chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Palpitations
Clinical narrative: palpitation for short period of time; Dizziness; little bit of anxious; This is spontaneous report from a contactable consumer (Mother). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Upper Arm Left on an unspecified date (Batch/Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that, her son he got the vaccine and an hours ago like around say 6 O' Clock and he had palpitation for short period of time and the dizziness. The reporter stated that, like an hour after the vaccination he started experiencing the Problem and It last about 40 seconds the palpitation. The patient experienced palpitation for short period of time, dizziness and little bit of anxious on an unspecified date. Reporter stated that, the patient did not receive any treatment for the events and he just sat down he was drinking a lot of fluids. The patient was not still experiencing the events, but he was little bit of anxious. She did not know if it was from the shot or not. Outcome of the event little bit of anxious was not recovered and other events were recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Bump under arm in arm pit area; 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: UNKNOWN) via an unspecified route of administration in the right arm on 11May2021 at 14:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included pulmonary embolism since 2004 and penicillin allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Apr2021 at 14:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 06:00 the patient experienced bump under arm in arm pit area. 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 anti-inflammatory medication (unspecified). The clinical outcome of the event bump under arm in arm pit area was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Headache; Hives; This is a spontaneous report from a contactable healthcare professional, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0173) via an unspecified route of administration in the left arm on 13May2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously received azithromycin (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 18:15, the patient experienced headache and hives. No therapeutic measures were received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache and hives was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee pain; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old male patient received the unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, after the vaccination, the patient experienced knee pain that was not previously extant. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event knee pain was resolved with sequelae on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Side of face and ear is numb; This is a spontaneous report from a non-contactable consumer reported for Patient (reporter's son) that A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; 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 were not reported. On an unspecified date the patient experienced side of face and ear is numb. It was reported by the reporter that she talked to someone earlier about symptoms her son had from the COVID Vaccine. States that his symptoms are not on the list of known symptoms. Caller states that the agent told her she was going to check on some stuff for her and then call her back. She states that she missed the call but was left the listed interaction number on her voicemail. She states that her son's side of face and ear is numb. Caller states that Pfizer just wants personal information. Says that her son already filled out a report online and they check in with him by text every day. She states the agent earlier did not have any information for her as the vaccine was still relatively new. Reporter says that she does not want to go through all the personal information again. States that she is so frustrated that Pfizer doesn't know what is calling this. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient.  A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an Intramuscular route of administration on 27Mar2021 as a single dose for COVID-19 immunisation. Medical history included cancer-multiple myeloma. The patient received unspecified medication within two weeks of vaccination.  It was unknown, whether the patient had allergic to medications, food, or other products Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced tinnitus after receiving second shot of Pfizer vaccine. Tinnitus was loud and lasted for about 4 hours. On an unknown date in 2021, the patient underwent unknown COVID-19 test and result was unknown. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tinnitus was recovered on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Mild chronic hives, multiple sites of 1cm flat bumps that itch; Mild chronic hives, multiple sites of 1cm flat bumps that itch; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) in the left arm on 26Feb2021(at the age of 73-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) in the left arm on 05Feb2021(at the age of 73-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced mild chronic hives, multiple sites of 1cm flat bumps that itched. The sites quickly resolved following application of topical triple antibiotic cream. They continued to appear without intervention. The patient reported that half tablet of zyrtec antihistamine suppressed symptoms for about four days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with topical triple antibiotic cream and zyrtec antihistamine. The clinical outcome of the event mild chronic hives, multiple sites of 1cm flat bumps that itched was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Worsening pain in knee; Pain in left leg; Hives; Itching; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 11May2021 at 11:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included exertional asthma, pre-diabetic, obesity, allergy to plants, grass allergy, pollen allergy, latex allergy and penicillin allergy. The patient previously took claritin, and caine group and experienced allergy. Concomitant medications included cortisone (MANUFACTURER UNKNOWN) injection in her knee on an unknown date for unknown indication. 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 right arm on 20Apr2021 at 11:30 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13May2021 at 13:00 the patient experienced worsening pain in knee, pain in left leg, hives and itching on the second day after the vaccine. There was no throat swelling. No therapeutic measures were taken as a result of the events. The clinical outcome of the events worsening pain in knee, pain in left leg, hives and Itching were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Insomnia
Clinical narrative: Severe shoulder pain; pain so bad that can not sleep,; hurts to use arm or raise it.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW01710), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7533), via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced severe shoulder pain and pain so bad that cannot sleep and hurt to use arm or raise it. It's reported that the patient had severe shoulder pain that had not went away, pain so bad that he cannot sleep, and it hurt to use arm or raise it. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe shoulder pain and pain so bad that cannot sleep and hurt to use arm or raise it was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: rash on the outside of left chin and outside of right chin. Rash on left hip followed by a rash on right hip. spreading on arms.; Rash blotches on right torso which spread over breast; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9809) via an unspecified route of administration in the left arm on 18Feb2021 at 08:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) and enalapril (MANUFACTURER UNKNOWN) all from an unknown date, for an unknown indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263) via an unspecified route of administration in the left arm on 28Jan2021 at 08:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. It was unknown, if the patient received any other vaccines within four weeks prior to the vaccination. On 01Mar2021, the patient experienced rash on the outside of left chin and right chin, rash blotches on right torso which spread over breast, rash on left hip followed by a rash on right hip and spreading on arms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with some kind of fungal cream, pepcid ac and zyrtec. The clinical outcome of the events of rash on the outside of left chin and right chin, rash blotches on right torso which spread over breast, rash on left hip followed by a rash on right hip and spreading on arms were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pain, Hypoaesthesia, Influenza like illness, Pain in jaw
Clinical narrative: Left ear pain; Left jaw pain; left jaw numbness; Flu like symptoms; Severe burning in legs; This is a spontaneous report from a contactable consumer (patient).   This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EA0170), on 14Apr2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Relevant medical history included latex allergy and hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 14Apr2021 at 17:00, the patient experienced severe burning in legs. On 15Apr2021, the patient experienced flu like symptoms. On 03May2021, the patient had an appointment with doctor for advice on whether to go ahead with 2nd shot as legs had been burning off and on since first shot. On 04May2021 the patient experienced left ear pain, left jaw pain and left jaw numbness. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events severe burning in legs, flu like symptoms, left ear pain, left jaw pain and left jaw numbness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: "Too weak to get up"; incredible vertigo; vomiting; severe headache; fatigue; "Slept most of the day"; very sore arm; insomnia; chills; 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: er8735) via an unspecified route of administration in the left arm on 08May2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome, syndrome, mast cell activation, mast cell activation syndrome, asthma, sensory processing disorder, chronic depression, anxiety, food allergy, topical adhesive allergy, topical adhesive allergy and chronic bronchitis. Concomitant medications included salbutamol (ALBUTEROL), montelukast sodium (SINGULAIR), glucosamine (MANUFACTURER UNKNOWN) and colecalciferol, calcium gluconate, calcium citrate, magnesium citrate, magnesium gluconate, potassium chloride, sodium chloride (SALTSTICK) and D(unspecified); all taken for unknown indication on an unknown date. The patient previously took Ancef, Advair and experienced drug allergy. The patient previously took Xylitol and experienced allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: er8727) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00( at the age of 40-years-old) as a single dose for COVID-19 immunisation and experienced soreness and (more) and fatigue (than normal). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021, Second shot day 1, the patient experienced very sore arm, insomnia, chills. On 10May2021, Second shot day 2-she was too weak to getup, incredible vertigo, vomiting, chills, severe headache and fatigue. Slept most of the day. Unable to keep her POTS/MCAS food & drink intake schedule. Second shot day 3-vertigo, vomiting, chills, severe headache, fatigue. Drank at least a gallon but didn't eat enough. Second shot day 4-less vertigo, chills, moderate-severe headache, fatigue. Drank at least a gallon + all salt needed but didn't eat enough. Second shot day 5/6-less vertigo, chills, moderate headache and fatigue. Second shot day 7-finally she could get out of bed without severe vertigo, chills and moderate headache. The patient did not receive any treatment for the events reported. The clinical outcome of the event very sore arm, insomnia, chills, "too weak to get up", incredible vertigo, vomiting, severe headache, slept most of the day and fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vertigo, Vomiting
Clinical narrative: "Too weak to get up"; incredible vertigo; vomiting; severe headache; fatigue; "Slept most of the day"; very sore arm; insomnia; chills; 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: er8735) via an unspecified route of administration in the left arm on 08May2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome, syndrome, mast cell activation, mast cell activation syndrome, asthma, sensory processing disorder, chronic depression, anxiety, food allergy, topical adhesive allergy, topical adhesive allergy and chronic bronchitis. Concomitant medications included salbutamol (ALBUTEROL), montelukast sodium (SINGULAIR), glucosamine (MANUFACTURER UNKNOWN) and colecalciferol, calcium gluconate, calcium citrate, magnesium citrate, magnesium gluconate, potassium chloride, sodium chloride (SALTSTICK) and D(unspecified); all taken for unknown indication on an unknown date. The patient previously took Ancef, Advair and experienced drug allergy. The patient previously took Xylitol and experienced allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: er8727) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00( at the age of 40-years-old) as a single dose for COVID-19 immunisation and experienced soreness and (more) and fatigue (than normal). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021, Second shot day 1, the patient experienced very sore arm, insomnia, chills. On 10May2021, Second shot day 2-she was too weak to getup, incredible vertigo, vomiting, chills, severe headache and fatigue. Slept most of the day. Unable to keep her POTS/MCAS food & drink intake schedule. Second shot day 3-vertigo, vomiting, chills, severe headache, fatigue. Drank at least a gallon but didn't eat enough. Second shot day 4-less vertigo, chills, moderate-severe headache, fatigue. Drank at least a gallon + all salt needed but didn't eat enough. Second shot day 5/6-less vertigo, chills, moderate headache and fatigue. Second shot day 7-finally she could get out of bed without severe vertigo, chills and moderate headache. The patient did not receive any treatment for the events reported. The clinical outcome of the event very sore arm, insomnia, chills, "too weak to get up", incredible vertigo, vomiting, severe headache, slept most of the day and fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: post-menopause spotting 2 days after second dose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 05May2021 15:00 as dose 2, single for covid-19 immunization at an urgent care center. Medical history included hypertension from an unknown date, and post menopause from an unknown date with last period was 3-4 years prior. The patient was taking an unspecified hypertension medication. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested since the vaccination. The patient previously received the first dose of bnt162b2 on an unspecified date at 52 years old for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07May2021, the patient experienced post-menopause spotting 2 days after second dose. No treatment was given. The reporter considered the event as serious, however, the event did not result in death or life threatening condition, caused or prolonged hospitalization, or disability. The outcome of the event was reported as recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Experience shingles outbreak starting May 12.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 30Apr2021 at 14:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles in 2018, sulfonamide allergy and allergies to several contract dyes. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received acetaminophen (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received SHINGRIX vaccine for shingles both doses by Aug2019.The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 08:00, the patient experienced shingles outbreak. The patient previously had shingles in 2018 and recovered in a few weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with valacyclovir HCL (MANUFACTURER UNKNOWN) 1-gram tablets. The clinical outcome of the event shingles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vaccination site pain
Clinical narrative: Dizziness; fever; pain at the injection site; This is a spontaneous report from a contactable physician. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via intramuscular route of administration in the left arm on 03May2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 1 diabetes since the patient was 6 years old. The patient had no known allergies. Concomitant medications included insulin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an intramuscular route of administration in the left arm on 12Apr2021 at 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 12:30, the patient experienced dizziness, fever and pain at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of dizziness, fever and pain at the injection site and included treatment with ibuprofen. The clinical outcome of the events dizziness, fever and pain at the injection site were recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps after eating/ Same foods would cause cramping one day and not the next but came back just as bad after second dose; Stomach cramps after eating/ Same foods would cause cramping one day and not the next; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age 33-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via unspecified route of administration in the left arm on 12May2021 at 11:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, the patient experienced stomach cramps after eating and the same foods would cause cramping one day and not the next day. She further reported that the event subsided before second dose but came back just as bad after second dose. Therapeutic measures taken as a result of stomach cramps which included the prescription of pantoprazole (MANUFACTURER UNKNOWN). The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of stomach cramps with onset of 23Apr2021 was recovered on an unknown date in 2021, while outcome of stomach cramps with onset of second dose was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting; got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: ER8727) via an unspecified route of administration on 29Mar2021 at 08:00 (at the age of 54-years-old) as a single dose in the left arm. Medical history included high risk lesions in breast, stop menstruating (I am taking Tamoxifen 200mg daily, which has made me stop menstruating) and COVID-19 (prior to vaccination), all from unspecified dates and unspecified if ongoing. The patient had no known allergies and no relevant past drug history. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included tamoxifen taken for an unspecified indication from Sep2020 and ongoing at 200mg, daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 23:30, the patient experienced got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting. The events were reported as non-serious. The events resulted in a doctor or other healthcare professional office/clinic visit. The course of events was reported as follows: "I am taking Tamoxifen 200mg daily, which has made me stop menstruating since I started taking it in Sep2020. I received the first dose of the COVID Vaccine at 8am on 29Mar2021.That night while sleeping I got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting. I received the second dose of the vaccine on 19Apr2021 and within 3 days, the same thing happened. I had a phone consultation with my oncologist to inform him of both incidents." Treatment was not received for the events. The clinical outcomes of the events got my period for the first time since Sep2020 and it was much heavier than I ever had it before with a lot of clotting were recovered/resolved on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: The patient received first dose on 23Apr2021 and second dose on 05May2021; Shingles outbreak across upper torso; This is a spontaneous report from a contactable consumer, the patient. A 35-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 05May2021 at 14:15 (at the age 35-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not take 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 left arm on 23Apr2021 (at the age 35-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021, one week after second shot, the patient experienced shingles outbreak across upper torso. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported event which included medication as prescribed by doctor. The clinical outcome of shingles outbreak across upper torso was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Injection side pain; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; This is a spontaneous report from a non-contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0183) via an unspecified route of administration in the left arm on 11May2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 16Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 22:00, the patient experienced injection side pain, tiredness, headache, muscle pain, chills, fever and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events injection side pain, tiredness, headache, muscle pain, chills, fever and feeling unwell were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Injection side pain; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; This is a spontaneous report from a non-contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0183) via an unspecified route of administration in the left arm on 11May2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 16Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 22:00, the patient experienced injection side pain, tiredness, headache, muscle pain, chills, fever and felt unwell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events injection side pain, tiredness, headache, muscle pain, chills, fever and feeling unwell were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: "72 hours after the injection I started bleeding from my nose"; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left  arm on 11May2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had] not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, 72 hours after the injection, the patient started bleeding from her nose. she had never had a nose bleed in her life.  It lasted a few minutes with a clump or clot coming out of her nose and then the bleeding stopped. 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. The clinical outcome of the event "72 hours after the injection I started bleeding from my nose" was resolved on 14May2021.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Lingering headache on the day prior to injection.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, asthma, anaphylaxis, seafood allergy, peanut allergy, allergy to nuts (Tree nut), pollen allergy, allergic to cats, allergic to dogs, allergy to animal dander (Pet dander), house dust mite allergy (Dust mite allergy), allergy to molds, cockroach allergy and allergy (Weeds). Concomitant medications included meningococcal vaccine b (MANUFACTURER UNKNOWN) dose number 02 in the left arm on 27Apr2021 for an unspecified indication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other vaccines within four weeks prior to the vaccination. On 12May2021 at 07:30, the patient experienced lingering headache on the day prior to injection. Patient also stated she had to take pain medicine for relief. 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 the event and included treatment with pain medicine, names unspecified. The clinical outcome of the event lingering headache on the day prior to injection was recovering   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 06May2021 at 09:15 (at the age of 43-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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021 at 20:00 the patient experienced tinnitus which started the evening she received the vaccine and has continued ever since. It was reported to be all the time. 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. No therapeutic measures were taken for the reported events. The clinical outcome of the event tinnitus was not resolved/ongoing at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Lump/knot in armpit area on same arm as shot; 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: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 39-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 11May2021 at 18:30 (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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 07:00, the patient experienced lump/knot in armpit area on the same arm as shot. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event lump/knot in armpit area was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Positron emission tomogram, Therapeutic response unexpected
Clinical narrative: First of all, What I am going to report is not the adverse effect of the vaccine. Instead it is the good effect of the vaccine. I was diagnosed as Malt Lymphoma in Sept. 2019. I believe the two doses of the Pfizer vaccine cured my lymphoma.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30(at the age of 68-year-old) as a dose for COVID-19 immunisation. Medical history included malt lymphoma. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has experienced unexpected therapeutic benefit from both the doses. On an unknown date the patient reports that "first of all", what she reported was not the adverse effect of the vaccine. Instead, it was the good effect of the vaccine. The patient was diagnosed with malt lymphoma on an unknown date in Sep2019. The patient believed that the two doses of Pfizer vaccine cured her lymphoma. On the report date(14May2021) she got her latest PET scan result which showed that lymphoma in her rectum was gone. She has never had any treatment for the lymphoma. The only symptom she had been had was the tender/pain in the lymphoma location in her lower ab. After the first dose of vaccine, she could feel that the pain was reduced. The patient developed multiple lymph nodes swollen, shortness of the breath, and night sweat etc. which were typical lymphoma symptoms after the second dose of the vaccine. At the same time, the pain at the lower ab had been significantly reduced. Also, her appetite had been improved a lot which made her to gain 4 lbs since 30Mar. This means a lot to the patient since she had lost the appetite and kept losing weight in the last few years. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. On an unknown date, the patient underwent positron emission tomography (PET) scan which showed that lymphoma in her rectum was gone. The clinical outcome of the event unexpected therapeutic benefit was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.