chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: big red itchy circle at the injection site.; 6 days post injection, area was a littleitch/day 8 I have a big red itchy circle at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on the left arm on 01Apr2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, ADHD and hypertension. Concomitant medications included ethinylestradiol/levonorgestrel (KURVELO), lisdexamfetamine mesilate (VYVANSE), losartan (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient was allergic to penicillin and lisinopril. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, 6 days after the vaccination, the patient's injection site area was a little itch. On 09Apr2021, 8 days after the vaccination, the patient had a big red itchy circle at the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events area was a little itch and a big red itchy circle at the injection site was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Lump at injection site; developed lump at injection site very sore and itchy; developed lump at injection site very sore and itchy; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 11:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure, hypothyroidism, anxiety, prediabetes and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), telmisartan (MANUFACTURER UNKNOWN) and venlafaxine hydrochloride (EFFEXOR); all for unknown indication from an unknown date. The patient previosuly received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 11:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 7:00, 48 hours post second vaccination, the patient experienced lump at injection site very sore and itchy. The patient reported that no meds were taken. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lump at injection site very sore and itchy were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Nasal congestion
Clinical narrative: Cough; Stuffed nose; 12 hours after the vaccine I had a fever of 100 degrees which lasted for 16 hours until I took tylenol; Aches; Chills; Tiredness and exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 08:30 (at the age of 33-yeasr-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient received birth control medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:30, 12 hours after the vaccination, the patient experienced fever of 100 degrees which lasted for 16 hours until the patient took tylenol. During that time patient had aches, chills, tiredness and exhaustion. The fever subsided after a day but the aches lasted about 2 days. On 07Apr2021, on the third day, the patient developed cough and stuffed nose which continued to the day of reporting. The patient underwent lab tests and procedures which included body temperature on 05Apr2021 at 20:30 and the result was 100 degrees (unspecified units). The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events fever, aches, chills, tiredness and exhaustion and included treatment with Tylenol. The clinical outcome of the event fever was recovered on 06Apr2021 at 12:30, the event aches was recovered on 07Apr2021 and the events chills, tiredness and exhaustion were recovered with lasting effects on an unknown date in Apr2021 and the events cough and stuffed nose were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Cough; Stuffed nose; 12 hours after the vaccine I had a fever of 100 degrees which lasted for 16 hours until I took tylenol; Aches; Chills; Tiredness and exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 05Apr2021 at 08:30 (at the age of 33-yeasr-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient received birth control medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:30, 12 hours after the vaccination, the patient experienced fever of 100 degrees which lasted for 16 hours until the patient took tylenol. During that time patient had aches, chills, tiredness and exhaustion. The fever subsided after a day but the aches lasted about 2 days. On 07Apr2021, on the third day, the patient developed cough and stuffed nose which continued to the day of reporting. The patient underwent lab tests and procedures which included body temperature on 05Apr2021 at 20:30 and the result was 100 degrees (unspecified units). The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events fever, aches, chills, tiredness and exhaustion and included treatment with Tylenol. The clinical outcome of the event fever was recovered on 06Apr2021 at 12:30, the event aches was recovered on 07Apr2021 and the events chills, tiredness and exhaustion were recovered with lasting effects on an unknown date in Apr2021 and the events cough and stuffed nose were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Rash, Throat tightness, Urticaria
Clinical narrative: Throat got tight; Got really hot; Sweaty; Hives; Rash all over skin; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient has known allergy to mint. Concomitant drugs included birth control (MANUFACTURER UNKNOWN), iron (IRON) and multivitamins (MANUFACTURER UNKNOWN) all for unspecified indications from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 17:00 about one hour after vaccination, the patient experienced hives and a rash all over skin, throat got tight and she got really hot and sweaty. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events hives and a rash all over skin, throat got tight and got really hot and sweaty was resolving at the time of report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever (101.6 degrees was highest temperature); Chills; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic rhabdomyolysis. The patient previously took Erythromycin (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced allergy. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), biotin (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN), all from unknown date, for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 08:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 02:00, the patient experienced fever (101.6 degrees was highest temperature, units not reported), chills, headache and fatigue. On 26Mar2021 at 02:00 the body temperature of the patient was measured and the result was 101.6 (units unspecified). 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 adverse events. The clinical outcome of the events fever, chills, headache and fatigue was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Pain
Clinical narrative: Fever of 102; Body aches; Headache; Weak; Tired; This is a spontaneous report from a contactable consumer, the patient. A 39-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 08Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 00:00, the patient experienced fever of 102, body aches, headache, weak and tired. The events did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events fever, body aches, headache, weak and tired was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102; Body aches; Headache; Weak; Tired; This is a spontaneous report from a contactable consumer, the patient. A 39-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 08Apr2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 00:00, the patient experienced fever of 102, body aches, headache, weak and tired. The events did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events fever, body aches, headache, weak and tired was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Skin burning sensation, Tremor
Clinical narrative: Fever; Uncontrollable shaking; Extreme pain and body ache; Nausea; Burning skin; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included lung disease (lung damage from COVID back in Oct2020) and COVID-19 infection in Oct2020. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN) and hydroxyzine (MANUFACTURER UNKNOWN) from unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 15:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 01:00 the patient experienced fever, uncontrollable shaking, extreme pain and body aches, nausea and burning skin. Many of the symptoms the patient had previously with COVID back in Oct2020. 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 reported events. The clinical outcome of the events fever, uncontrollable shaking, extreme pain and body aches, nausea and burning skin was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Soreness; Headache; Tiredness; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and buspirone hydrochloride (BUSPAR) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 17:00, the patient experienced headache, injection site pain, soreness and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events headache, injection site pain, soreness and tiredness was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; This is a spontaneous report from a contactable nurse. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 08Apr2021 at 14:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertrophic cardiomyopathy, acute heart failure and allergy to avocado. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 18Mar2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation and Wellbutrin on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 07:00, 16 hours post 2 dose of vaccination, the patient experienced fever, headache and chills. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care visit. Therapeutic measures were taken as a result of events and included treatment with Tylenol. The clinical outcome of the events experienced fever, headache and chills was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; body aches; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced sore arm and body aches. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events sore arm and body aches were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity, Paraesthesia oral
Clinical narrative: Tingle in tongue immediately after receiving the second dose; Metallic taste in the mouth for about two weeks after receiving the second dose.; Sore arm for a couple of days; This is a spontaneous report from a 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: ER2613) via an unspecified route of administration in the arm left on 20Mar2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient not had any relevant medical history. Concomitant medications included multivitamin (unspecified) and anxiety medication (unspecified), both are from unknown dates and for unspecified indications. 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 arm left on 27Feb2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 immediately after the vaccination, the patient experienced tingle in tongue, metallic taste in the mouth for about two weeks after receiving the second dose and sore arm for a couple of days. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events sore arm, tingle in tongue were recovered on an unknown date in 2021, while that of metallic taste in mouth was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea
Clinical narrative: I woke up with a menstrual period kind of pain but I dont have periods; It felt like bloating; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 at 01:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and penicillin allergy. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 08:00 the patient woke up with a menstrual period kind of pain(menustral pain), it felt like bloating (bloating) and menstrual pain. She did not had periods since 3 years ago. Therapeutic measures were taken as a result of bloating and menstrual pain which included treatment with ibuprofen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events menstrual period kind of pain (menustral pain), felt like bloating (bloating) and menstrual pain were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: 48 hours after injection neck stiffness and pain moving in any direction which has persisted for 3 days; 48 hours after injection neck stiffness and pain moving in any direction which has persisted for 3 days; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and hemangioma cavernous. The patient had no known allergies to food, medicine or other products. Concomitant medications taken within two weeks prior to the vaccination included bupropion (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:00, 30 hours after injection, the patient experienced severe stomach pain, vomiting, diarrhea, fatigue. On 07Apr2021 at 09:00, 48 hours after injection, the patient experienced neck stiffness and pain moving in any direction which had persisted for three days. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue and 48 hours after injection neck stiffness and pain moving in any direction which had persisted for 3 days 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 48 hours after injection neck stiffness and pain moving in any direction which has persisted for 3 days; 48 hours after injection neck stiffness and pain moving in any direction which has persisted for 3 days; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and hemangioma cavernous. The patient had no known allergies to food, medicine or other products. Concomitant medications taken within two weeks prior to the vaccination included bupropion (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:00, 30 hours after injection, the patient experienced severe stomach pain, vomiting, diarrhea, fatigue. On 07Apr2021 at 09:00, 48 hours after injection, the patient experienced neck stiffness and pain moving in any direction which had persisted for three days. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events 30 hours after injection severe stomach pain, vomiting, diarrhea, fatigue and 48 hours after injection neck stiffness and pain moving in any direction which had persisted for 3 days 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Hypersomnia, Influenza like illness, Pyrexia
Clinical narrative: Soreness in all joints; Overall felt like a bad case of flu; Slept for 13-1/2 hours.; 12 hours after receiving vaccination Ihad a 100.5 fever; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on 24Mar2021 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis, COVID-19, penicillin allergy, diary allergy, soy allergy and allergy to nuts. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient experienced "12 hours after receiving vaccination I had a 100.5 fever" and slept for 13-1/2 hours. On 26Mar2021, the following day the patient experienced soreness in all joints and overall felt like a bad case of flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Mar2021, the patient underwent lab test and procedure which included body temperature and result was shown as 100.5. The clinical outcome of the events "12 hours after receiving vaccination I had a 100.5 fever" and slept for 13-1/2 hours, soreness in all joints and overall felt like a bad case of flu were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Soreness at injection site; Vomiting; Diarrhea; Low grade fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 08Apr2021 at 18:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included IBS (irritable bowel syndrome). Concomitant medications were not reported. The patient previously received augmentin and cefprozil on an unknown date for an unknown indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 21:00, the patient experienced soreness at injection site, vomiting, diarrhea, low grade fever and chills. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care visit. The clinical outcome of the events soreness at injection site, vomiting, diarrhea, low grade fever and chills was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test
Clinical narrative: Diagnosed with POTS after vaccine; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 10:00 AM (at the age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. Medical history included covid-19 and patient had known allergies to codeine from an unknown date and unknown if ongoing. Concomitant medications was not reported. The patient didn't take any other vaccine in four weeks. The patient had covid prior vaccination, covid tested post vaccination. The patient diagnosed with POTS after vaccine on 01Apr2021 at 08:00 AM. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood test (Abbott antibody test): negative on 12Apr2021 and sars-cov-2 test: positive on 09Feb2021. Therapeutic measures were taken as a result of diagnosed with pots after vaccine with beta blockers and Pepcid. The events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Computerised tomogram abdomen, Echocardiogram
Clinical narrative: Tachycardia; rapid heart rate 90-105 sleeping; sitting/ Walking through my house as high as 125; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in arm left on 12Apr2021 at 13:00 (at the age of 56-years-old) as dose2, single for COVID-19 immunization. Medical history included, hypertension, type 2 diabetes mellitus and hyperthyroidism. The patient had known allergies of Levaquin and Norvasc. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207) via an unspecified route of administration, administered in left arm on Mar2021 at 13:00 (at the age of 56-years-old) as dose 1, singe for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Two weeks after initial dosage on 30Mar2021, she woke up 2 am to a series of palpitations. Her blood pressure was 156/106, heart rate 60 bpm, very lightheaded and shortness of breath. Her normal average blood pressure was 125/85 sitting heart rate 80-85 bpm. She went to the emergency room. They have performed EKG and CHEST X-RAY (resulted nothing). She continued to have same symptoms for 2 weeks. After 3 more emergency room Visits and 2 more EKG's; CT Scan on Abdomen; 2 Chest X-Rays; Multiple Lab Blood work including Troponin; 2 Different Cardiologist; Bluetooth Heart Monitor; Echocardiogram even a Gastroenterolo-gist thus far no explanation for Bradycardia. After second dose of vaccine, in Apr2021, she had a rapid heart rate 90-105 sleeping: sitting. walking through her house as high as 125. She was still wearing the heart monitor to record the now Tachycardia. Covid test post vaccination on 09Apr2021, Nasal Swab COVID-19 (STANDARD NAA), resulted Negative. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, SARS-CoV-2 test, Tachycardia
Clinical narrative: Tachycardia; rapid heart rate 90-105 sleeping; sitting/ Walking through my house as high as 125; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in arm left on 12Apr2021 at 13:00 (at the age of 56-years-old) as dose2, single for COVID-19 immunization. Medical history included, hypertension, type 2 diabetes mellitus and hyperthyroidism. The patient had known allergies of Levaquin and Norvasc. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207) via an unspecified route of administration, administered in left arm on Mar2021 at 13:00 (at the age of 56-years-old) as dose 1, singe for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Two weeks after initial dosage on 30Mar2021, she woke up 2 am to a series of palpitations. Her blood pressure was 156/106, heart rate 60 bpm, very lightheaded and shortness of breath. Her normal average blood pressure was 125/85 sitting heart rate 80-85 bpm. She went to the emergency room. They have performed EKG and CHEST X-RAY (resulted nothing). She continued to have same symptoms for 2 weeks. After 3 more emergency room Visits and 2 more EKG's; CT Scan on Abdomen; 2 Chest X-Rays; Multiple Lab Blood work including Troponin; 2 Different Cardiologist; Bluetooth Heart Monitor; Echocardiogram even a Gastroenterolo-gist thus far no explanation for Bradycardia. After second dose of vaccine, in Apr2021, she had a rapid heart rate 90-105 sleeping: sitting. walking through her house as high as 125. She was still wearing the heart monitor to record the now Tachycardia. Covid test post vaccination on 09Apr2021, Nasal Swab COVID-19 (STANDARD NAA), resulted Negative. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Tachycardia; rapid heart rate 90-105 sleeping; sitting/ Walking through my house as high as 125; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in arm left on 12Apr2021 at 13:00 (at the age of 56-years-old) as dose2, single for COVID-19 immunization. Medical history included, hypertension, type 2 diabetes mellitus and hyperthyroidism. The patient had known allergies of Levaquin and Norvasc. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207) via an unspecified route of administration, administered in left arm on Mar2021 at 13:00 (at the age of 56-years-old) as dose 1, singe for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Two weeks after initial dosage on 30Mar2021, she woke up 2 am to a series of palpitations. Her blood pressure was 156/106, heart rate 60 bpm, very lightheaded and shortness of breath. Her normal average blood pressure was 125/85 sitting heart rate 80-85 bpm. She went to the emergency room. They have performed EKG and CHEST X-RAY (resulted nothing). She continued to have same symptoms for 2 weeks. After 3 more emergency room Visits and 2 more EKG's; CT Scan on Abdomen; 2 Chest X-Rays; Multiple Lab Blood work including Troponin; 2 Different Cardiologist; Bluetooth Heart Monitor; Echocardiogram even a Gastroenterolo-gist thus far no explanation for Bradycardia. After second dose of vaccine, in Apr2021, she had a rapid heart rate 90-105 sleeping: sitting. walking through her house as high as 125. She was still wearing the heart monitor to record the now Tachycardia. Covid test post vaccination on 09Apr2021, Nasal Swab COVID-19 (STANDARD NAA), resulted Negative. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Muscle injury, Pain, Pain in extremity
Clinical narrative: felt a throbbing pain on her elbow; Joint pain.; She had sore arm; Feels as if her muscles were damaged; she cannot stretch her arm all the way to the back; that she cannot carry or hold anything on her left side; This is a spontaneous report from a non-contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 29JAN2021;second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 19Feb2021 as a single for COVID-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020 it was not severe just headache and body aches. The patient's concomitant medications were not reported. It was reported that, therapist counsellor said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 29JAN2021, and the 2nd dose on 19FEB2021. However, ever since she received the vaccine, she noticed that her muscles got affected to the point that she cannot carry or hold anything on her left side. She said that she cannot stretch her arm all the way to the back. She also said that she felt a throbbing pain on her elbow and feels as if her muscles were damaged. HCP also mentioned that she had sore arm and joint pain. She was concerned since she feels that the symptoms are not getting any better. HCP wants to know if there have been any reports similar to her reaction. HCP also mentioned that she previously had Covid back in Dec2020 but said that it was not severe just headache and body aches. No product quality complain was reported. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint movement impairment
Clinical narrative: felt a throbbing pain on her elbow; Joint pain.; She had sore arm; Feels as if her muscles were damaged; she cannot stretch her arm all the way to the back; that she cannot carry or hold anything on her left side; This is a spontaneous report from a non-contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 29JAN2021;second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 19Feb2021 as a single for COVID-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020 it was not severe just headache and body aches. The patient's concomitant medications were not reported. It was reported that, therapist counsellor said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 29JAN2021, and the 2nd dose on 19FEB2021. However, ever since she received the vaccine, she noticed that her muscles got affected to the point that she cannot carry or hold anything on her left side. She said that she cannot stretch her arm all the way to the back. She also said that she felt a throbbing pain on her elbow and feels as if her muscles were damaged. HCP also mentioned that she had sore arm and joint pain. She was concerned since she feels that the symptoms are not getting any better. HCP wants to know if there have been any reports similar to her reaction. HCP also mentioned that she previously had Covid back in Dec2020 but said that it was not severe just headache and body aches. No product quality complain was reported. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fibrin D dimer, Fibrin D dimer increased, SARS-CoV-2 test
Clinical narrative: If covid tested post vaccination: yes, covid test result positive; If covid tested post vaccination: yes, covid test result positive; Tachycardia; elevated d dimer; elevated blood pressure; This is a spontaneous report from a contactable consumer.   A 36-year-old (non-pregnant) female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982), via an unspecified route, administered in left arm on 12Jan2021 as dose 2, single for COVID-19 immunization at Hospital. The patient medical history included ongoing hypothyroidism, right bundle branch (block), cardiomegaly and no allergies. Concomitant medications included levothyroxin. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), intramuscularly administered in left arm on 22Dec2020 at 13:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccine. The patient did not have COVID-19 prior vaccination. On 12Jan2021 at 13:30, the patient experienced tachycardia, elevated d-dimer and elevated blood pressure. On 07Mar2021, the patient was diagnosed with Covid-19. The patient underwent lab tests and procedures which included blood pressure: elevated, D-dimer: elevated on 12Jan2021 and nasal swab: SARS CoV-2 test positive on 07Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not treated for the events. The outcome of If covid tested post vaccination: yes, covid test result positive was unknown. The outcome of rest of the events is recovered with sequel.  Follow-up attempts completed. No further information expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.