chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Chills.; sweating; Headache; Nausea; Tired; This is a spontaneous report received from a contactable consumer, the patient. A 28-years-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot number: En6205) via an unspecified route of administration in the left arm on 25Feb2021 at 14:45 (at the age of 28-years-old) and a second dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 16Mar2021 at 15:45 (at the age of 28-years-old), as single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medication included magnesium (MANUFACTURER UNKNOWN) and ZYRTEC initiated from unknown date and for unknown indications. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 02:30, the patient experienced chills, sweating, headache, nausea and tiredness. The patient did not receive any treatment for the events. At the time of this report in Mar2021, the events chills, sweating, headache, nausea and tiredness were recovered.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: Sore at injection site; Headache; Tiredness; General malaise; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in left arm on 16Mar2021 at 03:00 PM (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included digestive allergy to milk and gluten. The patient had previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3247) via unspecified route of administration on the left arm on 23Feb2021 at 02:45 PM as a single dose for COVID-19 immunisation. 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 vaccine. Concomitant medications included Allegra and unspecified vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 17Mar2021 at 06:00 AM, the patient experienced sore at injection site, headache, tiredness and general malaise. The patient did not receive treatment for the reported events. The clinical outcome of the events sore at injection site, headache, tiredness and general malaise was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Hives on hands, chest; Face redness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 10:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The patient had a history of allergy to penicillin and azithromycin. 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 was not receiving concomitant medications. The patient did not receive any other vaccine with four weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced hives on hands, chest and face redness (for now 10 days). It was unknown if therapeutic measures were taken for the adverse events. The clinical outcome of the events hives on hands, chest and face redness was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: About 2 weeks after second shot have had cold sores; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 52 years old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 16Jan2021 at 10:30, as a single dose for COVID-19 immunisation. The patient medical history included asthma from unknown date. The patient did not received any other medications within 2 weeks of vaccination. The patient has allergies to medications, food, or other products and  Sulfa was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. About 2 weeks after second shot, The patient experienced cold sores one after the other so far four on 27Feb2021. Therapeutic measures were taken as a result of cold sores and included treatment with oral Famvir. The clinical outcome of the cold sores was recovering.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pyrexia
Clinical narrative: Fever; Joint pain; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 16Mar2021 at 10:30 hours (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The medical history included high BP and cholesterol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 15:15 hours, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced fever, joint pain and weakness. The patient did not receive treatment for the reported events. The clinical outcome of fever, joint pain and weakness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable healthcare professional, the patient. A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration and unspecified anatomical site on 01Mar2021 at 02:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, sleep apnea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 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-19 vaccination. On 02Mar2021, the patient experienced migraine for 4 days. It was reported that the migraines was severe for first 2-3 days. Patient also stated that she was a migraine sufferer but these were severe. So went to doctor, but doctor said really nothing to do. Patient stated that she wishes not to have same migraines with 2nd shot on March 28. The patient did not receive any treatment for the event. The clinical outcome of migraine was recovered on an unknown date at the time of report. Information about lot number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Achey; Fever; Vomiting; Chills; Muscle aches and pains; Dizziness; Tiredness; Headache; Intense sweating; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9266) via an unknown route of administration in left arm on 04Mar2021 at 8:30 (at the age of 40 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6201) via an unknown route of administration in left arm on 12Feb2021 at 18:30 as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to penicillin, eggs, garlic and seasonal. Concomitant medications included Lexapro, Nuvaring, Collagen, turmeric and multivitamin (MANUFACTURER UNKNOWN) all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  On 04Mar2021 at 20:00 (within couple of hours) the patient experienced aches. About 14 hours after the second shot the patient had 101.9 (units and reference was not provided) fever with vomiting, chills, muscle aches and pains, dizziness, tiredness, headache and intense sweating. These lasted for about 48 hours. Since the vaccine the patient had lots of dizziness. Therapeutic measures included increase of Advil and Tylenol (dose unknown). The clinical outcome of the aches, fever, vomiting, chills, muscle pains, dizziness, tiredness, headache and sweating was recovered with sequelae on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: Achey; Fever; Vomiting; Chills; Muscle aches and pains; Dizziness; Tiredness; Headache; Intense sweating; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9266) via an unknown route of administration in left arm on 04Mar2021 at 8:30 (at the age of 40 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6201) via an unknown route of administration in left arm on 12Feb2021 at 18:30 as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to penicillin, eggs, garlic and seasonal. Concomitant medications included Lexapro, Nuvaring, Collagen, turmeric and multivitamin (MANUFACTURER UNKNOWN) all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  On 04Mar2021 at 20:00 (within couple of hours) the patient experienced aches. About 14 hours after the second shot the patient had 101.9 (units and reference was not provided) fever with vomiting, chills, muscle aches and pains, dizziness, tiredness, headache and intense sweating. These lasted for about 48 hours. Since the vaccine the patient had lots of dizziness. Therapeutic measures included increase of Advil and Tylenol (dose unknown). The clinical outcome of the aches, fever, vomiting, chills, muscle pains, dizziness, tiredness, headache and sweating was recovered with sequelae on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: Arm soreness; 2 small itchy spots about the size of a flea bite or smaller on neck about two hours after and a larger sized itchy bite like spot on other side of neck about 8 hours later; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 12:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included anemia, psoriasis, high cholesterol, dust allergy. Concomitant medications included vitamins. Allergies to medications, food, or other product reported as sensitive skin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 14:00, the patient experienced itchy rash (two small itchy spots about the size of a flea bite or smaller on neck about 2 hours later, and a larger sized itchy bite like spot on other side of neck about 8 hours later) and painful arm at 18:00. The patient did not receive treatment for the reported events. The clinical outcome of painful arm and of the itchy rash was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysarthria
Clinical narrative: Coughing uncontrollably; Slurred speech.; This is a spontaneous report from a contactable consumer, the patient. A 63 -year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2; Lot Number: Unknown) via an unspecified route of administration in the Left arm on 16Mar2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 Immunization. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16March2021 at 21:00, the patient experienced coughing uncontrollably and slurred speech. Patient did not received any treatment for the reported events. The Clinical outcome of the events coughing uncontrollably and slurred speech was resolved at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; nausea (moderate); pain at injection site (mild); This is a spontaneous report received from a non-contactable physician, the patient. A 61-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 09:15 (at the age of 61-year-old) and her second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EL3247,) via an unspecified route of administration in the left arm on 16Mar2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patients medical history included obesity. Concomitant medications included OZEMPIC 1mg/week, CONTRAVE, PRESERVISION, ALAVERT. The patient was allergic to aspirin. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 17Mar2021 at 06:00, the patient experienced headache, moderate nausea and mild injection site pain. The treatment received for the event headache included tylenol. The clinical outcome of the events headache, nausea and injection site pain were reported as recovering.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Loud ringing sound inside my right ear; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969), via an unspecified route of administration in the right arm on 16Mar2021 at 14:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer treatments completed recently including chemo and radiation. Concomitant medication included minocycline 100mg capsule and (sulfonamide) SULFACETAMID lotion 10% for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products was reported as None. On 16Mar2021 at 20:45, the patient experienced loud ringing sound inside right ear, that started about 6 hours after first dose. The patient did not receive treatment for the reported event. The clinical outcome of the ringing in ears was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Lymphadenopathy, Rash erythematous, Rash pruritic
Clinical narrative: chest pain; swollen lymph nodes; red rash; itchy rash; chest congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EN 6208), via an unspecified route of administration in the left arm on 13Mar2021 at 10:00 AM (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 vaccine within four weeks prior to the vaccination. Concomitant medications included dextromethorphan HBr and guaifenesin (Mucinex DM), pseudoephedrine (Sudafed), levocetirizine (Xyzal), fexofenadine (Allegra). On 15Mar2021, the patient experienced chest pain and congestion, swollen lymph nodes, red itchy bumpy rash on both of my ankles. Therapeutic measures were not taken for the events. The clinical outcome of the chest pain, chest congestion, swollen lymph nodes, red itchy bumpy rash were recovering at the time of report.  No follow-up attempts are needed. No further information is expected
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Swelling, Swelling face
Clinical narrative: Significant face and neck swelling; Significant face and neck swelling; redness 20 minutes after injection; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 59267-1000-01), via an unspecified route administration in the left arm on 12Mar2021 at 17:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included mild hypertension. Concomitant medications were not reported. The patient was allergic to bee stings. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 experienced face swelling, neck swelling and redness on 12Mar2021 at 17:35. It was reported that events were not anaphylactic and the condition peaked within 1 hour, returned to normal within 4 hours. The reported events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the reported events. The clinical outcome of the face swelling, neck swelling and redness was recovered on 12Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Gained 8 lbs. beginning within days of 1st vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot Number: EL1283k), via an unspecified route of administration in the left arm on 21Jan2021 at 08:15 (at the age of 69-years-old), as single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), quinapril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), VICTOZA for an unknown indication. 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 not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 25Jan2021, the patient reported that had not gained weight in last years, however post first dose of  vaccination within days gained 8 lbs. No therapeutic measures were taken for the event. The clinical outcome of the event weight gain was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Chills; Low grade fever; Shoulder pain; left arm pain; back pain; swollen lymph node in left axillary area; fatigue; headache; This is a spontaneous report from a contactable pharmacist, the patient. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 11:15 hours (at the age of 42-years) as a single dose for COVID-19 immunisation. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 11:15 hours as a single dose for COVID-19 immunisation. The patients medical history included hypertension. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) 12.5 (unit unspecified) once daily (QD). The patient received this medication within 2 weeks of vaccination and exact therapy dates and indication for it was not reported. On 16Mar2021, the patient experienced chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache. The patient received Motrin as a treatment medication. On an unknown date in Mar2021, the patient was recovered from the events chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache.   No follow up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Chills; Low grade fever; Shoulder pain; left arm pain; back pain; swollen lymph node in left axillary area; fatigue; headache; This is a spontaneous report from a contactable pharmacist, the patient. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 11:15 hours (at the age of 42-years) as a single dose for COVID-19 immunisation. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 22Feb2021 at 11:15 hours as a single dose for COVID-19 immunisation. The patients medical history included hypertension. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN) 12.5 (unit unspecified) once daily (QD). The patient received this medication within 2 weeks of vaccination and exact therapy dates and indication for it was not reported. On 16Mar2021, the patient experienced chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache. The patient received Motrin as a treatment medication. On an unknown date in Mar2021, the patient was recovered from the events chills, low grade fever, shoulder pain, left arm pain, back pain, swollen lymph node in left axillary area, fatigue and headache.   No follow up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Have had significant joint pain on both sides of body that have continued since second vaccination to now; This is a spontaneous report from contactable consumer, the patient. A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 15Feb2021 at 16:30 (at the age of 43-years-old) and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 08Mar2021 at 10:30 (at the age of 43-years-old) for COVID-19 immunisation. Medical history included asthma and seasonal allergies. Concomitant medications included SINGULAIR and NASONEX for unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 23:00, the patient experienced joint pain on both sides of body that had continued till day 9 after 2nd shot. The patient did not receive any treatment for reported adverse event. The clinical outcome of the event joint pain was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia, Vertigo, Vomiting
Clinical narrative: After vaccination I got vertigo; vomiting; fever; headache; feeling sick; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in an unspecified anatomical site on 16Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, after vaccination the patient experienced vertigo, vomiting, fever, headache and feeling sick. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, vomiting, fever, headache and feeling sick were not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Fatigue; Muscle soreness; Soreness at the injection site.; This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 16Mar2021 at 15:30 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The medical history was reported as Crohn's disease, chronic obstructive pulmonary disease and asthma. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 16Mar2021 at 19:00 the patient experienced fatigue, muscle soreness, and soreness at the injection site. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue, muscle soreness, and vaccination site pain were recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Hordeolum
Clinical narrative: Stye; left eye hurts in the corner; This is a spontaneous report received from a non-contactable consumer, patient. A 22-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in an unspecified arm on an unspecified date (at the age of 22-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has not been tested for COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left eye and stye on 16Mar2021. The patient did not receive any treatment for the events. The clinical outcome for events pain in left eye and stye was not recovered at the time of reporting.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Burning sensation, Drug eruption, Erythema, Nodule
Clinical narrative: a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); aggravated asthma (chest tightness); Body drug rash (swelling and pinkish skin color but no hives/welts); hands/fingers red; hands/fingers red hot/tingling/burning sensation; hands/fingers red hot/tingling/burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm as a single dose on 10Mar2021 at 09:45 hours (at the age of 50 years), for COVID-19 immunisation. The medical history included breast cancer since 2008, hernia, asthma and migraines. The patient was allergic to PEG (polyethylene glycol). The concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and DYMISTA. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Mar2021 at 09:00 hours, the patient experienced body drug rash (swelling and pinkish skin colour but no hives/welts); hands/fingers red hot/tingling/burning sensation and also aggravated asthma (chest tightness). On 15Mar2021, the patient experienced a painful lump on left pointer finger formed 4 days after vaccination and worsened 1 week later (solid bump with no pus). The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient received antihistamines (unspecified) and cortisone 2.5% inhaler as treatment for the adverse events. The clinical outcome of all the events body drug rash, hands/fingers red hot/tingling/burning sensation, aggravated asthma and painful lump on left pointer finger was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); a painful lump on left pointer finger formed 4 days after vaccination & worsening 1 week later (solid bump with no pus); aggravated asthma (chest tightness); Body drug rash (swelling and pinkish skin color but no hives/welts); hands/fingers red; hands/fingers red hot/tingling/burning sensation; hands/fingers red hot/tingling/burning sensation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm as a single dose on 10Mar2021 at 09:45 hours (at the age of 50 years), for COVID-19 immunisation. The medical history included breast cancer since 2008, hernia, asthma and migraines. The patient was allergic to PEG (polyethylene glycol). The concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and DYMISTA. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Mar2021 at 09:00 hours, the patient experienced body drug rash (swelling and pinkish skin colour but no hives/welts); hands/fingers red hot/tingling/burning sensation and also aggravated asthma (chest tightness). On 15Mar2021, the patient experienced a painful lump on left pointer finger formed 4 days after vaccination and worsened 1 week later (solid bump with no pus). The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The patient received antihistamines (unspecified) and cortisone 2.5% inhaler as treatment for the adverse events. The clinical outcome of all the events body drug rash, hands/fingers red hot/tingling/burning sensation, aggravated asthma and painful lump on left pointer finger was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Headache, Peripheral coldness
Clinical narrative: Upset stomach; Headache; Cold hands; Sore back in the kidney area; This is a spontaneous report received from a non-contactable consumer, the patient. A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm (at the age of 72 years) on 11Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6201) via an unspecified route of administration in the left arm on 18Feb2021 at 13:30 as a single dose for COVID-19 immunisation. 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 with COVID-19. Concomitant medications included ELIQUIS 5 mg tablet, telmisartan and atorvastatin; all for an unknown indication since unknown date and unknown if ongoing. On 17Mar2021 at 12:00, the patient experienced upset stomach, headache, cold hands and sore back in the kidney area. The patient did not receive treatment for the reported events. The clinical outcome of the events upset stomach, headache, cold hands and sore back in the kidney area was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache
Clinical narrative: Body chills lasting from 7-9 pm the following day; Fatigue; Headache; Stomach pain; This is a spontaneous report from a contactable consumer, patient. A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204), via an unspecified route of administration in the left arm on 14Mar2021 at 10:15 AM (at the age of 37-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 15Mar2021 at 7:00, the patient experienced body chills lasting from 7-9 pm the following day, headache, stomach pain and fatigue. Therapeutic measures were not taken for the events. The clinical outcome of body chills, headache, stomach pain and fatigue were recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches daily; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old, male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown) at an unspecified dose via unspecified route of administration on left arm on 08MAR2021 (at the age of 26-year-old at vaccination) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown) on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history included allergy to penicillin (Pcn). Concomitant medication was not provided. 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 vaccine within four weeks prior to the COVID-19 vaccine. On 09MAR2021, the patient experienced headaches daily. No treatment was received for the adverse event. The clinical outcome for the event headaches daily was reported as recovered with lasting effects at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Chills, Ear pain
Clinical narrative: elevated BP for 24 hours; pain in the ear; low grade fever; chills; pain in the joints; sharp shooting pain in the crown of the head; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old female patient received unknown dose of BNT162B2 (Pfizer -BioNTech Covid-19 mRNA Vaccine, lot number: EL3247), via an unspecified route of administration on 15Mar2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation . Medical history included hypothyroidism and autoimmune disease. Concomitant medications were not provided. 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 have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head and elevated BP for 24 hours. No therapeutic measures were taken for the events. The clinical outcome of the low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head was recovering and for elevated BP for 24 hours it was recovered on 17Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: elevated BP for 24 hours; pain in the ear; low grade fever; chills; pain in the joints; sharp shooting pain in the crown of the head; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old female patient received unknown dose of BNT162B2 (Pfizer -BioNTech Covid-19 mRNA Vaccine, lot number: EL3247), via an unspecified route of administration on 15Mar2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation . Medical history included hypothyroidism and autoimmune disease. Concomitant medications were not provided. 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 have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head and elevated BP for 24 hours. No therapeutic measures were taken for the events. The clinical outcome of the low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head was recovering and for elevated BP for 24 hours it was recovered on 17Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: laryngitis; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 25Feb2021 (at the age of 66-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported) for COVID-19 Immunisation. After the first dose Patient had some weird symptoms and had a very negative reaction to 1st dose. The patient medical history and concomitant medications were not reported. 2 weeks after vaccination, patient stated her coworker tested positive for COVID and she went to urgent care and got tested. She got tested for antibodies and had a PCR test which both tested negative. Caller was wondering if she was supposed to test negative for antibodies. She took a Medrol dose pack after her second dose of the vaccine and was wondering if that may suppress the immunity of the vaccine and negated antibodies in her system. After 2nd vaccine, patient developed laryngitis. They gave me Medrol dose pack, a prednisone steroid. Patient filled out something online and they sent me this booklet to fill out but have not gotten to it yet. She had just a little reaction to the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Diarrhea; Very achy; Extremely nauseated; Chills; Severe headache; This is spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via unspecified route of administration in the left arm on 15Mar2021 at 11:15 am (at the age of 58-years-old), as single dose for COVID-19 immunisation. Medical history included severe asthma and patient had no allergies to medications, food, or other products. Concomitant therapies included Xolair received on 11Mar2021, Lexapro, Trelegy, levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced very achy, extremely nauseated, had diarrhea, severe headache and chills. The patient did not receive any treatment for the events. The clinical outcome of the events very achy, extremely nauseated, diarrhea, severe headache and chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Flatulence
Clinical narrative: severe chills; severe headache; Injection site pain; Fatigued; severe aches and pains (felt like broken glass in my bones).; Tired; Diarrhea; stomach cramps; Gas; This a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL4237), via an unspecified route of administration in the left arm on 17Mar2021 at 13:45 hours (at the age 42-years-old) as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 13:00 hours (at the age of 42-years-old), as single dose for COVID-19 immunisation. Medical history included IBS (Irritable Bowel Syndrome) from an unknown date. Concomitant medications included probiotics (METAGENICS) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 20:00 hours, patient experienced diarrhea, gas/stomach cramps and was very tired. On 18Mar2021 at 01:30 hours, patient also experienced severe chills, headache and injection site pain. Patient continued to experience severe headache and pain. Therapeutic measure included self-treatment with EXCEDRIN which resulted into subsiding of the tension headache and body pain at 15:30 hours on 18Mar2021. The patient experienced fatigue and mostly slept rest of the day. The clinical outcome of tiredness, diarrhea, gas/stomach cramps, severe chills, headache, fatigue and injection site pain was resolving.   No follow-up attempts are needed. No further information is expected.