chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Swelling, Urticaria
Clinical narrative: After her 1st dose, she had an allergy so bad; Swelling and hives all over body; Swelling and hives all over body; This is a spontaneous report from a contactable nurse, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the arm on 23Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history included the patient was on blood thinner therapy; allergy to a lot of medications, mold and cut grass; operation to remove clots in Nov2020 (two months prior to vaccination); thyroid disorder. Concomitant medications included unspecified thyroid pills and apixaban (ELIQUIS) as a blood thinner. The patient previously took moxifloxacin (AVELOX) and experienced allergy and rash and was in the hospital. On 24Jan2021 (the next day after vaccination), the patient experienced an "allergy so bad", swelling and hives all over her body. The patient went to the emergency room due to the events and was "hooked up" with intravenous (IV)s for an hour before she could go home. The reactions were assessed as related to the vaccination by the patient. The patient was scheduled for her second dose on 23Mar2021. She was not given the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers until after being administered the first dose of the vaccine. If she had been given the fact sheet for recipients and caregivers before being administered the first dose, she would not have gotten the vaccine because the sheet says not to get the shot if you are allergic to other medications or other reasons for allergies or on blood thinners. The patient questioned whether she should get the second dose as her physician said she should not get the second dose while on apixaban. The clinical outcome of "after her 1st dose, she had an allergy so bad" and "swelling and hives all over body" was unknown.  Information on lot number/batch number has been requested.; Sender's Comments: Based on temporal relation and known safety profile of the vaccine, a causal relation between events allergy to vaccine, swelling, hives and BNT162B2 cannot be excluded.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial, Thrombosis
Clinical narrative: I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before.  The blood clot returned again to the same level of pain and the same; I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before.  The blood clot returned again to the same level of pain and the same; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Mar2021 13:30 (lot/batch number was not reported) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient had no known allergies. The patient's concomitant medications were not reported. On 04Mar2021 07:30, the patient had a return of a superficial thrombophlebitis on her left arm above where a catheter had been when she had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same. No treatment was received for the events. Patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and not tested for COVID post vaccination. Vaccine facility type was other. There was no other vaccine in four weeks and there was other medications in two weeks. The outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath; bradycardia; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EN6200), intramuscular in left arm on 24Feb2021 12:00 PM (received at the age of 89-years-old) at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within the four weeks prior to receiving BNT162B2. Medical history included known COPD (chronic obstructive pulmonary disease), hypertensive heart, CKD 3 (chronic kidney disease stage 3), and history of breast cancer. The patient had no COVID prior to vaccination. He had no known allergies. Concomitant medications included multiple unspecified medications. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number: EL9265), intramuscular in left arm on 02Feb2021 at a single dose for COVID-19 immunization. It was reported that the patient developed shortness of breath (SOB) and bradycardia 3 days after vaccination, on 27Feb2021. 1 day after that, 28Feb2021, it worsened, and the patient was admitted with SOB and bradycardia. Has known COPD, not on any negative chronotropic medication. The patient was cleared after a day in the hospital. The reported adverse events resulted in an emergency room/department or urgent care visit and hospitalization. The patient was hospitalized for 2 days (28Feb2021 to 02Mar2021). As corrective treatment, the patient received oral steroid. The patient recovered from the events on an unspecified date. The patient underwent Covid test post vaccination: Nasal Swab on 28Feb2021 with result of negative.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenergic syndrome, Agitation, Balance disorder, Blood test, Bronchitis
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Ear pruritus, Electrocardiogram, Facial pain
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Gait disturbance, Headache, Hypersensitivity
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Laboratory test, Limb discomfort, Lower respiratory tract infection, Malaise
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Muscle twitching, Muscular weakness, Musculoskeletal discomfort, Neck pain
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Paraesthesia, Paraesthesia oral, Productive cough, Pruritus
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tremor
Clinical narrative: Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of  unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Infection, Investigation
Clinical narrative: pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (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 took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pneumonia, Pyrexia
Clinical narrative: pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (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 took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Pain, Pneumonia
Clinical narrative: bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202; expiry date: not known), via an unspecified route of administration, administered in arm right on 24Feb2021 11:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020 with reported symptoms of bilateral pneumonia, severe headaches, bronchial cough, low grade fever, and body aches. The patient is not pregnant. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); and codeine phosphate, guaifenesin (CODEINE GUAIFENESIN). The patient previously took gabapentine and experienced allergies. No other vaccine received in four weeks. Clinical course was reported as follows: she tested positive for COVID-19 on 21Dec2020 and recovered. She had bilateral pneumonia, severe headaches with bronchial cough, low grade fever and body aches which lasted five weeks. She was fully recovered but had intermittent mild symptoms lingering. On 25Feb2021 08:00, within 24 hours of getting the first vaccine, she developed all these symptoms again, but they were severe again and had to start prescriptions meds again daily to manage them and she still experiencing them now. She was due to have her second vaccine on Wednesday, 17Mar2021 and she was considering postponing it after her primary care (PC) doctor suggested she did so till her symptoms subsided. These adverse events resulted in doctor/other healthcare professional office/clinic visit. The patient had COVID prior vaccination and had not tested post vaccination. The patient had not recovered from all the events.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202; expiry date: not known), via an unspecified route of administration, administered in arm right on 24Feb2021 11:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020 with reported symptoms of bilateral pneumonia, severe headaches, bronchial cough, low grade fever, and body aches. The patient is not pregnant. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); and codeine phosphate, guaifenesin (CODEINE GUAIFENESIN). The patient previously took gabapentine and experienced allergies. No other vaccine received in four weeks. Clinical course was reported as follows: she tested positive for COVID-19 on 21Dec2020 and recovered. She had bilateral pneumonia, severe headaches with bronchial cough, low grade fever and body aches which lasted five weeks. She was fully recovered but had intermittent mild symptoms lingering. On 25Feb2021 08:00, within 24 hours of getting the first vaccine, she developed all these symptoms again, but they were severe again and had to start prescriptions meds again daily to manage them and she still experiencing them now. She was due to have her second vaccine on Wednesday, 17Mar2021 and she was considering postponing it after her primary care (PC) doctor suggested she did so till her symptoms subsided. These adverse events resulted in doctor/other healthcare professional office/clinic visit. The patient had COVID prior vaccination and had not tested post vaccination. The patient had not recovered from all the events.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Computerised tomogram head, Diplopia, Dizziness
Clinical narrative: Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER told them she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband).  This 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6206), via intramuscular in the right arm, on 09Mar2021 (at 14:00) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) administered in the left arm on 15Feb2021 (at 14:00) for COVID-19 immunisation. Relevant medical history included psoriatic arthritis, chronic obstructive pulmonary disease (COPD), emphysema, blood pressure abnormal, blood cholesterol abnormal, blood potassium abnormal, sleep apnea (she used C-Pap machine). Past drug history included allergy to penicillin. Relevant concomitant medications included hydroxychloroquine sulfate (PLAQUENIL SULFATE) for psoriatic arthropathy, ixekizumab (TALTZ) for psoriatic arthropathy, levothyroxine sodium (SYNTHROID), rosuvastatin for blood cholesterol abnormal, ranolazine (RANEXA), losartan for blood pressure abnormal, carvedilol (COREG), clopidogrel bisulfate (PLAVIX), potassium chloride (KLOR-CON) for blood potassium abnormal, escitalopram oxalate (LEXAPRO) for blood pressure abnormal, furosemide, tiotropium bromide (SPIRIVA) for COPD, fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, acetylsalicylic acid (ASPIRIN (E.C.)), salbutamol (ALBUTEROL HFA) for emphysema and COPD and oxygen. On 11Mar2021, the patient became dizzy and nauseous and it just got worse and worse. She had also dry heaves. On 12Mar2021, she took meclozine hydrochloride (ANTIVERT, NDC 65162 0441 10) and ondansetron hydrochloride (ZOFRAN, NDC 65862 0187 30). Finally, on 13Mar2021 she had dry heaves and felt like she was going to pass out so they took her to the emergency room (ER). At ER, a computerized tomogram (CT) of head was done and resulted negative and blood work was normal except for high neutrophils and high sugar due to her drinking ginger ale for the nausea. The ER treated her with a shot of ANTIVERT and ZOFRAN and then lorazepam (ATIVAN). ATIVAN helped her so they sent her home with a prescription for ATIVAN. On 15Mar2021 (on Monday), she was no better. She was still dizzy and nauseous although the nausea was getting better as she could keep food down; she couldn't get off the couch without getting dizzy; under her eyes are so puffy and she was seeing double this morning when she woke up. The ER told them she had an allergic reaction. She was not sick at all when she got the shots; she was perfect. She used a C-Pap machine for sleep apnea and had oxygen that she used as needed. The patient had recovered from dry heaves on 14Mar2021, from seeing double on 15Mar2021; the patient had not recovered from dizziness and eye are puffy. The patient was recovering from nausea while the outcome of the remaining events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Laboratory test, Nausea, Neutrophil count, Neutrophil count increased
Clinical narrative: Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER told them she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband).  This 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6206), via intramuscular in the right arm, on 09Mar2021 (at 14:00) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) administered in the left arm on 15Feb2021 (at 14:00) for COVID-19 immunisation. Relevant medical history included psoriatic arthritis, chronic obstructive pulmonary disease (COPD), emphysema, blood pressure abnormal, blood cholesterol abnormal, blood potassium abnormal, sleep apnea (she used C-Pap machine). Past drug history included allergy to penicillin. Relevant concomitant medications included hydroxychloroquine sulfate (PLAQUENIL SULFATE) for psoriatic arthropathy, ixekizumab (TALTZ) for psoriatic arthropathy, levothyroxine sodium (SYNTHROID), rosuvastatin for blood cholesterol abnormal, ranolazine (RANEXA), losartan for blood pressure abnormal, carvedilol (COREG), clopidogrel bisulfate (PLAVIX), potassium chloride (KLOR-CON) for blood potassium abnormal, escitalopram oxalate (LEXAPRO) for blood pressure abnormal, furosemide, tiotropium bromide (SPIRIVA) for COPD, fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, acetylsalicylic acid (ASPIRIN (E.C.)), salbutamol (ALBUTEROL HFA) for emphysema and COPD and oxygen. On 11Mar2021, the patient became dizzy and nauseous and it just got worse and worse. She had also dry heaves. On 12Mar2021, she took meclozine hydrochloride (ANTIVERT, NDC 65162 0441 10) and ondansetron hydrochloride (ZOFRAN, NDC 65862 0187 30). Finally, on 13Mar2021 she had dry heaves and felt like she was going to pass out so they took her to the emergency room (ER). At ER, a computerized tomogram (CT) of head was done and resulted negative and blood work was normal except for high neutrophils and high sugar due to her drinking ginger ale for the nausea. The ER treated her with a shot of ANTIVERT and ZOFRAN and then lorazepam (ATIVAN). ATIVAN helped her so they sent her home with a prescription for ATIVAN. On 15Mar2021 (on Monday), she was no better. She was still dizzy and nauseous although the nausea was getting better as she could keep food down; she couldn't get off the couch without getting dizzy; under her eyes are so puffy and she was seeing double this morning when she woke up. The ER told them she had an allergic reaction. She was not sick at all when she got the shots; she was perfect. She used a C-Pap machine for sleep apnea and had oxygen that she used as needed. The patient had recovered from dry heaves on 14Mar2021, from seeing double on 15Mar2021; the patient had not recovered from dizziness and eye are puffy. The patient was recovering from nausea while the outcome of the remaining events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Retching
Clinical narrative: Seeing double; eye are puffy; high neutrophils; high sugar; Dizziness; Nausea; Dry heaves; The ER told them she had an allergic reaction; This is a spontaneous report from a contactable consumer (patient's husband).  This 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6206), via intramuscular in the right arm, on 09Mar2021 (at 14:00) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) administered in the left arm on 15Feb2021 (at 14:00) for COVID-19 immunisation. Relevant medical history included psoriatic arthritis, chronic obstructive pulmonary disease (COPD), emphysema, blood pressure abnormal, blood cholesterol abnormal, blood potassium abnormal, sleep apnea (she used C-Pap machine). Past drug history included allergy to penicillin. Relevant concomitant medications included hydroxychloroquine sulfate (PLAQUENIL SULFATE) for psoriatic arthropathy, ixekizumab (TALTZ) for psoriatic arthropathy, levothyroxine sodium (SYNTHROID), rosuvastatin for blood cholesterol abnormal, ranolazine (RANEXA), losartan for blood pressure abnormal, carvedilol (COREG), clopidogrel bisulfate (PLAVIX), potassium chloride (KLOR-CON) for blood potassium abnormal, escitalopram oxalate (LEXAPRO) for blood pressure abnormal, furosemide, tiotropium bromide (SPIRIVA) for COPD, fluticasone propionate, salmeterol xinafoate (ADVAIR) for COPD, acetylsalicylic acid (ASPIRIN (E.C.)), salbutamol (ALBUTEROL HFA) for emphysema and COPD and oxygen. On 11Mar2021, the patient became dizzy and nauseous and it just got worse and worse. She had also dry heaves. On 12Mar2021, she took meclozine hydrochloride (ANTIVERT, NDC 65162 0441 10) and ondansetron hydrochloride (ZOFRAN, NDC 65862 0187 30). Finally, on 13Mar2021 she had dry heaves and felt like she was going to pass out so they took her to the emergency room (ER). At ER, a computerized tomogram (CT) of head was done and resulted negative and blood work was normal except for high neutrophils and high sugar due to her drinking ginger ale for the nausea. The ER treated her with a shot of ANTIVERT and ZOFRAN and then lorazepam (ATIVAN). ATIVAN helped her so they sent her home with a prescription for ATIVAN. On 15Mar2021 (on Monday), she was no better. She was still dizzy and nauseous although the nausea was getting better as she could keep food down; she couldn't get off the couch without getting dizzy; under her eyes are so puffy and she was seeing double this morning when she woke up. The ER told them she had an allergic reaction. She was not sick at all when she got the shots; she was perfect. She used a C-Pap machine for sleep apnea and had oxygen that she used as needed. The patient had recovered from dry heaves on 14Mar2021, from seeing double on 15Mar2021; the patient had not recovered from dizziness and eye are puffy. The patient was recovering from nausea while the outcome of the remaining events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Feeling abnormal, Suicidal ideation
Clinical narrative: Impulsive suicidal thoughts; depression; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. Medical history included Diabetes, depression and high Cholesterol. The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine but took other unspecified medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Jan2021, the patient experienced impulsive suicidal thoughts, depression, Brain fog and fatigue. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received in response to the events included psychotherapy. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581) on 13Feb2021. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.