chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin eruption or rash all over body; This is a spontaneous report from a Non-contactable consumer(patient).   A 19-year-old non pregnant female patient bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date in 2021 (at the age of 19 year), as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced skin eruption or rash all over body. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Prednisone as a treatment medication. The patient was visited to Doctor or other healthcare professional office/clinic visit for the event. The event was resolved on an unspecified date in 2021.  The reporter did not consider the event to be serious.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Apnoea test, Chills, Fatigue, Headache
Clinical narrative: she was fighting tonsil infection or strep from what doctors assume; she was fighting tonsil infection or strep from what doctors assume; hair started to fall out; had every type of COVID symptom; vomiting; fevers; chills; sore throat; tiredness; headache; sleep apnea; pregnant at time of vaccination/ gestation period were 31 weeks; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 27-years, via unspecified route of administration at single dose for COVID-19 immunization, first dose in left arm on 25Jun2021 at 12:00 and second dose on unspecified date. Medical history included tonsillitis, functional neurological disorder with clink rare genes with child, GERD, autism. The patient was pregnant at time of vaccination. Patient last menstrual period date was 10Dec2020 and pregnancy due date 09Sep2021, gestation period were 31 weeks. No other vaccine in four weeks. No known allergies. No COVID-19 prior vaccination. Concomitant medications included prenatal (unspecified), folic acid, antibiotics. The patient reported that after her first and second dose her hair started to fall out. She was fighting tonsil infection or strep from what doctors assume. She probably should of waited until she was done taking her penicillin anti biotic. She had every type of COVID symptom but doctor was surprised to find no illnesses to explain her vomiting, fevers, chills, sore throat, tiredness, headache, etc. She saw a tonsil doctor to set up future removal. And sleep apnea testing. Adverse event start date on 20Jun2021 (as reported). Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No COVID-19 tested post vaccination. Outcome of the events was not recovered.   Information about batch/lot number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Oropharyngeal pain, Pharyngitis streptococcal, Pyrexia, Sleep apnoea syndrome
Clinical narrative: she was fighting tonsil infection or strep from what doctors assume; she was fighting tonsil infection or strep from what doctors assume; hair started to fall out; had every type of COVID symptom; vomiting; fevers; chills; sore throat; tiredness; headache; sleep apnea; pregnant at time of vaccination/ gestation period were 31 weeks; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 27-years, via unspecified route of administration at single dose for COVID-19 immunization, first dose in left arm on 25Jun2021 at 12:00 and second dose on unspecified date. Medical history included tonsillitis, functional neurological disorder with clink rare genes with child, GERD, autism. The patient was pregnant at time of vaccination. Patient last menstrual period date was 10Dec2020 and pregnancy due date 09Sep2021, gestation period were 31 weeks. No other vaccine in four weeks. No known allergies. No COVID-19 prior vaccination. Concomitant medications included prenatal (unspecified), folic acid, antibiotics. The patient reported that after her first and second dose her hair started to fall out. She was fighting tonsil infection or strep from what doctors assume. She probably should of waited until she was done taking her penicillin anti biotic. She had every type of COVID symptom but doctor was surprised to find no illnesses to explain her vomiting, fevers, chills, sore throat, tiredness, headache, etc. She saw a tonsil doctor to set up future removal. And sleep apnea testing. Adverse event start date on 20Jun2021 (as reported). Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No COVID-19 tested post vaccination. Outcome of the events was not recovered.   Information about batch/lot number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Tonsillitis, Vomiting
Clinical narrative: she was fighting tonsil infection or strep from what doctors assume; she was fighting tonsil infection or strep from what doctors assume; hair started to fall out; had every type of COVID symptom; vomiting; fevers; chills; sore throat; tiredness; headache; sleep apnea; pregnant at time of vaccination/ gestation period were 31 weeks; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 27-years, via unspecified route of administration at single dose for COVID-19 immunization, first dose in left arm on 25Jun2021 at 12:00 and second dose on unspecified date. Medical history included tonsillitis, functional neurological disorder with clink rare genes with child, GERD, autism. The patient was pregnant at time of vaccination. Patient last menstrual period date was 10Dec2020 and pregnancy due date 09Sep2021, gestation period were 31 weeks. No other vaccine in four weeks. No known allergies. No COVID-19 prior vaccination. Concomitant medications included prenatal (unspecified), folic acid, antibiotics. The patient reported that after her first and second dose her hair started to fall out. She was fighting tonsil infection or strep from what doctors assume. She probably should of waited until she was done taking her penicillin anti biotic. She had every type of COVID symptom but doctor was surprised to find no illnesses to explain her vomiting, fevers, chills, sore throat, tiredness, headache, etc. She saw a tonsil doctor to set up future removal. And sleep apnea testing. Adverse event start date on 20Jun2021 (as reported). Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No COVID-19 tested post vaccination. Outcome of the events was not recovered.   Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Liver transplant
Clinical narrative: Liver transplant; This case has been considered invalid as the event mentioned of Liver Transplant is a surgical procedure and does not classify to be adverse event of the vaccine.   This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced liver transplant (medically significant) on an unspecified date with outcome of unknown. It was not clarified if patient was scheduled to have transplant before or after 1st dose of vaccine. The patient also received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) in Jun2021 for COVID-19 immunisation.  The information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Cardiovascular function test
Clinical narrative: I could not drive, and had no energy; blood pressure was high 150/80 - which is not normal; lost 10 lbs; hypoglycemia; b/c y Dimer was elevated; Her blood sugar is also elevated; felt extremely short of breath while driving; This is a spontaneous report from a contactable consumer reported for self. This 47-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Right arm on 12Apr2021 13:00 at the age of 47-year-old (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for COVID-19 immunisation. No pregnancy at time of vaccination. Medical history included Hashimotos, Penicillin allergy, still have reactive hypoglycemia, allergies: Phenothiazines. No Covid prior vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) 10mg, and thyroid (ARMOUR THYROID). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Right arm on Mar2021 11:15 AM at the age of 47-year-old (lot number: ER2613) for COVID-19 immunisation. Approx 4 days following 2nd shot on 16Apr2021 10:45 AM, she left a spin class and felt extremely short of breath while driving. She went to the urgent care and then ER, b/c y Dimer was elevated. They ra tests and chest MRI was normal. One week Later, she went back to urgent care with same symptoms, blood pressure was high 150/80 - which is not normal. Over a period of three weeks she lost 10 lbs. She could not drive, and had no energy. (endo, cardio and primary) ordered a battery of test. Her endo figured that had an autoimmune attack on blood sugar. She still had reactive hypoglycemia - she wear a continuous glucose monitoring device. Her blood sugars drop at night to 50. Her blood sugar is also elevated. She took acarbose to manage it. Cardio has her on a zip patch to monitor her heart rhythm which is also affected. went to urgent care 6 times, had numerous # Appt. and ER once. Believe it is related to the vaccine, she was completely active and normal bef. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Seriousness criteria-Disabling/Incapacitating. No Covid tested post vaccination. Treatments were received for the events. Continuous glucose monitor, acerbose, and beta blocker were received. Outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Endocrine test, Fatigue, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: I could not drive, and had no energy; blood pressure was high 150/80 - which is not normal; lost 10 lbs; hypoglycemia; b/c y Dimer was elevated; Her blood sugar is also elevated; felt extremely short of breath while driving; This is a spontaneous report from a contactable consumer reported for self. This 47-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Right arm on 12Apr2021 13:00 at the age of 47-year-old (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for COVID-19 immunisation. No pregnancy at time of vaccination. Medical history included Hashimotos, Penicillin allergy, still have reactive hypoglycemia, allergies: Phenothiazines. No Covid prior vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) 10mg, and thyroid (ARMOUR THYROID). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Right arm on Mar2021 11:15 AM at the age of 47-year-old (lot number: ER2613) for COVID-19 immunisation. Approx 4 days following 2nd shot on 16Apr2021 10:45 AM, she left a spin class and felt extremely short of breath while driving. She went to the urgent care and then ER, b/c y Dimer was elevated. They ra tests and chest MRI was normal. One week Later, she went back to urgent care with same symptoms, blood pressure was high 150/80 - which is not normal. Over a period of three weeks she lost 10 lbs. She could not drive, and had no energy. (endo, cardio and primary) ordered a battery of test. Her endo figured that had an autoimmune attack on blood sugar. She still had reactive hypoglycemia - she wear a continuous glucose monitoring device. Her blood sugars drop at night to 50. Her blood sugar is also elevated. She took acarbose to manage it. Cardio has her on a zip patch to monitor her heart rhythm which is also affected. went to urgent care 6 times, had numerous # Appt. and ER once. Believe it is related to the vaccine, she was completely active and normal bef. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Seriousness criteria-Disabling/Incapacitating. No Covid tested post vaccination. Treatments were received for the events. Continuous glucose monitor, acerbose, and beta blocker were received. Outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Investigation, Magnetic resonance imaging thoracic, Weight, Weight decreased
Clinical narrative: I could not drive, and had no energy; blood pressure was high 150/80 - which is not normal; lost 10 lbs; hypoglycemia; b/c y Dimer was elevated; Her blood sugar is also elevated; felt extremely short of breath while driving; This is a spontaneous report from a contactable consumer reported for self. This 47-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Right arm on 12Apr2021 13:00 at the age of 47-year-old (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for COVID-19 immunisation. No pregnancy at time of vaccination. Medical history included Hashimotos, Penicillin allergy, still have reactive hypoglycemia, allergies: Phenothiazines. No Covid prior vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) 10mg, and thyroid (ARMOUR THYROID). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Right arm on Mar2021 11:15 AM at the age of 47-year-old (lot number: ER2613) for COVID-19 immunisation. Approx 4 days following 2nd shot on 16Apr2021 10:45 AM, she left a spin class and felt extremely short of breath while driving. She went to the urgent care and then ER, b/c y Dimer was elevated. They ra tests and chest MRI was normal. One week Later, she went back to urgent care with same symptoms, blood pressure was high 150/80 - which is not normal. Over a period of three weeks she lost 10 lbs. She could not drive, and had no energy. (endo, cardio and primary) ordered a battery of test. Her endo figured that had an autoimmune attack on blood sugar. She still had reactive hypoglycemia - she wear a continuous glucose monitoring device. Her blood sugars drop at night to 50. Her blood sugar is also elevated. She took acarbose to manage it. Cardio has her on a zip patch to monitor her heart rhythm which is also affected. went to urgent care 6 times, had numerous # Appt. and ER once. Believe it is related to the vaccine, she was completely active and normal bef. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Seriousness criteria-Disabling/Incapacitating. No Covid tested post vaccination. Treatments were received for the events. Continuous glucose monitor, acerbose, and beta blocker were received. Outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Glossodynia, Paraesthesia oral, Rash
Clinical narrative: my tongue got all swollen; my chest got like a big hive/rash/  I saw the hives on my chest.; my chest got like a big hive/rash; my tongue start hurting and tingle; my tongue start hurting and tingle; I couldn't breath properly; felt pressure on my chest; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jul2021 12:00 (Lot Number: ewo173) at 48 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included unspecified vitamins. The patient previously took humera and experienced drug allergy.  Soon after vaccine (02Jul2021 12:00 PM), the patient experienced felt pressure on her chest, then felt that she couldn't breath properly on the following days then nothing change but she didn't think it was an emergency then on Tuesday (06Jul2021) her tongue got all swollen and her chest got like a big hive/rash . The patient didn't figure it out till her tongue start hurting and tingle and then she saw the hives on her chest. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: my tongue got all swollen; my chest got like a big hive/rash/  I saw the hives on my chest.; my chest got like a big hive/rash; my tongue start hurting and tingle; my tongue start hurting and tingle; I couldn't breath properly; felt pressure on my chest; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jul2021 12:00 (Lot Number: ewo173) at 48 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included unspecified vitamins. The patient previously took humera and experienced drug allergy.  Soon after vaccine (02Jul2021 12:00 PM), the patient experienced felt pressure on her chest, then felt that she couldn't breath properly on the following days then nothing change but she didn't think it was an emergency then on Tuesday (06Jul2021) her tongue got all swollen and her chest got like a big hive/rash . The patient didn't figure it out till her tongue start hurting and tingle and then she saw the hives on her chest. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysaesthesia, Inappropriate schedule of product administration, Migraine, Musculoskeletal stiffness
Clinical narrative: Migraine for 4 weeks after; shocking feeling in body from legs to arms; stiff neck; dose 1 on 22May2021 10:30/ dose 2 on 22May2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 10:30 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm on 22May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included High blood pressure, and type 2 diabetes and both were controlled well, and allergies: Penicillin. Patient is not pregnant at time of vaccination. Patient did receive other medications within 2 weeks of vaccination. Migraine for 4 weeks after, shocking feeling in body from legs to arms, stiff neck and was caused emergency room/department or urgent care and hospitalized and seeing neurology doctor as symptoms are still here on 13Jun2021 07:00. The patient was hospitalized for 2 days. The treatment CT scan, MRI and visual watch were received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event Inappropriate schedule of vaccine administered was unknown while other events were recovering. Information regarding the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Therapeutic response unexpected
Clinical narrative: After 2nd Pfizer Covid-19 shot, my arm began to soften around and under the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included scleroderma, diabetes, and breast cancer. Patient is not pregnant at time of vaccination. Concomitant medications included triamterene; amlodipine; pravastatin; potassium chloride (POTCHLOR); and omeprazole. The patient previously took eucalyptus 14% and experienced allergy. Patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: F13247), on 02Feb2021 11:00 AM, in right arm for covid-19 immunisation. Patient had scleroderma in both right and left arm, wrist, and fingers. After 2nd Pfizer Covid-19 shot, her arm began to soften around and under the injection site. Over the next couple of months the tissue started to soften down the right arm, and now patient had more movement in that wrist but the left side remains the same. No treatment was received. No covid prior vaccination. The patient underwent lab tests and procedures which included Rapid Test (Nasal Swab): negative on Apr2021. The outcome of event was recovering. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat clearing
Clinical narrative: clearing throat; slight cough; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history included pneumonia 12 days ago. Concomitant medications were not reported. On an unspecified date, the patient experienced clearing throat/slight cough. Patient just finished antibiotics. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antineutrophil cytoplasmic antibody positive, Arrhythmia
Clinical narrative: positive C-ANCA blood test; heart arrhythmia; This is a spontaneous report from a contactable nurse (patient) reported for herself. This 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in left arm on 19Jan2021 08:00 (Lot Number: EH9899) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant.  Medical history included hypertension.  The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took amoxicillin and experienced drug allergy. Patient previously received first dose of bnt162b2 on 29Dec2020 08:00 AM (lot number=EK9231) in right arm for COVID-19 immunisation and experienced heart arrhythmia.  Almost exactly four hours of receiving vaccine, both times, patient had heart arrhythmia.  She had never had arrhythmias before. Arrhythmias had continued intermittently since but was getting less as times went by.  Additionally, after being in the hospital in March for condition (unrelated) she was diagnosed with a positive C-ANCA blood test on unspecified date. Her primary MD also agreed that she was "most likely" having a parasympathetic reaction to the vaccine. She was not sure if the C-ANCA was related to the vaccine or not - however- she was highly suspicious it may be?  She was a nurse practitioner and was certain she had some sort of reaction to this vaccine. She had never had issues with any vaccines before. Events resulted in Doctor or other healthcare professional office/clinic visit, no treatment received.  The outcome of events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "arrhythmia" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: After the first shot I felt very fatigued and tired; fall asleep while working; This is a spontaneous report form a contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 16:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation (age at vaccination: 50 years old).  Patient was not pregnant. Medical history included arthritis. Concomitant medications included duloxetine hydrochloride (CYMBALTA); levothyroxine (LEVOTHYROXINE); hydrocodone bitartrate, paracetamol (NORCO); morphine sulfate (MS CONTIN).  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 01:15, after the first shot patient felt very fatigued and tired.  That never seemed to go away.  She would be working and just fall asleep while working. Events resulted in Emergency room/department or urgent care, and patient was hospitalized for 3 days. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine; This is a spontaneous report from a contactable consumer or other healthcare professional. A female patient of an unspecified age received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisaion. The patient's medical history and concomitant medications were not reported. It was reported that, the report was cross referenced to report ID: withheld. The caller was a Pfizer colleague called in regards to the Pfizer Covid-19 vaccine. The caller reported that, she was diagnosed with shingles and the health care provider asked whether the caller had gotten the Covid-19 vaccine. The caller reported that, the health care provider said that, she's had other people, including her mother, the patient, who had gotten the Covid-19 vaccine and wound up with shingles. The caller reported that, she asked the provider whether the patients had received the Moderna or Pfizer Covid-19 vaccines and the provider informed her that it was a mix of the two. The provider stated that, her mother or some other relative and 2 other patients in the last day or so, were diagnosed with shingles after receiving the Covid-19 vaccine. Caller reported that, the provider didn't specify whether the patients had received one or the other vaccine. The caller declined to complete safety report as she was unable to provide further details for the patient or the other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine. The caller stated that, she just knew that she was obligated to report the adverse event as the Pfizer Covid-19 vaccine had been mentioned. Report was filed with minimal information provided by caller. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856879 Same reporter/drug/AE, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Colitis, Fatigue, Gastric disorder, Haematochezia
Clinical narrative: fatigued; Very little energy; colitis; Stomach issues; My bowel movements now have a gel layer on it.; Blood in my stool; This is a spontaneous report from a contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 29Apr2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant.  Medical history included arthritis. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); levothyroxine (LEVOTHYROXINE); hydrocodone bitartrate, paracetamol (NORCO); morphine sulfate (MS CONTIN).  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 at age of 50 years old on 22Mar2021 04:45 PM in left arm for COVID-19 Immunization, and experienced fatigued/tired, fall asleep.  In 2021, after the second shot patient still had days she got very fatigued and had very little energy.  Also, suddenly had some type of colitis that she had never had.  She had to be careful on what she eat or feel sick.  She ended up with blood in stool.  She was awaiting a colonoscopy but continual had stomach issues.  Her bowel movements now have a gel layer on it. Events resulted in Emergency room/department or urgent care, and patient was hospitalized for 3 days. Treatment included a diet of just liquids and worked up to solids. The outcome of events was not recovered.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on lot /batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mucous stools
Clinical narrative: fatigued; Very little energy; colitis; Stomach issues; My bowel movements now have a gel layer on it.; Blood in my stool; This is a spontaneous report from a contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 29Apr2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant.  Medical history included arthritis. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); levothyroxine (LEVOTHYROXINE); hydrocodone bitartrate, paracetamol (NORCO); morphine sulfate (MS CONTIN).  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 at age of 50 years old on 22Mar2021 04:45 PM in left arm for COVID-19 Immunization, and experienced fatigued/tired, fall asleep.  In 2021, after the second shot patient still had days she got very fatigued and had very little energy.  Also, suddenly had some type of colitis that she had never had.  She had to be careful on what she eat or feel sick.  She ended up with blood in stool.  She was awaiting a colonoscopy but continual had stomach issues.  Her bowel movements now have a gel layer on it. Events resulted in Emergency room/department or urgent care, and patient was hospitalized for 3 days. Treatment included a diet of just liquids and worked up to solids. The outcome of events was not recovered.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on lot /batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Restlessness
Clinical narrative: Feeding the infant; He got extremely restless; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a male patient(baby). An infant male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via trans-mammary route of administration on 06Jul2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Pharmacist said that he gave the second dose of the Pfizer Covid 19 vaccine to a patient yesterday even though she is breastfeeding. He said that the patient checked with her doctor and her doctor told her to move forward with the vaccination. Mother reported that last night after feeding the infant, he got extremely restless. The outcome of the event was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021855248 Maternal case
Sex: F
Vaccine: COVID19
Symptoms: Coeliac disease, Immunodeficiency, Metabolic disorder
Clinical narrative: celiac disease; Her immune system is extremely compromised.; possible metabolic disorder that has yet to be fully diagnosed; This is a spontaneous report from a contactable nurse. A 22-year-old female patient (reporter's niece) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, on an unknown date, as Dose 1, single and Dose 2, single; both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced celiac disease and a possible metabolic disorder that had yet to be fully diagnosed. It was reported that, patient's immune system was extremely compromised. The outcome of the events was unknown.  Information about Lot/batch number has been requested.; Sender's Comments: Based on the limited information, a causal association between the reported event of coeliac disease 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; This is a spontaneous report from a contactable consumer (Patient). An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date (at the age of 87-years-old) as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. It was reported that on an unspecified date, the patient was fatigued. The patient was enrolled in the patient assistance program, the patient shared her experience with the COVID-19 vaccine that she receives, and she knows they have to report those. Patient stated that she was fatigued and all in all her vaccines were successful. Patient stated most people thought the side effects were less with the Pfizer shot. The outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Giant cell arteritis, Headache
Clinical narrative: Patient reports headach lasting for one week; On 07Jun21 he was diagnosed with temporal arteritis; This is a spontaneous report from a contactable Nurse. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE NUMBER UNKNOWN, SINGLE (at the age of: 71-year-old) for covid-19 immunization. Medical history included hyperlipidaemia, intracranial aneurysm. The patient's concomitant medications were not reported. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. On 07Jun2021 the patient was diagnosed with temporal arteritis. On 25Jun2021 the patient experienced patient reports headache lasting for one week. The patient was hospitalized for patient reports headach lasting for one week (headache) for 3 and  on 07jun21 he was diagnosed with temporal arteritis (giant cell arteritis) for 3 days. Therapeutic measures were taken as a result of patient reports headach lasting for one week, on 07Jun21 he was diagnosed with temporal arteritis. The outcome of event was recovering.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events headache and temporal arteritis cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Muscle spasms, Musculoskeletal stiffness, Pain
Clinical narrative: She has had and continues to have the tightness in her legs and pain, terrible pain in her calves; She has had and continues to have the tightness in her legs and pain, terrible pain in her calves; Has difficulty sleeping, she can't sleep well; very tired all the time; She has had and continues to have the tightness in her legs and pain, terrible pain in her calves; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 29Mar2021 (Batch/Lot number: ER8730, Expiration Date: 31Jul2021) as DOSE 2 single for covid-19 immunisation. Medical history included Guillain Barre syndrome on an unspecified date in 2014. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/Lot number: EN6203) on 08Mar2021 for covid-19 immunization. On an unspecified date in 2021, patient experienced getting hard to sleep, very tired all the time, tightness in her legs, terrible pain in her calves. Patient stated she had the same symptoms as with GBS and asking if it is vaccine related or not. She reported that she has had and continues to have the tightness in her legs and pain, terrible pain in her calves, has difficulty sleeping, she can't sleep well. Lot number of Covid vaccine dose 1 and dose 2 was not provided. Patient also stated when she had the vaccine and called in and no one has gotten back to her regarding what happened when she had the vaccine. Caller states she may still be experiencing but she is not sure. She had the vaccine a couple of months ago and in 2014 had been treated with IVIG for Guillain-Barre Syndrome and since she had Guillen Barre Syndrome and was treated then she naturally had the Covid vaccine for comorbidities. Caller states that since the vaccine she has had and continues to have the tightness in her legs and pain, terrible pain in her calves. Caller states her symptoms are mimicking when she had Guillen Barre Syndrome but she doesn't have it. States she has difficulty sleeping, she can't sleep well, and is very tired all the time and doesn't know if this is part of the vaccine or not. States these are symptoms she had when she had Guillen Barre Syndrome but she doesn't have it now. States she doesn't want an EMG as it's very painful and she is not going for a spinal tap and that was how it was diagnosed in 2014. Outcome of events pain, muscle spasms, difficulty sleeping, fatigue was updated as unknown, for stiffness updated as not recovered.  Follow-up (08Jul2021): New follow-up information received from a contactable consumer (patient) included: Dose 1, 2 start date, lot number, expiration date, relevant history, event added.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: mild numbness in both arms/ numbness in his bilateral arms; This is a spontaneous report from a contactable nurse reported for a male consumer (patient) via medical information team.  A patient in his 60 decade (approximately 50 years) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-1 9 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced about 6 hours after the first dose mild numbness in both arms/ numbness in his bilateral arms. It lasted for about 48 hours and had resolved. The male patient (in his 50s) who had side effects after receiving his first Pfizer Covid vaccine dose. The reporter wants to know if Pfizer has information on if it's safe for the patients to receive the second dose of the vaccine. Reporter stated that the patient was considering whether to get the second dose. The outcome of the event was resolved.  Follow-up: This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable nurse reported.  No follow-up attempts are needed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: our arms hurt worse; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EW0172; Expiration Date: 31Aug2021) via an unspecified route of administration on 28Apr2021 (at an age of 63-years-old) as dose 2, single for COVID-19 immunization. The patient medical history include narcolepsy. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration on 07Apr2021 for COVID-19 immunization. After the second dose, the patient experienced our arms hurt worse, overly hydrate herself and I got body armor and drank one before and one after on Apr2021. No investigations were performed. Therapeutic measures were taken as a result of events with a couple doses of Tylenol and felt better. The clinical outcome of the our arms hurt worse was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021863092 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Mental disorder
Clinical narrative: his brain has been foggy; mental issues; This is a spontaneous report from a contactable reporter (Patient brother) reported for a male patient that: A male patient of 51- or 52-years age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on an unspecified date in Feb2021 and dose 1 (Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that his brother got both doses of the Pfizer Covid 19 vaccine and after his second dose in February his brain had been foggy and was experiencing mental issues on an unspecified date. He stated that he went to different doctors and said that it is possible that it was due to the vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.