chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches- generalized; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 25Feb2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) and unspecified multi-vitamins; 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: EL3247) via an unspecified route of administration in the left arm on 04Feb2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021 at 11:00, the patient experienced muscle aches- generalized. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle aches- generalized was resolved on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at injection site approximately 4- 5 days after; This is a spontaneous report from a contactable consumer, the patient. A 76-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 26Feb2021 at 12:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included dystonia and penicillin allergy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 00:00, the patient experienced rash at injection site approximately 4- 5 days after the vaccination. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash at injection site was not recovered 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Tinnitus
Clinical narrative: Loud ringing in ears.; Feeling cold; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 19:00 (at the age of 49-years old) as a single dose for COVID-19 immunisation. Medical history included colitis, penicillin allergy and gurds. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 at 19:30, the patient experienced loud ringing in ears and was feeling cold. 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 clinical outcome of the events ringing in ears and feeling cold was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Left lymph node has been swollen since the vaccination; This is a spontaneous report from a contactable consumer, the parent. An adult non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 08:15 as a single dose for COVID-19 immunisation. Medical history included asthma and rheumatoid arthritis from an unknown date and unknown if ongoing. 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. Concomitant medications included salbutamol (VENTOLIN) for asthma and budesonide, formoterol fumarate (SYMBICORT) for an unknown indication; both from an unknown date and unknown if ongoing. On 25Feb2021 (also reported as on 27Feb2021 at 13:00), the patient experienced left lymph node which was swollen since the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event left lymph node which was swollen since the vaccination which included treatment with unspecified medicine lozenges (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. Since the vaccination, the patient had been tested for COVID-19. On 28Feb2021, the patient underwent nasal swab test SARS CoV-2 test and the result was negative. The clinical outcome of the event left lymph node has been swollen since the vaccination was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on an unknown date (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D), for an unknown indication from an unknown date and unknown if ongoing. On 04Mar2021, the patient experienced arm soreness. 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 therapeutic measures were taken as a result of the reported events. The clinical outcome of the events arm soreness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; Stomach cramping; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 28Feb2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and carpal tunnel. 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 escitalopram oxalate (LEXAPRO), gabapentin (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN) and 8-Tetrahydrocannabinol (THC) (MANUFACTURER UNKNOWN), all for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Mar2021 at 02:00, the patient experienced diarrhea, nausea and stomach cramping. 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 events diarrhea, nausea and stomach cramping were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort
Clinical narrative: Slight dizziness; Feeling like "my" head was three feet thick; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 at 10:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included osteoporosis, penicillin allergy and lactose allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 10:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. On 27Feb2021 at 21:00, the patient experienced slight dizziness and felt like head was three feet thick. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight dizziness and feeling like head was three feet thick was recovered on an unknown date in 2021.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201; Expiry date: Jun2021) via an unspecified route of administration in the right arm on 19Feb2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus, high blood pressure, anxiety, depression, obesity and shellfish allergy. Prior to 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 received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 19Feb2021 at 15:45, the patient experienced pain at injection site. 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 pain at injection site was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Faeces discoloured, Fatigue, Nausea
Clinical narrative: Fatigue; Nausea; Dizziness; Black stool; This is a spontaneous report from a non-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 on 25Feb2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. 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 vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 25Feb2021, the patient experienced fatigue, nausea and dizziness serious enough to stay home from work and oily bright black stool (this was only once). The patient assumed that was from vaccine, symptoms started evening of vaccination (11:20 am), were worse the next day and gone within 48hours. 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 for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, nausea, dizziness and oily bright black stool was recovered within 48 hours on 27Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 25Feb2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified relevant medical history and had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Feb2021 at 11:00, the patient had diarrhoea and at the time of this report patient had 3 days of diarrhea. 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 event. The clinical outcome of the event diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: For 2 days following 2nd covid Pfizer vaccine, had dark/brown urine color, no pain or problem, just color change.; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Mar2021 at 14:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), heart disorder and hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included pantoprazole sodium sesquihydrate (PANTOPROZOLE); ranolazine (RANEXA), apixaban (ELIQUIS); atorvastatin calcium (LIPITOR) and unspecified medications; all from unknown indication from an unknown dates and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 29Jan2021 at 12:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. On 03Mar2021, at 00:00, the patient experienced for 2 days following 2nd covid Pfizer vaccine, dark/brown urine color, no pain or problem, just color change. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event brown urine 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 27Feb2021 at 16:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included amitriptyline hydrochloride (ELAVIL) and meloxicam (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown dates and unknown if ongoing. On 28Feb2021 at 08:30, the patient experienced injection site reaction, red, warm, swelling, tenderness. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events injection site reaction, red, warm, swelling, tenderness was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Disturbance in attention
Clinical narrative: Agitation; Unable to focus; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 73-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 05Feb2021 at 11:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included A-fib (atrial fibrillation). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received ibuprofen (MOTRIN), for unknown indication on an unknown date and experienced drug allergy. On 06Feb2021, the patient experienced agitation, unable to focus and anxiety. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events agitation, unable to focus and anxiety 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Feeling abnormal
Clinical narrative: Feeling bad during menstrual period; Stomach hurts on a unusual way; Mouth has this iron taste; This is a spontaneous report from a contactable consumer, the patient. A 42-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 09Feb2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included bleeding 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 vaccination. Concomitant medications included tranexamic acid (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing and unspecified hair vitamins from an unknown date and unknown if ongoing. The patient previously received desmopressin (MANUFACTURER UNKNOWN) and experienced drug allergy. It was reported that the patient felt fine after her first dose but now on 01Mar2021 at 10:00, she was feeling bad during her menstrual period. The patient's stomach hurt on an unusual way and her mouth had this iron taste like after her first COVID-19 vaccine shot. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events feeling bad during menstrual period, stomach hurts on an unusual way and mouth has this iron taste was recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Salivary hypersecretion
Clinical narrative: Watering in mouth; Medicinal taste that covered tongue; This is a spontaneous report from a contactable consumer, the patient. A 67-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 right arm on 01Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no 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. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) from an unknown date and for an unknown indication. On 01Mar2021 at 13:15, 15 minutes after the vaccination, the patient experienced watering in mouth and then a medicinal taste that covered her tongue. It lasted approximately 15 hours. 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 watering in mouth and medicinal taste that covered tongue were resolved on 02Mar2021 at 04:15, after the duration of 15 hours.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Sick to stomach; Fatigue; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6200) via an unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medication included vitamins (unspecified) for an unknown indication from an unknown date and unknown if ongoing. On 26Feb2021 at 21:00, the patient experienced sick to stomach and fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sick to stomach and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies 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 vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 25Feb2021, 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore arm was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Upper arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 at 02:30 (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 vaccination. On 25Feb2021, the patient experienced upper arm soreness. The event did not result in a visit to the doctors 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. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event upper arm soreness was recovered 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Day 2 brain fog; day 1 headache; Day 1 fatigue, Day 2 very fatigued; day 1 slightly nauseous; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 11:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified postnatal vitamins. On 28Feb2021 on day 1, the patient experienced headache, fatigue and slightly nauseous. On 01Mar2021 on day 2, the patient was very fatigued and brain fog. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue, slightly nauseous and brain fog were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: My tongue and mouth have metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8782) via an unspecified route of administration in the right arm on 09Feb2021 at 16:30 (at the age of 64-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 03Mar2021 at 09:45 (at the age of 64-year-old), both as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for unknown indication from unknown date and unknown if ongoing. The patient previously received ciprofloxacin (CIPRO) for unknown indication from unknown date and experienced drug allergy (years ago). On 16Feb2021 at 12:00, the patient experienced metallic taste in tongue and mouth. 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 event tongue and mouth have metallic taste was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon rupture
Clinical narrative: Left Biceps tendon partial rupture while weight lifting; This is a spontaneous report from a contactable physician (patient). A 47-year-old male patient received BNT162B2, via an unspecified route of administration, administered in left arm on 08Jan2021 (Batch/Lot Number: EL3248) at the age of 47 years old as dose 2, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and psoriasis. No known allergies. There were no concomitant medications. No other vaccine in four weeks; no other medication in two weeks. No COVID prior vaccination; not COVID tested post vaccination. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EJ1685) administered in right arm on 18Dec2021 at 11:30 AM. The patient experienced left biceps tendon partial rupture while weight lifting on 25Feb2021 11:00. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included surgery which was scheduled on 19Mar2021. Outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the currently available information  causal association between the event tendon rupture and the suspect drug BNT162B2 is considered unrelated.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Therapeutic response unexpected
Clinical narrative: Booster; Off label use; There was a (Positive Event.) Ive had sore knees for years, after the second dose of Covid -19 vaccine, I no longer had any pain in either knee. This is 5 days as of 3-5-21; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (at the age of 80-years-old) and a third dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included sore knees for years and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications were not reported. The patient previously 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 08Feb2021 at 09:00 (at the age of 80-years-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 01Mar2021 at 08:00, the patient experienced a positive event. The patient has had sore knees for years, after the second dose of COVID -19 vaccine, he no longer had any pain in either knee. It was 5 days as of 05Mar2021. Therapeutic measures were not taken as a result of the event. The event 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 there was a positive event; had sore knees for years, after the second dose of COVID -19 vaccine, no longer had any pain in either knee; it was 5 days as of 05Mar2021 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscle tightness
Clinical narrative: Dizziness; Muscle tightness at base of skull and top of neck; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and concussion. The patient had known allergies, but reported by patient that does not seem to apply here. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and doxazosin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 02Mar2021, the patient experienced dizziness, severe muscle tightness at base of skull and top of neck and severe headache (this area is an underlying condition in that it bore the brunt of a childhood concussion and the patient received almost daily chiropractic treatments to manage it, but the severity and dizziness was unique to this). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of dizziness, severe muscle tightness at base of skull and top of neck and severe headache included chiropractic adjustment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, severe muscle tightness at base of skull and top of neck and severe headache was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm pain from wrist to shoulder the day following the vaccine, for just a few hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 90-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Feb2021 at 11:30 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to 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: UNKNOWN) via an unspecified route of administration in the right  arm on 21Jan2021 at 11:30 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. On 10Feb2021, the patient experienced right arm pain from wrist to shoulder the day following the vaccine, for just a few hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm pain from wrist to shoulder was recovered on an unknown date in Feb2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red, swollen, painful, itchy at site of injection; red, swollen, painful, itchy at site of injection; red, swollen, painful, itchy at site of injection; red, swollen, painful, itchy at site of injection; This is a spontaneous report from a non-contactable consumer, the patient. A 52-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 04Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 05Mar2021 the patient experienced red, swollen, painful and itchy at the site of injection. 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 red, swollen, painful and itchy at the site of injection was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain
Clinical narrative: Chills; Aches; General unwell feelings; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 17:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included "MORTON" for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021 at 09:30, the patient experienced chills, aches, and general unwell feelings. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, and general unwell feelings was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Dizziness; Nausea; sore arm; This is a spontaneous report from a contactable consumer, the patient. A patient of unknown  gender and age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 at 09:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication 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. On 05Mar2021, the patient experienced dizziness, nausea and sore arm. 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 outcomes of the events dizziness, nausea and sore arm was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second 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 12:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included detached retina and melanoma. 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 amlodipine besilate and benazepril hydrochloride (LOTREL), venlafaxine hydrochloride (EFFEXOR) and atorvastatin calcium (LIPITOR), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 08Feb2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 15:00, the patient experienced ringing in ears. 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 any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Salivary hypersecretion
Clinical narrative: Within a few minutes, increased salivation; Metallic taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 01Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, spontaneous coronary artery dissection (SCAD) , trigeminal neuralgia, sulfonamide allergy, pollen allergy, dust allergy, allergy to feathers and allergy to animal hair. 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 01Mar2021, within a few minutes, the patient experienced increased salivation and metallic taste in mouth that lasted 24 hours. 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 increased salivation and metallic taste in mouth was recovered on 02Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Feeling hot, Nausea
Clinical narrative: With in 24 hours, became hot; Light headed; Felt clammy; Felt sick to my stomach; Vomited; Very weak; slept another 8 hours; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 11:00 (at the age of 79-year-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 vaccine within four weeks prior to the COVID vaccine. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and levothyroxine sodium (EUTHYROX); both from an unknown date for an unknown indication and was unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 11:00 as a single dose for COVID-19 immunisation. On an unknown date in Feb2021, within 24 hours, the patient experienced, hot and light headed. She felt clammy and began to shed the layers, she felt sick to her stomach and vomited. It was reported that she never throws up, the last time she did was when she was 7 years old. She made it to her living room couch and slept 5 hours, she was still very weak, made it to bed and slept another 8 hours. She didn't take her temperature and when she woke, she was more herself but remained weak for several more days. 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 for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt hot, light headed, felt sick to her stomach, slept for 8 hours and vomited was recovered on an unknown date Feb2021.  No follow-up attempts are needed. No further information is expected.