chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Off label use, Pyrexia, Vomiting
Clinical narrative: hot; sweaty; feeling tired; weak all over and couldn't stand up; She got a third booster dose on 01Sep2021; She got a third booster dose on 01Sep2021; She felt like she would faint.; throwing up; fever/temperature; This is a spontaneous report from a contactable consumer received from regulatory authority.   A 74-year old female consumer (patient) reported that she received the booster third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6205 or ED6205),  into the right arm on 01Sep2021 between 9:45AM and 10:00AM (at the age of 74-years-old) at single dose for COVID-19 immunization. The patient had received her second dose of BNT162B2 on 06Apr2021 and the first dose on 14Mar2021 (Lot Number: EN6199). Medical history included breast cancer diagnosed in 2013 and she had chemo and radiation through the first part of 2014. Concomitant drugs included Evista on it for about a year and a half for osteopenia and calcium supplements and vitamins and minerals for her thyroid.  The patient reported that after her third dose on day 4 after vaccination (05Sep2021) she had a set back of hot, sweaty, temperature, fever all over and she couldn't stand up. This has since resolved however she is still feeling tired.  She stated that was at church and teaching at school and it was so embarrassing. She came home and laid down. Her daughter called her other daughter that is a nurse. She said to get caller off her feet and just watch her. The sweating finally went away. Caller was throwing up, but not a lot. She thinks it was because she had not eaten much that morning. She had a small piece of toast. It has all cleared up. Within 2 to 3 hours she was totally better. She got up and took a shower because she sweated so badly. It knocked her off her feet. Nothing has ever knocked her off her feet like that. That is the only reason she called. She had never had a reaction like that ever, not with the other two. It all started in the morning at 9:30AM. All of a sudden she had to grab a chair and sit down. Her knees were like jelly. She got hot. She felt like she would faint. All of this occurred within 4 days of getting booster. Tiredness has improved some and she was able to come back to work. It was like she had stomach virus and that is what she was hoping.The patient doesn't think it was associated to BNT162B2.   The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Ulcer haemorrhage
Clinical narrative: Bleeding ulcers; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6205) at the age of 70-years-old as single dose for covid-19 immunization. Medical history included a bariatric bypass surgery 15 years ago. the patient on unspecified date in Oct2021 had received flu vaccine and  It made his arm sore for 5 days . There were no concomitant medications. The patient had received the first dose of the same vaccine on 13Feb2021, from lot  EL9267. The patient experienced bleeding ulcers on Aug2021 with outcome of recovered.  The patient was hospitalized for bleeding ulcers, which currently he had to receive 2 blood transfusions in the hospital. Last week he took a blood sample that was taken by his GI doctor and it revealed he has no immunity or antibodies for the Covid 19 right now. He is also Covid negative when checked by hospital. The patient stated he no longer has bleeding ulcer, but has to be on a drug regimen for the next 3 months from the GI doctor and basically for the rest of his life be taking Omeprazole once daily to prevent and too much acid from building up or happening.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Biopsy skin, Blood test, Dermatitis atopic, Rash
Clinical narrative: Also diagnosed with AFIB; Rash broke out all over body within 7-10 days of vaccine; Atopic dermatitis; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:15 (at the age of 75-year-old) (Batch/Lot Number: EN6198) as single dose for COVID-19 immunisation.  Medical history included high blood pressure, mild heart attack-stent, high chlolesterol. The patient had not experienced Covid-19 prior vaccination. Concomitant medication(s) included metoprolol tartrate (manufacturer unknown); atorvastatin calcium (manufacturer unknown); ramipril (manufacturer unknown); amlodipine besilate (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously took terbinafine hydrochloride (LAMISIL) orally for foot fungus and experienced ageusia 30 years ago.  No other vaccine in four weeks. The patient experienced rash broke out all over body within 7-10 days of vaccine (non-serious) on 03Mar2021 with outcome of not recovered, atopic dermatitis (non-serious) on 03Mar2021 with outcome of not recovered, also diagnosed with AFIB (non-serious) on 29Apr2021 with outcome of unknown. Event rash broke out all over body resulted in Doctor or other healthcare professional office/clinic visit. The course of events was as follows: On 03Mar2021 rash broke out all over body within 7-10 days of Vaccine. He had 6 visits to Dermatologist. He received 2 series of Prednisone 20 mg, steroid ointment/creams. He had skin biopsy, blood work and no definite conclusion (atopic dermatitis). Also diagnosed with AFIB 29Apr2021 (emergency room--cardioversion) not sure or origin but, still fighting this skin rash. The patient underwent lab tests and procedures which included biopsy skin: unknown results on 21May2021 No definite conclusion (atopic dermatitis), blood test: unknown results on 21May2021 No definite conclusion (atopic dermatitis), Sars-cov-2 test: negative on 21May2021. Therapeutic measures were taken as a result of rash broke out all over body within 7-10 days of vaccine, atopic dermatitis.  Follow-up attempts are completed. Lot/batch number has been requested. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Also diagnosed with AFIB; Rash broke out all over body within 7-10 days of vaccine; Atopic dermatitis; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:15 (at the age of 75-year-old) (Batch/Lot Number: EN6198) as single dose for COVID-19 immunisation.  Medical history included high blood pressure, mild heart attack-stent, high chlolesterol. The patient had not experienced Covid-19 prior vaccination. Concomitant medication(s) included metoprolol tartrate (manufacturer unknown); atorvastatin calcium (manufacturer unknown); ramipril (manufacturer unknown); amlodipine besilate (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously took terbinafine hydrochloride (LAMISIL) orally for foot fungus and experienced ageusia 30 years ago.  No other vaccine in four weeks. The patient experienced rash broke out all over body within 7-10 days of vaccine (non-serious) on 03Mar2021 with outcome of not recovered, atopic dermatitis (non-serious) on 03Mar2021 with outcome of not recovered, also diagnosed with AFIB (non-serious) on 29Apr2021 with outcome of unknown. Event rash broke out all over body resulted in Doctor or other healthcare professional office/clinic visit. The course of events was as follows: On 03Mar2021 rash broke out all over body within 7-10 days of Vaccine. He had 6 visits to Dermatologist. He received 2 series of Prednisone 20 mg, steroid ointment/creams. He had skin biopsy, blood work and no definite conclusion (atopic dermatitis). Also diagnosed with AFIB 29Apr2021 (emergency room--cardioversion) not sure or origin but, still fighting this skin rash. The patient underwent lab tests and procedures which included biopsy skin: unknown results on 21May2021 No definite conclusion (atopic dermatitis), blood test: unknown results on 21May2021 No definite conclusion (atopic dermatitis), Sars-cov-2 test: negative on 21May2021. Therapeutic measures were taken as a result of rash broke out all over body within 7-10 days of vaccine, atopic dermatitis.  Follow-up attempts are completed. Lot/batch number has been requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I broke out in hives around my trunk and arms; This is a spontaneous report from a contactable nurse (patient).   A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported. The patient experienced "I broke out in hives around my trunk and arms" on an unspecified date with outcome of unknown. The patient went to the ER.  They had given her packs of Benadryl and steroids.   The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Off label use
Clinical narrative: came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; came in to receive the Pfizer Covid-19 booster dose/patient received Moderna for the original 2-dose series; This is a spontaneous report from a contactable pharmacist.     A 69-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. The patient medical history and concomitant was not reported. Patient previously took Moderna dose 1 and dose 2 for covid 19 immunization. It was Reported that, Caller is a pharmacist who reports a patient (69 years old, female) came in to receive the Pfizer Covid-19 booster dose. Caller reported that the patient received Moderna for the original 2-dose series and is inquiring about additional information regarding this scenario. Pfizer has no information regarding the interchangeability of Covid-19 vaccines, however the CDC released interim considerations regarding interchangeability. Refer to the attached document and states "The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses. Pfizer is independent of these recommendations the patient experienced came in to receive the pfizer covid-19 booster dose/patient received moderna for the original 2-dose series on an, came in to receive the pfizer covid-19 booster dose/patient received moderna for the original 2-dose series on an unspecified date with outcome of unknown.   Follow-up (07Sep2021): This is a follow-up spontaneous report from a pharmacist reported information included.  Follow-up (07Sep2021):This is a follow-up spontaneous report from a pharmacist reported information included
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate irregular
Clinical narrative: having elevated heart rate; dizzy/Lightheaded; blood pressure being elevated/blood pressure a little elevated; Episodes of spike in heart rate; This is a spontaneous report from a contactable consumer (patient). A female consumer of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Sep2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for covid-19 immunisation. On 04Sep2021, the day after the vaccine, the patient started having elevated heart rate, resting 123 beat per minute (BPM); since then, the patient was having episodes elevated heart rate, blood pressure being elevated and dizzy. The patient had been trying to get in and of course no one was taking walk-ins, most appointments were booked. Pharmacist indicated because they are more like episodes rather than it being elevated consistently and uncontrollable, not thinking medical emergency. In 04Sep2021, blood pressure was little elevated, and heart rate was 123 (resting heart rate). The outcome of the events was unknown. Follow-up attempts are completed. The batch/lot number is not available despite the follow-up attempts made. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: having elevated heart rate; dizzy/Lightheaded; blood pressure being elevated/blood pressure a little elevated; Episodes of spike in heart rate; This is a spontaneous report from a contactable consumer (patient). A female consumer of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Sep2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for covid-19 immunisation. On 04Sep2021, the day after the vaccine, the patient started having elevated heart rate, resting 123 beat per minute (BPM); since then, the patient was having episodes elevated heart rate, blood pressure being elevated and dizzy. The patient had been trying to get in and of course no one was taking walk-ins, most appointments were booked. Pharmacist indicated because they are more like episodes rather than it being elevated consistently and uncontrollable, not thinking medical emergency. In 04Sep2021, blood pressure was little elevated, and heart rate was 123 (resting heart rate). The outcome of the events was unknown. Follow-up attempts are completed. The batch/lot number is not available despite the follow-up attempts made. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph node, axillary, ipsilateral to vaccine administration site. 10.5 cm (4.0+ inches). Tender. Mobile.; This is a spontaneous report from a contactable physician.    A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Sep2021 12:45 (Lot Number: FE3592) as dose number unknown, single (at the age of 53 years old) for COVID-19 immunisation. Medical history included hypercholesterolaemia, no allergies. Concomitant medications were not reported. On 07Sep2021 02:00, the patient experienced enlarged lymph node, axillary, ipsilateral to vaccine administration site. 10.5 cm (4.0+ inches). Tender. Mobile. The outcome of the events was not recovered. No treatment required. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The event lymphadenopathy was considered related to suspect drug based on temporal association and known safety profile of the drug.   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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Electromyogram, Pain in extremity, Ultrasound scan
Clinical narrative: Two weeks after her first dose she started feeling pain in her leg on left side, excruciating pain.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This is the second of two reports.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm on 09Jun2021 10:30 (Lot Number: EW0191; Expiration Date: 30Sep2021) as single dose (at the age of 59 years old) for COVID-19 immunisation.  Medical history none. There were no concomitant medications. The patient experienced that two weeks after her first dose she started feeling pain in her leg on left side, excruciating pain in Jun2021 with outcome of recovered. The event required a visit to the emergency room and a visit to the physician's office. No treatment was required. She went to the ER and they did a sonogram but did not see a DVT. That's why it took so long to get the second dose since she was concerned. Her leg pain went away. Then she decided to get the second dose and all hell broke loose. The patient underwent lab tests and procedures which included on unknown date electroencephalogram: normal  (it looks like it was normal), electromyogram: normal (it looks like it was normal, ultrasound scan: did not see a DVT.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101168866 Same patient/Vaccine, different event, different vaccine dose
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Pain in arm; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. 21K-163-4065072-00) from a non-contactable female consumer (patient) reported for herself.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 09Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 66 years old) for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at Citrate Free for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose intramuscular of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE on 12Feb2021 for COVID-19 immunisation On an unspecified date in 2021, the patient experienced rheumatoid arthritis flare up (medically significant), pain in arm. The outcome of the events was unknown. The action taken in response to the events for adalimumab was not applicable.  The reporter's causality for the event(s) of rheumatoid arthritis flare up with Humira (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of sore arm with Humira (ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events Rheumatoid arthritis and Pain in extremity are assessed as possibly related to the suspect drug BNT162B2 based on causal association but consider also possible contributory effects from patient's medical history and/or concomitant medications.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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19; Patient tested positive for COVID-19; This is a spontaneous report from a contactable Pfizer employee.     A female patient of an unspecified age received bnt162b2 (BNT162B2) dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  tested positive for covid-19  (medically significant) in Aug2021 with outcome of recovered in 2021.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   in Aug2021.  Prior to vaccination,  the patient was not diagnosed with COVID-19 Since the vaccination the patient has been tested for COVID-19?  Information about Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cardiac stress test, Migraine
Clinical narrative: congestive heart failure; 48 hours migraine; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose number unknown via an unspecified route of administration on an unspecified date (at an unspecified age of vaccination) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history was not reported. There were no concomitant medications.  The patient experienced congestive heart failure (medically significant) in 2021 with outcome of unknown, 48 hours migraine (medically significant) in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included; cardiac stress test: 30% on 2021 down from 65%.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Drug ineffective, Fatigue, Insomnia
Clinical narrative: She then contracted COVID 19 virus; She then contracted COVID 19 virus; feeling tired; arm pain; nausea; stomach ache; not being able to sleep at night anymore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in arm on 28Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter's daughter was concerned about getting the vaccine because she had heard that it could cause problems with fertility. Caller stated that she was scheduled to have injections in her knees that would be a series and the medication started with a VO. She would like to know if she could still have these injections done after having the second dose of the vaccine. Relayed to caller that there was no information on drug interaction with the vaccine at this time. Referred to let HCP know of recent health events and vaccination prior to the shots being given to discuss possible interactions. She had side effects with the first dose of the Pfizer COVID 19 vaccine of felt tired, arm pain, nausea, stomach ache, and she reported not being able to sleep at night anymore but she was unsure if that was due to the vaccine or the COVID virus. She would like to know if the second dose of the vaccine would cause her to have worse side effects or not. Caller stated that she was being transferred when she was disconnected. She relayed that she had spoke with multiple departments and she was unsure of what departments she spoke to. After 1 dose of vaccine, she contracted COVID 19 virus and received an antibody infusion to decrease her illness. After the vaccine, she was tested positive Covid 19 virus. She would like to know if this was true and if you had to wait to get the vaccine second dose for this case. Relayed to caller that there was no information at this time on the amount of time she should wait to receive the second dose after receiving the said infusion to decrease Covid 19 symptoms. She relayed that she was told that she needed to wait 90 days before getting her second dose of the vaccine. Referred to speak with site where she received the infusion and an HCP to discuss further. Someone told her to get the vaccine second dose (information withheld). She stated that her doctor pasted away and so she did not have a doctor at that time. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date in 2021. The outcome of all events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, SARS-CoV-1 test
Clinical narrative: She then contracted COVID 19 virus; She then contracted COVID 19 virus; feeling tired; arm pain; nausea; stomach ache; not being able to sleep at night anymore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in arm on 28Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter's daughter was concerned about getting the vaccine because she had heard that it could cause problems with fertility. Caller stated that she was scheduled to have injections in her knees that would be a series and the medication started with a VO. She would like to know if she could still have these injections done after having the second dose of the vaccine. Relayed to caller that there was no information on drug interaction with the vaccine at this time. Referred to let HCP know of recent health events and vaccination prior to the shots being given to discuss possible interactions. She had side effects with the first dose of the Pfizer COVID 19 vaccine of felt tired, arm pain, nausea, stomach ache, and she reported not being able to sleep at night anymore but she was unsure if that was due to the vaccine or the COVID virus. She would like to know if the second dose of the vaccine would cause her to have worse side effects or not. Caller stated that she was being transferred when she was disconnected. She relayed that she had spoke with multiple departments and she was unsure of what departments she spoke to. After 1 dose of vaccine, she contracted COVID 19 virus and received an antibody infusion to decrease her illness. After the vaccine, she was tested positive Covid 19 virus. She would like to know if this was true and if you had to wait to get the vaccine second dose for this case. Relayed to caller that there was no information at this time on the amount of time she should wait to receive the second dose after receiving the said infusion to decrease Covid 19 symptoms. She relayed that she was told that she needed to wait 90 days before getting her second dose of the vaccine. Referred to speak with site where she received the infusion and an HCP to discuss further. Someone told her to get the vaccine second dose (information withheld). She stated that her doctor pasted away and so she did not have a doctor at that time. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date in 2021. The outcome of all events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hormone level abnormal, Inflammation, Urticaria, Vaginal infection
Clinical narrative: Metallic taste in mouth; Hives all over; Flare in inflammation or pudendal nerve; Spike in hormone level; Vaginal inflammation; Vaginal infection; Change in vision; This is a spontaneous report received from a contactable other healthcare professional (patient). A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:00 (both doses at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included pudendal neuralgia, lichen sclerosis, pelvic congestion, covid-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The most recent COVID-19 vaccine facility was administered in workplace clinic. The patient experienced metallic taste in mouth, hives all over, flare in inflammation or pudendal nerve, spike in hormone level, vaginal inflammation, vaginal infection, change in vision on 23Aug2021 10:00. Treatment was received for the events (prescription for infection). Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vulvovaginal inflammation
Clinical narrative: Metallic taste in mouth; Hives all over; Flare in inflammation or pudendal nerve; Spike in hormone level; Vaginal inflammation; Vaginal infection; Change in vision; This is a spontaneous report received from a contactable other healthcare professional (patient). A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 23Aug2021 10:00 (both doses at the age of 49-years-old) as dose 2, single for COVID-19 immunisation. Medical history included pudendal neuralgia, lichen sclerosis, pelvic congestion, covid-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The most recent COVID-19 vaccine facility was administered in workplace clinic. The patient experienced metallic taste in mouth, hives all over, flare in inflammation or pudendal nerve, spike in hormone level, vaginal inflammation, vaginal infection, change in vision on 23Aug2021 10:00. Treatment was received for the events (prescription for infection). Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Drug hypersensitivity, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: her heart rate was sky high; had an allergic reaction which was probably from the lidocaine in it and was intubated; coughing; oxygen was very low; wheezing; having a hard time breathing; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 23-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter reported that the patient received the second dose and within 2 hours had an allergic reaction which was probably from the lidocaine in it and was intubated. Reporter also added that patient was the one who rushed her to code and that the nurse was a 23-year-old co-worker who ended up with tubes in her throat. Reporter said the patient ended up coughing and all of a sudden, her heart rate was sky high, oxygen was very low, and she was wheezing and having a hard time breathing. The case assessed as serious (medically significant). The patient underwent lab tests and procedures which included heart rate: high and oxygen saturation: very low on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Wheezing
Clinical narrative: her heart rate was sky high; had an allergic reaction which was probably from the lidocaine in it and was intubated; coughing; oxygen was very low; wheezing; having a hard time breathing; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 23-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter reported that the patient received the second dose and within 2 hours had an allergic reaction which was probably from the lidocaine in it and was intubated. Reporter also added that patient was the one who rushed her to code and that the nurse was a 23-year-old co-worker who ended up with tubes in her throat. Reporter said the patient ended up coughing and all of a sudden, her heart rate was sky high, oxygen was very low, and she was wheezing and having a hard time breathing. The case assessed as serious (medically significant). The patient underwent lab tests and procedures which included heart rate: high and oxygen saturation: very low on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate variability test, Palpitations
Clinical narrative: She feels her heart is racing; This is a spontaneous report from a contactable consumer (Parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On Sep2021, the patient experienced she feels her heart is racing.   Reporter stated that her daughter received her 2nd shot yesterday for Covid 19 Vaccine and she saying that she feels her heart is racing today now, she guess her question is on the myocarditis stop when it does take the place, does the heart actually race or is just the way you feel it racing. When paraphrased the concern, Reporter stated, Correct and informed about role of Pfizer Drug Safety and Pfizer Medical Information and provided with the number as # and requested to dial and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. Reporter added, Where can she get the information as of today on Sunday instead of Monday because her daughter feels her heart is racing and she need medical information on that. Reporter was informed to contact physician and informed about call back requested when the Pfizer medical information department is open. However, Reporter deny for call back and stated, "No thats wont be necessary, she just call the doctor (Hence call back request was not made), thats should be all she need as far as thing she get. When requested for further probing, Reporter stated, she don't have time, she need to call a doctor, she need to call doctor because her daughter is serious, so she don't have time for question now. No further information could be probed as the reporter hung up the call abruptly. Hence, limited information available over the call. The patient underwent lab tests and procedures which included heart rate variability test: unknown on heart is racing. The outcome for the event she feels her heart is racing was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nervousness, Overdose, Product preparation issue
Clinical narrative: Instead of diluting the Pfizer Covid-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient; Instead of diluting the Pfizer Covid-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient; Chills really bad; real shaky; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a 15-year-old patient that, A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: FC3182), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Patient did not have any medical conditions. The patient experienced, instead of diluting the Pfizer COVID-19 vaccine with 1.8ml of Sodium Chloride, it was diluted with 0.8ml by a technician and it was given to a patient Chills really bad; real shaky. She was asking also what the effects because of this. The outcome of the events were unknown.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Heart rate, Heart rate decreased, Ligament sprain, Vital signs measurement
Clinical narrative: has bradycardia; sprained his ankle; his heart rate was 45/had a slow heart rate/he has never had a slow heart rate like that; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced has bradycardia. On an 12Sep2021, the patient sprained his ankle and his heart rate was 45/had a slow heart rate/he has never had a slow heart rate like that. The reporter stated, the 14 years old son received the Pfizer vaccine the first dose about three weeks ago and he received the first dose in a Vaccine three weeks ago, he was healthy with no medical history and today he sprained his ankle, so we had to take him to the ER and they took his vital signs and his heart rate was 45 and he is never had a heart condition or abnormal heart rate. So he was due to get the second dose of the vaccine. The reporter enquired if that was the side effect bradycardia or heart arrhythmia. The reporter asked if this was a side effects heard before. The reporter stated, the reporter don't know if it was a side effect of the Pfizer vaccine but he has never had a slow heart rate like that. So the reporter was supposed to take him for the second dose actually today and was not doing that. The reporter asked for opinion and recommendation as what should be the next step. The report was not related to a study or programme. On 12Sep2021, the patient underwent lab tests and procedures which included heart rate: 45 and vital signs: unknown result. The outcome of the events 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: U
Vaccine: COVID19
Symptoms: Cold sweat, Deformity, Fatigue, Syncope, Vomiting
Clinical narrative: I feel like I throw a roller coaster ride my body was moving I was sitting still I was trying to hang on to keep them falling; Felt faints; I almost passed up in that quiet; First shot really wipe me out; I break at cold sweat which it doesn't say cold sweat in here; It feels and my whole back was wet and then about 2 hours later I get up and I threw up all; I get up and I threw up all over the place; I felt like to be in the deformities; This is a spontaneous report from a Contactable Consumer. This 58-year-old consumer (Patient) received bnt162b2 ( BNT162B2,Formulation : Solution for injection, Batch/lot number: Not reported) dose 1, via an unspecified route of administration on 09Sep2021 as a single dose for (at the age of 58 year) Covid-19 immunization. Medical history include high blood pressure around February stayed around 124-128 from then on. Concomitant medication include BUSPIRONE HYDROCHLORIDE (BUSPAR), Magnesium (further clarification unknown hence not captured in tab) use for anxiety, Vitamin D NOS, doxazosin (not clarified hence not captured) for her prostrate to squeeze the prostrate when she pee. She already had her first shot and it really wipe her out. She just got the shot on Thursday about 2 or 3 o'clock and then she got home and  was okay until there. The time when she had dinner and was sitting there just conversing with her roommate and all of a sudden it came on. She felt like throw a roller coaster ride. Her body was moving she was sitting still she was trying to hang on to keep them falling and then she felt faints and almost passed up in that quiet. Her roommate had help her to the room to lay down and then she break at cold sweat which it doesn't say cold sweat in here it feels and her whole back was wet. About 2 hours later she got up and threw up all over the place. She felt like to be in the deformities but they didn't mention any roller coaster ride I have been on because it came she was just sitting and talking. All of a sudden a boom it just came on her and she felt better today. It was a roller coaster ride I was on. No recent lab test performed. The outcome of the events was unknown.  Reason for no lot number of Covid 19 vaccine: Other: Consumer stated, "30-30BA." (Consumer was not sure)  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Hyperaemia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; Mild case of COVID Sept 2021 - cough, congestion - up to 72 hours; This is a spontaneous report from 2 contactable consumers or other non-healthcare professionals. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), intramuscular, administered in arm right on 06Apr2021 12:30 (at the age of 25-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. Historical vaccine included bnt162b2 dose 1 intramuscular, administered in arm right on 26Mar2021 12:30 (Batch/Lot Number: EP6955) for covid -19 immunization. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 01Sep2021, the patient experienced mild case of covid sept 2021 - cough, congestion - up to 72 hours. Since the vaccination, the patient has been tested for COVID-19. On 13Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative with nasal swab. On an unspecified date in Sep2021. The outcome of the events was recovered on an unspecified date in Sep2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac failure, Dyspnoea, Extra dose administered, Fatigue
Clinical narrative: Heart failure; Weak; She wasn't sure if she was running a fever but feels really hot right now; She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking; felt weird; Headache; Extremely tired; received booster or third dose of product; a little ill; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received third dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number/ NDC number/ expiration date was not reported) via an unspecified route of administration on 13Sep2021 15:00 as dose 3, single for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date: not reported), via an unspecified route of administration on as dose 1, single and dose 2, single both for COVID-19 immunisation. On an unspecified date, the patient experienced heart failure. On 13Sep2021 15:00, the patient received booster or third dose of product. On the same day at 17:00, patient felt weird, headache, extremely tired and at 17:30, patient felt weak, she wasn't sure if she was running a fever but feels really hot right now. On 13Sep2021, she also mentioned she had started walking but she felt like she couldn't breathe. she had difficulty breathing while walking and little il. Additional information included that the caller is calling regarding the Pfizer COVID-19 vaccine. She received her booster or her third dose yesterday and by the time she got home she felt weird and a little ill around 5:00PM. She also stated that she experienced a headache, weakness, and she felt extremely tired. She also mentioned that she is still not feeling that great right now. She stated that she did good with the 2 previous doses of the Pfizer COVID-19 vaccine and only experienced side effects with the third dose. She also stated that she wasn't sure if she was running a fever but feels really hot right now. She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking. She also brought up her medical condition that she had, she has heart failure and she is taking medication for that. The agent did not get name of that medication. It is not specified if the caller had the heart failure prior to receiving the Pfizer COVID-19 vaccines. Outcome of the events was unknown.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.