chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise, Nausea, Pain in extremity, Pallor
Clinical narrative: It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown.  Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown.  Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: I had my menstrual cycle. My last day of my menstrual cycle was 27Apr2021 which was just last week and now I am having my cycle again today; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05May2021 (Batch/Lot Number: EW0162) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as EK873 or CK873) in the left arm on 13Apr2021 COVID-19 Immunization. The patient reported that she had her menstrual cycle in May2021. Patient's last day of menstrual cycle was on 27Apr2021 which was just last week and now she is having her cycle again today. Patient did not received treatment for the event. Outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Eye movement disorder, Heart rate, Heart rate increased
Clinical narrative: eyes seemed to move quickly back and forth; felt weak and had no energy; heart began to beat fast like it was going to beat out of chest; shake all over her body; vision came back blurry; blood pressure and heart beat were high; vision went in and out while driving down the freeway; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received bnt162b2 (Pfizer product), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:45 (Lot Number: Ew0175) as single dose for covid-19 immunisation. Medical history and concomitant medications were none. No any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (lot number: Ew0161) in left arm on 15Apr2021 at 11:30 for covid-19 immunisation. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stayed for 20 minutes after getting the second vaccine and was fine so she headed to work. A total of 40 minutes after vaccine (06May2021 12:25), her vision went in and out while driving down the freeway. At 12: 45, she started to shake all over her body and heart began to beat fast like it was going to beat out of chest. Her vision came back blurry and was able to pull over on the side of the freeway and call 911. They took her blood pressure and heart beat, both were high. After 30 minutes her heart beat and blood pressure returned to normal. For the remainder of that day the episodes happened 3 times, but only lasted 2-3 minutes at a time. Two days after (08May2021), her vision was blurry and eyes seemed to move quickly back and forth and she felt weak and had no energy. The adverse events result in Emergency room/department or urgent care. Unknown if treatment received. The outcome of events was recovered with lasting effects.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tremor, Vision blurred, Visual impairment
Clinical narrative: eyes seemed to move quickly back and forth; felt weak and had no energy; heart began to beat fast like it was going to beat out of chest; shake all over her body; vision came back blurry; blood pressure and heart beat were high; vision went in and out while driving down the freeway; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received bnt162b2 (Pfizer product), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:45 (Lot Number: Ew0175) as single dose for covid-19 immunisation. Medical history and concomitant medications were none. No any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of bnt162b2 (lot number: Ew0161) in left arm on 15Apr2021 at 11:30 for covid-19 immunisation. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stayed for 20 minutes after getting the second vaccine and was fine so she headed to work. A total of 40 minutes after vaccine (06May2021 12:25), her vision went in and out while driving down the freeway. At 12: 45, she started to shake all over her body and heart began to beat fast like it was going to beat out of chest. Her vision came back blurry and was able to pull over on the side of the freeway and call 911. They took her blood pressure and heart beat, both were high. After 30 minutes her heart beat and blood pressure returned to normal. For the remainder of that day the episodes happened 3 times, but only lasted 2-3 minutes at a time. Two days after (08May2021), her vision was blurry and eyes seemed to move quickly back and forth and she felt weak and had no energy. The adverse events result in Emergency room/department or urgent care. Unknown if treatment received. The outcome of events was recovered with lasting effects.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Paraesthesia oral, Throat irritation
Clinical narrative: Cough; Throat itchiness; Tongue tingling; Anxiety; This is a spontaneous report from a non-contactable other HCP reporting for a patient. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0167) as a single dose (at the age of 39-years-old) for COVID-19 immunisation.  The patient medical history included recent visit to the ED on 02May2021 for tongue swelling, the patient took Benadryl prior to her arrival to the ED at that time, symptoms had resolved for her then.   The patient's concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on an unknown date (Lot number: ER8731) for COVID-19 immunisation. On 07May2021 the patient experienced cough, throat itchiness, tongue tingling and anxiety. The clinical course is as follows: The patient received the second dose of bnt162b2 on 07May2021. During her 30 minute waiting period after the injection, the patient began to experience cough, throat itchiness, tongue tingling.  She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Follow up response to treatment: good. The patient was transported to ED by POV. The Differential Diagnosis was reported as: Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash). The patient had stable and improving symptoms. The reporter stated: Certainly anxiety may be a factor playing into this but recommended that she seek emergency care for observation and follow up with her primary care along with allergist to look into her two reactions that she has had this week. Therapeutic measures were taken as a result of the event and included unspecified treatments. The clinical outcome of the events cough, throat itchiness, tongue tingling and anxiety were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Chills, Diarrhoea, Dizziness
Clinical narrative: allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hypersensitivity, Hypoaesthesia
Clinical narrative: allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pulse pressure increased, Rash, Vomiting
Clinical narrative: allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram abdomen, Micturition urgency, Nausea, Nephrolithiasis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 at the age of 29-years-old (Lot Number: EL9266) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included vaginal delivery on 16May2020; known allergies to Bactrim, sulfa; historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 27Jan2021 at the age of 29-years-old, Lot number EL8982. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS); lecithin (reported as sunflower lecithin). Back pain, urinary urgency and frequency began 25Apr2021. Went to urgent care and was prescribed antibiotic. 28Apr2021, extreme back pain with nausea and vomiting occurred, so presented to the emergency department and was admitted. Abdominal CT scan was performed in Apr2021, revealing kidney stones, one stuck in the left ureter 2 mm in size, an additional 2 mm stone in the left kidney with other smaller stones; left kidney was swollen and right kidney was unremarkable. Multiple pain medications, Flomax, and Zofran administered throughout the hospital admission. Left ureteral stent placed on 30Apr2021 and discharged from the hospital that evening. Stent removed 10May2021 in urology clinic. Additional kidney stones still in fact. Pending follow up ultrasound and 24 hour urine profile due in 5-6 weeks. AE treatment included medications and left ureteral stent. The outcome of events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 at the age of 29-years-old (Lot Number: EL9266) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included vaginal delivery on 16May2020; known allergies to Bactrim, sulfa; historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 27Jan2021 at the age of 29-years-old, Lot number EL8982. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS); lecithin (reported as sunflower lecithin). Back pain, urinary urgency and frequency began 25Apr2021. Went to urgent care and was prescribed antibiotic. 28Apr2021, extreme back pain with nausea and vomiting occurred, so presented to the emergency department and was admitted. Abdominal CT scan was performed in Apr2021, revealing kidney stones, one stuck in the left ureter 2 mm in size, an additional 2 mm stone in the left kidney with other smaller stones; left kidney was swollen and right kidney was unremarkable. Multiple pain medications, Flomax, and Zofran administered throughout the hospital admission. Left ureteral stent placed on 30Apr2021 and discharged from the hospital that evening. Stent removed 10May2021 in urology clinic. Additional kidney stones still in fact. Pending follow up ultrasound and 24 hour urine profile due in 5-6 weeks. AE treatment included medications and left ureteral stent. The outcome of events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: have some spotting blood  in urine at night; This is a spontaneous report from a contactable consumer(patient). The consumer reported similar events for herself with two doses. This is the first of two reports. The 53-year-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 26Mar2021 10:15 (Lot Number: Er8732) as 1st dose, single for covid-19 immunization. Medical history included paroxysmal nocturnal haemoglobinuria(PNH anemia) from 2006 to an unknown date , Latex allergy, bactrim allergy. Concomitant medications included iron (FE 10), cyanocobalamin (B12-VITAMIIN) and one a day women vitamins. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor side effects after first dose but did have some spotting blood in urine at night. (She was a PNH anemia patient).  There was physician office visit for event. Outcome of event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547423 same patient/drug, similar AE, different dose of vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevates heart rate 120-130 BPM at rest; This is a spontaneous report from contactable other HCP (patient). A 30-years-old female patient (No Pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 30-years-old,  intramuscular, administered in Arm Left on 10May2021 15:30 as single dose for covid-19 immunisation. No medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. No other medications the patient received within 2 weeks of vaccination. Patient received first dose of bnt162b2 at the age of 29-years-old, intramuscular, administered in Arm Left on 14Apr2021 09:45 AM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced elevates heart rate 120-130 bpm at rest on 11May2021 09:00 AM with outcome of recovering. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment received. Reporter Serious was No. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Anxiety, COVID-19, Cough
Clinical narrative: I found out 07May2021 that I am positive for COVID; I found out 07May2021 that I am positive for COVID; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I lost my taste and smell for 2 days which is how I found out; I lost my taste and smell for 2 days which is how I found out; This is a spontaneous report from a contactable other HCP (nurse) for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as sing dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. She found out 07May2021 that she was positive for COVID. She was having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. She was currently day 4. she lost her taste and smell for 2 days in May2021 which is how she found out. Outcome for event lost my taste and smell was recovered in May2021, for the rest was unknown.   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.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Dyspnoea, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: I found out 07May2021 that I am positive for COVID; I found out 07May2021 that I am positive for COVID; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I lost my taste and smell for 2 days which is how I found out; I lost my taste and smell for 2 days which is how I found out; This is a spontaneous report from a contactable other HCP (nurse) for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as sing dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. She found out 07May2021 that she was positive for COVID. She was having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. She was currently day 4. she lost her taste and smell for 2 days in May2021 which is how she found out. Outcome for event lost my taste and smell was recovered in May2021, for the rest was unknown.   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.
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, SARS-CoV-2 test
Clinical narrative: I found out 07May2021 that I am positive for COVID; I found out 07May2021 that I am positive for COVID; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I am a 30/F who is having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. I am currently day 4. I lost my taste and smell for 2 days which is how I found out.; I lost my taste and smell for 2 days which is how I found out; I lost my taste and smell for 2 days which is how I found out; This is a spontaneous report from a contactable other HCP (nurse) for herself. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as sing dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. She found out 07May2021 that she was positive for COVID. She was having increased anxiety, near panic attacks, SOB, cough, fatigue, mental fog and muscle aches. She was currently day 4. she lost her taste and smell for 2 days in May2021 which is how she found out. Outcome for event lost my taste and smell was recovered in May2021, for the rest was unknown.   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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging
Clinical narrative: Left side of my lips paralysis, affecting my ability to use American Sign Language accurately and to smile; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:00 (Lot Number: ER8729) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history reported as none. The patient's concomitant medications were not reported.  The patient previously took morphine for drug hypersensitivity.  The patient experienced Left side of lips paralysis on 02May2021 06:00, affecting ability to use American Sign Language accurately and to smile. The patient was told by Dr. to go into the ER to rule out, Bell Palsy or a Stroke. The patient had an MRI done with and without contrast in 2021. All looked good. This leaves the COVID vaccine as the cause of my problem. The patient received treatment for the event. The outcome of event was not recovered. No other vaccine in four weeks; Prior to vaccination, the patient was diagnosed with COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller states she received the first dose on 10 APR 2021 and her arm is still severely sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously had historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration as a single dose for covid-19 immunization. Caller states she received the second dose on 10Apr2021 and her arm was still severely sore. Left arm still severely painful, cannot raise arm. Caller states she went to the doctor on wednesday and she needs to have an X-ray done because your product has done something to my arm. Treatment was pain pills, which was not working. As of 11May2021 she was still experiencing pain in her arm. She does not think this is normal. She saw her primary care last Wednesday. She was in so much pain she had to seek out help and was placed on pain medication. That is how severe the pain is. She cannot raise her arm above her head. She reached out to Pfizer since it's their medication to seek assistance and to try and find out what is going on with her arm. She wants to know why she is still in pain and it's a month and a day later. Caller upset when informed even though this agent is a registered nurse would have to transfer to Medical Information. She stated the number she called previously asked if she was calling about COVID and if any questions to select #1 and that is what she selected. Caller questioned whose fault is that hers or ours. Caller confirmed she has reported this event to numerous people here at Pfizer and stated it's unfortunate we do not keep good records. She confirmed she reported these events yesterday. No reference number provided from previous report. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram normal, Near death experience, Pain
Clinical narrative: she was dying with the pain, it was severe cramping; severe stomach cramping; She's feeling a lot pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:20 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient had her 1st dose on 01Feb2021 at the age of 61 years old. Medical history included scoliosis, osteoporosis, major spine surgery from an unknown date. Concomitant medications included teriparatide (FORTEO) taken for osteoporosis from Jul2020 and ongoing. The patient received the 2nd dose of the Pfizer covid vaccine in the morning. By that evening, after eating, she had severe stomach cramping that has gone on for 2 months now. She has had everything looked at to see where the pain is coming from and is also now on antispasmatic drug. Feels like menstrual cramps. She is trying to eliminate all possible causes and is now down to the covid vaccine or a medication for her osteoarthritis. Additional Information for Concomitant Products forteo: It is daily injection. For her it is for bone growth because she had a major spine surgery. Had it 2.5 months before surgery it was a requirement from surgeon. She puts the pin needle on and inject. She has been having pain for the last 2 months. Every single stomach test and no one can find out the cause. They put her on Levsin, the generic for Levsin. It stops cramping. It is not all the way but it what GI doctors have given her. No further information provided. She asks if they have heard of severe stomach cramping from the vaccine. She's feeling a lot pain. She has dealt with so many doctors. She went through all the testing. Its either one of the injections she is taking or the vaccine. So we are ruling everything out to try to figure it out. She is recovering from a nine level spinal fusion, attempted to clarify what caller said. Caller stated she had a spinal fusion in October from scoliosis. She is having pain after meals. She has been having severe cramping. She was dying with the pain, it was severe cramping. She is on the medication Levsin. It doesn't work. The generic name is Hyoscyamine 0.125 mg sublingual. She clarifies when she said pain she meant the pain from the severe stomach cramping. She hasn't stopped the Forteo waiting for stomach cat scan results clarified as CT pelvis with contrast last test to see if something shows, to have an explanation to see if there is something like gastritis that is causing stomach cramping or vaccine. Only two things, it is either the vaccine or the Forteo injections she gets. Outcome of events was not recovered.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Secretion discharge
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).  A 19-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine) at single dose, on 05May2021, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient noticed some mucus build up, like a ball, in the back of his throat. Clinical outcome of the adverse event was unknown at time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count, Platelet count decreased
Clinical narrative: developed ITP (Idiopathic thrombocytopenic purpura); platelet count dropped; This is a spontaneous report from a contactable HCP. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient developed ITP (Idiopathic thrombocytopenic purpura) on 07May2021 after receiving her first dose of the Pfizer-Biontech Covid19 vaccine. The patients platelet count dropped to 3,000 on 07May2021. The reporter was looking for information regarding this AE and guidance on how to proceed with the second dose. Outcome of the events was unknown.   information about lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to reported events cannot be fully excluded based on implied temporal relationship. However, information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received.  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Hypoaesthesia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: fingertips went numb, purple, painful; fingertips went numb, purple, painful; fingertips went numb, purple, painful; This is a spontaneous report from a contactable consumer reported for herself. This 63-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 16: 00 as 0.3 ml single for COVID-19 immunization. Medical history was unknown. The patient had no known allergies. Concomitant medications included meloxicam, bupropion hydrochloride (WELLBUTRIN), carbidopa/levodopa (SINEMET), atorvastatin, pantoprazole (reported as "Pant"). The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 04:00 PM for COVID-19 immunization. The patient previously received ranitidine hydrochloride (ZANTAC) and omeprazole magnesium (PRILOSEC), both experiencing allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 10 days after the2nd vaccine, the patient experienced fingertips went numb, purple, painful on 26Apr2021 at 16:00.  The patient was hospitalized for 4 days and put on blood thinners. The Cardiologist, vascular surgeon, and Rheumatologist were not sure why this was happening.  This had continued for 2 weeks without any improvement.  The patient had had lots of tests and they were still trying to figure it out.  It may have nothing to do with the vaccine, but the patient thought you should be aware and have this information. The patient had covid test post vaccination on 03May2021 via Nasal Swab with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19. The events resulted in: Emergency room/department or urgent care. Treatment received for the events with Heparin Drip in hospital, Eliquis at home. Outcome of the events was not recovered.   Information about lot number/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Chills, Feeling abnormal, Pyrexia
Clinical narrative: Intermittent fevers (up to 103.1); inflamed asthma symptoms; bronchitis; chills; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730) via an unspecified route of administration in the left arm on 02Apr2021 15: 15 as single dose for COVID-19 immunization. Medical history included allergy induced asthma and hypothyroid. Concomitant medications included levothyroxine, simvastatin, omeprazole. 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. The patient experienced 4 weeks of intermittent fevers (up to 103.1), chills and inflamed asthma symptoms including bronchitis and brain fog. Then, week 5 just as the patient was beginning to feel better, vertigo. All stated on 03Apr2021 21:00. Treatment was received for the adverse event with steroids, antibiotics. The events result in: doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test post-vaccination on 27Apr2021 And on 12Apr2021, both via nasal swab and with negative results. Outcome of the events was not recovered. This report is reported as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Intermittent fevers (up to 103.1); inflamed asthma symptoms; bronchitis; chills; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730) via an unspecified route of administration in the left arm on 02Apr2021 15: 15 as single dose for COVID-19 immunization. Medical history included allergy induced asthma and hypothyroid. Concomitant medications included levothyroxine, simvastatin, omeprazole. 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. The patient experienced 4 weeks of intermittent fevers (up to 103.1), chills and inflamed asthma symptoms including bronchitis and brain fog. Then, week 5 just as the patient was beginning to feel better, vertigo. All stated on 03Apr2021 21:00. Treatment was received for the adverse event with steroids, antibiotics. The events result in: doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test post-vaccination on 27Apr2021 And on 12Apr2021, both via nasal swab and with negative results. Outcome of the events was not recovered. This report is reported as non-serious.