chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Tremor
Clinical narrative: Fever up to 101 degrees; Shakes; Overall soreness; This is a spontaneous report from a contactable consumer, the patient. A 57-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 right arm on 06Apr2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 COVID vaccine. On 07Apr2021 at 03:00, the patient experienced fever up to 101 degrees, shakes and overall soreness. The patient underwent lab tests which included Body temperature on 07Apr2021 at 03:00 and the result was 101 degrees (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event fever up to 101 degrees, shakes, overall soreness was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Palpitations
Clinical narrative: rapid heart rate/pounding heart for approximately 15-20 seconds (Very scary); Fatigue; intermittent rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208, Expiry date: not reported, age at vaccination: 59-year-old), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 07:15 AM as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing , penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included dexlansoprazole (DEXILANT) taken for an unspecified indication, start and stop date were not reported. The patient previously took clarithromycin, arythromicin and tylenol and experienced drug allergy. Previously, the patient received first dose bnt162b2 (lot number: EN6201,age at vaccination: 59-year-old), administered in left arm on 05Mar2021 at 07:30 AM for covid-19 immunization and experienced intermittent rapid heart rate, severe migraine and headache. The patient did not receive any other vaccines in four weeks. The patient did not have covid prior vaccination and not tested for covid post vaccination. On 26Mar2021 evening, the patient experienced rapid heart rate/pounding heart for approximately 15-20 seconds (very scary). Since an unknown date in Mar2021, the patient experienced fatigue, intermittent rapid heart rate. It was reported to physician. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: 5 days later I had severe diarrhea, fatigue and a fever.; 5 days later I had severe diarrhea, fatigue and a fever.; 5 days later I had severe diarrhea, fatigue and a fever.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient previously had penicillin and had experienced penicillin allergy. The patient received concomitant medication within two weeks prior to vaccination which included fish oil (MANUFACTURER UNKNOWN) and multi vitamin (unspecified), both from unknown date and for unknown indication. 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 27Mar2021 at 10:00, five days after the vaccination, the patient experienced severe diarrhea, fatigue and fever. No therapeutic measures were 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. The clinical outcome of the events severe diarrhea, fatigue and fever were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pruritus, Throat irritation
Clinical narrative: Slight itch in throat after vaccine; Slight cough. Thought cough was due to pollen in air.; As evening progressed, slight itching of fingers, toes, and top of head.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 16:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, chronic sinus infection, tree/grass/dust pollen allergies. The patient previously took sulfa drugs and experienced allergy. Past has allergy to raw onions and green beans. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR), cetirizine (MANUFACTURER UNKNOWN) and other unspecified medications. 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 06Apr2021 at 17:00 the patient experienced slight itch in throat after vaccine and slight cough. The patient thought cough was due to pollen in air. As evening progressed, the patient experienced slight itching on fingers, toes, and top of head. The patient took diphenhydramine hydrochloride (BENADRYL) for events before going to bed. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added medical history tree allergies.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Delayed onset on fatigue; Delayed onset of severe body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 2P7534) via an unspecified route of administration in the arm left on 26Mar2021 at 11:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included ADHD(Attention deficit hyperactivity disorder), de quervain (de quervains thyroiditis), penicillin and sulpha allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) 50 mg daily from unknown date for unspecified indication. 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 28Mar2021, the patient experienced delayed onset on fatigue and severe body aches for more than 10 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the event delayed onset on fatigue and severe body aches was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual cycle started nearly two weeks early; Spotting; Extreme pain over pancreas; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included epilepsy. Concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 18Mar2021 at 04:00, the patient reported that her menstrual cycle had started nearly two weeks early along with spotting. On 18Mar2021 at 04:00, the patient also experienced extreme pain over pancreas. The patient stated "I would have written this off as being 43 but I the 5th woman I know that has received the Pfizer vaccine (others Moderna) where this has happened with the hormonal issues and cycle coming too early with spotting and weight gain.It won't prevent me from getting the second shot but I think it's important to report and have Pfizer look into No I've managed but if it doesn't settle down after the second vaccine I'm going in. The events did not result in a doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events early menstrual cycle with spotting and pain over pancreas was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021) via Amendment: This follow-up report is being submitted to amend previously reported information: Age at Vaccination updated; Narrative added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Headache; facial and feet numbness/Numbness of the face in temple area/back of head like cheek bones cheek temples, nose area as well got numb; numb from lip, top of lip; tingling sensation; This is a spontaneous case received from a contactable two consumers (one was patient) via medical information team and Pfizer Sponsored Program.   A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 05Apr2021 (age at vaccination 50-year-old) as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial and feet numbness within 15 min of having vaccine and lasted several hours, Numbness of the face in temple area, turned numb from lip, top of lip to back of head like cheek bones, cheek temples, nose area as well got numb and some tingling sensation as if she had nonvaccine on 05Apr2021. The next day had a slight headache on 06Apr2021. Asking if it was safe for her to get the 2nd shot. Patient was not taking any medications. The outcome of events was unknown.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pharyngeal swelling
Clinical narrative: Lump/swelling in back of the throat; muscle pain/discomfort; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included (IBS) irritable bowel syndrome, sleep apnea, fatty liver and known allergy to melons. Concomitant medications included fluticasone propionate (FLONASE) for an unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH6207), via an unspecified route of administration in the left arm on an unknown date of Mar2021 at 10:00 (at the age of 39-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. 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 07Apr2021 at 10:15, the patient experienced lump/swelling in the back of the throat, muscle pain/discomfort, and tiredness. 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 reported events. The clinical outcome of the events lump/swelling in the back of the throat, muscle pain/discomfort, and tiredness were recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Major chills; Headache; Exhausted; Fever of 102; Diarrhea; Mild body aches; Sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not provided. The patient did not have any allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  On 02Apr2021 at 23:30, the patient experienced major chills, headache, exhausted, fever of 102, diarrhea, mild body aches and sore at injection site. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 02Apr2021 at 23:30, the patient underwent lab tests and procedures which included body temperature and the result was shown as 102. The clinical outcomes of the events major chills, headache, exhausted, fever of 102, diarrhea, mild body aches and sore at injection site were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Major chills; Headache; Exhausted; Fever of 102; Diarrhea; Mild body aches; Sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not provided. The patient did not have any allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  On 02Apr2021 at 23:30, the patient experienced major chills, headache, exhausted, fever of 102, diarrhea, mild body aches and sore at injection site. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 02Apr2021 at 23:30, the patient underwent lab tests and procedures which included body temperature and the result was shown as 102. The clinical outcomes of the events major chills, headache, exhausted, fever of 102, diarrhea, mild body aches and sore at injection site were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling followed by numbing of both arms and legs (one at a time or concurrent). 4 weeks post vaccinations still having numbing tingling episodes. Nonspecific times of day - mornings, daytime, middle of the night.; Tingling followed by numbing of both arms and legs (one at a time or concurrent). 4 weeks post vaccinations still having numbing tingling episodes. Nonspecific times of day - mornings, daytime, middle of the night.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: # EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 10:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient had no known allergies to any medications, food, or other products. Concomitant medications taken within two weeks prior to the vaccination included ascorbic acid (VITAMIN C) from unknown date for unknown indication. Prior to 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. The patient experienced tingling followed by numbing of both arms and legs (one at a time or concurrent). First event took place on 11Mar2021 at 10:35, 5 minutes after vaccine administration, and continued throughout the day. It was four weeks post vaccinations and the patient was still having numbing tingling episodes. The events occurred at nonspecific times of day - mornings, daytime, middle of the night. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tingling followed by numbing of both arms and legs (one at a time or concurrent) was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Migraine, Pain, Vertigo
Clinical narrative: 22 hrs after 2nd vaccination extreme fatigue; 22 hrs after 2nd vaccination extreme fatigue, body aches.; 22 hrs after 2nd vaccination extreme fatigue, body aches, SOB; 22 hrs after 2nd vaccination extreme fatigue, body aches, SOB, vertigo; 22 hrs after 2nd vaccination extreme fatigue, body aches, SOB, vertigo and migraine. Have continued vertigo and migraine improving but have had 1-2 weekly since onset of symptoms.; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3246) via an unspecified route of administration in the left arm on 07Jan2021 at 14:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) and escitalopram oxalate (LEXAPRO) from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK5730) via an unspecified route of administration in the left arm on 17Dec2020 at 12:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 COVID-19 vaccination. On 08Jan2021 at 12:00 (22 hours after the 2nd dose), the patient experienced  extreme fatigue, body aches, shortness of breath, vertigo and migraine. The patient reported that she was continued with vertigo and migraine which improved but had 1-2 times weekly since onset of symptoms. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events extreme fatigue, body aches, shortness of breath, vertigo and migraine were  recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccine date for first dose of bnt162b2 updated as 17Dec2020 in narrative.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Under right arm swollen lymph nodes; Itching along right side of breast tonipple; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 12:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), acyclovir (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), IBPROP and cetirizine hydrochloride (CETRIZEN) from unknown date for unknown indication. The patient was allergic to peanuts, he has taken DEPAKOTE on an unknown date and experienced drug allergy. The patient previously 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 04Mar2021 at 12:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 00:00,     the patient experienced under right arm swollen lymph nodes and itching along right side of breast to nipple. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lymphadenopathy axillary and itching was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Pyrexia, Vaccination site reaction
Clinical narrative: Injection site reaction; Fogginess; High fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient did not have a history of allergies to medications, food, or other products. 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 06Apr2021 at 14:30, the patient experienced vaccination site reaction, high fever, chills, nausea and fogginess (fuzzy).  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. The clinical outcome of the event vaccination site reaction, high fever, chills, nausea, fogginess was 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: COVID-19, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; cold; little fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 27Mar2021 at 23:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 16:00 the patient experienced getting cold and little fever. Tested positive for covid 19 on 06Apr2021. Patient did not receive 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 patient questioned, whether she should take the second shot. On 06Apr2021, the patient underwent a COVID-19 test: Nasal Swab, and the result was Positive COVID-19 test. The clinical outcome of events cold, fever and tested positive for covid 19 was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nasal congestion, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 38, via an unspecified route of administration, left arm on Apr 4, 2021, at 14:15, single dose, for COVID-19 immunisation. Medical history included blood donation on Mar 31, 2021. The patient has no allergies to medications, food or other products. Concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 6, 2021, at 14:15, after 2 days, patient experienced a runny/congested nose. At 16:00, patient experienced arm pain, sore throat and weak body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The arm pain resolved after 48 hours on Apr 8, 2021. Runny/congested nose, sore throat and weak body: not resolved. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hot flush
Clinical narrative: High fever; Chills; Hot flashes; Coughing; Headaches; Tired; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jan2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN) from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date  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 17Mar2021 the patient experienced high fever, chills, hot flashes, coughing, headaches, tired and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events high fever, chills, hot flashes, coughing, headaches, tired and nausea were resolving at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: High fever; Chills; Hot flashes; Coughing; Headaches; Tired; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jan2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included esomeprazole magnesium (NEXIUM), ibuprofen (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN) from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date  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 17Mar2021 the patient experienced high fever, chills, hot flashes, coughing, headaches, tired and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events high fever, chills, hot flashes, coughing, headaches, tired and nausea were resolving at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: redness  at the spot of injection; Half golf ball sized lump at spot of injection; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on the left arm on an unknown date in Apr2021 at 09:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lisinopril dihydrate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and atenolol (MANUFACTURER UNKNOWN) from an unknown date and an unknown indication. Patient was not aware if he had any allergies to food, medications, or other products. 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 COVID vaccine. On an unknown date in Apr2021 at 09:00, the patient experienced redness at the spot of injection and half golf ball sized lump at spot of injection. 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 adverse events. The clinical outcome of the events redness at the spot of injection and half golf ball sized lump at spot of injection were unknown at the time of this report.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information includes: Event coding updated from Injection site redness to Vaccination site erythema and Injection site lump to Vaccination site lump, and adverse event start time 9:00 added in narrative
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left arm pit sever swelling in the lymph node area; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 08:15(at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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 03Apr2021 at 16:30 the patient experienced  severe swelling in the lymph node area in the left arm pit. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event and included treatment with icepacks and TYLENOL. The clinical outcome of the event severe swelling in the lymph node area in the left arm pit was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Palpitations, Taste disorder
Clinical narrative: extreme fatigue; could taste the vaccine in my mouth and felt like I wanted to throw up; Heart started to race; felt a little light headed; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8737) via an unspecified route of administration in the arm left on 01Apr2021 at 06:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, penicillin allergy and allergy to edible fungus (mold). Concomitant medications included vitamins (MANUFACTURER UNKNOWN), lorazepam (ATIVAN) .05mg, both from on an unknown date for unknown indication. 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 01Apr2021 at 06:15, the patient experienced racing heart, nausea and lightheaded. On 02Apr2021, the patient experienced extreme fatigue. As soon as she stood up from chair after injection her heart started to race (felt a little light headed). she sat in the observation area and could taste the vaccine in her mouth and felt like she wanted to throw up. The heart racing stopped after about 15 minutes but the nauseousness lasted for 4 hours. The next day all she felt was extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event of the event heart racing and lightheaded was recovered on 01Apr2021 at 6:30. The clinical outcome of the event of nausea was recovered on 01Apr2021 at 10:15. The clinical outcome of the event of Taste abnormality was recovered on unknown date of Apr2021. The clinical outcome of the event extreme fatigue was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Phone number of reporter slide#1 and patient updated 2. Protect Confidentiality checked for reporter slide#2 3. Treatment received selected to NO for event Light-headed 4. Event could taste the vaccine in my mouth and felt like I wanted to throw up coded to Taste abnormality
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Dizziness; Minor pain at the injection site; 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: UNKNOWN), via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. The patient did not have any known allergies to medications, food, or other products. 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 COVID-19 vaccination. On 07Apr2021 at 10:15, the patient experienced dizziness that started about 30 minutes after the injection and minor pain at the injection site. The patient reported that the dizziness peaked about 2 hours after the injection and had slowly diminished over the past 5 hours. At this time of this report the patient still experienced dizziness and also the minor pain at the injection site had also slowly diminished. The events did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event dizziness and injection site pain (vaccination site pain) was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Large red patches just below injection site; Injection site burning; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products.  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 05Apr2021, three days after the vaccination, the patient experienced large red patches that patient felt like they are burning just below injection site. The clinical outcome of the event large red patches below injection site and injection site burning was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dysgeusia, Pain, Pain in extremity
Clinical narrative: Metallic taste in mouth; Body aches; sore arm; weak; Low grade fever of 99.0; This is a spontaneous report from a contactable consumer, the patient. A 34-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 arm left on 06Apr2021 at 11:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included non-alcoholic fatty liver. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) both for unknown indication from unknown date. The patient had no known allergies to medications, food 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 arm left on 16Mar2021 at 11:00 (at the age of 34-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 07Apr2021 at 08:00 the patient experienced metallic taste in mouth after second shot, body aches, sore arm, weak and Low-grade fever of 99.0. The patient underwent lab test and procedures, which included body temperature on 07Apr2021 and the result was 99.0 (unspecified unit). 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 event metallic taste in mouth, body aches, sore arm, low grade fever and weak were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Metallic taste in mouth; Body aches; sore arm; weak; Low grade fever of 99.0; This is a spontaneous report from a contactable consumer, the patient. A 34-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 arm left on 06Apr2021 at 11:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included non-alcoholic fatty liver. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) both for unknown indication from unknown date. The patient had no known allergies to medications, food 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 arm left on 16Mar2021 at 11:00 (at the age of 34-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 07Apr2021 at 08:00 the patient experienced metallic taste in mouth after second shot, body aches, sore arm, weak and Low-grade fever of 99.0. The patient underwent lab test and procedures, which included body temperature on 07Apr2021 and the result was 99.0 (unspecified unit). 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 event metallic taste in mouth, body aches, sore arm, low grade fever and weak were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Rash
Clinical narrative: Rash on both forearms; Muscle pains; Tiredness; Weakness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er2613) via an unspecified route of administration in the arm left on 02Apr2021 at 13:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, arthritis and heart murmur. The patient was allergic to penicillin, sulfa and tramadol (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included nifedipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), oxybutynin hydrochloride (OXYBUTIN) and naproxen (MANUFACTURER UNKNOWN) 500 m started on an unknown date for unknown indication. On 03Apr2021 at 12:00, the patient experienced rash on both forearms, muscle pains, tiredness, weakness and headache. 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. The clinical outcome of the events rash on both forearms, muscle pains, tiredness, weakness and headache were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.