chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (100.6 F max); This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 11May2021(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history included high blood pressure and high cholesterol (both controlled with medications). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The concomitant medications included hydrochlorothiazide/lisinopril (LISINOPRIL/HCTZ), metoprolol (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 20Apr2021 as a single dose for COVID-19 immunisation. The patient also took previously ciprofloxacin(MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 12May2021 at 06:00, about 18 hours after second dose vaccination, the patient experienced fever (100.6 F max). The fever ended about 24 hours after it began. The patient reported that this was the only adverse effect that he experienced. On the same day, the patient underwent body temperature test and the result was 100.6 degree fahrenheit. The adverse event did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (100.6 f max) was resolved on 13May2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: blood pressure went "way up when se got her COVID; This is a spontaneous report from a contactable physician, based on information received by Pfizer. (manufacturer control number: EC-2019-065480), for BNT162B2.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization and patient had received lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 19Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for unknown indication. Medical history included thyroid cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date it was reported that, patient daughter advised patient blood pressure went "way up when she got her COVID vaccine". Pfizer was vaccine brand. Patient blood pressure has come back down to normal. Patient was told to hold Lenvima for a few days due the high blood pressure and has since resumed at her regular dose. The patient underwent lab tests and procedures which included blood pressure measurement: went way up and has come back down to normal on an unspecified date. The action taken in response to the event for lenvatinib mesilate was temporarily withdrawn on an unspecified date. The outcome of event was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Stomach pain; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0168) via an unspecified route of administration in the left arm on 23May2021 at 12:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021 at 21:00 the patient experienced stomach pain, vomiting, diarrhea, for more than 4 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event stomach pain, vomiting, diarrhea, for more than 4 hours was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: kidney bean sized lump under her chin; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received unknown dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0168) via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On an unspecified date patient experienced a kidney bean sized lump under her chin. Event took place after use of product. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gait disturbance, Headache, Hypoaesthesia oral
Clinical narrative: I became really dizzy and wobbly to walk; Wobbly to walk; My tongue, teeth and lips became numb on and off for rest of night; Was really sleepy; Headache; Foggy head; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm  on 24May2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and thyroid. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and unspecified thyroid medication; all from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 24May2021, first day after the second dose, the patient had slight headache and foggy head and on 25May2021 at 17:30, on the second day, towards end of day, the patient became really dizzy and wobbly to walk, tongue, teeth and lips became numb on and off for rest of night. The patient was really sleepy and next day felt better with no issues. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight headache, foggy head, dizzy, wobbly to walk, tongue, teeth and lips became numb and was really sleepy was resolved on 26May2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I became really dizzy and wobbly to walk; Wobbly to walk; My tongue, teeth and lips became numb on and off for rest of night; Was really sleepy; Headache; Foggy head; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm  on 24May2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and thyroid. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and unspecified thyroid medication; all from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 24May2021, first day after the second dose, the patient had slight headache and foggy head and on 25May2021 at 17:30, on the second day, towards end of day, the patient became really dizzy and wobbly to walk, tongue, teeth and lips became numb on and off for rest of night. The patient was really sleepy and next day felt better with no issues. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight headache, foggy head, dizzy, wobbly to walk, tongue, teeth and lips became numb and was really sleepy was resolved on 26May2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: I'm calling my arm swell like; My bones I can hardly move are swollen; My hands and I can hardly move; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that:  A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164) via an unspecified route of administration in left arm on 20Apr2021 (at the age of 54-year-old) as dose 2, single for COVID-19 immunization Patient medical history include congestive heart failure myopathy (heart patient). Concomitant medication includes ACETYLSALICYLIC ACID (ASPIRIN) Batch/lot number: Unknown), Unspecified medication (Isotropin (Not further clarified hence captured as Unspecified Medication in tab), Batch/lot number: Unknown. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E46198) via an unspecified route of administration in left arm on 30Mar2021 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. On unspecified date she had side effects after 2nd shot in April. Patient had her arm swell like and bones hardly move as they are swollen. Her hands and she can hardly move. Patient states Isotropin and Aspirin, I'm allergic to those. I cannot take those. Patient have allergy to 'Isotropin' and Aspirin. The clinical outcome of the event was unknown.   Follow-up (05Jul2021): Follow-up attempts completed. No further information expected
Sex: F
Vaccine: PPV
Symptoms: Fear, Hypersensitivity, Palpitations
Clinical narrative: had an allergic reaction; heart palpitations; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. Medical history included chronic diabetes and allergies. The patient's concomitant medications were not reported. The patient had an allergic reaction and heart palpitations on an unspecified date. It was reported that the patient experienced heart palpitations and was rushed to the emergency room 2 hours after getting her Pneumonia shots. It turns out that there were ingredients of the vaccine that she had an allergic reaction with. She also has chronic diabetes, and given these medical conditions, she is considering getting the Pfizer BioNTech Covid-19 Vaccine. She states she had an allergic reaction to a pneumonia vaccine. She doesn't know which kind she got. The vaccine gave her heart palpitations. She ended up in the ER. She wanted to take the Covid vaccine, but she is afraid of it. She wanted to know if there is any way she could get ingredient information and compare them to the pneumonia vaccine and make sure that it is safe for her. Clarified with the patient that she was referring to Pfizer Covid-19 vaccine. She is afraid because she has a lot of allergies. She wanted to know if Pfizer also makes the pneumonia vaccine. She doesn't know the brand, but she knows there are two different kinds. She doesn't know which kind she took. It was several years ago. Her doctor said if she's allergic she probably shouldn't take it. She wanted to compare pneumonia vaccine ingredients with Covid vaccine ingredients. She may see an allergist so she can get all the info. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb mass, Lymphadenopathy
Clinical narrative: lymph node swelling; patient who has developed a lump in the arm after vaccination; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient had developed a lump in the arm after vaccination of the Pfizer COVID-19 vaccine. They were aware that lymph node swelling was an adverse event. However, patient would like to know if Pfizer had any recommendation in treating it or should that patient be worried about the lump. The outcome of both the events was unknown.  Follow-up (19Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Skin mass, Vaccination site pain
Clinical narrative: pain on his injection site; it's been spreading and it's like a hardness, a lump he can feel that started in his shoulder and now it's in his arm pit and now seems to have spread into the upper part of his back; sharp pain in the shoulder and the armpit which has now spread into the upper part of his back; sharp pain in the shoulder and the armpit which has now spread into the upper part of his back; sharp pain in the shoulder and the armpit which has now spread into the upper part of his back; This is a spontaneous report from a Contactable consumer. This 46-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 28May2021 as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date after the vaccination patient experienced a lot of pain on his injection site which, he mentioned was spreading. He also mentioned that he could feel like a hardness, a lump that started in his shoulder and now it was in his arm pit and seemed to have spread into the upper part of his back. He also mentioned that he has a sharp pain in the shoulder and the armpit which has now spread into the upper part of his back. He would like to know if this was normal and for how long should they last. Caller asked was this within the expectations of side effects. He had an appointment at 09:30. Caller was unable to complete report. The event outcome was unknown.  No follow up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation, lidocaine (ZTLIDO), topical from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for back pain. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced back pain (non-serious). The action taken in response to the events, for lidocaine was unknown. Outcome of the event was unknown.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dyspnoea, Fatigue, Nausea
Clinical narrative: Full body aches; nausea; anxiety; shortness of breath; cold chills; fatigue; This is a spontaneous report from a contactable Other HCP. This 32-year-old male Other HCP (patient) reported that:  A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jun2021 10:30 (at the age of 32 years old) as dose 1, single for covid-19 immunisation. Medical history included ongoing anxiety other medical history: Anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), propranolol (PROPRANOLOL) and Multi vitamin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 00:15, the patient experienced full body aches, nausea, anxiety, shortness of breath, cold chills and fatigue. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Full body aches; nausea; anxiety; shortness of breath; cold chills; fatigue; This is a spontaneous report from a contactable Other HCP. This 32-year-old male Other HCP (patient) reported that:  A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jun2021 10:30 (at the age of 32 years old) as dose 1, single for covid-19 immunisation. Medical history included ongoing anxiety other medical history: Anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), propranolol (PROPRANOLOL) and Multi vitamin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 00:15, the patient experienced full body aches, nausea, anxiety, shortness of breath, cold chills and fatigue. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Menstrual cramps were more intense; period almost 20 days out of the month/ periods were heavier; My menstrual cycle is only 10 -12 days. I am spotting by and on my period almost 20 days out of the month.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Jan2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's menstrual cycle was only 10 -12 days. On 01Feb2021, the patient experienced spotting by and on period almost 20 days out of the month, cramps were more intense and periods were heavier and none of this was how cycles were prior to the COVID-19 vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events spotting by and on period almost 20 days out of the month, cramps were more intense and periods were heavier was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Muscle pain at injection site; Diarrhea; Nausea; Vomiting; Abdominal pain; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and clonidine (MANUFACTURER UNKNOWN), both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021, the patient experienced muscle pain at injection site, diarrhea, nausea, vomiting, abdominal pain and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain at injection site, diarrhea, nausea, vomiting, abdominal pain and chills was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Muscle pain at injection site; Diarrhea; Nausea; Vomiting; Abdominal pain; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and clonidine (MANUFACTURER UNKNOWN), both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021, the patient experienced muscle pain at injection site, diarrhea, nausea, vomiting, abdominal pain and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain at injection site, diarrhea, nausea, vomiting, abdominal pain and chills was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: injection site was swollen and it was painfull to lift the arm; injection site was swollen and it was painfull to lift the arm; high fever (104 F), high fever (100F), 99.3 F; muscle and joint pain; muscle and joint pain; chills; headache; This is a spontaneous report from a contactable consumer (Patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiry date was not reported), via an unspecified route of administration on 07Jun2021 11:00 (at the age of 34-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took analgin [metamizole sodium] and experienced allergy. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0177 and Expiry date was not reported), via an unspecified route of administration on 17May2021 12:00 (at the age of 34-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested COVID-19 post vaccination. On 07Jun2021, the patient experienced adverse event 5 hours after receiving second dose, injection site was swollen and it was painful to lift the arm, 14 hours later she developed high fever (104 F), muscle and joint pain, chills and headache. The morning after still had high fever (100F), pain in muscles and joints. After taking one tablet of Paracetamol 500mg fever subsided to 99.3 F and the pain is almost gone. The Patient received treatment for the events Fever, pain in muscles and joints. The patient underwent lab tests and procedures which included body temperature: high fever (104 F) fahrenheit, body temperature: high fever (100F) fahrenheit, body temperature: 99.3 F fahrenheit. The outcome for the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site swelling
Clinical narrative: injection site was swollen and it was painfull to lift the arm; injection site was swollen and it was painfull to lift the arm; high fever (104 F), high fever (100F), 99.3 F; muscle and joint pain; muscle and joint pain; chills; headache; This is a spontaneous report from a contactable consumer (Patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiry date was not reported), via an unspecified route of administration on 07Jun2021 11:00 (at the age of 34-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took analgin [metamizole sodium] and experienced allergy. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0177 and Expiry date was not reported), via an unspecified route of administration on 17May2021 12:00 (at the age of 34-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested COVID-19 post vaccination. On 07Jun2021, the patient experienced adverse event 5 hours after receiving second dose, injection site was swollen and it was painful to lift the arm, 14 hours later she developed high fever (104 F), muscle and joint pain, chills and headache. The morning after still had high fever (100F), pain in muscles and joints. After taking one tablet of Paracetamol 500mg fever subsided to 99.3 F and the pain is almost gone. The Patient received treatment for the events Fever, pain in muscles and joints. The patient underwent lab tests and procedures which included body temperature: high fever (104 F) fahrenheit, body temperature: high fever (100F) fahrenheit, body temperature: 99.3 F fahrenheit. The outcome for the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Fever 101; Chills; Diarrhea; Vomiting; Dizzy; Weak; Muscle aches; Injection redness; Injection hot to touch; Injection soreness; Exhaustion; Headache; .Profuse sweating; Lack of hunger; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021 at 10:00, the patient experienced fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger. On the same day, the patient underwent body temperature test and the result was 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Fever 101; Chills; Diarrhea; Vomiting; Dizzy; Weak; Muscle aches; Injection redness; Injection hot to touch; Injection soreness; Exhaustion; Headache; .Profuse sweating; Lack of hunger; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021 at 10:00, the patient experienced fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger. On the same day, the patient underwent body temperature test and the result was 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: Fever 101; Chills; Diarrhea; Vomiting; Dizzy; Weak; Muscle aches; Injection redness; Injection hot to touch; Injection soreness; Exhaustion; Headache; .Profuse sweating; Lack of hunger; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021 at 10:00, the patient experienced fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger. On the same day, the patient underwent body temperature test and the result was 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: The person developed extreme aches and pains; As well as a severe headache; This is a spontaneous report from a contactable consumer. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jun2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Jun2021, the patient developed extreme aches and pains as well as a severe headache and was unable to go to school for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events, the person developed extreme aches and pains as well as a severe headache and was unable to go to school for 2 days was resolved on an unknown date in Jun2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation
Clinical narrative: Non itchy rash on stomach, back, arms, chest, legs - some of them were bigger and there was peeling.  Others were small.; Non itchy rash on stomach, back, arms, chest, legs - some of them were bigger and there was peeling.  Others were small.; This is a spontaneous report from a contactable consumer (parent). A 15-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration, administered in left arm on 15May2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications within 2 weeks of vaccination included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccine within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. The reporter reported that, on 15May2021, after vaccination, the patient experienced non itchy rash on stomach, back, arms, chest, legs; and some of them were bigger and there was peeling. Others were small. The patient received treatment for the adverse events. The events resulted in doctor or other healthcare professional office or clinic visit. The outcome for the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pruritus
Clinical narrative: I am very itchy; Have a lump on my left clavical; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0178) via an unspecified route of administration on 08Jun2021 16:30 (age at vaccination 46 years) as dose number unknown, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine administered was reported as Pharmacy or Drug Store. The patient had no known drug allergies. The patient did not receive any other vaccine in four weeks. Covid prior vaccination was unknown and covid tested post vaccination was reported as no. On 09Jun2021 16:00, patient experienced she was very itchy and have a lump on her left clavical. The patient did not receive any treatment for adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Joint swelling, Lip exfoliation, Myalgia
Clinical narrative: two 1/2 oblong patches of skin sloughed off inside bottom lip; two 1/2 oblong patches of skin sloughed off inside bottom lip; both hands swelled; total numbness; total loss of strength; knuckles red and swollen; severe itching both arms and lower back w/rash and swollen round areas; severe muscle pain; This is a spontaneous report from a contactable consumer (Patient).   A 72-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EW0187), dose 2 via an unspecified route of administration, administered in left arm on 24May2021 at 11:00 (at the age of 72-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included mitral regurgitation, collagenous colitis, atherosclerotic, high blood pressure. Concomitant medications included lisinopril taken for blood Pressure high, venlafaxine taken for depression, budesonide taken for shortness of breath and amoxicillin taken for an unspecified indication; start and stop date were not reported for all medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: ER8735), via an unspecified route of administration, administered in right arm on 03May2021 at 10:45 as DOSE 1, SINGLE for COVID-19 immunization. On 25May2021, the patient experienced severe muscle pain, on 26May2021, she experienced severe itching both arms, lower back w/rash and swollen round areas and on 27May2021, she experienced two 1/2 oblong patches of skin sloughed off inside bottom lip, (lose track of time) both hands swelled, total numbness, total loss of strength, knuckles red and swollen (then just left hand then just right hand and now on 10Jun2021 in right hand). As per reporter on 24May2021, she experienced none, 25May2021 awoke with severe muscle pain, 26May2021 ,27 May2021, and 28 May2021 severe itching both arms and lower back w/rash and swollen round areas, 27May2021 two 1/2 oblong patches of skin sloughed off inside bottom lip, (lose track of time) both hands swelled, total numbness, total loss of strength, knuckles red and swollen. then just left hand then just right hand, now 10Jun2021 right hand. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. No treatment was received in response to the adverse events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: two 1/2 oblong patches of skin sloughed off inside bottom lip; two 1/2 oblong patches of skin sloughed off inside bottom lip; both hands swelled; total numbness; total loss of strength; knuckles red and swollen; severe itching both arms and lower back w/rash and swollen round areas; severe muscle pain; This is a spontaneous report from a contactable consumer (Patient).   A 72-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EW0187), dose 2 via an unspecified route of administration, administered in left arm on 24May2021 at 11:00 (at the age of 72-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included mitral regurgitation, collagenous colitis, atherosclerotic, high blood pressure. Concomitant medications included lisinopril taken for blood Pressure high, venlafaxine taken for depression, budesonide taken for shortness of breath and amoxicillin taken for an unspecified indication; start and stop date were not reported for all medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: ER8735), via an unspecified route of administration, administered in right arm on 03May2021 at 10:45 as DOSE 1, SINGLE for COVID-19 immunization. On 25May2021, the patient experienced severe muscle pain, on 26May2021, she experienced severe itching both arms, lower back w/rash and swollen round areas and on 27May2021, she experienced two 1/2 oblong patches of skin sloughed off inside bottom lip, (lose track of time) both hands swelled, total numbness, total loss of strength, knuckles red and swollen (then just left hand then just right hand and now on 10Jun2021 in right hand). As per reporter on 24May2021, she experienced none, 25May2021 awoke with severe muscle pain, 26May2021 ,27 May2021, and 28 May2021 severe itching both arms and lower back w/rash and swollen round areas, 27May2021 two 1/2 oblong patches of skin sloughed off inside bottom lip, (lose track of time) both hands swelled, total numbness, total loss of strength, knuckles red and swollen. then just left hand then just right hand, now 10Jun2021 right hand. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. No treatment was received in response to the adverse events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.