chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Next day tired mild fever by 5 pm chillsand fever spiking over the next hrs to 102; Next day tired mild fever by 5 pm chillsand fever spiking over the next hrs to 102; Next day tired mild fever by 5 pm chillsand fever spiking over the next hrs to 102; 12 hrs after second shot body aches,can't get out of bed and can't sleep.; 12 hrs after second shot body aches,can't get out of bed and can't sleep.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure and anxiety. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL), tocopherol (VITAMIN E), cyanocobalamin (MANUFACTURER UNKNOWN) and multivitamins (reported as multi); all for unknown indication from an unknown date and unknown if ongoing.  The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Apr2021 as a single dose for COVID-19 immunisation. On 10Apr2021 at 22:00,12 hours after second shot the patient experienced body aches, cannot get out of bed and cannot sleep. On 11Apr2021, the next day at 12:00, the patient experienced tired and mild fever. On 11Apr2021 the next day at 17:00, the patient experienced chills. The patient reported soaked two sets of night clothes and two sets of sheets. On 11Apr2021, the patient underwent body temperature test and the result was 102 (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 12 hours after second shot body aches, cannot get out of bed and cannot sleep, next day tired mild fever by 5 pm chills and fever spiking over the next hours to102 was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever; vomiting; diarrhea; chills; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 26Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on an unknown date in 2021 at 12:00 as a single dose for COVID-19 immunisation. On 27Apr2021 at 02:00, the patient experienced fever, vomiting, diarrhea and chills. 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 fever, vomiting, diarrhea and chills were 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: Dyspnoea
Clinical narrative: Shortness of breath lasting over 7 days; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 14:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression, anxiety, restless legs, allergies, COVID-19 and ADHD (attention deficit hyperactivity disorder). The patient had known allergy to wheat, milk, peanuts, pollens, dust, cat and dog dander. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 08:00, the patient experienced shortness of breath lasting over 7 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shortness of breath was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Flatulence, Nausea, Pain in extremity, Sleep disorder
Clinical narrative: Painful stomach cramps, worse than period. First it just felt like mild, regular cramps.; Felt like severe gas; Woke "me" up in the middle of the night, could not sleep for the whole night due to the pain and COVID arm pain; COVID arm pain; Had slight nausea; Tried to make "myself" vomit; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemic. The patient was mildly allergic to pineapples. 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 medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021, the patient experienced painful stomach cramps, worse than period. First it just felt like mild, regular cramps. But later on in the night the pain woke her up and it felt like severe gas. It woke her up in the middle of the night and she could not sleep for the whole night due to the pain and COVID arm pain. The patient had slight nausea as well, which was taken care of when she tried to make herself vomit. 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 painful stomach cramps, woke her up and it felt like severe gas, could not sleep for the whole night due to the pain and COVID arm pain and had slight nausea and vomit was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Painful stomach cramps, worse than period. First it just felt like mild, regular cramps.; Felt like severe gas; Woke "me" up in the middle of the night, could not sleep for the whole night due to the pain and COVID arm pain; COVID arm pain; Had slight nausea; Tried to make "myself" vomit; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemic. The patient was mildly allergic to pineapples. 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 medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021, the patient experienced painful stomach cramps, worse than period. First it just felt like mild, regular cramps. But later on in the night the pain woke her up and it felt like severe gas. It woke her up in the middle of the night and she could not sleep for the whole night due to the pain and COVID arm pain. The patient had slight nausea as well, which was taken care of when she tried to make herself vomit. 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 painful stomach cramps, woke her up and it felt like severe gas, could not sleep for the whole night due to the pain and COVID arm pain and had slight nausea and vomit was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache; Chills; Fever; Stomach cramps; Vomiting; Aching; This is a spontaneous report from a contactable consumer, the patient. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 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: EP7533) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021 at 02:30 the patient experienced headache, chills, fever, stomach cramps, vomiting and aching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, chills, fever, stomach cramps, vomiting and aching were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Chills; Fever; Stomach cramps; Vomiting; Aching; This is a spontaneous report from a contactable consumer, the patient. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 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: EP7533) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021 at 02:30 the patient experienced headache, chills, fever, stomach cramps, vomiting and aching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, chills, fever, stomach cramps, vomiting and aching were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site pain, Vomiting
Clinical narrative: Dizziness; Nausea; Reportedly vomited; Feels soreness at the injection site; This is a spontaneous report from a contactable consumer (Pfizer colleague) reporting for the patient. A 30-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via intramuscular route of administration in the left arm on 26Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removal at some point within the last year (unknown date in 2020). The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL), dextromethorphan hydrobromide/ guaifenesin/ paracetamol/ pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide/ doxylamine succinate/ ephedrine sulfate/ ethanol/ paracetamol (NYQUIL)); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via intramuscular route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 10:30, within an hour of receiving his second vaccination the patient experienced dizziness and nausea. He reportedly vomited sometime after that. After vomiting, the patient stated that he took a nap and felt better but unsteady with no nausea. After a night's rest, the patient only feels soreness at the injection site and no other symptoms. 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 event dizziness, nausea and reportedly vomited was resolved on an unknown date in Apr2021; whereas feels soreness at the injection site was 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: Chills, Epistaxis, Headache, Pain
Clinical narrative: Body Aches; chills; really strong headaches behind the right eye; Right nostril seems to bleed when blowing nose.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 24Apr2021 at 11:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19. The patient's known allergies were reported as none. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of the vaccination. On 25Apr2021 at 16:00, the patient experienced body aches, chills, really strong headaches behind the right eye and right nostril seemed to bleed when blowing the nose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any 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 events body aches, chills, really strong headaches behind the right eye and right nostril seemed to bleed when blowing the nose were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts but it was going well; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 11:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of the vaccination. On an unknown date in Apr2021, the patient's arm hurts but it went well. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm hurts was unknown 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Aphthous ulcer, Eye irritation, Mouth swelling, Periorbital swelling, Pharyngeal swelling
Clinical narrative: Ringing in ears - same side asinjection.; Swelling mouth; Swelling throat; Swelling around eyes; Eye irritation; Canchre sores; Mouth irritation; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotic, allergic to cats, rabits and seasonal allergies. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination were not reported. On 14Apr2021 at 02:30, the patient experienced ringing in ears-same side as injection, swelling mouth and throat and around eyes, eye irritation, canchre sores and mouth irritation. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in ears, swelling mouth, swelling throat, swelling around eyes, eye irritation, canchre sores and mouth irritation was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Stomatitis, Tinnitus
Clinical narrative: Ringing in ears - same side asinjection.; Swelling mouth; Swelling throat; Swelling around eyes; Eye irritation; Canchre sores; Mouth irritation; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotic, allergic to cats, rabits and seasonal allergies. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination were not reported. On 14Apr2021 at 02:30, the patient experienced ringing in ears-same side as injection, swelling mouth and throat and around eyes, eye irritation, canchre sores and mouth irritation. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in ears, swelling mouth, swelling throat, swelling around eyes, eye irritation, canchre sores and mouth irritation was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: "I" have a consistent 30 day menses cycle which is now four days late, and may be a missed cycle; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 07:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The medical history included Irregular menstrual cycle (an interrupted cycle before as a result of receiving other powerful vaccines in the past). 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 22Apr2021, the patient had a consistent 30-day menses cycle which was now four days late, and may be a missed cycle. Because the patient was extremely consistent in tracking her menses, she noticed the change this month. The patient reported that she was not pregnant and had not been sexually active. She had not received any treatments or medications since her last cycle except the Pfizer vaccine and when she had to face a missed cycle. The patient reported that she always looked at medications or physical illness as a cause. The patient experienced an interrupted cycle before as a result of receiving other powerful vaccines in the past and she believe women need to be told that they could have an unexpected interruption in their cycles as a result of the vaccine. As the patient was going to receive her second dose soon, this could mean at least two months of irregularities or longer. 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 consistent 30-day menses cycle which was now four days late, and may be a missed cycle was unknown 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: Dermatitis, Skin burning sensation, Skin temperature
Clinical narrative: Burning sensation on skin - in particular on forehead, ears, and neck (felt like a sun-burn - temperature was raised and inflamed); Burning sensation on skin - in particular on forehead, ears, and neck (felt like a sun-burn - temperature was raised and inflamed); Burning sensation on skin - in particular on forehead, ears, and neck (felt like a sun-burn - temperature was raised and inflamed); 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: EW0161) via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, asthma, sulfonamide allergy, penicillin allergy and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) for unknown indication on unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 15:30 (at the age of 33-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. On 20Apr2021 at 12:00, the patient experienced burning sensation on skin - in particular on forehead, ears, and neck; felt like a sun-burn - temperature was raised and inflamed. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event burning sensation on skin - in particular on forehead, ears, and neck; felt like a sun-burn - temperature was raised and inflamed was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: 5 days after the 1st dose, I had the 1st nose bleed ever in my life. I had a few others before the 2nd dose. After the 2nd dose, the number of nose bleeds have increased. I now have several per day, each lasting about 15 minutes; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 65-years-old) and also 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 08Apr2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, fibromyalgia, cluster headaches and hernia surgery. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included verapamil (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and chromium (MANUFACTURER UNKNOWN); all from an unknown date taken for unknown indications and unknown if ongoing. On 23Mar2021 at 14:00, 5 days after the first dose the patient had the first nose bleed ever in his life and also had a few others before the second dose. On an unknown date in Apr2021, after the second dose, the number of nose bleeds had increased. He now (at the time of this report) had several per day, each lasting about 15 minutes. 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 5 days after the first dose had the first nose bleed ever in his life and also had a few others before the second dose and the number of nose bleeds had increased after second dose, now he had several per day, each lasting about 15 minutes was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo for 4 weeks after getting second shot Feb 24,2021; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an 24Feb2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. 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. Concomitant medications included unspecified medications for blood pressure 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: EN9581) via an unspecified route of administration in the left arm on 03Feb2021 at 02:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. On 05Apr2021, the patient experienced vertigo for 4 weeks after getting second shot 24Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo and included treatment with dizzy pills and a head scan. The clinical outcome of the event vertigo for 4 weeks after getting second shot 24Feb2021 was resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Chronic, debilitating headaches. Intermittent in nature.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 16Apr2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and known allergy to IVP dye and shellfish. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included buprenorphine (BUTRANS) 5mcg patch, tramadol (MANUFACTURER UNKNOWN) 50 mg and lisinopril (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:00 (at the age of 43-years-old as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced chronic, debilitating headaches which was intermittent in nature and occurred 1-2 times a day. The patient had no prolonged history of headaches of this nature. The patient reported to doctor, however no action was taken except to monitor. The event chronic, debilitating headaches which was intermittent in nature resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chronic, debilitating headaches which was intermittent in nature was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Therapeutic response unexpected
Clinical narrative: Menstrual cycle was extremely light; "my" PMS symptoms of back aches and cramps were nothing compared to what "I "usually have; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 23Apr2021 at 15:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (ADD), depression and migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), fluticasone propionate (FLONASE) and topiramate (TOPAMAX); all for unknown indication from an 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 first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date at 12:45 as a single dose for COVID-19 immunisation. On 23Apr2021 at 18:00, the patient experienced menstrual cycle that was extremely light and premenstrual syndrome (PMS) symptoms of back aches and cramps were nothing compared to what patient usually had. 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 menstrual cycle was extremely light was resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Pain in center of chest; Hard to breathe; Tingling in scalp left side mainly; Headaches and sudden head pain; Exhaustian; Heavy chest; This is a spontaneous report from a contactable consumer, the patient. A 62-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 15Apr2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), colecalciferol (D-3) and ascorbic acid (VITAMIN C); all from an unknown date for an 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 paracetamol, oxycodone hydrochloride (PERCOCET) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 14:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021, the patient experienced heavy chest and pain in center of chest, hard to breathe, tingling in scalp left side mainly, headaches, sudden head pain and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heavy chest, pain in center of chest, hard to breath, tingling in scalp left side, headaches, sudden head pain and exhaustion was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pain in center of chest; Hard to breathe; Tingling in scalp left side mainly; Headaches and sudden head pain; Exhaustian; Heavy chest; This is a spontaneous report from a contactable consumer, the patient. A 62-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 15Apr2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), colecalciferol (D-3) and ascorbic acid (VITAMIN C); all from an unknown date for an 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 paracetamol, oxycodone hydrochloride (PERCOCET) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 25Mar2021 at 14:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021, the patient experienced heavy chest and pain in center of chest, hard to breathe, tingling in scalp left side mainly, headaches, sudden head pain and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heavy chest, pain in center of chest, hard to breath, tingling in scalp left side, headaches, sudden head pain and exhaustion was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain
Clinical narrative: Large knot on upper arm near injection site that persisted for approximately 5-6 days.; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Once it started dissipating around day 5, I developed a rash in the same area that itches a little; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 19Apr2021 at 00:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to environmental allergens and the patient no known food or drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and famotidine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 17:00 the patient experienced a large knot on upper arm near injection site that persisted for approximately 5-6 days. It was red, swollen, very hard, painful, and warm to the touch. Once it started dissipating around day 5, the patient developed a rash on an unknown date in Apr2021, in the same area that itched a little. The patient was 8 days post shot at the time of report and still had a little rash. 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 event large knot on upper arm near injection site that persisted for approximately 5-6 days; was red, swollen, very hard, painful, and warm to the touch was resolved on an unknown date in Apr2021. The clinical outcome of the event once it started dissipating around day 5, developed a rash in the same area that itches a little, was 8 days post shot at the time of report and still had a little rash was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large knot on upper arm near injection site that persisted for approximately 5-6 days.; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Once it started dissipating around day 5, I developed a rash in the same area that itches a little; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 19Apr2021 at 00:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to environmental allergens and the patient no known food or drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and famotidine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 17:00 the patient experienced a large knot on upper arm near injection site that persisted for approximately 5-6 days. It was red, swollen, very hard, painful, and warm to the touch. Once it started dissipating around day 5, the patient developed a rash on an unknown date in Apr2021, in the same area that itched a little. The patient was 8 days post shot at the time of report and still had a little rash. 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 event large knot on upper arm near injection site that persisted for approximately 5-6 days; was red, swollen, very hard, painful, and warm to the touch was resolved on an unknown date in Apr2021. The clinical outcome of the event once it started dissipating around day 5, developed a rash in the same area that itches a little, was 8 days post shot at the time of report and still had a little rash was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Influenza like illness, Lymphadenopathy
Clinical narrative: Fever; Left arm hurts; Large red itchy bump; Swollen lymph nodes hurt under left arm; Very tired; Flu-like symptoms; Chills; This is a spontaneous report from a contactable consumer, the patient. A 56-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 10Apr2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously took cefprozil (CEFZIL) and azithromycin (Z-Pack) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation.  On 10Apr2021 at 22:00, the patient experienced chills, left arm hurts, large red itchy bump, swollen lymph nodes hurt under left arm, very tired and flu-like symptoms. On 11Apr2021, the patient experienced fever. The patient reported that, the chills started 13 hours after the injections and did not sleep during the night. She had fever of 39.7C, started after 26 hours of injection and took paracetamol after 26 hours of injection. She stated it took 2 days to go back to 37C. She also experienced left arm hurts, large red itchy bump, swollen lymph nodes hurt under left arm for 5 days, very tired and flu-like symptoms for 3 days. Therapeutic measures were taken as a result of fever and included treatment with paracetamol (MANUFACTURER UNKNOWN) from 11Apr2021 and unknown if ongoing. On 11Apr2021, the patient underwent body temperature test and the result was 39.7centigrade. On 13Apr2021, the patient underwent body temperature test and the result was 37 centigrade. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever was resolved on 13Apr2021, after a duration of 2 days; while that of the events very tired and flu-like symptoms were resolved on 13Apr2021, after a duration of 3 days. The clinical outcome of the event swollen lymph nodes hurt under left arm was resolved 15Apr2021, after a duration of 5 days; while that of the events chills left arm hurts and large red itchy bump were resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.