chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: possible symptoms related to mononucleosis; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced possible symptoms related to mononucleosis on an unspecified date in 2021. Therapeutic measures were taken as a result of mononucleosis. The outcome of possible symptoms related to mononucleosis was unknown  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Haemoptysis, Headache
Clinical narrative: headache; chills; blood at nose as well when he coughs sometimes; blood at nose as well when he coughs sometimes; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Feb2021 for COVID-19 immunization.  The patient experienced headache, chills, and blood at nose as well when he coughs sometimes on 16Mar2021. The clinical outcome of headache, chills, and blood at nose as well when he coughs sometimes was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles in Mar2021. The clinical course was reported as follows: The patient started taking antiviral medications the morning of 17Mar2021, which included valacyclovir hydrochloride (MANUFACTURER UNKNOWN) 500 mg tablets in a dose of one tablet, two times a day for yet undefined virus which is shingles like, believed to be like herpes (as reported). Her second dose was scheduled for 22Mar2021. Therapeutic measures were taken as a result of the event as aforementioned. The clinical outcome of shingles was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: big black blue bruise in her arms where the vaccine injected; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 26Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced big black blue bruise in her arms where the vaccine injected on an unspecified date. The clinical outcome of the event was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diplopia, Fatigue, Headache, Lymphadenopathy
Clinical narrative: He has double vision; Weakness; Tiredness; Headache; He had problem with lymph nodes; doesn't feel good; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in left shoulder on an unspecified date (at the age of 86-year-old) at SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included lisinopril taken for blood pressure. On an unspecified date, the patient experienced he has double vision, weakness, tiredness, headache, and he had problem with lymph nodes. The reporter further stated, "Now I realize that was Wednesday, now this Wednesday afternoon it will be a week do these symptoms last these long normally I am calling because I mean he is not ready for the hospital or anything like that but he just doesn't feel good." The reporter also mentioned that the patient has no fever. The patient was afraid to get the second shot. They are scheduled for the second dose of vaccine on 06Apr2021. There was no treatment received for all events. The patient was recovering from all events.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: He has double vision; Weakness; Tiredness; Headache; He had problem with lymph nodes; doesn't feel good; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in left shoulder on an unspecified date (at the age of 86-year-old) at SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included lisinopril taken for blood pressure. On an unspecified date, the patient experienced he has double vision, weakness, tiredness, headache, and he had problem with lymph nodes. The reporter further stated, "Now I realize that was Wednesday, now this Wednesday afternoon it will be a week do these symptoms last these long normally I am calling because I mean he is not ready for the hospital or anything like that but he just doesn't feel good." The reporter also mentioned that the patient has no fever. The patient was afraid to get the second shot. They are scheduled for the second dose of vaccine on 06Apr2021. There was no treatment received for all events. The patient was recovering from all events.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Affective disorder, Muscle spasms, Vaginal haemorrhage
Clinical narrative: wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distressed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730 and expiration date Jul2021) via unknown route on 01Apr2021at 16:00 at single dose for COVID-19 immunisation. Patient reported that she was allergic to bee stings so her doctor told her she should wait 30 minutes after getting the vaccine to observe for any reaction instead of the 15 minutes. The patient concomitant medications were Zydus, USP 75 mg Venlafaxine HCl (EFFEXOR XR).  Patient was fine and left, when she got to her car she took 2 Tylenol and went to the grocery store and did some errands. 4 hours later, patient took 2 more Tylenol. Patient reported that this morning (02Apr2021) she got up from bed to go to the bathroom and noticed that when she wiped herself there was blood on the toilet paper and "quite a bit in my pajamas". Patient reported she was experiencing cramps. Patient believes she's having her period. Patient sounded distressed, reported that she hasn't had a period in years and now she is anxious and scared. Is really scared and wanted so seek medical advice. Unable to contact personal doctor, Declined ISI, cold transferred to PMI due to hold time. Will fax AE for side effects. Patient reported that yesterday she also started a new dose of her Effexor which was increased from 37mg to 75mg which she takes for anxiety and depression, she took the first increased dose yesterday evening and doesn't know if that is what caused this or the Covid shot. Her second dose is scheduled for 29Apr2021. Patient reported that she called her General Practitioner who was not in the office today and her GYN who hasn't yet called her back but she reports that the nurse instructed her to go to the walk in clinic for evaluation, but the caller reports she don't want to go because of the Covid. She spoke with someone before speaking to this agent saying they read her a bunch of information but it was not clear if she spoke with safety or customer service. Obtained the lot number for her first vaccine dose with exp. Patient stated 'I'm a nervous wreck" asking, if the symptom she was experiencing is from her Covid vaccine. Patient asked if her second shot supposed to be more than 21 days from the first. The case was reported as non-serious. Upon callback, she stated she has had a really bad day and spent all afternoon at the walk in clinic. She found out her symptoms were not related to the vaccine and said she could not talk anymore because she was driving. Callback made but caller said she could not talk and did not request a callback. The outcome of the events was unknown.   Additional Information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Spinal compression fracture
Clinical narrative: compression fracture on her back; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on Mar2021 (lot number was not reported) as a single dose for COVID-19 immunization. She's due to take her 2nd dose of vaccine on Tuesday, 06Apr2021. She could not recall when her 1st dose was which was 4 weeks to the day on Tuesday. Medical history and concomitant medications were not reported. The patient had a compression fracture on her back last week on 2021, she's due to take her second dose of the vaccine on Tuesday. She's currently taking pain medications. She's wondering if she could still take her second shot as scheduled as she's aware that she could not take any medications along with the vaccine like pain relievers (Tylenol or Advil). The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blister, Erythema, Rash, SARS-CoV-2 test
Clinical narrative: weird rash on hand; 13 Days after 1st dose, redness appeared on left and right hand.; 24 hours after that, blisters and increased redness occurred in the area. Tested negative for COVID19.  Took a bacteria culture of the; This is a spontaneous report from a contactable consumer.   A 21-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 13Mar2021 at 13:30 (Batch/Lot Number: EN6204) at the age of 21 years-old,  as SINGLE DOSE for covid-19 immunisation  .  Medical history included   from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  On 28Mar2021,  at 0900, 13 Days after 1st dose, redness appeared on left and right hand. 24 hours after that, blisters and increased redness occurred in the area. Tested negative for COVID19 on 27Mar2021.  Took a bacteria culture of the area which grew NO bacteria. Taking antibiotics which have no observed effect.  The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Colonoscopy, Computerised tomogram
Clinical narrative: abdominal pain; feeling bloated; This is a spontaneous report received from a contactable consumer (Patient, self-reported). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 other, via an unspecified route of administration, (Batch/Lot Number was not provided) as SINGLE DOSE for covid-19 immunisation. Medical history includes Chron's. Concomitant medications were not reported. It was reported that Patient had colonoscopy about 6-7 weeks prior to the Pfizer Covid vaccine. After receiving his first Pfizer Covid vaccine he experienced abdominal pain & feeling bloated. Caller went to the ED and had a CT scan which showed a larger amount of air in the abdominal area, that wasn't there during the colonoscopy. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dermatomyositis
Clinical narrative: Dermatomyositis/disease flared up in both skin and muscle; Dermatomyositis/disease flared up in both skin and muscle; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration, in right arm, on 11Feb2021 12:15 (at the age of 70-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included dermatomyositis, IV contrast dye (Possibly IV contrast dye, minor itching). No COVID prior vaccination. Concomitant medication included prednisone. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in right arm, on 21Jan2021 (at the age of 70-year-old), at single dose, for COVID-19 immunization. Patient had dermatomyositis an autoimmune disease. 5 days after the second shot, on 16Feb2021, patient had disease flared up in both skin and muscle and had been prescribed prednisone 20 mg daily (6 weeks later). Prior to flare patient was stable on prednisone 5mg daily. Events resulted in doctor or other healthcare professional office/clinic visit. No COVID tested post vaccination. The outcome of the events was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Disease recurrence, Ophthalmological examination
Clinical narrative: Bell's Palsy/facial paralysis; Bell's Palsy/facial paralysis; This is a spontaneous report received from a consumer (patient's husband). A 78-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 78 years, administered in right bicep on 16Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Patient's medical history includes bells palsy from 1997, lower right lobe of her lung removed in 2016, and removed for carcinoid tumor on an unspecified date. Patient did not have prior vaccinations in 4 weeks. Concomitant medications were none. There were no other vaccines administered on the same date as the suspect. Patient previously too quite a few medications but she hasn't been taking for years or that would affect it. It was reported that patient and the reporter received first dose on 16Mar2021 at 09:00 AM in the right bicep as recommended by the pulmonologist and oncologist.  It was reported that on 29Mar2021, also reported as "13 days later from vaccination", facial paralysis started around noon. At the time of report, patient was experiencing Bell's Palsy from 29Mar2021 and asking for recommendation for second dose. Patient was also officially diagnosed with Bell's Palsy when she went to the ER on 31Mar2021. Patient has seen the doctor and been to the ER and the doctor refused to comment saying he had no opinion, they had asked him if she should do the second dose and he said he had no opinion. Reporter relayed that on the website there is no specific notable balance in the numerical groups to suggest a causal relationship to the vaccine. Reporter was asking if the second dose was prohibited, stating patient was scheduled for 06Apr2021 which is 21 days after her first dose. Patient's husband spoke from the FDA's briefing document that "Bell's palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination," and mentioned that  there have been 4 reports of Bell's Palsy during the study and 1 of those was after the first dose and 3 were after the second dose. They wanted to know if it is allowed should she get it or could it be rescheduled to a later date. For tests, no testing was done they just did a visual exam on an unspecified date. Vaccine was not administered at Facility. The outcome was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye haemorrhage, Headache, Hypersensitivity, Rhinorrhoea
Clinical narrative: symptoms started out with "the eyes"/"bloody eyes"; headache; allergies; runny nose; chills; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 2021 (lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 2021, the patient received the Pfizer BioNTech COVID-19 vaccine on Tuesday and has been having side effects and would like to know if she was able to take anything to help treat these side effects. Her symptoms started out "with the eyes" and a headache, and then reported symptoms similar to allergies, stating that she has had a runny nose and "bloody eyes". These symptoms had not stopped since she received her vaccine. She was having chills on 2021. She did not know if these symptoms were going to go away on their own or if she just had to wait them out. She would like to know if it was recommended she take the second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects that she experienced. The outcome of the events was not recovered.  Information about the lot/batch has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Nasal congestion, Rhinorrhoea, Sneezing, Vaccination site erythema
Clinical narrative: symptoms started out with "the eyes"/"bloody eyes"; headache; allergies; runny nose; chills; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 2021 (lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 2021, the patient received the Pfizer BioNTech COVID-19 vaccine on Tuesday and has been having side effects and would like to know if she was able to take anything to help treat these side effects. Her symptoms started out "with the eyes" and a headache, and then reported symptoms similar to allergies, stating that she has had a runny nose and "bloody eyes". These symptoms had not stopped since she received her vaccine. She was having chills on 2021. She did not know if these symptoms were going to go away on their own or if she just had to wait them out. She would like to know if it was recommended she take the second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects that she experienced. The outcome of the events was not recovered.  Information about the lot/batch has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: symptoms started out with "the eyes"/"bloody eyes"; headache; allergies; runny nose; chills; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 2021 (lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 2021, the patient received the Pfizer BioNTech COVID-19 vaccine on Tuesday and has been having side effects and would like to know if she was able to take anything to help treat these side effects. Her symptoms started out "with the eyes" and a headache, and then reported symptoms similar to allergies, stating that she has had a runny nose and "bloody eyes". These symptoms had not stopped since she received her vaccine. She was having chills on 2021. She did not know if these symptoms were going to go away on their own or if she just had to wait them out. She would like to know if it was recommended she take the second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects that she experienced. The outcome of the events was not recovered.  Information about the lot/batch has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Syncope, Tinnitus
Clinical narrative: Faint high pitched ringing; Faint high pitched ringing; Higher pitches not audible; This is a spontaneous report from program. A 46-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 01Apr2021 13:30 (Batch/Lot Number: EP6955) at a single dose for covid-19 immunisation.  The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. He was not also diagnosed with COVI-19 prior and since vaccination. He has not been tested positive with Covid-19.  Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported.  The patient previously took penicillin and experienced penicillin allergy.  The patient experienced faint high pitched ringing and higher pitches not audible on 02Apr2021 02:00 with outcome of not recovered. In addition, it was also described as faint high pitched ringing began about 12 hours after administration. Persists. Frequency ~ 13kHz (I do music/audio stuff so checked against tone generator). Higher pitches not audible, unknown if related to the symptom or simply age.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chronic lymphocytic leukaemia, Condition aggravated, Drug ineffective
Clinical narrative: so the vaccine did not work; His Chronic Lymphocytic Leukemia did not work well with the vaccine; His Chronic Lymphocytic Leukemia did not work well with the vaccine; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 1st dose (lot number: EL1284) on 13Jan2021, the 2nd dose (lot number: EL9263) on 03Feb2021; both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history included immunosuppressed and chronic lymphocytic leukemia. Concomitant medications were unknown. The patient said his doctor found out that his chronic lymphocytic leukemia (CLL) did not work well with the vaccine. His physician took a blood test (for CLL) the other day and said that there was a problem with his CLL results and the vaccines (like interference). The patient stated he was seeing his HCP yesterday or the day before yesterday, they took blood work and told him his CLL did not work and the Pfizer vaccine did not work good on him. The patient was asking what can be done; stated they took his blood work again and the CLL did not work so the vaccine did not work; no further clarifying details provided by the caller. He wanted to know what he should do about this. Response included "CONS-use in immunosuppressed patients (v3.0)" and "CONS-what is the pfizer-biontech covid-19 vaccine (v3.0)." The patient wanted to know if he can stop wearing masks whenever he's around people who had already been vaccinated with both doses of the Pfizer-BioNTech Covid-19 Vaccine. He also wanted to know if he can still be a carrier of the virus. Response was "CONS - post-vaccination precautions - wearing a mask and social distancing after receiving the vaccine (v5.0)." Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: a friend did experience that, from his back down he could not move his legs; This is spontaneous report received from contactable consumer, reporting for friend (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  When getting the second, the patient did experience that, from his back down he could not move his legs and had to go to the hospital, in 4 or 5 days he left. The outcome of the event was not reported.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Her husband was  in hospital for 36 hrs. due to respiratory problems and fever; Her husband was  in hospital for 36 hrs. due to respiratory problems and fever; tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that both patient and wife received their first Pfizer COVID vaccine dose on 06Mar2021. On 09Mar2021 they both tested positive for COVID-19 and got the virus. Patient's wife stated they are both negative at the time of report on 02Apr2021 and that her husband had to be hospitalized in Mar2021 for 36 hours due to respiratory problems and fever from an unspecified date in Mar2021. An infectious disease MD told her that they should wait 90 days and try to start over again with another series of COVID vaccines. Reporter wanted to know if they could get the second dose or not. The outcome of the event 'tested positive for COVID-19' was recovered on 02Apr2021, while for the other events, it was unknown. Case was reported as non-serious.   Information on the lot/batch number has been requested.      The patient experienced her husband had to be hospitalized and an infectious disease (infection) (hospitalization) on Mar2021 with outcome of unknown , tested positive for covid-19 (covid-19) (medically significant) on 09Mar2021 with outcome of recovered , her husband was  in hospital for 36 hrs. due to respiratory problems and fever (respiratory disorder) (hospitalization) on Mar2021 with outcome of unknown , her husband was  in hospital for 36 hrs. due to respiratory problems and fever (pyrexia) (hospitalization) on Mar2021 with outcome of unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cerebrovascular accident, Dysarthria, Fatigue, Gait disturbance
Clinical narrative: having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious.  Information on lot/batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Nausea, Speech disorder, Vaccination site pain
Clinical narrative: having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious.  Information on lot/batch number was available. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paralysis
Clinical narrative: Paralysis; Right lip swelling; This is spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Apr2021 at 05:15 PM (17:15), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 04Mar2021 for COVID-19 immunization (left arm). The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store facility. On 02Apr2021, the patient experienced right lip swelling and paralysis. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal pain, Respiratory tract infection
Clinical narrative: full blown Respiratory infection; sore throat; feel poorly; This is a spontaneous report from a contactable consumer.  A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7934), via an unspecified route of administration, administered in Arm Right on 28Mar2021 10:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced full blown respiratory infection, sore throat and feel poorly on 31Mar2021 17:00. The patient did not received any treatment for the events.The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Outcome of the events was not recovered.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Clonus, Fall, Heart rate, Hyperhidrosis
Clinical narrative: Patient unresponsive; presented with seizure like activity; Patient fall from chair within 15minutes of receiving Pfizer vaccine dose 1; pale; diaphoretic; nausea; Full body clonus; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 26 years of age), dose 1 intramuscular, administered in arm left on 03Apr2021 10:45 (Batch/Lot Number: ER8737) as a single dose for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient had no other vaccine prior to Covid vaccine. He was not diagnosed with COVID-19 prior to vaccination. It was unknown if patient has been tested for COVID-19 since the vaccination. It was reported that the patient fell from  chair within 15 minutes of receiving Pfizer vaccine dose 1. Patient was unresponsive, pale, diaphoretic. Awakened within minutes, placed in recovery position on left side. Patient complained of nausea then presented with seizure like activity. Full body clonus. 911 notified. Patient woke within seconds able to state, name, location, date of birth accurately. He was placed on stretcher. EMS arrived. VS 154/80 HR 84, POx99% 2LO2. He continues to be pale. Family of patient notified of event at patient's request. He was transferred to ED via EMS. The events started on 03Apr2021 at 10:45 AM (as reported). Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Additional information has been requested.; Sender's Comments: Bases on the information in the case report and a strong temporal relationship, A causal relationship between adverse events Unresponsive to stimuli, Seizure and suspect product BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor, Seizure, Unresponsive to stimuli
Clinical narrative: Patient unresponsive; presented with seizure like activity; Patient fall from chair within 15minutes of receiving Pfizer vaccine dose 1; pale; diaphoretic; nausea; Full body clonus; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 26 years of age), dose 1 intramuscular, administered in arm left on 03Apr2021 10:45 (Batch/Lot Number: ER8737) as a single dose for COVID-19 immunisation. The patient's medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient had no other vaccine prior to Covid vaccine. He was not diagnosed with COVID-19 prior to vaccination. It was unknown if patient has been tested for COVID-19 since the vaccination. It was reported that the patient fell from  chair within 15 minutes of receiving Pfizer vaccine dose 1. Patient was unresponsive, pale, diaphoretic. Awakened within minutes, placed in recovery position on left side. Patient complained of nausea then presented with seizure like activity. Full body clonus. 911 notified. Patient woke within seconds able to state, name, location, date of birth accurately. He was placed on stretcher. EMS arrived. VS 154/80 HR 84, POx99% 2LO2. He continues to be pale. Family of patient notified of event at patient's request. He was transferred to ED via EMS. The events started on 03Apr2021 at 10:45 AM (as reported). Therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Additional information has been requested.; Sender's Comments: Bases on the information in the case report and a strong temporal relationship, A causal relationship between adverse events Unresponsive to stimuli, Seizure and suspect product BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate, Heart rate increased, Paraesthesia oral
Clinical narrative: Woke up around 3:30 am on 02Apr2021 with a rapid heart rate; rush through her body from feet to head, very rapid heart rate (fluttering); tongue-tingling; This is a spontaneous report received from a contactable nurse (patient) reporting for herself. A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8733), via an unspecified route of administration, administered in right arm on 01Apr2021 08:45 (at the age of 63-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included exercise-induced asthma, SVT (Supraventricular tachycardia). Concomitant medication included sotalol. The patient previously took ciprofloxacin and diazepam (VALIUM) and had allergies to both. Approximately 5 minutes after receiving vaccine on 01Apr2021 (08:50), the patient experienced a rush through her body from feet to head, very rapid heart rate (fluttering) which lasted approximately 1min, tongue-tingling which lasted approx. 8 hours. Woke up around 3:30 am on 02Apr2021 with a rapid heart rate. She notified her PCP and cardiologist's office that morning. There was no treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event tongue-tingling on 01Apr2021 16:50. The outcome of the event rapid heart rate was not recovered.; Sender's Comments: Based on the information currently available and known vaccine safety profile, the causal association between the event of a rush through her body from feet to head, very rapid heart rate (fluttering) is assessed as unrelated to the usage of the vaccine BNT162B2 and more likely due to the possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Loss of personal independence in daily activities, Meniere's disease
Clinical narrative: developed Meniere's disease; It's severe and affecting my daily life; pregnant at the time of vaccination; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration into left arm on 05Mar2021 17:30 as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications include prenatal vitamins (unspecified). Patient was reportedly pregnant at the time of vaccination 05Mar2021 17:30 and was due to deliver on 29Jul2021. The last menstrual period was 23Oct2020. On 12Mar2021, patient developed meniere's disease which was reportedly severe and affecting her daily life. The patient was reportedly hospitalized on an unspecified date for 1 day. It was also reported that the patient was given a prescription for physical therapy as treatment. Outcome of events was not recovered.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Basal ganglia infarction, Echocardiogram, Facial paralysis, International normalised ratio, Investigation
Clinical narrative: Acute Infarct of R internal capsule and R basal ganglia; Acute Infarct of R internal capsule and R basal ganglia; Left (L) sided motor deficits; L facial droop; This is a spontaneous report from a contactable physician. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included truncus arteriosus (status post (s/p) right ventricle-to-pulmonary artery (RV-PA) conduit and prosthetic aortic valve s/p automatic implantable cardioverter defibrillator (AICD) placement) and arrhythmias. The patient have no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included sotalol taken for arrhythmias and warfarin. The patient was therapeutic on warfarin (INR 2.68) at admission and has been historically very compliant with medication. On 29Mar2021 14:00, the patient experienced acute infarct of right (R) internal capsule and R basal ganglia as diagnosed (dx) on magnetic resonance imagine (MRI), concerning for (C/f) cardio-embolic etiology in the setting of patient's complex cardiac history. However, cannot rule out other causes of infarct. Left (L) sided motor deficits on exam, L facial droop. Transthoracic echocardiogram (TTE) was unchanged from prior. The patient was hospitalized for the events from 29Mar2021 to 05Apr2021. The patient underwent other lab tests and procedures which included COVID-19 nasal swab test was negative on 29Mar2021 and on 30Mar2021. Therapeutic measures were taken as a result of the events and included treatment with anticoagulation. Outcome of the events was recovered with sequel on 2021.  The following information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. Consider also possible contributory effects from patient's pre-existing cardiac history. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic cerebral infarction, Magnetic resonance imaging, Motor dysfunction, SARS-CoV-2 test
Clinical narrative: Acute Infarct of R internal capsule and R basal ganglia; Acute Infarct of R internal capsule and R basal ganglia; Left (L) sided motor deficits; L facial droop; This is a spontaneous report from a contactable physician. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included truncus arteriosus (status post (s/p) right ventricle-to-pulmonary artery (RV-PA) conduit and prosthetic aortic valve s/p automatic implantable cardioverter defibrillator (AICD) placement) and arrhythmias. The patient have no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included sotalol taken for arrhythmias and warfarin. The patient was therapeutic on warfarin (INR 2.68) at admission and has been historically very compliant with medication. On 29Mar2021 14:00, the patient experienced acute infarct of right (R) internal capsule and R basal ganglia as diagnosed (dx) on magnetic resonance imagine (MRI), concerning for (C/f) cardio-embolic etiology in the setting of patient's complex cardiac history. However, cannot rule out other causes of infarct. Left (L) sided motor deficits on exam, L facial droop. Transthoracic echocardiogram (TTE) was unchanged from prior. The patient was hospitalized for the events from 29Mar2021 to 05Apr2021. The patient underwent other lab tests and procedures which included COVID-19 nasal swab test was negative on 29Mar2021 and on 30Mar2021. Therapeutic measures were taken as a result of the events and included treatment with anticoagulation. Outcome of the events was recovered with sequel on 2021.  The following information on the batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. Consider also possible contributory effects from patient's pre-existing cardiac history. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.