chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling of body temperature change, Haemorrhage subcutaneous, Heart rate, Hypoaesthesia
Clinical narrative: About 20+ blood spots on my arms, left shoulder, chest, left thigh, and legs.; Shortness of breath; Dizzy; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Pain on my upper left back; Cough; Chest tightness; Rash on my forearms (not itchy); Joint pain; Muscle pain; This is a spontaneous report received from contactable consumer (patient). A 30-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 23Apr2021 10:30 (at the age of 30-years-old) as 1st dose, single for covid-19 immunization.  Medical history included cold sores and allergies with mango, peach, and mold. The patient's concomitant medications were not reported. The patient previously took penicillin and erythromycin and experienced drug allergy in both. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within an hour after getting the first dose on 23Apr2021 at 11:00 AM, the patient felt dizzy and saw rash on her forearms (not itchy); then she started to feel weird in her heart, like it felt cold/numb sometimes and hot sometimes; it also developed into pain on her upper left back. At the same time, her heart beat also became fast (90-100/min). These symptoms lasted about another 3 days, and then she started to cough and had chest tightness and shortness of breath. The difficulty of breathing worsened within 2 days, so she took some Benadryl and it helped a bit. Then she noticed that there were about 20+ blood spots on her arms, left shoulder, chest, left thigh, and legs. All the events occurred on 23Apr2021 at 11:00 AM. She had muscle pain and joint pain in the next 3 to 4 days (in Apr2021), then the rash on her forearms disappeared. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: About 20+ blood spots on my arms, left shoulder, chest, left thigh, and legs.; Shortness of breath; Dizzy; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Pain on my upper left back; Cough; Chest tightness; Rash on my forearms (not itchy); Joint pain; Muscle pain; This is a spontaneous report received from contactable consumer (patient). A 30-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 23Apr2021 10:30 (at the age of 30-years-old) as 1st dose, single for covid-19 immunization.  Medical history included cold sores and allergies with mango, peach, and mold. The patient's concomitant medications were not reported. The patient previously took penicillin and erythromycin and experienced drug allergy in both. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within an hour after getting the first dose on 23Apr2021 at 11:00 AM, the patient felt dizzy and saw rash on her forearms (not itchy); then she started to feel weird in her heart, like it felt cold/numb sometimes and hot sometimes; it also developed into pain on her upper left back. At the same time, her heart beat also became fast (90-100/min). These symptoms lasted about another 3 days, and then she started to cough and had chest tightness and shortness of breath. The difficulty of breathing worsened within 2 days, so she took some Benadryl and it helped a bit. Then she noticed that there were about 20+ blood spots on her arms, left shoulder, chest, left thigh, and legs. All the events occurred on 23Apr2021 at 11:00 AM. She had muscle pain and joint pain in the next 3 to 4 days (in Apr2021), then the rash on her forearms disappeared. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Mydriasis, Pulse abnormal, Seizure, Syncope
Clinical narrative: Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 12May2021 09:45 (Batch/Lot Number: EW0182) (at the age of 25 years old) as 1st dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included COVID-19. Concomitant medication included lithium taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and had allergies. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 10:00, the patient experienced lose consciousness and faint as well as began to have a seizure, vitals were not great, faint pulse and dilated pupils. After vaccine administration, patient began to lose consciousness and faint as well as began to have a seizure. EMT's were called vitals were not great, faint pulse and dilated pupils. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included ambulance ride, EMT's (as reported). The patient was recovering with lasting effects. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae on unspecified date.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vital functions abnormal, Vital signs measurement
Clinical narrative: Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 12May2021 09:45 (Batch/Lot Number: EW0182) (at the age of 25 years old) as 1st dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included COVID-19. Concomitant medication included lithium taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and had allergies. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 10:00, the patient experienced lose consciousness and faint as well as began to have a seizure, vitals were not great, faint pulse and dilated pupils. After vaccine administration, patient began to lose consciousness and faint as well as began to have a seizure. EMT's were called vitals were not great, faint pulse and dilated pupils. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included ambulance ride, EMT's (as reported). The patient was recovering with lasting effects. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae on unspecified date.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Genital herpes, Herpes simplex test, Kidney infection, Lymphadenopathy
Clinical narrative: severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count and low lymphocytes; patient developed 102.6 fever; nausea; Swollen groin lymph nodes; kidney infection; severe UTI; the patient experienced bad leg pain; rash on legs; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer and Hashimoto disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 53-years-old on 01Apr2021 12:30 in the arm right for COVID-19 immunization. On 02May2021 22:00, the patient experienced bad leg pain, rash on legs, flowed by severe UTI and kidney infection. On 05May2021, day 3, the patient developed 102.6 fever, nausea, swollen groin lymph nodes, severe dysuria tested positive for HSV1 Genital, with bad lower pelvic pain, low WBC counts and low lymphocytes. The patient had 2 trips to ER in 3 days, missed 8 days of work due to the events. The patient received IV fluids, IV antibiotic, IV pain meds, anti-nausea as treatment for the events. The outcome of the event was recovered with sequel.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count and low lymphocytes; patient developed 102.6 fever; nausea; Swollen groin lymph nodes; kidney infection; severe UTI; the patient experienced bad leg pain; rash on legs; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer and Hashimoto disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 53-years-old on 01Apr2021 12:30 in the arm right for COVID-19 immunization. On 02May2021 22:00, the patient experienced bad leg pain, rash on legs, flowed by severe UTI and kidney infection. On 05May2021, day 3, the patient developed 102.6 fever, nausea, swollen groin lymph nodes, severe dysuria tested positive for HSV1 Genital, with bad lower pelvic pain, low WBC counts and low lymphocytes. The patient had 2 trips to ER in 3 days, missed 8 days of work due to the events. The patient received IV fluids, IV antibiotic, IV pain meds, anti-nausea as treatment for the events. The outcome of the event was recovered with sequel.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urinary tract infection, White blood cell count, White blood cell count decreased
Clinical narrative: severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count and low lymphocytes; patient developed 102.6 fever; nausea; Swollen groin lymph nodes; kidney infection; severe UTI; the patient experienced bad leg pain; rash on legs; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer and Hashimoto disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 53-years-old on 01Apr2021 12:30 in the arm right for COVID-19 immunization. On 02May2021 22:00, the patient experienced bad leg pain, rash on legs, flowed by severe UTI and kidney infection. On 05May2021, day 3, the patient developed 102.6 fever, nausea, swollen groin lymph nodes, severe dysuria tested positive for HSV1 Genital, with bad lower pelvic pain, low WBC counts and low lymphocytes. The patient had 2 trips to ER in 3 days, missed 8 days of work due to the events. The patient received IV fluids, IV antibiotic, IV pain meds, anti-nausea as treatment for the events. The outcome of the event was recovered with sequel.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria chronic
Clinical narrative: angioedema; hives/chronic urticaria; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 31 years of age), via an unspecified route of administration on 13Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included anaemia, type 1 diabetes mellitus (IDDM), hypothyroid, lymphocytic colitis, hyperlipidemia, known environmental allergies, and COVID-19 prior vaccination. Concomitant medications included insulin and levothyroxine sodium (SYNTHROID), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 on 22Dec2020 07:00 AM (at 31 years of age) (Batch/Lot number: EK5730) in the right arm for COVID-19 immunisation. The patient was not pregnant. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. About 2 weeks after receiving second dose on 13Jan2021, the patient developed hives and angioedema. She had now been diagnosed with chronic urticaria. The hives have been present everyday since. They are not responsive to antihistamines, steroids, or Montelukast. The patient stated that she had been waiting for insurance approval to try XOLAIR. The adverse event start date was 27Jan2021 07:15, which resulted to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not recovered from the events. Therapeutic measures were taken as a result of the events with antihistamines, steroids (po and topical), and Montelukast.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspectt drug BNT162B2 Cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Body temperature, Chest X-ray, Computerised tomogram, Myocardial infarction
Clinical narrative: Heart attack-like symptoms; 100 degree fever lasting one day with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on an unspecified date (Batch/Lot Number: ER8737) as 2nd dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient has no known allergies. The patient received the first dose of BNT162B2 on 24Mar2021 15:30 on the right arm (lot number: EN6205) for COVID-19 immunisation. The patient did not have other vaccine in four weeks and no other medication in two weeks. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On 29Apr2021, the patient had a 100-degree fever lasting one day with no symptoms. The patient was fine the next day. Then on 02May2021 at 20:00, she began having heart attack-like symptoms. She went to the ER and was having a heart attack. All of her testing from her angiogram to her chest x-ray to the CT of her lungs found nothing. She was a 100% healthy without any medical issues. She has no prior history of heart problems. The patient was hospitalized for a day for the event heart attack-like symptoms. Treatment included angiogram, chest x-ray, lung CT and blood thinners. The patient was recovering from heart attack-like symptoms and recovered from 100 degree fever.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Heart attack-like symptoms; 100 degree fever lasting one day with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on an unspecified date (Batch/Lot Number: ER8737) as 2nd dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient has no known allergies. The patient received the first dose of BNT162B2 on 24Mar2021 15:30 on the right arm (lot number: EN6205) for COVID-19 immunisation. The patient did not have other vaccine in four weeks and no other medication in two weeks. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On 29Apr2021, the patient had a 100-degree fever lasting one day with no symptoms. The patient was fine the next day. Then on 02May2021 at 20:00, she began having heart attack-like symptoms. She went to the ER and was having a heart attack. All of her testing from her angiogram to her chest x-ray to the CT of her lungs found nothing. She was a 100% healthy without any medical issues. She has no prior history of heart problems. The patient was hospitalized for a day for the event heart attack-like symptoms. Treatment included angiogram, chest x-ray, lung CT and blood thinners. The patient was recovering from heart attack-like symptoms and recovered from 100 degree fever.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Gait disturbance, Headache, Myalgia
Clinical narrative: Soreness at her injection site/arm would be sore; Arm was also bruised and swollen. Left arm; Arm was also bruised and swollen. Left arm; Headache; tired; fever; muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking; muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking; arm would be sore; This is a spontaneous report from a contactable nurse (patient). A 69 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EW0170), intramuscular, administered in arm right on 20Apr2021 (at the age of 69-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure abnormal (reported as blood pressure), heartburn and gastrooesophageal reflux disease (GERD), all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for blood pressure, pravastatin taken for an unspecified indication, esomeprazole magnesium (NEXUM) taken for dyspepsia and GERD, all start and stop dates were not reported. After the patient's first shot, her arm was killing her, it got swollen and it was bruised. It was the craziest thing she knew her arm would be sore after the shot but, not the opposite arm. She was tired, had a headache, all the ones that listed on the Pharmacy list she was given. She had a hard time with both shots, she is glad Pfizer only has 2. Soreness at her injection site after the 1st injection. Arm was also bruised and swollen. Left arm, she got it 12 in the afternoon but, the stuff showed up 5-6 hours later, nothing right away. It was the same yesterday with her shot, she was ok and about 6-7 hours after is started bothering her. She got the 1st injection on 20Apr2021. She knew her arm would be sore. She checked off everything on the her a list she got from the pharmacy, she had fever, her muscles were sore enough where she had a difficult time walking, her arm was sore. Headache, tired, fever, muscle soreness to where she couldn't even walk. This happened after her first shot that started on 20Apr2021. She confirmed that the left arm was bruised and swollen, not both. Treatment - No treatment sought. The events were assessed as serious and medically significant. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at her injection site/arm would be sore; Arm was also bruised and swollen. Left arm; Arm was also bruised and swollen. Left arm; Headache; tired; fever; muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking; muscle soreness to where she couldn't even walk/muscles were sore enough where she had a difficult time walking; arm would be sore; This is a spontaneous report from a contactable nurse (patient). A 69 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EW0170), intramuscular, administered in arm right on 20Apr2021 (at the age of 69-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure abnormal (reported as blood pressure), heartburn and gastrooesophageal reflux disease (GERD), all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for blood pressure, pravastatin taken for an unspecified indication, esomeprazole magnesium (NEXUM) taken for dyspepsia and GERD, all start and stop dates were not reported. After the patient's first shot, her arm was killing her, it got swollen and it was bruised. It was the craziest thing she knew her arm would be sore after the shot but, not the opposite arm. She was tired, had a headache, all the ones that listed on the Pharmacy list she was given. She had a hard time with both shots, she is glad Pfizer only has 2. Soreness at her injection site after the 1st injection. Arm was also bruised and swollen. Left arm, she got it 12 in the afternoon but, the stuff showed up 5-6 hours later, nothing right away. It was the same yesterday with her shot, she was ok and about 6-7 hours after is started bothering her. She got the 1st injection on 20Apr2021. She knew her arm would be sore. She checked off everything on the her a list she got from the pharmacy, she had fever, her muscles were sore enough where she had a difficult time walking, her arm was sore. Headache, tired, fever, muscle soreness to where she couldn't even walk. This happened after her first shot that started on 20Apr2021. She confirmed that the left arm was bruised and swollen, not both. Treatment - No treatment sought. The events were assessed as serious and medically significant. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lower back pain; This is a spontaneous report from a contactable physician reported that a 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 25Apr2021 (at the age of 44-years-old) as 2nd dose, single for covid-19 immunization. The patient has a significant medical history which included that she has problems with her immune system. The patient has an immune system disorder that when she was two years old, she had to be put in a bubble to isolate and to protect her from pathogens. The patient said that her heart stopped beating at that time. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) on an unspecified date as 1st dose for covid-19 immunisation. The patient's concomitant medications were not reported. After the second dose, the patient experienced lower back pain on 26Apr2021. The event resulted in two ER visits, two days apart, and physician office visit as the patient saw her primary care physician today (12May2021). The event was considered as medically significant. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event lower back pain cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cellulitis, Chest pain, Headache, Inappropriate schedule of product administration
Clinical narrative: BARD Power Port clogged with blood clot; cellulitis; Severe headache; abdominal pain; arm pain; chest pain; dose 1 administered in Leg Left; dose 1 and dose 2 on the same day; dose 1 and dose 2 on the same day; This is a spontaneous report receive from a contactable consumer (patient). A 38 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose, dose 1 administered in Leg Left on 19Mar2021 14:45 (Batch/Lot Number: EP7534), and dose 2 administered in Arm Right on 19Mar2021 (Batch/Lot Number: ER8729) for covid-19 immunisation. Medical history included myasthenia gravis, natural killer cell deficiency, gastroparesis, connective tissue disease, postural orthostatic tachycardia syndrome (POTS), known allergies: Gluten, dairy, xanthan gum, antibiotics, beta blockers, pain medication, latex. No other vaccine received in four weeks. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); montelukast sodium (SINGULAIR); diphenhydramine hydrochloride (BENADRYL); sumatriptan succinate (IMITREX); promethazine (PHENERGAN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced Severe headache 1.5 days, abdominal pain 3 days, arm pain and chest pain 7 days, BARD Power Port clogged with blood clot and subsequent cellulitis from many attempt to flush the clot (22Apr2021 04:00 PM). The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Home nursing visits and admitted to Emergency Room (ER). Outcome of the events was recovering/resolving.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administered at inappropriate site, Thrombosis
Clinical narrative: BARD Power Port clogged with blood clot; cellulitis; Severe headache; abdominal pain; arm pain; chest pain; dose 1 administered in Leg Left; dose 1 and dose 2 on the same day; dose 1 and dose 2 on the same day; This is a spontaneous report receive from a contactable consumer (patient). A 38 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose, dose 1 administered in Leg Left on 19Mar2021 14:45 (Batch/Lot Number: EP7534), and dose 2 administered in Arm Right on 19Mar2021 (Batch/Lot Number: ER8729) for covid-19 immunisation. Medical history included myasthenia gravis, natural killer cell deficiency, gastroparesis, connective tissue disease, postural orthostatic tachycardia syndrome (POTS), known allergies: Gluten, dairy, xanthan gum, antibiotics, beta blockers, pain medication, latex. No other vaccine received in four weeks. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included escitalopram oxalate (LEXAPRO); montelukast sodium (SINGULAIR); diphenhydramine hydrochloride (BENADRYL); sumatriptan succinate (IMITREX); promethazine (PHENERGAN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced Severe headache 1.5 days, abdominal pain 3 days, arm pain and chest pain 7 days, BARD Power Port clogged with blood clot and subsequent cellulitis from many attempt to flush the clot (22Apr2021 04:00 PM). The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Home nursing visits and admitted to Emergency Room (ER). Outcome of the events was recovering/resolving.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Pelvic fracture
Clinical narrative: bladder infection; broken pelvis; This is a spontaneous report from a Pfizer sponsored program  from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized due to bladder infection and broken pelvis on an unspecified date with outcome of unknown.  Information about lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Enterovesical fistula, Herpes zoster
Clinical narrative: some sort of tear between her bowels and her urination tract; has come down with shingles/it is dawning on her that it is pain from the shingles; This is a spontaneous report from a contactable consumer, the patient's husband.   An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the right arm on 20Feb2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (Lot Number: FL9265) at the age of 80-years-old, administered in the right arm on 30Jan2021 for COVID-19 immunisation. In 2021, the patient experienced some sort of tear between her bowels and her urination tract and shingles. The clinical course was as follows: The patient came down with shingles. It was unknown the date the shingles began for the patient as shingles was not suspected at first.  It could have started maybe 2-3 weeks after the second dose. Then, as of 03May2021, the patient was hospitalized for some sort of tear between her bowels and her urination tract which required an unspecified operation to be performed the same day.  At the time of the report, the patient was still in the hospital and the patient was in quite a bit of pain. It was assumed the pain was part of the operation. However, it was dawning on her that it was pain from the shingles and was worse than before. The clinical outcome of the shingles was not recovered, while that of the tear between her bowels and her urination tract was unknown.   Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Magnetic resonance imaging, Pain, Scan, X-ray
Clinical narrative: sounded like she had shingles; severe pain up her back that goes to her upper torso, left side only; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 78 years). Medical history included ongoing diabetes mellitus, ongoing degenerative joint disease, ongoing osteoarthritis and ongoing heart disorder. Concomitant medications included tramadol; pregabalin (LYRICA); gabapentin (GABAPENTIN "PCD").  The patient experienced severe pain up her back that goes to her upper torso, left side only on 03Mar2021. The patient also stated that she had sounded like she had shingles on an unspecified date. They felt that the vaccine was trying to fight the shingles virus that stays in her body. She has no bumps, fever or breakout. She went to the Emergency Room once to get pain medicine. She went to her doctor (physician office visit), she doesn't know if he reported this. The events were assessed as medically significant. The patient underwent lab tests and procedures which included MRI, scan and x-ray: unknown results on an unspecified date. Therapeutic measures were taken as a result of pain and shingles. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Disease recurrence
Clinical narrative: Sudden hearing loss - 100% hearing loss upon waking up in the left ear; Sudden hearing loss - 100% hearing loss upon waking up in the left ear; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for COVID-19 immunisation. It was reported that patient received first dose of BNT162B2 on 06Apr2021 09:00 (lot number: EP7533) in right arm, and second dose also on 06Apr2021 (lot number: EW0171) in left arm; both information has pending clarification. Medical history included underlying hearing loss from childhood. The patient was not pregnant at the time of vaccination. The patient received unspecified birth control, and vitamins within 2 weeks of vaccination. No any other vaccines received within 4 weeks prior to the COVID vaccine. The patient experienced sudden hearing loss - 100% hearing loss upon waking up in the left ear on 09Apr2021 05:30. Therapeutic measures were taken as a result of sudden hearing loss - 100% hearing loss upon waking up in the left ear which included steroid and antibiotics. The event resulted in emergency room/department or urgent care. The patient was recovering from the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Chest X-ray, Computerised tomogram, Electrocardiogram, Facial pain
Clinical narrative: clot in one of the vessels in her brain; severe headaches; Facial pain; This is a spontaneous report from a contactable consumer reporting on behalf of the patient.  A female patient (reporter's sister) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 on unspecified date (unknown lot number and expiration) for COVID -19 immunization. It was reported that the patient received the second shot of COVID vaccine on 4th of this month (04May2021) and developed severe headaches, facial pain, and other symptoms about a couple of years later. The severity of her headache is so much that they had to get her admitted where medical tests were done in the emergency. CT scan, MRI, ECG, and chest x-rays with unknown results. Everything was done and the doctor is suspecting a clot in one of the vessels in her brain. The reporter further stated, "Can you just guide me about how do I go about it?".  The events resulted in emergency room visit. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging
Clinical narrative: clot in one of the vessels in her brain; severe headaches; Facial pain; This is a spontaneous report from a contactable consumer reporting on behalf of the patient.  A female patient (reporter's sister) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 on unspecified date (unknown lot number and expiration) for COVID -19 immunization. It was reported that the patient received the second shot of COVID vaccine on 4th of this month (04May2021) and developed severe headaches, facial pain, and other symptoms about a couple of years later. The severity of her headache is so much that they had to get her admitted where medical tests were done in the emergency. CT scan, MRI, ECG, and chest x-rays with unknown results. Everything was done and the doctor is suspecting a clot in one of the vessels in her brain. The reporter further stated, "Can you just guide me about how do I go about it?".  The events resulted in emergency room visit. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis infective
Clinical narrative: knee joint infection; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer-sponsored program. A male patient of an unspecified age received the first dose of received bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 22Apr2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter called for her husband who got the first dose already and is due for the next day (13May2021). However, in between the doses he got a knee joint infection, so he is taking antibiotics. The second dose of vaccine was scheduled a day after the report, on 13May2021. The knee joint infection, she believes, was diagnosed this past Saturday (unspecified date). The antibiotic given was Keflex, 500 mg 4 times a day. The reporter added that she called because her mother-in-law (patient's mother) was on an antibiotic and was told to not get the vaccine until after. The reporter was trying to figure out if it is okay for her husband to take the second dose of the vaccine since he is on an antibiotic. Therapeutic measures were taken as a result of knee joint infection. Outcome of the event was unknown.   Information on batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated with the Pfizer vaccine/patient tested positive; fully vaccinated with the Pfizer vaccine/patient tested positive; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the first of 3 reports.   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on Dec2020 (Batch/Lot number was not reported) as 1st dose, single, dose 2 (Batch/Lot number was not reported) on an unspecified date as 2nd dose, single both via an unspecified route of administration for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. In April, their 6-year-old daughter contracted COVID-19 through an outbreak at school. This occurred after spring.  The patient was fully vaccinated with the Pfizer vaccine in Dec2020. She had the worst symptoms. None required hospitalization. They all self- treated at home. The patient tested positive shortly after their 6-year-old daughter tested positive in April. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539650 same reporter, same drug, similar event, different patient;US-PFIZER INC-2021539644 same reporter, same drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated with the Pfizer vaccine/patient tested positive in April; fully vaccinated with the Pfizer vaccine/patient tested positive in April; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the second of three reports.   A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in 2021 (Lot number was not reported) as 2nd dose, single and via an unspecified route of administration on an unspecified date in 2021 (Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer vaccine and tested positive on Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Apr2021. The patient did not require hospitalization and self- treated at home with an unspecified treatment. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539650 same reporter, same drug, similar event, different patient;US-PFIZER INC-2021539614 same reporter, same drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated with the Pfizer vaccine/patient tested positive with mild symptoms; fully vaccinated with the Pfizer vaccine/patient tested positive with mild symptoms; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. This consumer reported similar events for three patients. This is the third (grandmother) of three reports. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 2 as 2nd dose, single; and dose 1 as 1st dose, single; both via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) for covid-19 immunisation. Medical history included immunocompromised. The patient's concomitant medications were not reported. It was reported that the reporter was informed this morning that 3 neighbors that were fully vaccinated with Pfizer vaccine in Dec2020, Feb2021 and Mar2021 were positive in Apr2021. It was further reported that in Apr2021, a 6-year-old female child contracted COVID19 through an outbreak at school. This occurred after spring Break in a County that has a very high number of variant COVID 19 cases. Both mothers are 41 and 42 and her grandparent is 72 years of age. The grandparent is immunocompromised. The 6-year-old was taken to the doctor and tested positive at the office. The 3 adults all tested positive shortly after their daughter tested positive in Apr2021. None of the adults required hospitalization and they all self- treated at home. The grandmother also had mild symptoms. The Grandmother takes care of her granddaughter while the 2 Moms are working. The outcome of the events was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539614 same reporter/drug, similar event, different patient;US-PFIZER INC-2021539644 same reporter/drug, similar event, different patient