chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Soreness and stiffness at the shotlocation.; Soreness and stiffness at the shotlocation.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 15Mar2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication was reported as pantoprazole 20mg (MANUFACTURER UNKNOWN) for unknown indication received within 2 weeks of vaccination. The patient had a history of allergy to sulfa. 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 other vaccines within 4 weeks prior to the vaccine. On 15Mar2021 at 20:00, the patient experienced soreness and stiffness at the shot location. Therapeutic measures were not taken 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 soreness and stiffness at the shot location was resolved on unspecified date in Mar2021.  Information on lot/batch number has been requested. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: sore arm; headache; Fatigue; feeling drugged; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via unspecified route of administration in the left arm on 22Mar2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included mild osteoporosis and herpes. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced fatigue and feeling drugged on 22Mar2021 at 19:00. The patient experienced sore arm and headache on 23Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events fatigue, feeling drugged, sore arm and headache was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Dizziness, Dysgeusia, Parosmia, Vaccination site pain
Clinical narrative: Dizziness; Metallic taste; Metallic smell in mouth and nose; Eyes feels warm; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration on left arm, on 23Mar2021 at 09:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On an unknown date, the patient had experienced dizziness, weird metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain. No therapeutic measures were taken as a result of adverse events. 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 events dizziness, metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore shoulder at site of injection; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 17:30, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced sore shoulder at site of injection. The patient did not receive any treatment for the adverse event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for events. The clinical outcome of sore shoulder at site of injection was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Inappropriate schedule of vaccine administered; tinnitus in both ears; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via unspecified route of administration on 23Mar2021 (at the age of 49 years old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: EL9265) via an unspecified route of administration in right arm on 02Feb2021 at 12:00 (at the age of 49 years old), as a single dose for COVID-19 immunisation. The medical history of the patient included hypertension. The patient had not received any medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had no known allergies to medications, food or other products. The patient had not tested for COVID-19, since the vaccination. On 14Mar2021 at 12:00, the patient experienced tinnitus in both ears. The vaccine was administered outside the range of 19-42 days after the first dose.  No therapeutic measures were taken as result of 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 tinnitus in both ears was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Headache; Chills; Fatigue; Swollen lymph nodes in rightunderarm; This is a spontaneous report from a non-contactable other healthcare professional (the patient). A 32-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on right arm on 21Mar2021 at 18:15 (at the age of 32-year-old) as single dose for COVID-19 immunisation. The medical history of the patient was not reported. Concomitant medication included unspecified birth control. The patient had no known allergies. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. The patient had tested positive prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced fever, headache, chills, fatigue and swollen lymph nodes in right underarm. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome for the events of fever, headache, chills, fatigue and swollen lymph nodes in right underarm was recovering at the time of this report   Information about lot number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Odynophagia, Vital signs measurement
Clinical narrative: pain to throat when swallowing; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via intramuscular route of administration in left arm on 22Feb2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via intramuscular route of administration in right arm on 01Feb2021 (at the age of 33-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. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 22Feb2021 at 9:56, after receiving the vaccination patient complained of pain to throat while swallowing. The pain could not be resolved with water. It was reported that the vital signs stable with no swelling or erythema, uvula midline. At 10:31, dexamethasone 4 mg was taken by mouth. The adverse events not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of event pain to throat while swallowing was resolved on 22Feb2021 at 11:05. (As reported at 11:05, the patient verbalized symptom improvement). No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on unknown date in 2021 (at the age of 46-years-old), as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ev6204), via an unspecified route of administration on unknown date in 2021 (at the age of 46-years-old), as single dose for COVID-19 immunisation. Medical history included Graves disease and penicillin allergy. The patient previously took clindamycin and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced, fever, chills, body ache and lethargic Therapeutic measure and treatments were not taken in response to the events. 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 events fever, chills, body ache and lethargic was resolved on an unspecified date in Mar2021 at the time of this report.   No follow-up attempts are possible; Information about the lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Diarrhoea, Fatigue, Headache
Clinical narrative: Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehydrated; sensitive skin; This is a spontaneous report received from a contactable consumer. A 32-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 9:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and ADHD (attention deficit hyperactivity disorder). The patient was allergic to penicillin. Concomitant medications included amfetamine aspartate, amphetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and salbutamol (ALBUTEROL) for unknown indications. The patient did not receive any vaccination 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 18Mar2021, the patient experienced headache, myalgia, muscle spasm, fatigue, low grade fever (102 maximum) (unspecified unit), diarrhea, dehydration and sensitive skin. No treatment was received for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the events headache, myalgia, muscle spasm, fatigue, low grade fever, diarrhea, dehydration and sensitive skin was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pyrexia, Sensitive skin
Clinical narrative: Bad headache; Bad muscle pain; Cramps; Fatigue; Low grade fever (~102 max); Diarrhoea; Feeling dehydrated; sensitive skin; This is a spontaneous report received from a contactable consumer. A 32-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 9:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and ADHD (attention deficit hyperactivity disorder). The patient was allergic to penicillin. Concomitant medications included amfetamine aspartate, amphetamine aspartate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and salbutamol (ALBUTEROL) for unknown indications. The patient did not receive any vaccination 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 18Mar2021, the patient experienced headache, myalgia, muscle spasm, fatigue, low grade fever (102 maximum) (unspecified unit), diarrhea, dehydration and sensitive skin. No treatment was received for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the events headache, myalgia, muscle spasm, fatigue, low grade fever, diarrhea, dehydration and sensitive skin was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Arm site pain; Headache; chills; muscle aches; tired; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old female patient received second of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 22Mar2021 at 11:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and hypothyroidism. The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 01Mar2021 at 11:00 as a single dose for COVID-19 immunisation. Concomitant medications received within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and acetaminophen (TYLENOL) for unknown indications from unknown dates. On 22Mar2021 at 16:00, the patient experienced arm site pain, headache, chills, muscle aches and tired. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events arm site pain, headache, chills, muscle aches and tiredness were resolving at the time of this report. No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling face; Face numbness; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 23Mar2021 at 15:00(at the age of 35-years-old) as a single dose for Covid-19 immunisation. The patient had no medical history. Concomitant medication included ibuprofen (ADVIL) for unknown indication from unknown date .The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 23Mar2021, after 30 minutes of receiving the vaccine, the left side of patients face began tingling, then went numb for approximately 45 minutes. 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 event. The clinical outcome of the tingling of face and face numbness was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site irritation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: vaccination site warmth; vaccination site irritation; injection site redness; vaccination site tenderness; vaccination site swelling; This is a spontaneous report received from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on 20Mar2021 (at the age of 34-years-old) in right arm for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via unspecified route of administration on 27Feb2021 in right arm for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks of COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 20March2021 (day 1), the patient experienced some tenderness (vaccination site tenderness) and a small swelling, a bump of approximately the size of a quarter at the site injection (vaccination site swelling). There was no irritation or redness. On 21Mar2021 (day 2), the bump had softened and tenderness was replaced with slight irritation and redness of approximately 1.5 inches in diameter at the site of injection. On 22Mar2021 (day 3), the redness had grown to 3 inches in diameter with added irritation and noticeably warm to the touch (vaccination site warmth). 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 vaccination site tenderness, vaccination site swelling, vaccination site irritation, injection site redness and vaccination site warmth was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Tired; This is a spontaneous report from a contactable consumer, the patient. A 39 -year-old male 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 09:00 AM (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. 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 has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not receive any other medications/vaccines within two weeks prior to the vaccination. On 21Mar2021 (first day), the patient was tired. On 23Mar2021 (three days after injection) at 03:30 AM, the patient experienced chills. The patient did not receive any treatment for the reported events. Adverse event 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 tired and chills was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: Tingling lips; a throat reaction that feeling where you think you have to cough something out; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on an 16Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was mentioned as in the last two years the patient had a reaction to almonds and mango both in a moment when she was stressed where she had a throat reaction which was worse and wound up taking Benadryl. An allergist told to the patient that she had a slight allergy to peanuts. The patient did not have any other serious history of food allergies. Concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, about 30 minutes after vaccination, the patient experienced tingling lips which lasted for several hours but there was no swelling and it didnt get worse. The patient also experienced throat reaction three hours after the vaccine, when patient was eating some peanuts. The patient had throat reaction with feeling where she thought she had to cough something out but it didnt get to the point where she needed to take Benadryl. The patient reported that she might be eating them too fast hence experienced throat reaction. No treatment was received for the reported events. The clinical outcome of tingling lips and throat reaction was unknown at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; injection site pain.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8728) via an unspecified route of administration in the right arm on 22Mar2021 at 10:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included unspecified cholesterol medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Mar2021 at 13:00 (three hours after injection), the patient experienced injection site pain. It was reported that, the pain was uncomfortable but was not limiting use. The patient was able to sleep on the site at night. On 22Mar2021 at 20:15 (10 Hours after the injection), the patient had mild headache. Headache and arm pain were ameliorated by ibuprofen one dose before sleeping and another dose five hours later in the middle of the night. 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 injection site pain and headache were resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at site of injection; This is a spontaneous report received 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: Unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications were none. The patient was not allergic to food, medications and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021 at 5:00, the patient experienced soreness at the site of injection. 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 patient did not receive any treatment for the reported events. The clinical outcome of the soreness at the site of injection was resolved on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration, in left arm on 20Mar2021 at 11:15 AM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was reposted as none. Concomitant medication was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. 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 vaccine. On 22Mar2021 at 13:00, the patient experienced fatigue and headache. The patient did not receive any treatment for the events. 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 for events fatigue and headache were resolved on an unknown date.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; low-grade fever experienced approximately 16 hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 16Mar2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included seizures which was controlled with medicine and the patient also reported that there were no seizures in over 8 years. Concomitant medications included carbamazepine (TEGRETOL) 20mg once daily for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The Patient was not diagnosed with COVID-19 prior to the vaccination. The Patient had not been tested for COVID-19 since the vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 at 01:00, the patient experienced chills and low-grade fever, approximately 16 hours after injection. The patient did not receive treatment for the reported events. Adverse event 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 chills and low-grade fever was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: 4 canker sores at the side of tongue; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 12Mar2021 at 14:00, as a single dose for COVID-19 immunisation. Medical history included CV disease, high blood pressure and cancer. The patient had known allergies to sulfa, tetanus, pneumovac and strawberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccine, patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. On 14Mar2021 at 13:00, the patient experienced four canker sores at the side of the tongue, not large. Uncomfortable but not out of control. It disappeared in about a week; had appeared day and half after vaccination. The patient did not receive any treatment for the adverse event. The clinical outcome of the event was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site anaesthesia
Clinical narrative: felt weird and very odd. It fell like something rolled out.; got the 2nd dose of the vaccine yesterday and the needle did not hurt but they put the needle in and something in her arm rolled; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received second dose  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6204, Expiry date not reported) via an unspecified route of administration(Age at vaccination was 64-years) in Arm Left on 25Mar2021 10:20 as DOSE 2, single for covid-19 immunisation patient didn't receive other vaccinations with in 4weeks prior to vaccinations. Historical vaccination was reported as first dose (BNT162B2, Solution for injection, Batch/Lot Number: lot EN6203, Expiry date not reported) via an unspecified route of administration, in Arm Left on 04 Mar2021 10:20 asDOSE1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported No relevant tests were reported. On 25Mar2021 the patient experienced felt weird and very odd. it fell like something rolled out, got the 2nd dose of the vaccine and the needle did not hurt but they put the needle in and something in her arm rolled patient stated to make sure the second dose of vaccination went into her arm. The patient received both doses of the Pfizer vaccine. The first was fine. The second dose felt weird and very odd. It fell like something rolled out and inquired how can she verify if it is in her and what if the vaccine did not get into the muscle.she had no symptoms afterwards and did not have a sore arm and had nothing. Caller states is the vaccine going to be in her system because it felt so weird; states after the first dose she felt fine but with the second dose she felt weird and the needle didn't hurt.Caller states she could feel the first dose and could feel a muscle ache and did not that with the second dose of the vaccine and asked did it go in there or is lost somewhere in translation or if the needle went in did she get the dose. Caller states her age at the time of the muscle soreness after the 1st dose of the vaccine was age 64 and it was three weeks ago. States she had muscle soreness the same day that she got the 1st dose of the vaccine but the muscle soreness was gone by the next day and she did not require treatment.Caller states she was on other medications but they are not to do with this and declined to provide her medications.states she wants to make sure the 2nd dose of the Pfizer Vaccine went into her arm.Caller states she wants a side effect with the second dose of the Pfizer Vaccine; states she did not get any side effects with the second dose and after the first dose she was fine. The patient didn't visited the emergency room or physician office. No investigation was done. The outcome of the events feeling abnormal and vaccination site anaesthesia was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dizziness postural, Hypertension, Paraesthesia
Clinical narrative: Dizziness upon standing; tightness to throat with swallowing; dizziness; tingling to chest and neck; mild itching; BP 148/96; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via intramuscular route of administration in the left arm on 27Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 at 10:15, the patient complained of tingling to chest and neck, mild itching, tightness to throat with swallowing and sips of water, and dizziness. The BP was 148/96. The patient was given dexamethasone 4mg (MANUFACTURER UNKNOWN) by mouth at 10:21. The patient reported dizziness upon standing at 10:24. At 10:53, the patient was ambulating in hallway with no dizziness and left symptom free. 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 clinical outcomes of the events tingling of chest and neck, mild itching, tightness to throat with swallowing, dizziness, BP 148/96 and dizziness upon standing were recovered on 27Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: Dizziness upon standing; tightness to throat with swallowing; dizziness; tingling to chest and neck; mild itching; BP 148/96; This is a spontaneous report from a contactable Pharmacist. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via intramuscular route of administration in the left arm on 27Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 at 10:15, the patient complained of tingling to chest and neck, mild itching, tightness to throat with swallowing and sips of water, and dizziness. The BP was 148/96. The patient was given dexamethasone 4mg (MANUFACTURER UNKNOWN) by mouth at 10:21. The patient reported dizziness upon standing at 10:24. At 10:53, the patient was ambulating in hallway with no dizziness and left symptom free. 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 clinical outcomes of the events tingling of chest and neck, mild itching, tightness to throat with swallowing, dizziness, BP 148/96 and dizziness upon standing were recovered on 27Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore left arm; fatigue; mild headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6755) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to inderal (MANUFACTURER UNKNOWN), amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN) and moxifloxacin (AVELOX). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 10:30, as a single dose for COVID-19 immunisation. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), liraglutide (SAXENDA) and methylphenidate (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown date. The patient also received eletriptan (MANUFACTURER UNKNOWN) for headache from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 13:00, the patient experienced sore left arm, fatigue and mild headache. It was reported that headache was not likely caused by the vaccine. The patient had long history of headache and recently had headache a week prior to vaccination and took eletriptan. 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 events pain in arm, fatigue and mild headache was recovered on an unknown date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: then 3days after he was tested positive for Covid 19; This is a spontaneous report from contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A male patient of an unspecified age received bnt162b2 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 06Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Mar2021 patient had COVID-19. The patient had his 1st dose on 06Mar2021 then 3days after he was tested positive for Covid-19 and then wanted to reschedule his 2nd dose that was supposedly on the 27Mar2021 because he just got out of the hospital now and they would not let him get the 2nd dose on that day. The patient underwent lab tests and procedures which included tested for COVID-19: positive on 09Mar2021. There were no unaddressed medical questions referred or forwarded to Medical Information. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Oxygen saturation low; Night sweats; Diarrhea; Nausea; wheeze at the end of her exhale; severe headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 13:40 as 2nd dose, single for covid-19 immunization. Medical history included lipoedema (Adipose fat disorder) from 2017. The patient's concomitant medications was not reported. Historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in upper left shoulder on 13Feb2021 as 1ST DOSE, SINGLE, vaccinated at the age of 55 years for covid-19 immunization. She called about the covid vaccine and reported that she had no luck and had been sick for 10 days with sort of vaccine side effects and covid symptoms. All of the symptoms started 2 weeks after the second dose. On 14Mar2021, She had severe headache which was relieved by migraine medication, the headache came back when the medication wears off. On same day, she had chills. The chills have gone away. She also had a wheeze at the end of her exhale that she noticed really at night, she heard her breathing but did not know how to explain it. On 15Mar2021, she had nausea. Nausea improved when the headache went away. On 17Mar2021, She had diarrhea. The diarrhea went back and forth. 5 days ago on 18Mar2021, she started having night sweats but they happened early in the morning she wakes up in a puddle of sweat. On 19Mar2021, her oxygen saturation was low. It was reported that she had virtual doctors appointment. The patient's oxygen saturation was low on 17Mar2021 which was 90% lowest, 95% highest, she had been checking it at home with her pulse ox. On same day, she underwent sars-cov-2 antibody test which was negative. The outcome of severe headache, fatigue, Night sweats, Nausea, Diarrhea and Diarrhea was not recovered. Severe headache was reported as worsened. The outcome of Chills and Oxygen saturation low was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 antibody test, Wheezing
Clinical narrative: Oxygen saturation low; Night sweats; Diarrhea; Nausea; wheeze at the end of her exhale; severe headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 13:40 as 2nd dose, single for covid-19 immunization. Medical history included lipoedema (Adipose fat disorder) from 2017. The patient's concomitant medications was not reported. Historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in upper left shoulder on 13Feb2021 as 1ST DOSE, SINGLE, vaccinated at the age of 55 years for covid-19 immunization. She called about the covid vaccine and reported that she had no luck and had been sick for 10 days with sort of vaccine side effects and covid symptoms. All of the symptoms started 2 weeks after the second dose. On 14Mar2021, She had severe headache which was relieved by migraine medication, the headache came back when the medication wears off. On same day, she had chills. The chills have gone away. She also had a wheeze at the end of her exhale that she noticed really at night, she heard her breathing but did not know how to explain it. On 15Mar2021, she had nausea. Nausea improved when the headache went away. On 17Mar2021, She had diarrhea. The diarrhea went back and forth. 5 days ago on 18Mar2021, she started having night sweats but they happened early in the morning she wakes up in a puddle of sweat. On 19Mar2021, her oxygen saturation was low. It was reported that she had virtual doctors appointment. The patient's oxygen saturation was low on 17Mar2021 which was 90% lowest, 95% highest, she had been checking it at home with her pulse ox. On same day, she underwent sars-cov-2 antibody test which was negative. The outcome of severe headache, fatigue, Night sweats, Nausea, Diarrhea and Diarrhea was not recovered. Severe headache was reported as worsened. The outcome of Chills and Oxygen saturation low was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Antibody test, COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; Caller would like to can her son still have no smell before receiving the second dose; This is a spontaneous report received from contactable consumer (patient's mother) via a Pfizer-sponsored program . A 18-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 (at the age of 18-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that the patient tested positive for COVID-19 after going to college on 04Sep2020 and the patient tested negative for antibodies on 12Nov2020. After receiving first dose, patient tested positive for COVID-19 on 25Mar2021, and patient still have no smell before receiving the second dose. Reporter stated that she would like to know if the patient should stick to the 3-weeks schedule, second dose was scheduled on 07Apr2021. Reporter wanted to know that if the vaccine will give with COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got Covid virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 12Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient got the first dose of the Pfizer Covid vaccine on 12Jan2021 then got Covid virus on 20Jan2021. Patient never got the 2nd dose of the vaccine. Patient was inquired about the protocol for me getting the 2nd dose. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.