chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 2nd of 14 reports.   An elderly patient (more than 65 years) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 3rd of 14 reports.   An elderly patient (more than 65 years) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is the 4th of 14 reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Testing positive for COVID after receiving vaccine; Testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 14 patients. This report is for 5th of 14 patients. An elderly patient (more than 65 years old) of an unspecified gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced testing positive for COVID on 21Jan2021 after receiving vaccine. Since they were testing positive, physician wanted to administer Bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing positive for COVID  based on the known safety profile. However the short duration of 8 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021063794 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 6th of 14th reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (Lily drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 7th of 14 reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, there was  a reasonable possibility that the reported events were related to the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 8th of 14 reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 14 patients. This is the 9th of 14 reports.  An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It is reported patient testing positive for COVID after receiving vaccine. 8 Patients and 6 workers at a long-term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they are testing positive, physician wants to administer bamlanivimab (drug being administered under FDA EUA). Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021063794 Same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist reported similar events for 14 patients. This is 10th of 14th reports.   An elderly patient (more than 65 years old) of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing positive for COVID based on the known safety profile. However the short duration of 8 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021063794 as reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 11th of 14 report. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown a not available/provided to reporter at the time of report completion), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. For concomitant medications, it was unknown if other vaccine in four weeks or other medications in two weeks. The patient was testing positive for COVID after receiving vaccine. A total of 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The events start date was 21Jan2021, and resulting in doctor or other healthcare professional office/clinic visit. It was reported as unknown if treatment was taken for the events. The outcome of the events was unknown. It was unknown if patient had COVID prior to this vaccination. The patient had been tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "testing positive for COVID after receiving vaccine".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar event for 14 patients. This is 12th of fourteen reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 as reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 13th of 14 report. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown a not available/provided to reporter at the time of report completion), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. For concomitant medications, it was unknown if other vaccine in four weeks or other medications in two weeks. The patient was testing positive for COVID after receiving vaccine. A total of 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (drug being administered under FDA EUA). The events start date was 21Jan2021, and resulting in doctor or other healthcare professional office/clinic visit. It was reported as unknown if treatment was taken for the events. The outcome of the events was unknown. It was unknown if patient had COVID prior to this vaccination. The patient had been tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "testing positive for COVID after receiving vaccine".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is the 14th of 14 reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (Lily drug being administered under ). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "testing positive for COVID after receiving vaccine".,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel well after having received the second dose of the Pfizer COVID vaccine; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reporter that last week on a zoom call for work, a male participant told the group that he was not turning on his camera because he did not feel well after having received the second dose of the Pfizer COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: The 1st shot I had terrible arm pain, this time I took 2 Aleve and didn't have all that pain. What I had the 1st time was a ringing/buzzing in my ears/head. I again have the same thing this time.; This is a spontaneous report from a contactable healthcare professional who is also the patient.  A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL3249), intramuscularly, on 11Jan2021 at 06:45 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history includes status as pre-diabetic. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EL1284) on 21Dec2020 at 04:45 in the left arm. The patient is allergic to epinephrine, norethindrone and Comtrex. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication was reported as "none." Prior to the vaccination the patient had not received any other vaccination within the last four weeks.  On an unspecified date after the second vaccination, the patient experienced ringing/buzzing in her ears/head. She explained that after the first shot she had ringing/buzzing in her ears/head (AER 2020508246) and she again has the same thing this time. She commented that it never really went away before having this second shot. She also said that she only really hears the buzzing when things are quiet.  As treatment for the event ringing and buzzing in the head, the patient's primary care physician told her to take "Ginkgo" which she says helps somewhat. The clinical outcomes of the ringing/buzzing in the ear was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 14Jan2021 14:00 at single dose at left arm for covid-19 immunization. Medical history included thyroid disorder, irritable bowel syndrome diarrhea, colitis microscopic, low B12, low D, diarrhoea. Concomitant medication included levothyroxine for thyroid disorder, calcium, magnesium for colitis microscopic, cyanocobalamin (VIT B12) for low B12, vitamin d3 for low D, polycarbophil calcium (FIBERCON) for irritable bowel syndrome diarrhea, bifidobacterium infantis (ALIGN) for irritable bowel syndrome diarrhea, loperamide from May2020 for diarrhea, TRI Adrenopan for loss of adrenal function, multivitamin for losing vitamins; all ongoing. Right away after getting the vaccine, during the wee hours of the morning between 14Jan2021 and 15Jan2021 she got very severe diarrhea. Mentioned she previously had microscopic colitis so she was used to having some diarrhea so she didn't remember exactly the time in the night. Adds since that night she had been having six liquid stools a day. She was having to wear depends and can't go out of the house. Patient microscopic colitis was under control but now she had real bad diarrhea for seven days. Originally they thought she had IBSD, referring to irritable bowel syndrome diarrhea, but then they found out it was microscopic colitis. This condition predated treatment with Pfizer COVID 19 vaccine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The event required contacting the gastroenterologist and primary care by the portal. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Eye swelling, Hypersensitivity, Pruritus
Clinical narrative: it seemed she was so close to anaphylactic reaction; slight itching; swollen eyes; itchy throat; super red ears; generalized hives; rash; progressive hypersensitivity reaction; anxious; This is a spontaneous report from a non-contactable nurse(patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 at single dose for COVID-19 immunization. Medical history included skin asthma with severe eczema and severe allergy when she moved. Day 1 to 7 post-vaccine, there was no reaction, the patient was super fine. The patient remembered that on Day 4, she had slight itching relieved by loratadine (CLARITIN), just like her usual allergy symptoms. From Day 8 to Day 12, she had progressive hypersensitivity reaction that led to her swollen eyes, itchy throat, super red ears and generalized hives. It started as a rash similar to her usual allergy. She ended up going to urgent care by herself since her husband was at work, because it seemed she was so close to anaphylactic reaction (?). At first, loratadine was working but at the time of report, it did not work for the events. She was not admitted because there was no shortness of breath. The patient was on close monitoring for progression of symptoms starting on 22Jan2021. She was anxious and was having second thoughts of getting the second dose of the vaccine. According to her, she had skin asthma with severe eczema, so maybe, the vaccine was not to be recommended to persons with severe allergies like her. She had severe allergies when she moved and was planning to see an allergologist soon. The outcome of slight itching was recovering, of the events were not reported.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the time association and drug's safety profile, the event anaphylactic reaction is possibly related to suspect vaccine BNT162B2 administration. 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat irritation, Urticaria
Clinical narrative: it seemed she was so close to anaphylactic reaction; slight itching; swollen eyes; itchy throat; super red ears; generalized hives; rash; progressive hypersensitivity reaction; anxious; This is a spontaneous report from a non-contactable nurse(patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 at single dose for COVID-19 immunization. Medical history included skin asthma with severe eczema and severe allergy when she moved. Day 1 to 7 post-vaccine, there was no reaction, the patient was super fine. The patient remembered that on Day 4, she had slight itching relieved by loratadine (CLARITIN), just like her usual allergy symptoms. From Day 8 to Day 12, she had progressive hypersensitivity reaction that led to her swollen eyes, itchy throat, super red ears and generalized hives. It started as a rash similar to her usual allergy. She ended up going to urgent care by herself since her husband was at work, because it seemed she was so close to anaphylactic reaction (?). At first, loratadine was working but at the time of report, it did not work for the events. She was not admitted because there was no shortness of breath. The patient was on close monitoring for progression of symptoms starting on 22Jan2021. She was anxious and was having second thoughts of getting the second dose of the vaccine. According to her, she had skin asthma with severe eczema, so maybe, the vaccine was not to be recommended to persons with severe allergies like her. She had severe allergies when she moved and was planning to see an allergologist soon. The outcome of slight itching was recovering, of the events were not reported.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the time association and drug's safety profile, the event anaphylactic reaction is possibly related to suspect vaccine BNT162B2 administration. 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: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Vomiting, Wheezing
Clinical narrative: Coughing; Wheezing; Vomiting; Loss of appetite; This is a spontaneous report from a contactable consumer (daughter) reported for her mother that a 95-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm, on 20Jan2021 at single dose for covid-19 immunization. Medical history included atrial fibrillation in last 2 months in 2020 and ongoing; pacemaker inserted from 2020 to 2020, inserted about 2 months ago, also mentioned approximately Oct2020. She just had her second follow-up related to this day before getting first dose of Pfizer COVID-19 Vaccine. No notable results or information from that follow-up appointment. broken hip in Oct2020 and surgery for broken hip performed on 27Oct2020. The patient's concomitant medications were not reported. This daughter is the caregiver for her mother but is not a healthcare professional. She reported her mother was administered the first dose of Pfizer COVID-19 Vaccine on 20Jan2021. Starting 22Jan2021 around 08:45 she had onset of coughing; wheezing; vomiting; and loss of appetite. She wanted to know if these events could be related to the Pfizer COVID-19 Vaccine. Events outcome described as improved; the patient's nurse reported to daughter that they have subsided at this time. No adverse events required a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer suspect. Patient did not have any vaccinations within four weeks prior to the first administration date of the suspect vaccine. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Dysgeusia, Eye pruritus, Lacrimation increased, Mammogram
Clinical narrative: nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound breast, Weight
Clinical narrative: nipple drainage; itchy and watery eyes; itchy and watery eyes; sore arm; metallic taste; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. The patient took vaccine for work, and to get back to a normal life. The patient's medical history and concomitant medications were both reported as none. Shortly after her first dose of the vaccine, she developed nipple drainage. She didn't know if it was coincidental or what. She hadn't noticed it prior to the vaccine. She a work up with a mammogram and ultrasound. There were no masses or anything else. They showed no reason to have the drainage. She was unsure of her weight, but would get 140 or 150 lbs. With the first vaccine, she experienced a sore arm. It started the evening of the 30Dec2020 about 4-6 hours after the vaccine. That resolved, and she recovered completely. She also experienced a metallic taste in her mouth. It happened initially on 30Dec2020. She recovered completely. It only lasted a couple of hours. They were both not serious. She had noticed an increase in the itchy and watery eyes on an unknown date. It was ongoing and persisting. The patient underwent lab tests and procedures which included mammogram: normal, ultrasound breast: normal, weight: 140 or 150 lbs, all on an unknown date. The outcome of the nipple drainage was unknown, the outcome of the events sore arm and metallic taste was recovered on 30Dec2020, the outcome of the events increase in the itchy and watery eyes was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Condition aggravated, Eye pruritus, Fatigue, Lacrimation increased
Clinical narrative: itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the second dose; nipple drainage/increased again after the second dose; exhausted; nausea; low grade fever; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 30Dec2020 for COVID-19 immunization and experienced nipple drainage, sore arm, metallic taste in mouth, itchy and watery eyes. The nipple drainage decreased before getting the second dose, and then increased again after the second dose. She noticed an increase in the drainage on 21Jan2021. It was a yellowish to clearish drainage. She was wondering if there was any correlation. She was curious if other women have noticed this. She was unsure of her weight, but would get 140 or 150 lbs. She didn't have a prescribing doctor. She got it through her employer. Also she experienced other side effects. After the second dose she experienced different side effects. She experienced a low grade fever. It started on 19Jan2021 evening into 20Jan2021 morning. It lasted for 18- 24 hours. She recovered completely, and it was not serious. She also developed muscle aches on 19Jan2021, 6-8 hours after the second vaccine. She felt better now. She had a rough night last night. She has been doing Advil, and it had helped significantly. That stated on 19Jan2021. It had improved, and it was not serious. She had also been exhausted after the second vaccine. That started 20 hours after. It started the 20Jan2021. It was ongoing, but had improved. It was not serious. She developed the nausea six hours later on the 19Jan2021. It had improved, but she was not 100%. It was not serious. She had been taking Tylenol and Advil for event low grade fever and muscle aches. She had noticed an increase in the itchiness and watery eyes (She didn't know if it was related to winter and allergies or the vaccine.). It was ongoing and persisting. The outcome of the event low grade fever was recovered on 20Jan2021, of the events muscle aches, exhausted, nausea was recovering, of the events itchiness and watery eyes was not recovered, of the other events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: itchiness and watery eyes; itchiness and watery eyes; nipple drainage/increased again after the second dose; nipple drainage/increased again after the second dose; exhausted; nausea; low grade fever; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 30Dec2020 for COVID-19 immunization and experienced nipple drainage, sore arm, metallic taste in mouth, itchy and watery eyes. The nipple drainage decreased before getting the second dose, and then increased again after the second dose. She noticed an increase in the drainage on 21Jan2021. It was a yellowish to clearish drainage. She was wondering if there was any correlation. She was curious if other women have noticed this. She was unsure of her weight, but would get 140 or 150 lbs. She didn't have a prescribing doctor. She got it through her employer. Also she experienced other side effects. After the second dose she experienced different side effects. She experienced a low grade fever. It started on 19Jan2021 evening into 20Jan2021 morning. It lasted for 18- 24 hours. She recovered completely, and it was not serious. She also developed muscle aches on 19Jan2021, 6-8 hours after the second vaccine. She felt better now. She had a rough night last night. She has been doing Advil, and it had helped significantly. That stated on 19Jan2021. It had improved, and it was not serious. She had also been exhausted after the second vaccine. That started 20 hours after. It started the 20Jan2021. It was ongoing, but had improved. It was not serious. She developed the nausea six hours later on the 19Jan2021. It had improved, but she was not 100%. It was not serious. She had been taking Tylenol and Advil for event low grade fever and muscle aches. She had noticed an increase in the itchiness and watery eyes (She didn't know if it was related to winter and allergies or the vaccine.). It was ongoing and persisting. The outcome of the event low grade fever was recovered on 20Jan2021, of the events muscle aches, exhausted, nausea was recovering, of the events itchiness and watery eyes was not recovered, of the other events was unknown.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Swelling
Clinical narrative: Swelling; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, hyaluronic acid (RESTYLANE, Restylane kysse), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication as fillers. The patient's medical history and concomitant medications were not reported. The reporter became aware of a case in Israel wherein a patient previously treated with Restylane and Teosyal fillers had swelling at the filler placement sites after her first Pfizer vaccine injection. The reporter stated that here's a high-level summary of what the reporter had on the cases to-date that involve the Pfizer vaccine. It included this patient in US. It was reported that Vaccine (Dose#): Pfizer: (2), date: 05Jan2021 The patient experienced swelling at the filler placement sites. The action taken in response to the event for hyaluronic acid was unknown. The outcome of event was recovered on unknown date.  No follow-up attempts are Possible; information about batch/ lot number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Limb discomfort, SARS-CoV-2 test
Clinical narrative: Lost all sense of smell and taste; Lost all sense of smell and taste; Pain in the injection site; Chills that he could not shake; Upper arm discomfort; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 16Jan2021, the patient had upper arm discomfort. On 17Jan2021, the patient had pain in the injection site and chills that he could not shake. On 20Jan2021, the patient had lost all sense of smell and taste. The outcome of the events was recovered on 19Jan2021 for 'upper arm discomfort'; was recovering for 'chills that he could not shake'; was not recovered for 'lost all sense of smell and taste'; and was unknown for 'pain in the injection site'. The patient had COVID-19 test on 08Jan2021 (results were not provided).  Information about lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lost all sense of smell and taste; Lost all sense of smell and taste; Pain in the injection site; Chills that he could not shake; Upper arm discomfort; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 16Jan2021, the patient had upper arm discomfort. On 17Jan2021, the patient had pain in the injection site and chills that he could not shake. On 20Jan2021, the patient had lost all sense of smell and taste. The outcome of the events was recovered on 19Jan2021 for 'upper arm discomfort'; was recovering for 'chills that he could not shake'; was not recovered for 'lost all sense of smell and taste'; and was unknown for 'pain in the injection site'. The patient had COVID-19 test on 08Jan2021 (results were not provided).  Information about lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Blood pressure measurement, Hypertension
Clinical narrative: He felt like he was having an asthma attack; Blood pressure became elevated; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283), via an unspecified route of administration at right arm on an unspecified date at 77 years old at 09:30 AM at single dose for covid-19 immunization. Medical history included diabetes, sarcoidosis, hypertension, asthma, Idiopathic thrombocytopenic purpura, sleep apnea, arthritis. Known allergies included X-ray dye and statin medications. Concomitant medication included insulin, amlodipine, folic acid, nebivolol hydrochloride (BYSTOLIC), eicosapentaenoic acid ethyl ester (VASCEPA). No other vaccine in four weeks. No covid prior vaccination and Covid tested was not post vaccination. He felt like he was having an asthma attack and his blood pressure became elevated. He had to wait in the ER until they gave him his blood pressure medicine (Norvasc), a diuretic and an antacid (Pepcid). Adverse event start date was 22Jan2021 10:00 AM. The events resulted in: Emergency room/department or urgent care. Outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous report from a Contactable consumer (patient).  A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Fl3249), via an unspecified route of administration in left arm on 19Jan2021 13:00 at first single dose for COVID-19 immunization. Medical history included high cholesterol, gastrooesophageal reflux disease (GERD), dry eye syndrome, covid-19 (covid prior vaccination). Known allergies: No. Concomitant medication included atorvastatin, fish oil, pantoprazole. No other vaccine received in four weeks. The patient experienced tachycardia, shortness of breath, rigors, muscle pain, fatigue, headache, on 20Jan2021 02:30 AM. Events resulted in: Emergency room/department or urgent care. Events treatment inluded: Fluids, tylenol, clonazepam. Covid was not tested post vaccination. Outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous report from a Contactable consumer (patient).  A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Fl3249), via an unspecified route of administration in left arm on 19Jan2021 13:00 at first single dose for COVID-19 immunization. Medical history included high cholesterol, gastrooesophageal reflux disease (GERD), dry eye syndrome, covid-19 (covid prior vaccination). Known allergies: No. Concomitant medication included atorvastatin, fish oil, pantoprazole. No other vaccine received in four weeks. The patient experienced tachycardia, shortness of breath, rigors, muscle pain, fatigue, headache, on 20Jan2021 02:30 AM. Events resulted in: Emergency room/department or urgent care. Events treatment inluded: Fluids, tylenol, clonazepam. Covid was not tested post vaccination. Outcome of the events was recovering.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Vertigo
Clinical narrative: soreness on left shoulder; stomach spasm; vertigo; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (lot number: ek4176), via an unspecified route of administration in left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization.  Medical history included glaucoma, gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia (Bhp), and cholesterol. Concomitant medications included tamsulosin, metoprolol, and travoprost. Patient experienced soreness on left shoulder, stomach spasm and vertigo started on day 4 of vaccine on 15Jan2021 21:30. Patient went to hospital ER on tenth day after vaccine and released from hospital ER after 2.5 hours. AE result in: Emergency room/department or urgent care. Treatment was not received for these events. Outcome of the events was resolving.