chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling
Clinical narrative: Swollen itchy lips; Swollen itchy lips; This is a spontaneous report from a contactable consumer, the patient. A 38-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 14Apr2021 at 14:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other product. Concomitant medications included probiotic nos (PROBIOTIC), pyridoxine hydrochloride (VITAMIN B6), MULTIVITAMIN 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 after 2 days of vaccination the patient experienced swollen itchy lips. No therapeutic measures were taken as  a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen itchy lips was ongoing at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Rash
Clinical narrative: Patient c/o a rash all over her face about a week after the vaccine was administered. Patient also has a cough, chest tightness and fatigue.; Patient c/o a rash all over her face about a week after the vaccine was administered. Patient also has a cough, chest tightness and fatigue.; Patient c/o a rash all over her face about a week after the vaccine was administered. Patient also has a cough, chest tightness and fatigue.; Patient c/o a rash all over her face about a week after the vaccine was administered. Patient also has a cough, chest tightness and fatigue.; This is a spontaneous report from a contactable nurse, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on 07Apr2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was not reported if the patient received any medication within two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced a rash all over her face about a week after the vaccine was administered. Patient also had a cough, chest tightness and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash all over her face about a week after the vaccine was administered, cough, chest tightness and fatigue and included treatment with dexamethasone and Prednisone. The clinical outcome of the events a rash all over her face about a week after the vaccine was administered; also had a cough, chest tightness and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at site of injection a few hours after; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight, asthma, spring allergies and shrimp allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received phenobarbital (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN), all on unknown dates for unknown indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), vitamin b nos (MANUFACTURER UNKNOWN) and iron supplements (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. On 16Apr2021, a few hours after vaccination, the patient experienced pain at site of injection. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain at site of injection was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Peripheral swelling, Swelling, Vaccination site swelling
Clinical narrative: Shoulder was swollen half between neck and back; Right side of neck hurts when rotated to the right; Left arm was swollen to the tip of fingers and left leg still swollen to toes; Swelling appeared not only at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient 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 16Apr2021 at 15:15 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received typhoid vaccine (MANUFACTURER UNKNOWN) on an unknown date (when young) for unknown indication and experienced allergy to vaccine. On 16Apr2021 at 18:00, the patient experienced swelling that appeared not only at the injection site, but the shoulder was swollen half between neck and back. The patient's left arm was swollen to the tip of the fingers. At the time of reporting, the left leg was still swollen to the toes and the right side of the neck hurts when rotated to the right. 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. Therapeutic measures were not taken as a result of the events. The clinical outcomes of events shoulder was swollen half between neck and back, right side of neck hurts when rotated to the right, left arm was swollen to the tip of fingers and left leg still swollen to toes and swelling appeared not only at the injection site were 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: Fatigue, Headache, Migraine
Clinical narrative: Onset of symptoms (headache); Onset of symptoms (exhaustion); continued migraine; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in left arm on 13Apr2021 at 08:15 (at the age of 38-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) 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 left arm on 23Mar2021 at 08:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 at 12:30, 4 hours after the vaccination, the patient experienced headache and exhaustion, which were decreasing after 48 hours and there was continued migraine 4 days since the vaccination. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache and exhaustion were resolving and continued migraine was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever greater than 101 for 1st day, greater than 100 2nd day; Chills; body aches; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotic. 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 were not reported. On 15Apr2021 at 23:00, the patient experienced fever greater than 101 for 1st day, greater than 100 2nd day, chills, body aches, nausea. 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. On 15Apr2021, the patient underwent Body Temperature and the result was greater than 101 (UNSEPCIFIED UNITS). On 16Apr2021, the patient underwent Body Temperature and the result was greater than 100 (UNSEPCIFIED UNITS). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever greater than 101 for 1st day, greater than 100 2nd day, chills, body aches, nausea was recovering 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: F
Vaccine: COVID19
Symptoms: Dysphonia, Ear pruritus, Oropharyngeal pain, Throat irritation
Clinical narrative: had a mild sore throat and voice was lower; had a mild sore throat and voice was lower; Itchy back of throat at about 1.5 minutes, progressed to itchy throat and ear canals at 15 minutes.; Itchy back of throat at about 1.5 minutes, progressed to itchy throat and ear canals at 15 minutes.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient 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 01Apr2021 at 08:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish, black walnuts, adhesives and NSAIDS. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included curcuma longa rhizome (TURMERIC), vitamin d nos (MANUFACTURER UNKNOWN), fish oil (OMEGA 3), ascorbic acid (VITAMIN C) and probiotics nos (MANUFACTURER UNKNOWN): all from unknown date for an unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00, at about 1.5 minutes, the patient experienced itchy back of throat minutes, progressed to itchy throat and ear canals at 15 minutes. On 01Apr2021 at 08:30, at 30 minutes, the patient starting to get better and just had a mild sore throat and her voice was lower. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event itchy back of throat progressed to itchy throat and ear canals, mild sore throat and voice were lower was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Pain
Clinical narrative: Pain; Ear infection has progressively gotten worse; Ear pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 17:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. 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 the age of 32-year-old), as a single dose for COVID-19 immunisation. On 09Apr2021, 7 hours after second dose vaccination, the patient experienced ear pain. On 10Apr2021 at 00:00, the patient experienced pain and ear infection has progressively gotten worse, and had not responded to antibiotics. 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 antibiotic drops for ear and medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ear pain, pain and ear infection has progressively gotten worse, were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue
Clinical narrative: General light fatigue; moderate abdominal pains; This is a spontaneous report from a contactable consumer, the patient. A 30-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 15Apr2021 at 09:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. 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 25Mar2021 at 09:00 (at the age of 30-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 16Apr2021 at 05:00, the patient experienced general light fatigue and moderate abdominal pains throughout the day after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event general light fatigue and moderate abdominal pains was not recovered 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: Anosmia, Fatigue, Headache, Pain in extremity
Clinical narrative: Loss Of smell; headache; arm soreness; fatigue; 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: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 10:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient 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 COVID-19 vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT) and vitamin d nos (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. On 17Apr2021 at 12:30, the patient experienced loss of smell, headache, arm soreness, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL/ MOTRIN. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loss of smell, headache, arm soreness, fatigue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Flutter in my heart beat; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female 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 16Apr2021 at 11:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included FLONASE, ZYRTEC, and Vitamin D (MANUFACTURER UNKNOWN). All since 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: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 42-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. On 16Apr2021 at 20:00, 9 hours after being given the second vaccination, the patient experienced flutter in her heart beat which seemed to be taking place every 5-10 minutes. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if any therapeutic measures were taken for the reported events. The clinical outcome of the event flutter in the patient's heart beat was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: The left side of my face went a little numb for the rest of the day following my first shot. It lasted 2 days following my second shot.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 23-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medication included birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient had not been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 10:00, the patient's left side of the face went a little numb for the rest of the day following the first shot. It lasted two days following the second shot. 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 left side of the face went a little numb for the rest of the day following the first shot and lasted two days following the second shot was recovered on 16Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Persistent nausea; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 16Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included undiagnosed tremors, fatigue, and epilepsy. The patient had no known allergies to medications, food, or other products. 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 concomitant medications. 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 26Mar2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 08:00, the patient experienced persistent nausea, headache and chills. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events persistent nausea, headache, and chills were not recovered 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: Headache, Malaise, Nausea, Parosmia
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 28-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 28, via an unspecified route of administration, on Apr 16, 2021, at 15:15, single dose, for COVID-19 immunisation. Medical history included asthma. The patient has latex and penicillin allergy. It was not reported if the patient took any other medication within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination,  patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 17, 2021, patient started feeling unwell (headache and nausea) and had a heightened sense of smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events feeling unwell (headache and nausea) and a heightened sense of smell: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia
Clinical narrative: Right hand went numb for approx. 5 minutes; A hot, flushed feeling.; 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: unknown) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 cyanocobalamin (VITAMIN B-12) for unknown indication on unknown date and unknown if ongoing. The patient previously took cefalexin (KEFLEX) for unknown indication on unknown date and experienced drug allergy. On 14Apr2021 at 13:05, 5 minutes after receiving vaccine in left arm, right hand went numb for approximately for 5 minutes followed by a hot, flushed feeling. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right hand went numb and hot, flushed feeling was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Pain in arm gradually got worse, pain in shoulder and arm that the patient  can't lift or move arm without pain; Pain in arm gradually got worse, pain in shoulder and arm that the patient  can't lift or move arm without pain; can't lift or move arm without pain; This is a spontaneous report from a contactable non-healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0161) via an unspecified route of administration on 13Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation.  Medical history was not reported. The patient had no known allergies to medications, foods and other products. 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 13Apr2021, the patient experienced pain in arm gradually got worse, pain in shoulder and arm that the patient can't lift or move arm without pain. 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, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event pain in arm gradually got worse, pain in shoulder and arm that the patient can't lift or move arm without pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: Pain on left side; Headache; Joint pain; Fever; Nausea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old 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 14Apr2021 at 01:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 14Apr2021 at 16:00, the patient experienced pain on left side, headache, joint pain, fever, nausea and chills. 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 pain on left side, headache, joint pain, fever, nausea and chills were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain on left side; Headache; Joint pain; Fever; Nausea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old 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 14Apr2021 at 01:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 14Apr2021 at 16:00, the patient experienced pain on left side, headache, joint pain, fever, nausea and chills. 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 pain on left side, headache, joint pain, fever, nausea and chills were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Pain, Peripheral swelling
Clinical narrative: Cold sweats; swelling in the arm; large welt at the injection site; tiredness; body aches; headache.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced cold sweats, swelling in the arm, large welt at the injection site, tiredness, body aches and headache. 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 been tested for COVID-19. The clinical outcome of the events of  cold sweats, swelling in the arm, large welt at the injection site, tiredness, body aches and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Cold sweats; swelling in the arm; large welt at the injection site; tiredness; body aches; headache.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced cold sweats, swelling in the arm, large welt at the injection site, tiredness, body aches and headache. 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 been tested for COVID-19. The clinical outcome of the events of  cold sweats, swelling in the arm, large welt at the injection site, tiredness, body aches and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Dyspnoea, Fatigue, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: 14Apr sent to do lab for D Dimer which results received on Friday 16Apr indicated 1.23>.50; swelling and extreme tightness in both calves; swelling and extreme tightness in both calves; shortness of breath; muscle pain on top muscle area of both thighs; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 01Mar2021 at 17:00 (at the age of 63-year-old) as single dose for COVID-19 immunization at Hospital. Medical history of the patient included asthma, hypothyroid, high blood pressure, sinus, migraines. Patient had no known allergies. Concomitant/other medications in two weeks included Prescribed Medication (unspecified). Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 02Mar2021, patient experienced general fatigue and on 08Mar2021, patient experienced swelling and extreme tightness in both calves; muscle pain on top muscle area of both thighs, tightness and swelling was still there as of 20Apr2021, shortness of breath experienced for various situations where exerting more energy was required like walking up stair. Contacted PCP for visit in third week of Mar-appointment was set for mid Apr; pain continued. On 10Apr2021 visit, labs tests were done for salt-exercise, diet and stretching suggested; report received 13Apr2021 with negative results, 14Apr2021 patient was sent to do lab tests for D Dimer which results received on Friday 16Apr2021 indicated 01.23>.50; late response the day from PCP and went to ER for Ultrasound scan to check for blood clots. Report from ER indicated no blood clot found, suggested follow up with PCP-PT or other follow up from ER. On 19Apr2021 received response from PCP regarding follow up actions referring to PT services. General fatigue experienced for three weeks following vaccine (02Mar-27). AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included physical therapy. Outcome of the events were resolving.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Peripheral swelling, Ultrasound scan
Clinical narrative: 14Apr sent to do lab for D Dimer which results received on Friday 16Apr indicated 1.23>.50; swelling and extreme tightness in both calves; swelling and extreme tightness in both calves; shortness of breath; muscle pain on top muscle area of both thighs; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 01Mar2021 at 17:00 (at the age of 63-year-old) as single dose for COVID-19 immunization at Hospital. Medical history of the patient included asthma, hypothyroid, high blood pressure, sinus, migraines. Patient had no known allergies. Concomitant/other medications in two weeks included Prescribed Medication (unspecified). Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 02Mar2021, patient experienced general fatigue and on 08Mar2021, patient experienced swelling and extreme tightness in both calves; muscle pain on top muscle area of both thighs, tightness and swelling was still there as of 20Apr2021, shortness of breath experienced for various situations where exerting more energy was required like walking up stair. Contacted PCP for visit in third week of Mar-appointment was set for mid Apr; pain continued. On 10Apr2021 visit, labs tests were done for salt-exercise, diet and stretching suggested; report received 13Apr2021 with negative results, 14Apr2021 patient was sent to do lab tests for D Dimer which results received on Friday 16Apr2021 indicated 01.23>.50; late response the day from PCP and went to ER for Ultrasound scan to check for blood clots. Report from ER indicated no blood clot found, suggested follow up with PCP-PT or other follow up from ER. On 19Apr2021 received response from PCP regarding follow up actions referring to PT services. General fatigue experienced for three weeks following vaccine (02Mar-27). AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included physical therapy. Outcome of the events were resolving.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness from about 1 week; This is a spontaneous report from a 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: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 at 15:30 (at the age of 66-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 15:30 (at the age of 66-years-old); both as a single dose for COVID-19 immunisation. Medical history included meniere's disease. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021, the patient experienced dizziness from about 1 week after first shot till the present day. The dizziness was initially constant, was intermittent at the time of this report and worsened when patient was tired. 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 from about 1 week after first shot to present, the dizziness was initially constant, was intermittent at the time of this report and worsened when patient was tired was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 15Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced sore arm. 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 sore arm was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Arm was red at the injection site; Arm was swollen at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 14:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and women's probiotic (MANUFACTURER UNKNOWN). 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 16Apr2021 at 16:00, about 10-11 days after the vaccination, the arm of the patient was red and swollen at the injection site. It was not painful. 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. The clinical outcome of the events arm was red and swollen at the injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Mouth swelling, Mouth ulceration
Clinical narrative: Mouth is 100% numb; Random ulcer.; Mouth is 100% numb and swollen inside; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 12:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included unspecified birth control medication (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. On 17Apr2021 at 16:30, the patient experienced mouth is 100% numb and swollen inside and randomly got a random ulcer. 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 mouth is 100% numb and swollen inside and random ulcer were unknown at the time of reporting.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site scar
Clinical narrative: Scar on arm post vaccine administration; This is a spontaneous report from a contactable consumer. A 46-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 on an unknown date (at the age of 46-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 46-years-old) as single doses for COVID-19 immunisation.. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. It was not known, whether the patient received any medication within two weeks of vaccination. On 16Apr2021, the patient experienced scar on arm post vaccine administration. The 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 had tested for COVID-19, since the vaccination. It was unknown if the patient received treatment for the event. The clinical outcome of the event scar on arm post vaccine administration was unknown 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.