chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test, Swelling, Swelling face
Clinical narrative: Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Hives; Fever; Joint pain; Muscle pain; Uncontrollable itching on palms of hands and bottoms of feet.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male 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 an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL); 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: UNKNOWN), via an unspecified route of administration in the right arm on an unknown date, 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 Sep2021, the patient experienced swelling of face, lips, neck, hands and feet, hives, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache. The patient reported that hives were ongoing and other symptoms cleared up within a week to week in a half. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Sep2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events swelling of face, lips, neck, hands and feet, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache was resolved on an unknown date in 2021; while that of the event hives was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Hives; Fever; Joint pain; Muscle pain; Uncontrollable itching on palms of hands and bottoms of feet.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male 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 an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL); 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: UNKNOWN), via an unspecified route of administration in the right arm on an unknown date, 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 Sep2021, the patient experienced swelling of face, lips, neck, hands and feet, hives, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache. The patient reported that hives were ongoing and other symptoms cleared up within a week to week in a half. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Sep2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events swelling of face, lips, neck, hands and feet, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache was resolved on an unknown date in 2021; while that of the event hives was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Erythema, Peripheral swelling
Clinical narrative: arm swelling; redness; bruising; diarrhea; This is a spontaneous report from a non-contactable health care professional, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3014584) via an unspecified route of administration in the left arm on 03Oct2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies.  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 were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3183) via an unspecified route of administration in the left arm on 12Sep2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 18:00, the patient experienced arm swelling, redness, bruising and diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 arm swelling, redness, bruising and diarrhea was not recovered 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual period started early, very heavy; Menstrual period started early, very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration on 02Oct2021 (at the age of 41-years-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 04Oct2021, the patient had her menstrual period started early, very heavy. 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 menstrual period started early, very heavy was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging, SARS-CoV-2 test, Tremor
Clinical narrative: Numbness in "my" right arm and hand for 3 days; Tremors in right arm and hand and also on left side. Tremors in right leg at night; This is a spontaneous report from a contactable consumer, the patient. A 36-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 01Jul2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. 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 10Jun2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 01Jul2021 at 15:15, the patient experienced numbness in her right arm and hand for 3 days, tremors in right arm and hand and also on left side and tremors in right leg at night. On 02Aug2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. On an unknown date, the patient also underwent magnetic resonance imaging(MRI) and electrocardiogram(EKG) and the results were not reported. The adverse events resulted in emergency room/department or urgent care. Non-therapeutic measures were taken as a result of reported events included rest. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events numbness in right arm and hand was resolved with sequelae on 04Jul2021, while the clinical outcome of event tremors in right arm and hand and in right leg were resolved with sequelae on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use, Swelling face, Tenderness
Clinical narrative: Noticed that face was swelling on both sides about 4 days after the shot / Today is 8 days later, and look like a chipmunk/ The swollen area is a bit tender to the touch; Noticed that face was swelling on both sides about 4 days after the shot / Today is 8 days later, and look like a chipmunk; Day after shot, "I" was exhausted; Day after shot, was exhausted and muscles were very achy; The patient received a third/booster dose; The patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Sep2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and morbid obesity. 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 vaccination. The patient received unspecified concomitant medications within two weeks of vaccination which was reported as several, but nothing new. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 15:00 (at the age of 60-years-old) and also previously received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 29Sep2021, day after the shot, the patient was exhausted and muscles were very achy. On 02Oct2021 at 14:00, about 4 days after the shot, the patient noticed that her face began to swell on both sides, was not sure if the swelling had started earlier. On 06Oct2021, 8 days later, the patient "looked like a chipmunk", and the swollen area was a bit tender to the touch. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with mild prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhausted and muscles were very achy and face began to swell on both sides, 8 days later, the patient "looked like a chipmunk", and the swollen area was a bit tender to the touch was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Vaccination site pain, Vomiting
Clinical narrative: Migraine; Vomiting; Pain at injection site; Swollen and very painful lymph node in right armpit; Swollen and very painful lymph node in right armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the right arm on 04Oct2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included skin cancer. 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. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA) and lamotrigine (LAMICTAL), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin; clavulanic acid (AUGMENTIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 13Sep2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 06:00, the patient experienced migraine, vomiting, pain at injection site, swollen and very painful lymph node in right armpit. The events did not result in doctor 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, vomiting, pain at injection site, swollen and very painful lymph node in right armpit was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Vomiting
Clinical narrative: Severe Nausea; Vomiting in the middle of the night; Extra congestion and headaches during the day; Extra congestion and headaches during the day; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 09Feb2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and also received the third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301258A) via an unspecified route of administration in the left arm on 05Oct2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination which included influenza vaccine (reported as flu shot) (MANUFACTURER UNKNOWN) on 01Oct2021 for immunization. The patient did not receive other medications in two weeks of vaccination. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in left arm on 19Jan2021 at 08:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, after the second dose, the patient experienced severe nausea, vomiting in the middle of the night, extra congestion and headaches during the day. On 06Oct2021 at 01:00, after the third dose (booster dose), same events occurred. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting in the middle of the night and extra congestion and headaches during the day was resolving at the time of this report.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Pretty bad stomach pain, that comes in persistent waves while standing, makes "me" unable to go to work; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male 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 04Oct2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to 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 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 13Sep2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 07:00, the patient experienced pretty bad stomach pain, that comes in persistent waves while standing and made him unable to go to work. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pretty bad stomach pain, that comes in persistent waves while standing and made him unable to go to work was not resolved 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immunisation, Off label use
Clinical narrative: Headache; Lightheadedness and dizziness; Off label use; A third (booster) dose of BNT162b2 is administered subsequent to the initial 2 dose regimen of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 78-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, ulcerative colitis, COVID-19 and known allergies to sulfa and opioids. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and ascorbic acid/tocopheryl acetate/zinc oxide/cupric oxide/betacarotene (PRESERVISION); 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: UNKNOWN) via an unspecified route of administration in the left arm on 09Feb2021 at 11:15 (at the age of 77-years-old) as a single dose for COVID-19 immunisation and 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 02Mar2021 at 10:45 (at the age of 77-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-19 vaccine. On 28Sep2021 at 08:00, the patient experienced headache, lightheadedness and dizziness. 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 headache, lightheadedness and dizziness was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Immunisation, Lymphadenopathy
Clinical narrative: Visibly Swollen and tender lymph nodes in left collar bone area on left side of body / same side whereinjection was given in left shoulder / appeared about 24 hours after 3rd dose and persists through day 5; Visibly Swollen and tender lymph nodes in left collar bone area on left side of body / same side whereinjection was given in left shoulder / appeared about 24 hours after 3rd dose and persists through day 5; Sore arm; Aches; Headache; Loss of appetite; Tired; Heart palpitations; The patient received a third/booster dose; The patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and breast cancer gene 1 (BRCA1). The patient was allergic to latex, eggs, pets and environmental. Prior to 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 vaccination. Concomitant medications included ibuprofen (ADVIL), cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 44-years-old) and also previously 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 21Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 16:00, about 24 hours after the third dose, the patient noticed the appearance of visibly swollen and tender lymph nodes in left collar bone area on left side of body, same side where injection was given in left shoulder, and persisted through 06Oct2021, day 5 and also had sore arm, aches, headache, loss of appetite, tired and heart palpitations was felt after first 24 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 visibly swollen and tender lymph nodes in left collar bone area on left side of body, same side where injection was given in left shoulder and persisted through day 5, sore arm, aches, headache, loss of appetite, tired and heart palpitations were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pain in extremity, Palpitations
Clinical narrative: Visibly Swollen and tender lymph nodes in left collar bone area on left side of body / same side whereinjection was given in left shoulder / appeared about 24 hours after 3rd dose and persists through day 5; Visibly Swollen and tender lymph nodes in left collar bone area on left side of body / same side whereinjection was given in left shoulder / appeared about 24 hours after 3rd dose and persists through day 5; Sore arm; Aches; Headache; Loss of appetite; Tired; Heart palpitations; The patient received a third/booster dose; The patient received a third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and breast cancer gene 1 (BRCA1). The patient was allergic to latex, eggs, pets and environmental. Prior to 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 vaccination. Concomitant medications included ibuprofen (ADVIL), cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 44-years-old) and also previously 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 21Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 16:00, about 24 hours after the third dose, the patient noticed the appearance of visibly swollen and tender lymph nodes in left collar bone area on left side of body, same side where injection was given in left shoulder, and persisted through 06Oct2021, day 5 and also had sore arm, aches, headache, loss of appetite, tired and heart palpitations was felt after first 24 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 visibly swollen and tender lymph nodes in left collar bone area on left side of body, same side where injection was given in left shoulder and persisted through day 5, sore arm, aches, headache, loss of appetite, tired and heart palpitations were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthma, Dyspnoea paroxysmal nocturnal, Headache, Hypersomnia
Clinical narrative: Nightmares; Vivid dreams; Congestion; PND; Oversleeping; Headache; Site soreness for 48 hours; Asthma; This is a spontaneous report from a non-contactable consumer. A female non-pregnant patient patient of 38-years of age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the via an unspecified route of administration in the right arm on 02Oct2021 at 13:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, urticaria and known allergy to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received ketorolac tromethamine (TORADOL) and erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 04Oct2021 the patient experienced nightmares, vivid dreams, congestion, PND (paroxysmal nocturnal dyspnea), oversleeping, headache, site soreness for 48 hours, asthma. The events did not result in 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event site soreness for 48 hours was resolved on 06Oct2021 after a duration of 48 hours and the outcome of the events nightmares, vivid dreams, congestion, PND (paroxysmal nocturnal dyspnea), oversleeping, headache, asthma was resolving 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nightmare, Vaccination site pain
Clinical narrative: Nightmares; Vivid dreams; Congestion; PND; Oversleeping; Headache; Site soreness for 48 hours; Asthma; This is a spontaneous report from a non-contactable consumer. A female non-pregnant patient patient of 38-years of age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the via an unspecified route of administration in the right arm on 02Oct2021 at 13:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, urticaria and known allergy to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received ketorolac tromethamine (TORADOL) and erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 04Oct2021 the patient experienced nightmares, vivid dreams, congestion, PND (paroxysmal nocturnal dyspnea), oversleeping, headache, site soreness for 48 hours, asthma. The events did not result in 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. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event site soreness for 48 hours was resolved on 06Oct2021 after a duration of 48 hours and the outcome of the events nightmares, vivid dreams, congestion, PND (paroxysmal nocturnal dyspnea), oversleeping, headache, asthma was resolving 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Dysgeusia, Fatigue, Hot flush
Clinical narrative: Tinnitus- started 2 days or so after vaccine; Sleeplessness; Fatigue; Muscle pain throughout body; Fever; Injection site pain; Painful left tonsil for a few days; Bad taste in mouth; Extreme back ache; Tightness in chest; Sinus pain; Swollen left tonsil for a few days; Hot and sweat flashes; This is a spontaneous report from a contactable consumer, the patient. A 48-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 27Sep2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history includes COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021, at 17:00, the patient experienced bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil for a few days, hot and sweat flashes and on 29Sep2021, the patient experienced tinnitus which started 2 days or so after vaccine and still had it. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil, hot and sweat flashes, tinnitus was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia, Sinus pain, Tinnitus
Clinical narrative: Tinnitus- started 2 days or so after vaccine; Sleeplessness; Fatigue; Muscle pain throughout body; Fever; Injection site pain; Painful left tonsil for a few days; Bad taste in mouth; Extreme back ache; Tightness in chest; Sinus pain; Swollen left tonsil for a few days; Hot and sweat flashes; This is a spontaneous report from a contactable consumer, the patient. A 48-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 27Sep2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history includes COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021, at 17:00, the patient experienced bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil for a few days, hot and sweat flashes and on 29Sep2021, the patient experienced tinnitus which started 2 days or so after vaccine and still had it. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil, hot and sweat flashes, tinnitus was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar disorder, Tonsillar hypertrophy, Vaccination site pain
Clinical narrative: Tinnitus- started 2 days or so after vaccine; Sleeplessness; Fatigue; Muscle pain throughout body; Fever; Injection site pain; Painful left tonsil for a few days; Bad taste in mouth; Extreme back ache; Tightness in chest; Sinus pain; Swollen left tonsil for a few days; Hot and sweat flashes; This is a spontaneous report from a contactable consumer, the patient. A 48-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 27Sep2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history includes COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021, at 17:00, the patient experienced bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil for a few days, hot and sweat flashes and on 29Sep2021, the patient experienced tinnitus which started 2 days or so after vaccine and still had it. Therapeutic measures were not taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of bad taste in mouth, fatigue, extreme back ache and muscle pain throughout body, sleeplessness, fever, tightness in chest, sinus pain, injection site pain, swollen painful left tonsil, hot and sweat flashes, tinnitus was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Numbness in left hand and left leg below the knee; Cramps in left leg; Slight pain in left leg; Tingling in left hand and left leg below the knee; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 10Sep2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), gastrooesophageal reflux disease (GERD) and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), esomeprazole sodium (NEXIUM) and vilazodone hydrochloride (VIIBRYD); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 12Sep2021 at 00:00, the patient experienced numbness and tingling in left hand and left leg below the knee, slight pain and cramps in left leg. The events did not result in doctor 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. On 25Sep2021, 28Sep2021 and 02Oct2021, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events numbness and tingling in left hand and left leg below the knee, cramps in left leg and slight pain in left leg was not resolved at the time of this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 10:00 (at the age of 26-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. Concomitant medications include unspecified birth control medication from an unknown start date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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 06Oct2021 at 05:30, the patient experienced swollen lymph node. 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 event swollen lymph node was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 79-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 21Mar2021 at 13:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced rash on neck and chest, which lasted for 10 days. 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 rash on neck and chest was resolved on an unknown date in 2021, after the duration of 10 days.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: 2 days after vaccine right armpit extremely swollen and tender (lymph nodes in armpit); 2 days after vaccine right armpit extremely swollen and tender (lymph nodes in armpit); Body aches; Fatigue the following day; Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Oct2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received other vaccines within four weeks prior to the vaccination, which included tetanus vaccine (MANUFACTURER UNKNOWN) in the right arm on 29Sep2021 for immunisation. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 32-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021, the patient experienced body aches, fatigue the following day. On 07Oct2021, two days after vaccine, his right armpit was extremely swollen and tender, it was the lymph nodes in armpit. 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, body aches, fatigue the following day; two days after vaccine right armpit was extremely swollen and tender, it was the lymph nodes in armpit were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use, Pyrexia
Clinical narrative: A third (booster) dose of BNT162b2 was administered; Off label use; Fever; Headache; This is a spontaneous report from a contactable consumer. A female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was 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 on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced fever and headache. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever and headache was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling, redness, and itching at injection site; Swelling, redness, and itching at injection site; Swelling, redness, and itching at injection site; Swelling of lymph nodes under left arm; Off label use; A third (booster) dose of BNT162b2 was administered subsequent to the Initial 2 dose regimen of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 05Oct2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lithium (MANUFACTURER UNKNOWN), quetiapine fumarate (SEROQUEL) and multivitamin (MANUFACTURER UNKNOWN); 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: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 50-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-19 vaccine. On 06Oct2021, the patient experienced swelling, redness and itching at injection site and swelling of lymph nodes under left arm. 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 swelling, redness and itching at injection site and swelling of lymph nodes under left arm was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.