chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: burning sensation through my body; shakes; jitteriness; lightheaded; exhaustion; injection site redness and soreness; injection site redness and soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9264 and Expiration date: unknown), via an unspecified route of administration, in left arm on 07Feb2021 (at the age of 40-years-old) as dose 2, single for Covid-19 immunization. Facility where the most recent covid-19 vaccine was administered was hospital. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Historical vaccination included dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation and experienced injection site irritation. Patient had no allergies to medications, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07Feb2021 (at 09:45), the patient experienced after 2nd dose burning sensation through her body followed by shakes and jitteriness and lightheaded. Then exhaustion. 2 days later still had injection site redness and soreness. The case was assessed as non-serious. It was reported that " Was treatment received for the adverse event: Unknown". Outcome of the events was resolved on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm shoulder on 08Feb2021 at 14:00 (at the age of 39-year-old) as dose 1, single to protect his family and himself from COVID/ COVID-19 immunisation. The patient's medical history included ongoing vertigo. He has had vertigo in the past due to concussion, but that was a while back. Maybe 7 or 8 years ago. Concomitant medications was none. Family medical history relevant to adverse events was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. It was reported that, patient confirmed vaccine as COVID-19 vaccine. He received it at Pfizer site. It was reported that, he just had vaccine yesterday the first dose. Pfizer vaccine. He was calling to report side effects. After the injection on 08Feb2021, within an hour, he started feeling like his body was hot. Then he started feeling dizzy, vertigo around four hours after vaccination on 08Feb2021. Vertigo was worse today. Dizzy was reported as worsened. Weight was 170 to 180 pounds. The adverse events did not require a visit to emergency room and physician office. No investigation assessment. The outcome of the event body was hot was resolved on 08Feb2021 and not resolved for the other events.  Follow-up attempts completed. No further information expected.~
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Pain
Clinical narrative: chest pain that went around to my upper back also; chest pain that went around to my upper back also; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, expiration date: not reported), via an unspecified route of administration, administered in arm right on 06Feb2021 09:00 (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. Medical history included heart attack in 2019 and 5 stents put in, known allergies (unspecified), known allergies: yes. Historical vaccine patient received included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL2283, expiration date: not reported), via an unspecified route of administration, administered in arm right on 13Jan2021 08:00 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. Concomitant medications were not reported. other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 08Feb2021 08:00, the patient experienced 'chest pain that went around to my upper back also'. The patient underwent lab tests and procedures which included bloodwork, chest x-ray, electrocardiogram (EKG) and ultrasound scan, all with unknown results in 2021. Chest pain that went around to my upper back also lead to emergency room/department or urgent care. Unspecified treatment was given for chest pain that went around to her upper back also. The outcome for both events was resolved in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: chest pain that went around to my upper back also; chest pain that went around to my upper back also; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, expiration date: not reported), via an unspecified route of administration, administered in arm right on 06Feb2021 09:00 (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. Medical history included heart attack in 2019 and 5 stents put in, known allergies (unspecified), known allergies: yes. Historical vaccine patient received included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL2283, expiration date: not reported), via an unspecified route of administration, administered in arm right on 13Jan2021 08:00 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. Concomitant medications were not reported. other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 08Feb2021 08:00, the patient experienced 'chest pain that went around to my upper back also'. The patient underwent lab tests and procedures which included bloodwork, chest x-ray, electrocardiogram (EKG) and ultrasound scan, all with unknown results in 2021. Chest pain that went around to my upper back also lead to emergency room/department or urgent care. Unspecified treatment was given for chest pain that went around to her upper back also. The outcome for both events was resolved in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Condition aggravated, Neoplasm swelling, Pain in extremity, Peripheral swelling
Clinical narrative: pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; pain and swelling in my left breast and left arm; This is a spontaneous report from a contactable nurse (patient). A 50-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 28Jan2021 (age at the vaccination 50-year-old) as second dose single for covid-19 immunisation. Medical history included breast cancer survivor, extreme burning and ongoing swelling (I am a 16-year breast cancer survivor and had extreme burning and swelling at my tumor field). Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (Lot number: EH9899) via an unspecified route of administration, administered in left arm on 07Jan2021 12:00 PM for Covid-19 immunisation. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. if other vaccine in four weeks reported as no. On 28Jan2021 04:45 PM it was reported that patient 16-year breast cancer survivor and had extreme burning and swelling at my tumor field. Even today patient have pain and swelling in my left breast and left arm. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available currently available the reported events can be considered as an aggravation of the underlying medical condition, nevertheless the contributory role of the vaccine BNT162B2 to this aggravation cannot be excluded because of strong temporal relationship. The case will be reassessed if there is any 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in arm; kind of diminished for a day and then it came back; He can't even sleep; pain injection site radiating to elbow; pain injection site radiating to elbow; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old male patient received BNT162B2 (Formulation: Solution for injection, dose 1 intramuscular, administered in Deltoid Right on 18Feb2021 (at the age of 75-years-old) (Batch/Lot Number: EL9267) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in arm; kind of diminished for a day and then it came back and he can't even sleep. One week ago, on the 18Feb2021, patient had taken the first shot but had not taken the second shot. Patient stated, he just want to report and ask some advice about the pain after the vaccine. Patient stated, he was still having pain 7 days after the shot in his arm.  Reporter stated, it had gotten worse since Monday, every day it gets a little worse. Pain at injection site radiating to elbow AM of 20Feb2021, the extreme pain lasting 2-3 days. Now no pain in arm and he can sleep. He had not any lab tests. There was no anti-pyretic use around date of vaccination. The patient had no emergency room visit for adverse event. The outcome of the event was recovered on an unspecified date.  Follow-up attempts are needed Information on Lot/Batch number was available, additional information has been requested.  Follow up (18Jun2021): New information reported from a contactable consumer includes suspect product information, event details and outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: abnormal EKG; dizziness; lightheadedness; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6202), dose 1 via an unspecified route of administration on 23Feb2021 as 1st single dose for COVID-19 immunization. Patient had long history of motion sickness. Concomitant medications included dimenhydrinate (DRAMAMINE) and meclizine hcl (MECLIZINE HCL) both taken for motion sickness. On 23Feb2021, the patient experienced dizzy so patient went to bed early, feeling lightheaded, and patient sits most of the time instead of moving around the house. Slight dizziness was a concern because it has been 9 days. Patient want to know if it will go away by itself, or if she needs to do something and if this is a normal reaction to the vaccine, how long it will take for the symptoms to subside. Patient dizziness has lasted nine days and patient would like to know if it was a side effect or if it could be Meclizine. Patient want to reschedule 2nd dose and wait until the side effects go away before receiving the 2nd dose and want to know the medication had an interaction with the vaccine and it would be safe for her to take Meclizine before she receives 2nd dose. Patient wonders if there could have been a vaccine interaction with Dramamine or Meclizine that patient took that afternoon. Patient taking Meclizine since before vaccination, but patient did not think it worked that day. Patient wanted to know if it was safe to take dramamine chewable before the COVID-19 vaccine and what would happen if patient only gets one dose. The patient underwent lab tests and procedures which included electrocardiogram: abnormal. She had an abnormal EKG when patient went to urgent care last Friday on 05Mar2021 and also she went to the urgent care for dizziness and light headedness that experienced since first dose. Patient did not know if the dizziness and light headedness are related to the vaccine. Patient wanted to know if it was safe to get the second dose with an abnormal EKG. The outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue for two days; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). Upon Fu date (18Jun2021) case was upgraded to valid. A 74-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history included cholesterol. Concomitant medications included ongoing simvastatin 20 mg (SIMVASTATIN) taken from years for cholesterol and probiotics (PROBIOTICS) (ongoing). The patient previously took atorvastatin (LIPITOR) and reported of "Having a reaction from taking Lipitor". No other products that were taken together with those indicated suspect. It was reported that the patient had first shot and experienced just fatigue for 2 days on an unspecified date in 2021. The patient stated, "Nothing previous". The patient was taking probiotics. She will have colonoscopy in beginning of 2022. If anything will be shown on the colon the patient will contact. The patient did not think there was any problem with shot and simvastatin for cholesterol. The outcome of the event fatigue was reported as resolved on an unspecified date in 2021.   Information on batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue
Clinical narrative: Dizziness; Shortness of breath; Tiredness; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for herself that: This case has been considered invalid as there is no indication that the patient experienced any adverse event under suspect product BNT162B2.  Follow-up (05Mar2021): The initial case was missing the following minimum criteria: since only medical inquiry. Upon receipt of follow-up information on (05Mar2021), this case now contains all required information to be considered valid.  A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM8810), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 (at the age of 68-years-old) as dose 1, single for covid-19 immunization. Medical history included mitral valve replacement from Apr2020 to an unknown date, Blood Pressure and Heart, ankel Swelling. Concomitant medications included furosemide (LASIX [FUROSEMIDE]) taken for Ankle swelling; carvedilol taken for blood pressure; spironolactone taken for Ankle swelling; potassium taken for Ankle swelling (joint swelling), all the concomitant medications was ongoing. No history of all previous immunization with the Pfizer vaccine considered as suspect. No adverse events prior vaccinations. No family medical history relevant to adverse events. On 04Mar2021, the patient experienced shortness of breath (yesterday evening around 7pm, as reported) and tiredness (yesterday morning around 8am, as reported), on 05Mar2021 dizziness. (Serious: No, as reported). No emergency room and physician office visit. Outcome of the events shortness of breath and tiredness was recovered on 04Mar2021 and dizziness was recovered on 05Mar2021 (lasted for 30 minutes, as reported).  Additional Context: Calling about the Covid 19 Vaccine. States that she got it the day before yesterday, on 03Mar2021. She is calling in to report her side effects from yesterday. States that she was really tired, and got short of breath; and she also had a dizzy spell this morning. Caller does not have the full contact information to provide for her primary care physician. Dizziness lasted about 30 minutes. Shortness of breath started yesterday evening around 7pm; it went away around 8-9pm last night. The tiredness started around 8am. She felt like she didn't have any energy, so she just laid around all day. It went away around 5pm yesterday evening.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: low grade fever; chills; shake uncontrollably; Flu like symptoms; tiredness; headache; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Aug2021) via an unspecified route of administration and administered in left arm on 09Mar2021 as 0.3 ml single dose for COVID-19 immunization. The patient's medical history include osteoarthritis (that they called it osteoarthritis in her hip, but it is actually osteopenia). Concomitant medication included meloxicam (MELOXICAM) 15mg once a day by mouth as needed (which is the only prescription she takes, she says that her Meloxicam came in a pharmacy bottle, that says discard after 19Jul2021 and has a RX number on it. She says this prescription was filled 20Jul2020, so you can see how often she uses it. She says she doesn't take the meloxicam every day, and it has been at least two weeks since she took that), the only pills she takes are vitamin C and D and occasionally she takes something for her arthritis (no further details provided about vitamin C and D). She had the Pfizer COVID-19 vaccine tuesday and is having some side effect. She says some have gone away; some she is still having. She had her first Pfizer Covid vaccine shot last tuesday and woke up with a low-grade fever, chills, tiredness, headache, nausea, shake uncontrollably and feeling unwell. She says she has had a low-grade fever and chills to the point where she shakes uncontrollably. She says she woke up this morning doing the same thing. which does calm it down. She says her fever was 101.2, which she knows is low grade, today on thursday, and she had the vaccine on tuesday so she would like to know if it is normal to be having symptoms this far out from getting the shot. She says that it is flu like symptoms, and she almost feels like she has the flu. She says the vaccine card says 0.3mL BUD 6 hours at RT. She says that the expiry can 30Aug2021 or 30Jun2021. She says that the card says HCP clinic site LT. She says that tuesday was her first dose of the Pfizer COVID-19 vaccine. She says her temperature was 101.2 this morning when she got up, and she had chills and was shaking and she can't control them, unable to confirm temperature as being measured in fahrenheit during the call. She says that she took some Advil Liquigels 200mg, they are better when she takes the three Advil. She says she took the Advil today at 08:30 AM. Reporter says she has read all of the info, and she doesnt have all of the side effects and she doesnt have the severe ones, but this is Thursday, and she got the dose on Tuesday, can this be going on this long. On 11Mar2021, the patient underwent lab tests and procedures which included body temperature: 101.2. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Tremor
Clinical narrative: low grade fever; chills; shake uncontrollably; Flu like symptoms; tiredness; headache; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Aug2021) via an unspecified route of administration and administered in left arm on 09Mar2021 as 0.3 ml single dose for COVID-19 immunization. The patient's medical history include osteoarthritis (that they called it osteoarthritis in her hip, but it is actually osteopenia). Concomitant medication included meloxicam (MELOXICAM) 15mg once a day by mouth as needed (which is the only prescription she takes, she says that her Meloxicam came in a pharmacy bottle, that says discard after 19Jul2021 and has a RX number on it. She says this prescription was filled 20Jul2020, so you can see how often she uses it. She says she doesn't take the meloxicam every day, and it has been at least two weeks since she took that), the only pills she takes are vitamin C and D and occasionally she takes something for her arthritis (no further details provided about vitamin C and D). She had the Pfizer COVID-19 vaccine tuesday and is having some side effect. She says some have gone away; some she is still having. She had her first Pfizer Covid vaccine shot last tuesday and woke up with a low-grade fever, chills, tiredness, headache, nausea, shake uncontrollably and feeling unwell. She says she has had a low-grade fever and chills to the point where she shakes uncontrollably. She says she woke up this morning doing the same thing. which does calm it down. She says her fever was 101.2, which she knows is low grade, today on thursday, and she had the vaccine on tuesday so she would like to know if it is normal to be having symptoms this far out from getting the shot. She says that it is flu like symptoms, and she almost feels like she has the flu. She says the vaccine card says 0.3mL BUD 6 hours at RT. She says that the expiry can 30Aug2021 or 30Jun2021. She says that the card says HCP clinic site LT. She says that tuesday was her first dose of the Pfizer COVID-19 vaccine. She says her temperature was 101.2 this morning when she got up, and she had chills and was shaking and she can't control them, unable to confirm temperature as being measured in fahrenheit during the call. She says that she took some Advil Liquigels 200mg, they are better when she takes the three Advil. She says she took the Advil today at 08:30 AM. Reporter says she has read all of the info, and she doesnt have all of the side effects and she doesnt have the severe ones, but this is Thursday, and she got the dose on Tuesday, can this be going on this long. On 11Mar2021, the patient underwent lab tests and procedures which included body temperature: 101.2. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Hypoglycaemia, Hypotension
Clinical narrative: lightheadedness; hypoglycemia; hypotension; generalized rash; HTN; This is a spontaneous report from a non-contactable other hcp. A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration on an unspecified date (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included gait abnormal. The patient concomitant medications were not reported. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) HTN Overall well appearing, not in distress. Patient observed in the bay for approx. 25 minutes. Blood pressure (bp) slowly improving. Patient encouraged to monitor her bp at home. The patient underwent lab tests and procedures which included blood pressure measurement: slowly improving on Bp slowly improving. Therapeutic measures were taken as a result of lightheadedness included water and snacks. Follow up response to treatment was excellent. Patient was stable to go home and follow up with PCP.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: lightheadedness; hypoglycemia; hypotension; generalized rash; HTN; This is a spontaneous report from a non-contactable other hcp. A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration on an unspecified date (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included gait abnormal. The patient concomitant medications were not reported. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) HTN Overall well appearing, not in distress. Patient observed in the bay for approx. 25 minutes. Blood pressure (bp) slowly improving. Patient encouraged to monitor her bp at home. The patient underwent lab tests and procedures which included blood pressure measurement: slowly improving on Bp slowly improving. Therapeutic measures were taken as a result of lightheadedness included water and snacks. Follow up response to treatment was excellent. Patient was stable to go home and follow up with PCP.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Rash pruritic
Clinical narrative: Bad itchy rash all over body; tiredness; chills; dizziness; This is a spontaneous report from a contactable patient. A 51-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 09Mar2021 (at the age of 51-years-old) as single dose, for COVID-19 immunisation. Medical history included slight hypothyroidism started on an unknown date. The patient had no known allergies to medications, food, or other products. The patient neither had a COVID-19 test nor had symptoms associated with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ramipril (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication. Past drug history was not reported. On 09Mar2021 the patient experienced bad itchy rash all over body, tiredness, chills, dizziness. No treatment was taken for the events. The clinical outcome for events bad itchy rash all over body, tiredness, chills, dizziness was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's name added in patient tab. 2. Lot# UNKNOWN was removed from dosage regimens tab. 3. Patient's age was updated as 51-years in narrative.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain in extremity
Clinical narrative: eye with the new cornea turned bright red; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6205) via unspecified route of administration in the left arm on 15Mar2021 at 12:30 PM (age at vaccination 47-years-old), as a single dose for COVID-19 immunisation. Medical history included keratoconus, cornea transplant, epilepsy, depression. Past drug included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot no: EN6209) via unspecified route of administration in the left arm on 22Jan2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Concomitant medication included levetiracetam (KEPPRA), venlafaxine (EFFEXOR), ibuprofen (UNKNOWN MANFACTURER), for unknown indications from unknown date. The patient did not have allergies to medications, food, or other products. 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 reported that recently had a cornea transplant. My eye with the new cornea turned bright red after the vaccinations and also sore arm. On 15Mar2021 16:00 the patient experienced bright red eye, sore arm. Therapeutic measures included as Steroid eyedrops for the events bright red eye. The clinical outcome of the events bright red eye and sore arm was recovering.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient name added in general tab, 47 years added as age/units for Historical Vaccine since DOB and 1ST DOSE date provided, Start Date/Time and Stop Date/Time of 2nd dose updated to 15Mar2021 12:30, Vaccine Facility Information added, Keppra, Effexor, ibuprofen added as Concomitant drug, Onset Date/Time of events updated to 15MAR2021 16:00.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the injection arm after 3 weeks on the 2nd doose; This is a spontaneous report received from a contactable consumer, the patient. A 82-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 (at the age of 82-year-old) as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Medical history was not reported. Concomitant medications were not reported. On 01Mar2021, the patient experienced pain in the injection site arm after 3 weeks, on the 2nd dose. The patient did not receive any treatment for the event. The clinical outcome of vaccination site pain was not resolved.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: in reporter tab, was ticked for slide 1 reporter, Race and Ethnic Group added, lot unknown=False, First dose received on 05Feb2021 at 82 years, on right arm. Relevant history updated, Vaccine Facility Information added, Event treatment updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Upper-airway cough syndrome
Clinical narrative: A bad cough; The sides of my tongue went numb; My lips and cheeks started tingling; later my lips and cheeks started tingling.; I developed drainage in the back of my throat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 10:45 (at 34-year-old) (Batch/Lot number was not reported) as single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at workplace clinic. Medical history included fertility issues from an unknown date and unknown if ongoing. Concomitant medications reported as prenatal vitamin and folic acid supplement. Known allergies and allergies to medications, food, or other products was reported as no. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was waited for 15 minutes and then started drive to home. On 17Mar2021 at 11:15, the sides of tongue went numb, and then a few minutes later lips and cheeks started tingling. Also, developed drainage in the back of throat and a bad cough. The numbness in tongue only lasted a few minutes, but the other symptoms lasted several hours even after IV steroids and an epi shot. The events resulted in Emergency room/department or urgent care. The outcome of the event numbness in my tongue was recovered on 17Mar2021 whereas rest of the events was recovering.  Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: chills; body aches; headache; little tired; fever; This is a spontaneous report received from a non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on 16Mar2021 as dose number unknown, single for COVID-19 immunization. Medical history of the patient and concomitant medications was not reported. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination. On 16Mar2021, patient experienced little tiredness and had fever of 99.6 and experienced fever, chills, body aches and headache (17Mar2021), super tired and took nap on day 2 and day 3 day. She had a little tired on and off but that's it so far, then and fever again 99.6 so she had taken Advil now then Day 2 she had Fever, chills, body aches, headache, super tired and took a one hour nap at lunch and again at 7PM, Day 3 she had fever and Chills and nap one hour nap at 6PM, Day 3 she had perfectly fine all back to normal and she was super healthy so it kicked her butt. The patient had taken Advil as a treatment for tiredness and fever. Therapeutic measures were taken as a result of little tired, fever. The patient underwent lab tests and procedures which included fever: 99.6 on 16Mar2021. The clinical outcome of events was recovered on 18Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (23Jun2021): Amendment: This follow-up report is being submitted to amend previously reported information:  1. Protect Confidentiality ticked since reporter is patient.  2. patient's initial added as UNKNOWN since patient's name is unknown. 3. Country added in patient tab.  4. dose number leave blank and Dose Description added as DOSE NUMBER UNKNOWN, SINGLE. 5. leading sentence updated to a non-contactable consumer. 6. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained. Reported Event: a little tired on and off but that's it so far, then and fever again 99.6 so I was taking Advil now then Day 2 Fever, chills, body aches, headache, super tired and took a one hour nap at lunch and again at 7PM, Day 3 Fever and Chills and nap one hour nap at 6PM, Day 3 perfectly fine all back to normal and I was super healthy so it kicked my butt
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; body aches; headache; little tired; fever; This is a spontaneous report received from a non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Unknown), via an unspecified route of administration on 16Mar2021 as dose number unknown, single for COVID-19 immunization. Medical history of the patient and concomitant medications was not reported. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination. On 16Mar2021, patient experienced little tiredness and had fever of 99.6 and experienced fever, chills, body aches and headache (17Mar2021), super tired and took nap on day 2 and day 3 day. She had a little tired on and off but that's it so far, then and fever again 99.6 so she had taken Advil now then Day 2 she had Fever, chills, body aches, headache, super tired and took a one hour nap at lunch and again at 7PM, Day 3 she had fever and Chills and nap one hour nap at 6PM, Day 3 she had perfectly fine all back to normal and she was super healthy so it kicked her butt. The patient had taken Advil as a treatment for tiredness and fever. Therapeutic measures were taken as a result of little tired, fever. The patient underwent lab tests and procedures which included fever: 99.6 on 16Mar2021. The clinical outcome of events was recovered on 18Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (23Jun2021): Amendment: This follow-up report is being submitted to amend previously reported information:  1. Protect Confidentiality ticked since reporter is patient.  2. patient's initial added as UNKNOWN since patient's name is unknown. 3. Country added in patient tab.  4. dose number leave blank and Dose Description added as DOSE NUMBER UNKNOWN, SINGLE. 5. leading sentence updated to a non-contactable consumer. 6. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained. Reported Event: a little tired on and off but that's it so far, then and fever again 99.6 so I was taking Advil now then Day 2 Fever, chills, body aches, headache, super tired and took a one hour nap at lunch and again at 7PM, Day 3 Fever and Chills and nap one hour nap at 6PM, Day 3 perfectly fine all back to normal and I was super healthy so it kicked my butt
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo; This is a spontaneous report from a contactable consumer. An unspecified aged female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on unspecified date, as single dose for COVID-19 immunisation. Medical history was not reported, unknown if allergic to medications, food, or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was not known whether the patient been tested for COVID-19. It was not known whether the patient had received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced severe vertigo after receiving the first dose of the vaccine to the point where she had to lay down for several hours in Jan2021. it was not known if patient received any treatment for vertigo. The clinical outcome of Severe Vertigo was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained  Amendment: Added Race Information; removed one duplicated indication of SD; treatment received was selected as Unk and the leading sentence and final sentence was updated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Left abdominal pain, spleen; Myalgia; Fever 103; Fatigue; Sore throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 18Mar2021 at 14:45 (at the age of 50 years old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and immune compromised (1/2 spleen). Concomitant medications included zolpidem tartrate (AMBIEN), venlafaxine hydrochloride (EFFEXOR), and imipramine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6200) via an unspecified route of administration in right arm on 13Feb2021 at 12:00 PM, at the age of 50, as a single dose for COVID-19 immunisation. The patient also previously took niacin on unspecified date and experienced drug allergy. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient had not received any other vaccines within 4 weeks prior vaccination. On 18Mar2021 at 18:45 (night of vaccination and the next day), the patient experienced myalgia, fever 103, fatigue and sore throat. On 19Mar2021 (2nd night), the patient experienced left abdominal pain, spleen, still continues. The adverse events resulted into emergency room/department or urgent care visit. Therapeutic measures were taken for the events myalgia, fever 103, fatigue, sore throat and left abdominal pain which included unspecified treatment and test. The clinical outcome of the event myalgia, fever 103, fatigue, sore throat and left abdominal pain, spleen was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: date of laboratory test (body temperature) was added as 18Mar2021; event onset of abdominal pain was updated as 19Mar2021; and corresponding data field was ticked to reflect that all adverse events resulted into emergency room visit.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left abdominal pain, spleen; Myalgia; Fever 103; Fatigue; Sore throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 18Mar2021 at 14:45 (at the age of 50 years old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and immune compromised (1/2 spleen). Concomitant medications included zolpidem tartrate (AMBIEN), venlafaxine hydrochloride (EFFEXOR), and imipramine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6200) via an unspecified route of administration in right arm on 13Feb2021 at 12:00 PM, at the age of 50, as a single dose for COVID-19 immunisation. The patient also previously took niacin on unspecified date and experienced drug allergy. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient had not received any other vaccines within 4 weeks prior vaccination. On 18Mar2021 at 18:45 (night of vaccination and the next day), the patient experienced myalgia, fever 103, fatigue and sore throat. On 19Mar2021 (2nd night), the patient experienced left abdominal pain, spleen, still continues. The adverse events resulted into emergency room/department or urgent care visit. Therapeutic measures were taken for the events myalgia, fever 103, fatigue, sore throat and left abdominal pain which included unspecified treatment and test. The clinical outcome of the event myalgia, fever 103, fatigue, sore throat and left abdominal pain, spleen was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: date of laboratory test (body temperature) was added as 18Mar2021; event onset of abdominal pain was updated as 19Mar2021; and corresponding data field was ticked to reflect that all adverse events resulted into emergency room visit.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Musculoskeletal chest pain
Clinical narrative: Pain in sternum, spreading across rib cage; Pain in sternum, spreading across rib cage; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old female patient received unknown dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via an unspecified route of administration on an unspecified date (at the age of 17-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. The patient experienced pain in sternum, spreading across rib cage on an unknown date. The clinical outcome of the events was unknown. This report was reported as non-serious by reporter.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event was recoded to Skeletal pain and Rib pain.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red rash at injection site one week after vaccination; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration, on 12Mar2021 (at the age of 32 years), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021, the patient experienced red rash at injection site (vaccination site rash) one week after vaccination, no pain or itching reported. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of red rash at injection site  was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.