chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Vaccination site rash
Clinical narrative: 5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped; 5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped; developed the "Covid arm" rash around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 13:00 (at the age of 37 years), (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for covid-19 immunisation at medical facility. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included venlafaxine; buspirone and phentermine taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6204) for covid-19 immunisation. The Patient stated, "5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped. It had been extremely heavy the entire time. I also developed the "Covid arm" rash around the injection site". The events resulted in visit to Physician office. Treatment received for events was unknown. The clinical outcome of the events was not recovered at the time of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dermatitis contact, Feeling abnormal, Herpes zoster
Clinical narrative: confirmed shingles diagnosis; Poison Ivy type rash on torso front and back; pain in rib on left side of body; aches and pain in all joints; Chills; Sweats; Felt Awful; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0162, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Apr2021 19:15 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization, at pharmacy or drug Store. The patient medical history included Bi-Polar disorder. Concomitant medications included lithium (LITHIUM), liothyronine sodium (LIOTHYRONINE SOD.), and levetiracetam (LEV). The patient had no known allergies. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 27Mar2021 at 07:15 PM (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. No COVID test was performed post vaccination. It was reported that, the patient felt awful (the week of 25Apr-01May) on 25Apr2021. On 26Apr2021, experienced sweats, chills, and aches and pain in all joints. On 30Apr2021, developed pain in rib on left side of body. The patient thought he had moved the wrong way. On 03May2021, experienced poison ivy type rash on torso front and back. The patient called doctor, who put her on "1 gm Vyosyclovir". On 04May2021, confirmed shingles diagnosis in office. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The patient received "1 grm Vyocyclovir 2x/day" as treatment. The outcome of the events was reported as not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Musculoskeletal chest pain
Clinical narrative: confirmed shingles diagnosis; Poison Ivy type rash on torso front and back; pain in rib on left side of body; aches and pain in all joints; Chills; Sweats; Felt Awful; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0162, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 17Apr2021 19:15 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization, at pharmacy or drug Store. The patient medical history included Bi-Polar disorder. Concomitant medications included lithium (LITHIUM), liothyronine sodium (LIOTHYRONINE SOD.), and levetiracetam (LEV). The patient had no known allergies. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 27Mar2021 at 07:15 PM (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. No COVID test was performed post vaccination. It was reported that, the patient felt awful (the week of 25Apr-01May) on 25Apr2021. On 26Apr2021, experienced sweats, chills, and aches and pain in all joints. On 30Apr2021, developed pain in rib on left side of body. The patient thought he had moved the wrong way. On 03May2021, experienced poison ivy type rash on torso front and back. The patient called doctor, who put her on "1 gm Vyosyclovir". On 04May2021, confirmed shingles diagnosis in office. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The patient received "1 grm Vyocyclovir 2x/day" as treatment. The outcome of the events was reported as not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Heavy menstrual period ongoing from the start of my cycle; On and off cramps; breast tenderness; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:30 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 50-year-old) for covid-19 immunisation. Medical history included unusual periods, menopause from 2020 to an unknown, heavy menstrual bleeding from an unknown date and unknown if ongoing. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Patient did not receive other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heavy menstrual period ongoing from the start of my cycle, on and off cramps, breast tenderness on 28Apr2021. It was reported that Heavy menstrual period ongoing from the start of my cycle on 28/29Apr. On and off cramps and breast tenderness. Although I have had unusual periods with clots being passed due to menopause for the last year. It had never ever lasted this long in my entire life. The outcome for all events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Headache, Herpes zoster, Hyperhidrosis
Clinical narrative: headache; stuffy nose; fever; sweating; ears blocked; sore arm; shingles; felt like a car ran me over; This is a spontaneous report from a contactable consumer or other non hcp.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced headache (headache) (non-serious) on an unspecified date with outcome of unknown , stuffy nose (nasal congestion) (non-serious) on an unspecified date with outcome of unknown , fever (pyrexia) (non-serious) on an unspecified date with outcome of unknown , sweating (hyperhidrosis) (non-serious) on an unspecified date with outcome of unknown , ears blocked (ear discomfort) (non-serious) on an unspecified date with outcome of unknown , sore arm (limb discomfort) (non-serious) on an unspecified date with outcome of unknown , shingles (herpes zoster) (non-serious) on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of , shingles (herpes zoster).
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: headache; stuffy nose; fever; sweating; ears blocked; sore arm; shingles; felt like a car ran me over; This is a spontaneous report from a contactable consumer or other non hcp.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced headache (headache) (non-serious) on an unspecified date with outcome of unknown , stuffy nose (nasal congestion) (non-serious) on an unspecified date with outcome of unknown , fever (pyrexia) (non-serious) on an unspecified date with outcome of unknown , sweating (hyperhidrosis) (non-serious) on an unspecified date with outcome of unknown , ears blocked (ear discomfort) (non-serious) on an unspecified date with outcome of unknown , sore arm (limb discomfort) (non-serious) on an unspecified date with outcome of unknown , shingles (herpes zoster) (non-serious) on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of , shingles (herpes zoster).
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy/Caller is calling about a family member who received the first dose and felt Bell's Palsy; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable Pharmacist reported for a 28-year-old male patient that received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced bell's palsy/caller was calling about a family member who received the first dose and felt bell's palsy. It was reported that her concern was now for the second dose because he had held off because he doesn't want to get Bell's Palsy again because it took some time to resolve and it could affect his work. Caller stated she would like to know why was it a difference in the labeling and was there a way to get a medical exemption for the second dose at this time because of that. Caller would like to know what guidance does Pfizer suggest for her family member to receive the second dose of the vaccine. Caller stated he was seen by a physician and put on medicines and so on. Caller states the main reason for this call was the difference that she found in the other country versus what she could find here. Caller stated was it not still the Pfizer vaccine. Caller stated she was hoping Pfizer would have more information about their drug elsewhere but they do not and this very disappointing. Caller stated if you cant get the information from the manufacturer and don't know it gets a little frustrating. Caller stated unfortunately this was her second call to Pfizer and she knows where we are coming from and this is not that helpful which is too bad because there was not for sure a cause and effect of anything and in one labeling it says its a rare side effect and in another it doesn't and it just doesn't make sense to her. At the time of this report, the outcome of event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event Bell's palsy cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tongue ulceration
Clinical narrative: Ulcers on tongue; administration date: 12May2021, dose 2; administration date: 28Apr2021, dose 1.; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 12May2021 at 08:00 (at the age of 17-year-old), as dose 2, single for COVID-19 immunization. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 28Apr2021 at 16:00 (at the age of 17-year-old), as dose 1, single for COVID-19 immunization. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 08:00, the patient experienced administration date: 12May2021, dose 2; administration date: 28Apr2021, dose 1. On 13May2021, the patient experienced ulcers on tongue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen and cold liquids. The clinical outcome of the event ulcers on tongue was not recovered at the time of this report and outcome of another event was unknown.   The lot number for the vaccine (BNT162b2) was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Gastritis, Menstruation irregular
Clinical narrative: body aches; muscular pains; Chills; Bone pain; Fever; uterus pain as if I were about to get my period /uterus is hurting; nausea; vomiting; fatigue; gastritis; period lasting 2 weeks/early menstrual period; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16May2021 (at the age of 46 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation and experienced fevers, nausea, vomiting and early menstrual period that lasted for 15 days. On an unspecified date, consumer reported that she was so terrible, since 2 days ago she have had body aches, muscular pains and she was in bed right now. Consumer reported that yesterday she got her second vaccine dose and afterwards has experienced chills, bone pain, body aches, fever, nausea, vomiting, gastritis and once again, uterus pain as if she were about to get her period and her uterus was hurting along with fatigue, an early menstrual period, a period lasting for 2 weeks. She also took omeprazole for her gastritis. Consumer reported that she has never experienced this before, and reports having gone to the emergency room twice (not admitted to the hospital) where she reported being told that this was a normal side effect from the vaccine. Consumer reported that she has heard many reports of women experiencing heavy or changed periods after getting the vaccine and she wanted to make sure it was normal and that it was not going to cause any permanent long-term damage. The outcome of all events as unknown.  Information about lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Uterine pain
Clinical narrative: body aches; muscular pains; Chills; Bone pain; Fever; uterus pain as if I were about to get my period /uterus is hurting; nausea; vomiting; fatigue; gastritis; period lasting 2 weeks/early menstrual period; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16May2021 (at the age of 46 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation and experienced fevers, nausea, vomiting and early menstrual period that lasted for 15 days. On an unspecified date, consumer reported that she was so terrible, since 2 days ago she have had body aches, muscular pains and she was in bed right now. Consumer reported that yesterday she got her second vaccine dose and afterwards has experienced chills, bone pain, body aches, fever, nausea, vomiting, gastritis and once again, uterus pain as if she were about to get her period and her uterus was hurting along with fatigue, an early menstrual period, a period lasting for 2 weeks. She also took omeprazole for her gastritis. Consumer reported that she has never experienced this before, and reports having gone to the emergency room twice (not admitted to the hospital) where she reported being told that this was a normal side effect from the vaccine. Consumer reported that she has heard many reports of women experiencing heavy or changed periods after getting the vaccine and she wanted to make sure it was normal and that it was not going to cause any permanent long-term damage. The outcome of all events as unknown.  Information about lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: body aches; muscular pains; Chills; Bone pain; Fever; uterus pain as if I were about to get my period /uterus is hurting; nausea; vomiting; fatigue; gastritis; period lasting 2 weeks/early menstrual period; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16May2021 (at the age of 46 year) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation and experienced fevers, nausea, vomiting and early menstrual period that lasted for 15 days. On an unspecified date, consumer reported that she was so terrible, since 2 days ago she have had body aches, muscular pains and she was in bed right now. Consumer reported that yesterday she got her second vaccine dose and afterwards has experienced chills, bone pain, body aches, fever, nausea, vomiting, gastritis and once again, uterus pain as if she were about to get her period and her uterus was hurting along with fatigue, an early menstrual period, a period lasting for 2 weeks. She also took omeprazole for her gastritis. Consumer reported that she has never experienced this before, and reports having gone to the emergency room twice (not admitted to the hospital) where she reported being told that this was a normal side effect from the vaccine. Consumer reported that she has heard many reports of women experiencing heavy or changed periods after getting the vaccine and she wanted to make sure it was normal and that it was not going to cause any permanent long-term damage. The outcome of all events as unknown.  Information about lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Whole body (and teeth) started to shiver severely beyond my control; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration in arm right on 17May2021 at 16:45 (at the age of 38-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient 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 not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 17May2021, the patient experienced i was able to walk away after 30 minutes but it was a traumatic experience and on 17May2021 at 16:45, the patient experienced whole body and teeth started to shiver severely beyond my control. The patient reported right after receiving his Pfizer first dose, his whole body and teeth started to shiver severely beyond his control. He wasn't feeling cold or anything bad apart from that. That lasted for about 15 minutes or so and then it got milder by time. The pharmacist called an ambulance and paramedics checked his vital signs. He was able to walk away after 30 minutes but it was a traumatic experience. The events resulted in emergency room visit. It was unknown if the patient received treatment for the events. The patient recovered from the event on an unspecified date in May2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Shingles; rash in one leg; Pain in leg; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. After receiving the second dose of COVID-19 vaccine last 10May2021, that's Pfizer COVID-19 vaccine. So, patient experienced pain in the leg, rash in one leg and had shingles. So 10May2021 was Monday, so he had pain in the leg Tuesday, Wednesday is rash in the leg, one leg and had shingles Thursday. The outcome of the events was unknown.  Information on lot number/batch number was requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Colonoscopy, Decreased appetite, Dizziness, Endoscopy
Clinical narrative: Nausea; loss of appetite; unintended weight loss; chronic fatigue; weakness; light headed; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCIBE Solution for injection Lot Number: EN6207) via an unspecified route of administration in arm left on 23Mar2021 as dose 1, single and bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0158) via an unspecified route of administration in arm right on 23Mar2021 as dose 2, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included COPD, fibromyalgia, depression, allergies, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and tested COVID post vaccination. On 23Mar2021 12:00 PM, the patient experienced nausea, loss of appetite, unintended weight loss, chronic fatigue, weakness, light headed. The adverse event resulted in doctor or other healthcareprofessional office/clinic visit. Treatment received was medication endoscopy colonoscopy MRI. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on 09May2021, MRI resulted as unknown on an unknown date, endoscopy resulted as unknown on an unknown date, colonoscopy resulted as unknown on an unknown date. The clinical outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Magnetic resonance imaging, Nausea, SARS-CoV-2 test
Clinical narrative: Nausea; loss of appetite; unintended weight loss; chronic fatigue; weakness; light headed; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCIBE Solution for injection Lot Number: EN6207) via an unspecified route of administration in arm left on 23Mar2021 as dose 1, single and bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0158) via an unspecified route of administration in arm right on 23Mar2021 as dose 2, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included COPD, fibromyalgia, depression, allergies, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and tested COVID post vaccination. On 23Mar2021 12:00 PM, the patient experienced nausea, loss of appetite, unintended weight loss, chronic fatigue, weakness, light headed. The adverse event resulted in doctor or other healthcareprofessional office/clinic visit. Treatment received was medication endoscopy colonoscopy MRI. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on 09May2021, MRI resulted as unknown on an unknown date, endoscopy resulted as unknown on an unknown date, colonoscopy resulted as unknown on an unknown date. The clinical outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Nausea; loss of appetite; unintended weight loss; chronic fatigue; weakness; light headed; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCIBE Solution for injection Lot Number: EN6207) via an unspecified route of administration in arm left on 23Mar2021 as dose 1, single and bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0158) via an unspecified route of administration in arm right on 23Mar2021 as dose 2, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included COPD, fibromyalgia, depression, allergies, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and tested COVID post vaccination. On 23Mar2021 12:00 PM, the patient experienced nausea, loss of appetite, unintended weight loss, chronic fatigue, weakness, light headed. The adverse event resulted in doctor or other healthcareprofessional office/clinic visit. Treatment received was medication endoscopy colonoscopy MRI. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on 09May2021, MRI resulted as unknown on an unknown date, endoscopy resulted as unknown on an unknown date, colonoscopy resulted as unknown on an unknown date. The clinical outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Rash erythematous, Vaccination site erythema
Clinical narrative: Pruritis; Redness around the injection site that spread down her left arm; rash appeared as a raised linear wheal with surrounding erythema; rash appears most similarly to dermatographic urticaria.; This is a spontaneous report from a contactable physician.A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20May2021 at 13:45 (at the age of 14-year-old) as dose 1, single for COVID-19 immunization.The patient had no known allergies to medications, food or other products. Medical history included childhood asthma. Concomitant medications included drospirenone; ethinylestradiol betadex clathrate (YAZ) and iron supplementation (MANUFACTURER UNKNOWN).Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.It was unknown if patient received any other vaccines within four weeks prior to the vaccination.On 20May2021 at 13:45 PM, within 15 minutes of receiving the first vaccine, the patient developed pruritis and redness around the injection site that spread down her left arm. The rash appeared as a raised linear wheal with surrounding erythema, but no pain or sloughing of skin. She had no difficulty breathing, no swelling of her tongue or throat, no fevers/chills/malaise. The patient was well in the ED and the rash appears most similarly to dermatographic urticaria.Therapeutic measures were not taken as a result of the events. The events resulted in emergency room/department visit or urgent care. The patient recovered from all events in May2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swelling upper and lower lip areas, down to about the chin; Hives; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration administered in Left arm on 14May2021 at 12:00 (53-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included hives (had episodes in recent months) from an unknown date and unknown if ongoing. The patient had allergies to birch, dust mites, some grasses and Seasonal allergies. Concomitant medications included antihistamines (unspecified) from an unknown date for unknown indication. Historical vaccine included, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration administered in Left arm on 23Apr2021 at 12:00 PM (53-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 16May2021 21:00, the patient experienced swelling upper and lower lip areas, down to about the chin. Some hives reappeared, but the patient had episodes in recent months. No therapeutic measures were taken as a result of the reported events. The outcomes of events were recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Hypoaesthesia, Muscular weakness, Panic attack
Clinical narrative: Tingling; Very mild numbing sensation in the vaccinated arm (left arm); Left hand started warming up; Heart rate became rapid; Shaking uncontrollably; muscles became incredibly weak; panic attack; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 29-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: not reported/ Lot number: unknown) via an unspecified route of administration in left arm on 08May2021 at 17:00 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date to unknown stop date. Concomitant medications were not reported. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the vaccination. After receiving first vaccination, the patient was ushered to the waiting room to wait 15 minutes. On 08May2021 at 17:05, about after 5 minutes after sitting in chair, the patient noticed slight tingling and very mild numbing sensation in the vaccinated arm which was left arm. Then the patient had started warming up and the sensation progressed to the left side of face. The sensation did not proceed to move to the right side of the body. However, the patient's heart rate became rapid, was shaking uncontrollably and muscles became incredibly weak. The patient stated against the will of her muscles she was shaking like a person with Parkinson's disease. The patient made it to the counter to alert the nurse. The patient stated to nurse that she might be having a panic attack but had no idea what would have triggered it and she never experienced anything on this level. The staff proceeded to set patient back down in chair and fan was switched on. The patient did not need it as by that time, literally only about 4 minutes into this episode, the patient's body was beginning to calm down and was totally fine over after 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight tingling and very mild numbing sensation, warming up and the sensation progressed to the left side of face, shaking uncontrollably, muscles became incredibly weak and panic attack were resolved on 08May2021 at 17:35.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Tingling; Very mild numbing sensation in the vaccinated arm (left arm); Left hand started warming up; Heart rate became rapid; Shaking uncontrollably; muscles became incredibly weak; panic attack; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 29-year-old non pregnant female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: not reported/ Lot number: unknown) via an unspecified route of administration in left arm on 08May2021 at 17:00 (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date to unknown stop date. Concomitant medications were not reported. Prior to vaccination, patient was diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the vaccination. After receiving first vaccination, the patient was ushered to the waiting room to wait 15 minutes. On 08May2021 at 17:05, about after 5 minutes after sitting in chair, the patient noticed slight tingling and very mild numbing sensation in the vaccinated arm which was left arm. Then the patient had started warming up and the sensation progressed to the left side of face. The sensation did not proceed to move to the right side of the body. However, the patient's heart rate became rapid, was shaking uncontrollably and muscles became incredibly weak. The patient stated against the will of her muscles she was shaking like a person with Parkinson's disease. The patient made it to the counter to alert the nurse. The patient stated to nurse that she might be having a panic attack but had no idea what would have triggered it and she never experienced anything on this level. The staff proceeded to set patient back down in chair and fan was switched on. The patient did not need it as by that time, literally only about 4 minutes into this episode, the patient's body was beginning to calm down and was totally fine over after 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight tingling and very mild numbing sensation, warming up and the sensation progressed to the left side of face, shaking uncontrollably, muscles became incredibly weak and panic attack were resolved on 08May2021 at 17:35.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Off label use, Product use issue
Clinical narrative: flu like symptoms for 3-4 days; nurse a 9 month old; nurse a 9 month old; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration in the right arm on 20Apr2021 at 15:45 as dose 2, single for COVID-19 immunisation (at the age of 29-year-old). The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of the COVID vaccine. The patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number was unknown), via an unspecified route of administration and location on 30Mar2021 at 15:45 as dose 1, single for COVID-19 immunisation (at the age of 29-year-old). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was breastfeeding a 9-month-old male fetus and the baby ingested some of her blood due to latch issues at the time of vaccination. On 21Apr2021 at 04:00, the patient experienced "flu like symptoms for 3-4 days". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event flu like symptoms was recovered (reported with a duration of 3-4 days) on an unknown date in Apr2021.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy
Clinical narrative: blood clot disorder; This is a spontaneous report received from contactable consumer, the patient via Medical Information from Pfizer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 19May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced blood clot disorder. She was not asked about this on the 1st dose. 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: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I am having trouble breathing and feel like my lungs do not hold as much air and retain as much oxygen.; This is a spontaneous report from a contactable consumer (Other HCP, patient). A 23-year-old male patient (age at vaccination: 23 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization at nursing home/senior living facility. The patient's medical history included Tourette s syndrome and sleep apnea. Concomitant medications were not reported. The patient did not have known allergies. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he was having trouble breathing and feel like my lungs do not hold as much air and retain as much oxygen on an unspecified date. There was no hospitalization prolonged. The adverse event result in emergency room/department or urgent care. It was unknown if the patient received treatment. Outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pruritus, Swelling, Vaccination site erythema
Clinical narrative: erythema was seen around site of vaccination.; swelling; pruritus; bruising; erythema; This is a spontaneous report from a contactable physician. A adult female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. On 28Feb2021, the patient experienced erythema, swelling, pruritus. The patient was presented 45-60 days later to clinic with persistent pruritus in upper extremities and around the knee and inner thigh. Erythema was seen around site of vaccination. Bruising and erythema were in other locations as well. The physician was unsure if it was from the vaccine or resultant scratching due to pruritus. Therapeutic measures were taken as a result of erythema, swelling, pruritus and bruising and included treatment with loratidine (MANUFACTURER UNKNOWN) and topical steroids (MANUFACTURER UNKNOWN). The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcomes of the events erythema, swelling, pruritus, erythema was seen around site of vaccination and bruising in other locations as well was unknown at the time of reporting.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up  Follow up (16Sep2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: headache; chills; Fatigue; sleepless night; 101.5 degree fever; weak; flu like feeling; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19May2021 15:00 (at the age of 49-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid prior vaccination from an unknown date and unknown if ongoing. There were no concomitant medications. Patient previously took first dose of bnt162b2 (Batch/Lot number was not reported) administered in Left arm on28Apr2021 03:00 PM (at the age of 49-years-old) for covid-19 immunisation and patient experienced chills, headache, was lethargic which lasted 24 hours. Patient previously had Covid in late October and also recently had an antibody test that was positive for short term and long term antibodies in Apr2021 prior to the Pfizer vaccines. The second vaccines effects were much greater and patient had headache, chills, fatigue, sleepless night, 101.5 degree fever, weak, flu like feeling, all events on 19May2021, lasted 36 hours. Patient did not receive any treatment for adverse events. The patient had not received any other vaccine within 4 weeks and other medications in two weeks. Patient had not been tested since the vaccination. Patient did not have any known allergies. It was reported that Pfizer needed to study whether or not those who had Covid and still had antibodies need two vaccines. Seems like the guidance was one size fits all and was not make sense. Could it be studied as to whether one dose was adequate for those that have had Covid. Reporter felt worse from the vaccine each time then when he did have Covid. Outcome of all events were recovered on an unspecified date in 2021.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.