chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fever; Chills; Nasal Congestion; Muscle Aches; 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 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Nov2021 10:15 (Lot number: 330308D) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 22Nov2021; LEXAPRO; WELLBUTRIN; ATENOLOL; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 46 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 24Feb2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 10:15, outcome "unknown", described as "dose number: 3"; HEADACHE (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Chills"; NASAL CONGESTION (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Nasal Congestion"; MYALGIA (non-serious) with onset 30Nov2021 01:30, outcome "recovering", described as "Muscle Aches". Therapeutic measures were not taken as a result of headache, pyrexia, chills, nasal congestion, myalgia.  Additional Information: Reported seriousness was non-serious. Patient received unspecified vaccine prior vaccination within 4 weeks. The patient had no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Influenza, SARS-CoV-2 test
Clinical narrative: Flu symptoms-achiness all over, fatigue, slight fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 12:15 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 22Nov2021, stop date: 22Nov2021. Vaccination history included: Bnt162b2 (Dose 1, Single, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Single, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "Booster"; INFLUENZA (non-serious) with onset 30Nov2021 12:00, outcome "not recovered", described as "Flu symptoms-achiness all over, fatigue, slight fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza.  Additional information: Anatomical location where vaccine was administered was reported as Upper (not specified clearly). Facility of most recent Covid-19 vaccination was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had been tested for Covid-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Product use issue, Pyrexia, Sleep disorder, Vaccination site pain
Clinical narrative: COVID booster; COVID vaccine administered concurrently with flu vaccine; Low grade fever; soreness at injection site; lack of sleep following COVID booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: FLU VACCINE VII taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose:1, Manfacturer- Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manfacturer- Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "COVID booster"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "COVID vaccine administered concurrently with flu vaccine"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site"; SLEEP DISORDER (non-serious), outcome "unknown", described as "lack of sleep following COVID booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Disturbance in attention, Dizziness, Fall
Clinical narrative: Unable to fall asleep half the night on 30Nov2021; had a booster shot; Could not concentrate; Fatigue; almost fell; Body aches that make him feel uncomfortable; Body aches that make him feel uncomfortable; Low fever; Dizziness; 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 male patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (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: 1, He is healthy and he did not feel this way with the first two doses), for COVID-19 Immunization, reaction(s): "He is healthy and he did not feel this way with the first two doses"; Bnt162b2 (Dose: 2, He is healthy and he did not feel this way with the first two doses), for COVID-19 Immunization, reaction(s): "He is healthy and he did not feel this way with the first two doses". The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Body aches that make him feel uncomfortable"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low fever"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; INSOMNIA (non-serious) with onset 30Nov2021, outcome "unknown", described as "Unable to fall asleep half the night on 30Nov2021"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown", described as "Could not concentrate"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; FALL (non-serious) with onset 2021, outcome "unknown", described as "almost fell"; IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "had a booster shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:: wondering if he should take Tylenol. Stated that he tried to search online for PDF files and it did not mention any treatment. Wanted to know if these were side effects. Wanted to know if it was okay to travel. Clarified that it is for the Covid booster.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Insomnia, Pain, Pyrexia
Clinical narrative: Unable to fall asleep half the night on 30Nov2021; had a booster shot; Could not concentrate; Fatigue; almost fell; Body aches that make him feel uncomfortable; Body aches that make him feel uncomfortable; Low fever; Dizziness; 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 male patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (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: 1, He is healthy and he did not feel this way with the first two doses), for COVID-19 Immunization, reaction(s): "He is healthy and he did not feel this way with the first two doses"; Bnt162b2 (Dose: 2, He is healthy and he did not feel this way with the first two doses), for COVID-19 Immunization, reaction(s): "He is healthy and he did not feel this way with the first two doses". The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Body aches that make him feel uncomfortable"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Low fever"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; INSOMNIA (non-serious) with onset 30Nov2021, outcome "unknown", described as "Unable to fall asleep half the night on 30Nov2021"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "unknown", described as "Could not concentrate"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; FALL (non-serious) with onset 2021, outcome "unknown", described as "almost fell"; IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "had a booster shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:: wondering if he should take Tylenol. Stated that he tried to search online for PDF files and it did not mention any treatment. Wanted to know if these were side effects. Wanted to know if it was okay to travel. Clarified that it is for the Covid booster.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Pyrexia
Clinical narrative: dose received: 3; Severe shaking; chills; fever 101; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:00 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol. Concomitant medication(s) included: ALTACE; SIMVASTATIN. Vaccination history included: Bnt162b2 (dose 2), for COVID-19 Immunization; Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 12:00, outcome "unknown", described as "dose received: 3"; TREMOR (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "Severe shaking"; CHILLS (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "fever 101"; FATIGUE (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, chills, pyrexia, fatigue.  Additional information: The patient also received baby asa as concomitant medication.The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination.The patient did not get covid tested post vaccination. The patient had no known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: dose received: 3; Severe shaking; chills; fever 101; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 12:00 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol. Concomitant medication(s) included: ALTACE; SIMVASTATIN. Vaccination history included: Bnt162b2 (dose 2), for COVID-19 Immunization; Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 12:00, outcome "unknown", described as "dose received: 3"; TREMOR (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "Severe shaking"; CHILLS (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "fever 101"; FATIGUE (non-serious) with onset 30Nov2021 12:00, outcome "recovering", described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, chills, pyrexia, fatigue.  Additional information: The patient also received baby asa as concomitant medication.The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination.The patient did not get covid tested post vaccination. The patient had no known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Lymphadenopathy
Clinical narrative: Shingles outbreak on left arm; lymphadenopathy; Dose received: 3; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 12:30 (Lot number: FS1620) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression; "Influenza" (unspecified if ongoing), notes: other vaccine 4weeks product=Influenza. Concomitant medication(s) included: SERTRALINE HCL. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number=EK9231, vaccine location=Left arm), administration date: 08Jan2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, lot number=EH9899, vaccine location=Left arm), administration date: 19Dec2020, when the patient was 35 years old, for COVID-19 immunization; Influenza vaccine, administration date: Oct2021, for Influenza. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 12:30, outcome "unknown", described as "Dose received: 3"; HERPES ZOSTER (non-serious), outcome "not recovered", described as "Shingles outbreak on left arm"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "lymphadenopathy". Therapeutic measures were taken as a result of herpes zoster, lymphadenopathy  Additional information: Shingles outbreak on left arm with associated lymphadenopathy of left axilla (approximately golf ball size). Therefore, the patient received treated with Valacyclovir. The patient was neither diagnosed with Covid prior vaccination not tested post vaccination for Covid. The patient did not had any allergies.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Immunisation, Ocular hyperaemia
Clinical narrative: my left eye gets very blood shot and a little irritated; my left eye gets very blood shot and a little irritated; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 02:15 (Lot number: FF2587) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 26Apr2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "my left eye gets very blood shot and a little irritated", "my left eye gets very blood shot and a little irritated"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 05Apr2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "Booster dose"; OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious) all with onset 01Dec2021, outcome "recovering" and all described as "my left eye gets very blood shot and a little irritated". Therapeutic measures were not taken as a result of ocular hyperaemia, eye irritation.  Additional Information:The patient had no known allergies. The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Patient received any other medications in two weeks of vaccination was none reported. Prior to vaccination patient was not diagnosed with COVID-19 and post vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; chill; swollen glands including my left ampit; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8030) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Lower back pain" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; METFORMIN HYDROCHLORIDE; TRIAMTERENE/HYDROCHLOROTHIAZIDE. Past drug history included: Capoten for drug allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, prev dose lot number=EW0164 , prev dose  administration date=04Apr2021, prev dose vaccine location=Left arm), administration date: 04Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, prev dose lot number=Pfizer ER8732, prev dose administration date=03Mar2021 , prev dose vaccine location=Left arm), administration date: 03Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster dose"; PYREXIA (non-serious) with onset 18Nov2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 18Nov2021, outcome "recovered" (2021), described as "chill"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021, outcome "recovered" (2021), described as "swollen glands including my left ampit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, lymphadenopathy.  Additional information: No other vaccine was given to the patient in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation, Presyncope
Clinical narrative: 3rd dose; presyncopal episode along with 36hr of chills; presyncopal episode along with 36hr of chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Nov2021 (Lot number: fh8030) 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 20Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: fh1950), administration date: 22Apr2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: er2613), administration date: 01Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "3rd dose"; PRESYNCOPE (non-serious), CHILLS (non-serious) all with onset 2021, outcome "unknown" and all described as "presyncopal episode along with 36hr of chills". Therapeutic measures were not taken as a result of presyncope, chills.  Additional information: Patient took the other vaccine in four weeks. Patient did not have covid prior to vaccination. Patient did not tested covid positive post vaccination. Facility type was Public Health Clinic.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Parosmia, Taste disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 10:00 (Lot number: FF2590) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (Dose Number: 1; Batch/Lot No: ELO140; Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, My husband and I had Covid at the end of Sep of this year, 2021. I recovered. We recovered and our taste and smell was completely back to normal for many weeks.), administration date: 18Dec2020, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "I had Covid"; Bnt162b2 (Dose Number: 2; Batch/Lot No: EK9231; Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, My husband and I had Covid at the end of Sep of this year, 2021. I recovered), administration date: 15Jan2021, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "I had Covid". The following information was reported: IMMUNISATION (non-serious) with onset 20Oct2021 10:00, outcome "unknown", described as "Booster shot"; PAROSMIA (non-serious) with onset 21Oct2021 09:00, outcome "not recovered", described as "Soap smells like vomit"; TASTE DISORDER (non-serious) with onset 21Oct2021 09:00, outcome "not recovered", described as "many foods taste like pond water". Therapeutic measures were not taken as a result of parosmia, taste disorder.  Additional information: Patient reported that since the Booster shot, my taste and smell is screwed up. The booster shot 100% caused this and it has not changed. Today is 01Dec and taste and smell has not improved. Patient did not have any known allergies. Patient did not tested positive for Covid-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymphadenopathy, Nausea
Clinical narrative: Swollen lymph node near injection site; Head ache; Tired; Slightly nauseous; Sore arm; 3rd dose; 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 22Nov2021 10:45 (Lot number: Fh8027) at the age of 40 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: 2, Lot Number: Ep6955), for covid 19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: El3247), for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:45, outcome "unknown", described as "3rd dose"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Swollen lymph node near injection site"; HEADACHE (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Head ache"; FATIGUE (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Tired"; NAUSEA (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Slightly nauseous"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue, nausea, pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Swollen lymph node near injection site; Head ache; Tired; Slightly nauseous; Sore arm; 3rd dose; 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 22Nov2021 10:45 (Lot number: Fh8027) at the age of 40 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: 2, Lot Number: Ep6955), for covid 19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: El3247), for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:45, outcome "unknown", described as "3rd dose"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Swollen lymph node near injection site"; HEADACHE (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Head ache"; FATIGUE (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Tired"; NAUSEA (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Slightly nauseous"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue, nausea, pain in extremity. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vision blurred
Clinical narrative: Blurry vision in right eye within 36 hours of the third dose.; 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 (Lot number: FF8841) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes Type II" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Pre dose product=COVID 19,, Pre dose brand=Pfizer,, Pre dose brand unknown=False,, Pre dose lot number=EN6206,, Pre dose lot unknown=False,, Pre dose administration date=10Mar2021, Prev dose dose number=2,, Pre dose vaccine location=Right arm), administration date: 10Mar2021, when the patient was 68 years old, for Covid-19 immunization; Bnt162b2 (Pre dose product=COVID 19,, Pre dose brand=Pfizer,, Pre dose brand unknown=False,, Pre dose lot number=EL9267,, Pre dose lot unknown=False,, Pre dose administration date=10Feb2021, Pre dose dose number=1,, Pre dose vaccine location=Right arm), administration date: 10Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Oct2021, outcome "unknown", described as "3rd dose"; VISION BLURRED (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Blurry vision in right eye within 36 hours of the third dose.". The event "blurry vision in right eye within 36 hours of the third dose." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of vision blurred.  Additional information: The patient was treated with Steroidal drops. Prior to vaccination the patient had no covid, post vaccination the patient was not tested for covid and no known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, SARS-CoV-2 test
Clinical narrative: Booster shot-pain on left side where he got the shot from head to toe/pain from the booster is more severe and lasted a lot longer; Booster shot- headache; Booster shot-severe fatigue; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8030) at the age of 54 years 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 (Dose no: 1, Lot number: FN9166), administration date: 16Mar2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (Dose no: 2, Lot number: FN6207), administration date: 06Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Stated that two weeks prior to a holiday that he had the same symptoms as he had when he tested positive for Covid", "Stated that two weeks prior to a holiday that he had the same symptoms as he had when he tested positive for Covid", "Second shot- sore left arm", "Second shot: chest congestion", "Second shot: runny nose", "Second shot: coughing". The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 26Nov2021, outcome "recovering", described as "Booster shot-pain on left side where he got the shot from head to toe/pain from the booster is more severe and lasted a lot longer"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "Booster shot-severe fatigue"; HEADACHE (non-serious) with onset 26Nov2021, outcome "recovering", described as "Booster shot- headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Reporter stated that the pain from the booster is more severe and lasted a lot longer.   Follow-Up (03Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, Rash erythematous
Clinical narrative: booster; shingles; I broke out with a red rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "shingles"; RASH ERYTHEMATOUS (non-serious) with onset 2021, outcome "unknown", described as "I broke out with a red rash". The events "shingles" and "i broke out with a red rash" were evaluated at the physician office visit.  Additional information: Consumer stated I received the drug on a Tuesday, one week later, the following Tuesday, I broke out with a red rash. I went to my doctor's office, and they told me that it was shingles, and I am thinking that was a reaction to my getting the booster or third dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Immunisation
Clinical narrative: dose number: 3; loss of taste; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), solution for injection, intramuscular, administered in arm left, administration date Oct2021 (Batch/Lot number: unknown, expiry date was not reported) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose:01, prev dose vaccine location: Left arm, prev dose administrator route: Intramuscular), administration date: Feb2021, for COVID-19 Immunization; BNT162B2 (Dose:02, prev dose vaccine location: Left arm, prev dose administrator route: Intramuscular), administration date: Mar2021, for COVID-19 Immunization, reaction(s): "loss of taste". The patient experienced IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "dose number: 3"; AGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "loss of taste". Therapeutic measures were not taken as a result of ageusia.  Additional information included: Patient did not have any other vaccine in 4 weeks. The patient did not have covid prior to vaccination and did not test for covid post vaccination. The patient had no known allergies.Patient had experienced continuous loss of taste since the second dose. She never had symptoms of covid infection. The start date for event ageusia is Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Hypertension, Immunisation, Malaise
Clinical narrative: booster shot; wasn't feeling well; pains in the back of my leg; blood pressure was elevated; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrochlorothiazide for blood pressure, notes: they told me stop taking everything I was taking. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Aug2021, outcome "unknown", described as "booster shot"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "wasn't feeling well"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pains in the back of my leg"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "blood pressure was elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Causality: Nurse stated, she don't know if this is because of her blood pressure is up or because of the fourth shot or what because she tested, she didn't even realize that she had, she forgot about the third shot. Medical condition: Nurse stated, she went to the doctor because she was having the medical condition the back of my leg were hurting. (Further not clarified) she wasn't feeling good she have been feeling bad that's why she went to the doctor in the beginning. Nurse stated, "Yes, she took up the other medicine and she took medicines for her blood pressure and they change the medicine so they told me stop taking all the medicine that she was taking and they have now changed the medicine, she haven't even gotten the prescription filled they told me stop taking everything she was taking  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: booster shot; wasn't feeling well; pains in the back of my leg; blood pressure was elevated; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrochlorothiazide for blood pressure, notes: they told me stop taking everything I was taking. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Aug2021, outcome "unknown", described as "booster shot"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "wasn't feeling well"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pains in the back of my leg"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "blood pressure was elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Causality: Nurse stated, she don't know if this is because of her blood pressure is up or because of the fourth shot or what because she tested, she didn't even realize that she had, she forgot about the third shot. Medical condition: Nurse stated, she went to the doctor because she was having the medical condition the back of my leg were hurting. (Further not clarified) she wasn't feeling good she have been feeling bad that's why she went to the doctor in the beginning. Nurse stated, "Yes, she took up the other medicine and she took medicines for her blood pressure and they change the medicine so they told me stop taking all the medicine that she was taking and they have now changed the medicine, she haven't even gotten the prescription filled they told me stop taking everything she was taking  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 40-year-old female patient (not pregnant) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), intramuscularly, in arm left, on Nov 30, 2021, single dose, for COVID-19 immunisation. Medical history included allergy to sulfa (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty), for COVID-19 immunization. The patient reported immunization/booster/dose 3, onset Nov 30, 2021, with outcome of unknown; and pain/achiness, onset Dec 1, 2021, with outcome of recovering. No therapeutic measures taken as a result of pain. Additional information: Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient has not tested for COVID-19. The lot number for BNT162B2, not provided and will be requested during follow-up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Immunisation, Swelling of eyelid, Vaccination site discomfort, Vaccination site erythema
Clinical narrative: Swelling left eye upper lid; Swelling left eye upper lid; Hardness & redness at injection site; Hardness & redness at injection site; Hardness & redness at injection site; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 18:30 (Lot number: FJ1611) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dos: 2, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01May2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Batch/Lot No: Ew0151, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 08Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 18:30, outcome "unknown", described as "Dose received: 3"; EYE SWELLING (non-serious), SWELLING OF EYELID (non-serious) all with onset 27Nov2021 09:00, outcome "not recovered" and all described as "Swelling left eye upper lid"; VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 27Nov2021 09:00, outcome "not recovered" and all described as "Hardness & redness at injection site". Therapeutic measures were not taken as a result of eye swelling, swelling of eyelid, vaccination site discomfort, vaccination site reaction, vaccination site erythema.  Additional Information:  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No; List of any other medications the patient received within 2 weeks of vaccination: Various rx; Prior to vaccination, was the patient diagnosed with COVID-19?: No; Since the vaccination, has the patient been tested for COVID-19?: No.   Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Swelling left eye upper lid; Swelling left eye upper lid; Hardness & redness at injection site; Hardness & redness at injection site; Hardness & redness at injection site; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 18:30 (Lot number: FJ1611) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dos: 2, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01May2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Batch/Lot No: Ew0151, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 08Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 18:30, outcome "unknown", described as "Dose received: 3"; EYE SWELLING (non-serious), SWELLING OF EYELID (non-serious) all with onset 27Nov2021 09:00, outcome "not recovered" and all described as "Swelling left eye upper lid"; VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 27Nov2021 09:00, outcome "not recovered" and all described as "Hardness & redness at injection site". Therapeutic measures were not taken as a result of eye swelling, swelling of eyelid, vaccination site discomfort, vaccination site reaction, vaccination site erythema.  Additional Information:  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No; List of any other medications the patient received within 2 weeks of vaccination: Various rx; Prior to vaccination, was the patient diagnosed with COVID-19?: No; Since the vaccination, has the patient been tested for COVID-19?: No.   Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Lymphadenopathy
Clinical narrative: chills; fatigue; swollen lymph nodes; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 27Nov2021 (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: Comirnaty (Dose 1), for Covid-19 immunization; Comirnaty (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "booster"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.