chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Off label use, Paraesthesia, Product use issue, Vomiting
Clinical narrative: Then about 6 hours later I started to get burning feet and terrible gas pains; Then about 6 hours later I started to get burning feet and terrible gas pains; That night I woke up in a sweat; Then Nausea came back Tuesday; I could not stop vomiting; I am still having tingling sensations so I have started on electrolytes.; But other then some insomnia last nigh; janssen covid-19 vaccine was administered on the same date; janssen covid-19 vaccine was administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 58-Year-old female patient (no pregnant) received the second dose of bnt162b2 on 15May2021 (at the age of 57-year-old) (lot number: FG3527) via unknown route of administration in arm right at dose 2, single for COVID-19 immunization; janssen covid-19 vaccine on 15May2021 at 02:30 (lot number: 205A21A) via unknown route of administration at dose 1, single in arm right for unknown indication. Medical history was reported as none. Concomitant medications were reported as none. Patient previously took Codeine and experienced Allergies. On 29Oct2021 at 08:00 PM, patient felt fine when she left the store. Then about 6 hours later she started to get burning feet and terrible gas pains. That night she woke up in a sweat, then the next night and the next night also. Then she woke up Monday and felt really good. Then Nausea came back Tuesday and by then she could not stop vomiting and was admitted by ambulance to the hospital. She was still having tingling sensations so had started on electrolytes.  But other then some insomnia last night she was almost back to normal. Treatment included zofran and fluids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. The events resulted in Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The events did not result in Disability, Congenital anomaly, death and did not prolong Hospitalization.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Flatulence, Inappropriate schedule of product administration, Insomnia, Medication error
Clinical narrative: Then about 6 hours later I started to get burning feet and terrible gas pains; Then about 6 hours later I started to get burning feet and terrible gas pains; That night I woke up in a sweat; Then Nausea came back Tuesday; I could not stop vomiting; I am still having tingling sensations so I have started on electrolytes.; But other then some insomnia last nigh; janssen covid-19 vaccine was administered on the same date; janssen covid-19 vaccine was administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 58-Year-old female patient (no pregnant) received the second dose of bnt162b2 on 15May2021 (at the age of 57-year-old) (lot number: FG3527) via unknown route of administration in arm right at dose 2, single for COVID-19 immunization; janssen covid-19 vaccine on 15May2021 at 02:30 (lot number: 205A21A) via unknown route of administration at dose 1, single in arm right for unknown indication. Medical history was reported as none. Concomitant medications were reported as none. Patient previously took Codeine and experienced Allergies. On 29Oct2021 at 08:00 PM, patient felt fine when she left the store. Then about 6 hours later she started to get burning feet and terrible gas pains. That night she woke up in a sweat, then the next night and the next night also. Then she woke up Monday and felt really good. Then Nausea came back Tuesday and by then she could not stop vomiting and was admitted by ambulance to the hospital. She was still having tingling sensations so had started on electrolytes.  But other then some insomnia last night she was almost back to normal. Treatment included zofran and fluids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. The events resulted in Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The events did not result in Disability, Congenital anomaly, death and did not prolong Hospitalization.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Night sweats, Paraesthesia, Vomiting
Clinical narrative: Then about 6 hours later I started to get burning feet and terrible gas pains; Then about 6 hours later I started to get burning feet and terrible gas pains; That night I woke up in a sweat; Then Nausea came back Tuesday; I could not stop vomiting; I am still having tingling sensations so I have started on electrolytes.; But other then some insomnia last nigh; janssen covid-19 vaccine was administered on the same date; janssen covid-19 vaccine was administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 58-Year-old female patient (no pregnant) received the second dose of bnt162b2 on 15May2021 (at the age of 57-year-old) (lot number: FG3527) via unknown route of administration in arm right at dose 2, single for COVID-19 immunization; janssen covid-19 vaccine on 15May2021 at 02:30 (lot number: 205A21A) via unknown route of administration at dose 1, single in arm right for unknown indication. Medical history was reported as none. Concomitant medications were reported as none. Patient previously took Codeine and experienced Allergies. On 29Oct2021 at 08:00 PM, patient felt fine when she left the store. Then about 6 hours later she started to get burning feet and terrible gas pains. That night she woke up in a sweat, then the next night and the next night also. Then she woke up Monday and felt really good. Then Nausea came back Tuesday and by then she could not stop vomiting and was admitted by ambulance to the hospital. She was still having tingling sensations so had started on electrolytes.  But other then some insomnia last night she was almost back to normal. Treatment included zofran and fluids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. The events resulted in Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The events did not result in Disability, Congenital anomaly, death and did not prolong Hospitalization.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 40-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 right arm on 06Jul2021 as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. 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 concomitant medications included multivitamin womens from an unknown date for an unknown indication 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 on an unknown date as a single dose for COVID-19 immunisation. On 30Jul2021, about 2 weeks after the patient had received the second dose, the patient developed a constant eye twitch on the left eye on both upper and lower eye lids, which lasted over 2 months long. On 15Oct2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since, the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event constant eye twitch on the left eye on both upper and lower eye lids was resolved on unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Headache, Hyperhidrosis
Clinical narrative: The patient received third/ booster dose of BNT162B2; Arm pain; Redness; Lump-like swelling.; Headache everyday; Chills; Sweating enough to soak sheets and pillow for several days.; Diarrhea; Feeling sick; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 02Nov2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included non-hodgkins follicular lymphoma (6 months post rituxan maintenance). The patient received other vaccine within four weeks prior to the COVID vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU SHOT) in the left arm on 19Oct2021 for immunisation and venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR) and unspecified synthetic; all from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 63-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient previously took rituximab (RITUXAN) from an unknown date for follicular lymphoma and unknown if ongoing. On 02Nov2021, the patient experienced arm pain with redness and lump-like swelling, headache every day, chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick. The events arm pain with redness and lump-like swelling, headache everyday chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick 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 events arm pain with redness and lump-like swelling, headache everyday chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain with redness and lump-like swelling, headache everyday chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick was not resolved at the time of this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Pain in extremity, Swelling
Clinical narrative: The patient received third/ booster dose of BNT162B2; Arm pain; Redness; Lump-like swelling.; Headache everyday; Chills; Sweating enough to soak sheets and pillow for several days.; Diarrhea; Feeling sick; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 02Nov2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included non-hodgkins follicular lymphoma (6 months post rituxan maintenance). The patient received other vaccine within four weeks prior to the COVID vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (FLU SHOT) in the left arm on 19Oct2021 for immunisation and venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR) and unspecified synthetic; all from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 63-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient previously took rituximab (RITUXAN) from an unknown date for follicular lymphoma and unknown if ongoing. On 02Nov2021, the patient experienced arm pain with redness and lump-like swelling, headache every day, chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick. The events arm pain with redness and lump-like swelling, headache everyday chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick 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 events arm pain with redness and lump-like swelling, headache everyday chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain with redness and lump-like swelling, headache everyday chills, sweating enough to soak sheets and pillow for several days, diarrhea and feeling sick was not resolved at the time of this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Long term fever since October 18th. Averaging over 100 degrees.; Constant chills; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 18Oct2021 at 17:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included living kidney donor and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received clindamycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 18Oct2021 at 19:00, the patient experienced long term fever averaging over 100 degrees, constant chills and extreme fatigue. 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 been tested for COVID-19. On 03Nov2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events long term fever averaging over 100 degrees, constant chills and extreme fatigue were not resolved at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Some swelling and redness below the injection site.; Some swelling and redness below the injection site.; The patient received the third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 30Sep2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to pecans and cashews. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced some swelling and redness below the injection site for about 5 to 7 days but there was no pain. 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 some swelling and redness below the injection site were resolved on an unknown date in Oct2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 30Sep2021 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included depression and high blood pressure. The patient had no known allergies. 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 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 67-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 67-year-old), both as single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced some swelling and redness at the injection site for about 5 to 7 days and had no pain. The event did not result in doctor or other healthcare professional office/clinic, 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 some swelling and redness at the injection site was resolved on unknown date in Oct2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Immunisation, Incorrect dose administered
Clinical narrative: The patient received third/booster dose of BNT162B2; After fourth dose of Pfizer vaccine patient developed fever of 103.1F recorded on oral thermometer in ED; Chills; Tachycardic to 125bpm; Patient received 4th dose of BNT162B2; This is a spontaneous report from a non-contactable physician. A 55-year-old male patient received fourth dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Nov2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The medical history included intellectual disability, supraventricular tachycardia (SVT), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD) and allergy to penicillin which caused reaction of shortness of breath (SOB). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine in four weeks which included influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) on 08Oct2021. The concomitant medications were multiple including paracetamol (TYLENOL) and unspecified NSAIDs, all from unknown dates for unknown indications 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 on 24Mar2021(at the age of 55-years-old), second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 (at the age of 55-years-old) and third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Oct2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 23:00, after fourth dose of pfizer vaccine, the patient developed fever of 103.1 Fahrenheit (F) recorded on oral thermometer in the emergency department(ED), chills and tachycardic to 125 beats per minute (bpm). The reporter stated that the patient had no prior Pfizer COVID-19 vaccine reactions reported. On 05Nov2021, the patient underwent body temperature test and pulse rate and the result was 103.1F and 125 bpm respectively. On 06Nov2021, the patient underwent SARS-CoV-2 test (Flu/ respiratory syncytial virus (RSV/ polymerase chain reaction (PCR)) and the result was pending. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events included treatment with ketorolac tromethamine(TORADOL), paracetamol (TYLENOL) and unspecified fluids(unknown route of administration). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 103.1F, chills and tachycardic to 125 bpm were resolved on an unknown date in Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia
Clinical narrative: The patient received third/booster dose of BNT162B2; After fourth dose of Pfizer vaccine patient developed fever of 103.1F recorded on oral thermometer in ED; Chills; Tachycardic to 125bpm; Patient received 4th dose of BNT162B2; This is a spontaneous report from a non-contactable physician. A 55-year-old male patient received fourth dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Nov2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The medical history included intellectual disability, supraventricular tachycardia (SVT), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD) and allergy to penicillin which caused reaction of shortness of breath (SOB). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine in four weeks which included influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) on 08Oct2021. The concomitant medications were multiple including paracetamol (TYLENOL) and unspecified NSAIDs, all from unknown dates for unknown indications 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 on 24Mar2021(at the age of 55-years-old), second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 (at the age of 55-years-old) and third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Oct2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 23:00, after fourth dose of pfizer vaccine, the patient developed fever of 103.1 Fahrenheit (F) recorded on oral thermometer in the emergency department(ED), chills and tachycardic to 125 beats per minute (bpm). The reporter stated that the patient had no prior Pfizer COVID-19 vaccine reactions reported. On 05Nov2021, the patient underwent body temperature test and pulse rate and the result was 103.1F and 125 bpm respectively. On 06Nov2021, the patient underwent SARS-CoV-2 test (Flu/ respiratory syncytial virus (RSV/ polymerase chain reaction (PCR)) and the result was pending. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events included treatment with ketorolac tromethamine(TORADOL), paracetamol (TYLENOL) and unspecified fluids(unknown route of administration). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events fever of 103.1F, chills and tachycardic to 125 bpm were resolved on an unknown date in Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Immunisation, Salivary hypersecretion
Clinical narrative: The patient received third/booster dose of  BNT162B2; Abdominal pain; salivating; Chills; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old patient of unspecified gender received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 21Oct2021 as a single dose for COVID-19 immunisation. The patient's medical history were reported as none. 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 4 weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 30Mar2021 (at the age of 72-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 72-years-old), both as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced abdominal pain, chills and salivating. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abdominal pain, chills and salivating were resolved on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Myalgia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Swollen, red and itchy at injection site; Swollen, red and itchy at injection site; Swollen, red and itchy at injection site; Fatigue; Achy muscles; dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 04Nov2021 at 12:15 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hashimotos and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient received the first dose of influenza vaccine (MANUFACTURER UNKNOWN; lot number: 49281042150) in the left arm via unspecified route of administration on 12Oct2021 for immunisation, within 4 weeks prior to the COVID vaccine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID) and hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE) 20/12.5; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 52-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 52-year-old); both as single dose for COVID-19 immunisation. The patient previously received methylchloroisothiazolinone (MANUFACTURER UNKNOWN) and prochlorperazine maleate (COMPAZINE); both for unknown indications from unknown date and experienced drug allergy. On 04Nov2021 at 21:00, the patient experienced swollen, red and itchy at injection site, fatigue and achy muscles. 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 as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, red and itchy at injection site, fatigue and achy muscles was resolving at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen, red and itchy at injection site; Swollen, red and itchy at injection site; Swollen, red and itchy at injection site; Fatigue; Achy muscles; dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 04Nov2021 at 12:15 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hashimotos and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient received the first dose of influenza vaccine (MANUFACTURER UNKNOWN; lot number: 49281042150) in the left arm via unspecified route of administration on 12Oct2021 for immunisation, within 4 weeks prior to the COVID vaccine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID) and hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE) 20/12.5; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 52-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 52-year-old); both as single dose for COVID-19 immunisation. The patient previously received methylchloroisothiazolinone (MANUFACTURER UNKNOWN) and prochlorperazine maleate (COMPAZINE); both for unknown indications from unknown date and experienced drug allergy. On 04Nov2021 at 21:00, the patient experienced swollen, red and itchy at injection site, fatigue and achy muscles. 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 as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, red and itchy at injection site, fatigue and achy muscles was resolving at the time of this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Body temperature, Chills, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 03Nov2021 at 10:30 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included coronary artery disease and known allergy to penicillin. 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 vaccine. Concomitant medications included ROUVASTATIN 20 mg daily for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 13:15 (at the age of 67-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 25Mar2021 at 15:45 (at the age of 67-year-old), both as single dose for COVID-19 immunisation. On 04Nov2021 at 03:00, the next day and on 05Nov2021 (reported as Friday), the patient experienced chills and fever 101 (units unspecified). The fever was higher at night and lower to normal later in day, with Tylenol. The patient had mild headache throughout. On 06Nov2021 (reported as Saturday), patient was improving, had no fever, but tired with joint fatigue. 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 event fever and included treatment with TYLENOL from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (101) was resolved on 06Nov2021 and of chills, mild headache, and tired with joint fatigue was resolving at the time of this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 03Nov2021 at 10:30 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included coronary artery disease and known allergy to penicillin. 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 vaccine. Concomitant medications included ROUVASTATIN 20 mg daily for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 13:15 (at the age of 67-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 25Mar2021 at 15:45 (at the age of 67-year-old), both as single dose for COVID-19 immunisation. On 04Nov2021 at 03:00, the next day and on 05Nov2021 (reported as Friday), the patient experienced chills and fever 101 (units unspecified). The fever was higher at night and lower to normal later in day, with Tylenol. The patient had mild headache throughout. On 06Nov2021 (reported as Saturday), patient was improving, had no fever, but tired with joint fatigue. 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 event fever and included treatment with TYLENOL from unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (101) was resolved on 06Nov2021 and of chills, mild headache, and tired with joint fatigue was resolving at the time of this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain, Palpitations
Clinical narrative: Heart Palpitations; Shortness of Breath; Body Aches; Head Ache; Chills; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Nov2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 02:00, the patient experienced heart palpitations, shortness of breath, body aches, head ache, chills and pain at injection site. 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 as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart palpitations, shortness of breath, body aches, head ache, chills and pain at injection site were not resolved at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Heart Palpitations; Shortness of Breath; Body Aches; Head Ache; Chills; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Nov2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 02:00, the patient experienced heart palpitations, shortness of breath, body aches, head ache, chills and pain at injection site. 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 as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart palpitations, shortness of breath, body aches, head ache, chills and pain at injection site were not resolved at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Lymphadenopathy, Neck pain
Clinical narrative: Headache for 48hrs; Sore left deltoid x 3 days; Swollen left deltoid; Body aches; Joint aches; Neck ache; Left axillary lymphadenopathy; Administration date 03Nov2021 at 16:00, dose number=3; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 03Nov2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, psoriasis and anxiety. 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 included adalimumab (HUMIRA), metformin (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), atorvastatin calcium (LIPITOR), vitamin d nos (VIT D) and escitalopram (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on an unknown date as a single dose; both for COVID-19 immunisation. On 04Nov2021 at 01:00, the patient had headache for 48 hours, sore left deltoid for 3 days, swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy. The events headache for 48 hours, sore left deltoid for 3 days, swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy 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 events headache for 48 hours, sore left deltoid for 3 days, swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache for 48 hours was resolved on 06Nov2021 at 01:00 while sore left deltoid for 3 days was resolved on 07Nov2021. The clinical outcomes of the swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache for 48hrs; Sore left deltoid x 3 days; Swollen left deltoid; Body aches; Joint aches; Neck ache; Left axillary lymphadenopathy; Administration date 03Nov2021 at 16:00, dose number=3; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 03Nov2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, psoriasis and anxiety. 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 included adalimumab (HUMIRA), metformin (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), atorvastatin calcium (LIPITOR), vitamin d nos (VIT D) and escitalopram (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on an unknown date as a single dose; both for COVID-19 immunisation. On 04Nov2021 at 01:00, the patient had headache for 48 hours, sore left deltoid for 3 days, swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy. The events headache for 48 hours, sore left deltoid for 3 days, swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy 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 events headache for 48 hours, sore left deltoid for 3 days, swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache for 48 hours was resolved on 06Nov2021 at 01:00 while sore left deltoid for 3 days was resolved on 07Nov2021. The clinical outcomes of the swollen left deltoid, body aches, joint aches, neck ache and left axillary lymphadenopathy were resolving 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: Immunisation, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: Lymphadenopathy 48 hours later; Fever 24 hours later; Body aches 24 hours later; Malaise 24 hours later; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 05Nov2021 at 13:15 (at the age of 38-years old) as a single dose for COVID-19 immunisation. The medical history included hypothyroidism and allergy to sulfur drugs. 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 received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El8982) via an unspecified route of administration on 23Jan2021 at 12:00 (at the age of 37-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration on 13Feb2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 15:00, 24 hours later, the patient experienced fever, body aches and malaise. On 07Nov2021, 48 hours later, the patient experienced lymphadenopathy. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymphadenopathy, fever, body aches and malaise were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.