chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Nausea
Clinical narrative: Body aches; Joint pain; Fever 100.4; Nausea; Chills; Severe headache; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 10May2021 at 12:45 (at the age of-58-years-old) as a single dose for COVID-19 immunisation. Medical history included foramen ovale patent (PFO), sleep apnea, hypothyroidism, migraines, arthritis and COVID-19, diagnosed prior to the vaccination. The patient had known allergies (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and butalbital/caffeine/paracetamol (FIORICET); all for unknown indication from an unknown date and unknown if ongoing. On 11May2021 at 23:00, the patient experienced body aches, joint pain, fever 100.4, nausea, chills and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, joint pain, fever 100.4, nausea, chills and severe headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Joint pain; Fever 100.4; Nausea; Chills; Severe headache; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 10May2021 at 12:45 (at the age of-58-years-old) as a single dose for COVID-19 immunisation. Medical history included foramen ovale patent (PFO), sleep apnea, hypothyroidism, migraines, arthritis and COVID-19, diagnosed prior to the vaccination. The patient had known allergies (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and butalbital/caffeine/paracetamol (FIORICET); all for unknown indication from an unknown date and unknown if ongoing. On 11May2021 at 23:00, the patient experienced body aches, joint pain, fever 100.4, nausea, chills and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, joint pain, fever 100.4, nausea, chills and severe headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Disruption in menstrual cycle.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), unspecified birth control (MANUFACTURE UNKNOWN), ibuprofen (ADVIL), probiotics (MANUFACTURER UNKNOWN) and fish oil (OMEGA 3) taken for unspecified indications, 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: EP6955) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 14:00 the patient experienced disruption in menstrual cycle. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event disruption in menstrual cycle was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Mouth ulceration, Pain in extremity, Pyrexia
Clinical narrative: Unable to move my left arm without excruciating pain; Fever of 103.4 degrees Fahrenheit; Uncontrollable body shaking; Mouth ulcers; Extremely painful headaches; This is a spontaneous report from a contactable consumer, the patient. A 30-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 26Apr2021 at 14:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and known allergies to latex and reflag (as 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 did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received hydrocodone (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), cefalexin (KEFLEX); all for unknown indications from unknown date and experienced drug allergy. On 26Apr2021 at 17:00, after receiving the second dose of the vaccine, the patient was unable to move the left arm without excruciating pain. Later that evening, the patient experienced a fever of 103.4 degrees Fahrenheit, uncontrollable body shaking, and mouth ulcers. It had been two weeks since receiving the second dose and the patient was still experiencing mouth ulcers and extremely painful headaches. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 01May2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the event unable to move left arm without excruciating pain, fever of 103.4 degrees Fahrenheit, uncontrollable body shaking, mouth ulcers, and extremely painful headaches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Unable to move my left arm without excruciating pain; Fever of 103.4 degrees Fahrenheit; Uncontrollable body shaking; Mouth ulcers; Extremely painful headaches; This is a spontaneous report from a contactable consumer, the patient. A 30-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 26Apr2021 at 14:00 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and known allergies to latex and reflag (as 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 did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received hydrocodone (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN), cefalexin (KEFLEX); all for unknown indications from unknown date and experienced drug allergy. On 26Apr2021 at 17:00, after receiving the second dose of the vaccine, the patient was unable to move the left arm without excruciating pain. Later that evening, the patient experienced a fever of 103.4 degrees Fahrenheit, uncontrollable body shaking, and mouth ulcers. It had been two weeks since receiving the second dose and the patient was still experiencing mouth ulcers and extremely painful headaches. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had been tested for COVID-19. On 01May2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the event unable to move left arm without excruciating pain, fever of 103.4 degrees Fahrenheit, uncontrollable body shaking, mouth ulcers, and extremely painful headaches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, SARS-CoV-2 test
Clinical narrative: Was on day 2 or 3 when received vaccine. Days 2-4 or 5 are usually heaviest for me. Within 24h ofreceiving vaccine period stopped. Have he period for 20 years. Never this short.; This is a spontaneous report from a contactable consumer, the patient. A 32-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 right arm on 03May2021 at 10:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergy to lactose. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient received Ok (unspecified) medication within two weeks of vaccination. On 04May2021 at 00:00 the patient's period stopped within 24 hours after receiving vaccine. It was reported that the patient was on day 2 or 3 when she received the vaccine. Days 2-4 or 5 were usually heaviest for her. Within 24 hours of receiving the vaccine, the period stopped. She had her period for 20 years and was never of this short. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 11Jan2021, the patient underwent Rapid COVID-19 virus test (nasal swab) and the result was negative. The clinical outcome of the event within 24 hours of receiving vaccine period stopped was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Headache; Body aches; Fever; Dizziness; Diarrhea; Vertigo; This is a spontaneous report from a contactable healthcare professional, the patient. A 25-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 left arm on 10May2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to peanuts, peas, mung beans, fava beans, horses, jackfruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and acetylsalicylic acid (ASPIRIN); both for unknown indication from 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 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 as a single dose for COVID-19 immunisation. On 11May2021 at 04:30, the patient experienced headache, body aches, fever, dizziness, diarrhea, vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On unknown date in May2021, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were taken as a result of the events and included at home treatment with acetylsalicylic acid (ASPIRIN), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL). The clinical outcome of the events headache, body aches, fever, dizziness, diarrhea, vertigo 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Headache; Body aches; Fever; Dizziness; Diarrhea; Vertigo; This is a spontaneous report from a contactable healthcare professional, the patient. A 25-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 left arm on 10May2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to peanuts, peas, mung beans, fava beans, horses, jackfruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and acetylsalicylic acid (ASPIRIN); both for unknown indication from 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 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 as a single dose for COVID-19 immunisation. On 11May2021 at 04:30, the patient experienced headache, body aches, fever, dizziness, diarrhea, vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On unknown date in May2021, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were taken as a result of the events and included at home treatment with acetylsalicylic acid (ASPIRIN), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL). The clinical outcome of the events headache, body aches, fever, dizziness, diarrhea, vertigo 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo positional
Clinical narrative: Pronounced exacerbation of benign positional vertigo, such that turning "my" head rapidly (even when seated or laying down)  will trigger 30 seconds-1 minute of severe dizziness and related nausea.; Pronounced exacerbation of benign positional vertigo after 2nd dose, such that turning "my" head rapidly (even when seated or laying down) will trigger 30 seconds-1 minute of severe dizziness and related nausea.; Pronounced exacerbation of benign positional vertigo after 2nd dose, such that turning "my" head rapidly (even when seated or laying down) will trigger 30 seconds-1 minute of severe dizziness and related nausea.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1072) via an unspecified route of administration in the left arm on 21Apr2021 at 14:15(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included ehlers-danlos, hashimoto's thyroiditis, reynaud's, chronic migraines, attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), depression, varicose veins, post-nasal drip, intermittent flare-ups of perioral and periorbital dermatitis, repeated cervical and lumbar spinal injuries, "frayed" R anterior cruciate ligament (ACL), allergies to gluten, casein, dust mite feces and sulfa-based antibiotics are completely ineffective. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included atomoxetine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and unspecified medication of 100 mg, all from unknown dates for unknown indications 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 in left arm on 20Mar2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 09:30, after 2nd dose, the patient experienced pronounced exacerbation of benign positional vertigo, such that turning her head rapidly (even when seated or laying down) would trigger 30 seconds-1 minutes of severe dizziness and related nausea. 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 pronounced exacerbation of benign positional vertigo, severe dizziness and related nausea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion, Pain in extremity
Clinical narrative: Re-emergence of arm pain/Had cortisone shots 7 weeks and 3 weeks prior to vaccine amd was pain-free.  Several hours after the shot the pain returned on the left side far more severe than previously. Pain is still severe 9 days after the shot; Bulging cervical disks; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6198) via an unspecified route of administration in the left arm on 04May2021, at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included arm pain, bulging cervical disks and allergy to nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included colecalciferol (VITAMIN D3), calcium (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and an additional medication (reported as neuroma in the source document); all from an unknown date for unknown indications and unknown if ongoing. The patient previously received cortisone shots (MANUFACTURER UNKNOWN); seven weeks and three weeks prior to vaccine in 2021 for arm pain due to bulging cervical disks and was pain-free. On 04May2021, the patient experienced re-emergence of arm pain due to bulging cervical disks. It was reported that, after several hours of the shot the pain returned on the left side far more severe than previously and the pain was still severe nine days after the shot. 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 re-emergence of arm pain due to bulging cervical disks, after several hours of the shot the pain returned on the left side far more severe than previously and the pain was still severe nine days after the shot was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Discomfort
Clinical narrative: Dull pain on left side of abdomen that started 3 days after first shot intensified over next three weeks/after the 2nd shot pain started to slowly decrease currently still experiencing it but it's more tolerable; Bloating occured any time I ate anything; Uncomfortable to sit or bend over; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 10Apr2021 at 12:00, (at the age of 36-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on an unknown date in 2021, both as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 14Apr2021 at 12:00, that started 3 days after first shot (as reported), the patient experienced dull pain on left side of abdomen, intensified over next three weeks, bloating occurred any time when the patient ate anything and it was uncomfortable to sit or bend over. After the second shot pain, started to slowly decrease. Currently, (at the time of reporting) patient was still experiencing it but was more tolerable. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dull pain on left side of abdomen, bloating occurred any time when the patient ate anything and uncomfortable to sit or bend over was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Body temperature, Chest pain, Decreased appetite
Clinical narrative: Injection site pain; Recurrent Fever (37.8C to 40C); Myalgia; Arthralgia; Migraine; Insomnia; Light headedness and dizziness; Loss of appetite; Nausea; Sternal chest pain, non-radiating; Tachycardia; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021, at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to prawn and shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins nos and minerals nos (CENTRUM ADULT) and fish oil (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications and unknown if ongoing. 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: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00, (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, within 12 hours after vaccination, the patient experienced the following symptoms (in order of occurrence): injection site pain, recurrent fever (37.8C to 40C), myalgia, arthralgia, migraine, insomnia, light headedness and dizziness, loss of appetite, nausea, sternal chest pain, non-radiating, tachycardia and anxiety, and it was reported as the patient had to go on leave from work because of the symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of events. On 05Jan2021, the patient underwent Reverse transcription polymerase chain reaction (RT PCR) nasal swab COVID-19 test, and the result was negative. On 11May2021, the patient underwent body temperature test and the result was 37.8 to 40 degrees centigrade. The clinical outcome of the event recurrent fever (37.8C to 40C) was resolved on 13May2021 while migraine, insomnia, loss of appetite, nausea, anxiety and tachycardia was resolved on an unknown date in May2021. The clinical outcome of the event injection site pain was not resolved while the outcome of myalgia, arthralgia, light headedness and dizziness, sternal chest pain, non-radiating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Migraine, Myalgia, Nausea
Clinical narrative: Injection site pain; Recurrent Fever (37.8C to 40C); Myalgia; Arthralgia; Migraine; Insomnia; Light headedness and dizziness; Loss of appetite; Nausea; Sternal chest pain, non-radiating; Tachycardia; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021, at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to prawn and shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins nos and minerals nos (CENTRUM ADULT) and fish oil (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications and unknown if ongoing. 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: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00, (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, within 12 hours after vaccination, the patient experienced the following symptoms (in order of occurrence): injection site pain, recurrent fever (37.8C to 40C), myalgia, arthralgia, migraine, insomnia, light headedness and dizziness, loss of appetite, nausea, sternal chest pain, non-radiating, tachycardia and anxiety, and it was reported as the patient had to go on leave from work because of the symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of events. On 05Jan2021, the patient underwent Reverse transcription polymerase chain reaction (RT PCR) nasal swab COVID-19 test, and the result was negative. On 11May2021, the patient underwent body temperature test and the result was 37.8 to 40 degrees centigrade. The clinical outcome of the event recurrent fever (37.8C to 40C) was resolved on 13May2021 while migraine, insomnia, loss of appetite, nausea, anxiety and tachycardia was resolved on an unknown date in May2021. The clinical outcome of the event injection site pain was not resolved while the outcome of myalgia, arthralgia, light headedness and dizziness, sternal chest pain, non-radiating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia, Vaccination site pain
Clinical narrative: Injection site pain; Recurrent Fever (37.8C to 40C); Myalgia; Arthralgia; Migraine; Insomnia; Light headedness and dizziness; Loss of appetite; Nausea; Sternal chest pain, non-radiating; Tachycardia; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021, at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to prawn and shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins nos and minerals nos (CENTRUM ADULT) and fish oil (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications and unknown if ongoing. 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: EW0161) via an unspecified route of administration in the right arm on 20Apr2021 at 11:00, (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, within 12 hours after vaccination, the patient experienced the following symptoms (in order of occurrence): injection site pain, recurrent fever (37.8C to 40C), myalgia, arthralgia, migraine, insomnia, light headedness and dizziness, loss of appetite, nausea, sternal chest pain, non-radiating, tachycardia and anxiety, and it was reported as the patient had to go on leave from work because of the symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of events. On 05Jan2021, the patient underwent Reverse transcription polymerase chain reaction (RT PCR) nasal swab COVID-19 test, and the result was negative. On 11May2021, the patient underwent body temperature test and the result was 37.8 to 40 degrees centigrade. The clinical outcome of the event recurrent fever (37.8C to 40C) was resolved on 13May2021 while migraine, insomnia, loss of appetite, nausea, anxiety and tachycardia was resolved on an unknown date in May2021. The clinical outcome of the event injection site pain was not resolved while the outcome of myalgia, arthralgia, light headedness and dizziness, sternal chest pain, non-radiating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe chills; muscle aches; fatigue; nausea; fever; This is a spontaneous report from a non-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: EW0182) via an unspecified route of administration in the left arm on 12May2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to avocado (fruit allergy). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), ethinylestradiol/norgestimate (TRI LO ESTARYLLA) and loratidine (CLARITIN); all from an unknown date for unknown indication and unknown if ongoing. 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: EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 02:00 the patient experienced severe chills, muscle aches, fatigue, nausea, fever. 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 events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Severe chills, muscle aches, fatigue, nausea, fever were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: "My" menstrual cycle was disrupted. "My" period arrived 9 days earlier than usual, on day 18 of "my" cycle.This has never happened to me. My periodaways arrives on day 27, latest day 29. Never before that.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant 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 prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 03May2021, the patient's menstrual cycle was disrupted. The patient's period arrived 9 days earlier than usual, on day 18 of the cycle. This had never happened to the patient. The patient's period always arrived on day 27, latest day would be 29 and never before that. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 12May2021, the patient underwent COVID-19 PCR test via nasal swab and the result was negative. The clinical outcome of the event period arrived 9 days earlier than usual was resolved on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe ringing in both ears (tinnutis)within 1 hour of vaccine.; 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: EW0171) via an unspecified route of administration in the left arm on 13May2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy. 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 other medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 22Apr2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 17:30, one hour after the vaccination the patient experienced severe ringing in both ears (tinnitus). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe ringing in both ears (tinnitus) was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little arm pain; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication (other product) included nebivolol hydrochloride (BYSTOLIC) 10 mg, 1x/day taken for blood pressure measurement, start and stop date were not reported. The patient experienced a little arm pain on an unspecified date. The patient stated first one (first dose) was okay for me, it was a little arm pain. The patient received second dose of bnt162b2 on 23Feb2021 for covid-19 immunisation and experienced Fever, Chills and couldn't Sleep. The outcome of event reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Pyrexia, Swelling
Clinical narrative: Shortness of breath; High fever; Cough; Swelling in left armpit; Never ending headache.; Inability to quench thirst; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 15May2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 24Apr2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 16May2021, the patient experienced shortness of breath, high fever, cough, swelling in left armpit, inability to quench thirst, and never ending headache. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events shortness of breath, high fever, cough, swelling in left armpit, inability to quench thirst, and never ending headache was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Shortness of breath; High fever; Cough; Swelling in left armpit; Never ending headache.; Inability to quench thirst; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 15May2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 24Apr2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 16May2021, the patient experienced shortness of breath, high fever, cough, swelling in left armpit, inability to quench thirst, and never ending headache. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events shortness of breath, high fever, cough, swelling in left armpit, inability to quench thirst, and never ending headache was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Mass, Pain
Clinical narrative: feel pain on the left side which was the injection side of his body; started to get the swollen lumps on that side of the body; Not feeling the best the day on; This is a spontaneous report from a contactable consumer received via Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Reporter stated that she and her husband received the second dose of the COVID vaccine on Monday (17May2021), stated that her husband was not feeling the best the day on. On the next day (18May2021) he started to feel fine and on last night he started to feel pain on the left side which was the injection side of his body and then he started to get the swollen lumps on that side of the body. The clinical outcome was unknown for all events except for event, not feeling the best the day on was recovered on 18May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Heart rate, Heart rate increased
Clinical narrative: Heart rate in low 90s; Chills; Temp to 100.7; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the arm left on 15May2021 at 16:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic to sulpha drugs, allergic to raw onions and patient reported she was healthy. 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 the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 24Apr2021 at 16:00 (age at vaccination: unknown), as a single dose for COVID-19 immunisation. The patient previously had allergy to high doses of erythromycin (MANUFACTURER UNKNOWN). On 16May2021 at 10:00, 18 hours after second dose of vaccination, the patient experienced heart rate in low 90s, chills and temp to 100.7. On 16May2021 at 10:00, the patient underwent body temperature test and the result was found to be 100.7 (unspecified units) and heart rate was found to be low 90s (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart rate in low 90s, chills and temp to 100.7 were recovered on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Mass, Pain, Pyrexia
Clinical narrative: lump on like kind of under my armpit, it is kind of like where my armpit; It is a lump and it is sore; lump on like kind of under my armpit, it is kind of like where my armpit; It is a lump and it is sore; Chills; Headache; Fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23May2021, the patient experienced lump on like kind of under my armpit, it is kind of like where my armpit; it is a lump and it is sore, on 22May2021 the patient experience chills, headache and fever. It was stated she got the Pfizer shot on Friday and she did experience like chills, headache, and fever all the above, yesterday but then today she has a lump on like kind of under her armpit, it is kind of like where her armpit is and she guess where the strap of her bra meet. Like it is a kind of in that area. It is a lump, and it is sore, and she was just really concerned about. she means she heard about the fever, the chills and stuff like that might occur after vaccination. But she was not aware of the lump. This is the cause for the concern and what should she do. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot cannot be obtained.