chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Immunisation, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Tingling entire face; Right side chest pain; Mid lateral left thigh pain; Body ache; Fever; The patient received third/ booster dose of BNT162B2; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 18:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included fatty liver. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 02Nov2021 at 18:15, the patient experienced tingling entire face, right side chest pain, mid lateral left thigh pain, body ache and fever. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling entire face, right side chest pain, mid lateral left thigh pain, body ache and fever was resolved on an unknown date in Nov2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tingling entire face; Right side chest pain; Mid lateral left thigh pain; Body ache; Fever; The patient received third/ booster dose of BNT162B2; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 at 18:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included fatty liver. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 02Nov2021 at 18:15, the patient experienced tingling entire face, right side chest pain, mid lateral left thigh pain, body ache and fever. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling entire face, right side chest pain, mid lateral left thigh pain, body ache and fever was resolved on an unknown date in Nov2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Lymphadenopathy, Rash erythematous, Rash papular
Clinical narrative: Pain from right elbow down to wrist, postop 1 day - 2 days; Red rash with small raised bumps right medial wrist post 1 day to present; Red rash with small raised bumps right medial wrist post 1 day to present; Pain, redness at injection site x3days; Pain, redness at injection site x3days; Swollen right axillary lymph node x 3 days; Administration date 04Nov2021 at 14:00, dose number=3; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EG3527) via an unspecified route of administration in the right arm on 04Nov2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, sleep apnea and shingles. The patient had known allergies to latex and was lactose intolerant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), aciclovir (ACYCLOVIR) and unspecified probiotics; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 03Feb2021 at 10:00 (at the age of 59-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 11:00, the patient experienced pain, redness at injection site and swollen right axillary lymph node for 3 days. On 06Nov2021, the patient had pain from right elbow down to wrist, post out patient ("postop") 1 day to 2 days and red rash with small raised bumps right medial wrist post 1 day to present. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, redness at injection site and swollen right axillary lymph node for 3 days was resolved on 08Nov2021 at 11:00 while the event pain from right elbow down to wrist "postop" 1 day - 2 days was resolved on 08Nov2021. The clinical outcome of the events red rash with small raised bumps right medial wrist post 1 day to present was not resolved at the time of this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain from right elbow down to wrist, postop 1 day - 2 days; Red rash with small raised bumps right medial wrist post 1 day to present; Red rash with small raised bumps right medial wrist post 1 day to present; Pain, redness at injection site x3days; Pain, redness at injection site x3days; Swollen right axillary lymph node x 3 days; Administration date 04Nov2021 at 14:00, dose number=3; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EG3527) via an unspecified route of administration in the right arm on 04Nov2021 at 14:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis, sleep apnea and shingles. The patient had known allergies to latex and was lactose intolerant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), aciclovir (ACYCLOVIR) and unspecified probiotics; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 03Feb2021 at 10:00 (at the age of 59-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 11:00, the patient experienced pain, redness at injection site and swollen right axillary lymph node for 3 days. On 06Nov2021, the patient had pain from right elbow down to wrist, post out patient ("postop") 1 day to 2 days and red rash with small raised bumps right medial wrist post 1 day to present. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, redness at injection site and swollen right axillary lymph node for 3 days was resolved on 08Nov2021 at 11:00 while the event pain from right elbow down to wrist "postop" 1 day - 2 days was resolved on 08Nov2021. The clinical outcome of the events red rash with small raised bumps right medial wrist post 1 day to present was not resolved at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Immunisation, Lymphadenitis
Clinical narrative: Left lymph node within the armpit, extremely inflamed; Malaise; While I did not have a fever, chills and could not stay warm; Almost felt like a sinus infection; Whole body ached; Difficult breathing, like running in the winter, or hiking in higher elevations than accustomed to; "0" appetite; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 10Nov2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 12Mar2021 (at the age of 58-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CK8734) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. The patient previously also received tetracycline (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 11Nov2021, the patient experienced extreme inflammation of left lymph node within the armpit and malaise, while she did not have a fever but chills and could not stay warm. The patient  almost felt like a sinus infection, whole body ached, "0" appetite, difficult breathing, like running in the winter or hiking in higher elevations than accustomed to. For first two doses, the patient not had one side effect, not even a sore arm. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left lymph node within the armpit, extremely inflamed, malaise, while she did not have a fever, chills and could not stay warm, almost felt like a sinus infection, whole body ached, "0" appetite, difficult breathing, like running in the winter or hiking in higher elevations than accustomed to was resolving at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Sinusitis
Clinical narrative: Left lymph node within the armpit, extremely inflamed; Malaise; While I did not have a fever, chills and could not stay warm; Almost felt like a sinus infection; Whole body ached; Difficult breathing, like running in the winter, or hiking in higher elevations than accustomed to; "0" appetite; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 10Nov2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 12Mar2021 (at the age of 58-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CK8734) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. The patient previously also received tetracycline (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 11Nov2021, the patient experienced extreme inflammation of left lymph node within the armpit and malaise, while she did not have a fever but chills and could not stay warm. The patient  almost felt like a sinus infection, whole body ached, "0" appetite, difficult breathing, like running in the winter or hiking in higher elevations than accustomed to. For first two doses, the patient not had one side effect, not even a sore arm. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left lymph node within the armpit, extremely inflamed, malaise, while she did not have a fever, chills and could not stay warm, almost felt like a sinus infection, whole body ached, "0" appetite, difficult breathing, like running in the winter or hiking in higher elevations than accustomed to was resolving at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jun2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The medical history included herpes simplex and allergy to ragweed. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously took MORPHINE on an unknown date and experienced allergy. The patient stated there was no real adverse reaction and no area to report a possible potential treatment for other conditions with the vaccine. The patient stated that she had been plagued by herpes simplex in her entire adult life. Last year in 2020 and early in 2021, she had breakouts of cold sores almost monthly, but after she took the COVID-19 vaccine, she had not had any occurrences of an episode for the past 6 months, since 05May2021. She thought that the vaccine had helped her to control herpes and thought that it might be worth looking at the effect of it on the simplex in a clinical study. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after the COVID-19 vaccine, not had any occurrences of an episode of herpes simplex for the past 6 months was unknown at the time of this report.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dyspepsia, Gluten sensitivity, Nausea
Clinical narrative: After the first dose I developed extreme abdominal pains; Mucus/ Diarrhea; Nausea; Heartburn; I realized gluten was causing it and cut out wheat from my diet. I have felt much better and tried eating gluten again but cant. Now I am gluten intolerant.; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) in the left arm on 25Aug2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, after the first dose, the patient developed extreme abdominal pains, mucus and diarrhea as well as nausea and heartburn. This lasted every day for about 2 weeks. She had never experienced this before. She realized gluten was causing it and cut out wheat from her diet. She had felt much better and tried eating gluten again but could not and now (at the time of this report) she was gluten intolerant. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events abdominal pains, mucus, diarrhea, nausea and heartburn was resolved on an unknown date in 2021; while that of realized gluten was causing it and cut out wheat from her diet, felt much better and tried eating gluten again but could not and now (at the time of this report) she was gluten intolerant was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) in the left arm on 16Sep2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: After the first dose I developed extreme abdominal pains; Mucus/ Diarrhea; Nausea; Heartburn; I realized gluten was causing it and cut out wheat from my diet. I have felt much better and tried eating gluten again but cant. Now I am gluten intolerant.; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) in the left arm on 25Aug2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, after the first dose, the patient developed extreme abdominal pains, mucus and diarrhea as well as nausea and heartburn. This lasted every day for about 2 weeks. She had never experienced this before. She realized gluten was causing it and cut out wheat from her diet. She had felt much better and tried eating gluten again but could not and now (at the time of this report) she was gluten intolerant. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events abdominal pains, mucus, diarrhea, nausea and heartburn was resolved on an unknown date in 2021; while that of realized gluten was causing it and cut out wheat from her diet, felt much better and tried eating gluten again but could not and now (at the time of this report) she was gluten intolerant was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) in the left arm on 16Sep2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Pain in extremity, Sluggishness
Clinical narrative: Sore and slightly red arm on Saturday; Slightly red arm on Saturday.; Felt sluggish all day; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration on 12Nov2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD6955) via an unspecified route of administration on 23Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 13Nov2021 (Saturday), the next day after the vaccine (given on Friday), the patient experienced sore and slightly red arm on Saturday. The patient also felt sluggish all the day. Fully recovered on the next day (Sunday) (on 14Nov2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore and slightly red arm, felt sluggish all the day was resolved on 14Nov2021.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure inadequately controlled, Dyspnoea, Fatigue, Headache
Clinical narrative: Having trouble breathing; Blood pressure is out of control; Fatigue; Constant headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 12Oct2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included active epstein-barr virus infection (EVB), cytomegalovirus infection (CMV) and hypertension. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included colecalciferol (CHOLECALCIFEROL), lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ADULT LOW DOSE ASPIRIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 21Sep2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021, the patient experienced trouble breathing, blood pressure was out of control, fatigue and constant headaches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events trouble breathing, blood pressure was out of control, fatigue and constant headaches were not resolved at the time of this report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dysgeusia, Parosmia
Clinical narrative: It made my improving parosmia and dysgeusia worse; It made my improving parosmia and dysgeusia worse; Condition aggravated; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 13Oct2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 18Oct2021, it was reported that the vaccination made his improving parosmia and dysgeusia worse. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events it made his improving parosmia and dysgeusia worse was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 03Nov2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bells palsy; This is a spontaneous report from a contactable consumer (patient herself).. A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN9581), via an unspecified route of administration on 10Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (solution for injection, lot number: EL3246) on 20Jan2021 via an unspecified route of administration as dose 1, single for covid-19 immunization.The patient was diagnosed with bells palsy after her second dose of the vaccine, and asks if there are any reports of Bell's Palsy with the booster dose. Patient had her first dose was 20Jan2021 and her second dose was supposed to be on the 31st but she didn't get it until 10Feb2021 and got Bell's Palsy days afterwards. Days after her second covid shot she had an ER visit and was diagnosed with bells palsy. She was scared to death to get the booster. Patient stated none of her doctors will advise her, they remain neutral and she was scared to get the booster because she did not want Bell's Palsy again. Patient also asked if she can get the booster or not. This event was considered as medically significant. Clinical outcome of the event was reported as unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Faeces hard
Clinical narrative: Severe stomach cramps; Bad lower back pain; it felt like I was trying to pass a brick through my bowels; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EN6202), dose 1 via an unspecified route of administration in arm left on 03Mar2021 at 16:00 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. Patient medical history included known allergies from penicillin and had COPD, asthma, chronic pain, GERD, all from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. Patient denied for any other vaccine taken in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 18:00, the patient experienced severe stomach cramps, bad lower back pain and patient felt like he was trying to pass a brick through his bowels. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Pharyngeal swelling, Tachycardia
Clinical narrative: feel dizzy; Difficult to swallow; swollen throat; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, penicillin allergy, fruit allergy (kiwi and watermelon), drug allergy (sulfate antibiotics) and allergy to nuts (pistachios). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and mometasone furoate (FLONASE) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other medications in four weeks of COVID vaccine. On 06Apr2021 at 13:30, within 15 minutes the patient started to feel dizzy, difficult to swallow, swollen throat and rapid heart rate (tachycardia). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures taken included allegra for the reported adverse events. The clinical outcome of the events difficult to swallow, swollen throat, rapid heart rate and feel dizzy were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event verbatim typo error was correctly changed from Difficult to sallow' and was updated to Difficult to swallow'.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a program from a contactable consumer or other non hcp (patient).     A 34-years-old female patient received dose 1 of bnt162b2 (BNT162B2, Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in arm Left on 30Mar2021 13:45 as dose 1, single and dose 2 bnt162b2 (BNT162B2, Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in arm Left on 03May2021 11:30 as dose 2, single and for covid-19 immunisation (age at the vaccination 34 years old). Medical history included knee operation from an unknown date and unknown if ongoing. The patient tore the meniscus in her knee prior to the first dose of the vaccine, on an unspecified date in Jan2021. The patient's concomitant medications were not reported. The patient experienced chills and fever on 30Mar2021 18:00. The patient was not received the treatment. Outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash resembling insect bites on shins and forearms starting 4-5 days after first shot.; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 26Feb2021 at 15:00 (at the age of 67-years-old) (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included asthma/COPD Overlap Syndrome, seasonal and environmental allergies, sleep apnea, arthritis, rosacea and TIA. Known allergies included Tetracyclineand Latex. No other vaccine in four weeks. No covid prior vaccination and covid was not tested post vaccination. The patient's concomitant medications were not reported. On 03Mar2021, at 07:00, the patient experienced rash resembling insect bites on shins and forearms starting 4-5 days after first shot. AE resulted in Emergency room/department or urgent care. No treatment was received by the patient. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Right eye turned blood red; the eye ball itself was swollen; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient).  A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, expiry date: not reported) via an unspecified route of administration in the left arm on Apr2021 at 12:30 (at the age of 59-years old) as dose number unknown, single for covid-19 immunisation. Medical history included prediabetes. Concomitant medication(s) included berberine (BERBERINE), cinnamomum verum (CINNAMON), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc (ZINC) taken for an unspecified indications. The patient previously took tetracycline, terramycin and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, 01:00, the patient experienced right eye turned blood red, no pain though. Next day the eye ball itself was swollen, especially at the interior corner of eye. Still no pain. No discharge. Eye doctor could find no indication of anything in eye. Not allergies. Left eye was fine. This occurred 2 weeks past 1st vaccine. Doctor finally put patient on Prednisone which helped. Therapeutic measures were taken as a result of the events (Fluorometholone and then Prednisone). The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are required. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Migraine
Clinical narrative: Migraine - Lights and sounds made worse; Knee pain while standing; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0170, Expiration date was not reported), via an unspecified route of administration in arm left on 21Apr2021 at 17:45 (at the age of 30-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included was none. The patient had no known allergies. The patient's concomitant medications in two weeks was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730, Expiration date was not reported), via an unspecified route of administration in arm left on 27Mar2021 at 14:30 (at the age of 30-years-old) as a dose 1, single for COVID-19 immunization. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 22Apr2021 at 11:00, the patient experienced migraine - lights and sounds made worse, knee pain while standing and cold sweats. Ibuprofen only prevented pain for about 30 minutes. Treatment was received for the events migraine - lights and sounds made worse, knee pain while standing and treatment was not received for cold sweats. The outcome of the events was recovering.  No follow-up attempts are required. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma attack; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8735), via an unspecified route of administration, administered in left arm on 23Apr2021 08:15 (at the age of 56 years) as dose 2, single for COVID-19 immunization. The patients medical history included Asthma, diabetes, chronic migraines, sleep apnea. The patients concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT); clonazepam (KLONOPIN); fluoxetine hydrochloride (PROZAC); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); montelukast sodium (SINGULAIR). The patient previously took compazine, prednisone, ceftin, gabapentin, inderal and experienced allergy. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration, administered in left arm on 25Mar2021 06:30 (at the age of 56 years) as dose 1, single for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination. O 23Apr2021 08:30 the patient experienced asthma attack. Proair inhaler was given as a therapeutic measure as a result of asthma attack. The outcome of the events was recovered with sequelae on an unspecified date in Apr2021.   No follow-up attempts are required. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Injection site soreness; Right hip pain; This is a spontaneous report from a contactable Nurse. This 58-year-old female nurse (Patient) reported for herself that: A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 13Apr2021 11:00 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunization at physician office (reported as doctor's office/urgent care).  Medical history included eczema and endometriosis from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), estradiol, norethisterone acetate (COMBIPATCH), colecalciferol (D3) and nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COMPLEX [NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) all were taken for an unspecified indication, start and stop date were not reported for any. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 08:00, the patient experienced fatigue, injection site soreness and right hip arm. (Reported AEs description: fatigue (mild, 4/18-4/19), injection site soreness (mild, 4/14-4/15) and right hip pain (moderate, 4/15-4/19; mild, 4/20-ongoing). The patient did not receive any treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm with first and second; I have tightening and congestion in chest; I have tightening and congestion in chest; body aches; headache; tiredness; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Solution for injection, Lot number: Ew0175), via an unspecified route of administration, administered in left arm on 24Apr2021 at 10:30 as DOSE 2, SINGLE (at the age of 40-year-old) for covid-19 immunization. Medical history included asthma and possible fibromyalgia. The patient was not pregnant at the time of vaccination. Patient had Known allergies with Sulpha antibiotics and codeine. The patient previously received BNT162B2 (BNT162B2, Solution for injection, Lot number: Ew0150), via an unspecified route of administration, administered in left arm on 01Apr2021 at 10:00 as DOSE 1, SINGLE (at the age of 40-year-old) for covid-19 immunization and experienced sore arm. The patient had no other vaccine in four weeks. Prior vaccination, the patient had no covid. The patient was not tested covid post vaccination. On 24Apr2021 at 21:00, the patient experienced sore arm, tightening and congestion in chest, body aches, headache and tiredness. The patient had not received treatment as a result of events. Outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Sore arm with first and second; I have tightening and congestion in chest; I have tightening and congestion in chest; body aches; headache; tiredness; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old non-pregnant female patient received BNT162B2 (BNT162B2, Solution for injection, Lot number: Ew0175), via an unspecified route of administration, administered in left arm on 24Apr2021 at 10:30 as DOSE 2, SINGLE (at the age of 40-year-old) for covid-19 immunization. Medical history included asthma and possible fibromyalgia. The patient was not pregnant at the time of vaccination. Patient had Known allergies with Sulpha antibiotics and codeine. The patient previously received BNT162B2 (BNT162B2, Solution for injection, Lot number: Ew0150), via an unspecified route of administration, administered in left arm on 01Apr2021 at 10:00 as DOSE 1, SINGLE (at the age of 40-year-old) for covid-19 immunization and experienced sore arm. The patient had no other vaccine in four weeks. Prior vaccination, the patient had no covid. The patient was not tested covid post vaccination. On 24Apr2021 at 21:00, the patient experienced sore arm, tightening and congestion in chest, body aches, headache and tiredness. The patient had not received treatment as a result of events. Outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Condition aggravated, Feeling abnormal, Heart rate
Clinical narrative: My heart rate and blood pressure jumped; My heart rate and blood pressure jumped; I had trouble calming down my breathing; the waves started to come again and would not stop; had this weird sensation run through my body but it passed much quicker; This is a spontaneous report from a contactable consumer (patient).    A 42-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7533), via an unspecified route of administration, administered in right arm on 15Apr2021 at 14:15 (at the age of 42 years) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included vitamin D (colecalciferol) and multivitamin nos in two weeks. The patient previously took vicodin and experienced allergies. The patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration, administered in right arm on 25Mar2021 14:15 (at the age of 42 years) as dose 1, single for COVID-19 immunization and experienced a weird sensation ran through her body, from her head to feet, she got lightheaded and weak, she had trouble texting like her fingers did not have the strength, warm and agitated. The patient did not have COVID prior vaccination. The patient did get COVID tested post vaccination. On 15Apr2021, the patient experienced had this weird sensation run through her body but it passed much quicker, her heart rate and blood pressure jumped, she had trouble calming down her breathing. On 15Apr2021, at 15.20 the patient experienced the waves started to come again and would not stop, her heart rate and blood pressure jumped. The patient reported that she had her second shot on 15Apr2021, again she had this weird sensation run through her body but it passed much quicker and she left the facility within 20 minutes. An hour after her shot (15.20) the waves started to come again and would not stop. Her heart rate and blood pressure jumped, she had trouble calming down her breathing. She called a nurse who told her to go to the emergency room as her heart rate had been 133 while sitting down. They did a lot of tests, told to the patient she was not having a reaction but she continued to experience these symptoms (22Apr2021). The patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedure which includes on 01Apr2021 the patient had COVID test (Saliva based test) with result negative; On 13Apr2021 the patient had COVID test (Saliva based test) with result negative; heart rate: 133 on 15Apr2021, Laboratory test: unknown results, blood pressure: increased on 15Apr2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.