chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Goitre, Headache, Heart rate, Heart rate increased, Lip erythema
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip oedema, Oxygen saturation, Paraesthesia oral, Somnolence, Speech disorder
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Vaccination site pruritus, Vaccination site warmth, Vertigo
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Aphasia, Chills, Confusional state, Dizziness
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Eye pruritus, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Heart rate increased, Injection site pruritus, Injection site warmth
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Rash, Somnolence, Swelling, Swollen tongue
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on January 25, he tested positive for Covid on the 1st or 2nd week of February; 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on January 25, he tested positive for Covid on the 1st or 2nd week of February; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported. It was reported (by a Pharmacy Technician) that after their patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 25Jan2021, he tested positive for Covid on the 1st or 2nd week of Feb2021. Due to this, he missed his original schedule for the 2nd dose. Now, he has already recovered and is scheduled to receive the 2nd dose tomorrow. However, this would already be 49 days after his 1st dose. The reporter wants to know if that is still acceptable. The outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: lower eye area has been swollen; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202, expiry date: unknown), via an unspecified route of administration in the right arm, on 23Feb2021 15:30, as single dose, for covid-19 immunization, at a hospital. The patient's medical history and concomitant medications were not reported.  The patient had no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, expiry date: unknown) received at 33 years of age, via an unspecified route of administration in the left arm, on 01Feb2021 13:00, as single dose, for COVID-19 immunization. It was reported that the patient's lower eye has been swollen since 27Feb2021. This event resulted to physician office and emergency room visits. Treatment included warm compress twice a day. The outcome of the event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Itchy rash; swollen and redness at the injection site; swollen and redness at the injection site; This is a spontaneous report from a non-contactable consumer (the patient). A non-pregnant 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm Left on 13Mar2021 at 10:00 AM, at the  age of 70 years, (Lot Number: EN6206) as a single dose for COVID-19 vaccination. Medical history included atrial fibrillation, high cholesterol. Prior to the vaccination, the patient was diagnosed with COVID-19 Concomitant medication taken within two weeks of vaccination included apixaban (ELIQUIS), diltiazem, atorvastatin (ATORVASTATINE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm (Lot Number EL3246) in the left arm on 20Feb2021 at 10:15 AM as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 09:00 AM the patient experienced itchy rash, swollen and redness at the injection site. The patient had a physician office visit for events. Therapeutic measures were taken as a result of itchy rash, swollen and redness at the injection site and included Allegra 180mg and Hydrocortisone cream. The clinical outcome of the events itchy rash, swollen and redness at the injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive for Covid 19 virus after receiving Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 03Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 13Jan2021, the patient tested positive for COVID 19 virus after receiving COVID 19 vaccine on 03Jan2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 13Jan2021. Clinical outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I have tested positive for Covid; I have tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) from a 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration date unknown), via an unspecified route of administration, on 02Mar2021at single dose for Covid-19 immunization. The patient medical history and concomitant medication were not reported. On 15thMar2021, the patient tested positive for COVID-19 and is being quarantined for 10 days. The outcome of event was unknown.  Information on lot/ batch has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Antibody test that showed up negative for antibodies; This is a spontaneous report from a contactable healthcare professional (the patient) (also reported contactable consumer, pending clarification) from Pfizer. This reporter reported similar events for three patients. This is the first of three reports.  An 82-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 17Feb2021 16:00 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included unspecified medication for high blood pressure. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 around 15:30 on right arm, for COVID-19 immunization. On 09Mar2021, 20 days after the second dose of vaccination, the patient had an antibody test that showed up negative for antibodies. The patient stated that she had an antibody test performed on 09Mar2021 exactly 20 days after her second dose of the COVID-19 vaccine. She reported that the test result showed no antibodies. She is inquiring if she is supposed to be showing antibodies after both doses of the COVID-19 vaccine and if she doesn't have any antibodies, does that mean shot doesn't work? The event did not require a visit to Emergency Room. The patient went to her physician after receiving the negative antibody test results. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296623 same reporter, drug, and event, different patient;US-PFIZER INC-2021296704 same reporter, drug, and event, different patient
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: pressure behind my eyes; tested positive for Covid-19; He had tested positive for COVID using rapid test 16Mar2021; This is a spontaneous report from a contactable Consumer. A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included Deficiency of Vitamin D. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) at 2000 iU, once a day taken for hypovitaminosis. The patient experienced tested positive for covid-19 and drug ineffective (medically significant) on 16Mar2021. It was reported that patient had the 1st dose of the Pfizer-Biontech Covid-19 Vaccine last 10Mar2021 - 2 days after (12Mar2021) he experienced sinusitis then few days later he developed cough on 16Mar2021. He had tested positive for COVID using rapid test 16Mar2021. He was asking if he was still eligible to get the 2nd dose of the vaccine which is scheduled on 31Mar2021. Consumer also stated that he had symptoms on Friday which were sinus and then Saturday he was not that bad but on Sunday he had sinus, pressure behind his eyes and then slight headache and then his cough, he developed a cough once in a while, then on Monday he had the same symptom it felt like, he was really fatigue, he got tired very easily and then on Tuesday he woke up and it felt better so he work and then he still feel pressure, the slight of pressure and the cough and then he start to get tired again, so he went for the test that night, so yesterday he had and that was how he tested positive. Outcome of the event pressure behind my eyes was not recovered and outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibody test 1 week ago, it came back negative/ took a second one it also came back negative/ IgM: Negative, IgG: Negative; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) on 20Jan2021 and her second dose on 10Feb2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of COVID 19 vaccine on 20Jan2021 at a hospital and her second dose on 10Feb2021. They were planning a family vacation at the end of this month so as an added precaution, she took an antibody test 1 week ago (Mar2021), it came back negative, the second one (16Mar2021) was also negative. Both IgM and IgG were negative. The patient was at a loss as to what to do next since as per these results, she has not developed immunity. If possible, she would like to know what she can do next. The outcome of the event was not recovered. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 with symptoms; COVID-19 with symptoms; This is a spontaneous report from a non-contactable consumer (patient).  A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 03:30 PM, as a single dose for COVID-19 immunization. Medical history included Hashimoto's, Hyperlipidemia, Meniere's Disease and Sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL), celecoxib (CELEXA), hydrochlorothiazide/triamterene (DYAZIDE), atorvastatin (LIPITOR) and fusidate sodiume (ZETA). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was exposed to COVID on 07Mar2021 tested negative via SARS-CoV-2 test on 12Mar2021. The patient became symptomatic on 14Mar2021 and subsequently tested positive via SARS-CoV-2 test (via nasal swab) on 16Mar2021. The patient did receive any treatment for the events which included a steroid, inhaler, benzonatate (TESSALON). The clinical outcomes of the COVID was recovering.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Received 2 doses of Pfizer vaccine and was diagnosed with COVID 19; Received 2 doses of Pfizer vaccine and was diagnosed with COVID 19; This is a spontaneous report received from a contactable consumer, the patient. This 80-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) on 26Jan2021 (at the age of 79-year-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) on 16Feb2021 12:00 (at the age of 80-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history, allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received 2 doses of Pfizer vaccine and was diagnosed with COVID 19 on 16Mar2021. No treatment was received for the adverse events. The patient was tested positive for nasal swab COVID-19 test (post vaccination) on 16Mar2021. The clinical outcome of "received 2 doses of Pfizer vaccine and was diagnosed with COVID 19" was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over his body; This is a spontaneous report from a contactable nurse (patient's spouse). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular at the age of 80-years-old, administered in Arm Left on 17Feb2021 13:30 (Lot Number: EN6201) as a single dose for COVID-19 immunization. Medical history included recently, the patient had retinal detachment and had surgery for that on 18Jan2021, then he had to go back 26Feb2021 to have surgery on the same eye, he has a pacemaker. Concomitant medication included unspecified eye drop. The patient previously received bnt162b2 (BNT162B2), dose 1 intramuscular at the of 80-years-old, administered in Arm Left on 29Jan2021 11:00 (Lot Number: EL9263) as a single dose for COVID-19 immunization. The patient experienced rash all over his body on 19Feb2021. Reporter's husband (patient) has a rash all over his body. The rash has not bothered him. Reporter noticed the rash 3 days after he received the second dose, clarified as she noticed the rash 2 days after he received the second dose. Reporter just happened to walk into the room while patient's shirt was off. She was like "Oh my goodness, what is that." She has looked a couple of more times at patient's rash. After patient first gets out of the shower, his rash is more pronounced. She is not sure if it is because of the warm water or washing up that makes it more pronounced. She can run her hand over the rash and still feel it. The rash had gotten slightly better. Reporter stated that the rash has not concerned her until it has not gone away. Reporter is trying to decide whether or not to take patient to the doctors office since the rash has not went away. The outcome of the event rash was unknown. The event was considered as serious (medically significant).; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine cannot be excluded for the reported event of  rash, based on temporal relationship and the known product safety profile. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Headache
Clinical narrative: after taking Pfizer  vaccination I began to feel like I had covid all over again.; after taking Pfizer  vaccination I began to feel like I had covid all over again.; Body pain; chills; headaches; fatigue; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 02Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 12:00(also reported as 28Feb2021, pending clarification) (lot number:EN5318); both as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021 07:00, after taking Pfizer vaccination the patient began to feel like he had covid all over again. Body pain, chills, headaches, fatigue. The patient tested positive on 27Dec2020. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included covid-19: positive on 27Dec2020. The outcome of the events was not recovered.   No follow-up attempts possible. No further information expected. Batch/lot number already provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Suspected COVID-19
Clinical narrative: after taking Pfizer  vaccination I began to feel like I had covid all over again.; after taking Pfizer  vaccination I began to feel like I had covid all over again.; Body pain; chills; headaches; fatigue; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 02Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 12:00(also reported as 28Feb2021, pending clarification) (lot number:EN5318); both as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Mar2021 07:00, after taking Pfizer vaccination the patient began to feel like he had covid all over again. Body pain, chills, headaches, fatigue. The patient tested positive on 27Dec2020. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included covid-19: positive on 27Dec2020. The outcome of the events was not recovered.   No follow-up attempts possible. No further information expected. Batch/lot number already provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was fully vaccinated with the Pfizer vaccine for six weeks, but then I became infected with Covid; I became infected with Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated with the Pfizer vaccine for six weeks, but then she became infected with COVID on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.