chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient came in for Moderna booster, stated he is on medications that suppress his immune system. Patient qualified to receive 3rd dose of Moderna vaccine. At time of vaccination, patient brough in vaccination card showing prior Moderna doses on 4/7/21 and 5/5/21 from another facility. Patient did not inform staff that he has been vaccinated with Pfizer recently. This was discovered upon billing for the vaccination and was confirmed within the registry. At time of report, no adverse event reported
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: numbness, swelling and pain in his right foot and lower leg; numbness, swelling and pain in his right foot and lower leg; numbness, swelling and pain in his right foot and lower leg; numbness and pain in lower right leg and foot was reported as worsened; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 25-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 05-MAY-2021 09:00 am (at the age of 25-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Note: since he was 8 years old. The patient's concomitant medications were not reported. The patient previously took fluticasone (Dose-250mcg), salmeterol (Dose-25mcg). On 05May2021 the patient experienced numbness, swelling and pain in his right foot and lower leg, numbness and pain in lower right leg and foot was reported as worsened. Patient stated that he got the Pfizer COVID 19 vaccine at 9 am. Then, 3 hours later, he started experiencing numbness and pain in his right lower leg and foot. Is that normal? Caller doesn't have a prescribing doctor. It has become more numb since he first realized it. He does have Asthma since he was 8 years old. The outcome of the event was unknown for numbness and pain in lower right leg and foot was reported as worsened while Not recovered for numbness, swelling and pain in his right foot and lower leg.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Pain
Clinical narrative: Fast heartbeat; Shortness of breath; Full body aches; Chills; Sweats; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm right on 04May2021 at 10:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pure encapsulations ONE multivitamin and dysbiocide (MANUFACTURER UNKNOWN). The patient previously took DEMEROL and experienced Drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 08Apr2021 at 13:00 (at the age of 40-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 05May2021 at 02:00, the patient experienced fast heartbeat and shortness of breath starting 16 hours after second dose administration and lasting several hours and the patient also experienced chills, sweats, full body aches and headache. The patient was not received treatment for the events. The clinical outcome of events fast heartbeat, shortness of breath, chills, sweats, full body aches and headache were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021) via DSU Amendment: This follow-up report is being submitted to amend previously reported information:Past drug event Reaction updated; Treatment received updated for all events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Fast heartbeat; Shortness of breath; Full body aches; Chills; Sweats; Headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm right on 04May2021 at 10:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pure encapsulations ONE multivitamin and dysbiocide (MANUFACTURER UNKNOWN). The patient previously took DEMEROL and experienced Drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 08Apr2021 at 13:00 (at the age of 40-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 05May2021 at 02:00, the patient experienced fast heartbeat and shortness of breath starting 16 hours after second dose administration and lasting several hours and the patient also experienced chills, sweats, full body aches and headache. The patient was not received treatment for the events. The clinical outcome of events fast heartbeat, shortness of breath, chills, sweats, full body aches and headache were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021) via DSU Amendment: This follow-up report is being submitted to amend previously reported information:Past drug event Reaction updated; Treatment received updated for all events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash covering from neck; Rash covering neck to buttocks; This is a spontaneous report from a contactable consumer, the patient. A 50-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 02Apr2021 at 15:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no medical and past drug history. Concomitant medications included rosuvastatin calcium (CRESTOR) 40mg.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 21Apr2021 at 09:00 the patient experienced rash covering from neck to buttocks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with steroids(MANUFACTURER UNKNOWN) . On 03May2021, the patient underwent PCR test (nasal swab) and the result was negative. The clinical outcome of the event rash covering from neck to buttocks was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pain in extremity
Clinical narrative: Very extremely tired; Very sore arm can not sleep on that side; Lots of congestion; Headaches; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 30Apr2021 at 16:30 (at the age of 37-year-old) at single dose for COVID-19 immunisation. Medical history included anxiety with panic and hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient experienced very extremely tired, very sore arm could not sleep on that side, lots of congestion and headaches. 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. No treatment was received for the events. The clinical outcome of the events was recovered with sequelae (reported as recovered with lasting effects) in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: events details added (no treatment was received).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: elevated heart rate all night; aches; chills; Pain in arm; exhaustion; swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in the left arm on 04May2021 at 09:00 as a dose 2 single dose (at the age of 36-years old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as a dose 1 single dose (at the age of 36-year-old) 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. On an unknown date, the patient underwent lab test as heart rate and the result was elevated. On 05May2021 at 05:00, the patient experienced pain in arm, elevated heart rate all night, chills, exhaustion, aches and swollen lymph node in left armpit. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, elevated heart rate all night, chills, exhaustion, aches and swollen lymph node were recovering at the time of this report.   No follow-up attempts were needed; Information about lot/batch number could not be obtained.  Amendment: This follow-up report was being submitted to amend previously reported information: Treatment received ticked no for all events. The patient did not receive any treatment for the event and the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care added in narrative.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: elevated heart rate all night; aches; chills; Pain in arm; exhaustion; swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in the left arm on 04May2021 at 09:00 as a dose 2 single dose (at the age of 36-years old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on unspecified date as a dose 1 single dose (at the age of 36-year-old) 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. On an unknown date, the patient underwent lab test as heart rate and the result was elevated. On 05May2021 at 05:00, the patient experienced pain in arm, elevated heart rate all night, chills, exhaustion, aches and swollen lymph node in left armpit. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, elevated heart rate all night, chills, exhaustion, aches and swollen lymph node were recovering at the time of this report.   No follow-up attempts were needed; Information about lot/batch number could not be obtained.  Amendment: This follow-up report was being submitted to amend previously reported information: Treatment received ticked no for all events. The patient did not receive any treatment for the event and the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care added in narrative.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Light headed; Weak; Very sore arm; Headache; Tiredness/Fatigue; Groggy; 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: EW 0172) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included IgA deficiency, mannose-binding lectin deficiency and COVID-19. The patient had known allergies to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient previously 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 09Apr2021 at 12:00 (at the age of 27-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 30Apr2021 at 19:00, the patient experienced very sore arm, headache, tiredness/fatigue, light headed and weak/groggy. 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 very sore arm, headache, fatigue, light headed and weak/groggy was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Light headed; Weak; Very sore arm; Headache; Tiredness/Fatigue; Groggy; 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: EW 0172) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included IgA deficiency, mannose-binding lectin deficiency and COVID-19. The patient had known allergies to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient previously 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 09Apr2021 at 12:00 (at the age of 27-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 30Apr2021 at 19:00, the patient experienced very sore arm, headache, tiredness/fatigue, light headed and weak/groggy. 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 very sore arm, headache, fatigue, light headed and weak/groggy was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; 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: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 08:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulphur. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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.  On 28Apr2021 at 22:00, the patient had shingles outbreak. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event shingles outbreak and included treatment with valacyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles outbreak was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Irritability, Myalgia
Clinical narrative: Nausea; Dizziness; Fatigue; Pain at injection site; Muscle aches; Chills; Irritability; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 49-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 right arm on 06Apr2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included mild traumatic brain injury, fibromyalgia, spinal stenosis, a known allergy to penicillin, casein and lactose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate monohydrate (PRISTIQ), pramipexole dihydrochloride monohydrate (MIRAPEX), methylphenidate hydrochloride (RITALIN) and rosa canina; urtica dioica; tanacetum vulgare (NEUROTEC); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 20:00, the patient experienced nausea, dizziness, fatigue, pain at injection site, muscle aches, chills and irritability. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, fatigue, pain at injection site, muscle aches, chills and irritability was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 27Apr2021 at 15:00 hours (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Nausea; Dizziness; Fatigue; Pain at injection site; Muscle aches; Chills; Irritability; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 49-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 right arm on 06Apr2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included mild traumatic brain injury, fibromyalgia, spinal stenosis, a known allergy to penicillin, casein and lactose. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate monohydrate (PRISTIQ), pramipexole dihydrochloride monohydrate (MIRAPEX), methylphenidate hydrochloride (RITALIN) and rosa canina; urtica dioica; tanacetum vulgare (NEUROTEC); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 20:00, the patient experienced nausea, dizziness, fatigue, pain at injection site, muscle aches, chills and irritability. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, fatigue, pain at injection site, muscle aches, chills and irritability was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 27Apr2021 at 15:00 hours (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Muscle twitching, Muscular weakness, Nervousness, Paraesthesia
Clinical narrative: Feeling weakness on legs; Nervous feeling; Both legs and arms started shaking and twitching; Both legs and arms started twitching.; Pins and needle sensation in body and face.; Feeling of shakiness; Feeling of shakiness and rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 09:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to almonds, soybeans and hazelnut. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rhamnus purshiana (CASCARA SAGRADA) from 28Apr2021 for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced pins and needle sensation in body and face, feeling of shakiness and rapid heartbeat. On 29Apr2021 at 23:45, 3 days after vaccination, the patient experienced both legs and arms started shaking and twitching which subsided about 20 minutes later. On 30Apr2021, in the morning the patient experienced no muscle twitching but felt weakness on legs and nervous feeling. 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 both legs and arms started shaking and twitching was recovered on 30Apr2021, after the duration of about 20 minutes. The clinical outcome of the events pins and needle sensation in body and face, feeling of shakiness and rapid heartbeat, weakness on legs and nervous feeling was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Feeling weakness on legs; Nervous feeling; Both legs and arms started shaking and twitching; Both legs and arms started twitching.; Pins and needle sensation in body and face.; Feeling of shakiness; Feeling of shakiness and rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 09:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to almonds, soybeans and hazelnut. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rhamnus purshiana (CASCARA SAGRADA) from 28Apr2021 for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced pins and needle sensation in body and face, feeling of shakiness and rapid heartbeat. On 29Apr2021 at 23:45, 3 days after vaccination, the patient experienced both legs and arms started shaking and twitching which subsided about 20 minutes later. On 30Apr2021, in the morning the patient experienced no muscle twitching but felt weakness on legs and nervous feeling. 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 both legs and arms started shaking and twitching was recovered on 30Apr2021, after the duration of about 20 minutes. The clinical outcome of the events pins and needle sensation in body and face, feeling of shakiness and rapid heartbeat, weakness on legs and nervous feeling was 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: Dizziness
Clinical narrative: Dizziness within first hour of 2nd shot; This is a spontaneous report from a non-contactable consumer, the patient. A 28-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 30Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and panic disorder. 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. Patient did not receive any other medication within two weeks of vaccination. Patient had no known allergies to food, medication or other products. 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 09Apr2021 at 15:15 as a single dose for COVID-19 immunisation. On 30Apr2021 at 13:45, the patient experienced dizziness within first hour of 2nd shot. 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 patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was recovered on an unknown date in 2021 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: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Muscle aches: arms, legs, torso; Headache; Nausea; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 30Apr2021 at 10:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0158) via an unspecified route of administration in the arm left on 09Apr2021 at 08:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. 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. On 30Apr2021 at 19:00 the patient experienced muscle aches: arms, legs, torso; headache, nausea and fatigue. 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 muscle aches: arms, legs, torso; headache, nausea and fatigue were not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Muscle spasms, Pain, Pyrexia
Clinical narrative: low fever (100.4); whole body aches; muscle spams; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male 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 28Apr2021 at 10:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included cerebral palsy, asthma, anxiety disorder, processing delay and kidney disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), loratadine (MANUFACTURER UNKNOWN), potassium chloride (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and fish oil/ vitamin e nos (OMEGA 3); all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 as a single dose for COVID-19 immunisation. On 29Apr2021 at 02:00, the patient experienced low fever (100.4), whole-body aches and muscle spasms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low fever (100.4), whole-body aches and muscle spasms were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: Reaction of swelling, itching, and hives on face; Reaction of swelling, itching, and hives on face; Reaction of swelling, itching, and hives on face; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included dermal filler injection and COVID-19 on an unknown date. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was 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 27Apr2021, the patient experienced a reaction of swelling, itching and hives on face after getting dermal fillers. The doctor thought it could be due to vaccination as she had fillers many times with no reaction. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with methoprednisone and antihistamine. The clinical outcome of the events swelling, itching and hives on face were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Non-itchy hives all over trunk and chest, neck, partially neck and arms lasting two days; This is a spontaneous report from a contactable consumer, the patient. A 50-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 arm left on 27Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hives. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient had any allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, levonorgestrel (LESSINA) as birth control from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 12:00 the patient experienced non-itchy hives all over trunk and chest, neck, partially neck and arms lasting two days. The patient had this reaction about 6 times within the last 15 years, though patient was uncertain of what triggers it. No therapeutic measures was taken as a result of the event. Therapeutic measures were not 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 doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event non-itchy hives all over trunk and chest, neck, partially neck and arms lasting two days was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever (~100F); Fatigue; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0716) via an unspecified route of administration in the left arm on 30Apr2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease. The patient had known allergies to CT contrast media. Concomitant medications included vitamin d (vitamin d nos) (MANUFACTURER UNKNOWN), adalimumab (HUMIRA), escitalopram oxalate (LEXAPRO) and loratadine (CLARITIN) for unknown indications, from an unknown date and unknown if ongoing. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced low grade fever (~100F), fatigue and body aches. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures, which included body temperature on 01May2021 and the result was body temperature 100 Fahrenheit (low-grade fever (~100F)). The clinical outcome of the events low-grade fever (~100F), fatigue and body aches were resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches; Chills; Headache; Fatigue; Nausea; This is a spontaneous report from a non-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: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 18:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), anxiety, depression and allergy to sulfa based medications. The patient had known allergies to pethidine hydrochloride (DEMEROL) and topiramate (TOPAMAX). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and linum usitatissimum seed oil (FLAX SEED OIL); 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: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 18:00 (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 vaccination. On 30Apr2021 at 09:00, the patient experienced body aches, chills, headache, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills, headache, fatigue and nausea was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Mild tinnitus in both ears; Hearing acuity seems decreased; popping sounds intermittent and non rhythmic in left ear.; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received 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 23Mar2021 at 09:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included human papilloma virus infection, cough variant asthma, and COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 15:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Patient past drug was reported as no. Prior to the vaccination, the patient was 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 04Apr2021 at 12:00, the patient experienced mild tinnitus in both ears, hearing acuity seemed to be decreased, and experienced series of popping sounds intermittent and non rhythmic in left ear. The events resulted in doctor or other healthcare professional office/clinic visit. Unknown if the patient received any treatment for the events. The clinical outcome of the events mild tinnitus in both ears, hearing acuity decreased and series of "popping" sounds were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Peripheral coldness, Pruritus, Rash
Clinical narrative: Vaccinated arm is cold; all day now getting hot; Still very sore arm; Burning and itching on the forearm and wrist of arm that got the injection.; Rash on forearm of opposite arm; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as very healthy. The patient had unspecified outdoor allergies. Concomitant medications included norethisterone (NORA-BE), taken for birth control from an unknown date. 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 29Apr2021 at 15:05, within about 5 minutes of getting vaccinated, the patient experienced burning and itching on the forearm and wrist of arm that got the injection, rash on forearm of opposite arm. On 30Apr2021, 24 hours later, the vaccinated arm was cold all day and later it was getting hot and a little itchy at night and the patient had very sore arm in general. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included an unspecified treatment and the patient was referred to an allergist whom the patient was yet to consult. The clinical outcome of the events burning and itching on the forearm and wrist of arm, rash, cold vaccinated arm and later got hot, itchy at night and sore arm were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Joint stiffness, Ligament disorder, Musculoskeletal stiffness
Clinical narrative: Severe joint inflammation; Ligament stiffness in fingers, knees, elbows and shoulders; Ligament stiffness in fingers, knees, elbows and shoulders; Ligament stiffness in fingers, knees, elbows and shoulders; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 12:30 in the left arm (at an age of 66-years-old), as single dose for COVID-19 immunisation. Medical history included atrial fibrillation, thyroid underactive, high cholesterol and known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included apixaban (ELIQUIS), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID) and atorvastatin calcium (LIPITOR); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021, within one week of second shot, the patient developed severe joint inflammation and ligament stiffness in fingers, knees, elbows and shoulders lasting 4 weeks and beyond. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of severe joint inflammation and ligament stiffness in fingers, knees, elbows and shoulders was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lip pain, Paraesthesia
Clinical narrative: Sore lips; Tingling; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9X1LLQGH1GU6RL) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took tetracycline and experienced allergy to the medication. On 29Apr2021, the patient experienced sore lips and tingling. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore lips and tingling was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.