chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Suppressed lactation, Vaccination site pain
Clinical narrative: Injection site moderate pain, arm pain, slight joint pain (hands, arms and feet), severe pain in the knees, severe milk supply reduction (currently breastfeeding).; Injection site moderate pain, arm pain, slight joint pain (hands, arms and feet), severe pain in the knees, severe milk supply reduction (currently breastfeeding).; Injection site moderate pain, arm pain, slight joint pain (hands, arms and feet), severe pain in the knees, severe milk supply reduction (currently breastfeeding).; Injection site moderate pain, arm pain, slight joint pain (hands, arms and feet), severe pain in the knees, severe milk supply reduction (currently breastfeeding).; Injection site moderate pain, arm pain, slight joint pain (hands, arms and feet), severe pain in the knees, severe milk supply reduction (currently breastfeeding).; This is a spontaneous report from a contactable consumer. This 35-year-old female consumer (patient) reported for herself. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in Arm Right on 27May2021 12:00 (at the age of 35-years-old) as a single dose for covid-19 immunization. Medical history included haematoma -Huge hematoma after giving birth, not sure if recovered from that. The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included Pregnancy vitamins. 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 have any allergies. On 27May2021 18:00, the patient experienced injection site moderate pain, arm pain, slight joint pain (hands, arms and feet), severe pain in the knees, severe milk supply reduction (currently breastfeeding). The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report. Device Date was 28May2021 Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Joint pain; Muscle pain; Tiredness; This is a Spontaneous report from a Contactable Consumer reported for himself that:  A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via an intramuscular route of administration, administered in Arm Left on 02Apr2021 (At the age of 53 years) as DOSE 1, SINGLE and also received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161) via an intramuscular route of administration, administered in Arm Right on 23Apr2021 (At the age of 53 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On an unspecified date in May2021, the patient had experienced Joint pain, muscle pain and tiredness. Therapeutic measures were taken as a result of joint pain. The patient had taken vitamins like magnesium for joint pain. At the time of reporting, the event muscle pain was recovering and events tiredness and joint pain were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: chills; fever; nausea; sore arm; shortness of breath, along with sob on my daily morning walks; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0179), via an unspecified route of administration in the left arm on 30Apr2021 as dose 2, single for COVID-19 immunization (at the age of 69-years-old). The patient medical history and concomitant medications were not reported, patient was a healthy woman. There were no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), via an unspecified route of administration in the left arm on 09Apr2021 14:00 as dose 1, single for COVID-19 immunization (at the age of 69-years-old). The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that she received her second dose of Pfizer Covid vaccine on 30Apr2021. On 15May2021, she did have the side effects of chills, fever, nausea for 24 hours along with a sore arm. Two weeks after the vaccine she noticed shortness of breath while climbing stairs in her apartment along with sob on her daily morning walks with her dog. Then (30) days later she noticed it getting worse, she had no underlying conditions, she did not suffer from this prior to the vaccine. She was not on any prescription meds. She was a reformed smoker, she quit 28Apr1998. The patient did not receive any treatment for the events. The clinical outcome for events was not recovered except recovered for chills, fever and nausea on 16May2021.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Night sweats, Pyrexia
Clinical narrative: patient has had headaches for 10 days consistently; night sweats; fever; chills; This is a spontaneous report from a contactable physician. A 29-year-old female non pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiry date was not reported) via an unspecified route of administration on 12May2021 (age at vaccination: 29 years) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date 2021, it was reported that patient has had headaches for 10 days consistently, night sweats, fever, and chills. The case was assessed as non serious. The outcome of the event headache was recovered on an unspecified date 2021 and other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dehydration, Fatigue
Clinical narrative: Uncontrollable chills 12h after the shot; fever of 100 F for about 24 since the chills started; Extreme tiredness; Sore muscles and joints; Sore muscles and joints; Dehydration symptoms throughout; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), via an unspecified route of administration, administered in left arm on 17May2021 at 09:30 (at the age of 40 years old) as a single dose for COVID-19 immunisation. The patient's medical history included low blood pressure, melanoma from an unknown date and unknown if ongoing. Concomitant medications were none reported. The patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) on 19Apr2021 at 14:30 (at the age of 40 years old) on left arm for COVID-19 immunization. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not receive other vaccine within four weeks. The patient did not receive any other medications in two weeks. On 17May2021 the patient experienced Uncontrollable chills 12h after the shot, fever of 100-degree Fahrenheit for about 24 since the chills started, Extreme tiredness, Sore muscles and joints and Dehydration symptoms throughout. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 100.F on 17May2021. The outcome of the event of chills, muscle soreness, Soreness of joint and Dehydration was recovered on unspecified date of May2021. The outcome of the event of Fever was recovered on 19May2021. The outcome of the event of Tiredness was recovered on 20 May2021.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Uncontrollable chills 12h after the shot; fever of 100 F for about 24 since the chills started; Extreme tiredness; Sore muscles and joints; Sore muscles and joints; Dehydration symptoms throughout; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), via an unspecified route of administration, administered in left arm on 17May2021 at 09:30 (at the age of 40 years old) as a single dose for COVID-19 immunisation. The patient's medical history included low blood pressure, melanoma from an unknown date and unknown if ongoing. Concomitant medications were none reported. The patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) on 19Apr2021 at 14:30 (at the age of 40 years old) on left arm for COVID-19 immunization. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not receive other vaccine within four weeks. The patient did not receive any other medications in two weeks. On 17May2021 the patient experienced Uncontrollable chills 12h after the shot, fever of 100-degree Fahrenheit for about 24 since the chills started, Extreme tiredness, Sore muscles and joints and Dehydration symptoms throughout. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 100.F on 17May2021. The outcome of the event of chills, muscle soreness, Soreness of joint and Dehydration was recovered on unspecified date of May2021. The outcome of the event of Fever was recovered on 19May2021. The outcome of the event of Tiredness was recovered on 20 May2021.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Urticaria
Clinical narrative: Numb face approximately 30 minutes after shots 1 and 2.; Hives on right arm after shot 1; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0167, expiration date was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 08:15 (at the age of 49-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. The medical history included reynauds syndrome, hypothyroidism, high cholesterol. The patient historical vaccine included flu shot and experienced known allergies to flu shot. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), vitamin d3, calcium, all taken for unknown indications from an unknown date. Other medications patient received in two weeks included synthroid, crestor, multi vitamin D3, calcium. Patient did not receive any other vaccines with in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 21May2021 17:00 the patient experienced numb face approximately 30 minutes after shots 1 and 2. Hives on right arm after shot 1. Went to urgent care next afternoon. The adverse events resulted in emergency room/department or urgent care. Prednisone for 7 days was received as treatment for the adverse events. Therapeutic measures were taken as a result of numb face approximately 30 minutes after shots 1 and 2, hives on right arm after shot 1. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Very bad itching all over bodyIt happened as soon as patient got out of the facility; This is a spontaneous report from contactable consumer (patient himself). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route of administration, administered in arm right on 26May2021 14:00 (age at the vaccination was 35-year-old) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient had no known allergies Penicillin and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical vaccine included, the patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0173), via unspecified route of administration, administered in arm right on 05May2021 14:00 (age at the vaccination was 35-year-old) as dose 1, single for covid-19 immunisation. The patient experienced very bad itching all over body it happened as soon as patient got out of the facility on 26May2021 15:00. Timeframe between vaccination and starting of the event was 1 hour. Since the vaccination, patient was not tested for COVID-19. Zyretc treatment was received in response to the events. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Depression, Fatigue, Headache
Clinical narrative: Strong but became subdue headache in the frontal lobe region; Extreme fatigue; Sore left arm and under shoulder blade; Sore left arm and under shoulder blade; Feelings of clinical depression are amplifies compared to prior vaccine; Significant loss of appetite; It feels like I'll vomit if I do; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 25May2021 12:00 pm as dose 2, single for COVID-19 immunisation. Medical history included Clinical depression and Recovering alcoholic (Recovering alcoholic (last drink was Jan31)). Concomitant medications included sertraline hydrochloride (ZOLOFT) and etonogestrel (NEXPLANON). The patient received first dose of BNT162B2 on 27Apr2021 at 12:00 pm (Lot number:EW0173, Left Arm) for covid-19 immunization and experienced Temporary headache in frontal lobe area. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26May2021 the patient experienced Strong but became subdue headache in the frontal lobe region, Extreme fatigue, Sore left arm and under shoulder blade, Feelings of clinical depression are amplifies compared to prior vaccine, Significant loss of appetite and It feels like Ill vomit if I do. Therapeutic measures were taken as a result of Strong but became subdue headache in the frontal lobe region. The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Strong but became subdue headache in the frontal lobe region; Extreme fatigue; Sore left arm and under shoulder blade; Sore left arm and under shoulder blade; Feelings of clinical depression are amplifies compared to prior vaccine; Significant loss of appetite; It feels like I'll vomit if I do; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 25May2021 12:00 pm as dose 2, single for COVID-19 immunisation. Medical history included Clinical depression and Recovering alcoholic (Recovering alcoholic (last drink was Jan31)). Concomitant medications included sertraline hydrochloride (ZOLOFT) and etonogestrel (NEXPLANON). The patient received first dose of BNT162B2 on 27Apr2021 at 12:00 pm (Lot number:EW0173, Left Arm) for covid-19 immunization and experienced Temporary headache in frontal lobe area. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26May2021 the patient experienced Strong but became subdue headache in the frontal lobe region, Extreme fatigue, Sore left arm and under shoulder blade, Feelings of clinical depression are amplifies compared to prior vaccine, Significant loss of appetite and It feels like Ill vomit if I do. Therapeutic measures were taken as a result of Strong but became subdue headache in the frontal lobe region. The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Nasal congestion, Nausea
Clinical narrative: chills; nausea; chest congestion; nasal congestion; diarrhea; cough; body aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in Arm Left on 21May2021 09:30 (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included thrombosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that prior to four weeks of vaccination patient not received any other vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received medication Inflamma-Less by Irwin Naturals with in two weeks of vaccination. On 26May2021 8:00 patient experienced symptoms exactly 5 days after that includes but was not limited to nausea, chest congestion, nasal congestion, diarrhea, cough, body aches and chills. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623501 same reporter, vaccine and AE, different patient.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: chills; nausea; chest congestion; nasal congestion; diarrhea; cough; body aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in Arm Left on 21May2021 09:30 (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included thrombosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that prior to four weeks of vaccination patient not received any other vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received medication Inflamma-Less by Irwin Naturals with in two weeks of vaccination. On 26May2021 8:00 patient experienced symptoms exactly 5 days after that includes but was not limited to nausea, chest congestion, nasal congestion, diarrhea, cough, body aches and chills. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623501 same reporter, vaccine and AE, different patient.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Neck pain, Pain in extremity
Clinical narrative: aches pains hands,knees and feet; Neck and back pain; Neck and back pain; headaches; aches pains hands,knees and feet; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 56-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right on 21Apr2021 11:00 (age at vaccination 56-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Concomitant medication included trazodone (TRAZODONE) 50mg; amlodipine (AMLODIPINE) 10mg; fluoxetine (FLUOXETINE) 40mgreceived within two weeks. The patient previously took Codeine and Tylenol and experienced drug hypersensitivity. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533) via an unspecified route of administration, administered in Arm Right on 31Mar2021 11:00 (age at vaccination 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 23Apr2021, patient experienced Neck and back pain, headaches, aches pains hands, knees, and feet. For Ae treatment received was unknown. AE results in Physician Office Visit. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the event was unknown.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Mild fever; Headache; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 59267-1000-01), second dose via an unspecified route of administration, administered in left arm on 28May2021 at 15:00 as dose 2, single for COVID-19 immunisation at pharmacy or drug store. Medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 59267-1000-01), second dose via an unspecified route of administration, administered in left arm on 07May2021 at 15:00 as dose 1, single for COVID-19 immunisation at pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of COVID vaccine included Allergy Shot, Singular, Allegra, Claritin, Fish Oil. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced mild fever, headache on 29May2021 at 09:00. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the events. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test, Chest pain, Computerised tomogram
Clinical narrative: I'm sick with Fever; I'm sick with Fever; terrible headache; cold; dry cough; loss of taste and smell; loss of taste and smell; chest pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0173) via an unspecified route of administration, administered in Arm Right on 16May2021 at 10:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0169) via an unspecified route of administration, administered in Arm Right on 20Apr2021 at 09:15 AM (at the age of 33-years-old) as dose 1, single for covid-19 immunization. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient had no COVID prior to vaccination. On 30May2021, 2 weeks after the second dose the patient said, I was sick with fever, terrible headache, cold, dry cough, loss of taste and smell and chest pain. It was reported that, 2 weeks after the first dose on 04May2021 at 09:00 am I experienced severe abdominal pain and headache. I went to the emergency room 4 times; blood work and CT scan were good. Still don't know the nature of that pain. Today, 30May2021 2 weeks after the 2 dose I'm sick with Fever, terrible headache, cold, dry cough, loss of taste and smell, chest pain. Took a rapid COVID testing this morning, came back negative. The headache required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient under-went lab tests and procedures which included blood test that was good on 04May2021, computerized tomogram which was good on 04May2021. The patient took a rapid COVID testing, SARS-CoV-2, nasal swab, test came back negative on 30May2021. No treatment was given for adverse events. Device date was reported as 30May2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Illness, Nasopharyngitis, Pyrexia
Clinical narrative: I'm sick with Fever; I'm sick with Fever; terrible headache; cold; dry cough; loss of taste and smell; loss of taste and smell; chest pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0173) via an unspecified route of administration, administered in Arm Right on 16May2021 at 10:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0169) via an unspecified route of administration, administered in Arm Right on 20Apr2021 at 09:15 AM (at the age of 33-years-old) as dose 1, single for covid-19 immunization. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient had no COVID prior to vaccination. On 30May2021, 2 weeks after the second dose the patient said, I was sick with fever, terrible headache, cold, dry cough, loss of taste and smell and chest pain. It was reported that, 2 weeks after the first dose on 04May2021 at 09:00 am I experienced severe abdominal pain and headache. I went to the emergency room 4 times; blood work and CT scan were good. Still don't know the nature of that pain. Today, 30May2021 2 weeks after the 2 dose I'm sick with Fever, terrible headache, cold, dry cough, loss of taste and smell, chest pain. Took a rapid COVID testing this morning, came back negative. The headache required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient under-went lab tests and procedures which included blood test that was good on 04May2021, computerized tomogram which was good on 04May2021. The patient took a rapid COVID testing, SARS-CoV-2, nasal swab, test came back negative on 30May2021. No treatment was given for adverse events. Device date was reported as 30May2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I'm sick with Fever; I'm sick with Fever; terrible headache; cold; dry cough; loss of taste and smell; loss of taste and smell; chest pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0173) via an unspecified route of administration, administered in Arm Right on 16May2021 at 10:30 (at the age of 33-years-old) as dose 2, single for covid-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0169) via an unspecified route of administration, administered in Arm Right on 20Apr2021 at 09:15 AM (at the age of 33-years-old) as dose 1, single for covid-19 immunization. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient had no COVID prior to vaccination. On 30May2021, 2 weeks after the second dose the patient said, I was sick with fever, terrible headache, cold, dry cough, loss of taste and smell and chest pain. It was reported that, 2 weeks after the first dose on 04May2021 at 09:00 am I experienced severe abdominal pain and headache. I went to the emergency room 4 times; blood work and CT scan were good. Still don't know the nature of that pain. Today, 30May2021 2 weeks after the 2 dose I'm sick with Fever, terrible headache, cold, dry cough, loss of taste and smell, chest pain. Took a rapid COVID testing this morning, came back negative. The headache required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient under-went lab tests and procedures which included blood test that was good on 04May2021, computerized tomogram which was good on 04May2021. The patient took a rapid COVID testing, SARS-CoV-2, nasal swab, test came back negative on 30May2021. No treatment was given for adverse events. Device date was reported as 30May2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Hypoaesthesia, Pyrexia, Urticaria
Clinical narrative: Numb face approximately 30 minutes after shots 1 and 2.; Fever of 100.6 after second dose; Severe headache; Severe hives on neck, torso, arms,upper legs after shot 2.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0185, Expiry date: not reported ), via an unspecified route of administration in Arm Left on 21May2021 09:00 (at the age of 49-years) as DOSE 2, SINGLE for covid-19 immunisation in Public Health Clinic. Medical history included Raynaud's phenomenon, high cholesterol and hypothyroidism. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included Levothyroxine sodium (SYNTHROID), Rosuvastatin calcium (CRESTOR), Ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL, Colecalciferol (D3), Calcium taken for an unspecified indications, start and stop date were not reported, the patient has received first dose. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167, Expiry date: not reported ), via an unspecified route of administration in Arm Left on 30Apr2021 08:15 (at the age of 49-years) as DOSE 1, SINGLE for covid-19 immunisation. The patient also received Flu vaccine, via an unspecified route of administration on an unspecified date for Influenza immunisation. On 21May2021 17:00 the patient experienced numb face approximately 30 minutes after shots 1 and 2, fever of 100.6 after second dose, severe headache, severe hives on neck, torso, arms, upper legs after shot 2, 8 hours after shot. Went to urgent care next afternoon. Fever resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature increased: 100.6 Fahrenheit on 21May2021. Therapeutic measures were taken as a result of numb face, fever, severe headache, severe hives on neck, torso, arms, upper legs (prednisone for 7 days).The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Oxygen saturation
Clinical narrative: Strong dyspnea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267 and Expiration date was unknown), via an unspecified route of administration in left arm on 11Feb2021 at 17:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included none and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had no Known Allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 23:00, the patient had experienced Strong dyspnoea for 3 days after 1st dose starting first night. Then disappeared. The patient had visited urgent care, Primary doctors, Pulmonologist. Adverse event resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The patient did not receive any treatment for AE and no Hospitalization prolonged. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination was reported as Nasal Swab. On 13Apr2021, the patient underwent Covid 19 rapid diagnostic test and the result of covid test was reported as negative. The patient underwent lab tests and procedures which included blood test: ok, computerised tomogram thorax: negative, electrocardiogram: negative, oxygen saturation: ok, spirometry: normal, x-ray: negative in 2021. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Spirometry, X-ray
Clinical narrative: Strong dyspnea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267 and Expiration date was unknown), via an unspecified route of administration in left arm on 11Feb2021 at 17:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included none and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had no Known Allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 23:00, the patient had experienced Strong dyspnoea for 3 days after 1st dose starting first night. Then disappeared. The patient had visited urgent care, Primary doctors, Pulmonologist. Adverse event resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The patient did not receive any treatment for AE and no Hospitalization prolonged. Since the vaccination, the patient has been tested for COVID-19. Covid test type post vaccination was reported as Nasal Swab. On 13Apr2021, the patient underwent Covid 19 rapid diagnostic test and the result of covid test was reported as negative. The patient underwent lab tests and procedures which included blood test: ok, computerised tomogram thorax: negative, electrocardiogram: negative, oxygen saturation: ok, spirometry: normal, x-ray: negative in 2021. Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Nasal congestion, Nausea
Clinical narrative: Chills; Nausea; Chest congestion; Nasal congestion; Diarrhea; Cough; Body aches; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm left on 21May2021 at 09:30 as dose 1, single for COVID-19 immunisation. Medical history included blood clots from an unknown date and unknown if ongoing. Concomitant medication received as Inflamma-Less by Irwin Naturals on an unknown date. Reporter stated that she is not on the supplements. She was on other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient received vaccine facility name in Kroger pharmacy. My wife and I got our vaccines from the same pharmacy and pharmacist. We both got it on our left arm. We got our first shots 3 days apart (she was after myself). I showed symptoms exactly 5 days after that includes but is not limited to nausea, chest congestion, nasal congestion, diarrhea, cough, body aches and chills. She was now showing the same symptoms exactly 5 days after her shot. On 26May2021 at 08:00 the patient experienced chills, nausea, chest congestion, nasal congestion, diarrhea, cough, body aches. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021621155 same reporter, vaccine and AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: Chills; Nausea; Chest congestion; Nasal congestion; Diarrhea; Cough; Body aches; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Arm left on 21May2021 at 09:30 as dose 1, single for COVID-19 immunisation. Medical history included blood clots from an unknown date and unknown if ongoing. Concomitant medication received as Inflamma-Less by Irwin Naturals on an unknown date. Reporter stated that she is not on the supplements. She was on other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient received vaccine facility name in Kroger pharmacy. My wife and I got our vaccines from the same pharmacy and pharmacist. We both got it on our left arm. We got our first shots 3 days apart (she was after myself). I showed symptoms exactly 5 days after that includes but is not limited to nausea, chest congestion, nasal congestion, diarrhea, cough, body aches and chills. She was now showing the same symptoms exactly 5 days after her shot. On 26May2021 at 08:00 the patient experienced chills, nausea, chest congestion, nasal congestion, diarrhea, cough, body aches. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021621155 same reporter, vaccine and AE, different patient.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Discomfort, Headache, Lethargy, Pain
Clinical narrative: Extreme body soreness; body felt heavy like I couldn't move; headaches all day; lethargy; loss of taste persisting all day; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731) via an unspecified route, administered in left arm on 28May2021 at 15:45 (age at vaccination: 27 years) as dose 2, single for covid-19 immunisation at workplace clinic. Patient was not pregnant at the time of vaccination. The patients medical history included undifferentiated connective tissue disease (auto immune condition that is suspected lupus at last rheumatology visit). raynauds, chronic fatique. There were non known allergies. List of any other medications the patient received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), hydroxychloroquine, paracetamol (TYLENOL). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8731) via an unspecified route, administered in left arm on 07May2021 at 13:00 (age at vaccination was 27 years) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that prior to vaccination, the patient was diagnosed with COVID-19 and unknown for covid prior vaccination. On 29May2021 at 04:00, the patient experienced extreme body soreness, body felt heavy like she could not move, headaches all day, lethargy, loss of taste persisting all day. She did not receive treatment for adverse events. Since the vaccination, she was not tested covid post vaccination. The outcome of events not recovered.   Follow-up attempts were completed. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: fever; chills/severe shivering; hot sweats, cold sweats; hot sweats, cold sweats; severe nausea; body tense from head to toes; extreme headache near back; waves of shaking that started at head and slowly went down my body; couldnt focus on anything; just felt absolutely terrible; This is a spontaneous report from a contactable consumer. This 50-Year-Old female consumer (patient) reported for herself.  A 50-years-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0191, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 26May2021 at 17:00 (50-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included had foot/ankle surgery from 21May2021 (thus the pain meds). Concomitant medication(s) included norethindrone [norethisterone] (NORETHINDRONE [NORETHISTERONE]) taken for an unspecified indication, ketorolac (KETOROLAC) taken for an unspecified indication and acetaminophen; hydrocodone (ACETAMINOPHEN; HYDROCODONE) taken for an unspecified indication. The patient had no known allergies. Patient did not receive other vaccine in four weeks. Patient has no covid prior vaccination, not tested covid post vaccination. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0173, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 18:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. On 26May2021 at 23:00, 06 hrs after vaccination, the patient experienced fever, chills/severe shivering, hot and cold sweats, severe nausea, body tense from head to toes, extreme headache near back, waves of shaking that started at head and slowly went down my body, couldn't focus on anything and just felt absolutely terrible. It was reported that patient experienced fever, chills, hot sweats, cold sweats, severe shivering for hours on end, severe nausea, body tense from head to toes, extreme headache near back of head, waves of shaking that started at head and slowly went down my body, couldnt focus on anything and just felt absolutely terrible. Patient did not receive any treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events were recovering.  Follow-up attempts completed. No further information expected.