chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: swollen lymph nodes in left arm pit and left jaw/neck area.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 13:00 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history, Name of Drug as Reported: no, Reaction: Allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 13:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "swollen lymph nodes in left arm pit and left jaw/neck area.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. patient was not diagnosed with covid-19 prior to vaccination. since the vaccination patient was not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Immunisation, Vomiting
Clinical narrative: Severe headache; Vomiting (6+ times); Drinking anything made me sick; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old emale patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FG3527) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included LISINOPRIL; LEVOTHYROXINE; ASPIRIN; KOACT. Past drug history included Morphine, allergy reaction. Vaccination history included'''=[/ Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM), administration date: 06Mar2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM), administration date: 28Mar2021, when the patient was 61 years old, for COVID-19 immunization.  The following information was reported IMMUNISATION (non-serious) with onset 19Nov2021, outcome unknown; HEADACHE (non-serious) with onset 20Nov2021 09:00, outcome recovered (Nov2021); VOMITING (non-serious) with onset 20Nov2021 09:00, outcome recovered (Nov2021); ILLNESS (non-serious) with onset 20Nov2021 09:00, outcome recovered (Nov2021). Therapeutic measures were not taken as a result of headache, vomiting, and illness.  Other medications in two week, Lisinopril, levothyroxine, aspirin, and koact.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Food intolerance, Hyperhidrosis, Immunisation, Nausea
Clinical narrative: inexperienced diffuse aches/pains; chills; sweating; nausea; vomiting; Consumption of additional mild food and water was not tolerated; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 11:00 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa meds" (unspecified if ongoing), notes: known allergies: Yes, sulfa meds. Concomitant medication(s) included: FEXOFENADINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 14May2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Start date: 21Nov2021), when the patient was 36 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021 11:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "inexperienced diffuse aches/pains"; CHILLS (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "sweating"; NAUSEA (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "vomiting"; FOOD INTOLERANCE (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "Consumption of additional mild food and water was not tolerated". Therapeutic measures were taken as a result of pain, chills, hyperhidrosis, nausea, vomiting, food intolerance.  Additional information: Approximately 12 hours after the vaccine, inexperienced diffuse aches/pains, chills, and sweating. Approximately 15 hours after administration, he experienced severe nausea and vomiting. Emesis was not productive. Consumption of additional mild food and water was not tolerated, for up to 27 hours post-vaccine. The patient received acetaminophen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested since vaccination. The patient was administered COVID-19 vaccine in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The device date was 21Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: inexperienced diffuse aches/pains; chills; sweating; nausea; vomiting; Consumption of additional mild food and water was not tolerated; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Nov2021 11:00 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: sulfa meds" (unspecified if ongoing), notes: known allergies: Yes, sulfa meds. Concomitant medication(s) included: FEXOFENADINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 14May2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Start date: 21Nov2021), when the patient was 36 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021 11:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "inexperienced diffuse aches/pains"; CHILLS (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "sweating"; NAUSEA (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "vomiting"; FOOD INTOLERANCE (non-serious) with onset 21Nov2021 23:00, outcome "recovering", described as "Consumption of additional mild food and water was not tolerated". Therapeutic measures were taken as a result of pain, chills, hyperhidrosis, nausea, vomiting, food intolerance.  Additional information: Approximately 12 hours after the vaccine, inexperienced diffuse aches/pains, chills, and sweating. Approximately 15 hours after administration, he experienced severe nausea and vomiting. Emesis was not productive. Consumption of additional mild food and water was not tolerated, for up to 27 hours post-vaccine. The patient received acetaminophen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested since vaccination. The patient was administered COVID-19 vaccine in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The device date was 21Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain, Vaccination site pain
Clinical narrative: dose_number=3; Injection site soreness; Full body soreness; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 15:15 (Lot number: FF2593) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 46 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 15:15, outcome "recovering", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Injection site soreness"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Full body soreness"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, pain, headache.  Additional Information: 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. Vaccination facility was Hospital. Device Date was 20Nov2021.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: After receiving my booster shot of the COVID-19 vaccine; my lymph node swelled up; 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 (BNT162B2), administered in arm (Lot number: FH8027) 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: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "After receiving my booster shot of the COVID-19 vaccine"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "my lymph node swelled up".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Pain
Clinical narrative: Dose 3; body aches; body joint aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 50's 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 (1st dose, 2 previous Pfizer Covid-19 , vaccinations with minimal aches or joint pain.), for COVID-19 immunization, reaction(s): "minimal aches or joint pain", "minimal aches or joint pain"; Bnt162b2 (2nd dose, 2 previous Pfizer Covid-19 , vaccinations with minimal aches or joint pain.), for COVID-19 immunization, reaction(s): "minimal aches or joint pain"; Bnt162b2 (2nd dose, 2 previous Pfizer Covid-19 , vaccinations with minimal aches or joint pain., No underlying conditions known), for COVID-19 immunization, reaction(s): "minimal aches or joint pain". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose 3"; PAIN (non-serious), outcome "unknown", described as "body aches"; ARTHRALGIA (non-serious), outcome "unknown", described as "body joint aches". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest discomfort, Chest pain, Fatigue, Immunisation
Clinical narrative: My arm at injection site is much more sore than previous injections.; armpit is EXTREMELY sore; chest is tight on the same side (left) where the injection was given.; chest does not hurt as much; booster; a little more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 14:15 (Lot number: FF8841) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Diabetes (unspecified if ongoing); depression (unspecified if ongoing); anxiety (unspecified if ongoing); ADHD (unspecified if ongoing). Concomitant medication(s) included CELEXA; TRULICITY; SYNJARDY; BUPROPION. Past drug history included Codine, Drug Allergy. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Reaction: arm at injection site is much more sore than previous injections), administration date: 22Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s) included arm at injection site is much more sore than previous injections; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0612, Location of injection Arm Left. The Reaction included arm at injection site is much more sore than previous injections, administration date: 15Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021 14:15, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome not recovered; AXILLARY PAIN (non-serious) with onset 19Nov2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 19Nov2021, outcome recovering; FATIGUE (non-serious) with onset 18Nov2021, outcome recovering; CHEST PAIN (non-serious) with onset 19Nov2021, outcome recovering. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, chest discomfort, fatigue, and chest pain.  Patient arm at injection site is much more sore than previous injections. Her armpit is extremely sore and chest is tight on the same side (left) where the injection was given. The same day after receiving the shot, she had no pain. She was a little more tired than usual. The next day, her chest was tight, and armpit hurt real bad. Today is day 3 and still have armpit pain and pain at the injection site, chest does not hurt as much. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Fatigue onset was same day as the vaccination, while other events onset latency was 9 hours 45 minutes.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm at injection site is much more sore than previous injections.; armpit is EXTREMELY sore; chest is tight on the same side (left) where the injection was given.; chest does not hurt as much; booster; a little more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 14:15 (Lot number: FF8841) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Diabetes (unspecified if ongoing); depression (unspecified if ongoing); anxiety (unspecified if ongoing); ADHD (unspecified if ongoing). Concomitant medication(s) included CELEXA; TRULICITY; SYNJARDY; BUPROPION. Past drug history included Codine, Drug Allergy. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Reaction: arm at injection site is much more sore than previous injections), administration date: 22Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s) included arm at injection site is much more sore than previous injections; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0612, Location of injection Arm Left. The Reaction included arm at injection site is much more sore than previous injections, administration date: 15Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021 14:15, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome not recovered; AXILLARY PAIN (non-serious) with onset 19Nov2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 19Nov2021, outcome recovering; FATIGUE (non-serious) with onset 18Nov2021, outcome recovering; CHEST PAIN (non-serious) with onset 19Nov2021, outcome recovering. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, chest discomfort, fatigue, and chest pain.  Patient arm at injection site is much more sore than previous injections. Her armpit is extremely sore and chest is tight on the same side (left) where the injection was given. The same day after receiving the shot, she had no pain. She was a little more tired than usual. The next day, her chest was tight, and armpit hurt real bad. Today is day 3 and still have armpit pain and pain at the injection site, chest does not hurt as much. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Fatigue onset was same day as the vaccination, while other events onset latency was 9 hours 45 minutes.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: F51611) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary sequestration" (unspecified if ongoing); "Ovarian cysts" (unspecified if ongoing). Concomitant medication(s) included: PNEUMOCOCCAL 13 VALENT VACCINE, administration date 29Oct2021; ALLEGRA; JUNEL FE 1/20; VITAMIN D2. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM, No Events reported), administration date: 31Mar2021, when the patient was 28 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:30 AM), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 Immunization, reaction(s): "Began to have hives after 2nd dose". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:30, outcome "unknown", described as "Booster"; URTICARIA (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "Hours after 3rd dose, began to see hives again, on arm, face, chest."; PRURITUS (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "A little itchy but not serious". Therapeutic measures were not taken as a result of urticaria, pruritus. Additional information;    Addition information:  Prior to vaccination, was the patient diagnosed with COVID-19, Since the vaccination, has the patient been tested for COVID-19. Results in death, life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect: was non serious.   Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: She is feeling a bad reaction over the booster shot from Pfizer shot; She is feeling a bad reaction over the booster shot from Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FH8030) at the age of 80 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROZAC; BUSPAR. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "She is feeling a bad reaction over the booster shot from Pfizer shot".  Additional information: She took an Advil which was expired 2 years ago, 200 mg 1 tablet. Reporter stated lot number as PAA023944, but now was seeing the another number and do not know which was correct. On the side of the bottle it says expiration 02-20 and there was a number above it that was different than F99280.  Follow-up attempts completed. No further information expected
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Headache, Immunisation
Clinical narrative: felt dizzy with a severe headache; felt dizzy with a severe headache; slumped to the floor; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 10:15 (Lot number: FF2589) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; VYVANSE; BUSPAR; CLONAZEPAM; SERTRALINE; CLONIDINE; MELATONIN; BENADRYL. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207), administration date: 19Mar2021, when the patient was 23 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729), administration date: 12Apr2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 10:15, outcome "unknown", described as "Booster"; DIZZINESS (non-serious), HEADACHE (non-serious) all with onset 19Nov2021 10:30, outcome "recovered" (Nov2021) and all described as "felt dizzy with a severe headache"; FALL (non-serious) with onset 19Nov2021 10:30, outcome "recovered" (Nov2021), described as "slumped to the floor". The events "felt dizzy with a severe headache", "felt dizzy with a severe headache" and "slumped to the floor" were evaluated at the physician office visit. Therapeutic measures were taken as a result of immunisation, dizziness, headache, fall. Additional information: Facility where the most recent COVID-19 vaccine was administered was school or  health Clinic. Adverse event treatment She drank water and rested for approximately 45 minutes. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown. 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.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Illness, Immunisation, Influenza like illness
Clinical narrative: Booster; sick; fever; flu like symptoms; blood pressure has been high ever  since 140's over 80's; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 14:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "CPTSD" (unspecified if ongoing), notes: other medical history: CPTSD; "Asthma" (unspecified if ongoing); "Auto immune illness" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing), notes: Known Allergies: Sulfa. Concomitant medication(s) included: SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLOVENT; FIORICET. Past drug history included: Tegritol, reaction(s): "Known allergies: Tegritol", notes: Known Allergies: Tegritol; Haldal, reaction(s): "Known allergies: Haldal", notes: Known Allergies: Haldal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534,, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 22Mar2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO158, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 12Apr2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021 14:00, outcome "unknown", described as "Booster"; ILLNESS (non-serious) with onset 01Nov2021, outcome "unknown", described as "sick "; PYREXIA (non-serious) with onset 01Nov2021, outcome "unknown", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01Nov2021, outcome "unknown", described as "flu like symptoms"; HYPERTENSION (non-serious) with onset 01Nov2021, outcome "unknown", described as "blood pressure has been high ever since 140's over 80's". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Singular, Zertec, Flovent, Fiorcet. Patient stated that she was sick for a week, fever, flu like symptoms, her blood pressure has been high ever since 140's over 80's.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Booster; sick; fever; flu like symptoms; blood pressure has been high ever  since 140's over 80's; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 14:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "CPTSD" (unspecified if ongoing), notes: other medical history: CPTSD; "Asthma" (unspecified if ongoing); "Auto immune illness" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing), notes: Known Allergies: Sulfa. Concomitant medication(s) included: SINGULAIR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLOVENT; FIORICET. Past drug history included: Tegritol, reaction(s): "Known allergies: Tegritol", notes: Known Allergies: Tegritol; Haldal, reaction(s): "Known allergies: Haldal", notes: Known Allergies: Haldal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534,, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 22Mar2021, when the patient was 49 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO158, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 12Apr2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Nov2021 14:00, outcome "unknown", described as "Booster"; ILLNESS (non-serious) with onset 01Nov2021, outcome "unknown", described as "sick "; PYREXIA (non-serious) with onset 01Nov2021, outcome "unknown", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01Nov2021, outcome "unknown", described as "flu like symptoms"; HYPERTENSION (non-serious) with onset 01Nov2021, outcome "unknown", described as "blood pressure has been high ever since 140's over 80's". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Singular, Zertec, Flovent, Fiorcet. Patient stated that she was sick for a week, fever, flu like symptoms, her blood pressure has been high ever since 140's over 80's.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site mass
Clinical narrative: booster; I woke up with a big red bump where I got the shot and yesterday I still have the bump and today I still have the bump; 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 third dose of bnt162b2 (BNT162B2, Batch/Lot number: FG3527) administration date 19Nov2021 as DOSE 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Nov2021, outcome "not recovered", described as "I woke up with a big red bump where I got the shot and yesterday I still have the bump and today I still have the bump"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster".  Additional Information: Consumer stated that just wanted to talk about the side effects that had after getting the booster shot. Got the booster shot on Friday, did not had any reaction to it and then on Saturday, woke up with a big red bump where got the shot and yesterday still had the bump and today still have the bump so wanted to know if this was a normal side effect and if it will the bump go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Musculoskeletal stiffness, Rash erythematous
Clinical narrative: Developed diffuse rash on abdomen of small, pin size red dots within 24 hours of vaccine.; Also developed stiff neck on right side.; 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 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:15 (Lot number: Ff2593) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Eczema-not currently active; "ulcers" (unspecified if ongoing), notes: ulcers 37 years ago; "gall bladder removal" (unspecified if ongoing), notes: gall bladder removal 35 years ago; "facial filler", start date: Jul2020 (unspecified if ongoing), notes: facial filler. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; BIOTIN; VITAMIN C [ASCORBIC ACID]; TURMEE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0171, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 23Apr2021, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0183, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 54 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 09:15, outcome "unknown", described as "Dose number 3"; RASH ERYTHEMATOUS (non-serious) with onset 18Nov2021 11:30, outcome "recovered" (Nov2021), described as "Developed diffuse rash on abdomen of small, pin size red dots within 24 hours of vaccine."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 18Nov2021 11:30, outcome "recovered" (Nov2021), described as "Also developed stiff neck on right side.". Therapeutic measures were not taken as a result of rash erythematous, musculoskeletal stiffness.  Additional information: Was not itchy or painful. Second day the rash was light pink in color. Third day rash disappeared. Also developed stiff neck on right side. Had vaccine in left arm. Neck stiffness continued for about 32 hoursPrior 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.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Chills, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: Chills; Fever; sore arm; generalized bone pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 21Nov2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 21Nov2021, outcome "recovering", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "recovering", described as "sore arm"; BONE PAIN (non-serious) with onset 21Nov2021, outcome "recovering", described as "generalized bone pain". Therapeutic measures were taken as a result of chills, pyrexia, pain in extremity, bone pain.  Additional information: Treatment was given as Theraflu and Tylenol. Upon follow-up on 23Nov2021: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included Thanks for reporting to safety. There were two queries about the report are the patient withheld (myself), RN provided on the reporter email. But as per reporter email address, it seems that not consistent with initials CPD. Please help us to provide correct name of patient. And then start of AE Sunday Nov21 was provided the in reporter email. This adverse event start date, which was not always equal to the awareness date. The awareness date was reporter as 21Nov2021 for the adverse events. It was reported as Pfizer US Drug safety unit recently received the attached report submitted by reporter via withheld. This awareness date where reporter became aware of the occurrence of the reported events. If reporter were the patient in the case, the awareness date would be that reporter became aware were experiencing the reported events. This awareness date represents that Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. It was reported that do not consent further FU.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Malaise, Pain, Pyrexia
Clinical narrative: COVID-19 vaccine booster; soreness on the arm became the size of an egg; elevated body temperatures; Malaise; body aches; first side effects of soreness and pain on the injection site.; 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 (BNT162B2), administration date 17Nov2021 10:00 (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. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN (non-serious) with onset 18Nov2021, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome unknown; MALAISE (non-serious) with onset 18Nov2021, outcome recovering; PYREXIA (non-serious) with onset 18Nov2021 03:30, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 18Nov2021 07:00, outcome recovering. Relevant laboratory tests and procedures are available in the appropriate section.  Patient reported that Vaccine shot at around 10 am on 17Nov2021. Around noon first side effects of soreness and pain on the injection site. At 3:30am elevated body temperatures woke up patient on 18Nov. Malaise and body aches in the morning, resolving as time goes by. The soreness on the arm became the size of an egg around 7am this morning (18Nov). Also diminishing the size as the hours go by. COVID-19 vaccine booster. Event took place after use of product.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: COVID-19 vaccine booster; soreness on the arm became the size of an egg; elevated body temperatures; Malaise; body aches; first side effects of soreness and pain on the injection site.; 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 (BNT162B2), administration date 17Nov2021 10:00 (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. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN (non-serious) with onset 18Nov2021, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome unknown; MALAISE (non-serious) with onset 18Nov2021, outcome recovering; PYREXIA (non-serious) with onset 18Nov2021 03:30, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 18Nov2021 07:00, outcome recovering. Relevant laboratory tests and procedures are available in the appropriate section.  Patient reported that Vaccine shot at around 10 am on 17Nov2021. Around noon first side effects of soreness and pain on the injection site. At 3:30am elevated body temperatures woke up patient on 18Nov. Malaise and body aches in the morning, resolving as time goes by. The soreness on the arm became the size of an egg around 7am this morning (18Nov). Also diminishing the size as the hours go by. COVID-19 vaccine booster. Event took place after use of product.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Urticaria
Clinical narrative: Sever hives starting about 36 hours after dose.; Current age: 10 years, Dose recieved 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 15:15 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 17Nov2021 15:15, outcome "unknown", described as "Current age: 10 years, Dose recieved 1"; URTICARIA (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "Sever hives starting about 36 hours after dose.". The events "current age: 10 years, dose recieved 1" and "sever hives starting about 36 hours after dose." were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Other vaccine 4 weeks product included Flu. No other medications in two weeks. Sever hives starting about 36 hours after dose. Ongoing now pt say 6. Not had covid prior vaccination. Not tested covid post vaccination. No known allergies.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Lymph node pain, Pain, Pyrexia
Clinical narrative: body aches; lymph node soreness; Shot 1 - very sick for 3 days; fever; headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. This is the second of three reports. A 65-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Apr2021 16:00 (Lot number: EW0161) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no health issues other than extreme sensitivity to medications, migraines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: None. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shot 1 - very sick for 3 days"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "body aches"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "unknown", described as "lymph node soreness".  Additional information: No other medications in two weeks and no other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient had no covid prior vaccination and not covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101647144 Same reporter, patient, product; Different dose, events;US-PFIZER INC-202101647145 Same reporter, patient, product; Different dose, events
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Vaccination site bruising, Vaccination site discomfort, Vaccination site erythema
Clinical narrative: bruise about injection site and red spot underneath; bruise about injection site and red spot underneath; bruise right about injection site which she is not comfortable about; she got the booster; it is about 5 inches by 1 inch and is just getting bigger, wants to know if this is norma/bruise that is slightly above the injection site and a red spot that is getting worse; itchy/itches below the injection site that is painful; itchy/itches below the injection site that is painful; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 (Lot number: 33030BD) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Second dose, LOT-ER8731), administration date: 22Apr2021, for Covid-19 immunization, reaction(s): "tired", "sore arm"; Bnt162b2 (First dose, LOT-ER8735), administration date: 01Apr2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "bruise about injection site and red spot underneath"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "itchy/itches below the injection site that is painful"; VACCINATION SITE PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "itchy/itches below the injection site that is painful "; VACCINATION SITE DISCOMFORT (non-serious) with onset 20Nov2021, outcome "not recovered", described as "bruise right about injection site which she is not comfortable about"; CONDITION AGGRAVATED (non-serious) with onset Nov2021, outcome "not recovered", described as "it is about 5 inches by 1 inch and is just getting bigger, wants to know if this is norma/bruise that is slightly above the injection site and a red spot that is getting worse"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "she got the booster".  Follow-up attempts are completed. No further information is expected.