chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: The patient received third/ booster dose of BNT162b2; Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Nov2021 (at the age of 18-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 other vaccines within four weeks prior to the vaccination. The concomitant medication included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as single doses for COVID-19 immunisation. On 07Nov2021, the patient experienced some known/expected side effects fatigue, chills, pain in arm and fever as well as some unexpected side effects; nausea, gastro intestinal (GI) distress and vomiting in the middle of the night. This only happened after the third shot in the night of and day after. No unexpected side effects happened after the second shot. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills, pain in arm, fever, nausea, GI distress and vomiting were resolved on an unknown date on Nov2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Migraine
Clinical narrative: Had a migraine with all 3 shots / It occurs the one or two days after the shot; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 an unknown date; 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 an unknown date and also received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Nov2021 (at the age of 35-years-old); all as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. The patient had a migraine with all the three shots; on an unknown date after the first and the second shots and on 09Nov2021, after the third shot. It occurred one or two days after the shot. The event 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 the event which included treatment with an unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine after the first and the second shots was unknown; with the third shot the event 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Headache, Immunisation, Pain
Clinical narrative: Body aches; Low temp; Headache; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Nov2021 at 17:45 (at the age of 45-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 COVID vaccine. 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 left arm on 13Apr2021 (at the age of 45-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. On 09Nov2021, the patient experienced body aches, low temperature (low temp) and headache. On the same day, the patient underwent body temperature test and the result was low (low temp). 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 body aches, low temperature and headache 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Immunisation, Migraine
Clinical narrative: Site pain; Back pain; Muscle ache; Migraines; Fever; Diarrhea; Nausea; Chills-temporary; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the right arm on 05Nov2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse (MVP) and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atenolol (TENORMIN), acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL), hydrocodone bitartrate, paracetamol (NORCO) and ketorolac tromethamine (SPRIX); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 26Mar2021 at 12:00 (at the age of 53-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 16Apr2021 at 12:00 (at the age of 53-years-old), as single dose for COVID-19 immunisation. The patient previously took promethazine hydrochloride (PHENERGAN), moxifloxacin hydrochloride (AVELOX) and butorphanol tartrate (STADOL) and experienced drug allergy. On 05Nov2021 at 20:00, the patient experienced site pain, back pain, muscle ache, migraines, fever, diarrhea, nausea and chills-temporary. 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 chills-temporary was resolved on an unknown date in Nov2021; while that of events site pain, back pain, muscle ache, migraines, fever, diarrhea, nausea and  was resolving at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Site pain; Back pain; Muscle ache; Migraines; Fever; Diarrhea; Nausea; Chills-temporary; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the right arm on 05Nov2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse (MVP) and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atenolol (TENORMIN), acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL), hydrocodone bitartrate, paracetamol (NORCO) and ketorolac tromethamine (SPRIX); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 26Mar2021 at 12:00 (at the age of 53-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 16Apr2021 at 12:00 (at the age of 53-years-old), as single dose for COVID-19 immunisation. The patient previously took promethazine hydrochloride (PHENERGAN), moxifloxacin hydrochloride (AVELOX) and butorphanol tartrate (STADOL) and experienced drug allergy. On 05Nov2021 at 20:00, the patient experienced site pain, back pain, muscle ache, migraines, fever, diarrhea, nausea and chills-temporary. 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 chills-temporary was resolved on an unknown date in Nov2021; while that of events site pain, back pain, muscle ache, migraines, fever, diarrhea, nausea and  was resolving at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Excessive hair shedding; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was allergic to penicillin. 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 levothyroxine sodium (SYNTHROID) 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: EN6206) via an unspecified route of administration in the left arm on an unknown date at 12:00 as a single dose for COVID-19 immunisation. On 29Apr2021, the patient experienced excessive hair shedding. The event resulted in doctor or other healthcare professional office/clinic visit. 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 excessive hair shedding was resolving at the time of this report.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Nausea, Pyrexia
Clinical narrative: Chest pain; Light headed; Nausea; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 14-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Nov2021 (at the age of 14-years-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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Oct2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 07Nov2021 at 09:00, the patient experienced chest pain, light headed, nausea, and fever. The events resulted in doctor or other healthcare professional office/clinic visit. 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 chest pain, light headed, nausea, and fever 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 11Jun2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included borderline hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 12Jun2021 at 06:00, the patient experienced constant tinnitus in both ears. 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 constant tinnitus in both ears was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 16Jul2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, SARS-CoV-2 test
Clinical narrative: Gout flare up in elbow of the arm after the second vaccination, no previous history of gout flare ups in arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 25Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history included gout; the patient had previous history of gout flare ups 1-2 per year. The patient had no known drug allergy (NKDA). 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 medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an intramuscular route of administration in the left arm on 04Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 26Jan2021, after the second vaccination, the patient experienced gout flare up in elbow of the arm. There was no previous history of gout flare ups in arm. The patient had 15 flare ups in the 10 months since the vaccine. Since the vaccination, the patient had been tested for COVID-19. On 17May2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was found to be negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event included treatment with additional gout medication, allopurinol (MANUFACTURER UNKNOWN). The clinical outcome of the event gout flares up in elbow of the arm was not resolved at the time of this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Chronic stabbing pains at the injection site and radiates a couple of inches outward around the site of injection; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 19May2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), anxiety, depression and severe anemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination, for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received prazosin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 28Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 22May2021, the patient experienced chronic stabbing pains at the injection site that radiated a couple of inches outward around the site of injection. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 26Oct2021, the patient underwent binax test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the event chronic stabbing pains at the injection site that radiated a couple of inches outward around the site of injection was not resolved at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Mass
Clinical narrative: Another lump on 08Nov2021.; Lymph nodes in neck swollen and tender to the touch, the swelling continued to grow; Lymph nodes in neck swollen and tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 33-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 03Nov2021 at 12:00 (at the age of 33-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 had received unspecified medication within two weeks of vaccination. 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: UNKNOWN) via an unspecified route of administration in the right arm on 13Oct2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 12:00, lymph nodes in neck were swollen and tender to the touch. The swelling continued to grow and then she noticed another lump on 08Nov2021. It was reported that neither had reduced in size. The events resulted in doctor or other healthcare professional office/clinic visit. 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 lymph nodes in neck were swollen and tender to the touch, the swelling continued to grow and then noticed another lump 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Interchange of vaccine products, Vertigo
Clinical narrative: Dizziness. Dizziness increase as head is turned side to side; Vertigo; The patient received third/booster dose of BNT162b2; The patient received Moderna dose 1 on 23Mar2021, dose 2 on 20Apr2021 and received booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FJ1611) via an unspecified route of administration in the left arm on 08Nov2021 at 17:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and low blood pressure. 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 within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of COVID-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE; Lot Number: 04J21A) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 31-years-old) and second dose of COVID-19 vaccine mRNA (mRNA 1273)(MODERNA COVID-19 VACCINE; Lot Number: 044B21A) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 31-years-old); both as single doses for COVID-19 immunisation. On 09Nov2021 at 15:00, the patient experienced dizziness and vertigo. Dizziness increased as head turned side to side. 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 dizziness and vertigo; dizziness increased as head turned side to side was unknown at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Can feel where the shot was injected. When pressing on the spot, can feel pain at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 COVID vaccine. Concomitant medication included levonorgestrel (MIRENA) 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: EN6199) via an unspecified route of administration in the left arm on 16Mar2021 at 08:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021, the patient could feel where the shot was injected. When pressing on the spot, the patient could feel pain at injection site. 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 can feel where the shot was injected, when pressing on the spot, can feel pain at injection site was not resolved at the time of this report.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Myalgia, Pain, Product use issue
Clinical narrative: Muscular pain in left arm where injection was received. Pain radiated outwards towards arm and left pectoral muscle; Muscular pain in left arm where injection was received. Pain radiated outwards towards arm and left pectoral muscle/ I occasionally feel pain in my left pectoral muscle.; Joint pain was also present in the shoulder area; Muscular pain in left arm where injection was received. Pain radiated outwards towards arm and left pectoral muscle.; The patient received third/booster dose of BNT162b2; BNT162b2 was administered on same day when influenza vaccine was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 27Oct2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient also received influenza vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Oct2021, as single dose for immunization. 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 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 first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Mar2021 at 16:00 (at the age of 32-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 16:00 (at the age of 32-years-old) as single doses for COVID-19 immunisation. On 27Oct2021 at 11:00, the patient experienced muscular pain in left arm where injection was received. The pain radiated outwards towards arm and left pectoral muscle. Joint pain was also present in the shoulder area. This was lasted about 7-10 days before the pain started to subside. As of 10Nov2021, the patient occasionally felt pain in left pectoral muscle. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscular pain in left arm where injection was received, joint pain present in the shoulder area and pain radiated outwards towards arm and left pectoral muscle/feel pain in left pectoral muscle were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Muscular pain in left arm where injection was received. Pain radiated outwards towards arm and left pectoral muscle; Muscular pain in left arm where injection was received. Pain radiated outwards towards arm and left pectoral muscle/ I occasionally feel pain in my left pectoral muscle.; Joint pain was also present in the shoulder area; Muscular pain in left arm where injection was received. Pain radiated outwards towards arm and left pectoral muscle.; The patient received third/booster dose of BNT162b2; BNT162b2 was administered on same day when influenza vaccine was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 27Oct2021 at 10:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient also received influenza vaccine (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Oct2021, as single dose for immunization. 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 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 first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Mar2021 at 16:00 (at the age of 32-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 16:00 (at the age of 32-years-old) as single doses for COVID-19 immunisation. On 27Oct2021 at 11:00, the patient experienced muscular pain in left arm where injection was received. The pain radiated outwards towards arm and left pectoral muscle. Joint pain was also present in the shoulder area. This was lasted about 7-10 days before the pain started to subside. As of 10Nov2021, the patient occasionally felt pain in left pectoral muscle. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscular pain in left arm where injection was received, joint pain present in the shoulder area and pain radiated outwards towards arm and left pectoral muscle/feel pain in left pectoral muscle were resolving 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: Chills, Immunisation, Myalgia, Pyrexia, Tremor
Clinical narrative: Body chills; Body fever; Muscle pain in injection arm  (Left); Muscle pain in injection arm; Body shakiness; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Nov2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and pulmonary resection. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified prescribed medicines within two weeks of vaccination on unknown date for unknown indication and unknown if ongoing. The patient received other vaccines within four weeks prior to the vaccination, which included influenza vaccine (reported as flu shot) (MANUFACTURER UNKNOWN) on an unknown date in Oct2021 for immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 at 10:45 (at the age of 40-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 at 11:00 (at the age of 40-years-old); both as single doses for COVID-19 immunisation. On 09Nov2021 at 22:00, the patient experienced body chills and body fever, muscle pain in injection arm (left) and body shakiness. 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 body chills, body fever, muscle pain in injection arm (left) and body shakiness 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Body chills; Body fever; Muscle pain in injection arm  (Left); Muscle pain in injection arm; Body shakiness; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Nov2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and pulmonary resection. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified prescribed medicines within two weeks of vaccination on unknown date for unknown indication and unknown if ongoing. The patient received other vaccines within four weeks prior to the vaccination, which included influenza vaccine (reported as flu shot) (MANUFACTURER UNKNOWN) on an unknown date in Oct2021 for immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 at 10:45 (at the age of 40-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 at 11:00 (at the age of 40-years-old); both as single doses for COVID-19 immunisation. On 09Nov2021 at 22:00, the patient experienced body chills and body fever, muscle pain in injection arm (left) and body shakiness. 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 body chills, body fever, muscle pain in injection arm (left) and body shakiness 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: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister
Clinical narrative: Woke up with a clear blister/bump inside my lip. Never had it before; This is a spontaneous report from a contactable consumer, the patient. A 14-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 09Nov2021 at 16:15 (at the age of 14-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 COVID vaccine. The patient did not receive any concomitant medications. On 10Nov2021 at 06:45, the patient woke up with a clear blister/bump inside the lip. The patient never had it before. 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 woke up with a clear blister/bump inside the lip, never had it before 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Immunisation, Pain
Clinical narrative: The patient received third booster dose of BNT162b2; Fever; Chills; Headache; Bodyaches; Pain under my arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Nov2021 (at the age of 47-years-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 vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. 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 29Mar2021 (at the age of 47-years-old) and also 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 19Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation and had no side effects with both the doses. On 08Nov2021, with the third dose, the patient experienced fever, chills, headache, body aches and pain under the arm. 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 fever, chills, headache, body aches and pain under the arm were 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The patient received third booster dose of BNT162b2; Fever; Chills; Headache; Bodyaches; Pain under my arm; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Nov2021 (at the age of 47-years-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 vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. 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 29Mar2021 (at the age of 47-years-old) and also 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 19Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation and had no side effects with both the doses. On 08Nov2021, with the third dose, the patient experienced fever, chills, headache, body aches and pain under the arm. 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 fever, chills, headache, body aches and pain under the arm were 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: I broke out with hives on my neck and arms inside the elbow crease.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), pre-diabetic and high cholesterol. 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 taken within two weeks of vaccination included levothyroxine sodium (LEVOTHYROXIN), ezetimibe (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) amlodipine (MANUFACTURER UNKNOWN) and unspecified B (as reported); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received levofloxacin (MANUFACTURER UNKNOWN) and experienced possible drug allergy. On 14Mar2021, the patient broke out with hives on neck and arms inside the elbow crease. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified oral medication. Since the vaccination, the patient had been tested for COVID-19. On 31Jul2021 and on 18Oct2021, the patient underwent COVID-19 test via nasal swab and the results of both the test were found to be negative. The clinical outcome of the event broke out with hives on neck and arms inside the elbow crease was resolved on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a Solicited report from a Non-interventional (FACILITATED COLLECT) received from a contactable consumer  based on the information received by Pfizer manufacture number (21K-163-4121505-00).   A 81-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg,1 in 7 D for Crohn's disease  .  The patient medical history and concomitant medications were not reported.  The patient experienced covid-19 (drug ineffective) (death, medically significant) on an unspecified date.  The action taken in response to the event(s)  for adalimumab was unknown.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  On an unknown date, the patient experienced COVID-19. On unknown date, the patient died. The cause of death was reported as COVID-19. It is unknown if an autopsy was performed. PFIZER BIONTECH COVID-19 VAC-CINE (TOZINAMERAN) was also considered suspect.  The patients caregiver reported that patient died of covid-19.  The reporter assessed the causality between the reported event and the suspect vaccine (BNT162B2) as possible.  The reporter assessed the causality between the reported event and Humira as reasonably possible.  The lot number for vaccine [BNT162B2], was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to allow proper submission to health authorities.; Sender's Comments: Based on the known safety profile and information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19
Sex: F
Vaccine: COVID19
Symptoms: Completed suicide
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (reporting for mother). An 81-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced a serious adverse reaction that was incurable. After 5 months of suffering, she hung herself with her bathrobe belt . The patient died on unspecified date.  It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: she hung herself with her bathrobe belt
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer-sponsored program Support, from a contactable consumer (patient). A 73 (unit: unknown) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date. Patient also stated that he felt better than he has in the past year after receiving the vaccine. Outcome of the event was unknown.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sore; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program .  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was sore after the 1st dose and she wanted to know if she can take Aleve. Outcome of the event was unknown.  No follow-up attempts are possible; information on lot/batch cannot be requested. No further information expected.