chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer 10 years ago. The patient did not have any known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and venlafaxine hydrochloride (EFFEXOR) from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 16:00, the patient experienced shaky, nausea, diarrhea, couldn't walk, headache  and fever. Therapeutic measures were taken as a result of  the events included treatment with TYLENOL ,ADVIL, ZOFRON and IMODIUM. The clinical outcomes of the events shaky, nausea, diarrhea, couldn't walk, headache, fever were not recovered at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles two days after 2nd dose of vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 38-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 23Mar2021(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 03Mar2021(at the age of 38-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. On 25Mar2021, two days after second dose of vaccine, the patient developed shingles. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with antiviral medication. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: extreme dizziness after 6 hours and still have it; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8727) via unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 42-years-old) as a single dose for Covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 17:00, 6 hours after vaccination, patient experienced extreme dizziness and still had it. The patient received dizziness pills for the adverse event. The event resulted in emergency room/department or urgent care visit. The clinical outcome of the event dizziness was not resolved at the time of reporting.   No follow-up attempts are needed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye swelling, Urticaria
Clinical narrative: A 41-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via an unspecified route of administration on 23Mar2021 (at age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) on 02Mar2021 (at age of 41-years-old) as a single dose for COVID-19 immunisation. On an unspecified date, patient has welts on the arms and neck. Treatment received was diphenhydramine hydrochloride (BENADRYL) but they won't go away, she had been taking 1 capsule 25 mg once a day and now going to take 2 capsules because getting more welts and was scratching her arms. In addition, one day she woke up with a swollen left eye and the next day, the right eye too. At the time of reporting, the outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Myalgia, Nasopharyngitis, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), Dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took advil pain patches, Aleve, and Salonpas pain patches for bad back and bad knees. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced pain in her joints and muscle, feeling achy, feeling like was getting a cold with sneezing and coughing that lasted a day, and feeling sleepy for 2 days but she was over that. She was given the vaccination, she stated they put the needle in way top of my shoulder where the bone was. She wanted to know how long her side effects were expected to last. That morning she heard on a television program that the Pfizer BioNTech COVID-19 vaccine was good for up to 6 months. She understood that she would not have any of the protection against catching COVID-19 after 6 months and wanted to know what happened after the 6 months were over. She was concerned that in 6 months she would have to take another dose of the vaccine. She stated that when her daughter received her vaccination, her card had an expiration date written on it. Outcome of the events pain in her joints and muscle, feeling achy, feeling like was getting a cold with sneezing and coughing that lasted a day was reported as recovered on an unspecified date. Outcome of the events feeling sleepy for 2 days and given the vaccination, she stated they put the needle in way top of my shoulder where the bone was, was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Sneezing, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), Dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took advil pain patches, Aleve, and Salonpas pain patches for bad back and bad knees. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced pain in her joints and muscle, feeling achy, feeling like was getting a cold with sneezing and coughing that lasted a day, and feeling sleepy for 2 days but she was over that. She was given the vaccination, she stated they put the needle in way top of my shoulder where the bone was. She wanted to know how long her side effects were expected to last. That morning she heard on a television program that the Pfizer BioNTech COVID-19 vaccine was good for up to 6 months. She understood that she would not have any of the protection against catching COVID-19 after 6 months and wanted to know what happened after the 6 months were over. She was concerned that in 6 months she would have to take another dose of the vaccine. She stated that when her daughter received her vaccination, her card had an expiration date written on it. Outcome of the events pain in her joints and muscle, feeling achy, feeling like was getting a cold with sneezing and coughing that lasted a day was reported as recovered on an unspecified date. Outcome of the events feeling sleepy for 2 days and given the vaccination, she stated they put the needle in way top of my shoulder where the bone was, was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in left arm on 31Mar2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in left arm on 10Mar2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Since vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 23:00, the patient experienced headache. No therapeutic measures were taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event headache was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in left arm on 31Mar2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in left arm on 10Mar2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Since vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 23:00, the patient experienced headache. No therapeutic measures were taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event headache was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on an unknown date in Mar2021 (Batch/Lot Number: ER2613) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included Hepatitis A vaccine for immunization on an unspecified date (after 2 of them, I never had antibodies either, I didn't check after the third one). Patient stated received the first dose of Pfizer covid vaccine about 12 days ago, shortly after she had tingling in face and numbness on left side of her face on an unknown date in Mar2021. Her injection side was on the left. Her doctor had her take an antibody test taken 12 days after, and it came back negative, she also stated the next time if patient would get it, she would get it in her right arm and patient was also concerned if she would get the second dose, it may be worse. Patient also wanted to know by when the patient would be developing the antibodies. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which was negative. The outcome for both the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling cold, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer via Medical Information Team. A 56-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955), via an unspecified route of administration, administered in left arm (left upper arm as reported) on 22Mar2021 at 9:30 am (at the age of 56-years-old) as dose 1, single for COVID-19 immunization (vaccine was being given out by military but is not a military facility). The patient medical history included blood pressure. Concomitant medications included Amlodipine for blood pressure which patient had been taking for 7 years. There was no history of all previously immunization and no additional vaccines administered on same date. No family medical history reported. Patient had been feeling dizzy for about a month prior to the first dose. On 23Mar2021 (very next day of vaccination), patient diagnosed with Covid and experienced fever, chills, and feeling cold on an unspecified date in Mar2021. Patient stated that she had a doctor appointment and went to the ear, nose, throat doctor the next day and she was sent for further testing for a COVID-19 test and results came back positive. Patient attributed events to getting the vaccine, but then had tested positive. After testing Positive for COVID-19, the patient had quarantine for a couple of weeks, 10-14 days. The events were Non-serious. Patient was due to have the 2nd vaccine on 12Apr2021 and was asking if she should reschedule as she would be out of quarantine by then. Patient stated that she does not even know if the first one was effective; and wants to know if she needs to start over and was asking if ok to get the second shot or she should wait. Patient stated that she was curious and that this was terrible. Patient asked if first one affected (because tested positive for COVID), was it considered effective or do she have to restart over again. The patient underwent lab tests which included SARS-CoV-2 Test: Positive (COVID-19) on 23Mar2021. Patient stated was given no other treatment tests: exam by ear, nose, throat doctor, nothing significant. The outcome of the events was unknown. It was reported that there was a product complaint with description of complaint: Test result positive for COVID-19 after receiving first dose COVID-19 Vaccine. Description of complaint: Patient again described the entire events in the complaint description. And additional information reported was: Product strength and count size dispensed: unknown; Additional lot numbers: unknown; There was no sample of the product available to be returned, if requested. It was unknown if the packaging was sealed and intact. Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling lips; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 14:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive other medications within two weeks of vaccination. The patient had no allergies to food, drug or any other medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 16:00, the patient experienced tingling lips and tingling tongue. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tingling lips and tingling tongue was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history and allergic history to medications, food, or other products were reported as no. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and ibuprofen (MANUFACTURER UNKNOWN); all for unknown indication from an unspecified date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 01770605) via an unspecified route of administration in the left arm on 06Mar2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 02:00, 36 hours after receiving second dose the patient experienced arm swollen at injection site and swelling was the size of an egg.  On 29Mar2021 at 14:00, 48 hours after receiving second dose, patient lower lip swelled up and 6 hours later the top lip started swelling up. Lip swelling started going down 24 hours after the start of each area. The event 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 outcome of the events vaccination site swelling and lip swelling were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Musculoskeletal stiffness, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: slight pain/pinching sensation near lymph-nodes on armpit of injection arm; Stiffness/soreness on arm near injection; Stiffness/soreness on arm near injection; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 12:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included norethisterone acetate; ferrous fumarate; ethinylestradiol (JUNEL FE) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021, the patient experienced stiffness/soreness on arm near injection. On 29Mar2021, two days after injection, the patient experienced slight pain/pinching sensation near lymph-nodes in the armpit of injected arm. 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 underwent lab test on 30Mar2021 which included COVID test and the test result was pending. The patient did not receive any treatment for the events muscle stiffness, vaccination site pain and lymph node pain. The clinical outcomes of the events muscle stiffness, vaccination site pain and lymph node pain were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: low grade fever; fatigue; Injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8732) via an unspecified route of administration in the left arm on 28Mar2021 at 19:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no 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: en6205) via an unspecified route of administration in the left arm on 07Mar2021 at 19:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not undergo a COVID-19 test. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Following day of vaccination on 29Mar2021 at 00:00, the patient experienced low grade fever, fatigue and injection site sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events low grade fever, fatigue and injection site sore. The clinical outcomes of the events low grade fever, fatigue and injection site sore were recovering at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: extreme fatigue; body pain/ internal organ pain to the point of doubling over; slight fever; severe headache; weird skin sensations; nausea; diarrhea; painful left arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 12:15 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) 5 mg, for an unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 12:00 (7 days after the second vaccination), the patient experienced extreme fatigue, body pain, internal organ pain to the point of doubling over, slight fever, severe headache, weird skin sensations, nausea, diarrhea and very painful left arm. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme fatigue, body pain, internal organ pain to the point of doubling over, slight fever, severe headache, weird skin sensations, nausea, diarrhea and very painful left arm were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Skin discomfort
Clinical narrative: extreme fatigue; body pain/ internal organ pain to the point of doubling over; slight fever; severe headache; weird skin sensations; nausea; diarrhea; painful left arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 12:15 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) 5 mg, for an unknown indication from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 12:00 (7 days after the second vaccination), the patient experienced extreme fatigue, body pain, internal organ pain to the point of doubling over, slight fever, severe headache, weird skin sensations, nausea, diarrhea and very painful left arm. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme fatigue, body pain, internal organ pain to the point of doubling over, slight fever, severe headache, weird skin sensations, nausea, diarrhea and very painful left arm were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lip swelling, Pain in extremity
Clinical narrative: Swollen lip; Brain fog; Headache; Arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 . Since the vaccination, the patient had not been tested for COVID-19. On an unknown date the patient experienced headache, swollen lip, brain fog and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, swollen lip, brain fog and arm pain were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in arm one weekafter.; chills within 16 hours of shot lasting 18 hours.; fever within 16 hours of shot lasting 18 hours.; severe muscle aches within 16 hours of shot lasting 18 hours.; This is a spontaneous report from a non-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: unknown), via an unspecified route of administration in left arm on 21Mar2021 at 1200 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient medical history included allergic to codeine. Concomitant medications were not reported. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route and site of administration on an unknown date 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 the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, at 1500, the patient experienced chills, fever and severe muscle aches within 16 hours of shot which lasted for 18 hours. The patient also experienced severe pain in arm after one week on 29Mar2021. The adverse event did not result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events reported. The clinical outcome of the events chills, fever, muscle aches and pain in arm were recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever 100.5; chills; aches; very mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergic history to medications, food, or other products was not reported. The concomitant medications included cyanocobalamin (B12), pyridoxine hydrochloride (VITAMIN B-6), tocopherol (VITAMIN E), ascorbic acid (VITAMIN C), phytomenadione (VITAMIN K), iron (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. The patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 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 30Mar2021 at 10:00, the patient experienced fever 100.5 (unspecified units), chills, aches, very mild headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever 100.5, chills, aches, very mild headache was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Fatigue, Myalgia, Oral mucosal blistering
Clinical narrative: Blister appeared in mouth on the skin on the roof of mouth towards the back; Slight tightness in chest.; Fever (101); Muscle aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg and bupropion hydrochloride (WELLBUTRIN) 150mg SR. The patient experienced allergies to nickel, thimerosal, and other preservative found in soaps. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205,), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25Mar2021 at 05:00, the patient experienced fever (101) (unspecified units) with muscle aches and extreme fatigue. The patient also reported that these events lasted roughly 24 hours. On 27Mar2021, then each day after the patient experienced slight fatigue that worsened towards the end of the day. A week later, on an unspecified date in Apr2021, the patient also experienced a blister that appeared in mouth on the skin on the roof of mouth towards the back. The patient had never experienced this before. On an unspecified date in Apr2021, the patient experienced slight tightness in the chest and some fatigue still. Therapeutic measures included intake of TYLENOL on 25Mar2021. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events fever and muscle aches were resolved on 26Mar2021. The clinical outcomes of the events fatigue, blister appeared in mouth and slight tightness in chest were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Blister appeared in mouth on the skin on the roof of mouth towards the back; Slight tightness in chest.; Fever (101); Muscle aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg and bupropion hydrochloride (WELLBUTRIN) 150mg SR. The patient experienced allergies to nickel, thimerosal, and other preservative found in soaps. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205,), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25Mar2021 at 05:00, the patient experienced fever (101) (unspecified units) with muscle aches and extreme fatigue. The patient also reported that these events lasted roughly 24 hours. On 27Mar2021, then each day after the patient experienced slight fatigue that worsened towards the end of the day. A week later, on an unspecified date in Apr2021, the patient also experienced a blister that appeared in mouth on the skin on the roof of mouth towards the back. The patient had never experienced this before. On an unspecified date in Apr2021, the patient experienced slight tightness in the chest and some fatigue still. Therapeutic measures included intake of TYLENOL on 25Mar2021. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events fever and muscle aches were resolved on 26Mar2021. The clinical outcomes of the events fatigue, blister appeared in mouth and slight tightness in chest were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Menstruation irregular, Pain in extremity
Clinical narrative: Tiredness, severe insomnia, irregular menstrual cycle (6 days late and it's never late), sore arm for 2 days,  headaches; Tiredness; Severe insomnia; Irregular menstrual cycle; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 25Mar2021 at 16:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 17:30, the patient experienced tiredness, severe insomnia, irregular menstrual cycle (6 days late and it's never late), sore arm for 2 days and headache .The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tiredness, severe insomnia, irregular menstrual cycle, sore arm and headaches  was not recovered at the time of this report   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Nausea, Pain
Clinical narrative: Chills; Soreness in arm; Aches; Nausea; Headache; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in her left arm on 26Mar2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in her right arm on 05Mar2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had not received 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 27Mar2021 at 01:00, the patient experienced chills, soreness in arm, aches, nausea, headache and lethargy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events chills, soreness in arm, aches, nausea, headache and lethargy was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Chills; Soreness in arm; Aches; Nausea; Headache; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in her left arm on 26Mar2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in her right arm on 05Mar2021 at 12:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had not received 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 27Mar2021 at 01:00, the patient experienced chills, soreness in arm, aches, nausea, headache and lethargy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events chills, soreness in arm, aches, nausea, headache and lethargy was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test, Nasal congestion, Pain in extremity
Clinical narrative: loss taste; loss of smell; Runny nose and slight congestion; runny nose; Sore arm day of injection; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old  patient of unknown gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the arm right on 18Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive medication within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test on 26Mar2021 which included nasal swab test, blood test, PCR, rapid COVID test and COVID antibody test and all the test result was negative. On 18Mar2021 the patient experienced sore arm, on 23Mar2021 the patient experienced runny nose and congestion and on 26Mar2021 the patient experienced loss taste and loss of smell. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events sore arm, runny nose and congestion, loss taste and loss of smell was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: loss taste; loss of smell; Runny nose and slight congestion; runny nose; Sore arm day of injection; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old  patient of unknown gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the arm right on 18Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive medication within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test on 26Mar2021 which included nasal swab test, blood test, PCR, rapid COVID test and COVID antibody test and all the test result was negative. On 18Mar2021 the patient experienced sore arm, on 23Mar2021 the patient experienced runny nose and congestion and on 26Mar2021 the patient experienced loss taste and loss of smell. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events sore arm, runny nose and congestion, loss taste and loss of smell was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Swollen glands on my neck and on the right side; Pain severe.; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, hypertension, depression, anxiety, stroke. The patient was allergic to iodine and shellfish. Concomitant medications included unspecified medications received within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN62003) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination.  Prior to the vaccination, the patient had not been diagnosed with COVID-19. On 13Feb2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On an unknown date, the patient underwent unspecified blood test and the result was negative.  Since having the vaccine, the patient had been tested for COVID-19. On 28Mar2021 at 04:00, the patient experienced swollen glands on the neck and on the right side of head the side where glands were swollen, the pain was severe, it hurt till the temple of head. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen glands on my neck and on the right side and severe pain were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.