chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: liquid leakage; there is a little blood coming out on the injection part; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced liquid leakage, there is a little blood coming out on the injection part on 22Mar2021. Patient got her first dose (22Mar2021) and apparently while she in the process of the injection of the first dose there is a liquid leakage of the vaccine while she is taking it. Patient noticed there is a little blood coming out on the injection part and the liquid leakage is like 5 inches long on her arm and the administrator/nurse wiped it out. And also, her concern was if she will be going to take another shot of covid vaccine since there is a liquid leakage happened. This question referred or forwarded to Medical Information. Outcome of the events was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site muscle weakness, Mobility decreased, Myalgia
Clinical narrative: Muscle pain; Weakness at injection site; Limited mobility of arm/shoulder; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613 NNS Quadmed) via an unspecified route of administration in the right arm on 24Mar2021 at 10:00 (at the age of 35-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. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 20:00, the patient experienced muscle pain, weakness at injection site and limited mobility of arm/shoulder. 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 outcomes of the events muscle pain, weakness at injection site and limited mobility of arm/shoulder were not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; Body ache; headaches; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for Covid-19 immunisation. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since having the vaccine. It was reported that the patient was on medication for blood pressure and thyroid. On 22Mar2021, the patient experienced arm pain, it was reported that the pain was really sore at upper arm and underneath arm. After 3 days, on 25Mar202, the patient woke up with whole body aching, headache and swollen arm. It was reported that the patient was taking TYLENOL since getting the shot. The clinical outcome of the events arm pain, headache, body ache and swollen arm were unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; exhaustion; fever related symptoms without a known fever; This is a spontaneous report from a consumer, the patient. A 55-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 (at the age of 55-years-old) as a single dose for COVID- 19 immunisation. Medical history and allergic history were reported as no. 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-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 24Mar2021, the patient experienced body aches, exhaustion and fever related symptoms (without a known fever). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events. The clinical outcome of the events body ache, exhaustion and fever were recovering 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: Body temperature, Pyrexia
Clinical narrative: Mild fever (99.5+) for few hours; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 32-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. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 21:00, the patient experienced mild fever (99.5+) for a few hours in the evening after the second dose. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event mild fever (99.5+) for a few hours. The clinical outcome of the event mild fever (99.5+) for a few hours was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; Injection site soreness; Tiredness; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 33-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. 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 24Mar2021 at 15:15, the patient experienced headache, tiredness and injection site soreness. The adverse events did not result in a visit to the 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 headache, tiredness and injection site soreness. The clinical outcomes of the events headache, tiredness and injection site soreness were recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal discomfort, Poor quality sleep
Clinical narrative: Restless sleep; kept waking up thinking something was in throat; Mild headache; Exhaustion as a result; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac. The patient was allergic to gluten. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL) for unknown indication and from unspecified date. On 25Mar2021 at 12:00 the patient experienced restless sleep, kept woke up thinking something was in her throat, exhaustion as a result and mild headache. The patient received TYLENOL as treatment for the event mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleep restless, throat discomfort, exhaustion and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination site pain
Clinical narrative: Felt like punched in arm; Some soreness and some stiffness at the injection site; stiffness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-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 24Mar2021 at 16:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included mild obstructive sleep apnea. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) 40 mg and omeprazole (MANUFACTURER UNKNOWN) 20 mg daily; both for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 19:00, the patient experienced like punched in arm, some soreness and some stiffness at injection site. The patient used an ice pack and once taken 800 mg ibuprofen helped reduce this no worse than mild pain or soreness. Moving left arm overhead with a back-and-forth motion also provided relief. 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 felt like punched in arm, sore injection site and injection site stiffness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Sunburn
Clinical narrative: Inappropriate schedule of vaccine administered; Half of my stomach looked like it was sun burned. The area was red from under my right breast downto the bikini line with belly button being the dividing line; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food or other products. 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 concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 20:00, the patient had inappropriate schedule of vaccine administration. Approximately 8 hours post second dose, the patient was changing for bed and noticed that half of her stomach looked like it was sun burned, the area was red from under her right breast down to the bikini line with belly button being the dividing line. It was not hot to touch nor was it a rash. The patient would not have noticed it because it did not bother her except when she went to change her clothing it was visible. On 21Mar2021 (next morning), it was gone. The patient did not receive any treatment for the events half of my stomach looked like it was sun burned and the area was red from under my right breast down to the bikini line with belly button being the dividing line. The clinical outcomes of the events half of my stomach looked like it was sun burned and the area was red from under my right breast down to the bikini line with belly button being the dividing line were recovered on 21Mar2021 while that of inappropriate schedule of vaccine administered was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: a fever of 101 degrees F; body aches; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient was allergic to sulfonamide. The patient did not receive any other medications within two weeks of COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration in the left arm on 03Mar2021 at 09:00 (at the age of 35-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 was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 19:00, after 10 hours of injection the patient had a fever of 101 degrees F with full body aches and chills which lasted 30 hours. Everything had passed after that and had no effects anymore and felt fine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, body aches and chills were recovered on 24Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Cough; Fever; Muscle pain all over thebody; Headache; Fatigue; Muscle pain at the injection site; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6951), via an unspecified route of administration in the left arm on 22Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have 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 was receiving unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 18:00 (reported as first day), the patient experienced muscle pain at the injection site. On 23Mar2021 (reported as second day), the patient experienced fatigue and muscle pain at the injection site. On 24Mar2021 (reported as third day), the patient experienced fever, muscle pain at the injection site, muscle pain all over the body, headache, cough and fatigue. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue. The clinical outcomes of the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cough; Fever; Muscle pain all over thebody; Headache; Fatigue; Muscle pain at the injection site; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6951), via an unspecified route of administration in the left arm on 22Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have 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 was receiving unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 18:00 (reported as first day), the patient experienced muscle pain at the injection site. On 23Mar2021 (reported as second day), the patient experienced fatigue and muscle pain at the injection site. On 24Mar2021 (reported as third day), the patient experienced fever, muscle pain at the injection site, muscle pain all over the body, headache, cough and fatigue. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue. The clinical outcomes of the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lethargy, Muscular weakness
Clinical narrative: Weakness of muscles; body aches; lethargy; headache; shivers; joint pain; muscular pain; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3247) via an unspecified route of administration in left arm on 23Mar2021 at 09:30 (at the age of 25-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin since unknown date. The patient not had COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluticasone propionate (FLONASE) started from unknown date for unknown indication. Since the vaccination, the patient had not tested for COVID-19. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on an unknown date (also reported as 23Mar2021 at 09:00) as single dose for COVID-19 immunisation. On 23Mar2021 at 22:30, the patient experienced weakness of muscles, muscular pain, joint pain, body aches, headache, lethargy, shivers. The peak of these symptoms took place 14 hours after he got the shot. It persisted for 24 hours. 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 received treatment for the events. The clinical outcome of the events weakness of muscles, muscular pain, joint pain, body aches, headache, lethargy, shivers were resolved on 24Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Weakness of muscles; body aches; lethargy; headache; shivers; joint pain; muscular pain; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3247) via an unspecified route of administration in left arm on 23Mar2021 at 09:30 (at the age of 25-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin since unknown date. The patient not had COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluticasone propionate (FLONASE) started from unknown date for unknown indication. Since the vaccination, the patient had not tested for COVID-19. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on an unknown date (also reported as 23Mar2021 at 09:00) as single dose for COVID-19 immunisation. On 23Mar2021 at 22:30, the patient experienced weakness of muscles, muscular pain, joint pain, body aches, headache, lethargy, shivers. The peak of these symptoms took place 14 hours after he got the shot. It persisted for 24 hours. 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 received treatment for the events. The clinical outcome of the events weakness of muscles, muscular pain, joint pain, body aches, headache, lethargy, shivers were resolved on 24Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Nausea
Clinical narrative: Exhausted; Coughing; Feeling nauseous; Lightheaded; Chills; This is a spontaneous report from a contactable consumer, the patient. A 34- year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 12:30 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and sjogrens. 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. Concomitant medications received within two weeks of vaccination included certolizumab pegol CIMZIA (200mg), prednisone (MANUFACTURER UNKNOWN) (5mg) and hydroxychloroquine (MANUFACTURER UNKNOWN); all from unknown dates and for unspecified indications. On 18Mar2021 at 03:00, the patient experienced exhausted, coughing, feeling nauseous, lightheaded and congested for one week since receiving the shot. She had chills the first couple of nights. 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 events exhausted, coughing, feeling nauseous, lightheaded, congested and chills were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: High fever and chills 10 hours after 2nd dose; High fever and chills 10 hours after 2nd dose; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EK5730) via an unspecified route of administration in the left arm on 22Mar2021 at 17:45 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patients medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient did not take any concomitant medications. The patient had received unspecified other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 23Mar2021 at 09:30, the patient experienced high fever and chills 10 hours after second dose. 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 fever and chills. The clinical outcome of the event fever and chills were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non pregnant female patient received an unknown dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: UNKNOWN) via unspecified route of administration, in left arm on 24Mar2021 at 12:00 PM (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of allergy to sulfonamides. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Mar2021 at 20:00, 8 hours after vaccination, the patient experienced fever. On 25Mar2021 08:00 AM, 20 hours after vaccination, the patient experienced nausea, at 14:00, the patient experienced vaccination site pain. Therapeutic measures were taken as a result of the event which included treatment with Tylenol. The clinical outcome of the events fever, vaccination site pain, and nausea were resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Body ache; cough; Dizziness; Shortness of breath; Chills; congestion; Extreme exhaustion; Diarrhea; Headache; Pain at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 14Mar2021 at 14:15 (at the age of 54-year-old), as single dose for COVID-19 immunisation. The patient medical history included hypothyroidism, high cholesterol and bad cough. The patient had no known allergies. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), rosuvastatin (MANUFACTURER UNKNOWN), bupropion hydrochloride (BUPRION) and multivitamin (MANUFACTURER UNKNOWN) all 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. On 16Mar2021, the patient experienced vaccination site pain, headache, extreme exhaustion, body aches, diarrhea, chills, dizziness and shortness of breath. The patient reported allergies kicked in during that time as well with congestion and cough. It was reported that patient generally do not experience those symptoms with allergies. Therapeutic measures were taken as a result of flonase and benzonatate. The events did resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, headache, exhaustion, body aches, diarrhea, chills, dizziness, shortness of breath, nasal congestion and cough was recovering at the time of report.    No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pain, Vaccination site pain
Clinical narrative: Body ache; cough; Dizziness; Shortness of breath; Chills; congestion; Extreme exhaustion; Diarrhea; Headache; Pain at injection site; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 14Mar2021 at 14:15 (at the age of 54-year-old), as single dose for COVID-19 immunisation. The patient medical history included hypothyroidism, high cholesterol and bad cough. The patient had no known allergies. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), rosuvastatin (MANUFACTURER UNKNOWN), bupropion hydrochloride (BUPRION) and multivitamin (MANUFACTURER UNKNOWN) all 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. On 16Mar2021, the patient experienced vaccination site pain, headache, extreme exhaustion, body aches, diarrhea, chills, dizziness and shortness of breath. The patient reported allergies kicked in during that time as well with congestion and cough. It was reported that patient generally do not experience those symptoms with allergies. Therapeutic measures were taken as a result of flonase and benzonatate. The events did resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, headache, exhaustion, body aches, diarrhea, chills, dizziness, shortness of breath, nasal congestion and cough was recovering at the time of report.    No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; tired/extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 59-years-old) at 14:15 as a single dose for COVID-19 immunisation. Medical history included masto cytosis. The patient received medications (unspecified) within 2 weeks of vaccination. The patient had a history of allergy to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 21Mar2021 at 09:00, after receiving the first vaccine shot, the patient had suffered from a headache and was tired for 48 hours. It was reported that she had to miss her work on Monday, following her first vaccine shot due to continuing headache and extreme fatigue. Therapeutic measures were not taken as a result of adverse events. 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 headache, tired/extreme fatigue was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever of 102.4; chills; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 73-years-old) at 11:30 as a single dose for COVID-19 immunisation. The patient did not have any medical history. The did not have a history of allergy to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 02Mar2021 at 02:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab on 15Mar2021 and the result found to be negative. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 24Mar2021 at 03:00, the patient had experienced fever of 102.4 (unspecified units) and chills. The clinical outcome of the events fever of 102.4 and chills was resolved on unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain under left arm on side of breast; This is a spontaneous report from a contactable consumer, the patient. A 65-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 11Mar2021 at 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patients had no medical history reported. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included atorvastatin 20 mg per day received within 2 weeks of vaccination for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 00:00, the patient experienced pain under the left arm on the side of the breast. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive treatment for the event. The clinical outcome of the event pain under the left arm was recovered on an unknown day in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site warm to touch; Injection site itching; Injection site red; Injection site became raised; This is a spontaneous report from a contactable consumer, the patient. A 33-Year-old non-pregnant female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 22Mar2021 at 11:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lavandula angustifolia essential oil, mentha x piperita essential oil, citrus limon essential oil (DOTERRA TRIEASE) from unknown date for unspecified indication. The patient previously took nickel and experienced metal allergy and took kiwi and experienced fruit allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the Patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site raised on 23Mar2021 at 07:00 and  injection site red on 24Mar2021 (day 2) and  injection site warm to touch and itching on 25Mar2021 (day three). 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 treatment for reported events. The clinical outcome of the injection site raised, injection site red, injection site warm and injection site itching was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; shivering and chills; fever; body aches; headache (back of head,twd stem, then forehead. started 11hrs after the shot.; This is a spontaneous report from a non-contactable consumer. A 39-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ep6955), via unspecified route of administration on 24Mar2021 at 11:00 (at the age of 39-years-old), as a single dose for Covid-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: unknown), via an unspecified route of administration on 03Mar2021 at 16:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 22:00, 11 hours after the vaccination, the patient experienced sore arm, shivering and chills, fever, body aches, headache (back of head, toward stem, then forehead). The patient did not receive any treatment for the events sore arm, shivering and chills, fever, body aches, headache. The clinical outcome of the events sore arm, shivering and chills, fever, body aches, headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site; Fatigue; Joint pain; Low-grade fever; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 22Mar2021 at 11:15, as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, GERD, peripheral neuropathy and allergy to shellfish. Unspecified concomitant medications were taken by the patient. 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 01Mar2021 at 11:15, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced pain at injection site, fatigue, joint pain, and low-grade fever. 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 treatment for the reported events. The clinical outcomes of the events pain at injection site, fatigue, joint pain, and low-grade fever were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: nausea; stomach cramping; chills; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on an unspecified date in Mar2021 at 12:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to shellfish. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Mar2021 at 05:45 the patient experienced nausea with terrible stomach cramping for 5 hours, chills and slight fever. The patient did not receive any treatment for the adverse events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of nausea, stomach cramping, chills and slight fever was not resolved on an unspecified date in Mar2021.   Information about Lot number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache; Body ache; Fever/chills; Fatigue; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no. EP6955) via an unspecified route of administration in left arm, on 23Mar2021 at 13:45 hours (at the age of 65-years), as a single dose for COVID-19 immunisation. The patients medical history included high blood pressure and  paroxysmal atrial fibrillation (parox afib). The patient had no allergies to food, medications or other products. The Concomitant medication included chlorthalidone (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) 81 milligram (mg). 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 no. EN6198) via an unspecified route of administration in left arm, on 02Mar2021 at 09:30 hours, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 24Mar2021 at 02:30 hours, the patient experienced headache, body ache, fever chills, fatigue and stomach upset. 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 headache, body ache, fever chills, fatigue and stomach upset were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Hepatitis B core antibody, Hepatitis B surface antigen, Vaccination site discomfort, Viral load
Clinical narrative: strong metallic taste; injection site discomfort; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8727), via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included hepatitis B with surface antigen positive, no core antibody and no detectable viral load for a period of years. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks, prior to the COVID-19 vaccine. The patient did not have a history of allergy to medications, food and 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. On 22Mar2021 at 15:45, the patient had experienced injection site (vaccination site) discomfort and strong metallic taste which went away after 20 mins of vaccination but seemed to return the next day. The patient had no fatigue and no other symptoms. The patient had reported the event because metallic taste seemed to be somewhat rare. The patient had no other concerns and did not need to be contacted. The patient did not receive any treatment for the reported events. 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 strong metallic taste and injection site discomfort was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pruritus
Clinical narrative: Initial itchiness upon injection of vaccine; Chills within an hour of receiving the vaccine; Swelling of lymph nodes noticed one week after injection; This is a spontaneous report received from a non-contactable health care professional, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Ep7534), via unspecified route of administration on 17Mar2021 at 13:00 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. The patient medical history included depression, seasonal allergies, obesity, asthma. The patient was allergic to bananas and latex. The patient past drug history was not reported. The concomitant medication included Fluoxetine (PROZAC), FLONASE (fluticasone propionate and birth control (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not have any symptoms associated with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 13:00, the patient experienced itchiness. The patient experienced chills within an hour of receiving the vaccine. On an unknown date in Mar2021, the patient experienced swelling of lymph nodes which was noticed one week after injection. Treatment received for the adverse events was reported as no. 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. The clinical outcome of the event itchiness, chills and swelling of lymph node were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.