chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172 and expiration date not provided), via an unspecified route of administration, administered in Arm Left on 07May2021 12:30 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included exhaustion in Jan 2021, memory issues in Jan 2021, dizzy spells in Jan 2021, and COVID-19 in Jan 2021. The patient was not pregnant at time of Vaccination. The patient's concomitant medications were not reported. The patient was The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left first dose on 15Apr2021 for COVID-19 immunization. On 07May2021 01:00, the patient experienced Painful shocking/stabbing feeling throughout entire body, tinnitus, fever, chills, body aches, headache, and covid symptoms. No treatment was given to the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vitreous detachment, Vitreous floaters
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8730) via an unspecified route of administration, administered on the left arm on 20Apr2021 11:45 as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included sertraline; beta carotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL); and ascorbic acid, beta carotene, copper, nicotinamide, selenium, tocopherol, xantofyl, zinc (LUTEIN +). On 22Apr2021, the patient experienced right eye "floater": posterior vitreous detachment. Doctor said probably not due to the vaccination, "just a coincidence". The event resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Investigation, Mental status changes, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:30 at 77 years old as 2nd dose, single for COVID-19 immunization. Medical history included hypertension from an unknown date. No medications received within 2 weeks of vaccination. No other vaccine received within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose BNT162B2 on an unspecified date (lot number: EN6200) for COVID-19 immunization on the left arm. On 14Apr2021, it was reported that patient had lost energy to get out of bed. Patient was transported to the emergency room with fevers and altered mental status. The patient was admitted in the hospital for 6 days from 14Apr2021 to 20Apr2021. The reporter considered the events to have caused disability. The patient received an unspecified treatment. Multiple tests were done to the patient on an unspecified date with unknown result. The patient had a COVID-19 test post vaccination via nasal swab on 15Apr2021 with a negative result. The outcome of the events was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Pallor, Wound
Clinical narrative: pale and lost consciousness; fell from seated position; hit head causing a two inch laceration behind ear; pale and lost consciousness; This is a spontaneous report from a contactable healthcare professional. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Arm Left on 08May2021 (Batch/Lot Number: ER8731) as 2nd dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 17Apr2021 (Batch/lot number: EW0162) for covid-19 immunisation. On 08May2021, the patient walked to observation area and sat down. After about five minutes, the patient became pale and lost consciousness. The patient fell from seated position onto concrete ground and hit head causing a two-inch laceration behind ear. Ambulance was called and evaluated patient. The patient refuse to sign with AMR. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported loss consciousness which subsequently led to a fall resulting in a two-inch laceration behind ear and the use of BNT162B2 cannot be fully 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Transverse sinus thrombosis
Clinical narrative: transverse sinus thrombosis; This is a spontaneous report from a non-contactable pharmacist. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced transverse sinus thrombosis on 01May2021 which caused hospitalization. Therapeutic measures were taken as a result of transverse sinus thrombosis. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Facial paralysis, SARS-CoV-2 test
Clinical narrative: Left facial palsy; Left facial palsy; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (Lot Number: Ew0173), via an unspecified route of administration, administered in left arm on 03May2021 10:15 (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included left facial palsy in 2017. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: Ew0158), administered in left arm on 12Apr2021 09:00 (at the age of 25-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced left facial palsy on 07May2021 11:30. The event resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab, SARS CoV2 test (qRT pcr assay) on 07May2021 with negative result.  Therapeutic measures were taken as a result of the event which included Prednisone 60mg taper for 12 days. The outcome of the event was not recovered.    No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Drug ineffective
Clinical narrative: Caller's husband received the second dose on 17MAR2021 and tested positive for the Covid virus on 25MAR2021; Caller's husband received the second dose on 17MAR2021 and tested positive for the Covid virus on 25MAR2021; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is one of two reports.  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose on 17Mar2021 and tested positive on 25Mar2021. The patient did not experience any symptoms with the COVID virus. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515627 same reporter/drug, different patient, similar events
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Body temperature increased, Discomfort, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07May2021 11:35 (lot number and expiration date not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine yesterday (07May2021) on 11:35 and the patient wanted to report some possible side effects, after that last night (07May2021), the patient's body temperature got a little bit up, but there was no problem, then this morning (08May2021) at about 5:00 am, the patient suddenly felt uncomfortable so, the patient got up and went to the bathroom, and then the patient suddenly felt like the patient's body temperature kind of dropped and the patient just felt like the patient was going to faint, and then according to the patient, "I found myself, I possibly loss conscious, I am not sure but I found myself on the bathroom floor. And then after 7 minute I just felt fine again, but it was kind of that the body temperature suddenly dropped and the I totally lost conscious, I am not sure." Outcome of 'possibly loss conscious/the patient totally lost conscious' was recovered on 08May2021, while outcome of the remaining events was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07May2021 11:35 (lot number and expiration date not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine yesterday (07May2021) on 11:35 and the patient wanted to report some possible side effects, after that last night (07May2021), the patient's body temperature got a little bit up, but there was no problem, then this morning (08May2021) at about 5:00 am, the patient suddenly felt uncomfortable so, the patient got up and went to the bathroom, and then the patient suddenly felt like the patient's body temperature kind of dropped and the patient just felt like the patient was going to faint, and then according to the patient, "I found myself, I possibly loss conscious, I am not sure but I found myself on the bathroom floor. And then after 7 minute I just felt fine again, but it was kind of that the body temperature suddenly dropped and the I totally lost conscious, I am not sure." Outcome of 'possibly loss conscious/the patient totally lost conscious' was recovered on 08May2021, while outcome of the remaining events was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain worsen after getting the first dose and is lingering; This is a spontaneous report from a non-contactable other health professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on an unspecified date (batch/lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included allergic to antibiotics. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced joint pain worsen after getting the first dose and was lingering on an unspecified date with outcome of not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product BNT162B2 to the development of event  Arthralgia cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 10:00 (lot number and expiration date not reported) at the age of 27 years old, as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Historical vaccination included first dose of BNT162B2 for COVID-19 immunization on an unspecified date (anatomical location: right arm). The patient fainted approximately 29 hrs after receiving dose on an unspecified date with outcome of recovered. 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 has not been tested for COVID-19. No treatment was given for the event. No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). This 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 15:45 as single dose for COVID-19 immunization. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications the patient received within 2 weeks of vaccination. On 09Apr2021 at 07:30 PM, patient experienced left leg went numb (also reported as 3 hrs after shot), next day felt slightly better, by day 4 ended up in ER (emergency room) and was admitted for legs not working correctly and weakness in left leg. The events resulted in hospitalization for three days. Patient underwent COVID-19 (Nasal Swab) tested post vaccination on 11Apr2021, COVID-19 test result: Negative. Patient received treatment included medication, physical therapy for the adverse events. Outcome of the events was recovering. Follow-up attempts are needed; information about lot/batch number is requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Back pain, Disorientation, Dizziness
Clinical narrative: sharp passing pain near my heart; Almost fainted; woozyiness; disorientation; weakness in arm; Pain going across shoulders and across upper back; Pain going across shoulders and across upper back, lasted through part of the night; Fever started after I came home. I usually get fevers when I have an allergic response.; This is a spontaneous report from a contactable consumer (patient). This 50-years-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 04May2021 15:00 (Lot Number: EW0172) as single dose for covid-19 immunisation. Medical history included penicillin and latex (allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) administered in left arm on 13Apr2021 02:45 pm (at 50-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 15:15, patient experienced almost fainted, woozyiness, disorientation and weakness in arm, could feel the loss of control of arm, pain going across shoulders and across upper back, lasted through part of the night. Fever started after patient came home, she usually get fevers when had an allergic response. Patient experienced discomfort as drug initially moved through the body, she had a sharp passing pain near heart, this subsided after a few minutes on 04May2021. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the event sharp passing pain near heart was recovered on 04May2021, other events was recovered in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia, Syncope
Clinical narrative: sharp passing pain near my heart; Almost fainted; woozyiness; disorientation; weakness in arm; Pain going across shoulders and across upper back; Pain going across shoulders and across upper back, lasted through part of the night; Fever started after I came home. I usually get fevers when I have an allergic response.; This is a spontaneous report from a contactable consumer (patient). This 50-years-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 04May2021 15:00 (Lot Number: EW0172) as single dose for covid-19 immunisation. Medical history included penicillin and latex (allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) administered in left arm on 13Apr2021 02:45 pm (at 50-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 15:15, patient experienced almost fainted, woozyiness, disorientation and weakness in arm, could feel the loss of control of arm, pain going across shoulders and across upper back, lasted through part of the night. Fever started after patient came home, she usually get fevers when had an allergic response. Patient experienced discomfort as drug initially moved through the body, she had a sharp passing pain near heart, this subsided after a few minutes on 04May2021. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the event sharp passing pain near heart was recovered on 04May2021, other events was recovered in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Breakthrough seizures; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in right arm on 17Apr2021 (at the age of 27-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of the vaccination. Medical history included epilepsy. The patient had known allergies to Ceclor. Concomitant medications included levetiracetam (KEPPRA); lacosamide (VIMPAT); and sertraline hydrochloride (ZOLOFT). On an unspecified date, the patient experienced breakthrough seizures. The patient stated that she was on a medicine to control epilepsy and the night after getting the shot, she experienced a breakthrough seizure. There was no treatment received from the event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: A little soreness in the arm; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer report for husband. A 73-year-old male patient received bnt162b2 (BNT162B2) via an unspecified route of administration, dose 1 on 13Jan2021 (Batch/Lot Number: EL3249) as 1ST DOSE, SINGLE, and dose 2 on 02Feb2021 (Batch/Lot Number: EL9265) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid 19 on 06May2021. Patient had no issues after the shot but a little soreness in the arm. The event outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pruritus
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to report adverse side effect from the COVID-19 shot. Patient reported that this shot made him/her very devastated, stated "have itchiness in our ear to our bottom of our feet". Further reported that he/she had kidney failure from the shot, got chronic fatigue, had nausea, headache and was not doing well and stated "if I die from the shot I want to document that we were having adverse drug event from the Pfizer shot that we had". The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to report adverse side effect from the COVID-19 shot. Patient reported that this shot made him/her very devastated, stated "have itchiness in our ear to our bottom of our feet". Further reported that he/she had kidney failure from the shot, got chronic fatigue, had nausea, headache and was not doing well and stated "if I die from the shot I want to document that we were having adverse drug event from the Pfizer shot that we had". The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Crohn's disease, Fatigue, Gait disturbance
Clinical narrative: Crohn's disease/ acute Crohn's flare; got so bad and could hardly walk from bed to the living room; It was really bad, I wanted them to shoot me, I just wanted to die; Itching really bad all over; Severe muscle cramps in legs and back; Swelling; Fever; Chills; Tiredness; muscle pain; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number : 59267-1000-01), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (age: 66 years, as reported) for COVID-19 immunization. On 08Apr2021, the patient started to feel some of the side effect symptoms that were listed in the handout about the vaccine and also an autoimmune disease which is Crohn's disease; patient started to have acute Crohn's flare. Patient was also itching really bad all over, getting severe muscle cramps in legs and back, had swelling, fever, chills. The patient got so bad and could hardly walk from bed to the living room. Luckily it's only nine step to the bathroom so she could make it there. On the same day, the patient had to go to the emergency department due to the events. Upon arrival at the emergency room, patient required to do the COVID-19 test and was negative but was experiencing tiredness, muscle pain, joint pain, nausea, and feeling unwell. The patient started with the antibiotics and other unspecified medications for all the events and that's when the diarrhea started because of the strong antibiotic. Patient stated that the strong antibiotic gave her diarrhea. The patient was given a bunch of new medications. The patient stated, " It was really bad, I wanted them to shoot me, I just wanted to die." Right now, she was on 28 different medications as treatment for the events. The patient clarified that the events occurred on 08Apr2021. It was also reported that the patient was hospitalized for events Crohn's disease and could hardly walk from 03May2021 to 07May2021 and was treated with high doses of steroids. The final outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Myalgia, Nausea, Pruritus
Clinical narrative: Crohn's disease/ acute Crohn's flare; got so bad and could hardly walk from bed to the living room; It was really bad, I wanted them to shoot me, I just wanted to die; Itching really bad all over; Severe muscle cramps in legs and back; Swelling; Fever; Chills; Tiredness; muscle pain; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number : 59267-1000-01), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (age: 66 years, as reported) for COVID-19 immunization. On 08Apr2021, the patient started to feel some of the side effect symptoms that were listed in the handout about the vaccine and also an autoimmune disease which is Crohn's disease; patient started to have acute Crohn's flare. Patient was also itching really bad all over, getting severe muscle cramps in legs and back, had swelling, fever, chills. The patient got so bad and could hardly walk from bed to the living room. Luckily it's only nine step to the bathroom so she could make it there. On the same day, the patient had to go to the emergency department due to the events. Upon arrival at the emergency room, patient required to do the COVID-19 test and was negative but was experiencing tiredness, muscle pain, joint pain, nausea, and feeling unwell. The patient started with the antibiotics and other unspecified medications for all the events and that's when the diarrhea started because of the strong antibiotic. Patient stated that the strong antibiotic gave her diarrhea. The patient was given a bunch of new medications. The patient stated, " It was really bad, I wanted them to shoot me, I just wanted to die." Right now, she was on 28 different medications as treatment for the events. The patient clarified that the events occurred on 08Apr2021. It was also reported that the patient was hospitalized for events Crohn's disease and could hardly walk from 03May2021 to 07May2021 and was treated with high doses of steroids. The final outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Suicidal ideation, Swelling
Clinical narrative: Crohn's disease/ acute Crohn's flare; got so bad and could hardly walk from bed to the living room; It was really bad, I wanted them to shoot me, I just wanted to die; Itching really bad all over; Severe muscle cramps in legs and back; Swelling; Fever; Chills; Tiredness; muscle pain; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number : 59267-1000-01), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (age: 66 years, as reported) for COVID-19 immunization. On 08Apr2021, the patient started to feel some of the side effect symptoms that were listed in the handout about the vaccine and also an autoimmune disease which is Crohn's disease; patient started to have acute Crohn's flare. Patient was also itching really bad all over, getting severe muscle cramps in legs and back, had swelling, fever, chills. The patient got so bad and could hardly walk from bed to the living room. Luckily it's only nine step to the bathroom so she could make it there. On the same day, the patient had to go to the emergency department due to the events. Upon arrival at the emergency room, patient required to do the COVID-19 test and was negative but was experiencing tiredness, muscle pain, joint pain, nausea, and feeling unwell. The patient started with the antibiotics and other unspecified medications for all the events and that's when the diarrhea started because of the strong antibiotic. Patient stated that the strong antibiotic gave her diarrhea. The patient was given a bunch of new medications. The patient stated, " It was really bad, I wanted them to shoot me, I just wanted to die." Right now, she was on 28 different medications as treatment for the events. The patient clarified that the events occurred on 08Apr2021. It was also reported that the patient was hospitalized for events Crohn's disease and could hardly walk from 03May2021 to 07May2021 and was treated with high doses of steroids. The final outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Creatine urine increased, Feeling cold, Piloerection, Pruritus
Clinical narrative: started itching and itched like crazy all over her body on her shoulders and down her legs, on her buttocks, and all on her back/a little itch across her back; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; This is a spontaneous report from a contactable consumer (who reported for herself). A 84-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number EN62W) on 3Mar2021 at 1330 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization, in left arm.  Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL926F) dose 1 on 10Feb2021 at 1330, as a single dose, for covid-19 immunization, in left arm and experienced Arm was just barely and Back was itching. Medical history included: Lupus (From: 2004 and Ongoing) the creatinine in her urine had gone up; too much calcium in her urine; fasciitis in her foot in January; cortisone shot in her foot on 12Jan2021; on 08Feb2021 she had another cortisone shot in her foot. Concomitant medications included: Vitamin D2 50mg once a week; They took her off of it before she had the Covid injection. On 04Mar2021, the patient started itching and itched like crazy all over her body, felt real chilled and her skin felt like it had little goosebumps. She took Benadryl just about every night, but it makes her so sleepy and puts her to sleep. Her doctor sent her some topical cream, but it took 2 tubes of cream to cover the itchy spot. She used some, but it didn't help her at all. The Benadryl (Diphenhydramine HCl; barcode: 30048284) 25mg was the only thing that stopped it. She took one. She would take one when she would get ready to go to bed. It puts her to sleep real easy. She spoke with his (her doctor) nurse and she explained to him what was happening. She hasn't visited him about this. He prescribed the topical cream Triamcinolone Acetonide ointment USP, 0.1% 15 grams. The clinical outcome of the event pruritis was not recovered; chills, feeling cold, and Goose bumps was recovering.   Information on lot/ batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine calcium
Clinical narrative: started itching and itched like crazy all over her body on her shoulders and down her legs, on her buttocks, and all on her back/a little itch across her back; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; This is a spontaneous report from a contactable consumer (who reported for herself). A 84-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number EN62W) on 3Mar2021 at 1330 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization, in left arm.  Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL926F) dose 1 on 10Feb2021 at 1330, as a single dose, for covid-19 immunization, in left arm and experienced Arm was just barely and Back was itching. Medical history included: Lupus (From: 2004 and Ongoing) the creatinine in her urine had gone up; too much calcium in her urine; fasciitis in her foot in January; cortisone shot in her foot on 12Jan2021; on 08Feb2021 she had another cortisone shot in her foot. Concomitant medications included: Vitamin D2 50mg once a week; They took her off of it before she had the Covid injection. On 04Mar2021, the patient started itching and itched like crazy all over her body, felt real chilled and her skin felt like it had little goosebumps. She took Benadryl just about every night, but it makes her so sleepy and puts her to sleep. Her doctor sent her some topical cream, but it took 2 tubes of cream to cover the itchy spot. She used some, but it didn't help her at all. The Benadryl (Diphenhydramine HCl; barcode: 30048284) 25mg was the only thing that stopped it. She took one. She would take one when she would get ready to go to bed. It puts her to sleep real easy. She spoke with his (her doctor) nurse and she explained to him what was happening. She hasn't visited him about this. He prescribed the topical cream Triamcinolone Acetonide ointment USP, 0.1% 15 grams. The clinical outcome of the event pruritis was not recovered; chills, feeling cold, and Goose bumps was recovering.   Information on lot/ batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dry skin, Pruritus, Systemic lupus erythematosus
Clinical narrative: started itching and itched like crazy all over her body on her shoulders and down her legs, on her buttocks, and all on her back/a little itch across her back; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; This is a spontaneous report from a contactable consumer (who reported for herself). A 84-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number EN62W) on 3Mar2021 at 1330 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization, in left arm.  Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL926F) dose 1 on 10Feb2021 at 1330, as a single dose, for covid-19 immunization, in left arm and experienced Arm was just barely and Back was itching. Medical history included: Lupus (From: 2004 and Ongoing) the creatinine in her urine had gone up; too much calcium in her urine; fasciitis in her foot in January; cortisone shot in her foot on 12Jan2021; on 08Feb2021 she had another cortisone shot in her foot. Concomitant medications included: Vitamin D2 50mg once a week; They took her off of it before she had the Covid injection. On 04Mar2021, the patient started itching and itched like crazy all over her body, felt real chilled and her skin felt like it had little goosebumps. She took Benadryl just about every night, but it makes her so sleepy and puts her to sleep. Her doctor sent her some topical cream, but it took 2 tubes of cream to cover the itchy spot. She used some, but it didn't help her at all. The Benadryl (Diphenhydramine HCl; barcode: 30048284) 25mg was the only thing that stopped it. She took one. She would take one when she would get ready to go to bed. It puts her to sleep real easy. She spoke with his (her doctor) nurse and she explained to him what was happening. She hasn't visited him about this. He prescribed the topical cream Triamcinolone Acetonide ointment USP, 0.1% 15 grams. The clinical outcome of the event pruritis was not recovered; chills, feeling cold, and Goose bumps was recovering.   Information on lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac disorder, Malaise, Migraine
Clinical narrative: Sick; Major Migraine; blood pressure up to around 210 I believe or little higher than that they couldn't stabilized it; heart was propagating; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that unfortunately had been in the hospital for 3 days. The patient had taken the first vaccination shot on an unspecified date (reported as "Friday around 1 o'clock") and 5 minutes later, on an unspecified date, patient got really sick and got transferred to the emergency and had to stay there for 3 days. Patient stated that heart was propagating and had to take nitroglycerine 3 times. The patient's blood pressure (unknown date): up to around 210 or little higher than that they couldn't stabilized it like this. Patient had a major migraine, so bad like head was gonna burst. So, patient asked the doctor at the emergency if still needed to take the second shot. They told the patient that would have to talk to patient's general doctor. General doctor was not sure and suggested to call Pfizer because patient had a bad reaction. The patient was hospitalized due to the events. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Neurologic symptoms; Body ache; Chills; Extreme fatigue; Tingling in my extremities/like a buzzing sensation, vibrating sensation in my body; Heart palpitation; Cold extremities; Extreme muscle weakness/could barely open my hand muscles; Fluctuating rapid heart beat/heart rate was like 130; Feels like my muscles in my face not working well, especially in my mouth; Thyroid is been out of range; Super light headed/dizzy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm 07Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection and sinusitis. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism; valaciclovir hydrochloride (VALTREX) for Epstein-Barr virus infection; and cetirizine hydrochloride (ZYRTEC ALLERGY) for sinusitis. In Apr2021, after the first dose of vaccination, the patient had neurologic symptoms; body ache; chills; extreme fatigue; tingling in the extremities/like a buzzing sensation and vibrating sensation in the body; heart palpitations; cold extremities; extreme muscle weakness that she could barely open her hand muscles, and would feel like she was going to collapse; fluctuating rapid heartbeat where heart rate was like 130; felt like the muscles in the face were not working well especially in the mouth; thyroid has been out of range; and was super light headed/dizzy. The patient had reported the events to be serious side effects (medically significant) of the vaccine. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Apr2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neurological symptom, Pain, Palpitations, Paraesthesia
Clinical narrative: Neurologic symptoms; Body ache; Chills; Extreme fatigue; Tingling in my extremities/like a buzzing sensation, vibrating sensation in my body; Heart palpitation; Cold extremities; Extreme muscle weakness/could barely open my hand muscles; Fluctuating rapid heart beat/heart rate was like 130; Feels like my muscles in my face not working well, especially in my mouth; Thyroid is been out of range; Super light headed/dizzy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm 07Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection and sinusitis. Concomitant medications included thyroid (ARMOUR THYROID) for hypothyroidism; valaciclovir hydrochloride (VALTREX) for Epstein-Barr virus infection; and cetirizine hydrochloride (ZYRTEC ALLERGY) for sinusitis. In Apr2021, after the first dose of vaccination, the patient had neurologic symptoms; body ache; chills; extreme fatigue; tingling in the extremities/like a buzzing sensation and vibrating sensation in the body; heart palpitations; cold extremities; extreme muscle weakness that she could barely open her hand muscles, and would feel like she was going to collapse; fluctuating rapid heartbeat where heart rate was like 130; felt like the muscles in the face were not working well especially in the mouth; thyroid has been out of range; and was super light headed/dizzy. The patient had reported the events to be serious side effects (medically significant) of the vaccine. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Apr2021.