chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Running on and off fever of 102+ for 5+ days with flu like symptoms; RUNNING ON AND OFF FEVER OF102+ FOR 5+ DAYS; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, pneumothorax spontaneous, bronchitis chronic, chronic sinusitis and allergy to raw fruit and vegetables. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included buspirone hydrochloride (MANUFACTURER UNKNOWN) 30 mg, methocarbamol (ROBAXIN) 750 mg and clonazepam (CLONOPIN); all for an unknown indication and unknown start date and unknown if ongoing. The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 03:00, the patient had running on and off fever of 102+ for 5+ days with flu like symptoms. On 09Apr2021, patient body temperature was measured and the result was 102+ (unspecified units). 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 running on and off fever of 102+ for 5+ days with flu like symptoms was recovered with sequelae at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), escitalopram oxalate (LEXAPRO) and alprazolam (XANAX); all from unknown dates for unknown indications 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 24Mar2021 at 16:30 (at the age of 55-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 16Apr2021 at 10:00, after 2 days of second dose,  the patient experienced swollen lymph node under the left arm pit. 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 of swollen lymph node under left the arm pit was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever between 101-102 for 36 hours.; Fever between 101-102 for 36 hours, along with chills.; Headache; Fatigue; Ringing in ear; 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: ER8731) via an unspecified route of administration in the arm left on 15Apr2021 at 10:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included long COVID hauler (2 confirmed separate COVID cases). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included amitriptyline (AMATRIPLINE) and thyroid medication (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had allergies to medications, food or other products (unspecified). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 43-year-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 15Apr2021 at 18:30, the patient experienced fever between 101-102 for 36 hours, along with chills, headache, fatigue and ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever between 101-102 for 36 hours, along with chills, headache, fatigue and ringing in ears were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Fever between 101-102 for 36 hours.; Fever between 101-102 for 36 hours, along with chills.; Headache; Fatigue; Ringing in ear; 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: ER8731) via an unspecified route of administration in the arm left on 15Apr2021 at 10:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included long COVID hauler (2 confirmed separate COVID cases). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included amitriptyline (AMATRIPLINE) and thyroid medication (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had allergies to medications, food or other products (unspecified). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 43-year-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 15Apr2021 at 18:30, the patient experienced fever between 101-102 for 36 hours, along with chills, headache, fatigue and ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever between 101-102 for 36 hours, along with chills, headache, fatigue and ringing in ears were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in joints of fingers; This is a spontaneous report from a contactable consumer, the parent. A 25-year-old male 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 16Apr2021 at 10:00, (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 in March 2020 but did not receive a COVID-19 test and therefore diagnosis was not clinically confirmed. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 11:00 hours, (at the age of 25-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 01:00, the patient experienced pain in joints of fingers. No therapeutic measures were taken as a result of reported event. 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 not been tested for COVID-19. The clinical outcome of the event pain in joints of fingers was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 38, via an unspecified route of administration, left arm, on Mar 26, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient has no reported medical history. The patient has no known allergies to medications, food or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 26, 2021, at 15:00, patient experienced "pins and needles" feeling in hands, which started about an hour after she received the vaccine. It has not gone away and it has been over 3 weeks. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures not taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of "pins and needles" feeling in hands: not resolved (at the time of this report). No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Mobility decreased, Pain, Pyrexia
Clinical narrative: Difficulty moving  due to body pain.; difficulty moving due to body pain; Severe chills 12 hours after shot; High fever, normally run fever at 99, fever spiked at 102.5, fever was very high; This is a spontaneous report from a contactable consumer, the patient. A 49-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 arm left on 16Apr2021 at 12:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The medical history included blood pressure high (HBP, under control with medication), post-traumatic stress disorder (PTSD, under control with medication) and high cholesterol (under control with medication). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included citalopram hydrobromide (CELEXA), lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), fenofibrate (MANUFACTURER UNKNOWN) and antacid (unspecified), all from unknown dates and for unknown indications. On 17Apr2021 at 00:15, the patient experienced high fever ( the patient normally ran fevers at 99). After 12 hours of shot, the fever hit with severe chills and fever spiked at 102.5. The patient had difficulty moving due to body pain. The patient understood that these symptoms ran normally with influenza, however, the fever was very high for the patient and the patient did not had influenza. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On an unknown date, the patient underwent body temperature and tested with a temperature of 102.5 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event difficulty moving, body pain, severe chills, high fever and fever spiked at 102.5  was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP6955), at the age of 24, via an unspecified route of administration, left arm, Apr 16, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient has no reported medical history. The patient has no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 24, via an unspecified route of administration, left arm, on Mar 26, 2021, at 10:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 16, 2021, at 21:00, patient experienced fever, headache, nausea, chills and aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of fever, headache, nausea, chills and aches: not resolved (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Initial insomnia, Insomnia
Clinical narrative: Arm was sore (worse 2nd day); Dizziness after 15 minutes of sitting down; Headaches; Body aches (back); Insomia; Nightmares; Trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 10:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included acid reflux, slight asthma (due to COVID-19), seasonal allergies and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Allergies to medications, food, or other products were reported as not applicable. Concomitant medications included haloperidol (PANDOL), ibuprofen (TABCIN), multi-vitamin (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all for unknown indications from unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Apr2021 at 00:00, the patient reported that his arm was sore (worse the second day), dizziness after 15 minutes of sitting down, headaches, body aches (back), insomnia, nightmares and trouble sleeping. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the events arm was sore (worse 2nd day), dizziness after 15 minutes of sitting down, headaches, body aches (back), insomnia, nightmares, trouble sleeping was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nightmare, Pain in extremity
Clinical narrative: Arm was sore (worse 2nd day); Dizziness after 15 minutes of sitting down; Headaches; Body aches (back); Insomia; Nightmares; Trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 10:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included acid reflux, slight asthma (due to COVID-19), seasonal allergies and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Allergies to medications, food, or other products were reported as not applicable. Concomitant medications included haloperidol (PANDOL), ibuprofen (TABCIN), multi-vitamin (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all for unknown indications from unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Apr2021 at 00:00, the patient reported that his arm was sore (worse the second day), dizziness after 15 minutes of sitting down, headaches, body aches (back), insomnia, nightmares and trouble sleeping. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the events arm was sore (worse 2nd day), dizziness after 15 minutes of sitting down, headaches, body aches (back), insomnia, nightmares, trouble sleeping was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: two short waves of numbness through his body; This is a spontaneous report received from a non-contactable consumer patient of unspecified age and gender received first dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced two short waves of numbness through his body on 15Apr2021. The outcome of the events was unknown. The patient was suggested to followup with MD if symptoms return.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: I had a fever that was 103; Headache; Body aches; Nausea; Vomiting; Chills; Fatigue; My arm now has a big knot at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. The patient had known allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); from an unknown date for unspecified indication. 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 22Mar2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021 at 04:00, the day after receiving the shot, the patient experienced fever that was 103 (unspecified units), headache, body aches, nausea, vomiting, chills and fatigue. It took 8 hours for the fever to break but was not under 101 (unspecified units) for 2 days. These side effects lasted 4 days. On an unknown date in Apr2021, after the 4th day, the patient experienced that the arm had a big knot at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of reported events which included call to the primary care physician (PCP). The clinical outcome of the events fever, headache, body aches, nausea, vomiting, chills and fatigue was recovered on 17Apr2021. The clinical outcome of the event arm had a big knot at the injection site was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site mass, Vomiting
Clinical narrative: I had a fever that was 103; Headache; Body aches; Nausea; Vomiting; Chills; Fatigue; My arm now has a big knot at the injection site.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and high blood pressure. The patient had known allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); from an unknown date for unspecified indication. 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 22Mar2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021 at 04:00, the day after receiving the shot, the patient experienced fever that was 103 (unspecified units), headache, body aches, nausea, vomiting, chills and fatigue. It took 8 hours for the fever to break but was not under 101 (unspecified units) for 2 days. These side effects lasted 4 days. On an unknown date in Apr2021, after the 4th day, the patient experienced that the arm had a big knot at the injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of reported events which included call to the primary care physician (PCP). The clinical outcome of the events fever, headache, body aches, nausea, vomiting, chills and fatigue was recovered on 17Apr2021. The clinical outcome of the event arm had a big knot at the injection site was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eyelid irritation, Eyelid skin dryness, Periorbital irritation, Swelling of eyelid
Clinical narrative: Irritation of the under eyes; Irritation of eyelids; Symptoms containing redness and dryness, and slight swelling of lids.; Symptoms containing redness and dryness, and slight swelling of lids.; Slight swelling of lids; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9809) via an unspecified route of administration in the arm left on 10Mar2021 at 19:15 (at the age of 22-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the arm left on 31Mar2021 at 19:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The 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 concomitant medication were not reported. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced allergy. On 16Mar2021, about a week after first dose, the patient experienced irritation of the under eyes and eyelids, symptoms contained redness and dryness and slight swelling of lids. It was off and on- will be very irritated for 2- 3 days, then got better before become irritated again. It was not subsided before or after the second dose. The patient did not receive any treatment for the reported events. The adverse 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 not been tested for COVID-19. The clinical outcome of the events irritation of the under eyes, irritation of eyelids, redness, dryness and slight swelling of lids were not recovered 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: Ear pain
Clinical narrative: Sudden pain in right ear that would come and go. It started about 3 hrs after the vaccine was received, and continued, with less severity and frequency 24 hrs after receiving the vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 65-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 16Apr2021 at 10:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), and venlafaxine (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 13:30, the patient experienced sudden pain in right ear that would come and go. It started about three hours after the vaccine was received, and continued, with less severity and frequency 24 hours after receiving the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sudden pain in right ear that would come and go that started three hours after the vaccine was received, and continued, with less severity and frequency 24 hours after receiving the vaccine 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Haematoma, Headache, Pain
Clinical narrative: hematomas; bruising on knees, ankles; intense headache; fatigue; some minor body aches; bruising on knees, ankles, and thighs; This is a spontaneous report from a contactable consumer, the patient. A 41-years-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 right arm on 15Apr2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. 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 were not reported. On 17Apr2021 at 08:00, the patient experienced hematomas, bruising on knees, bruising on ankles and thighs (more appear throughout the day), intense headache, fatigue with some minor body aches. Therapeutic measures were not taken as a result of the event. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hematomas, bruising on knees, ankles and thigh, intense headache, fatigue and some minor body aches was not resolved/ongoing.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swollen, sore rash occurred at injection site; sore rash occurred at injection site; sore rash occurred at injection site; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 05Apr2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On14Apr2021, exactly 9 days after the vaccination, the patient experienced swollen, sore rash that occurred at the injection site. The events did not result 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 swollen, sore rash occurred at the injection site were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 5 Days after second dose patient developed a large red rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet; Raised rash on both arms from elbow to wrist,; 5 Days after second dose patient developed a large red rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet; Itchy rash; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 15:30 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, since unknown date. The patient had no known allergies. Concomitant medications included SINGULAIR on an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 16Mar2021 at 16:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 15:00, five days after second dose, the patient developed a large red, raised rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet. It was itchy and warm. It started fading after 24 hours. Therapeutic measures were taken as a result of these events and included treatment with cortisone 10 and benadryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events large red, raised rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet. It was itchy and warm were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing; This is a spontaneous report from a contactable consumer, the patient. A 51-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 05Apr2021 at 13:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient did not receive other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:00, the patient experienced ear ringing persistent, low level, and cyclical in pitch, but very noticeable. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event ear ringing was not resolved at the time the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: The following ady, i have  headaches on the back part of my head comes and goes with Tylenol.; The body ache comes and  goes with Tylenol; Dizziness lingers for7 days now. Even with pain reliever.; Lightheadedness lingers for7 days now. Even with pain reliever.; Headaches is worsening; I have chills on the 30th hour. The following day, I have mostly occasional chills; I have fevers on the 30th hour; This is a spontaneous report from a contactable consumer, the patient. A 57-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 06Apr2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to latex. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) indicated for unknow, on unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  left arm on 15Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 15:45 the patient experienced chills and fevers on the thirty hours. On 08Apr2021, the following day, patient experienced mostly headaches, body aches and occasional chills. The body ache and headache on the back part of head comes and goes with tylenol. The dizziness and lightheadedness lingers for seven days, even with pain reliever, headaches was worsening. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of occurred events and included treatment with tylenol and even with pain reliever. The clinical outcome of the events chills, fevers, headaches, body aches, dizziness, lightheadedness and headaches was worsening was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Inflammation, Mastication disorder, Noninfective gingivitis
Clinical narrative: Right cheek inflamed; redgums on the right side inflamed; hurt to chew; Slight and constant pain/ pressure on right ear drum; Fever 99.3; Felt hot to touch but no fever; Slight runny nose; 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: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 13:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history reported that the patient was obese and had allergies to food with soy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 12:00, the patient had her right cheek inflamed and red gums on the right side inflamed and hurt to chew, slight and constant pain/ pressure on right ear drum, fever 99.3 was the highest, felt hot to touch but no fever and slight runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events right cheek inflamed, redgums on the right side inflamed, hurt to chew, slight and constant pain/ pressure on right ear drum, fever 99.3, felt hot to touch but no fever and slight runny nose were not recovered 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: Pyrexia, Rhinorrhoea, Skin warm
Clinical narrative: Right cheek inflamed; redgums on the right side inflamed; hurt to chew; Slight and constant pain/ pressure on right ear drum; Fever 99.3; Felt hot to touch but no fever; Slight runny nose; 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: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 13:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history reported that the patient was obese and had allergies to food with soy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 12:00, the patient had her right cheek inflamed and red gums on the right side inflamed and hurt to chew, slight and constant pain/ pressure on right ear drum, fever 99.3 was the highest, felt hot to touch but no fever and slight runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events right cheek inflamed, redgums on the right side inflamed, hurt to chew, slight and constant pain/ pressure on right ear drum, fever 99.3, felt hot to touch but no fever and slight runny nose were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Very sore arm; Saw black spots night of, saw neon green spots morning after; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unknown age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 12:30 (at an unknown age) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins 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. On 10Apr2021 at 19:00,  the patient experienced very sore arm and "saw black spots night of, saw neon green spots morning after". Therapeutic measures were not taken as a result of the event(s). 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 events very sore arm and "saw black spots night of, saw neon green spots morning after" were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 in the left arm on 09Apr2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. 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: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient underwent PCR test for COVID-19 and the result was negative. On 14Apr2021, the patient experienced swollen lymph node at upper left chest near neck. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event swollen lymph node was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia, Product administered at inappropriate site, X-ray dental
Clinical narrative: Numbness in lips; Tingling sensation throughout body; Administration site: Left leg; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left leg on 19Mar2021 at 12:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure (BP). The patient had known allergies to amoxicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced numbness in lips and tingling sensation throughout body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with dental x-ray and PC visit to check for sign of ill. On an unknown date, the patient underwent dental x-ray and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness in lips and tingling sensation throughout body was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Heart rate, Heart rate increased, Insomnia, Paraesthesia
Clinical narrative: Elevated heart rate; Tingling in feet; Lack of sleep; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on an unknown date in Feb2021 at 08:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included lisinopril dihydrate (LISINOPRIL), cyanocobalamin (B-12), unspecified multivitamin (MANUFACTURER UNKNOWN) and hydrachloricide; all taken 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 COVID vaccine. On 02Mar2021 at 20:00, the patient experienced elevated heart rate, loss of appetite, tingling in feet and lack of sleep. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19. On 15Mar2021, the patient underwent nasal swab COVID-19 test and the result was negative. The clinical outcome of the events elevated heart rate, loss of appetite, tingling in feet and lack of sleep were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.