chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired healing
Clinical narrative: Mosquito bites seem to be lasting much longer than they did prior to the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 28May2021 (at the age of 47-year-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 18Jun2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 11Jun2021, the mosquito bites seemed to be lasting much longer than they did prior to the vaccine. The patient could not say if it was the vaccine. They were lasting for days when they used to be healed in hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mosquito bites seem to be lasting much longer than they did prior to the vaccine was recovered on an unknown date in 2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cyanosis
Clinical narrative: Violent chills/teeth chattering; Blue lips; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 08Jul2021 at 13:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included XYZAL for unknown indication from unknown date and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 17Jun2021 at 14:00 (at the age of 45 year old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Jul2021 at 01:15, the patient experienced violent chills/teeth chattering with blue lips. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events violent chills/teeth chattering and blue lips was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands left armpit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 09Jul2021 at 08:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, right thyroidectomy, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. On 10Jul2021 at 12:30, the patient experienced swollen glands left armpit. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen glands left armpit was not recovered at the time of event.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart pounding; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW191) via an unspecified route of administration in the right arm on 11Jun2021 at 14:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and mitral valve prolapse. The patient was allergic to penicillin. Concomitant medications included SYNTHROID, insulin LEVEMIR, losartan, and insulin NOVALOG, all taken for unspecified indications from unknown dates. The patient previously took ciprofloxacin and EPINEPHRINE and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW178) via an unspecified route of administration in the right arm on 21May2021 at 14:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, two weeks after the second dose, the patient experienced heart pounding. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event heart pounding was not resolved at the time of this report.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got shingles; This is a spontaneous report from a non- contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration on 26May2021(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Jul2021 the patient got shingles. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event  shingles was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Affect lability, Fear, Screaming
Clinical narrative: Emotionally unstable/ out of control/ emotional; Scared/ Afraid; Screamed/ yelled; Very very unusual of him; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left  arm on 10Jul2021 at 12:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. It was unknown whether the patient was allergic to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was very happy when he woke up. After the shot the patient was perfectly fine. It was not until later in the day that he was acting very emotionally unstable, out of control, emotional, scared, afraid, screamed, yelled at 21:30 on 10Jul2021. Very very unusual of the patient, not one bit like the patient. They were very confused about his behavior he did not understand himself or why. The only thing different of that particular day was the vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events emotionally unstable/out of control/emotional, scared/afraid, very very unusual of him and screamed/yelled were unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Swollen feet; Left/right leg numbness; Tingling and numbness sensations on the legs remain and come and go throughout the day and night; Fever and exhaustion were present the day and the day after of the second dose of the vaccine; Fever and exhaustion were present the day and the day after of the second dose of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 27Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 27Apr2021, the patient experienced fever and exhaustion present on the day and the day after of the second dose of the vaccine. On 01May2021 at 16:00, the patient experienced swollen feet, left/right leg numbness and tingling, feeling of having tight socks on the legs. These symptoms began on the 4 days after the second dose of the vaccine. Tingling and numbness sensations on the legs remained and come and go throughout the day and night. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures on an unknown date, which included COVID-19 test (nasal swab) and the results were negative. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever, exhaustion, swollen feet, left/right leg numbness/ feeling of having tight socks on the legs and tingling was not resolved at the time of this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Swollen feet; Left/right leg numbness; Tingling and numbness sensations on the legs remain and come and go throughout the day and night; Fever and exhaustion were present the day and the day after of the second dose of the vaccine; Fever and exhaustion were present the day and the day after of the second dose of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 27Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 27Apr2021, the patient experienced fever and exhaustion present on the day and the day after of the second dose of the vaccine. On 01May2021 at 16:00, the patient experienced swollen feet, left/right leg numbness and tingling, feeling of having tight socks on the legs. These symptoms began on the 4 days after the second dose of the vaccine. Tingling and numbness sensations on the legs remained and come and go throughout the day and night. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures on an unknown date, which included COVID-19 test (nasal swab) and the results were negative. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events fever, exhaustion, swollen feet, left/right leg numbness/ feeling of having tight socks on the legs and tingling was not resolved at the time of this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 10Jul2021 at 17:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jul2021 at 18:00, the patient experienced soreness in injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event soreness in injection site was not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Left index and middle finger tingles constantly; Sore upper arm muscle; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 24Jun2021 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included women multi vitamin from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Jun2021 at 08:15, the patient experienced left index and middle finger tingles constantly as well as sore upper arm muscle. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events left index and middle finger tingles and sore upper arm muscle were not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Headache; Fatigue; Large swollen painful lymph nodes in right armpit; Large swollen painful lymph nodes in right armpit; Fever 102 for 2.5 days; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 08Jul2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression and anxiety. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone hydrochloride (BUSPAR), pantoprazole sodium sesquihydrate (PROTONIX) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 17Jun2021 at 18:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jul2021 at 22:00, the patient experienced fever 102 for 2.5 days, large swollen painful lymph nodes in right armpit and fatigue. On 08Jul2021 at 22:00, the patient underwent Body temperature and the result was 102 (unit unspecified). On 10Jul2021, on day 3, the patient experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large swollen painful lymph nodes in right arm pit, fatigue and headache was resolved with sequelae on an unknown date in Jul2021; while that of the fever 102 was resolved on 11Jul2021, after the duration of 2.5 days.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fatigue; Large swollen painful lymph nodes in right armpit; Large swollen painful lymph nodes in right armpit; Fever 102 for 2.5 days; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 08Jul2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression and anxiety. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone hydrochloride (BUSPAR), pantoprazole sodium sesquihydrate (PROTONIX) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 17Jun2021 at 18:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jul2021 at 22:00, the patient experienced fever 102 for 2.5 days, large swollen painful lymph nodes in right armpit and fatigue. On 08Jul2021 at 22:00, the patient underwent Body temperature and the result was 102 (unit unspecified). On 10Jul2021, on day 3, the patient experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large swollen painful lymph nodes in right arm pit, fatigue and headache was resolved with sequelae on an unknown date in Jul2021; while that of the fever 102 was resolved on 11Jul2021, after the duration of 2.5 days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Pruritus
Clinical narrative: Flare up dermatitis atopic; Itching; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19May2021, (at the age of 43-year-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization; dupilumab (DUPIXENT, pre-filled pen, strength: unknown), subcutaneous from 07Apr2021 (Batch/Lot Number: 0F025A; Expiration Date: 31Oct2022) to 07Apr2021, at 600 mg, 1x/day, subcutaneous from 2021 (Batch/Lot Number: 0F025A; Expiration Date: 31Oct2022) and ongoing, at 300 mg QOW for dermatitis atopic. It was reported loading dose of 600 mg 1X (once) and 300mg SQ every other week as maintenance dose. Last dose of dupilumab was this morning 15Jun2021, and her other dose was taken on 01Jun2021. It was not the first time that patient had used the product. The patient medical history included dermatitis atopic and concomitant medications were not reported. On 19May2021, the patient experienced flare up dermatitis atopic and itching. The patient was treated with prednisone for Dermatitis atopic. The clinical outcome of the event dermatitis atopic was recovered on 10Jun2021 whereas the event itching outcome was unknown.  Follow-up activities closed. Batch/lot number not available.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Tenderness
Clinical narrative: Swelling of the glands under the armpit; On side of the body resulting in tenderness; Inability to relax arm fully because pressure on the area causes pain; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 at 15:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines and COVID-19 infection. The patient had known allergies to bee stings and calamari. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Jul2021 the patient experienced swelling of the glands under the armpit, on side of the body resulting in tenderness and inability to relax arm fully because pressure on the area causes pain. No therapeutic measures were taken as a result of reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the swelling of the glands under the armpit, on side of the body resulting in tenderness and inability to relax arm fully because pressure on the area causes pain was not recovered at the time of this report.  The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Pink circle spread down arm; Left arm sore at injection site; Left arm warm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 07Jul2021 at 15:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 16Jun2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced left arm sore and warm at injection site. On 09Jul2021, the patient noticed pink circle which spread down the arm and the arm was still warm at injection site all the way down to end of the pink area. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm sore at injection site was unknown, while that of left arm warm at injection site and pink circle which spread down the arm were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Couple hours after 2nd vaccine tinnitus  started; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6200) via an unspecified route of administration in the right arm on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergic seasonal allergy, and hypothyroidism. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9267) via an unspecified route of administration in the left arm on 09Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 the patient experienced tinnitus. Therapeutic measures were taken as a result of tinnitus which included treatment with Aleve. The adverse event resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was unknown at the time of this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 09Jul2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took cefalexin (KEFLEX) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 15Jun2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Jul2021 the patient experienced COVID arm. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event COVID arm was unknown at the time of this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; body aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 09Jul2021 at 18:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jul2021 at 06:00, the patient experienced fever, body aches and chills. Fever was continuing on day 2. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches and chills were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Very swollen axilla lymph nodes 2 weeks after receiving first does; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 21Jun2021 at 17:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included being allergic to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jul2021 at 00:00, two weeks after the vaccination, the patient experienced very swollen axilla lymph nodes. Since the vaccination, the patient had been tested for COVID-19. On 08Jul2021, the patient underwent nasal swab Sars Cov-2 test and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event swollen axilla lymph nodes was not recovered at the time of the report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Fever of 100.5 for 3 days; Nauseous for 24 hours; Headache to the point couldnt get out of bed; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 07Jul2021 at 16:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 16Jun2021 at 16:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. On 08Jul2021, the patient experienced fever of 100.5 for three days, nauseous for 24 hours and headache to the point couldn't get out of bed. The events did not result in doctor or other healthcare professional office or clinic visit,  emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. On 08Jul2021, the patient underwent lab test and procedure which included body temperature and the result was shown as 100.5 (units unspecified). The clinical outcome of the events fever of 100.5 for 3 days was resolved on 10Jul2021. The clinical outcome of the event nauseous for 24 hours was recovered on 09Jul2021. The clinical outcome of the event headache to the point couldn't get out of bed was unknown at the time of this report.    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: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain and soreness in left hand and fingers; Stiffness developed in my left hand and fingers; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jul2021 at 17:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to red dye. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jul2021 at 00:30 the patient experienced pain, soreness and stiffness in her left hand and fingers approximately six to eight hours after injection. The pain was still present and however comes and goes. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain, soreness and stiffness in her left hand and fingers approximately six to eight hours after injection was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Tenderness
Clinical narrative: Tenderness and soreness in armpit; Tenderness and soreness in armpit; Enlarged lymph nods in left arm near on side of injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 09Jul2021 at 01:15 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan (HYDROCHLOROTHIAZIDE;LOSARTAN) for unspecified indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 14Jul2021 at 11:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jul2021 at 16:00, the patient experienced tenderness and soreness in armpit and enlarged lymph nodes in left arm near on side of injection site which had started hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tenderness and soreness in armpit, enlarged lymph nodes in left arm near on side of injection site was not recovered at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vertigo positional
Clinical narrative: Vertigo/dizziness when walking; fatigue; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 08Jul2021 at 15:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included prior breast cancer and high triglycerides. The patient was allergic to lactose. Concomitant medications included fish oil (OMEGA 3) and monascus purpureus (RED YEAST RICE); about 2 days prior to vaccination, on an unknown date in Jul2021 for an unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jul2021, the patient experienced some pain in the injection site but nothing else for the first 2 days. On 10Jul2021, Saturday morning woke up with vertigo and recognized that turning her head to the left and down made it worse. Lots of fatigue and dizziness when walking. The day of reporting was day 3 (as reported) and still had some vertigo and dizziness while walking. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, vertigo/dizziness when walking and fatigue were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to arthropod bite
Clinical narrative: Excessive swelling of sting sight (right arm and interior of elbow to wrist); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 02Apr2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included BP (blood pressure) (controlled), cholesterol (controlled), high BMI (body mass index) ("240") and insect allergies mainly bee. The patient reported that due to the history of bee sting allergy, he was prescribed EPI pen (epinephrine pen) which was first given to him 20 years ago when he had an adverse reaction and had to visit the emergency room. The patient had various encounters with stings over the years but they were minor and did not include EPI use or inordinate medical care. The patient also had an allergy to some statin drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified blood pressure and cholesterol medications within two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 02Mar2021 at 10:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 28Apr2021 at 18:00, about 3 weeks after the second shot, the patient was stung by a hornet and experienced an excessive swelling of sting sight (right arm and interior of elbow to wrist). The patient reported that this last sting was the worst reaction that he had in 20 years. The patient was advised to seek medical help if the swelling increased and if he had breathing issues. The patient stated that he did not have breathing problems and the swelling was from elbow to wrist, eventually cleared in 3 days. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures included treatment with steroid cream and anti-itch pills (unspecified) which was prescribed by the patient's provider on 29Apr2021, the day after the sting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event excessive swelling of sting sight (right arm and interior of elbow to wrist) was resolved on 01May2021, after the duration of 3 days.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; This is a spontaneous report from a contactable consumer. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 23Apr2021, after the second dose of vaccine, the patient developed a high fever which had lasted for a day. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event high fever was resolved on 24Apr2021.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient developed a mild fever; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 as a single dose for COVID-19 immunisation. The patient did not receive any concomitant medication. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. On 23Apr2021, after receiving the second dose of vaccination, patient experienced mild fever. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event mild fever was recovered on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during the follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Skin warm, Swelling
Clinical narrative: Dose 1 on 07Apr2021 and dose 2 on 07Jul2021; Body chills but hot to touch; Body chills but hot to touch; armpit swelling/neck swollen; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jul2021 at 07:00, the patient experienced body chills but hot to touch, armpit swelling and neck swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body chills but hot to touch, armpit swelling and neck swollen were not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Insomnia
Clinical narrative: Temperature; Sleepless night; This is a spontaneous report from a non-contactable consumer, the patient. An unspecified aged elderly patient of unknown gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 11Jul2021 at 08:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had known allergies to dust. Concomitant medications included apixaban (ELIQUIS) from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 11Jul2021 at 12:00, the patient experienced sleepless night and temperature. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event sleepless night and temperature was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected