chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Pain in right shoulder and joints on right side of body; Extreme exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 29Mar2021 at 06:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back, right hip and knee chronic pain. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. 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 right arm on 08Mar2021 at 11:00 (at the age of 52-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-19 vaccine. On 30Mar2021 at 18:00, the patient experienced pain in right shoulder and joints on right side of body. On 30Mar2021 at 18:45, the patient experienced extreme exhaustion that began 24 hours after second dose. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events pain in right shoulder and joints on right side of body and extreme exhaustion. The clinical outcomes of the events pain in right shoulder and joints on right side of body and extreme exhaustion were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Arm soreness; Extreme body aches; Headache; Nausea; Chills; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER873) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD) stage 3, recent surgery of brain aneurysm, COVID-19 and penicillin allergy. The patient previously received BACTRIM on unknown date for unspecified indication and patient experienced drug allergy. The patient had received concomitant medications within two weeks of vaccine included clopidogrel bisulphate (PLAVIX) and acetylsalicylic acid (ASPIRIN) started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 61-years-old) and experienced arm soreness, extreme body aches, headache, nausea, chills and sweating. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 19:30 (8 hours 30 minutes after the vaccine), the patient experienced arm soreness, extreme body aches, headache, nausea, chills and sweating. 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 patient did not receive any treatment for reported events. The clinical outcome of the events arm soreness, extreme body aches, headache, nausea, chills and sweating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; Extreme body aches; Headache; Nausea; Chills; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER873) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD) stage 3, recent surgery of brain aneurysm, COVID-19 and penicillin allergy. The patient previously received BACTRIM on unknown date for unspecified indication and patient experienced drug allergy. The patient had received concomitant medications within two weeks of vaccine included clopidogrel bisulphate (PLAVIX) and acetylsalicylic acid (ASPIRIN) started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 61-years-old) and experienced arm soreness, extreme body aches, headache, nausea, chills and sweating. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 19:30 (8 hours 30 minutes after the vaccine), the patient experienced arm soreness, extreme body aches, headache, nausea, chills and sweating. 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 patient did not receive any treatment for reported events. The clinical outcome of the events arm soreness, extreme body aches, headache, nausea, chills and sweating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: hives; bumps on back; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included vitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the left arm on 02Mar2021 at 15:00 (at the age of 58-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 31Mar2021 at 08:00, approximately 30 hours after the second shot (as reported), the patient experienced severe allergic reaction (hives and bumps on back (allergic reaction)). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events included 200 mg of BENADRYL and 2% hydrocortisone. The clinical outcome of the events hives and bumps on back were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration in the left arm on 18Feb2021 at 13:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, pre-diabetic and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications included losartan potassium (LOSARTIN), metformin (MANUFACTURER UNKNOWN), potassium chloride (KLOR CON) and metoprolol (MANUFACTURER UNKNOWN) and atorvastatin (LIPTOR); all for unknown indications 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 18Feb2021 at 18:00, the patient experienced tiredness. 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 patient did not receive any treatment for the event. The clinical outcome of the tiredness was recovered. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: injection site pain; tiredness; fever; nausea; joint and muscle pain; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received pethidine hydrochloride (DEMEROL), cefaclor (CECLOR) and amoxicillin, clavulanate potassium (AUGMENTIN) and experienced drug allergy. 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 31Mar2021 at 09:00, the patient had injection site pain, tiredness, fever, nausea, joint and muscle pain. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site pain, tiredness, fever, nausea, joint and muscle pain. The clinical outcomes of the events injection site pain, tiredness, fever, nausea, joint and muscle pain were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; tiredness; fever; nausea; joint and muscle pain; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received pethidine hydrochloride (DEMEROL), cefaclor (CECLOR) and amoxicillin, clavulanate potassium (AUGMENTIN) and experienced drug allergy. 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 31Mar2021 at 09:00, the patient had injection site pain, tiredness, fever, nausea, joint and muscle pain. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events injection site pain, tiredness, fever, nausea, joint and muscle pain. The clinical outcomes of the events injection site pain, tiredness, fever, nausea, joint and muscle pain were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: a metallic taste in mouth for one hour; This is a spontaneous report from non-contactable healthcare professional. A 79-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 5318) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. It was unknown if the patient had diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had tested for COVID-19 since the vaccination. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced a metallic taste in mouth for one hour. The events did not result in doctor 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 metallic taste was resolved on 31Mar2021 (for one hour).   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Vaccination site erythema, Vaccination site swelling
Clinical narrative: inappropriate schedule of vaccine administered; Swollen lymph nodes in armpit on both sides, worse on left.; Swollen arm at injection site; Red arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-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 arm left on 29Mar2021 at 10:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), Vit D (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously 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 15Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to penicillin. The patient did not receive any medications within two weeks of vaccination. 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 31Mar2021 at 18:00, the patient experienced swollen lymph nodes in armpit on both the sides, worse on the left, swollen and red arm at injection site. The vaccine was administered outside the range of 19-42 days after the 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events swollen lymph nodes in armpit on both the sides, worse on the left, swollen and red arm at injection site were not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Localized arm pain; Muscle aches; Fatigue; Vertigo; Headache; Chills; Fever; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the arm left on 12Mar2021 at 09:45 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included graves disease, hypothyroidism, afib, vertigo, Hx BrCA w/chemo/radiation (breast cancer, chemotherapy, radiotherapy) and COVID-19. The patient received other vaccine (HPV vaccine VLP rL1 2v (baculovirus)) (Lot number: 95JR5), in the left arm on 12Feb2021 within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), calcium, colecalciferol (CALCIUM AND VIT D), metoprolol succinate (METOPROLOL) and estradiol (ESTRING); all taken for unknown indication from unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, at 03:00 the patient experienced localized arm pain, muscle aches, fatigue, vertigo, headache, chills and fever of 100.3 within 24 hours of vaccine. The chills and fever lasted only one day while remaining symptoms lasted 3.  The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for localized arm pain, muscle aches, fatigue, vertigo, headache, chills and fever. The clinical outcome of the events localized arm pain, muscle aches, vertigo and headache were resolved, while that of the events fatigue was resolved in Mar2021 (patient felt fatigue for one week); chills and fever was resolved on 14Mar2021 (lasted only one day).  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vertigo
Clinical narrative: Localized arm pain; Muscle aches; Fatigue; Vertigo; Headache; Chills; Fever; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the arm left on 12Mar2021 at 09:45 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included graves disease, hypothyroidism, afib, vertigo, Hx BrCA w/chemo/radiation (breast cancer, chemotherapy, radiotherapy) and COVID-19. The patient received other vaccine (HPV vaccine VLP rL1 2v (baculovirus)) (Lot number: 95JR5), in the left arm on 12Feb2021 within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), calcium, colecalciferol (CALCIUM AND VIT D), metoprolol succinate (METOPROLOL) and estradiol (ESTRING); all taken for unknown indication from unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, at 03:00 the patient experienced localized arm pain, muscle aches, fatigue, vertigo, headache, chills and fever of 100.3 within 24 hours of vaccine. The chills and fever lasted only one day while remaining symptoms lasted 3.  The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for localized arm pain, muscle aches, fatigue, vertigo, headache, chills and fever. The clinical outcome of the events localized arm pain, muscle aches, vertigo and headache were resolved, while that of the events fatigue was resolved in Mar2021 (patient felt fatigue for one week); chills and fever was resolved on 14Mar2021 (lasted only one day).  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 16-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 23Mar2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medications within two weeks of COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced slightly sore arm. No therapeutic measures were taken as a result of the event. The adverse event 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 event slightly sore arm was recovered on unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; Fatigue; Chills; Fever; This is a spontaneous report from a non-contactable pharmacist, the patient. A 30-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 right arm on 31Mar2021 at 12:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products was not provided. The patient did not take any concomitant medication. 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 unspecified date as a single dose for COVID-19 immunisation. 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 01Apr2021 at 00:30, approximately 12 hours post vaccination, the patient experienced fatigue, chills, fever, and body aches. The events did not result in doctor 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 outcomes of the events fatigue, chills, fever, and body aches were resolved on 01Apr2021 at an unspecified time.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Nausea; diarrhea; headache; injection site pain; injection site swelling; chills; fever; joint pain; tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old 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 30Mar2021 at 14:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 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 31Mar2021 at 07:00 the patient experienced nausea, diarrhea, headache, injection site pain, injection site swelling, chills, fever, joint pain and tiredness. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  On an unknown date, the patient received TYLEX as a treatment for the events. The clinical outcomes of the events nausea, diarrhea, headache, injection site pain, injection site swelling, chills, fever, joint pain, tiredness were resolved on an unknown date in 2021 at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Nausea; diarrhea; headache; injection site pain; injection site swelling; chills; fever; joint pain; tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old 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 30Mar2021 at 14:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 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 31Mar2021 at 07:00 the patient experienced nausea, diarrhea, headache, injection site pain, injection site swelling, chills, fever, joint pain and tiredness. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  On an unknown date, the patient received TYLEX as a treatment for the events. The clinical outcomes of the events nausea, diarrhea, headache, injection site pain, injection site swelling, chills, fever, joint pain, tiredness were resolved on an unknown date in 2021 at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Tremor
Clinical narrative: Muscle twitching; tremors; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 09:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown duration and COVID-19 prior to vaccination. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unknown indication and received within two weeks of vaccination. The patient did not had allergy to any medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 10:00, the patient experienced muscle twitching and tremors. Right arm twitch started right after the vaccination and later when the patient went to bed both arms started having uncontrollable twitches and tremors including legs too. It keeps happening but it was lessening. The patient did not receive any treatment for the event. The clinical outcome of the events muscle twitching and tremors were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Blurred vision; dizzy; This is a spontaneous report from a contactable healthcare professional. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications were not reported. It was unknown prior to the vaccination whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient tested for COVID-19. It was unknown if any other vaccines were taken within four weeks prior to the vaccination. On 31Mar2021, the patient experienced blurred vision for 30 minutes and was dizzy for 20 minutes. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events blurred vision and dizzy was resolved.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; tender lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 32-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 30Mar2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included nicotine (MANUFACTURER UNKNOWN) and (salbutamol) ALBUTEROL. 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 01Apr2021 at 00:00 hours, the patient experienced swollen and tender lymph nodes. Therapeutic measures and treatments were not taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen and tender lymph nodes was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea; This is a spontaneous report from a contactable consumer. This consumer reported for patient that a female patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she is calling about the covid Vaccine, he is a Pfizer employee and reporting multiple patient adverse events. Pfizer employee reported that last Friday on 07May2021 he was reading comments on social media, he was social media friends with multiple customers. One was a medical assistant, she put on her social media page that she had 3 patients phone in about adverse events with the covid 19 shot, they complained of amenorrhea and haven't had their periods in 3 months. Pfizer Employee stated that he has no patient details to provided, he has no initials, height, weight, ages. When queried if he knew the patient's sex, he stated that it is a gynecologic office and they're complaining about amenorrhea. Pfizer employee has no further information to provided. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021531880 same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Amenorrhea and haven't had their periods in 3 months.; This is a spontaneous report from a contactable consumer. This consumer reported for patient that:   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He is a Pfizer employee and reported multiple patients adverse events. Pfizer employee reported that last Friday on 07May2021 he was read comments on social media, his social media friends with Multiple customers one is a medical assistant, she put on social media that she has had 3 patients' phone in about adverse events with the covid 19 shot, they complain of amenorrhea and haven't had their periods in 3 months. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021531880 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: She said she is not pregnant and her menstrual cycle is a week late; This is spontaneous report from a contactable consumer (patient). This consumer reported for herself that a 24-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC: Unknown, batch/lot number: EW0173; expiry date: 31Aug2021), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medication history and concomitant medications were not reported. The patient informed that she received her first dose of the Pfizer covid vaccine and she did not get her period. She said she was not pregnant, and her menstrual cycle was a week late. Caller wanted to know if that has been reported as a possible side effect of the vaccine. The The patient reported menstruation after she got the Pfizer Covid Vaccine. She was curious about possible symptoms, if menstruation was considered irregular or as like a symptom from the Pfizer Covid Vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Musculoskeletal stiffness, Pain
Clinical narrative: Pain and discomfort and stiffness; Pain and discomfort and stiffness; Pain and discomfort and stiffness; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER8736 and Expiry date was not reported) dose 2 via an unspecified route of administration in arm Left on 11May2021 (age at vaccination was 59-year-old) and dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included Irregular Blood Pressure and hot flashes from an unknown date and unknown if ongoing. Concomitant medications included prescribed hormones pills from doctor for hot flashes, start and stop date were not reported. Patient stated that facing side effect day after her vaccination, on 12May2021 patient experienced Pain, discomfort and stiffness. Treatment received for the events was Ibuprofen 800mg. Outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose  Diarrhea
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose  Diarrhea
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose  Diarrhea
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Oligomenorrhoea
Clinical narrative: Long heavy menstrual cycle. Cycle started June 24 and ended July 3. Then I started spotted for a few days (5days). Cycle became heavy July 19 and hasn?t stopped as of today July 21
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: Muscle or body aches, sore throat
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Cough
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received their first dose on 24June 2021. Patient then came in and received their second dose on 13July2021, on day 19. Patient has had no adverse reactions. Patient has been notified of their early dosing.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Fatigue, Hypoxia, Oxygen saturation decreased
Clinical narrative: Cough, fatigue and low oxygen level. Mild hypoxia
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, C-reactive protein increased, Joint swelling, Peripheral swelling, Red blood cell sedimentation rate increased
Clinical narrative: Developed rheumatoid arthritis within 6 months of vaccine, with no prior problems or any family history of rheumatoid arthritis or any other autoimmune diseases.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Rheumatoid arthritis, Swelling, X-ray abnormal
Clinical narrative: Developed rheumatoid arthritis within 6 months of vaccine, with no prior problems or any family history of rheumatoid arthritis or any other autoimmune diseases.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: Chest pain intermittently for a few days with some fast heart rates occasionally
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram normal, Gastrooesophageal reflux disease, Palpitations
Clinical narrative: Chest pain, palpitations, Acid reflux.  Took omeprazole for 2 weeks for acid reflux, acidity reduced. But  chest pain and palpitations still persist .  It is more than a month , I am still suffering .
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Oropharyngeal pain
Clinical narrative: sore throat; had a 101.4F temperature starting on 17May2021 at 5am that gradually lowered to 98.6F on 18May2021 at 6:45am after taking OTC acetaminophen; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 16-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736, Expiry date: not reported, age at vaccination: 16-year-old), via an unspecified route of administration, in Arm Left on 16May2021 at 14:15 as single dose for COVID-19 immunisation administered in Pharmacy or Drug Store. The patient medical history and concomitant medication was not reported. Previously the patient received first dose of bnt162b2 (Lot number ER8731), in Arm left on 25Apr2021 at 15:00 for COVID-19 immunization and there is no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received OTC women's gummy vitamins received within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 since the vaccination. On 17May2021 at 5:00 Am, the patient had a 101.4f temperature that gradually lowered to 98.6f on 18may2021 at 6:45am after taking otc acetaminophen, resting at home and drinking a lot of water. The patient also had chills, headache and sore throat starting on 17May2021 at 5 Am that also gradually went away by taking OTC medicine, sore throat medicine, resting at home and drinking a lot of water. The outcome of event body temperature increased was recovered on 18May2021 while all other events recovered on an unknown date in May2021.   Device Date : 30May2021  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Device issue, Fatigue, Incorrect dose administered, Vaccination site haemorrhage
Clinical narrative: Tiredness; Device issue; Inappropriate dose of drug administered; Injection site bleeding; This is a spontaneous report from a contactable consumer (patient) or other non health care professional. This report based on the information received by Pfizer (Manufacturer Control No: 21K-163-3943518-00). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported ), dose 2 intramuscular on 17Mar2021 (at the age of 65-years-old)  as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg, 1 in 2 week) for rheumatoid arthritis . Patient  was only able to receive some solution of Humira, solution of Humira was leaking, misfire, tired and solution present on skin with Humira 40 mg/0.4 ml (Adalimumab).  Medical history included non-smoker, alcohol use: one glass of wine, occasionally, penicillin allergy, was manifested by felt dizzy and flushed. The patient's concomitant medications were not reported. The patient experienced inappropriate dose of drug administered and injection site bleeding and device issue on 04Jun2021. Patient had tiredness on 08Jun2021. Patient  was only able to receive some solution of humira, solution of humira was leaking, misfire and solution present on skin resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The outcome of the event Injection site bleeding, Inappropriate dose of drug administered and Device issue was recovered on 04Jun2021. The outcome of Tiredness was not recovered. Humira was Ongoing At least two months ago. Causality for humira 40 mg/0.4 ml (adalimumab) :The reporter's causality for the event(s) of blood on injection site and tired with humira 40 mg/0.4 ml (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of was only able to receive some solution of humira, solution of humira was leaking, misfire and solution present on skin was not provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Body hurting; Headache; Chills; Fever of 99.0 Fahrenheit; This is a spontaneous report from a contactable consumer (patient).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 19Jun2021 11:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162B2 dose 1 on an unspecified date for  covid-19 immunisation and had no reaction. The patient experienced body hurting, headache, chills and fever of 99.0 Fahrenheit, all in Jun2021 after second dose. He is asking if he can take Advil/Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.0 fahrenheit in Jun2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021738286 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Malaise, Muscle twitching, Pain, Pyrexia
Clinical narrative: I have been sick to the stomach; Rather then feeling comfort; I am having bad Twitching in my upper right arm.; I had a fever, of both injection; I couldnt leave the bed, just really sore all over.; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose and received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose  for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that I am having bad Twitching in my upper right arm. I had a really bad reaction with the second shot for two days, I had a fever, of both injection, I have been sick to the stomach. I couldn't leave the bed, just really sore all over on an unspecified date, so I have bad experience with dose, which I understand, can happen and my doctor said, were of two, I have been taking for, I see many things larger than normal dosages but I am asking you is, who is collecting data that said that, I have twitching in my arm. Consumer further stated, I am asking, if Pfizer is collecting data on the experience of people, who had the shot. Consumer stated, But I would think, you would wants to report that and you are not asking. I am calling you voluntarily. When other, when people are telling that Moderna is fallowing up with them to find out with their, if you having any reaction or adverse event to the Moderna vaccine that comforts me, knowing them Moderna is staying on type of it. In fact both, my husband and I had both of our Covid shots, both had Pfizer but nobody is asked a question about how we are doing that concerns me so, rather then feeling comfort, I feel Concerned. The outcome of all event was unknown.  Information on the lot/batch number has been requested.