chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old male patient received the second dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0168), via an unspecified route of administration, administered in Arm Left on 27May2021 09:00 as a single dose, and dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 09:15 (Batch/Lot Number: Ew0171) as a single dose for COVID-19 immunization . Medical history included blood cholesterol increased from an unknown date and unknown if ongoing and High cholesterol and triglycerides , blood triglycerides increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On the third day after the second shot the patient did some yard work and then after coming inside passed out and was twitching and gasping for air on the ground for less than a minute. I then sat up took some juice and was fine. The patient experienced passed out (loss of consciousness) , twitching (muscle twitching) and gasping for air on the ground for less than a minute (dyspnoea). patient underwent lab tests and procedures which included blood cholesterol: high on High cholesterol and triglycerides , blood pressure measurement: fine and blood triglycerides. Prior and since the vaccination, patient was not tested for COVID-19. The patient didn't take any other vaccines 4 weeks before the COVID vaccine.   The patient took the covid19 vaccine in hospital. Device date reported to be 11Jul2021.  Follow-up actions are needed. Further information has been requested.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Fatigue, Laboratory test abnormal
Clinical narrative: Tumor in muscle of uterus area; Lymph nodes swollen; Chest pressure; trouble breathing; Bloodwork is showing certain levels high; tired; forgetful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history and concurrent conditions included herniated disks. The patient's concomitant medications received within 2 weeks of vaccination included gabapentin and oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]). It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 01Feb2021 at 14:00, the patient experienced tumor in muscle of uterus area, lymph nodes swollen, chest pressure, trouble breathing, tired, forgetful. Bloodwork was showing certain levels high. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No prolonged hospitalization. Treatment received for the events was surgery. On 01Feb2021, the patient underwent lab tests and procedures which included bloodwork, resulted as high, certain levels high. The device date was on 11Jul2021. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Memory impairment, Uterine neoplasm
Clinical narrative: Tumor in muscle of uterus area; Lymph nodes swollen; Chest pressure; trouble breathing; Bloodwork is showing certain levels high; tired; forgetful; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in arm left on 20Jan2021 at 14:00 (at the age of 50-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history and concurrent conditions included herniated disks. The patient's concomitant medications received within 2 weeks of vaccination included gabapentin and oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]). It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 01Feb2021 at 14:00, the patient experienced tumor in muscle of uterus area, lymph nodes swollen, chest pressure, trouble breathing, tired, forgetful. Bloodwork was showing certain levels high. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No prolonged hospitalization. Treatment received for the events was surgery. On 01Feb2021, the patient underwent lab tests and procedures which included bloodwork, resulted as high, certain levels high. The device date was on 11Jul2021. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Nerve injury, Paraesthesia
Clinical narrative: Loud, chronic ear tinnitus; chronic tingling tongue and skin; chronic tingling tongue and skin; keep disrupt healthy sleep; headaches; loss of sleep; loss of sleep and quality of life; exhausted; nerve damage issue; This is a spontaneous report from a contactable consumer reported for self. This 42-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 06Apr2021 at age of 42 years old (Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. None pregnant at time of vaccination. Medical history included Chronic spine, knee, wrist, and shoulder issues/pain. Degenerative disc disease in spine and Intolerant to dairy. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 06Apr2021, she experienced Loud, chronic ear tinnitus which was Disability. Chronic tingling tongue and skin. Never had these symptoms prior to Pfizer covid vaccination. These side effects keep disrupt healthy sleep and cause headaches. Concerned as to what the long term side effects will be from loss of sleep and quality of life. She was exhausted. Concerned if this is a nerve damage issue. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Quality of life decreased, Sleep disorder, Tinnitus
Clinical narrative: Loud, chronic ear tinnitus; chronic tingling tongue and skin; chronic tingling tongue and skin; keep disrupt healthy sleep; headaches; loss of sleep; loss of sleep and quality of life; exhausted; nerve damage issue; This is a spontaneous report from a contactable consumer reported for self. This 42-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 06Apr2021 at age of 42 years old (Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. None pregnant at time of vaccination. Medical history included Chronic spine, knee, wrist, and shoulder issues/pain. Degenerative disc disease in spine and Intolerant to dairy. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 06Apr2021, she experienced Loud, chronic ear tinnitus which was Disability. Chronic tingling tongue and skin. Never had these symptoms prior to Pfizer covid vaccination. These side effects keep disrupt healthy sleep and cause headaches. Concerned as to what the long term side effects will be from loss of sleep and quality of life. She was exhausted. Concerned if this is a nerve damage issue. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Blood glucose, Body temperature, Diarrhoea
Clinical narrative: My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Endocrine test, Full blood count, Headache, Lymphadenopathy
Clinical narrative: My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site rash, Vaccination site swelling, Vomiting
Clinical narrative: My left arm where the injection was had swollen three times the normal size; Swelling; Dizzy; I used cold compress to stop itching and swelling; Lymphadenopathy; Arm Pain; Vomiting; Headache; Diarrhea; Muscle pain; Joint Pain; Nausea; Rash at the injection site; rash on the arm; Fever of 99.9; Fever of 101; This is a spontaneous report from a Contactable Consumer reported for self. This 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Jun2021 17:00 at the age of 52-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID. Concomitant medication included hormone medication, It is Best 3 milligram, T 2 Milligram topical cream (Name not confirmed hence not captured in tab) and taking Progesterone 200mg. She felt great for 12 hours, like 5 O' Clock the next day (29Jun2021 5:00) left arm where the injection was had swollen three times the normal size. She had started getting a fever of 99.9 (29Jun2021) and she started getting dizzy, nausea, vomiting and diarrhea. It persisted for 14 days, the swelling on 29Jun2021, the headache, the muscle pain, the joint pain, the fever of 101 and the rash at the injection site and the lymph node, lymphadenopathy, diarrhea, vomiting and arm pain on 29Jun2021. So, every side effect that was documented as a side effect, had a rash on the arm that look like a flower and its incitingly. Treatment included took Benadryl to stop swelling but don't know if it helped, it took 4 days for the swelling to stop and used cold compress to stop itching and swelling. Lab data included had a full hormone panel and CBC Diffs (Unclear and not clarified) test were normal. Cholesterol and sugar were great, everything was great, except hormone. Outcome of the event Arm Pain, Lymphadenopathy, Rash at the injection site; rash on the arm, Joint Pain, Muscle pain, Headache, Diarrhea, Vomiting, Fever of 99.9; Fever of 101, Swelling was recovered in Jul2021. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, X-ray
Clinical narrative: Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer.   A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EWC198), via an unspecified route of administration on 2021 as DOSE 1, SINGLE for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Shortness of breath on an unspecified date in 2021, Chest pain on an unspecified date. The patient was hospitalized for 2 days for the event. The patient underwent lab tests and procedures which included blood test: unknown on 10Jul2021, Electrocardiogram: unknown results on 2021, x-ray: unknown on 2021. Treatment received was inhaler and inflammatory for both the events. There was no prior vaccination within 4 weeks. There was no Investigation Assessment. The outcome of event was unknown  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RA; This is a spontaneous report from a contactable consumer reported for herself. This female patient of unspecified age received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient was watching the news last night and saw having a booster trial coming up. The patient had RA and also had some antibodies. The patient's husband and she were vaccinated against covid and were both interested in participating in this booster trial. Outcome of the event was unknown. Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Anxiety, Cardiac discomfort, Chest discomfort, Chest pain
Clinical narrative: Pressure and pain and in the the left heart area and above the heart in the chest; Waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack; Waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack; Intense adrenaline rush; Fatigue; Inability to concentrate; Anxiety attacks throughout the day; Pressure and pain and in the the left heart area and above the heart in the chest; Pressure and pain and in the the left heart area and above the heart in the chest; Pressure and pain and in the the left heart area and above the heart in the chest; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient and his son had the same reaction and that was waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack. Just intense adrenaline rush, fatigue, inability to concentrate. There are anxiety attacks throughout the day, there was pressure and pain and in the left heart area and above the heart in the chest and his son has probably been to 10 or 12 different doctors to try to figure out what was going on and nobody knows what it was and patient was having similar effects and he had been to a heart doctor twice. The outcomes of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873350 Same reporter/drug, events, different patient
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Nightmare, Norepinephrine increased, Panic attack
Clinical narrative: Pressure and pain and in the the left heart area and above the heart in the chest; Waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack; Waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack; Intense adrenaline rush; Fatigue; Inability to concentrate; Anxiety attacks throughout the day; Pressure and pain and in the the left heart area and above the heart in the chest; Pressure and pain and in the the left heart area and above the heart in the chest; Pressure and pain and in the the left heart area and above the heart in the chest; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient and his son had the same reaction and that was waking up in he middle of the night with, they both have nightmares and they wake up in a panic attack. Just intense adrenaline rush, fatigue, inability to concentrate. There are anxiety attacks throughout the day, there was pressure and pain and in the left heart area and above the heart in the chest and his son has probably been to 10 or 12 different doctors to try to figure out what was going on and nobody knows what it was and patient was having similar effects and he had been to a heart doctor twice. The outcomes of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873350 Same reporter/drug, events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: immunnocompromised; This is a spontaneous report from a contactable consumer (patient).This patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Dose 1 on an unspecified date and Dose 2 on Mar2021; both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. The patient was interested in the clinical trials for the booster. The patient was immunnocompromised. Outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Pyrexia, Rectal abscess
Clinical narrative: rectal abscess; this time it worsened; I was in pain; high fever; This is a spontaneous report received from a contactable consumer (patient). A 60-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0171) via an unspecified route of administration on 27Apr2021 at 18:15 (at 60-year-old), as dose 2, single for COVID-19 immunization. The medical history of the patient included amoxicilin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was mentioned that patient was not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. On 10Apr2021 at 07:00 the patient had rectal abscess which started 3 days after the first jab. It peaked in 10 days and without the surgery and disappeared in about 17-18 days. The abscess returned 3 days after the second jab on an unspecified date in Apr2021 and this time it worsened and required Surgery as treatment to get rid of. The patient was in pain and high fever for several days on an unspecified date in Apr2021. Therapeutic measures were taken as a result of events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information had been requested
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Contusion, Gastrointestinal disorder, Pyrexia, Urticaria
Clinical narrative: Hives; Bruising; Fever of 102, almost 103; GI problems; This is a spontaneous report from a contactable consumer (patient). This 77-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 05Mar2021 18:00 (Batch/Lot number was not reported) (at the age of 77-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure abnormal (was taking blood pressure medications to bring it normal), hard of hearing with hearing aids. Concomitant medication(s) included Losartan taken for blood pressure. Patient received first dose of BNT162B2 on 10Feb2021 06:00 PM (Lot number: EL3247). Patient was reporting a possible side effect from the Pfizer COVID shot in March. Around 02Apr2021 patient had hives, the broke out and he went to different doctor, dermatologist, the allergist, regular doctor. He was in the hospital for 3 days because the hives were actually pretty bad to the point where they were bruising and the blood vessels were 'worsening' from the top of head to the sole to feet, every part of the body. Now patient tried 3 times to get rid of them by using Prednisone given by doctor and the antihistamines. As soon as go off to Prednisone the hives come back and retrieved. Patient did all kind of test for that and never find what's causing the problem, doctors couldn't find the cause of hives. The only thing they point to, is the fact that the month patient had the vaccine shot that developed this, 3 times. Patient got the both shots the first and the second shots and after the second shot, the day after he developed fever of 102, almost 103 and that pretty well went away, they said that could happen and that did. It went away after one day and he was fine, then this other stuff started later. Patient was experiencing lot of GI problems, he thought this is due to COVID shot. Treatment included Prednisone, Antihistamine (Unspecified Medication) as well Allegra, Zyrtec and Benadryl. when he was on prednisone, the hives went away. When off Prednisone they came right back. When went down to lower doses, they came right back again. He was not taking Prednisone anymore. The outcome of Fever was recovered, of other events was not recovered.  Information on lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies, Computerised tomogram, Confusional state, Cough, Dizziness
Clinical narrative: I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Magnetic resonance imaging, Pulmonary thrombosis, Thrombosis
Clinical narrative: I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Diarrhoea, Ear swelling, Nausea, Paraesthesia
Clinical narrative: possible hearing loss; swollen ears; tingling in arms; diarrhea; vomiting; nausea; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). This female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen ears, tingling in arms, diarrhea, vomiting, possible hearing loss and nausea. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: possible hearing loss; swollen ears; tingling in arms; diarrhea; vomiting; nausea; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). This female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen ears, tingling in arms, diarrhea, vomiting, possible hearing loss and nausea. The outcome of events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: I have had almost a non-stop migraine since my first dose of the COVID vaccine.; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7533), via unspecified route of administration in the right arm, on 02Apr2021 at 10:15 AM, as 1st dose, single for COVID-19 Immunisation. Medical history included chronic migraine. Concomitant medications included rizatriptan benzoate (MAXALT), Naproxen sodium (ALEVE), gabapentin. The patient had no known allergies. The patient was not a pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW6170), via unspecified route of administration in the right arm, on 25Apr2021 at 02:30 PM, as 2nd dose, single for COVID-19 Immunisation. On 03Apr2021, the patient experienced non-stop migraine, suffered from migraines for decades, but this was noticeably worse. It was reported that normal preventative measures do not helped like they did before. The patient stated that her triptan drugs (rizatriptan or naratriptan) do still provide relief. The patient received neurological treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not resolved.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: His whole heart was inflamed, he had inflammation around his heart, so he was in the hospital; His whole heart was inflamed, he had inflammation around his heart, so he was in the hospital; This is a spontaneous report from a contactable consumer (husband). A 49-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: was not reported), via unspecified route of administration, as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported.  On an unspecified date, the patient's whole heart was inflamed, he had inflammation around his heart and he was hospitalized. Reporter stated that the patient was admitted in the hospital and before that he had a clean bill of record no cholesterol, no diabetes and he is not over weight. And she was assuming that the hospital was supposed to report it. Reporter stated that the only problem for calling was because she can't, bills keep coming and it was ridiculous, she cannot afford to pay all these bills that vaccine gave him this illness. The patient would like Pfizer to convince her why the rest of my family should go get a vaccine. The reporter stated that she was noticed on the news they keep saying teenagers, young teenagers, but somebody needs to tell the truth out there. Reporter was informed that the information was captured to file a safety report and if in case a follow-up is requested then it can be done by this information. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: TIA - Transcient Ischemic attach; Both vaccines was administered on same day; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (at the age of 76-year-old) (Batch/Lot Number: E200187) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included glaucoma and cardiac disorder. Concomitant medication included acetylsalicylic acid (ASPIRINA); carvedilol (CARVEDILOL) and furosemide taken for an unspecified indication, start and stop date were not reported. On 04Jun2021 13:00 the patient was hospitalized for tia - transcient ischemic attach for 2 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Patient do not have any allergies. Patient tested positive post vaccination. Patient received treatment for adverse event as Physical Therapy. Post vaccination the patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jun2021. The outcome of event was recovered and unknown for both vaccines was administered on same day.  Follow-up actions are needed. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: subject had a mild case of COVID after weeks of getting the second dose; subject had a mild case of COVID after weeks of getting the second dose; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in May2021 at dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, patient was diagnosed with COVID-19 was unknown. After the vaccination patient had been tested positive for covid-19. Patient had a mild case of COVID after weeks of getting the second dose. The outcome of event was unknown.  Information on lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, COVID-19, Chest pain, Drug ineffective
Clinical narrative: She also added that she has had the COVID disease; She also added that she has had the COVID disease; Chest pain feeling like heart attack; she feels like she is going to die; Woke up 12Jul2021 at 01:00 in excruciating pain; Having severe muscle cramps now/severe muscle cramps now was reported as worsened; Dealing with slurred Speech; Has memory loss; Losing sense of balance; Has really severe kidney pain on the right side as well; Felt a little bit tired; This is a spontaneous report from a contactable consumer (patient). A female patient of 32-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was WAG13871 ), first dose via an unspecified route of administration on left arm on 11Jul2021, 15:00 at unknown dose single for COVID-19 immunization. Medical history includes seizure disorder, 20 major surgeries, ortopedic bone surgery, heart attack, post op pain, vision impaired. Family Medical History includes patient father died of heart attack. No concomitant medication reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine . On 12Jul2021 patient start experiencing excruciating pain, , having severe muscle cramps, dealing with slurred Speech, memory loss, Losing sense of balance, Has really severe kidney pain on the right side, The tiredness  about 3 hours later, Chest pain. She was tested positive after vaccination. She cannot afford to go to the emergency room or the physicians office right now. She comes from a HCP family and is HCP herself. When asked to specify what type, she mentioned withheld. She is a resident of withheld, currently in withheld. She mentioned she is aware of the expected side effects with the Pfizer BioNTech. Outcome of she had covid disease, losing sense of balance, chest pain feeling like heart attack, she feels like she is going to die was unknown, recovered from fatigue, outcome of pain, Dealing with slurred Speech, has memory loss, has really severe kidney pain on the right side as well was recovering, outcome of having severe muscle cramps now/severe muscle cramps now was reported as worsened was not recovered   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Fatigue, Feeling abnormal, Muscle spasms, Pain
Clinical narrative: She also added that she has had the COVID disease; She also added that she has had the COVID disease; Chest pain feeling like heart attack; she feels like she is going to die; Woke up 12Jul2021 at 01:00 in excruciating pain; Having severe muscle cramps now/severe muscle cramps now was reported as worsened; Dealing with slurred Speech; Has memory loss; Losing sense of balance; Has really severe kidney pain on the right side as well; Felt a little bit tired; This is a spontaneous report from a contactable consumer (patient). A female patient of 32-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was WAG13871 ), first dose via an unspecified route of administration on left arm on 11Jul2021, 15:00 at unknown dose single for COVID-19 immunization. Medical history includes seizure disorder, 20 major surgeries, ortopedic bone surgery, heart attack, post op pain, vision impaired. Family Medical History includes patient father died of heart attack. No concomitant medication reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine . On 12Jul2021 patient start experiencing excruciating pain, , having severe muscle cramps, dealing with slurred Speech, memory loss, Losing sense of balance, Has really severe kidney pain on the right side, The tiredness  about 3 hours later, Chest pain. She was tested positive after vaccination. She cannot afford to go to the emergency room or the physicians office right now. She comes from a HCP family and is HCP herself. When asked to specify what type, she mentioned withheld. She is a resident of withheld, currently in withheld. She mentioned she is aware of the expected side effects with the Pfizer BioNTech. Outcome of she had covid disease, losing sense of balance, chest pain feeling like heart attack, she feels like she is going to die was unknown, recovered from fatigue, outcome of pain, Dealing with slurred Speech, has memory loss, has really severe kidney pain on the right side as well was recovering, outcome of having severe muscle cramps now/severe muscle cramps now was reported as worsened was not recovered   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.