chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: 8/10/2021 tested positive for COVID; 8/10/2021 tested positive for COVID; swollen sinuses with very little clear mucus from my nose; insomnia; sinus pressure; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer(patient) reported for herself that: A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6199; Expiration Date: on an unspecified date in Jun2021), dose 2 via an unspecified route of administration on 08Mar2021 (age at vaccination was 55-year-old) as DOSE 2, single dose and dose 1 via an unspecified route of administration on 15Feb2021 (Lot Number: EL9261 and Expiry date was not reported) as DOSE 1, single dose, both for covid-19 immunisation. She was a Pfizer representative vaccinated with first dose 15Feb2021 and the second dose 08Mar2021. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for anxiety, start and stop date were not reported. Although overweight she relatively healthy. she exercises 50 minutes daily. On 04Aug2021 she came home from work early because she was so tired, constantly sneezing, on 05Aug2021 patient experienced sore throat, but she frequently had a sore throat, headache, fatigue/ tired, lots of drainage, sinus pressure, no energy, on 07Aug2021, she was feeling better just lots of congestion, lost taste, lost smell, on 10Aug2021, tested positive for covid, currently her symptoms are swollen sinuses with very little clear mucus from her nose, insomnia. Still having quite, a bit of drainage down my throat, sore throat, insomnia the last 2 nights. On 05Aug2021 and 06Aug2021 stayed in bed most of the days with symptoms listed above. She was able to clean house and steam all her floors. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, sars-cov-2 test: tested again for covid on 09Aug2021, sars-cov-2 test: positive on 10Aug2021. Treatment received for the event insomnia was Ambien PRN. Outcome of the event covid 19 was unknown, sore throat, lots of drainage, swollen sinuses with very little clear mucus from her nose and insomnia was not recovered, and rest of the events was recovered.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of personal independence in daily activities
Clinical narrative: hard time being able to function without falling over.; falls on his face; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient fiancee). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified in 2021, the patient experienced dizziness and hard time being able to function without falling over. Reporter and patient got the Pfizer Vaccine last week and reporter believed patient may be having some adverse side effects. He was having a dizziness and hard time being able to function without falling over. Reportedly, it was 6:00 in the morning in (withheld) which means it was only 7:00 in (withheld), reporter asked so what are we supposed to do he woke up at 06:00 in the morning central time and falls on his face. This was (withheld) pounds man reporter talking about. Reporter cannot just pick him up. Reporter asked gonna be a better solution then some helpdesk that was only open form 8 to 8. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: He was 66 years old and diabetic but and he got a COVID shot (COVID 19 Vaccine), both COVID shots and it was not clarified whether he was diabetic before getting the shot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient reported that he was 66 years old and diabetic but and he got a covid shot (covid 19 vaccine), both covid shots and it was not clarified whether he was diabetic before getting the shot on an unspecified date. 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: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Ventricular extrasystoles
Clinical narrative: Short episodes a fib; increased PVCs; This is a spontaneous report from a contactable physician (patient).  This 69-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm on 30Jan2021 at 16:00 PM at patient age of 69-year-old (Lot number EL9265 and EN6203) as single dose for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. No other vaccine in four weeks and no other medications in two weeks. The patient experienced short episodes A fib, increased premature ventricular contractions (PVCs) on 01Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment.  COVID was not tested post vaccination. The outcome of the event was resolved in 2021.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of atrial fibrillation and increased premature ventricular contractions 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angina pectoris, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: feeling off; felt very sick/don't feel too well; Out of breath; Upset stomach; uncomfortable feeling in chest; Tired; Very dizzy all the time; heart is hurting very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Aug2021 (Lot Number: EW0186, unknown expiration; at the age of 30 years old) as dose number unknown, single for COVID-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine shot on Friday, 06Aug2021. She experienced feeling off on 06Aug2021. It's been 4 days and symptoms are getting worse. She felt very sick and just don't feel too well in Aug2021. The patient also experienced out of breath, upset stomach, and her heart is hurting very uncomfortable in Aug2021. She has uncomfortable feeling in chest, was tired, and very dizzy all the time in Aug2021. The patient took one ibuprofen yesterday (on 09Aug2021). The patient asked what she should do now and if she should go to the ER. The patient had not yet recovered from feeling off, while unknown outcome for the remaining events.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: feeling off; felt very sick/don't feel too well; Out of breath; Upset stomach; uncomfortable feeling in chest; Tired; Very dizzy all the time; heart is hurting very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Aug2021 (Lot Number: EW0186, unknown expiration; at the age of 30 years old) as dose number unknown, single for COVID-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine shot on Friday, 06Aug2021. She experienced feeling off on 06Aug2021. It's been 4 days and symptoms are getting worse. She felt very sick and just don't feel too well in Aug2021. The patient also experienced out of breath, upset stomach, and her heart is hurting very uncomfortable in Aug2021. She has uncomfortable feeling in chest, was tired, and very dizzy all the time in Aug2021. The patient took one ibuprofen yesterday (on 09Aug2021). The patient asked what she should do now and if she should go to the ER. The patient had not yet recovered from feeling off, while unknown outcome for the remaining events.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Magnetic resonance imaging, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: mini-stroke; Could not keep my balance; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular, administered in the right arm, on 09Feb2021 10:00 (Batch/lot number: EL9269), at age 74 years old, as dose 1, single, for COVID-19 immunisation. Relevant medical history was reported as none. Concomitant medications included amlodipine besilate, olmesartan medoxomil (AZOR) and potassium chloride both taken for unknown indications, start and stop dates not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 09Feb2021 11:00, 1 hour after the first vaccination, the patient could not keep his balance. The patient underwent MRI on an unspecified date which showed a mini stroke. The patient underwent COVID-19 test on 19Jan2021 which was negative. The patient then received the second dose of BNT162B2 on 02Mar2021 10:00 (Batch/lot number: EN6189), intramuscular in the left arm. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eyelid ptosis, Strabismus, Swelling face
Clinical narrative: eye drooping; exotropia; facial swelling; chills; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a physician who states she had a female patient who after receiving that Pfizer COVID 19 vaccines experienced some symptoms of left sided chills, left sided facial swelling and left exotropia or eye drooping. This was evaluated by the urgent care the patient went to for symptoms at the time. She is two weeks from her first dose now and many of the symptoms have resolved. She is still experiencing some left sided head chills. The HCP states that this patient is looking for an exemption from receiving the second dose of the vaccine. HCP states that from looking at the website that currently it looks like to only reason for an exemption would be for a severe allergic reaction and she does not believe that this patient's reaction was severe. She would like to know if there is any information on this circumstance or the exemptions for patients to receive the second dose? The outcome of the events head chills was not recovered, for other events was recovered on unknown date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Death
Clinical narrative: passed away; heart problem; This is a spontaneous report from a contactable consumer. A 73-year-old male patient (reporter's father) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient passed away from taking Covid vaccine. He never had a heart problem until he took the first Covid vaccine shot. The outcome of event heart problem was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I was vaccinated in March was diagnosed Covid; covid; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date in Mar2021 as dose number unknown, single for Covid-19 immunization. The patients medical history included asthma. The patients concomitant medications were not provided. Patient was vaccinated on an unspecified date in March was diagnosed Covid. If patient did not get vaccinated, Doctor said patient would probably be in hospital bed. The vaccine did its job so far. Patient was looking forward to be infused with antibody. The patient underwent lab tests and procedures which included Covid-19 test: positive on an unspecified date (diagnosed Covid Saturday). The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ephelides, Fatigue, Limb discomfort, Nausea, Petechiae
Clinical narrative: rash on her face, red dots that looked like freckles; petechiae and is spreading to her neck.; red rash on her face; red dots that looked like freckles; fatigue; nausea; throwing up; fever; experienced arm discomfort; This is a spontaneous report from a contactable other hcp (Nurse). This nurse (mother) reported for a 23-year-old female patient (daughter) that, A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 09Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 09Aug2021, the patient had arm discomfort (limb discomfort). On 10Aug2021, the patient developed fatigue, nausea, throwing up (vomiting), fever (pyrexia). On 11Aug2021, the patient had rash on her face, red dots that looked like freckles (rash), petechiae and is spreading to her neck (petechiae), red rash on her face (rash erythematous). Therapeutic measures were taken as a result of fatigue (fatigue), nausea (nausea), throwing up (vomiting), fever (pyrexia). The events fatigue, nausea, throwing up and fever that was resolved by taking Tylenol. The clinical outcome for the other events was Unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Vomiting
Clinical narrative: rash on her face, red dots that looked like freckles; petechiae and is spreading to her neck.; red rash on her face; red dots that looked like freckles; fatigue; nausea; throwing up; fever; experienced arm discomfort; This is a spontaneous report from a contactable other hcp (Nurse). This nurse (mother) reported for a 23-year-old female patient (daughter) that, A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 09Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 09Aug2021, the patient had arm discomfort (limb discomfort). On 10Aug2021, the patient developed fatigue, nausea, throwing up (vomiting), fever (pyrexia). On 11Aug2021, the patient had rash on her face, red dots that looked like freckles (rash), petechiae and is spreading to her neck (petechiae), red rash on her face (rash erythematous). Therapeutic measures were taken as a result of fatigue (fatigue), nausea (nausea), throwing up (vomiting), fever (pyrexia). The events fatigue, nausea, throwing up and fever that was resolved by taking Tylenol. The clinical outcome for the other events was Unknown.  Information about lot/batch has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: one side of face swollen; hives to one side of her face; This is a spontaneous report from a contactable consumer. This contactable consumer reported that a 16-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) at right arm at single dose for COVID-19 immunisation on 10Aug2021 at 3:45 pm (16-year-old at the time of vaccination). Relevant history was none. Relevant concomitant drug was none.  The patient woke up with one side of face swollen with hives at the next morning (11Aug2021). The mother told her to take Benadryl and she had taken that so far. The patient had gone to a clinic.  The outcome of events was not resolved; the hives and swelling to one side of her face were worsened.  Relevant lab test was none.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heart disease, COPD, and diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller received the first dose of the Pfizer Covid-19 vaccine on 01Apr2021 and started having complaints of shortness of breath that lasted one day. Caller's HCP was informed of the shortness of breath and advised Caller to not receive the second dose of the Pfizer Covid-19 vaccine but then later advised the Caller to get the second dose. Caller was told by a retail pharmacy that they would not give her the second dose of the Pfizer Covid-19 vaccine because it was more than 42 days from her first dose. After the first dose of the Pfizer covid 19 vaccine in Feb, the caller had shortness of breath. The caller's PCP told her to not get the second dose, so she didn't. The caller later clarifies and confirms that her first dose was on 01Apr. The caller recently went to get the second dose and Pharmacy name refused since it had been after the 42 days that Pfizer recommends. That night the caller started to feel like she couldn't breathe and then it went away after a day. Then the caller's PCP said it was okay for her to get the second dose but when she went to pharmacy, they said it was too many days between the two doses. The outcome of the event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Feeding disorder, Headache, Malaise
Clinical narrative: sick/not feeling well; ache; diarrhea; headache; dehydration; hasn't been able to eat and she is only eating popsicles; nausea; vomiting; muscle pain and aches; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 07Aug2021 (at the age of 62 years) as dose 1, single for covid-19 immunisation. The patient medical history included Covid-19 on an unspecified date. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat, nausea and vomiting. This was the patients first day out of bed, she reported being very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat and she was only eating popsicles. Patient said her main concern has been her nausea and vomiting. Patient said that she did not experience coughing or shortness of breath, like when she had covid. Patient asked how these side effects will last. Patient stated that she was terrified to get the second dose of the vaccine and was thinking about not taking the second dose. Patient added that she contacted her doctor about her symptoms from the first dose and was informed that she could not be seen because of the risk. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Vomiting
Clinical narrative: sick/not feeling well; ache; diarrhea; headache; dehydration; hasn't been able to eat and she is only eating popsicles; nausea; vomiting; muscle pain and aches; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 07Aug2021 (at the age of 62 years) as dose 1, single for covid-19 immunisation. The patient medical history included Covid-19 on an unspecified date. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat, nausea and vomiting. This was the patients first day out of bed, she reported being very sick, having muscle pain and aches, diarrhea, headache, not feeling well, experienced dehydration, has not been able to eat and she was only eating popsicles. Patient said her main concern has been her nausea and vomiting. Patient said that she did not experience coughing or shortness of breath, like when she had covid. Patient asked how these side effects will last. Patient stated that she was terrified to get the second dose of the vaccine and was thinking about not taking the second dose. Patient added that she contacted her doctor about her symptoms from the first dose and was informed that she could not be seen because of the risk. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: dysphagia; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A female patient of an unspecified age 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 on 01Aug2021 as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient received the first dose of the vaccine on 01Aug2021. She reported dysphagia 1day post vaccination on 02Aug2021, and which still ongoing. Patient wants to know if these side effects were reported. If patients had these side effects how were they treated. The outcome for the event was reported as not resolved at the time of this report.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable other-healthcare professional. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 intramuscular, administered in Arm Left on 17Feb2021 (Lot Number: EN5318) as single dose and dose 1 intramuscular, administered in Arm Right on 27Jan2021 (Lot Number: EN5318) as single dose (Age at Vaccination: 31 Years) for covid-19 immunization. The patients medical history included motor vehicle accident (MVC) (recovering from an MVC). The patient's concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 09Aug2021, patient developed symptoms of loss of taste and smell and tested positive for COVID by nasal swab test. Adverse events resulted doctor or other healthcare professional office/clinic visit. Treatment information was unknown. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available the lack of efficacy of the vaccine BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infection; This is a spontaneous report from a non-contactable consumer and a employee.  A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dosefor covid-19 immunisation.  Medical history was none.  Patient was not pregnant. There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ear infection on Aug2021.  The event resulted in Doctor or other healthcareprofessional office/clinic visit. Treatment included antibiotic. The outcome of the event was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Menstruation delayed, Menstruation irregular, Oligomenorrhoea
Clinical narrative: My menstrual cycle came late in April (5weeks); My menstrual cycle came late in April (5weeks) and then I had another cycle 2 weeks later and it lasted 13 days; My cycles have been very irregular since; I became pregnant in June and miscarried; This is a spontaneous report from a contactable consumer (patient). A 38 years old female patient received the second dose of BNT162B2 (Batch/lot number: EN6205) at right arm for COVID-19 immunisation on 30Mar2021 at 15:30 (38 years old at the time of vaccination). The patient was not pregnant at time of vaccination. Relevant history included Hashimitos, hypothyroidism, and allergies: Bactrim, adhesive, wasps.  Relevant concomitant drug included Armour Thyroid, multi-vitamin. The patient previously received the first dose of BNT162B2 (Batch/lot number: EN6202) at right arm for COVID-19 immunisation on 09Mar2021 at 15:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's menstrual cycle came late in April (5weeks) and then she had another cycle 2 weeks later and it lasted 13 days. Her cycles had been very irregular since 22Apr2021.  The patient became pregnant in June and miscarried. The outcome of events was unknown.  The patient had visited the doctor or other healthcare professional office/clinic visit.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.    Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Menopausal symptoms, Palpitations
Clinical narrative: She hasn't had menopause in 10 years but is now experiencing hot flashes and menopause symptoms; She hasn't had menopause in 10 years but is now experiencing hot flashes and menopause symptoms; racing heart; very exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 27Jul2021 (at the age of 64 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has not had menopause in 10 years but on an unspecified date in 2021 she was experiencing hot flashes and menopause symptoms as well as racing heart and being very exhausted. The school district she works for was now mandating vaccines and her doctor this year was new and does not want to give her an exemption. She wanted to know if the side effects from the second dose are worse than the first dose. Patient wanted to know what information was available regarding menstrual changes, from the studies how many people were post-menopausal women and how many of them had side effects, were others having hormonal side effects. Patient concerned about my daughter who was in her childbearing years, what was this doing to her. Patient stated she knows its affecting her hormonally. Patient stated everyone was pushing the vaccine, the CDC, the TV, and the drug companies but no one gives a darn about the people having side effects. After the vaccination clinic there was no follow up about my side effects, she had to go out to report it. No one wants to hear it. Its not okay. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Tachycardia
Clinical narrative: tachycardia; pain in her chest; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 31Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tachycardia, pain in her chest. Patient wanted to know if it was recommended to get the 2nd dose of the vaccine. Patient stated that she was concerned about the probability for myocarditis from the second dose and that was why she was calling. She stated that she read people have been getting myocarditis from the second vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: He tested positive for COVID-19 after being fully vaccinated.; He tested positive for COVID-19 after being fully vaccinated.; This is a spontaneous report from a other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular route of administration in right arm on 26Jan2021 (at the age of 51-year-old) (Batch/Lot Number: EN5318) as dose 1, single and via intramuscular route of administration in right arm on 16Feb2021 (at the age of 51-year-old) (Batch/Lot Number: EN5318) as dose 2, single for COVID-19 immunisation at workplace clinic. Medical history was not reported. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced he tested positive for covid-19 after being fully vaccinated on 28Jul2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR (sars-cov-2 test): positive on 28Jul2021, test type was nasal swab. The patient did not receive any treatment for the events.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of COVID-19. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: welts to the lower part of her back; lower part of her back that are itching; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Patient). A 74-years-old 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 on 07Aug2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the Pfizer COVID vaccine on this past Saturday 07Aug2021, patient stated she has welts to the lower part of her back that were itching and spreading to her lower legs on unknown date in Aug2021. Patient was looking for treatment recommendations. The outcome for the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 after being fully vaccinated.; Tested positive for COVID-19 after being fully vaccinated.; This is a spontaneous report from a contactable nurse (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via Intramuscularly, in Arm Left, on 26Jan2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via Intramuscularly, in Arm Left, on 16Feb2021, as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes and high blood pressure. The patient did not have known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jul2021, the patient was tested positive for COVID-19 after being fully vaccinated. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR test (nasal swab): positive on 24Jul2021. The patient received steroids and antibiotic tablets as treatment for the events. Outcome of the events was not recovered.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 after being fully vaccinated; Tested positive for COVID-19 after being fully vaccinated; This is a spontaneous report from a contactable nurse. A 58-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN5318), dose 1 intramuscular, administered in left arm on 26Jan2021 (at the age of 58 years) as a single dose, and dose 2 intramuscular, administered in the left arm on 17Feb2021 (Batch/Lot Number: EN5318) (at the age of 58 years) as a single dose for COVID-19 immunisation. The patient had no medical history and took no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for COVID-19 after being fully vaccinated. On 22Jul2021, PCR Nasal Swab was positive. The patient was seen by a doctor or other healthcare professional office/ clinic visit. The patient received no treatment. The outcome of tested positive for COVID-19 was recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Fatigue, Feeling abnormal, Headache, Partial seizures
Clinical narrative: focal seizure; feeling off; Hands were shaking; eyes fluttering; Blurry vision; headache for a few hours; Feeling tired; This is a spontaneous report received from a contactable Other Health Professional (patient). A 37-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 10Aug2021 16:45 (at the age of 37-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included Epilepsy and major depression, Grand mals. known allergies: No. Pregnant at the time of vaccination: No. Concomitant medications included lamotrigine; fluoxetine hydrochloride (PROZAC).  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine: No. The patient experienced focal seizure, feeling off, Hands were shaking, eyes fluttering, blurry vision, headache for a few hours, all on 10Aug2021 22:00 with outcome of recovered on 11Aug2021, feeling tired on 10Aug2021 22:00 with outcome of recovering. Clinical course: Approx 5 hours after the shot the patient was awaken feeling off, the patient was an epileptic and the patient started experiencing the symptoms of a focal seizure, hands were shaking, eyes fluttering, blurry vision etc . The patient's seizures were well controlled and she had never experienced tremors with her focal seizures only when she had had grand mals which had been over 8 years ago. The patient experienced a headache for a few hours afterwards but issues have been resolved by morning except feeling tired which was common for her after her seizures. Adverse events were not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event partial seizures and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: focal seizure; feeling off; Hands were shaking; eyes fluttering; Blurry vision; headache for a few hours; Feeling tired; This is a spontaneous report received from a contactable Other Health Professional (patient). A 37-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in left arm on 10Aug2021 16:45 (at the age of 37-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included Epilepsy and major depression, Grand mals. known allergies: No. Pregnant at the time of vaccination: No. Concomitant medications included lamotrigine; fluoxetine hydrochloride (PROZAC).  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine: No. The patient experienced focal seizure, feeling off, Hands were shaking, eyes fluttering, blurry vision, headache for a few hours, all on 10Aug2021 22:00 with outcome of recovered on 11Aug2021, feeling tired on 10Aug2021 22:00 with outcome of recovering. Clinical course: Approx 5 hours after the shot the patient was awaken feeling off, the patient was an epileptic and the patient started experiencing the symptoms of a focal seizure, hands were shaking, eyes fluttering, blurry vision etc . The patient's seizures were well controlled and she had never experienced tremors with her focal seizures only when she had had grand mals which had been over 8 years ago. The patient experienced a headache for a few hours afterwards but issues have been resolved by morning except feeling tired which was common for her after her seizures. Adverse events were not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event partial seizures and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Menstruation delayed
Clinical narrative: has not had her period since May; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 47-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 28Mar2021 at the age of 46-year-old, as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS, Had it for over 20 years now) from 1998 and ongoing, lost vision because the MS progressed (taken a lot of her vision. She could still see, but not good at all), it was even worse now and she was legally blind, she couldn't see and drive any more and needed a magnifying glass. She had hearing loss, bowel movement issues, and urinary but those are MS things too. The patient's concomitant medications were not reported, nothing new within two weeks of having her last period in May. The patient previously received first dose of BNT162B2 in left arm on 07Mar2021 at the age of 46-year-old for covid-19 immunisation. The patient reported that she did not have her menstrual cycle sine May2021. She had a history of multiple sclerosis, and was disabled, her doctor did not think she was going through menopause. The last menstrual period started on 12May2021. She has not had her period since May2021. Her average weight was around 140. During COVID quarantine the gym was closed and she was not exercising as much, so she gained some weight. She had a physical trainer due to her vision. She couldn't believe the period. She hated her period and couldn't stand it. She has more health here. When she went to her MS doctor, they took her normal blood because of medications she was on. When she was at PCP, she took her blood. She gave blood test to check to see if she was pregnant. She was just being precautious. The outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.