chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pain, Pruritus
Clinical narrative: 36 hrs after redness, warmth & soreness at site; 36 hrs after redness, warmth & soreness at site; 36 hrs after redness, warmth & soreness at site; Muscle/body aches; Muscle/body aches; Fatigue; Fever >102 F/ fever 99-100.5 F; Injection site flat macular red rash 7 x 17 cm, thatremains warm to touch, not painful; Generalized pruritus; Injection site flat macular red rash 7 x 17 cm, thatremains warm to touch, not painful; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 13Sep2021 at 07:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified multi-history and allergy to multi-medications, never vaccines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included prescribed multi medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 16Aug2021 at 07:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021 at 19:30, 36 hours after the vaccination, the patient experienced redness, warmth and soreness at site and fever of greater than 102 Fahrenheit, muscle/body aches and fatigue. Reportedly, 48 hours (15Sep2021) after the vaccination and reoccurring every evening since vaccine, the patient experienced fever 99-100.5 Fahrenheit, generalized pruritus and injection site flat macular red rash 7 x 17 cm, that remained warm to touch but not painful. 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 taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN), from day 2 to through today (at the time of this report) and diphenhydramine hydrochloride (BENADRYL) every bedtime (qhs). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, warmth and soreness at site and fever, muscle/body aches, fatigue, generalized pruritus and injection site flat macular red rash were recovered with lasting effects on an unknown date in Sep2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: 36 hrs after redness, warmth & soreness at site; 36 hrs after redness, warmth & soreness at site; 36 hrs after redness, warmth & soreness at site; Muscle/body aches; Muscle/body aches; Fatigue; Fever >102 F/ fever 99-100.5 F; Injection site flat macular red rash 7 x 17 cm, thatremains warm to touch, not painful; Generalized pruritus; Injection site flat macular red rash 7 x 17 cm, thatremains warm to touch, not painful; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 13Sep2021 at 07:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified multi-history and allergy to multi-medications, never vaccines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included prescribed multi medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 16Aug2021 at 07:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021 at 19:30, 36 hours after the vaccination, the patient experienced redness, warmth and soreness at site and fever of greater than 102 Fahrenheit, muscle/body aches and fatigue. Reportedly, 48 hours (15Sep2021) after the vaccination and reoccurring every evening since vaccine, the patient experienced fever 99-100.5 Fahrenheit, generalized pruritus and injection site flat macular red rash 7 x 17 cm, that remained warm to touch but not painful. 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 taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN), from day 2 to through today (at the time of this report) and diphenhydramine hydrochloride (BENADRYL) every bedtime (qhs). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, warmth and soreness at site and fever, muscle/body aches, fatigue, generalized pruritus and injection site flat macular red rash were recovered with lasting effects on an unknown date in Sep2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: 36 hrs after redness, warmth & soreness at site; 36 hrs after redness, warmth & soreness at site; 36 hrs after redness, warmth & soreness at site; Muscle/body aches; Muscle/body aches; Fatigue; Fever >102 F/ fever 99-100.5 F; Injection site flat macular red rash 7 x 17 cm, thatremains warm to touch, not painful; Generalized pruritus; Injection site flat macular red rash 7 x 17 cm, thatremains warm to touch, not painful; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 13Sep2021 at 07:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified multi-history and allergy to multi-medications, never vaccines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included prescribed multi medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 16Aug2021 at 07:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 14Sep2021 at 19:30, 36 hours after the vaccination, the patient experienced redness, warmth and soreness at site and fever of greater than 102 Fahrenheit, muscle/body aches and fatigue. Reportedly, 48 hours (15Sep2021) after the vaccination and reoccurring every evening since vaccine, the patient experienced fever 99-100.5 Fahrenheit, generalized pruritus and injection site flat macular red rash 7 x 17 cm, that remained warm to touch but not painful. 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 taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN), from day 2 to through today (at the time of this report) and diphenhydramine hydrochloride (BENADRYL) every bedtime (qhs). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, warmth and soreness at site and fever, muscle/body aches, fatigue, generalized pruritus and injection site flat macular red rash were recovered with lasting effects on an unknown date in Sep2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Upon waking the morning after the 1st dose, was dizzy and had sweating; Upon waking the morning after the 1st dose, was dizzy and had sweating; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 17Sep2021 at 07:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) 20 mg (milligram) and unspecified oral birth control; both from unknown dates for unknown indications and unknown if ongoing. On 18Sep2021 at 07:45, upon waking the morning after the first dose, the patient was dizzy and had sweating. 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 upon waking the morning after the 1st dose, was dizzy and had sweating was unknown at the time of the report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair is falling out rapidly in the shower and every time "I" brush it; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. 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 did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 10May2021, the patient's hair was falling out rapidly in the shower and every time she brushed it. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hair is falling out rapidly in the shower and every time she brush it was not recovered at the time of this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Chest discomfort, Feeling hot, Hypoaesthesia
Clinical narrative: Arm swollen to wrist; Could not feel fingers; Tight chest; Burning throat to chest; Lethargy and pain is worse since shot; Palpitations; Nasal congestion; Lethargic hair loss; Joint pain; All around sick; Overheating; Lethargy and pain is worse since shot; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date in 2021, ongoing lethargy and pain from an unknown date. The patient was a long haul COVID-19 sufferer. The patient had phantom, distorted and no smell since Feb2021. The patient had unspecified 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 included tetracycline (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and unspecified allergy nasal and pill; all for unknown indication from unknown date and unknown if ongoing. On 09Sep2021 at 09:00, the patient had arm swollen to wrist, could not feel the fingers, tight chest, burning throat to chest, lethargy, palpitations and nasal congestion. The patient felt as if she had COVID-19 all over again. On the same day, the patient experienced lethargic hair loss and joint pain. The lethargy and pain were worsened since the shot and the patient was all around sick. The patient also experienced overheating. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent COVID-19 test (reported as blood test) and result was negative. On 20Aug2021, the patient underwent COVID-19 test (reported as blood test) and the result showed antibodies 16.4 positive (greater than 0.8). Therapeutic measures were taken as a result of events and included treatment with an unspecified "recommendation" and testing. The clinical outcome of the events arm swollen to wrist, could not feel fingers, tight chest, burning throat to chest, lethargy and pain is worse since shot, palpitations, nasal congestion, lethargic hair loss, joint pain, all around sick and overheating were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy, Nasal congestion, Pain, Palpitations
Clinical narrative: Arm swollen to wrist; Could not feel fingers; Tight chest; Burning throat to chest; Lethargy and pain is worse since shot; Palpitations; Nasal congestion; Lethargic hair loss; Joint pain; All around sick; Overheating; Lethargy and pain is worse since shot; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date in 2021, ongoing lethargy and pain from an unknown date. The patient was a long haul COVID-19 sufferer. The patient had phantom, distorted and no smell since Feb2021. The patient had unspecified 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 included tetracycline (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and unspecified allergy nasal and pill; all for unknown indication from unknown date and unknown if ongoing. On 09Sep2021 at 09:00, the patient had arm swollen to wrist, could not feel the fingers, tight chest, burning throat to chest, lethargy, palpitations and nasal congestion. The patient felt as if she had COVID-19 all over again. On the same day, the patient experienced lethargic hair loss and joint pain. The lethargy and pain were worsened since the shot and the patient was all around sick. The patient also experienced overheating. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent COVID-19 test (reported as blood test) and result was negative. On 20Aug2021, the patient underwent COVID-19 test (reported as blood test) and the result showed antibodies 16.4 positive (greater than 0.8). Therapeutic measures were taken as a result of events and included treatment with an unspecified "recommendation" and testing. The clinical outcome of the events arm swollen to wrist, could not feel fingers, tight chest, burning throat to chest, lethargy and pain is worse since shot, palpitations, nasal congestion, lethargic hair loss, joint pain, all around sick and overheating were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 antibody test, SARS-CoV-2 test, Throat irritation
Clinical narrative: Arm swollen to wrist; Could not feel fingers; Tight chest; Burning throat to chest; Lethargy and pain is worse since shot; Palpitations; Nasal congestion; Lethargic hair loss; Joint pain; All around sick; Overheating; Lethargy and pain is worse since shot; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Sep2021 at 09:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date in 2021, ongoing lethargy and pain from an unknown date. The patient was a long haul COVID-19 sufferer. The patient had phantom, distorted and no smell since Feb2021. The patient had unspecified 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 included tetracycline (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and unspecified allergy nasal and pill; all for unknown indication from unknown date and unknown if ongoing. On 09Sep2021 at 09:00, the patient had arm swollen to wrist, could not feel the fingers, tight chest, burning throat to chest, lethargy, palpitations and nasal congestion. The patient felt as if she had COVID-19 all over again. On the same day, the patient experienced lethargic hair loss and joint pain. The lethargy and pain were worsened since the shot and the patient was all around sick. The patient also experienced overheating. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent COVID-19 test (reported as blood test) and result was negative. On 20Aug2021, the patient underwent COVID-19 test (reported as blood test) and the result showed antibodies 16.4 positive (greater than 0.8). Therapeutic measures were taken as a result of events and included treatment with an unspecified "recommendation" and testing. The clinical outcome of the events arm swollen to wrist, could not feel fingers, tight chest, burning throat to chest, lethargy and pain is worse since shot, palpitations, nasal congestion, lethargic hair loss, joint pain, all around sick and overheating were resolving 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: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Headache; Fatigue; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the right arm on 17Sep2021 at 13:00 (at the age of 32-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) 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: EW0198) via an unspecified route of administration in the left arm on 25Aug2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 02:00, the patient experienced fever, headache and fatigue. 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 fever, headache and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Mood swings, Muscle spasms, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Cramping; Mood swing; Heavy pink discharge like spotting; Had a lighter than normal period; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm on an unknown date in 2021 (at the age of 39-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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 03Apr2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 06Sep2021, the patient had a period that was lighter than normal period. On 18Sep2021, the patient experienced cramping, mood swing, and heavy pink discharge like spotting while the patient had her period on the 06Sep2021, this never happened. It was also reported that the patient had no chance of being pregnant. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent a nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cramping, mood swing, heavy pink discharge like spotting, and had a lighter than normal period was not recovered at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: Arm is getting progressively redder at injection site and each day the red area is growing larger/spreading further; This is a spontaneous report from a contactable consumer, the patient. A 39-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 15Sep2021 at 16:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and birth control. 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 COVID-19 vaccine. Concomitant medications included unspecified birth control medication from unknown date and unknown if ongoing and unspecified vitamins for unknown indications from unknown dates and unknown if ongoing. On 16Sep2021, the patient's arm was getting progressively redder at injection site and each day the red area was growing larger and spreading further. The patient was documenting it with pictures. 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, on an unknown date, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the event arm is getting progressively redder at injection site and each day the red area is growing larger/spreading further 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: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on an unknown date in Aug2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 concomitant medications. The patient previously received cefalexin monohydrate (CEPHALEXIN) antibiotic and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 28Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 31Aug2021 at 20:00, on the 11th day after taking the second dose of Pfizer vaccine, the patient experienced a delayed reaction of severe hives all over body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified antihistamine tablet. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe hives all over body was resolving at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in lymph nodes right arm pit; 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: UKNOWN) via an unspecified route of administration in the right arm on 13Sep2021 at 13:00 (at the age of 48-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 14Sep2021 at 09:00, the patient experienced swelling in lymph nodes of right arm pit. 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 event swelling in lymph nodes right arm pit was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death, Urinary tract infection
Clinical narrative: He died within 5 minutes of getting the morphine.; hospitalized for a severe UTI; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a male patient (father).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took Morphine and experienced allergic to morphine. It was stated that, the patient was older but very healthy. On an unspecified date, the patient experienced complicated severe UTI and was hospitalized, within 4 days he went from a nasal cannula to a BIPAP. He kept pulling at his BIPAP so the doctor used Morphine (for which he was allergic). He died within 5 minutes of getting the morphine. The vaccine started killing him and then the morphine finished him off. Therapeutic measures were taken as a result of the events. The seriousness of the events was serious and hospitalized. The outcome of the event was death and for complicated severe UTI was unknown. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Follow-up (21Sep2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Reported Cause(s) of Death: He died within 5 minutes of getting the morphine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin disorder
Clinical narrative: A small bump on left thumb 2 days ago, top just below the nail near knuckle.; Arthritis type swelling/pain in both thumbs, Left thumb swelling is still present; Pain in both thumbs; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 12:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced arthritis type swelling/pain in both thumbs. The left thumb swelling was still present, but right thumb affects was not currently present. On unknown date in Sep2021, the patient noticed a small bump on left thumb 2 days ago, top just below the nail near knuckle. 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 arthritis type swelling/pain in both thumbs and small bump on left thumb was unknown at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Gait disturbance, Headache, Heavy menstrual bleeding
Clinical narrative: Still have edema in extremities; Where it is hard to walk; Legs are swollen; Period is super heavy; Period is super heavy and always late; Break out in hives at random times now; Dizziness constantly; Headaches; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration on 27May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had no known allergies. 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: EW0164) via an unspecified route of administration on 06May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, 4 months later the patient still had edema in extremities to where it was hard to walk because legs were swollen and period was super heavy and always late. The patient broke out in hives at random times now and had dizziness constantly as well as headaches. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent COVID-19 via nasal swab test on 03Jun2021, 10Jun2021, 17Jun2021, 24Jun2021, 01Jul2021, 08Jul2021, 15Jul2021, 26Aug2021, 02Sep2021, 09Sep2021 and 16Sep2021 and the result found to be negative. Therapeutic measures were taken as a result of the reported events included on an unknown date in 2021, blood tests run was conducted and also MRI (magnetic resonance imaging) performed results were unknown. The clinical outcome of the events still had edema in extremities, where it was hard to walk, legs were swollen, period was super heavy, period was super heavy and always late, break out in hives at random times now, dizziness constantly and headaches was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Menstruation delayed, Oedema peripheral, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Still have edema in extremities; Where it is hard to walk; Legs are swollen; Period is super heavy; Period is super heavy and always late; Break out in hives at random times now; Dizziness constantly; Headaches; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration on 27May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had no known allergies. 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: EW0164) via an unspecified route of administration on 06May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, 4 months later the patient still had edema in extremities to where it was hard to walk because legs were swollen and period was super heavy and always late. The patient broke out in hives at random times now and had dizziness constantly as well as headaches. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent COVID-19 via nasal swab test on 03Jun2021, 10Jun2021, 17Jun2021, 24Jun2021, 01Jul2021, 08Jul2021, 15Jul2021, 26Aug2021, 02Sep2021, 09Sep2021 and 16Sep2021 and the result found to be negative. Therapeutic measures were taken as a result of the reported events included on an unknown date in 2021, blood tests run was conducted and also MRI (magnetic resonance imaging) performed results were unknown. The clinical outcome of the events still had edema in extremities, where it was hard to walk, legs were swollen, period was super heavy, period was super heavy and always late, break out in hives at random times now, dizziness constantly and headaches was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Still have edema in extremities; Where it is hard to walk; Legs are swollen; Period is super heavy; Period is super heavy and always late; Break out in hives at random times now; Dizziness constantly; Headaches; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration on 27May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had no known allergies. 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: EW0164) via an unspecified route of administration on 06May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, 4 months later the patient still had edema in extremities to where it was hard to walk because legs were swollen and period was super heavy and always late. The patient broke out in hives at random times now and had dizziness constantly as well as headaches. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent COVID-19 via nasal swab test on 03Jun2021, 10Jun2021, 17Jun2021, 24Jun2021, 01Jul2021, 08Jul2021, 15Jul2021, 26Aug2021, 02Sep2021, 09Sep2021 and 16Sep2021 and the result found to be negative. Therapeutic measures were taken as a result of the reported events included on an unknown date in 2021, blood tests run was conducted and also MRI (magnetic resonance imaging) performed results were unknown. The clinical outcome of the events still had edema in extremities, where it was hard to walk, legs were swollen, period was super heavy, period was super heavy and always late, break out in hives at random times now, dizziness constantly and headaches was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Pain assessment
Clinical narrative: 6 weeks after receiving the 2nd shot "my" current IBS condition went from 2 on a scale of 1-10 to a 10; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) which was ongoing. 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's concomitant medications included gabapentin (MANUFACTURER UNKNOWN), thioctic acid (ALPHA LIPOIC ACID) and unspecified hydrochloride (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on an unknown date at 00:00 as a single dose for COVID-19 immunisation. On 09May2021 at 14:00, 06 weeks after receiving the second dose of vaccine, the patient's current IBS condition went from 2 on a scale of 1 to 10 to a 10. It was reported that it was urgent and multi bowel movement (BM) diarrhea episodes were happening suddenly almost overnight. These were subsided but only after going gluten free and eliminating many foods from the patient's diet that she had previously been able to consume. It was reported that the patient was very concerned about getting the booster. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 6 weeks after receiving the 2nd shot "my" current IBS condition went from 2 on a scale of 1-10 to a 10 was not resolved at the time of this report.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Severe chills; Severe body aches; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587), via an unspecified route of administration in the left arm on 18Sep2021 at 12:30 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183), via an unspecified route of administration in the left arm on 28Aug2021 at 10:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation.  On 18Sep2021 at 21:30, the patient experienced fever, severe chills, severe body aches and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL), heating pad, fluids and rest from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, severe chills, severe body aches and severe headache was not resolved at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: Left arm bicep swollen; Left armpit swollen; Painful to light touch down to breast; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 17Sep2021 (at the age of 50-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 did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin b complex (MANUFACTURER UNKNOWN) as over the counter (OTC) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the right arm on 25Aug2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 19Sep2021, the patient experienced left arm bicep swollen, left armpit swollen and painful to light touch down to breast. The events did not result in doctor or other healthcare professional office/clinic visit, 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 reported events. The clinical outcome of the events left arm bicep swollen, left armpit swollen and painful to light touch down to breast were not resolved at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, SARS-CoV-2 test
Clinical narrative: Menstrual Cycle - have been having a period for over a month now; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 16Jul2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Jan2021, the patient underwent nasal swab test and the result was unknown. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. On 15Aug2021, the patient was having a period for over a month. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19 (also reported as yes). The clinical outcome of the event having a period for over a month was not resolved at the time of this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, SARS-CoV-2 test
Clinical narrative: Dizziness; Headache; This is a spontaneous report from a non-contactable nurse, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 25Aug2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included sciatica and environmental sleep disorder. 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 did not receive any concomitant medications. The patient previously received sulfamethoxazole; trimethoprim (SEPTRA) and experienced drug allergy. On 28Aug2021, the patient experienced dizziness and headache. The patient was still experiencing after 21 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On 15Sep2021, the patient underwent COVID-19 via saliva test and the result found to be negative. The clinical outcome of the events dizziness and headache was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular, Migraine
Clinical narrative: Heart felt like it was going to burst out of the chest when pulse checked it was 112 and after a few minutes it went down to 89; Sharp onset of Migraines; Intense heart beating when sitting; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via intramuscular route of administration in the left arm on 19Feb2021 (at the age of 35-years-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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced sharp onset of migraines and intense heart beating when sitting. On an unknown date in Aug2021 (also reported as the most recent was last month), the patient experienced that his heart felt like it was going to burst out of her chest and when the patient checked the pulse it was 112 and after a few minutes it went down to 89. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp onset of migraines and intense heart beating when sitting was unknown while that of the event heart felt like it was going to burst out of the chest when pulse checked it was 112 and after a few minutes it went down to 89 was resolved on an unknown date in Aug2021.   No follow-up attempts are possible. No further information is expected.