chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Myocardial infarction
Clinical narrative: Major heart attack; He kept getting sick back to back; This is a spontaneous report from a non-contactable consumer. This consumer reported for a male patient (reporter's father) that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient suffered a major heart attack and passed was on 04Jul2021. Ever since the vaccine was given to him, he kept getting sick back to back in 2021. He was never diagnosed with anything before the shot. The outcome of event getting sick back to back was unknown. The outcome of event major heart attack was fatal. The patient died on 04Jul2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: major heart attack
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Myocardial infarction
Clinical narrative: he suffered a major heart attack and passed was in 04Jul; he kept getting sick back to back.; This is a spontaneous report from a contactable consumer via Pfizer sale representative.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient suffered a major heart attack and passed was in 04jul on 04Jul2021.Since the vaccine was given to him, he kept getting sick back to back on 04Jul2021. He was never diagnosed with anything before the shot.  The patient died on an unspecified date.  It was not reported if an autopsy was performed. Outcome of heart attack and passed was fatal, of others was unknown.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: he suffered a major heart attack and passed was in 04Jul
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Procedural pain
Clinical narrative: Pain from left knee replacement; Pain from left knee replacement; This is a solicited report received from marketing program 'Facilitated Collect' based on the information received by Pfizer (MFR Control No. # 21K-163- 4026604-00) from a consumer (patient). The consumer reported two reports for same patient and different doses, this is the second of two reports for second dose.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 10Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 vaccination; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer BioNTech. She had covid a couple of weeks after the first vaccine for covid. On 10Jul2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer BioNTech. On 21Jul2021, the patient had knee replacement and experienced pain from left knee replacement. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient was still having pain from left knee replacement done on 21Jul2021. In 2021, the patient experienced pain from left knee replacement. The action taken in response to upadacitinib for events was unknown. The patient outcome was not recovered from the pain, of other events was unknown.   Causality for RINVOQ(UPADACITINIB): The reporter's causality for the events of pain from left knee replacement onset 21Jul2021, pain from left knee replacement onset in 2021 and covid was not provided. AbbVies opinion is that there is no reasonable possibility that the events of pain from left knee replacement onset 21Jul2021, pain from left knee replacement onset in 2021 and COVID are related to RINVOQ (UPADACITINIB).  Causality for vaccine: The reporter's causality for COVID-19 was possible, for other events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the events of Joint injury and Procedural pain are  assessed as not related to BNT162B2, and more likely due to  underlying medical condition of Rheumatoid arthritis for which patient underwent Knee replacement.,Linked Report(s) : US-PFIZER INC-202101170219 same reporter/ patient, different dose/AE
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Overdose, Pain in extremity, Product preparation error
Clinical narrative: Gave her the full vial undiluted with the five to six doses in it; she had that large amount; Gave her the full vial undiluted with the five to six doses in it; she had that large amount; Arm soreness; She on the second day did not feel so well; This is a spontaneous report from a contactable consumer (parent). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported), dose 2 via an unspecified route of administration on Sep2021 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient concomitant medications was not reported. As it was reported on Sep2021 daughter received the full vial undiluted with the five to six doses in it; she had that large amount and also patient experienced arm soreness and patient on the second day did not feel so well. For the events arm soreness and on the second day did not feel so well was recovering. Outcome of the event gave her the full vial undiluted with the five to six doses in it; she had that large amount was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen left sided supraclavicular lymph node, now almost two weeks out still swollen; This is a spontaneous report from a contactable nurse, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 08Sep2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia (SVT), rheumatoid arthritis, postural orthostatic tachycardia syndrome (POTS), fatty liver, eosinophilic esophagitis, asthma, COVID-19 and allergy to contrast iodine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient previously took clarithromycin (MANUFACTURER UNKNOWN) and ketorolac tromethamine (TORADOL) both for an unknown indication from unknown date and experienced drug allergy. On 09Sep2021, the patient experienced swollen left sided supraclavicular lymph node, almost two weeks at the time of report and still swollen. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen left sided supraclavicular lymph node, almost two weeks at the time of report and still swollen was not resolved at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Neck pain
Clinical narrative: Chills; Aches; Drowsiness; Dizziness; Nausea; Extreme pain starting from left arm up the left side of neck; Extreme pain starting from left arm up the left side of neck; Pain shooting down spine; Pain jabs in right side sinus cavities; Pain jabs in right side of frontal lobe; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: JDAMH) via an unspecified route of administration in the left arm on 15Sep2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medicines (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448,) via an unspecified route of administration in the left arm on 25Aug2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 03:30, the patient experienced chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and the patient also developed itchy, red, hot spot where vaccine was injected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and itchy, red, hot spot where vaccine was injected was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sinus pain, Somnolence, Spinal pain
Clinical narrative: Chills; Aches; Drowsiness; Dizziness; Nausea; Extreme pain starting from left arm up the left side of neck; Extreme pain starting from left arm up the left side of neck; Pain shooting down spine; Pain jabs in right side sinus cavities; Pain jabs in right side of frontal lobe; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: JDAMH) via an unspecified route of administration in the left arm on 15Sep2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medicines (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448,) via an unspecified route of administration in the left arm on 25Aug2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 03:30, the patient experienced chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and the patient also developed itchy, red, hot spot where vaccine was injected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and itchy, red, hot spot where vaccine was injected was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Chills; Aches; Drowsiness; Dizziness; Nausea; Extreme pain starting from left arm up the left side of neck; Extreme pain starting from left arm up the left side of neck; Pain shooting down spine; Pain jabs in right side sinus cavities; Pain jabs in right side of frontal lobe; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; Itchy, red, hot spot where injected; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: JDAMH) via an unspecified route of administration in the left arm on 15Sep2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified birth control medicines (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448,) via an unspecified route of administration in the left arm on 25Aug2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 03:30, the patient experienced chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and the patient also developed itchy, red, hot spot where vaccine was injected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches, drowsiness, dizziness, nausea, extreme pain starting from left arm up the left side of the neck, pain shooting down the spine, pain jabs in the right side of sinus cavities, pain jabs in the right side of the frontal lobe and itchy, red, hot spot where vaccine was injected was not resolved 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: Maternal exposure during pregnancy, Product use issue, Rash pruritic, Rash pustular
Clinical narrative: Cluster and single pustules, red in color, raised off the skin, itchy, scattered all over the body; Cluster and single pustules, red in color, raised off the skin, itchy, scattered all over the body; Patient was pregnant at the time of vaccination/ Gestation period: 16 weeks; COVID-19 vaccine start date: 10Sep2021 and Flu vaccine start date: 10Sep2021; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old 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 10Sep2021 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. The patient's last menstrual date was 18May2021, gestational period was 16 weeks and expected delivery date was 22Feb2022. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the COVID-19 vaccine which included first dose of influenza vaccine (FLU; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 for an unknown indication. The patient did not receive any concomitant medications. On 11Sep2021 at 11:00, the patient experienced cluster and single pustules, red in color, raised off the skin, itchy and scattered all over the body. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cluster and single pustules, red in color, raised off the skin, itchy, scattered all over the body was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: First menstrual period after the vaccine has been full of the worst pain/have cramped intensely for several days; This is a spontaneous report from a contactable nurse. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 22Jul2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nickel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was reported as not applicable (as per source document). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0181) via an unspecified route of administration in the left arm on 30Jun2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 12Sep2021, the patient experienced her first menstrual period after the vaccine had been full of the worst pain, the patient have had since she started her period 12 years ago. The patient had cramped intensely for several days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event first menstrual period after the vaccine has been full of the worst pain/have cramped intensely for several days was recovering at the time of this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Off label use, Pyrexia, Vomiting
Clinical narrative: Fever; Headache; Vomiting; Patient received dose 3; Patient received dose 3; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Sep2021 at 08:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 18Sep2021 at 02:00 the patient experienced fever, headache, and vomiting. The events did not result in 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 which included treatment with ondansetron (ZOFRAN), paracetamol (TYLENOL), and famotidine (PEPCID). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache, and vomiting was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Breast swelling, Hormone level abnormal
Clinical narrative: Hormonal change; Swellness in the breast; Lost of hair; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. On an unknown date, the patient had hormonal change, swellness in the breast and lost of hair. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hormonal change, swellness in the breast and lost of hair was not resolved at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Paining like a hit by something at the left side back shoulder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Sep2021, the patient had paining like a hit by something at the left side back shoulder and the pain was there for three days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event paining like a hit by something at the left side back shoulder was resolved on 15Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: Painful and delayed menstruation; Painful and delayed menstruation; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 25Mar2021 at 07:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced painful and delayed menstruation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful and delayed menstruation was resolved on an unknown date in 2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Had extreme heart palpitations.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 15Feb2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included factor 5 Leiden and known allergy to strawberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) and spironolactone (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 19:45, the patient experienced extreme heart palpitations, at the time of this report the patient had them on and off throughout the day ever since. The patient never had heart palpitations prior to receiving the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 26Aug2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event extreme heart palpitations was not resolved at the time of this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion
Clinical narrative: "I" developed a dry cough /fatigue/congestion within 12 hrs of getting this vaccine; "I" developed a dry cough /fatigue/congestion within 12 hrs of getting this vaccine; "I" developed a dry cough /fatigue/congestion within 12 hrs of getting this vaccine; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via intramuscular route of administration in the right arm on 15Sep2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported.  On 15Sep2021, at 20:00, the patient developed dry cough, fatigue and congestion within 12 hours of getting this vaccine. It was also reported that these symptoms were still going on and it had been 4 days after receiving it. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with benzonatate (MANUFACTURER UNKNOWN) 200MG capsule to help relieve the cough. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed a dry cough, fatigue and congestion within 12 hours of getting this vaccine was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Missed menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Sep2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 14Sep2021 the patient experienced missed menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed menstrual cycle was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Getting "my" periods every two weeks/The last four months "I" have gotten "my" period every two weeks; Gotten "my" period every two weeks. Heavier; Gotten "my" period every two weeks. Heavier and more cramps; Headaches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included patient been on birth control and except when the patient was pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date, the patient noticed getting periods every two weeks. The patient had been on birth control, except when the patient was pregnant for 12 years and was getting period on the dot with pills. Since last four months, the patient has gotten period every two weeks, heavier and more cramps and headaches as well. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 14Jun2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events getting periods every two weeks, last four months have gotten period every two weeks, heavier, more cramps and headaches was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FC3184), at the age of 41, via an unspecified route of administration, left arm, on Sep 17, 2021, at 08:30, single dose, for COVID-19 immunisation. Medical history included allergy to hazelnut. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0172), at the age of 41, via an unspecified route of administration, left arm, on Aug 27, 2021, at 09:15, single dose, for COVID-19 immunisation. On Sep 17, 2021 at 09:15, patient felt flushed, had tingling in left arm and hand, also felt very dizzy and very tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of feeling flushed, tingling in left arm and hand, feeling very dizzy, and very tired were not resolved at the time of this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Malaise, Pain in extremity
Clinical narrative: Right knee pain; Arm pain; Felt extremely ill and weak; Felt extremely ill and weak; 102.9 fever; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0911995-07981) via an unspecified route of administration in the right arm on 16Sep2021 at 18:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0904499-07981) via an unspecified route of administration and unspecified anatomical location on an unspecified date (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 17Sep2021 at 09:00, the patient reports 102.9 fever that started 15 hours after vaccine, and lasted 12 hours. On 17Sep2021 at 10:15 patient experienced right knee pain, arm pain and also felt extremely ill and weak. It was unreported if therapeutic measures were taken as a result of events 102.9 fever, right knee pain, arm pain, felt extremely ill and weak. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 102.9 fever was resolved and of the events right knee pain, arm pain, felt extremely ill and weak was resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Right knee pain; Arm pain; Felt extremely ill and weak; Felt extremely ill and weak; 102.9 fever; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0911995-07981) via an unspecified route of administration in the right arm on 16Sep2021 at 18:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0904499-07981) via an unspecified route of administration and unspecified anatomical location on an unspecified date (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 17Sep2021 at 09:00, the patient reports 102.9 fever that started 15 hours after vaccine, and lasted 12 hours. On 17Sep2021 at 10:15 patient experienced right knee pain, arm pain and also felt extremely ill and weak. It was unreported if therapeutic measures were taken as a result of events 102.9 fever, right knee pain, arm pain, felt extremely ill and weak. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 102.9 fever was resolved and of the events right knee pain, arm pain, felt extremely ill and weak was resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: Fever 102; Fatigue; Headache; Dizziness; Weak; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Sep2021 at 16:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies (reported as none that the patient knew of). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Aug2021 at 16:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 03:30 (reported as 12 hours after second shot), the patient experienced fever 102 (unspecified units), fatigue, headache, dizziness and was weak. On 19Sep2021 at 00:30, at hour 32, the fever remained at 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102 (unspecified units), headache, fatigue, dizziness, and weak was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102; Fatigue; Headache; Dizziness; Weak; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Sep2021 at 16:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies (reported as none that the patient knew of). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Aug2021 at 16:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 03:30 (reported as 12 hours after second shot), the patient experienced fever 102 (unspecified units), fatigue, headache, dizziness and was weak. On 19Sep2021 at 00:30, at hour 32, the fever remained at 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102 (unspecified units), headache, fatigue, dizziness, and weak was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout - painful gout in right toe; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 24Aug2021 at 13:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 13:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 26Aug2021 at 07:00, the patient experienced gout - painful gout in right toe. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event gout-painful gout in the right toe and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gout - painful gout in right toe was not resolved at the time of this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular hyperaemia, Periorbital swelling
Clinical narrative: Extremely itchy eyes; Slight swelling under eyes; Redness of eyes; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 11Sep2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 13Sep2021 the patient experienced extremely itchy eyes, slight swelling under eyes and redness of eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely itchy eyes, slight swelling under eyes and redness of eyes was not resolving at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dehydration, Extra dose administered, Fatigue, Insomnia
Clinical narrative: Pain at injection site; Dehydration; Fatigue; Unable to sleep; Shaky/unbalanced; Shaky/unbalanced; This was the booster shot.; This was the booster shot.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on 19Sep2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown dates as a single dose for COVID-19 immunisation and reportedly no reactions to first 2 shots. On 19Sep2021 at 13:30 the patient experienced pain at injection site, dehydration, fatigue but unable to sleep, shaky/unbalanced. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, dehydration, fatigue but unable to sleep, shaky/unbalanced was not recovered at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Tremor, Vaccination site pain
Clinical narrative: Pain at injection site; Dehydration; Fatigue; Unable to sleep; Shaky/unbalanced; Shaky/unbalanced; This was the booster shot.; This was the booster shot.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the right arm on 19Sep2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown dates as a single dose for COVID-19 immunisation and reportedly no reactions to first 2 shots. On 19Sep2021 at 13:30 the patient experienced pain at injection site, dehydration, fatigue but unable to sleep, shaky/unbalanced. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, dehydration, fatigue but unable to sleep, shaky/unbalanced was not recovered at the time of this report.