chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, Dyskinesia, Full blood count
Clinical narrative: I recently got COVID; I recently got COVID; Involuntary muscle movements in my upper right arm and shoulder; I got Pneumonia from having COVID; the first dose was 11Jan2021 and second dose was 28Jan; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 44-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 11Jan2021 as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 44-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 28Jan2021 as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included High blood pressure, ADHD. Concomitant medication(s) included losartan (LOSARTAN) taken for hypertension, start and stop date were not reported; lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported. No prior vaccinations within 4 weeks. On 19Aug2021, the patient experienced covid, on an unspecified date in 2021, the patient experienced pneumonia from having covid, the first dose was 11Jan2021 and second dose was 28Jan2021, on an unspecified date in Feb2021, the patient experienced involuntary muscle movements in her upper right arm and shoulder, It happened on a daily basis. The patient underwent lab tests and procedures which included full blood count: unknown results on Aug2021 normal, metabolic function test: unknown results on Aug2021 normal, sars-cov-2 test positive on 19Aug2021. Patient visit emergency room for events (I recently got COVID, I got Pneumonia from having COVID). Therapeutic measures were taken as a result of recently got covid as Zetac 250 mg taken for 5 days and a steroid (Prednisone took 40mg for 4 days), no treatment received for event (I got Pneumonia from having COVID, Involuntary muscle movements in my upper right arm and shoulder). The outcomes of events (the first dose was 11Jan2021 and second dose was 28Jan2021, recently got covid, Involuntary muscle movements in her upper right arm and shoulder) were unknown, and the outcome of event (I got Pneumonia from having COVID) was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Metabolic function test, SARS-CoV-2 test
Clinical narrative: I recently got COVID; I recently got COVID; Involuntary muscle movements in my upper right arm and shoulder; I got Pneumonia from having COVID; the first dose was 11Jan2021 and second dose was 28Jan; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 44-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 11Jan2021 as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 44-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 28Jan2021 as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included High blood pressure, ADHD. Concomitant medication(s) included losartan (LOSARTAN) taken for hypertension, start and stop date were not reported; lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported. No prior vaccinations within 4 weeks. On 19Aug2021, the patient experienced covid, on an unspecified date in 2021, the patient experienced pneumonia from having covid, the first dose was 11Jan2021 and second dose was 28Jan2021, on an unspecified date in Feb2021, the patient experienced involuntary muscle movements in her upper right arm and shoulder, It happened on a daily basis. The patient underwent lab tests and procedures which included full blood count: unknown results on Aug2021 normal, metabolic function test: unknown results on Aug2021 normal, sars-cov-2 test positive on 19Aug2021. Patient visit emergency room for events (I recently got COVID, I got Pneumonia from having COVID). Therapeutic measures were taken as a result of recently got covid as Zetac 250 mg taken for 5 days and a steroid (Prednisone took 40mg for 4 days), no treatment received for event (I got Pneumonia from having COVID, Involuntary muscle movements in my upper right arm and shoulder). The outcomes of events (the first dose was 11Jan2021 and second dose was 28Jan2021, recently got covid, Involuntary muscle movements in her upper right arm and shoulder) were unknown, and the outcome of event (I got Pneumonia from having COVID) was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Menstrual disorder, Migraine, Pain
Clinical narrative: Blood clots during period..quater size; Migraine; Body aches; Profusely sweating; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 07Sep2021 (Lot Number: 301308A) at the age of 39-year-old as single dose covid-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient had not taken other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced blood clots during period-quater size, migraine, body aches and profusely sweating in Sep2021 with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: losing his hearing; This is a spontaneous report from two non-contactable consumers (one is patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer actually was calling on behalf of her boyfriend who received his second vaccine, they both did on Tuesday and patient was having as a side effects with his hearing- losing his hearing on an unspecified date. Outcome of event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Lip swelling, Pruritus, Rash
Clinical narrative: Swelling of upper lip; slight skin rash; itchiness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 301308A), via an unspecified route of administration, administered in left arm on 08Sep2021 09:30 (at 72-year-old, non-pregnant at time of vaccination) as dose number unknown, single for covid-19 immunisation. Vaccine was received in hospital. Medical history included low thyroid, high blood pressure, cholesterol. Known allergies: Penicillin. No COVID prior vaccination. The patient's concomitant medications included other medications in two weeks. No other vaccine in four weeks. The patient experienced swelling of upper lip and slight skin rash, itchiness on 10Sep2021 at 12:00 AM. The events resulted in emergency room/department or urgent care. No COVID tested post vaccination. Therapeutic measures were taken as a result of the events included steroid shot along with antihistamine shot. The outcome of the events was recovered on an unspecified date.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: Swelling of upper lip; slight skin rash; itchiness; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 301308A), via an unspecified route of administration, administered in left arm on 08Sep2021 09:30 (at 72-year-old, non-pregnant at time of vaccination) as dose number unknown, single for covid-19 immunisation. Vaccine was received in hospital. Medical history included low thyroid, high blood pressure, cholesterol. Known allergies: Penicillin. No COVID prior vaccination. The patient's concomitant medications included other medications in two weeks. No other vaccine in four weeks. The patient experienced swelling of upper lip and slight skin rash, itchiness on 10Sep2021 at 12:00 AM. The events resulted in emergency room/department or urgent care. No COVID tested post vaccination. Therapeutic measures were taken as a result of the events included steroid shot along with antihistamine shot. The outcome of the events was recovered on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Dizziness, Rheumatoid arthritis, Systemic lupus erythematosus, Vertigo
Clinical narrative: RA; Lupus; Graves; vertigo; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Aug2021 14:30 (Batch/Lot Number: Fc3128) as dose 1, single for covid-19 immunisation. Medical history included Known allergies: Citrate, graves, lupus, RA auto immune. No covid prior vaccination. No covid tested post vaccination. Concomitant medications included vitamin D NOS (VITAMIN D); ascorbic acid (VITAMIN C); selinum coreanum (reported as selinum); zinc; alprazolam (reported as aloprozam). Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks.  The patient experienced RA, lupus, graves, vertigo, dizziness, all on 07Sep2021 07:30 with outcome of not recovered.   Ae resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 6 people got Covid; 3 were vaccinated; 6 people got Covid; 3 were vaccinated; This is a spontaneous report from a contactable consumer. This is for the 3/3 patient of 6 people got Covid, 3 were vaccinated.   A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that at her workplace, 6 people got Covid, 3 were vaccinated (did not know if it was Pfizer) and 3 were not. The outcome of evens was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Haematochezia, Hyperhidrosis, Muscle spasms
Clinical narrative: blood was pouring from her rectum down my legs; toilet was full of blood; felt the urge for bowel movement on completion there was no sign of stool; Woke during the night from severe stomach pain, cramp, spasm; Woke during the night from severe stomach pain, cramp, spasm; Woke during the night from severe stomach pain, cramp, spasm; sweating; diarrhea; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 61-year-old female patient received bnt162b2 (BNT162B2), first dose, via an unspecified route of administration, administered in arm left on 30Jul2021 16:15 (Lot Number: EW0172) at the age of 61 years old, as single dose for covid-19 immunisation. Medical history included colon rectal cancer, high blood pressure, diabetic type 2, known allergies: Iodine contrast. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient previously took (diphtheria vaccine toxoid, tetanus vaccine toxoid) TD vaccine for immunisation and experienced known allergies: TD vaccine. On 10Aug2021 22:30, the patient woke during the night from severe stomach pain, cramp, spasm, and sweating follow by diarrhea. Had 4 episode during the night. In the morning on 11Aug2021 felt the urge for bowel movement on completion there was no sign of stool toilet was full of blood, had 3 episode of this event. Later that morning on 11Aug2021 when walking in the house blood was pouring from her rectum down her legs at this point she went to the emergency room and was later admitted. The patient was hospitalized for 3 days. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Treatment antibiotics was received for all events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 11Aug2021. The outcome of the events was recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events rectal haemorrhage, haematochezia, sleep disorder, abdominal pain upper, muscle spasms, hyperhidrosis, diarrhoea, rectal tenesmus and suspect drug BNT162B2 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage, Rectal tenesmus, SARS-CoV-2 test, Sleep disorder
Clinical narrative: blood was pouring from her rectum down my legs; toilet was full of blood; felt the urge for bowel movement on completion there was no sign of stool; Woke during the night from severe stomach pain, cramp, spasm; Woke during the night from severe stomach pain, cramp, spasm; Woke during the night from severe stomach pain, cramp, spasm; sweating; diarrhea; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 61-year-old female patient received bnt162b2 (BNT162B2), first dose, via an unspecified route of administration, administered in arm left on 30Jul2021 16:15 (Lot Number: EW0172) at the age of 61 years old, as single dose for covid-19 immunisation. Medical history included colon rectal cancer, high blood pressure, diabetic type 2, known allergies: Iodine contrast. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient previously took (diphtheria vaccine toxoid, tetanus vaccine toxoid) TD vaccine for immunisation and experienced known allergies: TD vaccine. On 10Aug2021 22:30, the patient woke during the night from severe stomach pain, cramp, spasm, and sweating follow by diarrhea. Had 4 episode during the night. In the morning on 11Aug2021 felt the urge for bowel movement on completion there was no sign of stool toilet was full of blood, had 3 episode of this event. Later that morning on 11Aug2021 when walking in the house blood was pouring from her rectum down her legs at this point she went to the emergency room and was later admitted. The patient was hospitalized for 3 days. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Treatment antibiotics was received for all events. The patient underwent lab tests and procedures which included Nasal Swab: negative on 11Aug2021. The outcome of the events was recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events rectal haemorrhage, haematochezia, sleep disorder, abdominal pain upper, muscle spasms, hyperhidrosis, diarrhoea, rectal tenesmus and suspect drug BNT162B2 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.
Sex: U
Vaccine: COVID19
Symptoms: Electromyogram, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: couldn't feel left foot at all, it's like tingling and then numb and then same thing happened with right foot and then both of calf muscles; couldn't feel left foot at all, it's like tingling and then numb and then same thing happened with right foot and then both of calf muscles; it's like painful; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This happened to patient, and patient since had having EMG to check and see if it was 'peripheral' neuropathy (Consumer was unsure) or something else. It happened like, right after the shot, within a couple of minutes. So yeah it was that. They had vaccine in the past and within 3-5 minutes patient couldn't feel left foot at all, it's like tingling and then numb and then same thing happened with right foot and then both of calf muscles. Now, they are not numb or patient can't walk, but they are numb when patient sit or lay and it's like painful, especially while 'lagging'. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Headache, Injection site pain
Clinical narrative: Very painful injection site; chills; fever; cough; muscle and joint pain; muscle and joint pain; nausea; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 65 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an 09Sep2021 12:00 PM (Batch/Lot number FC3182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing , breast cancer from an unknown date and unknown if ongoing. The patient experienced very painful injection site, chills, fever, cough, muscle and joint pain causing myalgia, muscle and joint pain causing arthralgia, nausea and headache on Sep2021 with outcome of recovering. The patient underwent lab tests and procedures which included pyrexia at 102 Fahrenheit.    .    Follow-Up (16Sep20211): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Very painful injection site; chills; fever; cough; muscle and joint pain; muscle and joint pain; nausea; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 65 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an 09Sep2021 12:00 PM (Batch/Lot number FC3182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing , breast cancer from an unknown date and unknown if ongoing. The patient experienced very painful injection site, chills, fever, cough, muscle and joint pain causing myalgia, muscle and joint pain causing arthralgia, nausea and headache on Sep2021 with outcome of recovering. The patient underwent lab tests and procedures which included pyrexia at 102 Fahrenheit.    .    Follow-Up (16Sep20211): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Extra dose administered, Fatigue, Glycosylated haemoglobin increased, Haemoglobin
Clinical narrative: Fever; cold/night sweats; cold/night sweats; severe headache; body aches; horrible fatigue; Neutrophils - 37% (L); Lymphocytes - 46.7 % (H); Hemoglobin A1c - 5.9 % (H); syncope each morning upon rising -- less each day (first morning after vaccine the worst), lasted for 5 days.; Third shot; Third shot; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (PENDING CLASSIFICATION, Batch/Lot Number: aw0175), at the age of 61 years old, as DOSE 3, SINGLE for covid-19 immunisation. The patient received the first dose of BNT162B2 on 06Feb2021 (PENDING CLASSIFICATION, at the age of 61 years old), Lot no: ema9809 for COVID-19 immunization and experienced Fatigue, headache, body aches x 3 days, then one day normal, then 1 days of fatigue. The patient received the second dose of BNT162B2 on 06Feb2021 (PENDING CLASSIFICATION, at the age of 61 years old), Lot no: en6202 for COVID-19 immunization and experienced Fatigue, headache, body aches x 4 days. Then one day normal, then 2 days of fatigue. Patient had allergies to Levaquin, Meloxicam, Codeine. Medical history included Sjogrens Syndrome, Asthma, Rheumatism, Arthritis, Radiation enteritis, migraine, periodic chronic fatigue. Unspecified concomitant medication was reported. Patient experienced on 27Aug2021 19:00 fever, cold/night sweats, severe headache, body aches, horrible fatigue, syncope each morning upon rising -- less each day (first morning after vaccine the worst), lasted for 5 days. Fatigue, body aches, headache lasted 10 days. NEUTROPHILS - 37% (L) LYMPHOCYTES - 46.7 % (H) HEMOGLOBIN A1C - 5.9 % (H) Normally these tests are normal for me. No treatment received. Events resulted in Physician Office Visit. Outcome of events was recovered in 2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphocyte count, Lymphocyte count increased, Neutrophil count, Neutrophil count decreased
Clinical narrative: Fever; cold/night sweats; cold/night sweats; severe headache; body aches; horrible fatigue; Neutrophils - 37% (L); Lymphocytes - 46.7 % (H); Hemoglobin A1c - 5.9 % (H); syncope each morning upon rising -- less each day (first morning after vaccine the worst), lasted for 5 days.; Third shot; Third shot; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (PENDING CLASSIFICATION, Batch/Lot Number: aw0175), at the age of 61 years old, as DOSE 3, SINGLE for covid-19 immunisation. The patient received the first dose of BNT162B2 on 06Feb2021 (PENDING CLASSIFICATION, at the age of 61 years old), Lot no: ema9809 for COVID-19 immunization and experienced Fatigue, headache, body aches x 3 days, then one day normal, then 1 days of fatigue. The patient received the second dose of BNT162B2 on 06Feb2021 (PENDING CLASSIFICATION, at the age of 61 years old), Lot no: en6202 for COVID-19 immunization and experienced Fatigue, headache, body aches x 4 days. Then one day normal, then 2 days of fatigue. Patient had allergies to Levaquin, Meloxicam, Codeine. Medical history included Sjogrens Syndrome, Asthma, Rheumatism, Arthritis, Radiation enteritis, migraine, periodic chronic fatigue. Unspecified concomitant medication was reported. Patient experienced on 27Aug2021 19:00 fever, cold/night sweats, severe headache, body aches, horrible fatigue, syncope each morning upon rising -- less each day (first morning after vaccine the worst), lasted for 5 days. Fatigue, body aches, headache lasted 10 days. NEUTROPHILS - 37% (L) LYMPHOCYTES - 46.7 % (H) HEMOGLOBIN A1C - 5.9 % (H) Normally these tests are normal for me. No treatment received. Events resulted in Physician Office Visit. Outcome of events was recovered in 2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Off label use, Pain, Pyrexia, Syncope
Clinical narrative: Fever; cold/night sweats; cold/night sweats; severe headache; body aches; horrible fatigue; Neutrophils - 37% (L); Lymphocytes - 46.7 % (H); Hemoglobin A1c - 5.9 % (H); syncope each morning upon rising -- less each day (first morning after vaccine the worst), lasted for 5 days.; Third shot; Third shot; This is a spontaneous report from a contactable consumer (patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (PENDING CLASSIFICATION, Batch/Lot Number: aw0175), at the age of 61 years old, as DOSE 3, SINGLE for covid-19 immunisation. The patient received the first dose of BNT162B2 on 06Feb2021 (PENDING CLASSIFICATION, at the age of 61 years old), Lot no: ema9809 for COVID-19 immunization and experienced Fatigue, headache, body aches x 3 days, then one day normal, then 1 days of fatigue. The patient received the second dose of BNT162B2 on 06Feb2021 (PENDING CLASSIFICATION, at the age of 61 years old), Lot no: en6202 for COVID-19 immunization and experienced Fatigue, headache, body aches x 4 days. Then one day normal, then 2 days of fatigue. Patient had allergies to Levaquin, Meloxicam, Codeine. Medical history included Sjogrens Syndrome, Asthma, Rheumatism, Arthritis, Radiation enteritis, migraine, periodic chronic fatigue. Unspecified concomitant medication was reported. Patient experienced on 27Aug2021 19:00 fever, cold/night sweats, severe headache, body aches, horrible fatigue, syncope each morning upon rising -- less each day (first morning after vaccine the worst), lasted for 5 days. Fatigue, body aches, headache lasted 10 days. NEUTROPHILS - 37% (L) LYMPHOCYTES - 46.7 % (H) HEMOGLOBIN A1C - 5.9 % (H) Normally these tests are normal for me. No treatment received. Events resulted in Physician Office Visit. Outcome of events was recovered in 2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blepharospasm, Eyelid disorder, Pain in jaw, Taste disorder
Clinical narrative: has Bell's Palsy; started having a weird taste in her mouth; felt sharp pains in her jawline; eyes started twitching and her eyelids would not close; eyes started twitching and her eyelids would not close; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot Number: FA8448 expiry date was unknown) via an unspecified route of administration arm left on 28Aug2021 15:00 (at the age of 51-years-old) as a single dose for covid-19 immunisation. Medical history and no concomitant medications. Prior Vaccinations (within 4 weeks): Reporter stated she has never had a vaccine. Reporter declined to provide HCP contact information and states she can look at her medicine but then stated she does not know the HCP's name or other information. Stated her patient card has the lot number handwritten on it and has another person on the line and call recording notification provided on the line again; Reporter stated she has her glasses on and can't see the lot number written and it looks like FA8448 and the card does not have the NDC, or expiry date written on it. Provide the time of onset of AE(s): Reporter stated she was not sure when the Bell's Palsy began but she started having a weird taste in her mouth about a week ago and after that felt sharp pains in her jawline and her eyes started twitching and her eyelids would not close and that happened within the past week on Saturday, stated her eyelids started not being able to close three days ago. Stated the weird taste in her mouth was ongoing and she went to her dentist for something to do with infection in her mouth and took Amoxicillin for that and the Amoxicillin did not work, and she still has the weird taste in her mouth; stated her eyes stopped closing and the twitching began and she went to her doctor and he told her this on 09Sep2021. Stated the weird taste in her mouth was ongoing and the same as when it began; stated the Amoxicillin was in an orange pharmacy bottle and the dose is 875mg but because it was an orange pharmacy bottle, it has no lot, expiry date or NDC. Stated for her eye twitching, the eyes were twitching a couple of days ago and maybe last Friday and Monday and Tuesday they were twitching and then Wednesday her eyes would not close. Stated she has not had the 2nd dose of the Pfizer Vaccine and it was supposed to be next Saturday. Reporter asked if she could get a copy of this report and was provided with report reference number. Outcome of the events Taste disorder and pain in jaw was not recovered, all othe events was unknown.  Follow-Up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Nasal congestion, Nasal disorder, SARS-CoV-2 test
Clinical narrative: Rapid +; Rapid +; Stuffy nose; post nasal; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced Stuffy nose, post nasal drip, headache, Rapid +. On unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Rapid +; Rapid +; Stuffy nose; post nasal; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced Stuffy nose, post nasal drip, headache, Rapid +. On unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Hallucination, Insomnia, Paranoia, SARS-CoV-2 test
Clinical narrative: Extreme paranoia; insomnia for 72+ hours; hallucinations; hospitalized in mood disorders; This is a spontaneous report from a contactable consumer. This 24-year-old female consumer(patient) reported for herself (patient).   A 24-years-old non pregnant female adult patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 26Jan2021 as dose 1, single for covid-19 immunisation (at the age of 24-year-old). The patient medical history was not reported and concomitant medications were none. Facility type vaccine was workplace clinic. The patient did not received any other vaccines within 4 weeks prior to the Covid 19 vaccine. The patient did not received any other medications within the 2 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient had been tested for Covid 19 post vaccination through nasal swab test. On 29Jan2021, 03 days after vaccination, the patient experienced extreme paranoia, insomnia for 72+ hours, hallucinations, hospitalized in mood disorders unit for 10 days with no previous symptoms or hospitalizations. The events resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 10 days. The patient received treatment medications for the events. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test): results were unknown. The clinical outcome of the events was Resolved with Sequel on an unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got diagnosed with covid-19 after experience symptoms; Got diagnosed with covid-19 after experience symptoms; This is a spontaneous report from a contactable consumer or other non-HCP. This report was received via a sales representative.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient experienced got diagnosed with COVID-19 after experience symptoms and exhibited vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date 2021 She just got diagnosed with COVID-19 after experience symptoms. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Chills, Fatigue, Pyrexia, Stress
Clinical narrative: Spondylitis ankylosing aggravated; Stress; Fever; Chills; Fatigue; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program FACILITATED COLLECT, based on information received by Pfizer from, manufacturer control number: 21K-163-4065604-00.   Solicited report from the consumer of a 43 year old female with events of non-serious chills, fatigue, stress, fever and ankylosing spondylitis flare up with (HUMIRA). The patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date and ongoing, at citrate free for ankylosing spondylitis. On 23Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech at age of 42-year-old, on 13Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech at age of 42-year-old, in 2021, patient received booster COVID-19 Vaccine manufactured by Pfizer BioNTech, all via intramuscular for COVID-19 vaccination. There was no reported medical history and concomitant medications. On unknown dates, the patient experienced stress and ankylosing spondylitis flare up. On 16Aug2021, the patient experienced chills, fatigue and fever. Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was dose not changed. The outcome of chills, fatigue and fever was unknown, the outcome of stress and ankylosing spondylitis flare up was not resolved.   Causality for adalimumab: The reporter's causality for the events of chills, fatigue and fever with (HUMIRA) was no reasonable possibility. The reporter's causality for the events of stress and ankylosing spondylitis flare up with adalimumab was a reasonable possibility. Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) was also considered suspect.  The reporter's assessment of the causal relationship of the events with the suspect product PFIZER BIONTECH COVID-19 VACCINE was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 events Ankylosing spondylitis, chills, Fatigue, stress and pyrexia 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysmenorrhoea, Illness, Menstruation delayed, SARS-CoV-2 test
Clinical narrative: I got the virus and I have strong symptoms; My period is extra painful now; I got late 60 days than 45 days; I'm very sick; I got the virus and I have strong symptoms; This is a spontaneous report from a contactable consumer. This 32-Year old female consumer (patient) reported that:  A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: En6208) via an unspecified route of administration, administration, on an arm (details unspecified) on an unspecified date in Mar2021 as dose 1, single and had bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ew0151) via an unspecified route of administration, on an arm (details unspecified) on 12Apr2021 12.00 as dose 2, (age at the time of vaccination 32-years-old) single for covid-19 immunization. Patient had no known allergies. The patient relevant medical history include asthma. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr202112:00 AM, I never had problems with my period before. In February I had an ultrasound and everything was great. In march I took the vaccine amd everything messed up. My period is extra painful now. At first I got late 60 days than 45 days. It is been way kore clog and painful and I have no health issues. I regret taking it bc I want to try to conceive and now I'm concerned. And guess what? I got the virus and I have strong symptoms. I'm very sick. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has been was tested for COVID-19. On 04Sep2021, the patient had Nasal Swab, Pcr which results positive. At the time of reporting, the outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaccination failure
Clinical narrative: I got the virus and I have strong symptoms; My period is extra painful now; I got late 60 days than 45 days; I'm very sick; I got the virus and I have strong symptoms; This is a spontaneous report from a contactable consumer. This 32-Year old female consumer (patient) reported that:  A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: En6208) via an unspecified route of administration, administration, on an arm (details unspecified) on an unspecified date in Mar2021 as dose 1, single and had bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Ew0151) via an unspecified route of administration, on an arm (details unspecified) on 12Apr2021 12.00 as dose 2, (age at the time of vaccination 32-years-old) single for covid-19 immunization. Patient had no known allergies. The patient relevant medical history include asthma. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr202112:00 AM, I never had problems with my period before. In February I had an ultrasound and everything was great. In march I took the vaccine amd everything messed up. My period is extra painful now. At first I got late 60 days than 45 days. It is been way kore clog and painful and I have no health issues. I regret taking it bc I want to try to conceive and now I'm concerned. And guess what? I got the virus and I have strong symptoms. I'm very sick. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has been was tested for COVID-19. On 04Sep2021, the patient had Nasal Swab, Pcr which results positive. At the time of reporting, the outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: lost baby; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority Support from a non-contactable consumer. The reporter reported three same cases. This is one the three cases. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot/batch number unknown) via an unspecified route of administration as a single dose, on an unspecified date, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lost her baby after receiving the covid-19 vaccine. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101200160 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200159 Same reporter/drug/event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: lost baby; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority with Support from a non-contactable consumer. The reporter reported three same cases. This is one the three cases. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot/batch number unknown) via an unspecified route of administration as a single dose, on an unspecified date, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had lost her baby after receiving the covid-19 vaccine. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101200160 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200080 Same reporter/drug/event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: lost baby after receiving the covid-19 vaccine.; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority with Support from a non-contactable consumer. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The reporter reported three same cases. This is one of the three cases. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on unspecified date at single dose, dose number unknown for COVID-19 immunization. Patient was pregnant at time of vaccination and event onset. Medical history and concomitant medications were not reported. Caller inquiring on if the vaccine was FDA approved. Started reading ISI and caller interrupted and asked about women that are pregnant. Caller stated that the patient had lost her baby after receiving the covid-19 vaccine. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101200159 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200080 Same reporter/drug/event, different patients.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abortion spontaneous, Haemorrhage, Menstruation delayed, Nausea
Clinical narrative: Hemorrhaging in the hospital; Suspected to be pregnant has a miscarriage; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting.; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; This is a spontaneous report from a Pfizer Sponsored Program  A contactable consumer reported for a female patient   A female patient of age 3 decade received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) Via an unspecified route of administration on an unspecified date as a dose number unknown, single for (at the age of 3 decade) COVID-19 immunization. Patient medical history and concomitant medication were not provided. After administration of the vaccine, on an unspecified date she was hemorrhaging in the hospital and suspected to be pregnant, has a miscarriage. Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.