chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenitis, Myalgia
Clinical narrative: Pain; lymph nodes inflammation.; Throughout the rest of your body: Tiredness; Headache; Muscle pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as N/A. Concomitant medications included levothyroxine sodium (SYNTHROID) and lisinopril (MANUFACTURER UNKNOWN), both for unknown indications on unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 22:00, the patient experienced pain, lymph nodes inflammation, throughout the rest of the body tiredness, headache, muscle pain, chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events  pain, lymph nodes inflammation, throughout the rest of the body tiredness, headache, muscle pain, chills and fever was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain; lymph nodes inflammation.; Throughout the rest of your body: Tiredness; Headache; Muscle pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as N/A. Concomitant medications included levothyroxine sodium (SYNTHROID) and lisinopril (MANUFACTURER UNKNOWN), both for unknown indications on unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 22:00, the patient experienced pain, lymph nodes inflammation, throughout the rest of the body tiredness, headache, muscle pain, chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events  pain, lymph nodes inflammation, throughout the rest of the body tiredness, headache, muscle pain, chills and fever was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: left side of my face feels like its sort of half asleep; blood pressure raised; Headache; little bit short of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient self).      A 82-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose unknown via an unspecified route of administration on an unspecified date (age at 82-years-old) as single dose for COVID-19 immunisation.  Medical history included cardiac failure congestive, diabetes mellitus. The patient's concomitant medications were not reported. On an unspecified date, the patient reported that blood pressure has been raised up, had headache. The left side of face felt like its sort of half asleep and little bit short of breath. The patient asked if they had to go to hospital. The patient underwent lab tests and procedures which included blood pressure measurement: raised on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Chills, Dehydration, Dry mouth
Clinical narrative: chills; mind foggy; muscle aches; dehydration; lack of sleep; lack of energy; funky dreams; dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 02Apr2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antihistamine therapy (cannot take antihistamines). Concomitant medications were reported as none. 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 02Apr2021 at 16:00 the patient experienced foggy mind, dehydration, lack of sleep, lack of energy, funky dreams, dry mouth, chills and muscle aches. The patient did not receive any treatment for the event. 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 foggy mind, dehydration, lack of sleep, lack of energy, funky dreams, dry mouth, chills and muscle aches was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Myalgia
Clinical narrative: chills; mind foggy; muscle aches; dehydration; lack of sleep; lack of energy; funky dreams; dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 02Apr2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antihistamine therapy (cannot take antihistamines). Concomitant medications were reported as none. 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 02Apr2021 at 16:00 the patient experienced foggy mind, dehydration, lack of sleep, lack of energy, funky dreams, dry mouth, chills and muscle aches. The patient did not receive any treatment for the event. 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 foggy mind, dehydration, lack of sleep, lack of energy, funky dreams, dry mouth, chills and muscle aches was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 17Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to unspecified different medications. The patient had received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 17Mar2021 at 14:15, the patient experienced headache and low grade fever. 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 event headache and low grade fever was resolved on an unknown date in 2021.     No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site erythema, Oropharyngeal pain, Pain
Clinical narrative: Headache; Body aches; Sore throat; Rash all over torso; Fever 100-101; Injection site swollen; Injection site swollen and red and tender (3 diameter); Injection site swollen and red and tender (3diameter); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included valaciclovir (VALACYCLOVIR) for unknown indication from an unspecified date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 57-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 COVID-19 vaccine. On 06Apr2021, the patient experienced  fever 100-101, injection site swollen, red and tender (3" diameter)". On 07Apr2021, the patient had  headache, body aches, sore throat and rash all over torso. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, vaccination site swelling, injection site redness, vaccination site tenderness, headache, body aches, sore throat and rash all over torso were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache; Body aches; Sore throat; Rash all over torso; Fever 100-101; Injection site swollen; Injection site swollen and red and tender (3 diameter); Injection site swollen and red and tender (3diameter); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included valaciclovir (VALACYCLOVIR) for unknown indication from an unspecified date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 at 11:00 (at the age of 57-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 COVID-19 vaccine. On 06Apr2021, the patient experienced  fever 100-101, injection site swollen, red and tender (3" diameter)". On 07Apr2021, the patient had  headache, body aches, sore throat and rash all over torso. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, vaccination site swelling, injection site redness, vaccination site tenderness, headache, body aches, sore throat and rash all over torso were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Left lymph node swollen; Left lymph node sore; This is a spontaneous report from a contactable healthcare professional. A 38-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 left arm on 03Apr2021 at 10:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date 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 05Apr2021 at 06:00, the patient experienced left lymph node swollen and left lymph node sore. No therapeutic measures were taken as a result of the 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 left lymph node swollen and left lymph node sore were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; Sore throat; Cough; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male 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 05Apr2021 at 10:00 (at the age of 19-years-old), as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, adhd (attention deficit hyperactivity disorder) and depression. The patient did not have allergies to medications, food or other products. Concomitant medications included lamotrigine (LAMICTAL) from unknown date for unknown indication and quetiapine fumarate (SEROQUEL) from unknown date for unknown indication. 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 06Apr2021, the patient experienced fever, sore throat, cough, fatigue and headache. No therapeutic measures were taken as a result of the 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 fever, sore throat, cough, fatigue and headache were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain
Clinical narrative: Excessive sweating; Full body aches day one; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male 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 05Apr2021 at 09:00 hours (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and migraine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); both started on an unknown date for unknown indication. It was unknown whether the patient had any 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 medications or vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient experienced full body aches day one and excessive sweating and body aches on day 2 (06Apr2021). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events full body aches and excessive sweating were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Swollen, feverish, pink rash; Swollen, feverish, pink rash; Swollen, feverish, pink rash; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable and the patient had allergy to sulfa drugs and surgical stainless steel. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL), all taken from unknown dates for unspecified indications. 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 03Apr2021 at 11:00, ninth day after the vaccination, the patient experienced swollen, feverish, pink rash approximately 3.5" in height by 2.25" in width. By 06Apr2021, it was approximately 4" in height, 2.75" in width and in lighter pink color. 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. The patient did not receive any treatment for the events. The clinical outcome of the events swollen, feverish, pink rash was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration on 24Mar2021 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included depression. The patient had no allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (ZOLOFT), fluticasone propionate (FLONASE) and vitamin D (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. 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 24Mar2021, immediately after the vaccination, the patient experienced severe tinnitus. It was reported that the patient never had tinnitus before and the event had not subsided 2 weeks later. 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. The patient did not receive any treatment for the event. The clinical outcome of the event severe tinnitus was not resolved 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: Erythema, Lymphadenopathy, Malaise, Pyrexia, Swelling
Clinical narrative: Swollen lymph node on right side of neck where neck and face jawbone meet; Severe red swelling on left side of face; Severe red swelling on left side of face; Low grade fever; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and seasonal allergy. Concomitant medications included gliclazide (CLARITIN), levothyroxine sodium (LEVOTHYROXINE), buspirone (MANUFACTURER UNKNOWN) and levonorgestrel (MIRENA) intrauterine device (IUD). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and nitrofurantoin (MACROBID) and experienced allergy to both. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 16:45, the patient experienced swollen lymph node on right side of neck where neck and face jaw bone meets, severe red swelling on left side of face, low grade fever and felt unwell. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the event swollen lymph node on right side of neck where neck and face jaw bone meets, severe red swelling on left side of face, low grade fever and felt unwell were not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 45-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 right on 05Apr2021 at 10:15 hours (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination. 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 06Apr2021 at 06:00 hours, the patient experienced diarrhea. The patient did not receive any treatment for the reported event. The adverse 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 diarrhea was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Blood pressure measurement, Body temperature, Chills
Clinical narrative: Fever of 102.4, temperature is 100.4 today.; swollen lymph nodes in left armpit; chills; back body aches; headaches/ 7 days I am still experiencing headaches; I also do not feel myself like I am in a cloud; blood pressure is 140/107 today; This is a spontaneous report from a contactable consumer. A 39-years-old Non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left (Age at vaccination39 years) on 18Mar2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 15:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood pressure measurement and No allergies. The patient's concomitant medications were not reported. Patient was not Pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. On 02-APR-2021 07:15, The patient experienced fever of 102.4, temperature is 100.4 today, swollen lymph nodes in left armpit, chills, back body aches, headaches/ 7 days i am still experiencing headaches, i also do not feel myself like i am in a cloud, blood pressure is 140/107 today. The patient underwent lab tests and procedures which included blood pressure measurement: 140/107   on 02Apr2021, body temperature: 100.4 on 02Apr2021, body temperature: 102.4 on Apr2021. No treatment was received. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever of 102.4, temperature is 100.4 today.; swollen lymph nodes in left armpit; chills; back body aches; headaches/ 7 days I am still experiencing headaches; I also do not feel myself like I am in a cloud; blood pressure is 140/107 today; This is a spontaneous report from a contactable consumer. A 39-years-old Non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left (Age at vaccination39 years) on 18Mar2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 15:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood pressure measurement and No allergies. The patient's concomitant medications were not reported. Patient was not Pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. On 02-APR-2021 07:15, The patient experienced fever of 102.4, temperature is 100.4 today, swollen lymph nodes in left armpit, chills, back body aches, headaches/ 7 days i am still experiencing headaches, i also do not feel myself like i am in a cloud, blood pressure is 140/107 today. The patient underwent lab tests and procedures which included blood pressure measurement: 140/107   on 02Apr2021, body temperature: 100.4 on 02Apr2021, body temperature: 102.4 on Apr2021. No treatment was received. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Tinnitus
Clinical narrative: Severe ear ringing; sour taste in mouth every day since (nonstop); This is a spontaneous report from a contactable health care professional. A 48-years-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 right arm on 19Mar2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not take any concomitant medication. The patient was allergic to BENADRYL. Prior to vaccination, the patient was 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 vaccination. On 19Mar2021 at 11:00, the patient experienced severe ear ringing and a sour taste in the mouth every day since (nonstop). The patient received antianxiety, antihistamines, chiropractor and yoga as a treatment for the reported events. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events severe ear ringing and a sour taste in the mouth were not recovered at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Headache; Tiredness; Nausea; Weakness; Dizziness; Pain; Stiffness; This is a spontaneous report from a contactable consumer, the patient. A 30-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 left arm on 06Apr2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, hypothyroidism, endometriosis, depression, anxiety and ADHD, penicillin allergy from an unknown date, COVID-19 on an unspecified datea. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), sertraline (MANUFACTURER UNKNOWN), and nitrofurantoin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 06Apr2021 at 18:30 the patient experienced headache, tiredness, nausea, weakness, dizziness, pain and stiffness. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events headache, tiredness, nausea, weakness, dizziness, pain and stiffness was resolving at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Headache; Tiredness; Nausea; Weakness; Dizziness; Pain; Stiffness; This is a spontaneous report from a contactable consumer, the patient. A 30-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 left arm on 06Apr2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, hypothyroidism, endometriosis, depression, anxiety and ADHD, penicillin allergy from an unknown date, COVID-19 on an unspecified datea. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), sertraline (MANUFACTURER UNKNOWN), and nitrofurantoin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 06Apr2021 at 18:30 the patient experienced headache, tiredness, nausea, weakness, dizziness, pain and stiffness. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events headache, tiredness, nausea, weakness, dizziness, pain and stiffness was resolving at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pain of skin
Clinical narrative: Body and skin aches; Body and skin aches; Headaches; Fever; Chills; Lymph node under both arms; 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: 8730) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Cox-2 inhibitors and some NSAIDs. Concomitant medications included  estradiol (ESTROGEN), progesterone (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (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 vaccination. On 05Apr2021 at 20:00, the patient experienced headaches, body and skin aches, fever, chills and lymph node under both arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ADVIL. The clinical outcome of the events headaches, body and skin aches, fever, chills and lymph node under both arms was resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body and skin aches; Body and skin aches; Headaches; Fever; Chills; Lymph node under both arms; 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: 8730) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Cox-2 inhibitors and some NSAIDs. Concomitant medications included  estradiol (ESTROGEN), progesterone (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (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 vaccination. On 05Apr2021 at 20:00, the patient experienced headaches, body and skin aches, fever, chills and lymph node under both arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ADVIL. The clinical outcome of the events headaches, body and skin aches, fever, chills and lymph node under both arms was resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Malaise
Clinical narrative: bad headache due to high blood pressure, it went up to 174/114; was in bed for three days feeling very bad; bad headache due to high blood pressure, it went up to 174/114; This is a spontaneous report from a contactable consumer (the patient). This non-pregnant 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 at 09:00 (Lot number was not reported - misplaced/discarded)  at the age of 55 years, as DOSE 1, SINGLE for COVID-19 immunization.  Medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination On 22Mar2021 at 09:30 the patient experienced bad headache due to high blood pressure, it went up to 174/114. She was in bed for three days feeling very bad. The verbatim clinical course was reported as follows: When the patient was waiting to see if she had any reactions her blood pressure went to the roof, had the paramedics testing her, it never went away, she was in bed for three days feeling very bad. Went to emergency room on her own since that same afternoon it just wouldn't go away, bad headache due to high blood pressure, it went up to 174/114. The patient did not receive any treatment for the bad headache due to high blood pressure, it went up to 174/114. The clinical outcome of bad headache due to high blood pressure, it went up to 174/114, and was in bed for three days feeling very bad was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Pyrexia
Clinical narrative: 102.5 °F Fever that went up to 102.8 °F; The syringe with the vaccine in it was dropped on the floor prior to being administered. Clarifies that the cap was on the needle whenever the syringe was dropped; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Apr2021, the syringe with the vaccine in it was dropped on the floor prior to being administered. Clarifies that the cap was on the needle whenever the syringe was dropped. Consumer received second dose of Pfizer-BioNTech COVID-19 Vaccine yesterday 06Apr2021 (first dose was received on 16Mar2021) and wanted to know if her vaccine dose was considered valid: yesterday morning somehow the vaccine, not the vial, the syringe fell to the floor, although she did not see it come off. If it says do not shake it, my question was whether falling down was considered shaking. Dropping the syringe, if they dropped it was that still okay. The Pharmacist said cap was still on and kept on administering it. On an unknown date she had a 102.5 degree F Fever that went up to 102.8 degree F. She had not taken any Tylenol. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: hard itchy lump at the vaccination; Serious pain in the vaccination site for both first and second dose; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 41-years-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: er8733), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 as (At the age of 41-years) dose 1, single for covid-19 immunisation. Medical history included Known allergies Sulfa, shellfish.  Concomitant medication included amoxicillin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient experienced Serious pain in the vaccination site for both first dose on Mar2021 and second dose. The second dose was worse and now the pain has abated somewhat I can feel a hard itchy lump at the vaccination site. Patient did not receive any treatment for events. The outcome of event serious pain in the vaccination site for both first and second dose was not recovered and outcome of event hard itchy lump at the vaccination was unknown.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372659 similar report from same reporter
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hot flush, Hypoaesthesia, Migraine, Pain in extremity
Clinical narrative: Strong migraines; Hot flashes; Numbness in the legs; Sore arms; Sore joints; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8738) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had history of known allergies to NSAIDS and ibuprofen (MANUFACTURER UNKNOWN). The patient did not take any concomitant medications. 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 06Apr2021 at 12:00, the patient experienced strong migraines, hot flashes, numbness in the legs, sore arms and joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of strong migraines, hot flashes, numbness in the legs, sore arms and joints were unknown.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: having elevated Heart Rate; shortness of breath; chest tightness; dizziness; interrupted sleep due to these symptoms; This is a spontaneous report from a contactable consumer, the patient herself. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in Left arm on 26Mar2021 at 09:15 am as dose 1, single (at the age of 38 years), for covid-19 immunization. Medical history was reported as none. There were no allergies to medications, food, or other products. Concomitant medications were not reported. Other medications the patient received within 2 weeks of vaccination was reported as not applicable. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, on 28Mar2021 at 12:00, two days (2 days 2 hrs 45 min) after first dose, she started having elevated heart rate, shortness of breath, chest tightness, dizziness and interrupted sleep due to these symptoms. She was still experiencing this (day 12 after vaccine). The events were reported as non-serious. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She went to the ER (emergency room) on 31Mar2021 and followed up with cardiologist on 06Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 via Nasal swab sample on 03Apr2021 and the results came out to be negative. It was unknown if corrective treatment received for the adverse event. The outcome for the events was reported as not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: having elevated Heart Rate; shortness of breath; chest tightness; dizziness; interrupted sleep due to these symptoms; This is a spontaneous report from a contactable consumer, the patient herself. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in Left arm on 26Mar2021 at 09:15 am as dose 1, single (at the age of 38 years), for covid-19 immunization. Medical history was reported as none. There were no allergies to medications, food, or other products. Concomitant medications were not reported. Other medications the patient received within 2 weeks of vaccination was reported as not applicable. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, on 28Mar2021 at 12:00, two days (2 days 2 hrs 45 min) after first dose, she started having elevated heart rate, shortness of breath, chest tightness, dizziness and interrupted sleep due to these symptoms. She was still experiencing this (day 12 after vaccine). The events were reported as non-serious. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She went to the ER (emergency room) on 31Mar2021 and followed up with cardiologist on 06Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 via Nasal swab sample on 03Apr2021 and the results came out to be negative. It was unknown if corrective treatment received for the adverse event. The outcome for the events was reported as not recovered at the time of report. No follow-up attempts are needed. No further information is expected.