chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021 at 12:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that on 24-Sep-2021, patient received the Moderna vaccine which expired on 22-Sep-2021. The patient did not have any adverse events and did not require any medical attention. No problems were reported from the patient.  No concomitant medication was reported. No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Influenza like illness, Vaccination site pain
Clinical narrative: large tender area below injection site on arm; received the larger than expected dose; flu-like symptoms for about 8 hrs.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hrs.), VACCINATION SITE PAIN (large tender area below injection site on arm) and INCORRECT DOSE ADMINISTERED (received the larger than expected dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (received the larger than expected dose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hrs.) and VACCINATION SITE PAIN (large tender area below injection site on arm). On 17-Oct-2021, INCORRECT DOSE ADMINISTERED (received the larger than expected dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hrs.) had resolved and VACCINATION SITE PAIN (large tender area below injection site on arm) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient was not immunocompromised.   This case was linked to MOD-2021-360706 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: blurry vision; diaphoretic; This is a spontaneous report from a non-contactable pharmacist. A 81-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an intramuscular route of administration in the left arm on 24Feb2021 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced blurry vision, code med and diaphoretic and transferred to emergency department. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and received unspecified treatment. Since the vaccination, it was unknown whether the patient have tested for COVID-19. The clinical outcome of the events blurry vision, code med and diaphoretic was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Night sweats, Pyrexia, Vomiting
Clinical narrative: Vomiting; Diarrhea; Fever; Night sweats; Severe weakness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Sep2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, degenerative disc disease, fibromyalgia, post-traumatic stress disorder (PTSD) and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation and received bupropion hydrochloride (WELLBUTRIN), metoclopramide (REGLAN) and prochlorperazine maleate (COMPAZINE); all for unknown indication on unknown date and experienced drug allergy. On 25Sep2021 at 14:00, the patient experienced vomiting, diarrhea, fever, night sweats and severe weakness. 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 vomiting, diarrhea, fever, night sweats and severe weakness was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: Cough; Fatigue; Sore throat; Congestion; Chills; Nausea; Headache; Tiredness; Pain at vaccination site; Swelling and redness at the vaccination site; Swelling and redness at the vaccination site; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Sep2021 at 15:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included Diabetes, obesity, shortness of breath, dysphagia, neck, low and upper back problems. 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 metformin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Aug 2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 24Sep2021 at 00:00, the patient experienced cough, fatigue, sore throat, congestion, chills, nausea, headache, tiredness, pain, swelling and redness at the vaccination 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cough, fatigue, sore throat, congestion, chills, nausea, headache, tiredness, pain, swelling and redness at the vaccination site was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Cough; Fatigue; Sore throat; Congestion; Chills; Nausea; Headache; Tiredness; Pain at vaccination site; Swelling and redness at the vaccination site; Swelling and redness at the vaccination site; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Sep2021 at 15:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included Diabetes, obesity, shortness of breath, dysphagia, neck, low and upper back problems. 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 metformin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Aug 2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 24Sep2021 at 00:00, the patient experienced cough, fatigue, sore throat, congestion, chills, nausea, headache, tiredness, pain, swelling and redness at the vaccination 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cough, fatigue, sore throat, congestion, chills, nausea, headache, tiredness, pain, swelling and redness at the vaccination site was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report from a non-contactable pharmacist. A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the left arm on 02Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced tachycardia which was elevated for an hour and went away after 20 minutes. It was reported that the patient was 17 weeks pregnant. Therapeutic measures were not taken as a result of the event. It was unknown if since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event tachycardia was resolved on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia
Clinical narrative: Dizziness and lightheadedness; Difficulty swallowing for 15 minutes; This is a spontaneous report from a non-contactable pharmacist. A 26-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration on 04Jun2021(at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown that the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced dizziness, lightheadedness and difficulty swallowing for 15 minutes. The events did not result in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown that the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, lightheadedness and difficulty swallowing was resolved on an unknown date in 2021, after a duration of 15 minutes.    No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Poor quality sleep, Pyrexia
Clinical narrative: Fatigue; Low grade fever; Weakness; Poor sleep; This is a spontaneous report from a contactable consumer. An 89-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Sep2021 (at the age of 89-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 COVID vaccine. On 25Sep2021, the patient experienced fatigue, low grade fever, weakness and poor sleep. 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 fatigue, low grade fever, weakness and poor sleep was resolved on an unknown date in Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Cough, Headache
Clinical narrative: The day following vaccination, experienced lethargy; Somnolence; Headache; Myalgia; Joint pain; Left axillary tenderness/lymphadenopathy; Left axillary tenderness/lymphadenopathy; Fever (highest 102.1),; Cough; This is a spontaneous report from a non-contactable physician, the patient. A 43-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 25Sep2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension) and Graves disease from an unknown date, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received amlodipine (MANUFACTURER UNKNOWN) on unknown date, for unspecified indication and experienced drug allergy. On 26Sep2021, the day following vaccination, the patient experienced lethargy, somnolence, headache, myalgia, joint pain, left axillary tenderness, lymphadenopathy, fever (highest 102.1), cough. All symptoms resolved within the following day except for L axillary lymphadenopathy which remained unresolved. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. On the same day, the patient underwent body temperature and the result was 102.1 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events lethargy, somnolence, headache, myalgia, joint pain, left axillary tenderness, fever (highest 102.1), cough were resolved on an unknown date in 27Sep2021, whereas the event left axillary lymphadenopathy was not resolved 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lymphadenopathy, Myalgia, Pyrexia, Somnolence
Clinical narrative: The day following vaccination, experienced lethargy; Somnolence; Headache; Myalgia; Joint pain; Left axillary tenderness/lymphadenopathy; Left axillary tenderness/lymphadenopathy; Fever (highest 102.1),; Cough; This is a spontaneous report from a non-contactable physician, the patient. A 43-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 25Sep2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension) and Graves disease from an unknown date, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received amlodipine (MANUFACTURER UNKNOWN) on unknown date, for unspecified indication and experienced drug allergy. On 26Sep2021, the day following vaccination, the patient experienced lethargy, somnolence, headache, myalgia, joint pain, left axillary tenderness, lymphadenopathy, fever (highest 102.1), cough. All symptoms resolved within the following day except for L axillary lymphadenopathy which remained unresolved. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. On the same day, the patient underwent body temperature and the result was 102.1 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events lethargy, somnolence, headache, myalgia, joint pain, left axillary tenderness, fever (highest 102.1), cough were resolved on an unknown date in 27Sep2021, whereas the event left axillary lymphadenopathy was not resolved 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose fluctuation
Clinical narrative: Blood sugar was going up and down after the vaccine; This is a spontaneous report from a non-contactable pharmacist. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via intramuscular route of administration in the right arm on 27Sep2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was unknown. It was unknown whether the patient was pregnant. It was unknown if the patient had any allergies. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Sep2021, the patient experienced blood sugar going up and down after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown if since the vaccination, the patient had been tested for COVID-19. On 27Sep2021, the patient underwent blood glucose test and the result was blood sugar going up and down. It was unknown whether the patient had taken therapeutic measures as a result of the event. The clinical outcome of the event blood sugar was going up and down after the vaccine was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Horrible headaches; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Jan2021(at the age of 53-years-old) , as a single dose for COVID-19 immunisation. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 13Jan2021, the patient had horrible headaches and had not gone away. She went to doctor appointments and nothing has taken them away. Therapeutic measures were not taken as a result of the event.  The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event horrible headaches was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Gingival discomfort, Gingival erythema, Hypersensitivity, Lip erythema
Clinical narrative: Redness and burning along lower lip and gum line.; Rawness on inside of lower lip andalong lower gum line; Tingling lips; She looked up and told me this was an allergic response; Sore on right lower lip within first two hours. This has spread to multiple cold like sores on lower lip.; Burning along lower lip and gum line.; Burning along lower lip and gum line.; Redness and burning along lower lip and gum line.; This is a spontaneous report from a contactable healthcare professional. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Sep2021 at 10:30 as a single dose for COVID-19 immunisation. Medical history included epstein-barr and adverse reactions to stomach medicine as teenager and anesthesia in 2006. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021 at 12:00 the patient experienced sore on right lower lip within first two hour that had spread to multiple cold like sores on lower lip and a rawness on inside of lower lip and along lower gum line and the patient reported redness and burning along lower lip and gum line and burning and tingling. When she went to schedule next vaccine she asked pharmacist if she could wait until sores healed. She removed my mask and showed her mouth. She looked up and told the patient this was an allergic response and not to get second vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event sore on right lower lip within first two hour that had spread to multiple cold like sores on lower lip and a rawness on inside of lower lip and along lower gum line and the patient reported redness and burning along lower lip and gum line and burning and tingling and allergic response was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Oral herpes, Paraesthesia oral
Clinical narrative: Redness and burning along lower lip and gum line.; Rawness on inside of lower lip andalong lower gum line; Tingling lips; She looked up and told me this was an allergic response; Sore on right lower lip within first two hours. This has spread to multiple cold like sores on lower lip.; Burning along lower lip and gum line.; Burning along lower lip and gum line.; Redness and burning along lower lip and gum line.; This is a spontaneous report from a contactable healthcare professional. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Sep2021 at 10:30 as a single dose for COVID-19 immunisation. Medical history included epstein-barr and adverse reactions to stomach medicine as teenager and anesthesia in 2006. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021 at 12:00 the patient experienced sore on right lower lip within first two hour that had spread to multiple cold like sores on lower lip and a rawness on inside of lower lip and along lower gum line and the patient reported redness and burning along lower lip and gum line and burning and tingling. When she went to schedule next vaccine she asked pharmacist if she could wait until sores healed. She removed my mask and showed her mouth. She looked up and told the patient this was an allergic response and not to get second vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event sore on right lower lip within first two hour that had spread to multiple cold like sores on lower lip and a rawness on inside of lower lip and along lower gum line and the patient reported redness and burning along lower lip and gum line and burning and tingling and allergic response 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Malaise, Rhinorrhoea
Clinical narrative: Chills; Body malaise/muscle pain on affected area/not feeling well; Runny nose; Booster; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received the booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 27Sep2021 at 14:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 4 weeks prior to the COVID vaccine. The patient previously received the first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On 27Sep2021 at 23:00, the patient experienced chills, body malaise, runny nose, muscle pain on affected area. The patient was not feeling well after the COVID shot booster. Even she took Tylenol and still her symptoms did not go away. This is first time to experience this kind of side effects. 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 events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, runny nose and body malaise/muscle pain on affected area/not feeling well after the COVID shot booster 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Influenza like illness, Myalgia, Sneezing
Clinical narrative: sick with flu like symptoms; Sneezing; coughing; muscle pain; feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 15:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 of vaccination. On 13Sep2021, the patient got sick with flu like symptoms and the symptoms included sneezing, coughing, muscle pain and was feeling tired. These were common symptoms of a flu, but the fact was that the patient was sick like that only once before in 2016 after she travelled by plain to abroad.  The patient got sick like she got like virus vaccine, which she did not appreciate at all. 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 sick with flu like symptoms, sneezing, coughing, muscle pain, feeling tired, common symptoms of a flu was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Herpes zoster, Investigation, Pain
Clinical narrative: About a week and a half or two weeks ago he broke out in a rash on his stomach/ Rash are worse; Diagnosed with shingles; He had burning sensations on his skin; Back pain; Pain in his hip; rash is also painful; This is a spontaneous report from a contactable consumer or other non HCP.    A 33-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FE3592), dose 1 via an unspecified route of administration, administered in Arm Left on 07Sep2021 (Batch/Lot Number: FE3592) as dose 1, single for covid-19 immunisation. Medical history none. There were no concomitant medications. No Prior vaccination with in four weeks. It was reported that, Caller stated about the Pfizer Covid19 vaccine and got the 1st shot about three weeks ago and about a week and a half or two weeks ago he broke out in a rash on his stomach; states he left the rash alone and is a pretty healthy 33-year-old and has no medical history and does not go to the doctor and does not take Advil or Motrin and left the rash alone. States he was working and took the vaccine because of the mandate forced him to get the vaccine or they would fire him. States he took the 1st shot of the vaccine and was breaking out with a rash and finished the workday and had a day off and was scheduled for the 2nd dose of the vaccine today but did not get the 2nd dose. States he wanted to call to report this information because he went to the urgent care yesterday and was diagnosed with shingles. The outcome of the event back pain was recovered, and the other events was not recovered. The patient underwent lab tests and procedures which included investigation: shingles on 27Sep2021 he went to the urgent care yesterday and was diagnosed with shingles. Therapeutic measures were taken as a result of about a week and a half or two weeks ago he broke out in a rash on his stomach/ rash are worse (rash), diagnosed with shingles (herpes zoster), he had burning sensations on his skin (skin burning sensation), back pain (back pain), pain in his hip (arthralgia) , rash is also painful (pain). Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: About a week and a half or two weeks ago he broke out in a rash on his stomach/ Rash are worse; Diagnosed with shingles; He had burning sensations on his skin; Back pain; Pain in his hip; rash is also painful; This is a spontaneous report from a contactable consumer or other non HCP.    A 33-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FE3592), dose 1 via an unspecified route of administration, administered in Arm Left on 07Sep2021 (Batch/Lot Number: FE3592) as dose 1, single for covid-19 immunisation. Medical history none. There were no concomitant medications. No Prior vaccination with in four weeks. It was reported that, Caller stated about the Pfizer Covid19 vaccine and got the 1st shot about three weeks ago and about a week and a half or two weeks ago he broke out in a rash on his stomach; states he left the rash alone and is a pretty healthy 33-year-old and has no medical history and does not go to the doctor and does not take Advil or Motrin and left the rash alone. States he was working and took the vaccine because of the mandate forced him to get the vaccine or they would fire him. States he took the 1st shot of the vaccine and was breaking out with a rash and finished the workday and had a day off and was scheduled for the 2nd dose of the vaccine today but did not get the 2nd dose. States he wanted to call to report this information because he went to the urgent care yesterday and was diagnosed with shingles. The outcome of the event back pain was recovered, and the other events was not recovered. The patient underwent lab tests and procedures which included investigation: shingles on 27Sep2021 he went to the urgent care yesterday and was diagnosed with shingles. Therapeutic measures were taken as a result of about a week and a half or two weeks ago he broke out in a rash on his stomach/ rash are worse (rash), diagnosed with shingles (herpes zoster), he had burning sensations on his skin (skin burning sensation), back pain (back pain), pain in his hip (arthralgia) , rash is also painful (pain). Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence, Urticaria
Clinical narrative: Fever; Drowsiness; Hives; Pain in my hands; Pain in feet; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Sep2021 at 17:00(at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other vaccines within two weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on unknown date, as a single dose for COVID-19 immunisation.  The patient had known allergy to ZOFRAN. On 25Sep2021 at 10:00,  the patient experienced fever, drowsiness, hives, pain in hands and feet. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the treatment of these adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever, drowsiness, hives, and pain in hands and feet 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypokinesia, Painful respiration, SARS-CoV-2 test
Clinical narrative: The day after receiving the vaccine I had severe back pain; I couldnt walk much without being in pain for the first four days after vaccine; While breathing my back would hurt.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Sep2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy, epidural anesthesia and delivery on unknown dates. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Sep2021 at 09:00, the day after receiving the vaccine, the patient experienced severe back pain. She couldn't walk much without being in pain for the first four days after vaccine. Also, sometimes while breathing her back would hurt. The pain was so much worse than when she gave birth to both her kids. The area of pain was where she got the epidural on her spine for her first born. She did not get the epidural for her second child. But it was so much worse than the pain she felt when giving birth. She did not go to hospital because she had kids (single mom) and couldn't drive or leave her kids, also she thought she was just having a bad reaction since it only lasted for four days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 08Sep2021, the patient underwent COVID-19 (SARS-CoV-2); nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event couldn't walk much without being in pain severe back pain was resolved on 11Sep2021, after a duration of 4 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Diarrhoea, Headache, Lethargy
Clinical narrative: Muscle pain; Lethargy; Headache; Temp of 100.9; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 78-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 right arm on 27Sep2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer surgery in Nov2020 and high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. Concomitant medications included influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT) on 15Sep2021 for unknown indication; letrozole (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR); both for unknown indications from an unknown date and unknown if ongoing. On 27Sep2021 at 20:30, the patient experienced muscle pain, lethargy, headache, temperature (temp) of 100.9, diarrhea and nausea. On the same day, the patient underwent body temperature test and the result was 100.9 (units unspecified). 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 muscle pain, lethargy, headache, temp of 100.9, diarrhea and nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Muscle pain; Lethargy; Headache; Temp of 100.9; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 78-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 right arm on 27Sep2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer surgery in Nov2020 and high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. Concomitant medications included influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT) on 15Sep2021 for unknown indication; letrozole (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR); both for unknown indications from an unknown date and unknown if ongoing. On 27Sep2021 at 20:30, the patient experienced muscle pain, lethargy, headache, temperature (temp) of 100.9, diarrhea and nausea. On the same day, the patient underwent body temperature test and the result was 100.9 (units unspecified). 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 muscle pain, lethargy, headache, temp of 100.9, diarrhea and nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Headache; Muscle aches; Weakness; Fatigue; Axillary adenopathy; This is a spontaneous report from a contactable consumer, the patient. An 83-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 right arm on 27Sep2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to 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 meloxicam (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); all medications from an unknown date for unknown indication and unknown if ongoing. On 16Aug2021, the patient underwent PCR test via nasal swab for COVID-19 and the result was found to be negative. On 28Sep2021 at 03:00, the patient experienced headache, muscle aches, weakness, fatigue and axillary adenopathy. 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 reported events. Since the vaccination, the patient had been tested for COVID-19 (as reported).  The clinical outcome of the events headache, muscle aches, weakness, fatigue and axillary adenopathy was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Headache; Muscle aches; Weakness; Fatigue; Axillary adenopathy; This is a spontaneous report from a contactable consumer, the patient. An 83-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 right arm on 27Sep2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to 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 meloxicam (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); all medications from an unknown date for unknown indication and unknown if ongoing. On 16Aug2021, the patient underwent PCR test via nasal swab for COVID-19 and the result was found to be negative. On 28Sep2021 at 03:00, the patient experienced headache, muscle aches, weakness, fatigue and axillary adenopathy. 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 reported events. Since the vaccination, the patient had been tested for COVID-19 (as reported).  The clinical outcome of the events headache, muscle aches, weakness, fatigue and axillary adenopathy was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: 3rd dose/Primary Immunization series complete but unknown manufacturer; 3rd dose really knocked her down; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Sep2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of this report. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On 28Sep2021, the patient said that 3rd dose really "knocked her down." No other details were provided. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event 3rd dose really knocked her down was unknown 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomited Tuesday Sept 28; Nauseous; This is a spontaneous report from a contactable consumer. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Sep2021 at 16:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 28Sep2021 at 07:00, the patient vomited and was still nauseous at the time of report. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event vomited was resolved on 28Sep2021 and the event nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.