chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy rash on the arm around the site of injection; itchy rash on the arm around the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 09Mar2021 at 09.45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6201) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 11Mar2021, the patient experienced itchy rash on the arm around the site of injection. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy rash on the arm around the site of injection was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear irrigation, Tinnitus
Clinical narrative: Got First covid shot, reported AE. inquiry about the second shot after AE. Would she have less antibodies.; ringing in her ears / he continues to have the ringing now in my whole head/woke up with ringing in her ear, tinnitus; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199, Expiration Date: 30Jun2021), via an unspecified route of administration on 06Mar2021 at 13:30 (at the age of 63-years-old) as single dose for COVID-19 immunisation. The patient's medical history included breast cancer 4 years ago, and takes Anastrozole as an estrogen blocker. She says that her bottle changes all the time, it is in a pharmacy bottle, Anastrozole LOT/EXP not provided on the pharmacy label. NDC: 16729-0035-16. The patient's concomitant medications were not reported. The patient previously took anastrozole as estrogen blocker for breast cancer. Patient stated that she had her first Pfizer COVID-19 vaccine shot 06Mar2021, Saturday afternoon and on Sunday morning 07Mar2021 at 03:00, she woke up with ringing in her ear, tinnitus, which she has had this whole week. When it was started it was her left ear ringing, and now it was kind of a buzzing in her head or ringing, it was hard to try to describe it. She reported it woke her up even, the ringing ear, and then kind of as times going she did not notice it in a distinct ear, it was in her head and not her left or right ear, an annoying noise. Patient stated she went to see her GP about it because she was hoping it was wax in her ear, which he cleaned it out on Thursday and she still had an issues. She was going to go see an ENT tomorrow. She says she is going to go see an ENT tomorrow, that is how much this is bothering her. She was afraid to get second dose she would like to know if there would be any problems other than not being fully vaccinated, or if it was like not taking all of antibiotics can be where it can cause issues. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumstance or information capable of leading to medication error, Tinnitus
Clinical narrative: Got First covid shot, reported AE. inquiry about the second shot after AE. Would she have less antibodies.; ringing in her ears / he continues to have the ringing now in my whole head/woke up with ringing in her ear, tinnitus; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199, Expiration Date: 30Jun2021), via an unspecified route of administration on 06Mar2021 at 13:30 (at the age of 63-years-old) as single dose for COVID-19 immunisation. The patient's medical history included breast cancer 4 years ago, and takes Anastrozole as an estrogen blocker. She says that her bottle changes all the time, it is in a pharmacy bottle, Anastrozole LOT/EXP not provided on the pharmacy label. NDC: 16729-0035-16. The patient's concomitant medications were not reported. The patient previously took anastrozole as estrogen blocker for breast cancer. Patient stated that she had her first Pfizer COVID-19 vaccine shot 06Mar2021, Saturday afternoon and on Sunday morning 07Mar2021 at 03:00, she woke up with ringing in her ear, tinnitus, which she has had this whole week. When it was started it was her left ear ringing, and now it was kind of a buzzing in her head or ringing, it was hard to try to describe it. She reported it woke her up even, the ringing ear, and then kind of as times going she did not notice it in a distinct ear, it was in her head and not her left or right ear, an annoying noise. Patient stated she went to see her GP about it because she was hoping it was wax in her ear, which he cleaned it out on Thursday and she still had an issues. She was going to go see an ENT tomorrow. She says she is going to go see an ENT tomorrow, that is how much this is bothering her. She was afraid to get second dose she would like to know if there would be any problems other than not being fully vaccinated, or if it was like not taking all of antibiotics can be where it can cause issues. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: The side effects I experienced included the following: injection site pain; tiredness; headache; chills; nausea; and feeling unwell.; tiredness; Headache; Nausea; Chiils; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hyperlipidemia, allergy to pistachios and cashews  and allergic to mango. Concomitant medications included insulin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), metformin hydrochloride (METFORMIN) and atorvastatin calcium (ATORVASTATIN) all were taken from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 17Feb2021 at 13:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. On 11Mar2021 at 09:00 the patient experienced the side effects experienced included the following: injection site pain; tiredness; headache; chills; nausea; and feeling unwell. Therapeutic measures were taken as a result of occurred adverse events and included treatment with tylenol started from unknown date and stopped on unknown date. Since the vaccination the patient was not diagnosed with COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, chills, nausea and feeling unwell. was recovered on an unknown date in Mar2021 at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: The side effects I experienced included the following: injection site pain; tiredness; headache; chills; nausea; and feeling unwell.; tiredness; Headache; Nausea; Chiils; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hyperlipidemia, allergy to pistachios and cashews  and allergic to mango. Concomitant medications included insulin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), metformin hydrochloride (METFORMIN) and atorvastatin calcium (ATORVASTATIN) all were taken from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 17Feb2021 at 13:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. On 11Mar2021 at 09:00 the patient experienced the side effects experienced included the following: injection site pain; tiredness; headache; chills; nausea; and feeling unwell. Therapeutic measures were taken as a result of occurred adverse events and included treatment with tylenol started from unknown date and stopped on unknown date. Since the vaccination the patient was not diagnosed with COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, chills, nausea and feeling unwell. was recovered on an unknown date in Mar2021 at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: The side effects I experienced included the following: injection site pain; tiredness; headache; chills; nausea; and feeling unwell.; tiredness; Headache; Nausea; Chiils; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hyperlipidemia, allergy to pistachios and cashews  and allergic to mango. Concomitant medications included insulin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), metformin hydrochloride (METFORMIN) and atorvastatin calcium (ATORVASTATIN) all were taken from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 17Feb2021 at 13:15 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. On 11Mar2021 at 09:00 the patient experienced the side effects experienced included the following: injection site pain; tiredness; headache; chills; nausea; and feeling unwell. Therapeutic measures were taken as a result of occurred adverse events and included treatment with tylenol started from unknown date and stopped on unknown date. Since the vaccination the patient was not diagnosed with COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, chills, nausea and feeling unwell. was recovered on an unknown date in Mar2021 at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain in extremity
Clinical narrative: Day of vaccine - tired; Both arms hurt at approx same spot as injection.; Both arms hurt at approx same spot as injection.; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and unspecified store brought medicine; both for an unknown indication from an unknown date and unknown if ongoing. On 24Feb2021 at 14:00, the patient experienced day of vaccine -tired, both arms hurt at approx same spot as injection, headache. Day 2&3 - still tired, headache, both arms continue to hurt at same spot as injection and this has continued daily. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tired and headache were recovered with sequelae on an unknown date in 2021 while the events both arms hurt at approx same spot as injection and this has continued daily were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Day of vaccine - tired; Both arms hurt at approx same spot as injection.; Both arms hurt at approx same spot as injection.; Headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and unspecified store brought medicine; both for an unknown indication from an unknown date and unknown if ongoing. On 24Feb2021 at 14:00, the patient experienced day of vaccine -tired, both arms hurt at approx same spot as injection, headache. Day 2&3 - still tired, headache, both arms continue to hurt at same spot as injection and this has continued daily. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tired and headache were recovered with sequelae on an unknown date in 2021 while the events both arms hurt at approx same spot as injection and this has continued daily were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Periorbital swelling, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Swelling of throat and neck; Swelling of throat and neck; rash; hives; itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration Date was not reported), via an unspecified route of administration, administered in the left arm on 14Mar2021 11:00 (at the age of 69-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included atorvastatin; lisinopril; amlodipine; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of throat and neck, rash, hives, itching on 15Mar2021 18:00. Events resulted to treatment with course of prednisone and hydroxyzine and Doctor or other healthcare professional office/clinic visit. The outcome of events was not reported.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Swelling of throat and neck; Swelling of throat and neck; rash; hives; itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration Date was not reported), via an unspecified route of administration, administered in the left arm on 14Mar2021 11:00 (at the age of 69-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included atorvastatin; lisinopril; amlodipine; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of throat and neck, rash, hives, itching on 15Mar2021 18:00. Events resulted to treatment with course of prednisone and hydroxyzine and Doctor or other healthcare professional office/clinic visit. The outcome of events was not reported.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Swelling of throat and neck; Swelling of throat and neck; rash; hives; itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration Date was not reported), via an unspecified route of administration, administered in the left arm on 14Mar2021 11:00 (at the age of 69-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included atorvastatin; lisinopril; amlodipine; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of throat and neck, rash, hives, itching on 15Mar2021 18:00. Events resulted to treatment with course of prednisone and hydroxyzine and Doctor or other healthcare professional office/clinic visit. The outcome of events was not reported.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hot flush, Pruritus, Rash
Clinical narrative: my face felt very warm; my face was very red.; itching; Rash all over/sandpaper like feel; similar to scarlatina; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative.   A 38-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Left arm on 24Mar2021 15:30 (at the age of 38 year old) as dose 1, single for COVID-19 immunisation. Medical history included endometriosis, asthma, allergies from an unknown date. Patient has known allergies to pertussis vaccine (Dtap). Concomitant medications included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA); fluticasone propionate; fluticasone propionate, salmeterol (WIXELA INHUB); MVT, ascorbic acid (VIT C), FOLBIC all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, patient had been diagnosed with COVID-19. After receiving the vaccine, within 20 minutes , her face felt very warm. She thought that was because she was wearing a mask and was in a large room that was stuffy  with a lot of people for the first time since COVID. The patient observed for 30 minutes. In the car she removed mask and her face felt as if it was on fire. When she arrived home, her husband noted that her face was very red. Also, developed itching where her clothing was tight (bra and underwear lines). When she looked in the mirror, her face was very red with a sandpaper like rash all over (similar to scarlatina). So she took Benadryl 50 mg and it did not worsen. At the time of report, her face is still pink and has a sandpaper like feel to it. Also, there were increased redness again 26Mar2021 evening and had to take Benadryl again. The events resulted in physician office visit. It was reported that, event took place after use of product. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Scarlet fever
Clinical narrative: my face felt very warm; my face was very red.; itching; Rash all over/sandpaper like feel; similar to scarlatina; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative.   A 38-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Left arm on 24Mar2021 15:30 (at the age of 38 year old) as dose 1, single for COVID-19 immunisation. Medical history included endometriosis, asthma, allergies from an unknown date. Patient has known allergies to pertussis vaccine (Dtap). Concomitant medications included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA); fluticasone propionate; fluticasone propionate, salmeterol (WIXELA INHUB); MVT, ascorbic acid (VIT C), FOLBIC all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, patient had been diagnosed with COVID-19. After receiving the vaccine, within 20 minutes , her face felt very warm. She thought that was because she was wearing a mask and was in a large room that was stuffy  with a lot of people for the first time since COVID. The patient observed for 30 minutes. In the car she removed mask and her face felt as if it was on fire. When she arrived home, her husband noted that her face was very red. Also, developed itching where her clothing was tight (bra and underwear lines). When she looked in the mirror, her face was very red with a sandpaper like rash all over (similar to scarlatina). So she took Benadryl 50 mg and it did not worsen. At the time of report, her face is still pink and has a sandpaper like feel to it. Also, there were increased redness again 26Mar2021 evening and had to take Benadryl again. The events resulted in physician office visit. It was reported that, event took place after use of product. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Loss of personal independence in daily activities, Pain
Clinical narrative: I developed an itchy rash on the back of both knees in the crease; The rash is made up of many tiny bumps; fever (103); fatigue; chills; body aches just like when I had COVID in December 2020; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:15 as DOSE 1, SINGLE (Age at vaccination: 46) for covid-19 immunization at Pharmacy or Drug Store. Medical history included gastrooesophageal reflux disease, obesity, Patient had covid-19 in Dec2020 to an unknown date. known allergies include penicillin, amoxicillin, nickel. Concomitant medication(s) included omeprazole, famotidine (PEPCID AC), diltiazem , vitamin all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was diagnosed with COVID. Since the vaccination, the patient was not tested for COVID-19. No other vaccine received in four weeks. Pfizer have permission to contact reporter about the report and Pfizer have permission to contact the patient's healthcare provider about this report. On 27Mar2021 14:00 the patient experienced developed an itchy rash on the back of both knees in the crease, rash is made up of many tiny bumps, fever (103), fatigue, chills, body aches just like when patient had covid in December 2020. No treatment received for the adverse event. It was reported that After 24 hours of getting the vaccine, patient developed an itchy rash on the back of both knees in the crease. The rash is made up of many tiny bumps and also developed the more common side effects of fever (103), fatigue, chills and body aches just like when patient had COVID in December 2020. All symptoms resolved 48 hours after getting the vaccine except for the rash on the back of the knees patient still have it. The outcome of events was recovered on unspecified date in Mar2021 except itchy rash on the back of the knees which is not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I developed an itchy rash on the back of both knees in the crease; The rash is made up of many tiny bumps; fever (103); fatigue; chills; body aches just like when I had COVID in December 2020; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:15 as DOSE 1, SINGLE (Age at vaccination: 46) for covid-19 immunization at Pharmacy or Drug Store. Medical history included gastrooesophageal reflux disease, obesity, Patient had covid-19 in Dec2020 to an unknown date. known allergies include penicillin, amoxicillin, nickel. Concomitant medication(s) included omeprazole, famotidine (PEPCID AC), diltiazem , vitamin all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was diagnosed with COVID. Since the vaccination, the patient was not tested for COVID-19. No other vaccine received in four weeks. Pfizer have permission to contact reporter about the report and Pfizer have permission to contact the patient's healthcare provider about this report. On 27Mar2021 14:00 the patient experienced developed an itchy rash on the back of both knees in the crease, rash is made up of many tiny bumps, fever (103), fatigue, chills, body aches just like when patient had covid in December 2020. No treatment received for the adverse event. It was reported that After 24 hours of getting the vaccine, patient developed an itchy rash on the back of both knees in the crease. The rash is made up of many tiny bumps and also developed the more common side effects of fever (103), fatigue, chills and body aches just like when patient had COVID in December 2020. All symptoms resolved 48 hours after getting the vaccine except for the rash on the back of the knees patient still have it. The outcome of events was recovered on unspecified date in Mar2021 except itchy rash on the back of the knees which is not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash pruritic
Clinical narrative: I developed an itchy rash on the back of both knees in the crease; The rash is made up of many tiny bumps; fever (103); fatigue; chills; body aches just like when I had COVID in December 2020; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:15 as DOSE 1, SINGLE (Age at vaccination: 46) for covid-19 immunization at Pharmacy or Drug Store. Medical history included gastrooesophageal reflux disease, obesity, Patient had covid-19 in Dec2020 to an unknown date. known allergies include penicillin, amoxicillin, nickel. Concomitant medication(s) included omeprazole, famotidine (PEPCID AC), diltiazem , vitamin all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was diagnosed with COVID. Since the vaccination, the patient was not tested for COVID-19. No other vaccine received in four weeks. Pfizer have permission to contact reporter about the report and Pfizer have permission to contact the patient's healthcare provider about this report. On 27Mar2021 14:00 the patient experienced developed an itchy rash on the back of both knees in the crease, rash is made up of many tiny bumps, fever (103), fatigue, chills, body aches just like when patient had covid in December 2020. No treatment received for the adverse event. It was reported that After 24 hours of getting the vaccine, patient developed an itchy rash on the back of both knees in the crease. The rash is made up of many tiny bumps and also developed the more common side effects of fever (103), fatigue, chills and body aches just like when patient had COVID in December 2020. All symptoms resolved 48 hours after getting the vaccine except for the rash on the back of the knees patient still have it. The outcome of events was recovered on unspecified date in Mar2021 except itchy rash on the back of the knees which is not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: I developed an itchy rash on the back of both knees in the crease; The rash is made up of many tiny bumps; fever (103); fatigue; chills; body aches just like when I had COVID in December 2020; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 26Mar2021 15:15 as DOSE 1, SINGLE (Age at vaccination: 46) for covid-19 immunization at Pharmacy or Drug Store. Medical history included gastrooesophageal reflux disease, obesity, Patient had covid-19 in Dec2020 to an unknown date. known allergies include penicillin, amoxicillin, nickel. Concomitant medication(s) included omeprazole, famotidine (PEPCID AC), diltiazem , vitamin all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was diagnosed with COVID. Since the vaccination, the patient was not tested for COVID-19. No other vaccine received in four weeks. Pfizer have permission to contact reporter about the report and Pfizer have permission to contact the patient's healthcare provider about this report. On 27Mar2021 14:00 the patient experienced developed an itchy rash on the back of both knees in the crease, rash is made up of many tiny bumps, fever (103), fatigue, chills, body aches just like when patient had covid in December 2020. No treatment received for the adverse event. It was reported that After 24 hours of getting the vaccine, patient developed an itchy rash on the back of both knees in the crease. The rash is made up of many tiny bumps and also developed the more common side effects of fever (103), fatigue, chills and body aches just like when patient had COVID in December 2020. All symptoms resolved 48 hours after getting the vaccine except for the rash on the back of the knees patient still have it. The outcome of events was recovered on unspecified date in Mar2021 except itchy rash on the back of the knees which is not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision in left eye which persists; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm right on 25Mar2021 (at the age of 69-years-old) at 11:30 as a single dose for COVID-19 immunisation. Medical history included palsy bells, penicillin allergy and grave's eye disease in 2006 and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 (at the age of 69-years-old) at 11:30 as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 26Mar2021 at 07:30 morning after the second COVID vaccination, had blurred vision in left eye which persists. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event blurred vision in left eye which persists was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin induration
Clinical narrative: after second dose this lump increased size; body pain; vomiting; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 30Mar2021 at 07:45 (at the age of 41 years old) (Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of the events. The patient has no known allergies. Concomitant medications included potassium citrate taken for an unspecified indication, start and stop date were not reported; paracetamol, phenyltoloxamine citrate (BEFLEX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. Anticontraceptive, potassium citrate, bifllex, and wate way were received in two weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 on 09Mar2021 for COVID-19 immunisation and experienced lump. On an unspecified date (approximately 8 hours after second dose), the patient experienced after second dose this lump increased size, body pain, vomiting, headache, and fever. It was reported that the lump is visible before it was only palpable. No treatment was received for the events. Events resulted in consultation or medial appointment or other healthcare professional appointment, anomaly, or birth defect. 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.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia, Vomiting
Clinical narrative: after second dose this lump increased size; body pain; vomiting; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 30Mar2021 at 07:45 (at the age of 41 years old) (Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of the events. The patient has no known allergies. Concomitant medications included potassium citrate taken for an unspecified indication, start and stop date were not reported; paracetamol, phenyltoloxamine citrate (BEFLEX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. Anticontraceptive, potassium citrate, bifllex, and wate way were received in two weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 on 09Mar2021 for COVID-19 immunisation and experienced lump. On an unspecified date (approximately 8 hours after second dose), the patient experienced after second dose this lump increased size, body pain, vomiting, headache, and fever. It was reported that the lump is visible before it was only palpable. No treatment was received for the events. Events resulted in consultation or medial appointment or other healthcare professional appointment, anomaly, or birth defect. 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.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dizziness, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; extreme weakness; fatigue; unable to climb down stairs; slight iron deficiency; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the left arm on 21Feb2021 at 13:30 (age at the time of vaccination was 75-year-old) as dose 2, single for COVID-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in the left arm on 31Jan2021 at 10:30 (age at the time of vaccination was 75-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included high cholesterol, hypertension, bipolar and hay fever, all from an unknown date and unknown if ongoing. Patient was allergic to Sulfa and Vicodid. Prior to vaccination patient was not identified for Covid-19. Concomitant medication included simvastatin (SIMVASTATIN), tamsulosin (TAMSULOSIN), lamotrigine (LAMICTAL) and montelukast (MONTELUKAST) all taken for an unspecified indication, start and stop date were not reported. No other medications in four weeks. On 24Feb2021, the patient experienced shortness of breath, for almost SEVEN weeks (starting first week) (quick, forceful, repeated, EXHALATIONS, interspersed with short, normal inhalations), extreme weakness, fatigue, unable to climb downstairs and slight iron deficiency. AE required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive any treatment for events. Since the vaccination patient has tested for covid-19. On 10Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) result was negative. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Laboratory test, Red blood cell count decreased, X-ray
Clinical narrative: shortness of breath; extreme weakness; fatigue; unable to climb down stairs; slight iron deficiency; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the left arm on 21Feb2021 at 13:30 (age at the time of vaccination was 75-year-old) as dose 2, single for COVID-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in the left arm on 31Jan2021 at 10:30 (age at the time of vaccination was 75-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included high cholesterol, hypertension, bipolar and hay fever, all from an unknown date and unknown if ongoing. Patient was allergic to Sulfa and Vicodid. Prior to vaccination patient was not identified for Covid-19. Concomitant medication included simvastatin (SIMVASTATIN), tamsulosin (TAMSULOSIN), lamotrigine (LAMICTAL) and montelukast (MONTELUKAST) all taken for an unspecified indication, start and stop date were not reported. No other medications in four weeks. On 24Feb2021, the patient experienced shortness of breath, for almost SEVEN weeks (starting first week) (quick, forceful, repeated, EXHALATIONS, interspersed with short, normal inhalations), extreme weakness, fatigue, unable to climb downstairs and slight iron deficiency. AE required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive any treatment for events. Since the vaccination patient has tested for covid-19. On 10Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) result was negative. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Iron deficiency, Laboratory test
Clinical narrative: shortness of breath; extreme weakness; fatigue; unable to climb down stairs; slight iron deficiency; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the left arm on 21Feb2021 at 13:30 (age at the time of vaccination was 75-year-old) as dose 2, single for COVID-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in the left arm on 31Jan2021 at 10:30 (age at the time of vaccination was 75-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included high cholesterol, hypertension, bipolar and hay fever, all from an unknown date and unknown if ongoing. Patient was allergic to Sulfa and Vicodid. Prior to vaccination patient was not identified for Covid-19. Concomitant medication included simvastatin (SIMVASTATIN), tamsulosin (TAMSULOSIN), lamotrigine (LAMICTAL) and montelukast (MONTELUKAST) all taken for an unspecified indication, start and stop date were not reported. No other medications in four weeks. On 24Feb2021, the patient experienced shortness of breath, for almost SEVEN weeks (starting first week) (quick, forceful, repeated, EXHALATIONS, interspersed with short, normal inhalations), extreme weakness, fatigue, unable to climb downstairs and slight iron deficiency. AE required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive any treatment for events. Since the vaccination patient has tested for covid-19. On 10Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) result was negative. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, SARS-CoV-2 test negative
Clinical narrative: shortness of breath; extreme weakness; fatigue; unable to climb down stairs; slight iron deficiency; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the left arm on 21Feb2021 at 13:30 (age at the time of vaccination was 75-year-old) as dose 2, single for COVID-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in the left arm on 31Jan2021 at 10:30 (age at the time of vaccination was 75-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included high cholesterol, hypertension, bipolar and hay fever, all from an unknown date and unknown if ongoing. Patient was allergic to Sulfa and Vicodid. Prior to vaccination patient was not identified for Covid-19. Concomitant medication included simvastatin (SIMVASTATIN), tamsulosin (TAMSULOSIN), lamotrigine (LAMICTAL) and montelukast (MONTELUKAST) all taken for an unspecified indication, start and stop date were not reported. No other medications in four weeks. On 24Feb2021, the patient experienced shortness of breath, for almost SEVEN weeks (starting first week) (quick, forceful, repeated, EXHALATIONS, interspersed with short, normal inhalations), extreme weakness, fatigue, unable to climb downstairs and slight iron deficiency. AE required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive any treatment for events. Since the vaccination patient has tested for covid-19. On 10Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) result was negative. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.