chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cutaneous lupus erythematosus, Sjogren's syndrome
Clinical narrative: slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; slight uptick in Sjogren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly.; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9264), via an unspecified route of administration on the right arm on 25Jan2021 16:30 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history included Systemic Lupus with Interstitial Lung Disease, Anti phospholipid syndrome, Discoid Lupus, Sjogren's Syndrome, Joint Hypermobility, Post-Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), and Borderline Personality; all from an unknown date. Patient was not pregnant at the time of vaccination. Concomitant medication included buspirone taken from an unspecified date for an unspecified indication. It was reported that on 02Feb2021 08:00, the patient had slight uptick in Sjorgren's syndrome and Discoid Lupus symptoms. Her lesion opened and oozed, and dry eyes and dry mouth increased significantly. The patient will resume prednisone after 10 days as recommended by physicians. The patient received Clobetasol eye drops as treatment for the events. The outcome of the events was recovering. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 8982) on 15Feb2021 17:15.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Haemorrhage, Pain in extremity
Clinical narrative: pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Deafness, Dizziness, Lymphadenopathy, Pain
Clinical narrative: Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient.  A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.   The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported).  The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting episode; Loss of hearing; Left collar-bone lymph node enlarged noticeable swelling to area and left lower neck near carotid artery/lymph nodes; Soreness in area; Cold sweats; Light-headedness; This is a spontaneous report from a contactable consumer, the patient.  A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Feb2021 at 07:00 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.   The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no symptoms until 5 days post vaccination. On 13Feb2021 at 12:15, the patient experienced fainting episode, loss of hearing, left collar-bone lymph node enlarged (noticeable swelling to area and left lower neck near carotid artery/lymph nodes), soreness in area, cold sweats, and light-headedness. The events required a visit to the physician's office and emergency room (as reported).  The clinical outcomes of the fainting episode, loss of hearing, left collar-bone lymph node enlarged, soreness in area, cold sweats, and light-headedness were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Developed Belle's Palsy within 48 hours; This is a spontaneous report from contactable consumers. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 03Feb2021 16:00 at single dose (left arm) for COVID-19 immunisation. Medical history included prostate cancer from 1994. The patient was not diagnosed with covid prior vaccination and since the vaccination, patient was not covid tested. Patient was not aware of any known allergies. Concomitant medication included bisoprolol. The patient did not receive no other vaccine in four weeks prior to Covid vaccine. On 05Feb2021, 15:00, the patient developed bell's palsy within 48 hours. The patient was treated with a prescription of prednisone 5mg. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of event was not recovered.  Information on the Lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Feeling hot, Nausea, Presyncope
Clinical narrative: felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN).  The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows:  About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: under my lymph nodes are very painful; right arm was sore for first 2 days/under my right arm are very painful; This is a spontaneous report from a contactable consumer (patient himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 12Feb2021 13:45 at single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Nov2020 (diagnosed with COVID 19 at the end of November 2020 but tested negative since from Dec onwards 2020). Concomitant medication included finasteride at 1 mg (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that, my right arm was sore for first 2 days on an unspecified date in Feb2021, however since Monday (15Feb2021 06:00 AM) under my lymph nodes, under my right arm are very painful. The events were considered as non-serious by the consumer. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, Hyperhidrosis
Clinical narrative: anaphylaxis; head was feeling funny; sweating profusely; This is a spontaneous report from a contactable consumer (patient). This 79 (unit unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 10Feb2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose on 10Feb2021 at 12:00. On the same day (10Feb2021), at 20:00, the patient's head was feeling funny, sweating profusely, and felt like "anaphylaxis". Patient also asked about potential receipt of second dose. Patient stated she will reach out to healthcare professional (HCP). Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza A virus test, Influenza B virus test, Insomnia
Clinical narrative: neuropathy on feet, arms, and chest; chills; fatigue; lack of sleep for the last 12 days; This is a spontaneous report from a contactable consumer, reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration at the left arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was administered at a military base. Medical history included hypertension (controlled with medication) from an unknown date and unknown if ongoing. There were no known allergies. There was no other vaccine in four weeks. Concomitant medication included lisinopril, felodipine and tamsulosin (reported as medications in two weeks).  On 04Feb2021 at 17:00, the patient experienced chills, fatigue, neuropathy on feet, arms, and chest and lack of sleep for the last 12 days. The patient was advised to drink plenty of water and take Tylenol. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The events required a doctor office and emergency room visits. The patient underwent lab tests and procedures which included influenzas A: negative, influenzas B: negative, both on unspecified dates; and COVID-19 nasal swab: negative on 08Feb2021, 11Feb2021 and 12Feb2021. The outcome of the events was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: neuropathy on feet, arms, and chest; chills; fatigue; lack of sleep for the last 12 days; This is a spontaneous report from a contactable consumer, reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration at the left arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was administered at a military base. Medical history included hypertension (controlled with medication) from an unknown date and unknown if ongoing. There were no known allergies. There was no other vaccine in four weeks. Concomitant medication included lisinopril, felodipine and tamsulosin (reported as medications in two weeks).  On 04Feb2021 at 17:00, the patient experienced chills, fatigue, neuropathy on feet, arms, and chest and lack of sleep for the last 12 days. The patient was advised to drink plenty of water and take Tylenol. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The events required a doctor office and emergency room visits. The patient underwent lab tests and procedures which included influenzas A: negative, influenzas B: negative, both on unspecified dates; and COVID-19 nasal swab: negative on 08Feb2021, 11Feb2021 and 12Feb2021. The outcome of the events was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Body temperature, Chest pain, Feeling abnormal
Clinical narrative: my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100°F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious.  Information on the batch/lot number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Respiratory arrest
Clinical narrative: my chest started hurting me at 3:50 a.m. this morning; stomach hurts; felt squeezed, I could not breath; had the feeling of being squeezed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 25Jan2021 and experienced AFib, diabetic, COPD, stomach issues, chest pains and fever. About 20 minutes after the first dose, I had chest pains, from one side clear across the other side. She took a nitro, and had fever over a 100°F for 24 hours on Jan2021. She received second dose on 15Feb2021 and experienced they had her get an EKG. Patient felt squeezed, she could not breath on Feb2021. Her oxygen level and blood pressure were both fine on Feb2021. She had the feeling of being squeezed on Feb2021. Her chest started hurting at 3:50 a.m. (16Feb2021) this morning, stomach hurts like doing flip flops inside her. She did not have anything that would aggravate it. The outcome of the events was unknown. The events was reported as non-serious.  Information on the batch/lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anaphylactic reaction, Anosmia, Condition aggravated, Cough
Clinical narrative: Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Muscle spasms, Rhinorrhoea
Clinical narrative: muscle spasms; bad fibromyalgia; runny nose; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 (at the age of 81 years old), for COVID-19 immunisation. Medical history included highly allergic to some medications and bleeding disorder (she was on a blood thinner). Concomitant medications were not reported. On an unspecified date the patient experienced muscle spasms and spent 3 days at the hospital. She had to go again on an unspecified date in Feb2021, she got a lot of illnesses, she was also on a blood thinner and was highly allergic to some medications. Since an unspecified date she had really bad fibromyalgia. All these symptoms were usual for the patient, other than the runny nose. She needed to get a hold of her doctor, she had a follow up like right now. She wasn't supposed to go (for her appointment) until the 23Feb2021. She was scheduled for the second vaccine dose on 08Feb2021, however she was in the hospital and was wondering if it was too late. Events outcome was unknown. Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Defaecation urgency, Discomfort
Clinical narrative: Headache; vomited in the toilet for 15 minutes; Woke up another couple times with soft urgent poop; Woke up another couple times with soft urgent poop; couldn't get comfortable or to sleep because of position and chills/hot flashes; nausea; cold flash; acid reflux; small dose of lower back pain; had arm and shoulder pain; had arm and shoulder pain; uncomfort on side of injection/shoulder joint uncomfort on left side (vaccination side); chills; hot flashes; This is a spontaneous report from a contactable consumer (patient).  The 22-year-old female patient received second dose BNT162B2(lot_number: EN 5318?, incomplete number), via an unspecified route of administration in left arm on 15Feb2021 15:30 at single dose for covid-19 immunization.  The patient medical history was not reported.  Concomitant medication included venlafaxine, ethinylestradiol, norgestimate (TRI-SPRINTEC), loratadine (ALLERCLEAR). The patient previously took z-pak for antibiotic therapy and experienced rash, sertraline hydrochloride(ZOLOFT) and experienced dizziness, first dose bnt162b2(lot: EN5318?) for covid-19 immunization on 26Jan2021 at 03:30 in left arm.  The patient experienced started on 15Feb2021 at 10 pm with acid reflux and a small dose of lower back pain, had arm and shoulder pain, uncomfort on side of injection, chills and hot flashes kept waking her up throughout the night, at 2:15 on 16Feb2021 she woke up went to bathroom and had a hot flash/nausea so laid on the floor until cold flash came. At 2:30 She got back up and vomited in the toilet for 15 minutes (total of 10 or so times within the 15 minutes first few were just dry heaving until anything came out.) She took acetaminophen before going back to bed. She woke up another couple times with soft urgent poop. She couldn't get comfortable or to sleep because of position and chills/hot flashes. At 6:30 I was feeling nauseous and still chills. At 11 am she woke up with just a headache and minimal chills. Headache lasted until 5pm or so she had taken meds again for the headache. On 16Feb2021 had acid reflux again. After finally getting to sleep she woke up 17Feb2021 morning with just shoulder joint uncomfort on left side (vaccination side). Therapeutic measures were taken as a result of vomited in the toilet for 15 minutes, headache. There was no treatment for other events. Events were assessed as non-serious. Outcome of events was recovered in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces soft, Feeling cold, Gastrooesophageal reflux disease, Headache, Hot flush
Clinical narrative: Headache; vomited in the toilet for 15 minutes; Woke up another couple times with soft urgent poop; Woke up another couple times with soft urgent poop; couldn't get comfortable or to sleep because of position and chills/hot flashes; nausea; cold flash; acid reflux; small dose of lower back pain; had arm and shoulder pain; had arm and shoulder pain; uncomfort on side of injection/shoulder joint uncomfort on left side (vaccination side); chills; hot flashes; This is a spontaneous report from a contactable consumer (patient).  The 22-year-old female patient received second dose BNT162B2(lot_number: EN 5318?, incomplete number), via an unspecified route of administration in left arm on 15Feb2021 15:30 at single dose for covid-19 immunization.  The patient medical history was not reported.  Concomitant medication included venlafaxine, ethinylestradiol, norgestimate (TRI-SPRINTEC), loratadine (ALLERCLEAR). The patient previously took z-pak for antibiotic therapy and experienced rash, sertraline hydrochloride(ZOLOFT) and experienced dizziness, first dose bnt162b2(lot: EN5318?) for covid-19 immunization on 26Jan2021 at 03:30 in left arm.  The patient experienced started on 15Feb2021 at 10 pm with acid reflux and a small dose of lower back pain, had arm and shoulder pain, uncomfort on side of injection, chills and hot flashes kept waking her up throughout the night, at 2:15 on 16Feb2021 she woke up went to bathroom and had a hot flash/nausea so laid on the floor until cold flash came. At 2:30 She got back up and vomited in the toilet for 15 minutes (total of 10 or so times within the 15 minutes first few were just dry heaving until anything came out.) She took acetaminophen before going back to bed. She woke up another couple times with soft urgent poop. She couldn't get comfortable or to sleep because of position and chills/hot flashes. At 6:30 I was feeling nauseous and still chills. At 11 am she woke up with just a headache and minimal chills. Headache lasted until 5pm or so she had taken meds again for the headache. On 16Feb2021 had acid reflux again. After finally getting to sleep she woke up 17Feb2021 morning with just shoulder joint uncomfort on left side (vaccination side). Therapeutic measures were taken as a result of vomited in the toilet for 15 minutes, headache. There was no treatment for other events. Events were assessed as non-serious. Outcome of events was recovered in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site discomfort, Vomiting
Clinical narrative: Headache; vomited in the toilet for 15 minutes; Woke up another couple times with soft urgent poop; Woke up another couple times with soft urgent poop; couldn't get comfortable or to sleep because of position and chills/hot flashes; nausea; cold flash; acid reflux; small dose of lower back pain; had arm and shoulder pain; had arm and shoulder pain; uncomfort on side of injection/shoulder joint uncomfort on left side (vaccination side); chills; hot flashes; This is a spontaneous report from a contactable consumer (patient).  The 22-year-old female patient received second dose BNT162B2(lot_number: EN 5318?, incomplete number), via an unspecified route of administration in left arm on 15Feb2021 15:30 at single dose for covid-19 immunization.  The patient medical history was not reported.  Concomitant medication included venlafaxine, ethinylestradiol, norgestimate (TRI-SPRINTEC), loratadine (ALLERCLEAR). The patient previously took z-pak for antibiotic therapy and experienced rash, sertraline hydrochloride(ZOLOFT) and experienced dizziness, first dose bnt162b2(lot: EN5318?) for covid-19 immunization on 26Jan2021 at 03:30 in left arm.  The patient experienced started on 15Feb2021 at 10 pm with acid reflux and a small dose of lower back pain, had arm and shoulder pain, uncomfort on side of injection, chills and hot flashes kept waking her up throughout the night, at 2:15 on 16Feb2021 she woke up went to bathroom and had a hot flash/nausea so laid on the floor until cold flash came. At 2:30 She got back up and vomited in the toilet for 15 minutes (total of 10 or so times within the 15 minutes first few were just dry heaving until anything came out.) She took acetaminophen before going back to bed. She woke up another couple times with soft urgent poop. She couldn't get comfortable or to sleep because of position and chills/hot flashes. At 6:30 I was feeling nauseous and still chills. At 11 am she woke up with just a headache and minimal chills. Headache lasted until 5pm or so she had taken meds again for the headache. On 16Feb2021 had acid reflux again. After finally getting to sleep she woke up 17Feb2021 morning with just shoulder joint uncomfort on left side (vaccination side). Therapeutic measures were taken as a result of vomited in the toilet for 15 minutes, headache. There was no treatment for other events. Events were assessed as non-serious. Outcome of events was recovered in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Dizziness, Electrocardiogram, Headache
Clinical narrative: random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Palpitations, Pyrexia, Syncope
Clinical narrative: random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fall, Gait inability, Investigation
Clinical narrative: fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thoracic vertebral fracture
Clinical narrative: fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blast cell crisis, Off label use, Product use issue, Pulmonary embolism, Thrombosis
Clinical narrative: bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events "patient's WBC was 150,000" and "bilateral blood clots in legs that then went to lungs then went into BLAST crisis" was recovering.  Information on the lot/ batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events "patient's WBC was 150,000" and "bilateral blood clots in legs that then went to lungs then went into BLAST crisis" was recovering.  Information on the lot/ batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test, Eating disorder, Facial paralysis
Clinical narrative: Loss of taste and partial smell; Loss of taste and partial smell; Hard to talk or eat or drink; Hard to talk or eat or drink; Hard to talk or eat or drink; Bells Palsy; Blurry vision; Fever; Felt achy; This is a spontaneous report from a contactable consumer (patient).  This 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261), via an unknown route, on 29Jan2021 (at 10:00 AM) at a single dose in the left arm for COVID-19 immunisation. Relevant medical history includes diabetes, arteriolosclerosis, blocked carotid artery, gastrooesophageal reflux disease (GERD) and chronic prostatitis. Past drug history included allergy to penicillin and cefixime (FLEXERIL). Relevant concomitant medications included doxazosin mesylate (CARDURA), lisinopril, metformin, omeprazole, repaglinide (PRANDIN) and other unspecified medications. He had fever and felt achy for a couple of day. On 03Feb2021 (at 08:00), the patient had total paralyzed on right side of his face, right eye will not close, mouth paralyzed on right side. Hard to talk or eat or drink. Blurry vision in right eye due to not closing. On 04Feb2021, the patient has loss of taste and partial smell. The patient performed physician office visit. Then, he went to the emergency room (ER) and Bells Palsy was confirmed on 06Feb2021. He stated that his blood work is currently fine. He was given prednisone and acyclovir for Bells Palsy and for hard to talk or eat or drink. The patient was not treated for the remaining events. Pre and post vaccination COVID test were not performed. All events were considered serious for disability except of fever and felt achy. The outcome of the events fever and felt achy was unknown while the outcome of the remaining events was not recovered.