chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Immunisation, Lymph node pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028, solution for injection) via an unspecified route of administration in the left arm on 11Nov2021 at 18:00 (at the age of 46-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included iron deficiency and had known allergies to penicillin. 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. Concomitant medications received within two weeks of vaccination included FOCUS FACTOR at 2x/week, VITAMIN D3, and NUTRILITE at 2x/week, all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 17:00 (at the age of 46-years-old) as dose 1, single and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 25Apr2021 at 11:00 (at the age of 46-years-old) as a dose 2, single for COVID-19 immunisation. On 11Nov2021 at 18:00, immediately after injection, the patient had pain at injection site. On 12Nov2021 at 03:00, after 9 hours (all side effects started around the same time), the patient experienced chills, fever (38 centigrade), sweating, pain in lymph nodes (left arm pit), fatigue, nausea, muscles and joints pain, light headache, and loss of appetite. After about 80 hours almost all above side effects diminished except for sweating and lymph node pain in the left arm pit. On 14Nov2021 at 06:00, after about 60 hours, mild intermittent pain started in upper left abdomen area, which got worse about 15 minutes after each meal and improved, but did not go away after about 4 hours, which was still present at 78 hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL 1 tablet only, which did not help at all. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, chills, fever (38C), fatigue, nausea, muscles and joints pain, light headache, and loss of appetite was recovering. The events sweating, pain in lymph nodes, and mild intermittent pain started in upper left abdomen area was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028, solution for injection) via an unspecified route of administration in the left arm on 11Nov2021 at 18:00 (at the age of 46-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included iron deficiency and had known allergies to penicillin. 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. Concomitant medications received within two weeks of vaccination included FOCUS FACTOR at 2x/week, VITAMIN D3, and NUTRILITE at 2x/week, all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 17:00 (at the age of 46-years-old) as dose 1, single and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 25Apr2021 at 11:00 (at the age of 46-years-old) as a dose 2, single for COVID-19 immunisation. On 11Nov2021 at 18:00, immediately after injection, the patient had pain at injection site. On 12Nov2021 at 03:00, after 9 hours (all side effects started around the same time), the patient experienced chills, fever (38 centigrade), sweating, pain in lymph nodes (left arm pit), fatigue, nausea, muscles and joints pain, light headache, and loss of appetite. After about 80 hours almost all above side effects diminished except for sweating and lymph node pain in the left arm pit. On 14Nov2021 at 06:00, after about 60 hours, mild intermittent pain started in upper left abdomen area, which got worse about 15 minutes after each meal and improved, but did not go away after about 4 hours, which was still present at 78 hours post injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL 1 tablet only, which did not help at all. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, chills, fever (38C), fatigue, nausea, muscles and joints pain, light headache, and loss of appetite was recovering. The events sweating, pain in lymph nodes, and mild intermittent pain started in upper left abdomen area was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: off label use; 6 yo female had fever and 24hra post first dose of Covid 19 vaccine; 6 yo female had fever and 24hra post first dose of Covid 19 vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off label use"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "6 yo female had fever and 24hra post first dose of Covid 19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: 3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul; Interchange of vaccine products; 3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul; fever of 100.4 which lasted for about 24 hours; severe arm pain; fatigue; headache; heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate; heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jul2021 11:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Sinopharm (1st dose, did not experience any side effects), administration date: 21Feb2021, when the patient was 25 years old, for COVID-19 immunization; Sinopharm (2nd dose, experienced arm pain, fatigue, and a hotter body (but my body temperature is normal), administration date: 11Mar2021, when the patient was 25 years old, for Covid-19 immunization; Sinopharm (2nd dose), for Covid-19 immunization, reaction(s): "fatigue", "hotter body", "arm pain". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 25Jul2021 22:00, outcome "unknown" and all described as "3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "Interchange of vaccine products"; PYREXIA (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "fever of 100.4 which lasted for about 24 hours"; PAIN IN EXTREMITY (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "severe arm pain"; FATIGUE (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "headache"; PALPITATIONS (non-serious), HEART RATE INCREASED (non-serious) all with onset 25Jul2021 22:00, outcome "unknown" and all described as "heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Palpitations
Clinical narrative: 3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul; Interchange of vaccine products; 3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul; fever of 100.4 which lasted for about 24 hours; severe arm pain; fatigue; headache; heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate; heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jul2021 11:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Sinopharm (1st dose, did not experience any side effects), administration date: 21Feb2021, when the patient was 25 years old, for COVID-19 immunization; Sinopharm (2nd dose, experienced arm pain, fatigue, and a hotter body (but my body temperature is normal), administration date: 11Mar2021, when the patient was 25 years old, for Covid-19 immunization; Sinopharm (2nd dose), for Covid-19 immunization, reaction(s): "fatigue", "hotter body", "arm pain". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 25Jul2021 22:00, outcome "unknown" and all described as "3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "Interchange of vaccine products"; PYREXIA (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "fever of 100.4 which lasted for about 24 hours"; PAIN IN EXTREMITY (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "severe arm pain"; FATIGUE (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "headache"; PALPITATIONS (non-serious), HEART RATE INCREASED (non-serious) all with onset 25Jul2021 22:00, outcome "unknown" and all described as "heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul; Interchange of vaccine products; 3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul; fever of 100.4 which lasted for about 24 hours; severe arm pain; fatigue; headache; heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate; heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jul2021 11:00 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Sinopharm (1st dose, did not experience any side effects), administration date: 21Feb2021, when the patient was 25 years old, for COVID-19 immunization; Sinopharm (2nd dose, experienced arm pain, fatigue, and a hotter body (but my body temperature is normal), administration date: 11Mar2021, when the patient was 25 years old, for Covid-19 immunization; Sinopharm (2nd dose), for Covid-19 immunization, reaction(s): "fatigue", "hotter body", "arm pain". The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 25Jul2021 22:00, outcome "unknown" and all described as "3rd Shot: I got another shot of Pfizer at 11 AM on 25Jul"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "Interchange of vaccine products"; PYREXIA (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "fever of 100.4 which lasted for about 24 hours"; PAIN IN EXTREMITY (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "severe arm pain"; FATIGUE (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 25Jul2021 22:00, outcome "unknown", described as "headache"; PALPITATIONS (non-serious), HEART RATE INCREASED (non-serious) all with onset 25Jul2021 22:00, outcome "unknown" and all described as "heart raced (my resting rate is usually 50-60 BPM but it reached 70-80 after the shot)/Increased heart rate". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation
Clinical narrative: received the booster on 2nd Sep; having a widespread joint pain.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US118963_NS.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Patient received COVID shot on 23rd Feb 2021 and March of this year), administration date: 23Feb2021, when the patient was 68 years old, for COVID-19 immunisation; Bnt162b2 (Patient received COVID shot on 23rd Feb 2021 and March of this year), administration date: Mar2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "having a widespread joint pain."; IMMUNISATION (non-serious) with onset 02Sep2021, outcome "unknown", described as "received the booster on 2nd Sep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Body temperature, Gingival pain, Immunisation, Pain
Clinical narrative: booster shot; vomiting; fever of a hundred degrees; mouth pain in my gums; canker sore; body aches; swelling in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (Lot number: ff2590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2), when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "booster shot"; VOMITING (non-serious) with onset 13Nov2021, outcome "unknown", described as "vomiting"; PYREXIA (non-serious) with onset 13Nov2021, outcome "unknown", described as "fever of a hundred degrees"; GINGIVAL PAIN (non-serious) with onset 13Nov2021, outcome "unknown", described as "mouth pain in my gums"; APHTHOUS ULCER (non-serious) with onset 13Nov2021, outcome "unknown", described as "canker sore"; PAIN (non-serious) with onset 13Nov2021, outcome "unknown", described as "body aches"; PERIPHERAL SWELLING (non-serious) with onset 13Nov2021, outcome "unknown", described as "swelling in my arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient started having side effects about sixteen hours after the booster shot.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: booster shot; vomiting; fever of a hundred degrees; mouth pain in my gums; canker sore; body aches; swelling in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (Lot number: ff2590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2), when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "booster shot"; VOMITING (non-serious) with onset 13Nov2021, outcome "unknown", described as "vomiting"; PYREXIA (non-serious) with onset 13Nov2021, outcome "unknown", described as "fever of a hundred degrees"; GINGIVAL PAIN (non-serious) with onset 13Nov2021, outcome "unknown", described as "mouth pain in my gums"; APHTHOUS ULCER (non-serious) with onset 13Nov2021, outcome "unknown", described as "canker sore"; PAIN (non-serious) with onset 13Nov2021, outcome "unknown", described as "body aches"; PERIPHERAL SWELLING (non-serious) with onset 13Nov2021, outcome "unknown", described as "swelling in my arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient started having side effects about sixteen hours after the booster shot.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; pain in both elbow joints; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 25Apr2021, for COVID-19 immunization, reaction(s): "Pain in glutes", "restless muscles", "Fever"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization, reaction(s): "No reaction for dose 01". The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "recovered", described as "pain in both elbow joints". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia.  Additional Information : 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, has the patient been tested for COVID-19. Treatment received as Tylenol for the arthralgia. COVID test post vaccination: COVID test type post vaccination: Nasal Swab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pyrexia
Clinical narrative: booster; felt achy; had a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "felt achy"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "had a fever".  Additional information: withheld states he with Pfizer Pharmaceuticals Vaccine Customer Service Department and states he has no CEP or program number to provide; states he had a caller on the line who reported that patient had a reaction to the Pfizer Booster vaccine and she described she was having an issue and her doctor recommended her to fast prior to the shot and she took a pill she mentioned for fasting for her booster and after this she experienced events lasted for about 5 days and was asking for information. As per reporter details Transferring agent state he believes the caller spells her name as documented and states he has no further details to provide.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Immunisation, Pain in extremity
Clinical narrative: Had headache; fever; backache; aches in both upper and lower legs; fatigue; dose received:3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FH 8030) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; LEVOTHYROXINE. Past drug history included: Codine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 6201, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 84 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9261, Location of injection: Arm Left), administration date: 29Jan2021, when the patient was 84 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "dose received:3"; HEADACHE (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "Had headache"; PYREXIA (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "fever"; BACK PAIN (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "backache"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "aches in both upper and lower legs"; FATIGUE (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "fatigue". The events "dose received:3", "had headache", "fever", "backache", "aches in both upper and lower legs" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, pyrexia, back pain, pain in extremity, fatigue.  Additional Information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the flonase, prednisone as a treatment for the events.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had headache; fever; backache; aches in both upper and lower legs; fatigue; dose received:3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FH 8030) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; LEVOTHYROXINE. Past drug history included: Codine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 6201, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 84 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9261, Location of injection: Arm Left), administration date: 29Jan2021, when the patient was 84 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "dose received:3"; HEADACHE (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "Had headache"; PYREXIA (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "fever"; BACK PAIN (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "backache"; PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "aches in both upper and lower legs"; FATIGUE (non-serious) with onset 10Nov2021 20:00, outcome "recovering", described as "fatigue". The events "dose received:3", "had headache", "fever", "backache", "aches in both upper and lower legs" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache, pyrexia, back pain, pain in extremity, fatigue.  Additional Information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the flonase, prednisone as a treatment for the events.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Movement disorder, Product use issue, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Injection site for Booster shot in left arm, administered on November 4th, still sore when raising arm; can feel a bit of discomfort when pressing on injection site; Injection site for Booster shot in left arm, administered on November 4th, still sore when raising arm; Dose received: 3; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 12:30 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 04Nov2021; VALACYCLOVIR [VALACICLOVIR]; LAMOTRIGINE; BUPROPION; ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021, outcome "unknown", described as "Dose received: 3"; PRODUCT USE ISSUE (non-serious) with onset 04Nov2021, outcome "unknown", described as "Product use for unapproved combination"; MOVEMENT DISORDER (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 05Nov2021 08:00, outcome "not recovered" and all described as "Injection site for Booster shot in left arm, administered on November 4th, still sore when raising arm"; VACCINATION SITE DISCOMFORT (non-serious) with onset 05Nov2021 08:00, outcome "not recovered", described as "can feel a bit of discomfort when pressing on injection site". Therapeutic measures were not taken as a result of movement disorder, vaccination site discomfort, vaccination site pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain, Pain in extremity, Pyrexia
Clinical narrative: I just took the booster dose; Fever; body aches; Headache; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8030) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "I just took the booster dose"; PYREXIA (non-serious) with onset 16Nov2021, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset 16Nov2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 16Nov2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome "unknown", described as "Arm pain".  Additional Information: I didn't have any side effects from the 2nd dose but did from the booster.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Pfizer booster for the Covid vaccine; itchy bump appeared at the injection site; red spot appeared at the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, she had no reaction with the first 2 doses), for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (Second Dose, she had no reaction with the first 2 doses), for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Pfizer booster for the Covid vaccine"; VACCINATION SITE PRURITUS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "itchy bump appeared at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "red spot appeared at the injection site."  Additional information: Per caller after receiving the Pfizer Covid 19 booster vaccine, she developed an itchy bump. The bump has now went away and she has a red spot that appeared. The bump and red spot appeared at the injection site. Caller asking if it is normal. If it would go away. Calling about the Pfizer booster for the Covid vaccine. She stated that she got the booster a couple weeks ago and she still had a red spot. Is that normal and will the red spot go away or will she be left with a spot there. She stated that she had no reaction with the first 2 doses, but after the booster she did a have little itchy bump, but the itchy bump had gone away and now she just had this red spot. She stated she only had a few minutes before she had to leave, and requests to be transferred to address her questions.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: dose number: 3; Arm was very sore; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: EW0196) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 04Mar2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 24Mar2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "dose number: 3"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "Arm was very sore"; PYREXIA (non-serious) with onset 16Nov2021, outcome "recovered" (2021), described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, pain in extremity, pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Off label use, Product use issue, Rash
Clinical narrative: Got a rash on most of body; The patient received the third/booster dose of BNT162b2; The patient received influenza vaccine (flu shot) and BNT162b2 on the same day (23Oct2021); The patient received influenza vaccine (flu shot) and BNT162b2 on the same day (23Oct2021); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 12:15 (Lot number: EW0217) at the age of 31 years as dose 3 (booster), single for covid-19 immunization; influenza vaccine (INFLUENZA), administered in arm right, administration date 23Oct2021 (Batch/Lot number: unknown) for immunization. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Scallops. The patient took concomitant medications. Past drug history included: Zyrtec, reaction(s): "Drug allergy", notes: Known allergies: Zyrtec; Levaquin, reaction(s): "Drug allergy", notes: Known allergies: Levaquin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6200; Administration time: 15:30; Anatomical site: Left arm), administration date: 16Feb2021, when the patient was 31 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot Number: EN6199; Administration time: 12:30; Anatomical site: Left arm), administration date: 09Mar2021, when the patient was 31 years old, for COVID-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Oct2021, outcome "unknown" and all described as "The patient received influenza vaccine (flu shot) and BNT162b2 on the same day (23Oct2021)"; IMMUNIZATION (non-serious) with onset 23Oct2021 12:15, outcome "unknown", described as "The patient received the third/booster dose of BNT162b2"; RASH (non-serious) with onset 24Oct2021, outcome "recovered" (2021), described as "Got a rash on most of body". The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with diphenhydramine (BENADRYL) and it stopped the spread. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up (24Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, SARS-CoV-2 test
Clinical narrative: alopecia areata; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Nov2021 13:30 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 23Oct2021. The following information was reported: ALOPECIA AREATA (non-serious) with onset 19Nov2021, outcome "unknown", described as "alopecia areata". The event "alopecia areata" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of alopecia areata.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Feeling hot, Immunisation
Clinical narrative: Covid 19 booster vaccine; Fever of 100.5 after booster; Feels weak after booster; Feels overheated after booster; Chills after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid 19 booster vaccine"; PYREXIA (non-serious), outcome "unknown", described as "Fever of 100.5 after booster"; ASTHENIA (non-serious), outcome "unknown", described as "Feels weak after booster"; FEELING HOT (non-serious), outcome "unknown", described as "Feels overheated after booster"; CHILLS (non-serious), outcome "unknown", described as "Chills after booster". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.   Additional information:  Caller asks what should she do for that, maybe besides taking a Tylenol for the fever Caller does not states that she has taken Tylenol as of yet.  Caller states the vaccine instructions that she received are confusing and they do not instruct about the booster. Caller asks how will she feel. Caller declines to complete a safety report. Caller states she is starting to have chills. Caller states she woke up in the morning feeling this way.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Covid 19 booster vaccine; Fever of 100.5 after booster; Feels weak after booster; Feels overheated after booster; Chills after booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid 19 booster vaccine"; PYREXIA (non-serious), outcome "unknown", described as "Fever of 100.5 after booster"; ASTHENIA (non-serious), outcome "unknown", described as "Feels weak after booster"; FEELING HOT (non-serious), outcome "unknown", described as "Feels overheated after booster"; CHILLS (non-serious), outcome "unknown", described as "Chills after booster". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.   Additional information:  Caller asks what should she do for that, maybe besides taking a Tylenol for the fever Caller does not states that she has taken Tylenol as of yet.  Caller states the vaccine instructions that she received are confusing and they do not instruct about the booster. Caller asks how will she feel. Caller declines to complete a safety report. Caller states she is starting to have chills. Caller states she woke up in the morning feeling this way.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Immunisation, Ligament pain
Clinical narrative: Struggle with breathing; One week soreness in ligaments; Aches; High fever -102; Chills; Administration date 12Nov2021 at 13:30, dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 13:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: unknown, Anatomical site: Left arm, Administration time: 14:45), administration date: 31Mar2021, when the patient was 52 years old, for COVID-19 immunisation, reaction(s): "Administration date=17Mar2021, Dose 1/Administration date=31Mar2021, Dose 2"; Bnt162b2 (Dose 1, Lot number: unknown, Anatomical site: Left arm, Administration time: 13:30), administration date: 17Mar2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 13:30, outcome "unknown", described as "Administration date 12Nov2021 at 13:30, dose number: 3"; DYSPNOEA (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Struggle with breathing"; LIGAMENT PAIN (non-serious) with onset 13Nov2021 19:30, outcome "recovered" (20Nov2021), described as "One week soreness in ligaments"; PAIN (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Aches"; PYREXIA (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "High fever -102"; CHILLS (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, ligament pain, pain, pyrexia, chills.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At 30 hour, after 3rd dose patient experienced high fever -102, chills, aches, struggle with breathing and 1 week soreness in ligaments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.