chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dyspnoea, Lymphadenopathy, Night sweats, Positron emission tomogram
Clinical narrative: First of all, What I am going to report is not the adverse effect of the vaccine. Instead it is the good effect of the vaccine. I was diagnosed as Malt Lymphoma in Sept. 2019. I believe the two doses of the Pfizer vaccine cured my lymphoma.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30(at the age of 68-year-old) as a dose for COVID-19 immunisation. Medical history included malt lymphoma. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has experienced unexpected therapeutic benefit from both the doses. On an unknown date the patient reports that "first of all", what she reported was not the adverse effect of the vaccine. Instead, it was the good effect of the vaccine. The patient was diagnosed with malt lymphoma on an unknown date in Sep2019. The patient believed that the two doses of Pfizer vaccine cured her lymphoma. On the report date(14May2021) she got her latest PET scan result which showed that lymphoma in her rectum was gone. She has never had any treatment for the lymphoma. The only symptom she had been had was the tender/pain in the lymphoma location in her lower ab. After the first dose of vaccine, she could feel that the pain was reduced. The patient developed multiple lymph nodes swollen, shortness of the breath, and night sweat etc. which were typical lymphoma symptoms after the second dose of the vaccine. At the same time, the pain at the lower ab had been significantly reduced. Also, her appetite had been improved a lot which made her to gain 4 lbs since 30Mar. This means a lot to the patient since she had lost the appetite and kept losing weight in the last few years. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. On an unknown date, the patient underwent positron emission tomography (PET) scan which showed that lymphoma in her rectum was gone. The clinical outcome of the event unexpected therapeutic benefit was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected, Weight increased
Clinical narrative: First of all, What I am going to report is not the adverse effect of the vaccine. Instead it is the good effect of the vaccine. I was diagnosed as Malt Lymphoma in Sept. 2019. I believe the two doses of the Pfizer vaccine cured my lymphoma.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30(at the age of 68-year-old) as a dose for COVID-19 immunisation. Medical history included malt lymphoma. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has experienced unexpected therapeutic benefit from both the doses. On an unknown date the patient reports that "first of all", what she reported was not the adverse effect of the vaccine. Instead, it was the good effect of the vaccine. The patient was diagnosed with malt lymphoma on an unknown date in Sep2019. The patient believed that the two doses of Pfizer vaccine cured her lymphoma. On the report date(14May2021) she got her latest PET scan result which showed that lymphoma in her rectum was gone. She has never had any treatment for the lymphoma. The only symptom she had been had was the tender/pain in the lymphoma location in her lower ab. After the first dose of vaccine, she could feel that the pain was reduced. The patient developed multiple lymph nodes swollen, shortness of the breath, and night sweat etc. which were typical lymphoma symptoms after the second dose of the vaccine. At the same time, the pain at the lower ab had been significantly reduced. Also, her appetite had been improved a lot which made her to gain 4 lbs since 30Mar. This means a lot to the patient since she had lost the appetite and kept losing weight in the last few years. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. On an unknown date, the patient underwent positron emission tomography (PET) scan which showed that lymphoma in her rectum was gone. The clinical outcome of the event unexpected therapeutic benefit was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Palpitations, Rash, SARS-CoV-2 test
Clinical narrative: Sob/very sob at rest position; Palpitations/severe palpitations of 128 to 133; Severe skin rash was developed through my arms,legs, belly and under chin neck and upper arms; Skind feels like sand paper; This is a spontaneous report from a contactable other HCP. A 56-year-old other HCP (patient) of unknown gender reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN 6208), intramuscular into the left arm on 17Mar2021 at 09:15 AM (at the age of 56-years-old) at single dose for COVID-19 immunization. the patient had no known allergies. Medical history included High bp. Prior to vaccination,  the patient was not diagnosed with COVID-19. Concomitant drugs were unknown. 24 hrs from first dose of vaccine on 18Mar2021 at 08:00 AM, severe skin rash developed through the arms, legs, belly and under chin neck and upper arms. Causing sob and palpitations. The patient got an appointment with primary care Dr and he asked not to do 2nd dose and the patient did not took. At he time of reporting as almost 2 months from vaccine day and the patient still presented sob symptoms, also rash on legs, arms and neck has considerably increasing, further also skin feels like sand paper. Had an emergency room visit due to severe palpitations of 128 to 133. Also very sob at rest position After the patient followed up with primary order more meds and lab test. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Pills and creams. The reporter considered the events as non serious. The outcome of the events was not recovered. Covid Nasal Swab post vaccination done on 09May2021 was negative.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Skin discomfort
Clinical narrative: Sob/very sob at rest position; Palpitations/severe palpitations of 128 to 133; Severe skin rash was developed through my arms,legs, belly and under chin neck and upper arms; Skind feels like sand paper; This is a spontaneous report from a contactable other HCP. A 56-year-old other HCP (patient) of unknown gender reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN 6208), intramuscular into the left arm on 17Mar2021 at 09:15 AM (at the age of 56-years-old) at single dose for COVID-19 immunization. the patient had no known allergies. Medical history included High bp. Prior to vaccination,  the patient was not diagnosed with COVID-19. Concomitant drugs were unknown. 24 hrs from first dose of vaccine on 18Mar2021 at 08:00 AM, severe skin rash developed through the arms, legs, belly and under chin neck and upper arms. Causing sob and palpitations. The patient got an appointment with primary care Dr and he asked not to do 2nd dose and the patient did not took. At he time of reporting as almost 2 months from vaccine day and the patient still presented sob symptoms, also rash on legs, arms and neck has considerably increasing, further also skin feels like sand paper. Had an emergency room visit due to severe palpitations of 128 to 133. Also very sob at rest position After the patient followed up with primary order more meds and lab test. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Pills and creams. The reporter considered the events as non serious. The outcome of the events was not recovered. Covid Nasal Swab post vaccination done on 09May2021 was negative.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pyrexia, Sensitive skin
Clinical narrative: Elevated heart rhythm; fever; chills; sensitive skin; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 01May2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (ADVIL) and ibuprofen (MOTRIN) both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 08Apr2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 04:00, the patient experienced Elevated heart rhythm, fever, chills and sensitive skin. 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. The clinical outcome of the events Elevated heart rhythm, fever, chills and sensitive skin were recovered on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site tenderness; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1261) via an unspecified route of administration in the right arm on 13May2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder and sleep apnea. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), quetiapine fumarate (SEROQUEL XR) and zolpidem tartrate (AMBIEN) all for unspecified indications from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1261) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, at 14:30 the patient experienced injection site tenderness. The event 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 event. The clinical outcome of the event injection site tenderness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Erythema, Illness
Clinical narrative: bright red and pink; was sick for 2 days; joints and bones ached; Fever; joints and bones ached; back ache; This is a spontaneous report from a contactable consumer (parent). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 18:30 (at the age of 45 years old) as dose 2, single for COVID-19 immunisation. Medical history included underactive thyroid. No investigation assessment. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from an unspecified start date and ongoing. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021 (at the age of 45 years old) as single for COVID-19 immunisation and experienced sore arm. The patient experienced fever, joints and bones ached, back ache, bright red and pink, was sick for 2 days on 06May2021. Reported as, reporter mentioned daughter who had the shot and was sick for 2 days. This was with the second vaccination, she had the Pfizer. All of her symptoms, fever, joints and bones aching, back ache and being bright red and pink, lasted 2 days. Outcome of all the events were recovered on May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bright red and pink; was sick for 2 days; joints and bones ached; Fever; joints and bones ached; back ache; This is a spontaneous report from a contactable consumer (parent). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 18:30 (at the age of 45 years old) as dose 2, single for COVID-19 immunisation. Medical history included underactive thyroid. No investigation assessment. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from an unspecified start date and ongoing. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021 (at the age of 45 years old) as single for COVID-19 immunisation and experienced sore arm. The patient experienced fever, joints and bones ached, back ache, bright red and pink, was sick for 2 days on 06May2021. Reported as, reporter mentioned daughter who had the shot and was sick for 2 days. This was with the second vaccination, she had the Pfizer. All of her symptoms, fever, joints and bones aching, back ache and being bright red and pink, lasted 2 days. Outcome of all the events were recovered on May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Finger numbness; Underarm pain; Chest pain; Swollen lymph nodes; Feverish after 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1076) via an unspecified route of administration in the left arm on 01May2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis. Concomitant medications included vitamins (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL); all from an unknown dates, for an unknown indications, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP5733) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 the patient experienced finger numbness, underarm pain, chest pain, swollen lymph nodes and feverish. It was unknown whether any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of finger numbness, underarm pain, chest pain, swollen lymph nodes and feverish were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Night sweats
Clinical narrative: hot flashes; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8736) via an unspecified route of administration in the arm left on 10May2021 at 15:15(at the age of 54-years-old)as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO), omeprazole magnesium (OMEPRAZOLE), multivitamins (Unspecified) and acetylsalicylic acid (BABY ASPIRIN) all for unknown indications and from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0161) via an unspecified route of administration in the arm left on 19Apr2021 at 15:15(at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021, the patient experienced hot flashes and night sweats. The patient reported that she were previously managed the events by pempro and events were returned. Therapeutic measures were taken as a result of hot flashes and night sweats and included treatment with prempro ongoing at the time of report. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency department or urgent care. The clinical outcome of the events hot flashes and night sweats was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine-like headaches, concentrated in occipital/neck area; This is a spontaneous report from a contactable healthcare professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 03May2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included diclofenac potassium (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on an unknown date of Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 14:00, the patient experienced migraine-like headaches, concentrated in occipital/neck area. The patient had migraine-like headaches, concentrated in occipital/neck area, beginning and early afternoon each day and lasting into the evening. Symptoms had begun the day following vaccination and had persisted every day (10 days) after, with no resolve. The patient did not regularly suffer from headaches. No therapeutic measures were taken as result of the event. The clinical outcome of the event migraine-like headaches, concentrated in occipital/neck area was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Approximately 8 hours after administration of second vaccine, patient began to feel chills; Approximately 8 hours after administration of second vaccine, patient began headache; Approximately 8 hours after administration of second vaccine, patient began nausea; This is a spontaneous report from a non-contactable consumer. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via intramuscular route of administration in the left arm on an unknown date in May2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamins (unspecified) 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: unknown) via intramuscular route of administration in the left arm on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 an unknown date in May2021, approximately 8 hours after administration of second vaccine, the patient began to feel chills, headache and nausea that lasted approximately 10 hours. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events feel chills, headache and nausea were recovered on an unknown date in May2021 (lasted approximately 10 hours).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: I started to smell burnt bacon and coffee; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021(at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included Adhd and stress. Concomitant medications included adhd medication and stress medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021 the patient started to smell burnt bacon and coffee. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event started to smell burnt bacon and coffee was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Fever of 101; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the left arm on 13May2021 at 14:30 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL) for unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 05:00, the patient experienced fever of 101, body aches, chills, nausea for 12 hours, commencing 15 hrs after vaccine. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the events. On 14May2021 at 05:00, the patient underwent body temperature test and the result was fever of 101. The clinical outcome of the events fever of 101, body aches, chills, nausea was resolved on 14May2021 at 17:00.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Muscle tightness
Clinical narrative: Muscle tightness in upper back (shoulders); soreness in upper back (shoulders); Headache; Mild fever ranging between 99.7 - 100.8 degreesFahrenheit; Lower back pain/muscle soreness; Lower back muscle soreness; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12May2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 12May2021, the patient experienced chills at around 16:00 lasting approx. 15 minutes, lower back pain/muscle soreness at 16:30, headache and mild fever ranging between 99.7 - 100.8 degrees Fahrenheit at 2100 and significant muscle tightness/soreness in upper back (shoulders) at 21:30. Headache lasted till 14May2021 and ultimately took naproxen which alleviated it and has not returned. All other symptoms were resolved by 13May2021. On 12May2021 patient underwent lab test which include body temperature and the result was ranging between 99.7 - 100.8 degrees Fahrenheit. Therapeutic measures were taken as a result of headache and included treatment with naproxen (MANUFACTURER UNKNOWN). No therapeutic measures were taken for other events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills was recovered at 16:15 on 12May2021, mild fever, muscle tightness/soreness in upper back (shoulders) and lower back pain/muscle soreness were recovered on 13May2021 and headache was recovered on 14May2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle tightness in upper back (shoulders); soreness in upper back (shoulders); Headache; Mild fever ranging between 99.7 - 100.8 degreesFahrenheit; Lower back pain/muscle soreness; Lower back muscle soreness; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12May2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 12May2021, the patient experienced chills at around 16:00 lasting approx. 15 minutes, lower back pain/muscle soreness at 16:30, headache and mild fever ranging between 99.7 - 100.8 degrees Fahrenheit at 2100 and significant muscle tightness/soreness in upper back (shoulders) at 21:30. Headache lasted till 14May2021 and ultimately took naproxen which alleviated it and has not returned. All other symptoms were resolved by 13May2021. On 12May2021 patient underwent lab test which include body temperature and the result was ranging between 99.7 - 100.8 degrees Fahrenheit. Therapeutic measures were taken as a result of headache and included treatment with naproxen (MANUFACTURER UNKNOWN). No therapeutic measures were taken for other events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills was recovered at 16:15 on 12May2021, mild fever, muscle tightness/soreness in upper back (shoulders) and lower back pain/muscle soreness were recovered on 13May2021 and headache was recovered on 14May2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: "Dose number one given 26Jan2021/ Dose number two given 11Feb2021 I dont think enough time passed to take second dose"; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received the first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262) in the left arm on 26Jan2021 at 09:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11Feb2021, the patient reported that dose number one was given on 26Jan2021 and dose number two was given on 11Feb2021. The patient reported that he did not think enough time had passed to take the second dose. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event.       No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Hyperaesthesia, Pain
Clinical narrative: chest tightness; slight wheezing; total head/body aches; total head/body aches; skin very sensitive/tender; skin very sensitive/tender; chills; Injection site extremely tender for 5-7 days; rash all over body; This is a spontaneous report from a contactable Nurse (patient). A 53-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), intramuscular, administered in left arm on 11May2021 at 10:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (lot number EL9263) on 20Apr2021 and experienced total head/body aches, skin very sensitive/tender, chills and injection site extremely tender. Medical history included high blood pressure (BP), depression, high cholesterol and COVID (Prior to vaccination). Concomitant medications included metoprolol succinate, candesartan, vilazodone hydrochloride (VIIBRYD), estradiol, amlodipine besylate, bupropion, hctz, atorvastatin, amylase/ascorbic acid/cellulase/folic acid/lipase/protease nos (JUICE PLUS), cyanocobalamin (B12), fish oil (OMEGA 3) and apoaequorin/colecalciferol (PREVAGEN) taken. On 11May2021 at 16:00 the patient experienced total head/body aches, skin very sensitive/tender, chills, injection site extremely tender for 5-7 days, rash all over body, and slight wheezing. On 13May2021 the patient experienced chest tightness. The events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with Benedryl and anti itch cream. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.; Sender's Comments: Based on the closet temporal relationship and known drug safety profile, the association between the reported events with BNT162b2 cannot be fully 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Rash, Vaccination site pain, Wheezing
Clinical narrative: chest tightness; slight wheezing; total head/body aches; total head/body aches; skin very sensitive/tender; skin very sensitive/tender; chills; Injection site extremely tender for 5-7 days; rash all over body; This is a spontaneous report from a contactable Nurse (patient). A 53-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), intramuscular, administered in left arm on 11May2021 at 10:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (lot number EL9263) on 20Apr2021 and experienced total head/body aches, skin very sensitive/tender, chills and injection site extremely tender. Medical history included high blood pressure (BP), depression, high cholesterol and COVID (Prior to vaccination). Concomitant medications included metoprolol succinate, candesartan, vilazodone hydrochloride (VIIBRYD), estradiol, amlodipine besylate, bupropion, hctz, atorvastatin, amylase/ascorbic acid/cellulase/folic acid/lipase/protease nos (JUICE PLUS), cyanocobalamin (B12), fish oil (OMEGA 3) and apoaequorin/colecalciferol (PREVAGEN) taken. On 11May2021 at 16:00 the patient experienced total head/body aches, skin very sensitive/tender, chills, injection site extremely tender for 5-7 days, rash all over body, and slight wheezing. On 13May2021 the patient experienced chest tightness. The events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with Benedryl and anti itch cream. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.; Sender's Comments: Based on the closet temporal relationship and known drug safety profile, the association between the reported events with BNT162b2 cannot be fully 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills, body aches after second dose; chills, body aches after second dose; This is a spontaneous report from a contactable consumer, patient. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0168) via an unspecified route of administration in the left arm on 15Apr2021(at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any known allergies to food, medication or other product.  The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021 at 16:00, the patient experienced chills, body aches after second dose. There were no symptoms after first dose. The events did not result in a visit to the doctors 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. The clinical outcome of the events chills and body ache were recovered on unknown date in 2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Peripheral swelling, Rash, Urticaria
Clinical narrative: rash; swelling in hands; develop hives all over body (flare) on day 3; inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Apr2021 14:00 (Batch/Lot number was not reported) at the age of 40 years, as dose 2, single for COVID-19 immunisation. Medical history included undifferentiated connective tissue disease (UCTD) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received no other medications within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as dose 1 for COVID-19 immunization and experienced rash and swelling in hands. The patient was not diagnosed with COVID-19 prior to vaccination. On 30Apr2021, the patient experienced rash and swelling in hands and developed hives all over body (flare) on day 3. The patient have been on steroid for 7 days to decrease inflammation but it was not going away. The events resulted in resulted in doctor or other healthcare professional office/clinic visit. Treatment included steroids (methylprednisolone)/ antihistamine. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination.  The lot number for the vaccine BNT162B2 , was not provided and will be requested during follow-up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Rash in splotches all over body except head/neck on the day after receiving vaccine, it spread into bigger splotches and new splotches; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ew0153) via an unspecified route of administration in the left arm on 13May2021 at 15:30 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included "Adhd". The patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 02:00, on the day after receiving, the patient experienced rash in splotches all over body except head/neck, the second day on 15May2021, it spread into bigger splotches and new splotches. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event rash in splotches all over body except head/neck on the day after receiving vaccine, it spread into bigger splotches and new splotches was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: After 55 hours I got chills, a fever, severe vomiting for about an hour.; After 55 hours I got chills, a fever, severe vomiting for about an hour.; After 55 hours I got chills, a fever, severe vomiting for about an hour.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12May2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included appendectomy 8 years ago. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 23:00, after 55 hours the patient got chills, a fever, severe vomiting for about an hour. The patient could not think of any other reason this would have happened so she wanted to tell because it seemed long after the shot. The patient felt perfectly fine until then. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events after 55 hours the patient got chills, a fever, severe vomiting for about an hour was resolving at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on chest; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the arm right on 06May2021 at 14:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included barrett's esophagus, COVID-19 and rash on chest 10 days after the patient recovered from the virus in Nov2020. The patient previously took AVALOX on an unknown date and experienced allergy. Concomitant medications included esomeprazole sodium (NEXIUM), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), loratadine (CLARITIN) from unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient underwent nasal swab and the result was negative. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the arm left on 15Apr2021 at 14:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. On 14May2021, at 18:00, 10 days after second dose, the patient developed a rash on chest. Therapeutic measures were taken as a result of event and included treatment with anti-itch cream from unspecified date. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash on chest was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.