chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: High fever of 103 F/ temperature increased; Chills; Terrible head ache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6207) via an unspecified route of administration in the left arm as a single dose for COVID-19 Immunisation on 17Mar2021 at 09:00 (at the age of 70-year-old). Medical history and concomitant medications were not reported. The patient was not allergic to any medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, 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 17Mar2021 at 11:30, the patient experienced fever of 103 F/ increased temperature, chills, terrible head ache and body ache. Around midnight temperature increased and by the morning she ran high fever of 103 F and also had chills, terrible head ache, body ache, for 2 days. The patient did not take any treatment for the reported events. The clinical outcome of the fever of 103 F/ increased temperature, chills, terrible head ache and body ache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: bad headache; whole body muscle ache,; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration on 18Mar2021 (at the age of 45-year-old) for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested positive for COVID-19. Concomitant medications were not reported. On 18Mar2021 at 22:00, she had experienced bad headache and whole body muscle ache which was getting worse overnight. The patient took Tylenol for the reported adverse events as a part of therapeutic measures. The clinical outcome of the events bad headache and whole body muscle ache was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: left sided facial numbness; decreased movement of the facial muscles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 15Mar2021 at 10:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and diabetes. The patient had no known drug allergies. Concomitant medications of included amlodipine (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN), OZEMPIC and lisinopril (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date. 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 vaccination, the patient had not been tested positive for COVID-19. It was reported that within an hour or two patient experienced left sided facial numbness and decreased movement of the facial muscles and asymmetrical smile. It was reported that symptoms had improved slightly but still persists. On 15Mar2021, the patient experienced facial numbness and decreased movement of the facial muscles. The patient contacted doctor of medicine (MD), but instructed if symptoms worsened to seek emergency care. The patient did not receive any treatment for the reported events. The clinical outcome of the event facial numbness and decreased movement of the facial muscles was not recovered at the time of report; information about lot/ batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs.; Itching of (pre-existent) eczema; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Medical history included eczema, taste disorder, gastro-intestinal reflux, arthritis, drug allergy (sulfa drugs) and breast cancer (small lump). 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 23Feb2021 at 10:00, as a single dose for COVID-19 immunisation. Concomitant medications included losartan (MANUFACTURER UNKOWN), pantoprazole (MANUFACTURER UNKOWN), rosuvastatin (MANUFACTURER UNKOWN) and sucralfate (MANUFACTURER UNKOWN) all for an unknown indication from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the 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 had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00, the patient experienced inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs. The patient self-administered EUCRISA and hydrocortisone was given as treatment for the events. The clinical outcomes of the events insomnia and itching were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash on abdomen arms and legs; Developed rash on abdomen arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Eng202) via an unspecified route of administration in the left arm on 03Mar2021 at 16:15 hours (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The medical history included poison ivy reaction prior to vaccination and allergy to sulfa and statins. The concomitant medications included lisinopril/hydrochlorothiazide (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), SINGULAIR, BENADRYL and m (unspecified medication). 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 and was not tested for COVID-19 since having the vaccine. On 06Mar2021, the patient developed rash on abdomen, arms and legs. The events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measures taken as a result of the event included steroid shot. The clinical outcome of the event developed rash on abdomen, arms and legs was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Faeces soft, Retching, Vomiting
Clinical narrative: I had stomach upset and felt horrible; had a soft stool, but not diarrhea; vomited several times; dry heaves.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non pregnant female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included diltiazem (MANUFACTURER UNKNOWN) capsule 240 mg  and estradiol (MANUFACTURER UNKNOWN) tablet 2MG received within 2 weeks of vaccination.  Allergies to medications, food, or other products reported to Sulfa. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced stomach upset and felt horrible, had a soft stool, but not diarrhea and vomited several times and had the dry heaves on 18Mar2021 at 10:00. 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 stomach upset, a soft stool, vomiting and dry heaves was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Ear pain, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: Fatigue; neck stiffness and pain; extremely sore occipital bone; ; inabilityto move my neck from left to rightwithout pain; nauseated;; inner ear pain; eye sensitive to light; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: D46207) via an unspecified route of administration in the left arm on 15Mar2021 at 16:30 as a single dose for COVID-19 immunisation. The patient's medical history was not specified. Concomitant medications were Flonase, Levothyroxine, Lexapro, Xyzal, Nexium and Met started on unspecified dates. The patient had a history of allergies to food, medications or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has received Flonase, Levothyroxine, Lexapro, Xyzal, Nexium and Met within 2 weeks of the vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 16Mar2021, the patient experienced fatigue, neck stiffness and pain, extremely sore occipital bone, inability to move her neck from left to right without pain, nausea, inner ear pain and eyes that are sensitive to light. Events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue, neck stiffness and pain, extremely sore occipital bone, inability to move my neck from left to right without pain, nausea, inner ear pain, eyes that are sensitive to light were resolving.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Photophobia
Clinical narrative: Fatigue; neck stiffness and pain; extremely sore occipital bone; ; inabilityto move my neck from left to rightwithout pain; nauseated;; inner ear pain; eye sensitive to light; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: D46207) via an unspecified route of administration in the left arm on 15Mar2021 at 16:30 as a single dose for COVID-19 immunisation. The patient's medical history was not specified. Concomitant medications were Flonase, Levothyroxine, Lexapro, Xyzal, Nexium and Met started on unspecified dates. The patient had a history of allergies to food, medications or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has received Flonase, Levothyroxine, Lexapro, Xyzal, Nexium and Met within 2 weeks of the vaccination. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. On 16Mar2021, the patient experienced fatigue, neck stiffness and pain, extremely sore occipital bone, inability to move her neck from left to right without pain, nausea, inner ear pain and eyes that are sensitive to light. Events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue, neck stiffness and pain, extremely sore occipital bone, inability to move my neck from left to right without pain, nausea, inner ear pain, eyes that are sensitive to light were resolving.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Cluster headache, Heart rate, Heart rate increased
Clinical narrative: Really bad cluster headache on righthand side of head; High blood pressure; Racing pulse rate; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), bromocriptine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and amitriptyline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 (at the age of 43-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. The patient was not diagnosed with COVID -19 prior to vaccination and since the vaccination, the patient had not been tested for COVID -19. On 18Mar2021 at 02:00, the patient experienced really bad cluster headache on right hand side of head, fever, chills, high blood pressure and racing pulse rate. The patient did not receive any treatment for reported events. The clinical outcome of the events really bad cluster headache on right hand side of head, fever, chills, high blood pressure and racing pulse rate were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: Really bad cluster headache on righthand side of head; High blood pressure; Racing pulse rate; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), bromocriptine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and amitriptyline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 15:30 (at the age of 43-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. The patient was not diagnosed with COVID -19 prior to vaccination and since the vaccination, the patient had not been tested for COVID -19. On 18Mar2021 at 02:00, the patient experienced really bad cluster headache on right hand side of head, fever, chills, high blood pressure and racing pulse rate. The patient did not receive any treatment for reported events. The clinical outcome of the events really bad cluster headache on right hand side of head, fever, chills, high blood pressure and racing pulse rate were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash pruritic
Clinical narrative: itchy rash; Redness on my face; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received unknown single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no:  Ep6955) via unspecified route of administration on the left arm on 17Mar2021 at 15:15, for COVID-19 immunisation. No medical history and the patient concomitant medications were not reported and he had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19 and 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 18Mar2021, at 12:30 the patient had itchy rash on the wrist about 30 hours after the vaccination, the rash spread overnight and itching felt worst and also the patient developed redness on the face. Treatment medications for the events included the use of BENADRYL. Also, it was reported that the redness on face improved after taking half a pill of Benadryl. The clinical outcome of itchy rash was not recovered and redness in the face was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under left armpit; Painful lymph nodes under left armpit; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the left arm on 12Mar2021 at 14:45 (at the age of 32-year-old), as single dose for COVID-19 immunisation. The patients medical history included fibromyalgia and penicillin allergy. The patients past drug history included penicillin (MANUFACTURER UNKNOWN) for unspecified indication. Concomitant medication included pantoprazole (MANUFACTURER UNKNOWN) for an unspecified indication and from an unknown date. 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 14Mar2021, the patient had swollen and painful lymph nodes under left armpit. The clinical outcome of the events Painful lymph nodes under left armpit and swollen lymph nodes under left armpit was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Wrong dose
Clinical narrative: Inadvertant administration of > thanrecommended dose. Vial was notreconstituted with diluent and patientreceived 0.3ml of undiluted vaccine; Inadvertant administration of greater than recommended dose.; This is a spontaneous report from a contactable pharmacist, the patient. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an intramuscular route of administration on left arm on 19Mar2021 at 9:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history not reported. The patients allergies to medications, food, or other products were NKDA. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient was pregnant. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has tested for COVID-19 since the vaccination. Concomitant medication not reported. On 09Mar2021 at 9:30 the patient had inadvertant administration of greater than recommended dose, vial was not reconstituted with diluent and the patient received 0.3ml of undiluted vaccine. The clinical outcome for the event inadvertant administration of greater than recommended dose, vial was not reconstituted with diluent and patient received 0.3ml of undiluted vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: extremely fatigued; slight chills; slight nausea; This is a spontaneous report received from a contactable patient. A 75-years-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534 via an unspecified route of administration in left arm at 11:45 on 16Mar2021, at the age of 75 years as a single dose, for COVID-19 immunisation. Medical history was not reported. 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 positive for COVID-19. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) on unspecified dates taken for unspecified indication, magnesium (MANUFACTURER UNKNOWN) on unspecified dates taken for unspecified indication, glucosamine (MANUFACTURER UNKNOWN) on unspecified dates taken for unspecified indication and biotin (MANUFACTURER UNKNOWN) on unspecified dates taken for unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269 via an unspecified route of administration in left arm at 16:00 on 22Feb2021, as a single dose, for COVID-19 immunisation. After receiving second dose, patient experienced extremely fatigue, slight chills and slight nausea at 19:00 on 17Mar2021. The patient did not receive any treatment for events. Facility where the most recent COVID-19 vaccine was administered: Other. The clinical outcome of events extremely fatigued, slight chills and slight nausea was recovered on an unspecified date at the time of reporting. No follow up required. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site pain
Clinical narrative: Dizziness; Injection site pain; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 37-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration in left arm on 08Mar2021, at 14:30(at the age of 37-year-old) as a single dose, for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN), SYNTHROID and WELLBUTRIN. The patient experienced dizziness, vaccination site pain and fatigue on 08Mar2021, at 16:00. No therapeutic measures were taken for the reported events. The clinical outcome of events vaccination site pain, fatigue and dizziness was recovered on unknown date in Mar2021.  Information about lot number cannot be obtained. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Body temperature, Confusional state, Diarrhoea
Clinical narrative: Confusion; Severe stomach pain; Balance; Body aches; severe vomiting/ puking; Temperature 100.3; Diarrhea; Fatigue; Arm ache; Severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old, male 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 16Mar2021 at 13:00 (at the age of 74-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Diabetes, emphysema, HTN, COPD, and COVID-19 on an unspecified date in Nov2020. Concomitant medications were not reported. The patient did not have allergies to food, medication and other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was tested positive for COVID-19 in Nov2020. Since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, at 1700, the patient experienced events, severe nausea, vomiting, puking, temperature 100.3(Units unspecified), arm ache, body aches, fatigue, severe stomach pain and diarrhea, balance, and confusion, The patient did not receive any treatment as a result of adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care'. The clinical outcome of the events nausea, vomiting, fatigue, loss of balance, confusion, pain in arm, generalized body pains, stomach pain, diarrhea, and increase body temperature was recovered with sequelae.   No follow-up attempts are possible; No further information is expected
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Confusion; Severe stomach pain; Balance; Body aches; severe vomiting/ puking; Temperature 100.3; Diarrhea; Fatigue; Arm ache; Severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old, male 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 16Mar2021 at 13:00 (at the age of 74-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Diabetes, emphysema, HTN, COPD, and COVID-19 on an unspecified date in Nov2020. Concomitant medications were not reported. The patient did not have allergies to food, medication and other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was tested positive for COVID-19 in Nov2020. Since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, at 1700, the patient experienced events, severe nausea, vomiting, puking, temperature 100.3(Units unspecified), arm ache, body aches, fatigue, severe stomach pain and diarrhea, balance, and confusion, The patient did not receive any treatment as a result of adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care'. The clinical outcome of the events nausea, vomiting, fatigue, loss of balance, confusion, pain in arm, generalized body pains, stomach pain, diarrhea, and increase body temperature was recovered with sequelae.   No follow-up attempts are possible; No further information is expected
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Confusion; Severe stomach pain; Balance; Body aches; severe vomiting/ puking; Temperature 100.3; Diarrhea; Fatigue; Arm ache; Severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old, male 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 16Mar2021 at 13:00 (at the age of 74-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Diabetes, emphysema, HTN, COPD, and COVID-19 on an unspecified date in Nov2020. Concomitant medications were not reported. The patient did not have allergies to food, medication and other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was tested positive for COVID-19 in Nov2020. Since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, at 1700, the patient experienced events, severe nausea, vomiting, puking, temperature 100.3(Units unspecified), arm ache, body aches, fatigue, severe stomach pain and diarrhea, balance, and confusion, The patient did not receive any treatment as a result of adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care'. The clinical outcome of the events nausea, vomiting, fatigue, loss of balance, confusion, pain in arm, generalized body pains, stomach pain, diarrhea, and increase body temperature was recovered with sequelae.   No follow-up attempts are possible; No further information is expected
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore arm; chills; tiredness; swollen lymph node; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: EN6206), via an unspecified route of administration in her left arm on 18Mar2021 at 17:00 hours (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included Obstructive Sleep Apnea (OSA), pre-diabetic, obesity, non-alcoholic fatty liver disease and gastroparesis. No concomitant medications were not reported within two weeks of vaccination. The patient had previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: EN6202), via an unspecified route of administration in her left arm on 25Feb2021 at 17:00 hours, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not tested positive for COVID-19 since receiving the vaccine. On 18Mar2021, the patient experienced sore arm, chills, tiredness, and swollen lymph node. No therapeutic measures were taken as a result of the events experienced. The clinical outcome of the events sore arm, chills, tiredness and swollen lymph node was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in underarm area; This is a spontaneous report from a contactable consumer, the  patient. A 34-years-old-male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown,) via an unspecified route of administration in left arm on 14Mar2021 at 12:45  (at the age of 34-years-old)  as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no allergy to medications, food, or other products. The patient had not received any vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19.  On 15Mar2021 at 18:00, the patient experienced swollen lymph node in underarm area.  The patient had not received any therapeutic measure or treatment taken for the resulted adverse event. The clinical outcome of  swollen lymph node was resolving.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Vaccination site pain
Clinical narrative: Soreness at the injection site; Mild itchy tingling type sensation and a mild pins and needles sensation all over her body; Mild itchy tingling type sensation and a mild pins and needles sensation all over her body; This is a spontaneous report from a contactable other hcp. (patient).  A 47-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Right on 15Mar2021 15:58 (at the age of 47-years-old) (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ear disorder from 03Feb2021 to an unknown date. Caller stated this is all COVID issue post COVID.  Caller stated this ended within the last maybe week or so. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient previously took a medication which was a steroid called Methylprednisolone for her ear problems that she ended up discontinuing because she had an adverse effect to the medication, so she discontinued it on 15Feb2021. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations details was reported as none. Caller stated she received the vaccine on Monday 15Mar2021 at 15:58 HR and three hours later noticed a pen and needle itchy sensation all over the body and it is mild not severe. Caller stated it was noticeable of course more like annoyance right now. Caller stated the other symptom was soreness at the injection site (on 15Mar2021 20:00). For pen and needle itchy sensation all over the body the as time went on and the following day it was a moderate type soreness then started declining so it is improving. Caller stated she was still feeling a little soreness, but it was improving. Called stated she was not certain of the seriousness criteria of the pen and needle itchy sensation all over the body. Caller stated she knew it was not feeling tingly and the pen needle feelings she did not feel before but now she was felling that sensation and she was not sure if it was connected. AE(s) did not require a visit to emergency room or physician office. Caller stated she tried antihistamine Benadryl (25mg) lot numbers: 1761324, expiration Mar2022, did not really, maybe a minor difference, but sensation is still there so not resolving. The outcome of the events mild itchy tingling type sensation and a mild pins and needles sensation all over her body was not recovered and outcome for soreness at the injection site was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 43-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 her left arm on 16Mar2021 at 13:30(at the age of 43-years-old), as a single dose for COVID-19 immunization. The patient medical history included diabetic and latex allergy. The patient past drug history included lisinopril (MANUFACTURER UNKNOWN). Concomitant medications included januvia, metoprolol (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient had diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. The patient was allergic to latex and lisinopril. On 16Mar2021 at 15:30, the patient was ill for 2 full days, fever, nausea, chills, body aches and headache. The patient did not receive treatment for the reported events. The clinical outcome for illness, fever, nausea, chills, body aches, headache was recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 43-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 her left arm on 16Mar2021 at 13:30(at the age of 43-years-old), as a single dose for COVID-19 immunization. The patient medical history included diabetic and latex allergy. The patient past drug history included lisinopril (MANUFACTURER UNKNOWN). Concomitant medications included januvia, metoprolol (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient had diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. The patient was allergic to latex and lisinopril. On 16Mar2021 at 15:30, the patient was ill for 2 full days, fever, nausea, chills, body aches and headache. The patient did not receive treatment for the reported events. The clinical outcome for illness, fever, nausea, chills, body aches, headache was recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness at site of injection; This is a spontaneous report received from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 04Mar2021 at 10:30 (at the age of 43-year-old) as a single dose, for COVID-19 immunisation. Medical history included hypothyroid and anemia. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) with a dose of 112 microgram, orally once a day and multivitamin. No known allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Mar2021 at 17:30, the patient experienced mild soreness at site of injection. The patient did not receive any treatment for the adverse event. 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 mild soreness at site of injection was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from non-contactable other healthcare professional. A 70-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left deltoid muscle on 16Mar2021 (at the age of 70-year-old), as single dose for COVID-19 immunisation. Medical history included previous reactions of anaphylaxis to an unspecified eye gtt as a teenager. Concomitant medications were not reported. On 16May2021, the patient experienced headache during her 30-minute waiting period after the injection. Therapeutic measures were taken as a result of headache and included treatment with Tylenol, observation and snacks. The follow up response to treatment was excellent and the patient was stable to go home and follow up with PCP. The clinical outcome of headache was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: eight days after my first vaccine, I had a routine blood test and the results of my platelet count was 111.; This is a spontaneous report from a contactable consumer, the patient. A 69-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 03Mar2021 at 10:45 (at the age of 69 years old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, high blood pressure, seasonal allergies, obstructive sleep apnea, and kidney stones. Concomitant medications included prescribed medications and two over the counter medications which are unspecified. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that he had been reading about the possibility of low platelet counts due to the vaccine. On 23Jun2020 his platelet count was 130, on the low normal range. On 11Mar2021, eight days after his first vaccine, he had a routine blood test and the results of his platelet count was 111 (low platelet count). The patient doubted if it had any correlation. The patient did not receive treatment for the event. The clinical outcome of abnormal platelet count was unknown.  Information about lot number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: My face and hands flushed red for about 45 minutes about 30 minutes after the injection.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via unspecified route of administration on 18Mar2021 (at the age of 59-years-old) at 1000 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient medical history included myasthenia Gravis, Barret's, benign prostate hyperplasia (BHP), asthma, degenerative disc disease. The patient was allergic to actifed, biaxin, IVP dye(contrast), morphine, cologne/perfume. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 1245, the patient experienced face and hands flushed red for about 45 minutes (also reported as about 30 minutes after the injection). No therapeutic measures were taken as a result of face and hands flushed red. The clinical outcome of the event face and hands flushed red was recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Full body rash breakout; Small spots with raising and clear liquid in some; 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: En6304), via an unspecified route of administration in the left arm on 15Mar2021 13:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included NUVARING for unknown indication. The patient has no known allergies to food, medications or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 20:00 the patient experienced full body rash breakout and small spots with raising and clear liquid in some. The patient did not receive any treatment for rash. The clinical outcome of the events rash and rash macular was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Vomiting
Clinical narrative: Migraine; vomiting; flu like symptoms; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number : EN6198, via an unspecified route of administration in the left arm on 25Feb2021 at 12:00 (at the age of 55-years old) as a single dose for COVID-19 immunisation. Medical history included connective joint arthritis, HTN, fibromyalgia. Concomitant medications include prednisone (MANUFACTURER UNKNOWN), hydrocodone (MANUFACTURER UNKNOWN), fentanyl patch (MANUFACTURER UNKNOWN), duloxetine (CYMBATLA), all for unknown indication from unknown date. 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 vaccine. On 26Feb2021 at 00:00, the patient experienced migraine, vomiting and flu like symptoms. The clinical  outcome of the migraine, vomiting and flu like symptom was recovered on unknown date in 2021.   No follow-up attempts are possible needed.  No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node under left arm pit; This is a spontaneous report from a contactable patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via unspecified route of administration in the left arm on 17Mar2021 at 1700 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient has no medical history and no known allergies to medications, food or other products. The patient did not have any concomitant medication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch no: Unknown) via unspecified route of administration in the left arm on 23Feb2021 at 1700 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested positive for COVID-19. On 19Mar2021, the patient experienced swollen lymph node under left arm pit. No therapeutic measures were taken for the event. The clinical outcome of the event swollen lymph node under left arm pit was not recovered at the time of this report. No follow up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.