about an hour or two he started feeling funny, and that evening he hit the floor, was found unconscious; patient seems incoherent; Received Johnson and Johnson vaccine after the Pfizer vaccine; received Johnson and Johnson vaccine after the Pfizer vaccine; his eyes were looking like he was not comprehending what was going on; he cannot even walk; patient weighed 280 before he went to jail now he weighs maybe 190-180lb; This is a spontaneous report from a contactable consumer (patient's fiancee). A 64-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 at the age of 64-yar-old as single dose for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jul2021, at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, oxygen therapy (on Oxygen prior to the vaccines), Covid-19 months prior to the vaccines, use a machine to sleep (not know what the condition was called but he had it bad that he could just fall asleep while driving). There were no concomitant medications. The patient received first dose of the Pfizer Biontech COVID19 vaccine on May2021 but was jailed between his 1st and 2nd dose. After the 1st dose vaccine, he ended up going to jail, when it was time for his second shot and he told the nurse in the jail there that he had the Pfizer and there he was given the Johnson and Johnson, the nurse told the patient it didn't matter that all the shots were the same, she gave him the shot. On Jul2021, he received Janssen as a second dose. The patient told the caller that after about an hour or two (2nd dose vaccination) he started feeling funny, and that evening he hit the floor, was found unconscious and went to the emergency room, he was (now) in a wheel chair, stated he had a stroke and doctor said that he was going to have another stroke. Caller stated the patient seems incoherent. Every time he started talking about it the jail hang up his call, stated now they will not let the patient call her. She went to go see the patient and yesterday they would not let the patient talk to her during her visitation, caller stated he looked so bad, his eyes were looking like he was not comprehending what was going on. Stated he also had to have some type of surgery on his stomach, she was unsure of exact details. Exact dates are unknown. Stated he cannot even walk, he was in a wheelchair. The patient was hospitalized and unknown dates of hospitalizations. Caller stated the patient weighed 280 before he went to jail now he weighs maybe 190-180lb. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Loss of consciousness, Off label use, Thinking abnormal, Weight decreased
Clinical narrative: stroke; was found unconscious; after about an hour or two he started feeling funny, and that evening he hit the floor, was found unconscious; after about an hour or two he started feeling funny, and that evening he hit the floor, was found unconscious; patient seems incoherent; Received Johnson and Johnson vaccine after the Pfizer vaccine; received Johnson and Johnson vaccine after the Pfizer vaccine; his eyes were looking like he was not comprehending what was going on; he cannot even walk; patient weighed 280 before he went to jail now he weighs maybe 190-180lb; This is a spontaneous report from a contactable consumer (patient's fiancee). A 64-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 at the age of 64-yar-old as single dose for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jul2021, at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, oxygen therapy (on Oxygen prior to the vaccines), Covid-19 months prior to the vaccines, use a machine to sleep (not know what the condition was called but he had it bad that he could just fall asleep while driving). There were no concomitant medications. The patient received first dose of the Pfizer Biontech COVID19 vaccine on May2021 but was jailed between his 1st and 2nd dose. After the 1st dose vaccine, he ended up going to jail, when it was time for his second shot and he told the nurse in the jail there that he had the Pfizer and there he was given the Johnson and Johnson, the nurse told the patient it didn't matter that all the shots were the same, she gave him the shot. On Jul2021, he received Janssen as a second dose. The patient told the caller that after about an hour or two (2nd dose vaccination) he started feeling funny, and that evening he hit the floor, was found unconscious and went to the emergency room, he was (now) in a wheel chair, stated he had a stroke and doctor said that he was going to have another stroke. Caller stated the patient seems incoherent. Every time he started talking about it the jail hang up his call, stated now they will not let the patient call her. She went to go see the patient and yesterday they would not let the patient talk to her during her visitation, caller stated he looked so bad, his eyes were looking like he was not comprehending what was going on. Stated he also had to have some type of surgery on his stomach, she was unsure of exact details. Exact dates are unknown. Stated he cannot even walk, he was in a wheelchair. The patient was hospitalized and unknown dates of hospitalizations. Caller stated the patient weighed 280 before he went to jail now he weighs maybe 190-180lb. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tourette's disorder
Clinical narrative: extreme symptoms of Tourette Syndrome; 1st dose, 28Apr2021; 2nd dose, 12May2021; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 12May2021 (at 20-year-old, non-pregnant at time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included ongoing chronic pelvic pain, depression, eczema from an unknown date and unknown if ongoing. Prior to vaccination, the was not patient diagnosed with COVID-19. Concomitant medication included etonogestrel (NEXPLANON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had known allergies: doxycycline. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 28Apr2021 (at 20-year-old) as dose 1, single for covid-19 immunisation. The patient experienced extreme symptoms of Tourette Syndrome on 01Jun2021. She had minor, unnoticeable symptoms of Tourette's until experiencing extreme sudden onset sometime after vaccination. The event resulted in doctor or other healthcare professional office/clinic visit, not resulted in hospitalization prolonged. Seriousness criteria were reported as disability and medically significant. Therapeutic measures were taken as a result of event Tourette Syndrome included guanfacine and recommended therapy. The outcome of the event Tourette Syndrome was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tourette's disorder
Clinical narrative: symptoms of Tourette's; This is a spontaneous report from a non-contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had minor, unnoticeable symptoms of Tourette's until experiencing extreme sudden onset sometime after vaccination on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from contactable consumers. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 11Mar2021 at 21-years-old (Batch/Lot Number: EN6207) as dose 1, single for COVID-19 immunization. Medical history included Asthma. Facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced break-through covid infection on 31Jul2021 (as reported) with outcome of recovered in 2021. No treatment was given. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. Results of tests and procedures for investigation of the patient: PCR (03Aug2021): Positive (Lab Notes: Nasal Swab).  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Mouth swelling, Oral pain, Swelling face
Clinical narrative: her mouth hurts and had swelling; her mouth hurts and had swelling; swollen face; puffy lips; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, spontaneous. This 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 09Aug2021 at 37-year-old for Covid-19 immunization. Medical history included broken tooth. Concomitant drug were not provided. She had a broken tooth and asked "If you have an infection in the body will the vaccine make it worst?". Few minutes after her 1st dose her mouth hurts and had swelling. She woke up the next morning with swollen face and puffy lips. It was further reported that went on Monday to get her vaccine and received her first dose. Instantly her mouth started hurting. Hours later, her mouth and left side of face started swelling up.  She researched everything and did not find that if a person had a broken tooth prior to the COVID Vaccine, that person should not get the vaccine. The 2nd dose would be on 30Aug2021. Outcome of the events was unknown.     The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: I only had mild symptoms after the 1st dose, sore arm, and fatigue; I only had mild symptoms after the 1st dose, sore arm, and fatigue; This is a spontaneous report from a contactable female consumer (patient herself) via Pfizer-sponsored program. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: WAG09, expiry date: unknown) via unspecified route of administration, in right arm (or right shoulder at the top of arm as reported) on 20Jul2021 11:40 (age at vaccination: 54-years) as dose 1, single for covid-19 immunisation. Vaccine was not administered at military facility. Medical history of patient included ongoing high blood pressure. Co-suspect drug included ongoing amlodipine 5 mg, daily, taken for unspecified indication, start and stop date unknown. She had no family medical history relevant to ae. On 20Jul2021, patient experienced only mild symptoms after the 1st dose, sore arm, and fatigue. Patient stated she didnt have much fatigue. The fatigue lasted about a day, didnt last very long, about 24 hours. Patient had not received the second dose Pfizer Covid 19 Vaccine yet, and was planning to receive the second dose tomorrow, 12Aug2021. No other vaccines was administered on same date with the Pfizer vaccine considered as suspect. There was no physician office or emergency room visit due to the adverse events. There were no prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. Patient previously took the tetanus shot that was years ago, over 10 years ago. No relevant tests were done due to the adverse events. The outcome of the events was recovered on 21Jul2021.   Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Severe chest pain; breathlessness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 21Apr2021 (Batch/Lot Number: Ew0161) (at the age of 40-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Er8733) on 31Mar2021 (at the age of 40-years-old) in the left arm for COVID-19 immunisation. On 04Jun2021, the patient experienced severe chest pain and breathlessness. The patient was not given any treatment for the events. The events resulted in ER visit and physician office visit. Outcome of events was recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer. A 44-year-old (non-pregnant) female patient received the 1st dose, BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), at the age of 44, via an unspecified route of administration, left arm, on Aug 10, 2021, 12:30, single dose, for COVID-19 immunisation. The patient's medical history included asthma, from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took sulfa (sulfa/penicillin) and experienced known allergies. Patient did not receive other vaccine in four weeks and other medications in two weeks. On Aug 10, 2021, at 16:00, patient experienced muscle cramps, fatigue, shortness of breath, wheezing, headache, fever and chills. The patient received rescue inhaler as treatment for the events. The outcome of the events: not recovered. The patient did not have COVID-19 prior to vaccination. Patient has not tested for COVID-19 post vaccination. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: This is a spontaneous report from a contactable consumer. A 44-year-old (non-pregnant) female patient received the 1st dose, BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), at the age of 44, via an unspecified route of administration, left arm, on Aug 10, 2021, 12:30, single dose, for COVID-19 immunisation. The patient's medical history included asthma, from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took sulfa (sulfa/penicillin) and experienced known allergies. Patient did not receive other vaccine in four weeks and other medications in two weeks. On Aug 10, 2021, at 16:00, patient experienced muscle cramps, fatigue, shortness of breath, wheezing, headache, fever and chills. The patient received rescue inhaler as treatment for the events. The outcome of the events: not recovered. The patient did not have COVID-19 prior to vaccination. Patient has not tested for COVID-19 post vaccination. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Superficial Thrombus in the left leg; This is a spontaneous report from a contactable Nurse (patient herself). A 30-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 29Jul2021 16:00 as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. Concomitant medications included drospirenone, ethinylestradiol (LORYNA) taken for contraception, start and stop date were not reported. Other medications the patient received within 2 weeks of vaccination are Loryna Birth Control. Patient did not diagnose with COVID-19 prior or since the vaccination. There were no known allergies were reported. On 09Aug2021 the patient experienced superficial thrombus in the left leg. The adverse event resulted in emergency room/department or urgent care. No treatment was received for adverse event. Seriousness criteria-resulting in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect reported as no. The outcome of the event was recovering on an unspecified date.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, SARS-CoV-2 antibody test
Clinical narrative: agitated; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 and dose 2 via an unspecified route of administration on 06Apr2021 and 27Apr2021 respectively, both as single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced agitated on an unspecified date. The patient received both doses of the Pfizer Biontech COVID19. Her first dose was on 06Apr2021 while her second dose was on 27Apr2021. She reported that not even an hour ago, she had an antibody test and the result was she had no antibody (negative). She reported that her pharmacist would call them since she received a negative antibody test. She also mentioned that she knew someone who had COVID and was not vaccinated who showed antibody. She wanted to know if they have some information on receiving a negative antibody after being fully vaccinated and if she was covered or protected. The patient further reported that she was in an agitated state right now as she received both doses and did not have any antibodies. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Aug2021. 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diffuse large B-cell lymphoma
Clinical narrative: Lymphoma /Diffuse large B cell lymphoma (DLBCL); This is a spontaneous report from a contactable consumer (the patient).     A 71-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6208) as as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced lymphoma /diffuse large b cell lymphoma (DLBCL)  (medically significant) in 2021 with outcome of unknown.   Unknown therapeutic measures were taken as a result of lymphoma /diffuse large b cell lymphoma. The patient stated the lymphoma first appeared between the first and second dose. Caller stated that he is under the care of a doctor and is being treated for the lymphoma. He also added that received the second dose on 09APR2021, lot number ER8729. Also he is an "exceptionally healthy, senior athlete" and he is scared to death.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electromyogram, Magnetic resonance imaging, Nerve injury
Clinical narrative: nerve damage; Revealed neuropathy; This is a spontaneous report from a contactable consumer  (the patient)     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular in the left upper arm on 22Mar2021 17:40 (Batch/Lot Number: ER8727) as single dose  for covid-19 immunisation  .  Medical history included , eosinophilic pneumonia from 15Oct2012 and ongoing (courses of Prednisolone Antibiotics as needed).  The patient's concomitant medications were not reported. On 01Mar2021 the patient received the first dose of BNT162B2 vaccine and experienced several events.  The patient experienced  neuropathy peripheral (medically significant) on 29Jun2021 with outcome of unknown , nerve damage  (medically significant) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: unknown, electromyogram: neuropathy   on 29Jun2021 , magnetic resonance imaging: unknown, sars-cov-2 test: negative   on 03Apr2021 Mouth swab , sars-cov-2  test: negative   on 15Jun2021 Nasopharynx swab.    Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: nerve damage; Revealed neuropathy; This is a spontaneous report from a contactable consumer  (the patient)     A 68-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular in the left upper arm on 22Mar2021 17:40 (Batch/Lot Number: ER8727) as single dose  for covid-19 immunisation  .  Medical history included , eosinophilic pneumonia from 15Oct2012 and ongoing (courses of Prednisolone Antibiotics as needed).  The patient's concomitant medications were not reported. On 01Mar2021 the patient received the first dose of BNT162B2 vaccine and experienced several events.  The patient experienced  neuropathy peripheral (medically significant) on 29Jun2021 with outcome of unknown , nerve damage  (medically significant) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: unknown, electromyogram: neuropathy   on 29Jun2021 , magnetic resonance imaging: unknown, sars-cov-2 test: negative   on 03Apr2021 Mouth swab , sars-cov-2  test: negative   on 15Jun2021 Nasopharynx swab.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: developed covid infection; This is a spontaneous report from a contactable consumer. This consumer (Parent) reported for 22-Years-old patient (son) that.  A 22-years-old male 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 DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported he received first dose of pfizer covid vaccine and then 5 days later, he developed covid infection. He was in quarantine. He got his first dose on a Saturday and the following Wednesday he felt sick, had a fever and went to the doctor and tested positive. He still has a lingering cough, but he is better now. It was further stated that he is due to get second dose this Saturday of Pfizer Covid-19 vaccine and asked 'should he even get the second dose'. Reporter stated that 'the doctors don't know, pharmacist wasn't sure, and further stated that I don't see the point of getting the vaccine because he should already have anti-bodies. The events were assessed as Non serious by reporter. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of event was unknown.  Information on the lot batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Chest pain
Clinical narrative: chest or heart pain; chest or heart pain; tightness on her chest; This is a spontaneous report from Pfizer-sponsored program. A contactable female consumer (patient, unknown age) reported for herself that she received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine and shortly afterwards she experienced chest or heart pain and tightness on her chest. Withheld from Pfizer-sponsored program already told her to seek medical attention but wanted to speak to a medical professional.  The outcome of event was unknown.    Information on the lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Anorgasmia, Erectile dysfunction, Penis disorder, SARS-CoV-2 test
Clinical narrative: completely impotent/unable to achieve an erection; no feeling in penis; unable to achieve orgasm; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0175) at single dose on 29Apr2021 10:00 AM via an unknown route in left arm at 54-year-old for Covid-19 immunization. Medical history included diabetes, hypogonadism, slight hypertension. Patient had no known allergies. There was no any other medications the patient received within 2 weeks of vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0150) on 08Apr2021  10:00 AM in left arm at 54-year-old for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient become completely impotent. He had no feeling in private area. He was unable to achieve orgasm. Even taking Ed medication he was unable to achieve an erection. The event onset date was 01May2021 at 12:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit due to disability or permanent damage. No other treatment received for the adverse event. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: nasal Swab PCR on 21Jul2021 and 23Jul2021, both were negative. Outcome of the events was not resolved.    The event was reported as serious with disabling/Incapacitating.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: moderate to severe flare up; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8731) at single dose via an unknown route on 10May2021 in right arm at 63-year-old for Covid-19 immunization. Medical history included epileptic, high blood pressure, and ongoing ulcerative colitis since 2012 and had been in remission for many years. Patient did not have covid prior vaccination. Patient had no known allergies. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0162) at 63-year-old via an unknown route on 19Apr2021 in right arm for Covid-19 immunization. Patient did not have other vaccine in four weeks. Concomitant medications in two weeks included eslicarbazepine acetate (APTIOM), mesalamine, atorvastatin, and triamterene. Patient had ulcerative colitis since 2012 and had been in remission for many years, but four to five weeks after the second dose , patient was having a moderate to severe flare up and having to take 40mg of prednisone daily along with 100mg/60ml nightly hydrocortisone retention enema and 4800mg mesalamine dr tabs, that had not resolved the problem. Adverse event start date was reported as Jun2021. The event resulted in doctor or other healthcare professional office/clinic visit. The event treatment was still going on as of 11Aug2021. No covid tested post vaccination. Outcome of the event was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: near syncopal episode; This is a spontaneous report from a contactable physician (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient recieved the Pfizer Covid 19 Vaccine in early January. Caller stated that he had a "near syncopal episode, was seen by cardiologist and everything was fine. Patient asking if the Pfizer Covid 19 Vaccine has graphene oxide in it. He is a doctor, and one of the first people to get vaccinated in Jan2021, when his hospital got access to the vaccine. He got a bad reaction after the second dose. He had near syncope. He has been reading reports on certain websites that the vaccine could contain toxins, such as graphene oxide? has been hearing reports, that graphene oxide is poison. he has read this in many places on websites and on the internet, but wanted more information to make sure in wasn't anti vaccination hysteria. He does not know what to believe anymore. Event outcome was recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased, Panic attack
Clinical narrative: she had a panic attack and went to the hospital; Elevated heart rate; anxiety; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. (patient reported for self) A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02May2021 (at the age of 22-years-) as a dose 1, single for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported. She relayed that right after having the vaccine (on 02May2021) she experienced an elevated heart rate but that the nurses at the vaccine site checked her and she was fine. She stated that, she received the dose on a Sunday and then on that following Wednesday she had a panic attack and went to the hospital. She did not have anxiety before the vaccine. She stated that her mom thought that the anxiety may have been a side effect from the vaccine, but she was not sure. She mentioned that she drank coffee that morning as well. She would like to know if this was a known side effect after the vaccine and since she had an anxiety disorder now, would like to know if this was a reason that she shouldn't get the second dose. She did not receive the second dose as scheduled due to conflict in her schedule. She asked if she would still get the second dose of the vaccine or does she need to restart with the first dose again. She was advised to speak with HCP prior to receiving the second dose of the vaccine. Lab data included elevated heart rate on 02May2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: She states that the caller developed tachycardia 2-3 days after the first dose; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for Covid-19 immunization. Medical history included heart valve replacement from an unknown date and unknown if ongoing She had artificial heart valve 6 years ago. The patient's concomitant medications were not reported. On Jan2021 the patient experienced she states that the caller developed tachycardia 2-3 days after the first dose, shortness of breath. Patient states that the caller developed tachycardia 2-3 days after the first dose. Patient is also on chemo for stage 4 lung cancer and her immune system is suppressed and her cancer doctor told her to get the vaccine give her approximately 80 percent resistance back in January. Patient has had a brain tumor removed, lots of surgeries and she says she only has part of one lung. Patient is not hearing that she is halfway protected being that she takes the chemo every day. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: patient received the second dose shot in the left arm, it was sore next few days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the left arm on 18Mar2021 15:00 (batch/lot number: EP6955) at 53 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history included diabetes and high blood pressure, both from 2017 and ongoing. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in the right arm on 25Feb2021 15:00 (batch/lot number: EN6202) at 53 years old, as DOSE 1, SINGLE for COVID-19 immunization and experienced shoulder pain, right arm still hurts (pain in arm), can't throw a ball or move arm quickly (mobility decreased), with limited range of motion at times (joint range of motion decreased). The patient received the second dose shot in the left arm, it was sore next few days (in Mar2021) and then went to back normal. The patient recovered from the event on an unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, ER8730, Expiry date: unknown), via an unspecified route of administration on 29Mar2021 as dose number unknown, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient not received any other vaccines within 4 weeks and 2 weeks prior to the COVID vaccine. On 08Aug2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative. On 11Aug2021, the patient got tested and received a positive diagnosis for COVID-19 (medically significant) and Drug Ineffective, due to which as a result of event patient had doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 11Aug2021. It was reported that patient was not prolonged hospitalization and no treatment received. The clinical outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Central nervous system infection, Chest X-ray, Lumbar puncture, Mammogram, Polyneuropathy
Clinical narrative: The polyneuropathy increased 10-fold after the Pfizer vaccine for the first 2 days after the first shot and even worse after the 2nd shot.; fever; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports.     A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Jul2021 14:00 (Lot Number: EW0198) as single dose (at 65 years old)  for COVID-19 immunisation.  The vaccine was administered at Pharmacy or Drug store. Medical history included Guillain-barre syndrome from Oct1986 to Apr1987 (Paralyzed waist down), breast cancer from Aug2015 to Jul2016 (Right mastectomy reconstruction), lung neoplasm malignant from Jan2020 to Jan2020. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EW0173 on 25Jun2021 (at 64 years old) for COVID-19 immunisation and experienced polyneuropathy. The patient previously also received tetanus boost on 04Jun2017 for immunization and experienced polyneuropathy and muscle weakness.  The patient experienced the polyneuropathy increased 10-fold after the Pfizer vaccine for the first 2 days after the first shot and even worse after the 2nd shot in Jul2021 with outcome of recovering, fever in Jul2021 with outcome of unknown. No treatment required for polyneuropathy. The patient underwent lab tests and procedures which included central nervous system infection: negative in 2017, central nervous system infection: negative  in 2019, central nervous system infection: negative in 2020, chest x-ray: positive in Jan2020, lumbar puncture: negative in Oct1986, mammogram: positive in Aug2015, x-ray: negative in Oct1986.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100908602 same patient, different event and dose
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, X-ray
Clinical narrative: The polyneuropathy increased 10-fold after the Pfizer vaccine for the first 2 days after the first shot and even worse after the 2nd shot.; fever; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports.     A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 16Jul2021 14:00 (Lot Number: EW0198) as single dose (at 65 years old)  for COVID-19 immunisation.  The vaccine was administered at Pharmacy or Drug store. Medical history included Guillain-barre syndrome from Oct1986 to Apr1987 (Paralyzed waist down), breast cancer from Aug2015 to Jul2016 (Right mastectomy reconstruction), lung neoplasm malignant from Jan2020 to Jan2020. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number: EW0173 on 25Jun2021 (at 64 years old) for COVID-19 immunisation and experienced polyneuropathy. The patient previously also received tetanus boost on 04Jun2017 for immunization and experienced polyneuropathy and muscle weakness.  The patient experienced the polyneuropathy increased 10-fold after the Pfizer vaccine for the first 2 days after the first shot and even worse after the 2nd shot in Jul2021 with outcome of recovering, fever in Jul2021 with outcome of unknown. No treatment required for polyneuropathy. The patient underwent lab tests and procedures which included central nervous system infection: negative in 2017, central nervous system infection: negative  in 2019, central nervous system infection: negative in 2020, chest x-ray: positive in Jan2020, lumbar puncture: negative in Oct1986, mammogram: positive in Aug2015, x-ray: negative in Oct1986.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100908602 same patient, different event and dose
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Within one hour of receiving my second Pfizer covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later.; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (at vaccination age of 36-year-old) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 13:15 (lot number: EW0186) (at vaccination age of 36-year-old) as single dose for COVID-19 immunisation. The patient medical history was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no any other medications the patient received within 2 weeks of vaccination. Relevant past drug history was reported as no. The patient experienced 'Within one hour of receiving my second Pfizer Covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later' on 06Aug2021 13:00. Hospitalization prolonged was reported as no. Treatment received was reported as no. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. As reported, within one hour of receiving his second Pfizer Covid 19 shot, he started experiencing ringing in his ears. It has not gone away 5 days later. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device date was 11Aug2021. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Frustration tolerance decreased, Tinnitus
Clinical narrative: Within one hour of receiving my second Pfizer covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later.; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (at vaccination age of 36-year-old) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 13:15 (lot number: EW0186) (at vaccination age of 36-year-old) as single dose for COVID-19 immunisation. The patient medical history was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no any other medications the patient received within 2 weeks of vaccination. Relevant past drug history was reported as no. The patient experienced 'Within one hour of receiving my second Pfizer Covid 19 shot, I started experiencing ringing in my ears. It has not gone away 5 days later' on 06Aug2021 13:00. Hospitalization prolonged was reported as no. Treatment received was reported as no. Facility where the most recent COVID-19 vaccine was administered was in doctor's office/urgent care. As reported, within one hour of receiving his second Pfizer Covid 19 shot, he started experiencing ringing in his ears. It has not gone away 5 days later. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device date was 11Aug2021. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: extreme fatigue; nauseated; muscle aches everyway; dizziness; headaches really bad; generalized weakness through out the body and it effected her vision; generalized weakness through out the body and it effected her vision; she was sick for about a week; chills; diarrhea; This is a spontaneous report from a contactable other HCP (nurse) via Pfizer sponsored program. An 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has mitral and tricuspid leaky valves and faulty heart valves. Ileostomy s/p large bowel removal and clotting problems that patient took Eliquis for this. Patient also has Lupus, Rheumatoid Arthritis, a pacemaker and patient was being watched closely for a blood cancer. Blood cancer runs in patient family. The patient's concomitant medications were not reported. Patient previously took Eliquis for clotting problems. On an unspecified date, patient experienced extreme fatigue, nauseated, muscle aches everyway, dizziness, headaches really bad, and generalized weakness through out the body and it affected her vision, patient was sick for about a week, Felt like patient was going to die, also chills and diarrhea. Reporter further wanted to know that there was any chance that this cardiac inflammation, listed in the possible side effects, could be exacerbated by the fact that patient has the 2 leaky valves? Patient was afraid to get the second dose because they have heard the second dose was worse than the first. Therapeutic measures were taken as a result of events experienced. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Nausea, Visual impairment
Clinical narrative: extreme fatigue; nauseated; muscle aches everyway; dizziness; headaches really bad; generalized weakness through out the body and it effected her vision; generalized weakness through out the body and it effected her vision; she was sick for about a week; chills; diarrhea; This is a spontaneous report from a contactable other HCP (nurse) via Pfizer sponsored program. An 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has mitral and tricuspid leaky valves and faulty heart valves. Ileostomy s/p large bowel removal and clotting problems that patient took Eliquis for this. Patient also has Lupus, Rheumatoid Arthritis, a pacemaker and patient was being watched closely for a blood cancer. Blood cancer runs in patient family. The patient's concomitant medications were not reported. Patient previously took Eliquis for clotting problems. On an unspecified date, patient experienced extreme fatigue, nauseated, muscle aches everyway, dizziness, headaches really bad, and generalized weakness through out the body and it affected her vision, patient was sick for about a week, Felt like patient was going to die, also chills and diarrhea. Reporter further wanted to know that there was any chance that this cardiac inflammation, listed in the possible side effects, could be exacerbated by the fact that patient has the 2 leaky valves? Patient was afraid to get the second dose because they have heard the second dose was worse than the first. Therapeutic measures were taken as a result of events experienced. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.