chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Weight decreased
Clinical narrative: immediate loss of energy; sore arm; shaking; feeling completely depleted/feel worse; complete loss of appetite; had a low temp of 99 for a day and a half; fatigue; lost 22 lbs; This is a spontaneous report from a contactable other hcp (the patient, reported for self).  A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0142) single dose via an unspecified route of administration, administered in arm left on 05Jan2021 14:00 as for COVID-19 immunisation. Medical history included asthma, diabetes (Diabetes mellitus). Concomitant medication included metformin 500 mg, empagliflozin (JARDIANCE) 10 mg both taken for unspecified indications from unspecified dates. The patient did not have COVID prior vaccination. On 08Jan2021 14:00 three days after the event patient felt an immediate loss of energy, combined with a sore arm, shaking and feeling completely depleted. I went home and continued to feel worse, shaking, complete loss of appetite, and fatigue had a low temp of 99 for a day and a half. Continued to feel bad, staying in touch. Also lost 22 lbs. The patient did not tested COVID post vaccination. The outcome for all the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lip swelling, Throat irritation
Clinical narrative: patient had the 1st dose last 27Mar and 2nd dose 28Jun; swelling of lips; itchy throat; This is a spontaneous report via a Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 27Mar2021 as dose 1, single for covid-19 immunisation. A pharmacist is calling on behalf of a patient who received both doses of the Pfizer Covid-19 vaccine and had allergic reactions such as swelling of lips and itchy throat after the 2nd dose. The patient will also have a colonoscopy and the doctor prescribed Gavilyte however there is a contraindication between Gavilyte and Pfizer Covid-19 vaccine. The patient had the 1st dose last 27Mar and 2nd dose 28Jun (93 days apart). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A female patient of an unspecified age received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was, and concomitant medications were not reported. caller she took her second Pfizer Covid 19 Vaccine on Thursday after lunch before 2pm. She experienced pain in her arm as she did with the first dose on an unspecified date. The pain continued along with swelling and feeling a little uncomfortable that started that night. Just before 4am she experienced a fever. The rest of the day her bones were hurting especially her pelvic bone around behind her butt cheek. She had leg, arm, knee and sometimes chest pain. On that Saturday she had red blotches about 3 inches from her elbow up to her shoulder. They were cluster as well as individual spots on her left arm (injection are). Injection site has been swollen and hurting. She experienced a shocking sensation over her body. Pain from the base of her neck up the side behind her ear to the back of her head.  On Sunday she had fine boils coming up at her shoulder around to the back of her clavicle. On Sunday the bumps were itchy with a weird tingling sensation. The red blotchy all over arms have not itched. Caller continues to have pain along with the "little bumps". Caller asking if she should have bloodwork drawn. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Condition aggravated, Erythema, Illness, Malaise
Clinical narrative: felt unwell; her feet turned red and were breaking out, everything turned really red and she broke out; she was sick for weeks.; She also had digestive symptom after the vaccine; it was like the vaccine aggravated those symptoms.; Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. Reason for no lot number due to complainant does not have the product with them at the time of call. Patient, reporting on the Pfizer Covid 19 vaccine and who explains that she works at a nursing home. They had an outbreak and she got Covid. In the spring she got the vaccine but did not report back then her experience after her first injection. On an unspecified date, the patient feet turned red and were breaking out, everything turned really red, and she broke out. She felt unwell; she was sick for weeks. Due to this she was not able to take the second dose. She also had digestive symptom after the vaccine. The caller notes that these were also the symptoms she had with COVID, it was like the vaccine aggravated those symptoms. The caller reports that because she didn't get the second dose she is still considered not vaccinated, even though she had one dose and couldn't get the second dose due to the side effects. This was reported to the DON at her facility, and she is following up with doctors. She is calling because a friend of hers, the friend's daughter had a similar experience after the first dose but she was put in the database that she is fully vaccinated since she can't get the second shot due to a reaction. She is wanting to know how she can get that status of fully vaccinated. She does note that she is still under the care of a doctor as she has had the rash since Mar2021, she was seeing a dermatologist. The outcome of events was reported as not recovered for rash and unknown for other events.  Follow-up attempts are completed. no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: felt unwell; her feet turned red and were breaking out, everything turned really red and she broke out; she was sick for weeks.; She also had digestive symptom after the vaccine; it was like the vaccine aggravated those symptoms.; Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. Reason for no lot number due to complainant does not have the product with them at the time of call. Patient, reporting on the Pfizer Covid 19 vaccine and who explains that she works at a nursing home. They had an outbreak and she got Covid. In the spring she got the vaccine but did not report back then her experience after her first injection. On an unspecified date, the patient feet turned red and were breaking out, everything turned really red, and she broke out. She felt unwell; she was sick for weeks. Due to this she was not able to take the second dose. She also had digestive symptom after the vaccine. The caller notes that these were also the symptoms she had with COVID, it was like the vaccine aggravated those symptoms. The caller reports that because she didn't get the second dose she is still considered not vaccinated, even though she had one dose and couldn't get the second dose due to the side effects. This was reported to the DON at her facility, and she is following up with doctors. She is calling because a friend of hers, the friend's daughter had a similar experience after the first dose but she was put in the database that she is fully vaccinated since she can't get the second shot due to a reaction. She is wanting to know how she can get that status of fully vaccinated. She does note that she is still under the care of a doctor as she has had the rash since Mar2021, she was seeing a dermatologist. The outcome of events was reported as not recovered for rash and unknown for other events.  Follow-up attempts are completed. no further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Mass, Pain
Clinical narrative: itching; Weight: Commented she is losing weight; burning; lump underneath the swelling painful to touch and heat as heat on my arm; lump underneath the swelling painful the touch and heat as heat on my arm; lump underneath the swelling painful the touch and heat as heat on my arm; redness; Rash; Swelling/slight swelling; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 02Sep2021 (at the age of 77-years-old) as a single dose for covid-19 immunization. Time administered: She mentioned she got it either somewhere between 12:30-12:45 or 1:00. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration administered in Arm Right on 12Aug2021 as a single dose for covid-19 immunization. It was unknown, whether the patient was pregnant or not, at the time of this report. Medical history included ongoing asthma, arthritis, atrial fibrillation and pain from an unknown date and unknown if ongoing. Prior vaccinations included Flu shot 20 years ago she had a slight rash on her arm. It's not like it is now, very light. Concomitant medication(s) included diltiazem; budesonide, formoterol fumarate (SYMBICORT) taken for asthma; paracetamol (TYLENOL ARTHRITIS) taken for pain; apixaban (ELIQUIS). The patient recevied first vaccine and had no reaction; second vaccine on 02Sep2021, on an unspecified date in Sep2021. the patient experienced rash slight swelling lump underneath the swelling painful the touch and heat as heat on her arm she still have the rash. The patient underwent lab tests and procedures which included weight: losing. She does not know her exact weight, but the last time she weighed she was 280 pounds. Therapeutic measures were taken as a result of itching, burning. She placed a little Benadryl Cream on it the 4th day. The adverse event did not let patient to visit emergency room and physician office. Outcome of the event rash, swelling was recovering and all other events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Weight, Weight decreased
Clinical narrative: itching; Weight: Commented she is losing weight; burning; lump underneath the swelling painful to touch and heat as heat on my arm; lump underneath the swelling painful the touch and heat as heat on my arm; lump underneath the swelling painful the touch and heat as heat on my arm; redness; Rash; Swelling/slight swelling; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 02Sep2021 (at the age of 77-years-old) as a single dose for covid-19 immunization. Time administered: She mentioned she got it either somewhere between 12:30-12:45 or 1:00. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration administered in Arm Right on 12Aug2021 as a single dose for covid-19 immunization. It was unknown, whether the patient was pregnant or not, at the time of this report. Medical history included ongoing asthma, arthritis, atrial fibrillation and pain from an unknown date and unknown if ongoing. Prior vaccinations included Flu shot 20 years ago she had a slight rash on her arm. It's not like it is now, very light. Concomitant medication(s) included diltiazem; budesonide, formoterol fumarate (SYMBICORT) taken for asthma; paracetamol (TYLENOL ARTHRITIS) taken for pain; apixaban (ELIQUIS). The patient recevied first vaccine and had no reaction; second vaccine on 02Sep2021, on an unspecified date in Sep2021. the patient experienced rash slight swelling lump underneath the swelling painful the touch and heat as heat on her arm she still have the rash. The patient underwent lab tests and procedures which included weight: losing. She does not know her exact weight, but the last time she weighed she was 280 pounds. Therapeutic measures were taken as a result of itching, burning. She placed a little Benadryl Cream on it the 4th day. The adverse event did not let patient to visit emergency room and physician office. Outcome of the event rash, swelling was recovering and all other events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: Red swollen eyes.; Red swollen eyes.; Puffie face; This is a spontaneous report from a contactable consumer (patient) reporter for herself. A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FE3592), via an unspecified route of administration in left arm on 08Sep2021 at 18:30 (at the age of 51 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had known allergies to prednisone. There were no concomitant medications. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 08Sep2021 at 18:30 patient experienced red swollen eyes, puffie face. Therapeutic measures were taken as a result of red swollen eyes, puffie face with eye drops. No hospitalization required. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Red circle and some inflammation, increase the skin temperature like warm where got the shot; Red circle and some inflammation, increase the skin temperature like warm where got the shot; Red circle and some inflammation, increase the skin temperature like warm where got the shot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of approximately 47-year-old received first dose of 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 in Aug2021 as dose 1, single for COVID-19 immunization, in pharmacy. The patient medical history and concomitant medications were not reported. It was reported that, it had been 10 days since the patient received the vaccine and said she still had red circle and some inflammation when she received the shot (vaccine) warm like increase the skin temperature (red circle and some inflammation, increase the skin temperature like warm where got the shot) on an unspecified date in 2021. The patient did not remember in which arm she got vaccination, the patient said she had the red circle where she got the shot. The patient asked was that normal. The patient was suggested to reach out where she received the shot. She reached out to the Doctor to find out if it was normal or what they should do to find out Medical (assistance). The patient received no treatment for the events. Limited information was available over the call and appropriate response could not be provided. The outcome of the events was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Dyspnoea, Heart rate
Clinical narrative: I have a runny nose; I am sneezing; I am having vertigo; my mouth taste 'tangy'; I am winded; I am having pain in areas that I never had pain before; I feel so dizzy like it fells like I am gonna pass out; This is a spontaneous report from a contactable consumer (patient). A 56-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 12Sep2021 (at the age of 56-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, renal transplant; post kidney transplantation, anxiety, post-traumatic stress disorder: PTSD from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF), mycophenolate sodium (MYFORTIC), prednisone (PREDNISONE), fish oil (OMEGA 3 FISH OILS), xantofyl (LUTEIN) and magnesium (MAGNESIUM) taken for an unspecified indication. It was reported that, patient had first dose of COVID 19 virus (COVID-19 Vaccine) about 2 hours ago. Almost 11 years ago patient had a life donor kidney transplant (Intent: Medical History). Patient was on 2 different types of immunosuppressant (concomitant product). Patient worked for government and was being pressured to take the vaccine patient had the vaccine and about 2 hours ago on an unspecified date in Sep2021 patient had a runny nose, sneezing, having vertigo, dizzy, mouth taste tangy (Further not clarified), patient was winded and patient was having pain in areas that patient never had pain before. Patient did exercise so feel so dizzy like it fells like patient gonna pass out. Patient's blood pressure and pulse seems to be fine. Patient did not have a temperature and that was only 2 hours after vaccine. patient was not sick already and as far as patient did not have COVID and had not been around any point with COVID. Treatment: Consumer stated, No. Patient took immune suppressant prior to (Incomplete sentence), take immunosuppressant 3 times a day and patient took second dose (Of Immunosuppressant) an hour and a half before the injection but patient did not take any medication to correct any of the feelings (Adverse Event). The patient underwent lab tests and procedures on an unspecified dates which included blood pressure measurement: fine, body temperature: do not have a temperature; do not have a temperature and that was only 2 hours after vaccine, heart rate: fine; pulse seems to be fine and SARS-COV-2 test: did not have COVID and had not been around any point with COVID. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Taste disorder
Clinical narrative: I have a runny nose; I am sneezing; I am having vertigo; my mouth taste 'tangy'; I am winded; I am having pain in areas that I never had pain before; I feel so dizzy like it fells like I am gonna pass out; This is a spontaneous report from a contactable consumer (patient). A 56-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 12Sep2021 (at the age of 56-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, renal transplant; post kidney transplantation, anxiety, post-traumatic stress disorder: PTSD from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF), mycophenolate sodium (MYFORTIC), prednisone (PREDNISONE), fish oil (OMEGA 3 FISH OILS), xantofyl (LUTEIN) and magnesium (MAGNESIUM) taken for an unspecified indication. It was reported that, patient had first dose of COVID 19 virus (COVID-19 Vaccine) about 2 hours ago. Almost 11 years ago patient had a life donor kidney transplant (Intent: Medical History). Patient was on 2 different types of immunosuppressant (concomitant product). Patient worked for government and was being pressured to take the vaccine patient had the vaccine and about 2 hours ago on an unspecified date in Sep2021 patient had a runny nose, sneezing, having vertigo, dizzy, mouth taste tangy (Further not clarified), patient was winded and patient was having pain in areas that patient never had pain before. Patient did exercise so feel so dizzy like it fells like patient gonna pass out. Patient's blood pressure and pulse seems to be fine. Patient did not have a temperature and that was only 2 hours after vaccine. patient was not sick already and as far as patient did not have COVID and had not been around any point with COVID. Treatment: Consumer stated, No. Patient took immune suppressant prior to (Incomplete sentence), take immunosuppressant 3 times a day and patient took second dose (Of Immunosuppressant) an hour and a half before the injection but patient did not take any medication to correct any of the feelings (Adverse Event). The patient underwent lab tests and procedures on an unspecified dates which included blood pressure measurement: fine, body temperature: do not have a temperature; do not have a temperature and that was only 2 hours after vaccine, heart rate: fine; pulse seems to be fine and SARS-COV-2 test: did not have COVID and had not been around any point with COVID. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I have a runny nose; I am sneezing; I am having vertigo; my mouth taste 'tangy'; I am winded; I am having pain in areas that I never had pain before; I feel so dizzy like it fells like I am gonna pass out; This is a spontaneous report from a contactable consumer (patient). A 56-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 12Sep2021 (at the age of 56-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, renal transplant; post kidney transplantation, anxiety, post-traumatic stress disorder: PTSD from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF), mycophenolate sodium (MYFORTIC), prednisone (PREDNISONE), fish oil (OMEGA 3 FISH OILS), xantofyl (LUTEIN) and magnesium (MAGNESIUM) taken for an unspecified indication. It was reported that, patient had first dose of COVID 19 virus (COVID-19 Vaccine) about 2 hours ago. Almost 11 years ago patient had a life donor kidney transplant (Intent: Medical History). Patient was on 2 different types of immunosuppressant (concomitant product). Patient worked for government and was being pressured to take the vaccine patient had the vaccine and about 2 hours ago on an unspecified date in Sep2021 patient had a runny nose, sneezing, having vertigo, dizzy, mouth taste tangy (Further not clarified), patient was winded and patient was having pain in areas that patient never had pain before. Patient did exercise so feel so dizzy like it fells like patient gonna pass out. Patient's blood pressure and pulse seems to be fine. Patient did not have a temperature and that was only 2 hours after vaccine. patient was not sick already and as far as patient did not have COVID and had not been around any point with COVID. Treatment: Consumer stated, No. Patient took immune suppressant prior to (Incomplete sentence), take immunosuppressant 3 times a day and patient took second dose (Of Immunosuppressant) an hour and a half before the injection but patient did not take any medication to correct any of the feelings (Adverse Event). The patient underwent lab tests and procedures on an unspecified dates which included blood pressure measurement: fine, body temperature: do not have a temperature; do not have a temperature and that was only 2 hours after vaccine, heart rate: fine; pulse seems to be fine and SARS-COV-2 test: did not have COVID and had not been around any point with COVID. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Mobility decreased, Pain
Clinical narrative: she knows 3 other people with the same symptoms/body pain; shoulders are really painful; legs are like she lost mobility; inflammation; This is a spontaneous report from a contactable consumer, reporting same events under the same suspect product for 4 patients. This is one of the 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she knew 3 other people (patient) with the same symptom, body pain, shoulders are really painful, legs were like lost mobility, inflammation on an unspecified date in 2021. The clinical outcome for the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182532 same reporter/drug/event, different patient
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Heavy menstrual bleeding, Oropharyngeal pain
Clinical narrative: cough; headache; chill; heaving period than usual (2 weeks); 2nd day developed sore throat and slight fever; 2nd day developed sore throat and slight fever; Sore arm within of few hours of getting the 1st and 2nd dose of Pfizer-BioNTech COVID-19 Vaccine This is a spontaneous report from a contactable consumer reported for herself that. A 33-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Sep2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 33 years). The patient 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 other vaccine within 4 weeks prior to covid-19 vaccination. There were no allergies was reported. The patient has not received other medications in two weeks. The patient experienced Sore arm within of few hours of getting the 1st and 2nd dose of Pfizer BioNTech COVID-19 Vaccine EUA on 02Sep2021 2nd day developed sore throat and slight fever on 03Sep2021. On 4Sep2021, Day 3-9 fever, cough, headache chill, heaving period than usual (2 weeks), sore throat, and fever like symptoms. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was received. The event outcome was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: cough; headache; chill; heaving period than usual (2 weeks); 2nd day developed sore throat and slight fever; 2nd day developed sore throat and slight fever; Sore arm within of few hours of getting the 1st and 2nd dose of Pfizer-BioNTech COVID-19 Vaccine This is a spontaneous report from a contactable consumer reported for herself that. A 33-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Sep2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 33 years). The patient 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 other vaccine within 4 weeks prior to covid-19 vaccination. There were no allergies was reported. The patient has not received other medications in two weeks. The patient experienced Sore arm within of few hours of getting the 1st and 2nd dose of Pfizer BioNTech COVID-19 Vaccine EUA on 02Sep2021 2nd day developed sore throat and slight fever on 03Sep2021. On 4Sep2021, Day 3-9 fever, cough, headache chill, heaving period than usual (2 weeks), sore throat, and fever like symptoms. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was received. The event outcome was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation, Vaccination site irritation, Vaccination site pain
Clinical narrative: Minor irritation / Chronic irritation; (minor awareness of irritation in left arm)/ just minor irritation.; Still noticing minor soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EN6204, expiry date was not reported) via intramuscular route of administration, administered in arm left on 11Mar2021 14:30 (age at vaccination 63-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. The patient still noticing minor soreness at injection site (minor awareness of irritation in left arm) no bumps or bruising on an unspecified date Mar2021. The patient had just minor irritation/chronic irritation on 11Mar2021, and I am righthanded and this could be that left arm has less muscle. The patient did not receive any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: has herpes simplex II/five break outs since her first dose/she has had breakouts after the shot one right after the other; has herpes simplex II/five break outs since her first dose/she has had breakouts after the shot one right after the other; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Aug2021 at dose 1, single for covid-19 immunisation. Medical history included ongoing herpes simplex virus 2 (had herpes simplex II for 34 years. Stated that before she would have 6-8 breakouts a year). Concomitant medications were not reported. Reporter stated that she had received her first dose of the Pfizer vaccine shot 09Aug2021 and has herpes simplex II. Reporter has a medical history of herpes simplex virus 2 prior to the vaccine. Stated that she had breakouts after the shot one right after the other. Stated that she has had herpes simplex II for 34 years. Stated that before she would have 6-8 breakouts a year. Stated that since the first shot that she has had 5 breakouts. Stated that she is due for the second dose and is wondering if this is a long or short term effect. Is for Pfizer Covid vaccine. Is concerned about getting the second dose. Reporter details: Email address captured as provided. Outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: sore at the shot site like they hit a nerve; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 27Sep2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2, via an unspecified route of administration, administered in deltoid left (also reported as upper left arm) on 05May2021 14:20 (Batch/Lot Number: ER8734) at the age of 55 years old, as dose 2, single for COVID-19 immunisation. Medical history included degenerative disc from 1988 and ongoing, gall bladder from 1981 (taken out 1981), gastric bypass from 2008 and ongoing (lap band 2008), vasectomy from 1998 and ongoing, heart burn and heart health. Concomitant medication(s) included famotidine (PEPCID AC) taken for heart burn and acetylsalicylic acid (ASPIRIN BAYER) taken for heart health from an unspecified start date and ongoing. The patient previously received first dose of BNT162B2 (Batch/Lot Number: ER8730), intramuscular administered in upper left arm on 04Apr2021 14:20. No prior vaccination. The patient got his Pfizer vaccine first dose on 04Apr2021 (also reported as 21Apr2021) and the second dose on 05May2021. He got sore at the shot site like they hit a nerve on 10May2021, not very often. If he flexed his arm or rubbed it that it went away. It was starting to get worst. He was getting it every day or once every few days. It went away for a few days and came back like 25May2021 (as reported). Stated that that before he would go a week or so and nothing and wanted to know if it persists what should he do. A persistent site discomfort, like a ghost after shot feeling. Flex the muscle or rub the site and it goes away, but returns, maybe in a hour, maybe tomorrow. Always different. There was no treatment. Adverse event was still ongoing Relevant Test included COVID-19: Negative. Outcome of event was not recovered. Reporter assessed the event as serious with seriousness criteria of persistent/significant/disability/incapacity.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lethargy, Pain, Pyrexia
Clinical narrative: flu like symptoms; Body aches; fever; lethargic; chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 13Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that I took the 2nd dose of the Pfizer vaccine yesterday (Monday 13Sep2021) and on an unspecified date of Sep2021 I have flu like symptoms. Body aches, fever, lethargic and chills. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Swelling, Swelling face
Clinical narrative: Swelling inside your mouth, around your neck.; Swelling inside your mouth, around your neck.; Some facial swelling; little in my face but lips now particular; This is a spontaneous report from a contactable consumer. This consumer (patient) of unknown age and gender reported that he/she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3180) via an unspecified route of administration on 23Aug2021 at about 10-10:30 in the morning as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced side effect, including swelling inside mouth around neck and some facial swelling and little in my face but lips now particular. The event outcome was unknown for all events.  Consumer was informed about the role of Pfizer drug safety and asked to file the drug safety report   Consumer was unwilling to complete the report and provide the further information, Hence limited information available over the call.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Dyspnoea, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: Shortness of breath weeks after; gastrointestinal issues; painful menstrual cycles; This is a spontaneous report from a contactable consumer. This 29-year-old female consumer (Patient) reported. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 23Aug2021 (at the age of 29-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. On 01Sep2021, the patient experienced shortness of breath weeks after, gastrointestinal issues, painful menstrual cycles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative- Nasal Swab. Since the vaccination, the patient had been tested for COVID-19. Adverse event resulted in patient to visit doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the event was not recovered, at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heavy menstrual bleeding, Pain, Polymenorrhoea
Clinical narrative: pain; weakness; Heavy period/Short in between time/interval between periods shortened; periods are very heavy; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 1 via an unspecified route of administration on shoulder on 16Apr2021 16:30 (at the age of 35-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04May2021, the patient reported that since first covid vaccine my periods were very heavy with at least 2x200 Ibuprofen 3 times a day. Pain lasts for at least 2 full days (It used to be 1 say. Ibuprofen/heavy periods). Weakness. Interval between periods shortened. Patient reported heavy period/short in between on 31May2021 and 27Jun2021. Patient received treatment of 2x200 Ibuprofen 3 times a day for the events. The clinical outcome was recovering for event heavy bleeding and outcome was unknown for the other events.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Feeling hot, Immunisation, Limb deformity
Clinical narrative: having a cellulitis in my arm; my arm is reading is formed it's painful; my arm is reading is formed it's painful; it's reddened; it's warm; Off label use; Booster; This is a spontaneous report from a non contactable other hcp (patient). A 62-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), dose 3 via an unspecified route of administration on 01Oct2021 (age at vaccination 62-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. On 01Oct2021, the patient received my covid booster on friday december first (name) and october first ten one and friday december first (name) received my booster from my employer and ten one twenty-one she think having a syllabus and my arm was reading was formed it was painful and she thought she was having a cellulitis in her arm, it's reddened, it's warm, it's painful and had pain in her zoloft, off label use and booster. The clinical outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: having a cellulitis in my arm; my arm is reading is formed it's painful; my arm is reading is formed it's painful; it's reddened; it's warm; Off label use; Booster; This is a spontaneous report from a non contactable other hcp (patient). A 62-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), dose 3 via an unspecified route of administration on 01Oct2021 (age at vaccination 62-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. On 01Oct2021, the patient received my covid booster on friday december first (name) and october first ten one and friday december first (name) received my booster from my employer and ten one twenty-one she think having a syllabus and my arm was reading was formed it was painful and she thought she was having a cellulitis in her arm, it's reddened, it's warm, it's painful and had pain in her zoloft, off label use and booster. The clinical outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I developed tinnitus, could be some correlation with the vaccine for tinnitus; This is a spontaneous report from a contactable consumer (patient).   A patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date in Jul2021 as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. The patient had the Pfizer two shots, the second was in July and as of yesterday the patient developed tinnitus and just came, never had it in the patient life, came out of nowhere and was looking online with a, could be some correlation with the vaccine for tinnitus. The patient just take, the only and did not take any medicine just take one medicine, it was Flomax (Further clarification unknown, hence suspect captured conservatively) the patient spoke to the urologist he said that this should not cause tinnitus. The patient stated, It was two, not immediately, the patient just, two months later, the patient had no idea what cause this.  QR Comment: Reporter type could not be probed as the consumer hung up the call abruptly, hence captured by default as consumer or other non-health professional in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.