chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Ear pain, Gait disturbance
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Joint swelling, Nausea, Oral pain, Oropharyngeal pain
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral venous disease, Pyrexia, Rash, Somnolence
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip pain, Lip swelling, Mouth cyst, Thrombosis, Visual impairment
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: had blood clots; have her bad eye sight get worse after vaccination; small cyst in my mouth on the upper pallet; her lips are not swollen anymore but there is a lingering feeling and it hurts; her lips are not swollen anymore but there is a lingering feeling and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "had blood clots"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "have her bad eye sight get worse after vaccination"; MOUTH CYST (non-serious), outcome "unknown", described as "small cyst in my mouth on the upper pallet"; LIP SWELLING (non-serious), LIP PAIN (non-serious), outcome "unknown" and all described as "her lips are not swollen anymore but there is a lingering feeling and it hurts". The events "had blood clots", "have her bad eye sight get worse after vaccination", "small cyst in my mouth on the upper pallet", "her lips are not swollen anymore but there is a lingering feeling and it hurts" and "her lips are not swollen anymore but there is a lingering feeling and it hurts" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: results unknown. Clinical Course: Patient had a small cyst in my mouth on the upper pallet after the first dose of the Pfizer-BioNTech COVID-19 Vaccine. Her doctor took a picture and was advised to go to the dentist. She had an X-ray and her dentist didn't know what it is and was advised to go back to her doctor. She noted that her lips are not swollen anymore but there is a lingering feeling and it hurts. She wants to know what it is and what to do or whose help should she get. Patient reporting to have her bad eye sight get worse after vaccination. She also had blood clots. She has checked with her doctor and was advised not to get the second dose. She is going to the opera and is concern if there are any regulation and rules that may not allow her to get in with not having fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Asthenia, Confusional state, Dysphagia, Haematoma
Clinical narrative: Patient presented with SOB, and cough. Patient ended up testing positive for COVID-19.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Hysteroscopy abnormal, Metabolic encephalopathy, Thrombosis, Urine analysis
Clinical narrative: Patient presented with SOB, and cough. Patient ended up testing positive for COVID-19.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Patient presented with SOB, and cough. Patient ended up testing positive for COVID-19.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Patient presented with SOB, and cough. Patient ended up testing positive for COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Blood lactate dehydrogenase increased, C-reactive protein increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Pt fully vaccinated 2/9/21 and 3/2/21 for COVID, developed severe covid pneumonia requiring intubation and prolonged complicated hospitalization beginning 8/29/21
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, SARS-CoV-2 test positive, White blood cell count increased
Clinical narrative: Pt fully vaccinated 2/9/21 and 3/2/21 for COVID, developed severe covid pneumonia requiring intubation and prolonged complicated hospitalization beginning 8/29/21
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Endotracheal intubation
Clinical narrative: Pt fully vaccinated 2/9/21 and 3/2/21 for COVID, developed severe covid pneumonia requiring intubation and prolonged complicated hospitalization beginning 8/29/21
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Headache, Malaise
Clinical narrative: they are not only sore in their arms; also experiencing extreme fatigue and tiredness,; sleepy very very sleepy; its irritating right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, PFIZER-BIONTECH COVID-19 VACCINE), administration date: 22Jan2021, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "they are not only sore in their arms"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "also experiencing extreme fatigue and tiredness,"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "sleepy very very sleepy"; IRRITABILITY (non-serious) with onset 2021, outcome "unknown", described as "its irritating right now".  Additional Information: This consumer reported similar events for herself and 1 patient (Husband). This is a fourth of four reports. This consumer reported for a male patient. The caller reported that the events "extreme fatigue and tiredness, sleepy very very sleepy" started right away or a couple days after. It was reported that the patient had already been to his doctor and was told that he was fine and nothing was wrong. The caller was asking about side effects lasting so long from the shot and what the caller could take or what could be done to make the symptom better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239663 same reporter/drug/dose/event, different patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Irritability, Pain in extremity, Somnolence
Clinical narrative: they are not only sore in their arms; also experiencing extreme fatigue and tiredness,; sleepy very very sleepy; its irritating right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, PFIZER-BIONTECH COVID-19 VACCINE), administration date: 22Jan2021, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "they are not only sore in their arms"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "also experiencing extreme fatigue and tiredness,"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "sleepy very very sleepy"; IRRITABILITY (non-serious) with onset 2021, outcome "unknown", described as "its irritating right now".  Additional Information: This consumer reported similar events for herself and 1 patient (Husband). This is a fourth of four reports. This consumer reported for a male patient. The caller reported that the events "extreme fatigue and tiredness, sleepy very very sleepy" started right away or a couple days after. It was reported that the patient had already been to his doctor and was told that he was fine and nothing was wrong. The caller was asking about side effects lasting so long from the shot and what the caller could take or what could be done to make the symptom better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239663 same reporter/drug/dose/event, different patient
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Flu like symptoms; cough; runny nose; This spontaneous case was retrieved on 27-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1774817-1), reported by other non-healthcare professional and concerned an adult, female patient of unreported age.   The patient had no relevant medical history and was not taking any concomitant medications.  On unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location: not reported). The batch number was not reported.  On unknown date, an unspecified amount of time after receiving influenza virus vaccine polyvalent, the patient developed non-serious events flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea). It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of unreported age developed flu like symptoms, rhinorrhea and cough after receiving influenza virus vaccine polyvalent. Due to lack of information regarding chronology, causality for the reported events is unassessable.; Sender's Comments: A female patient of unreported age developed flu like symptoms, rhinorrhea and cough after receiving influenza virus vaccine polyvalent. Due to the lack of information regarding chronology, causality for the reported events is unassessable.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Influenza like illness, Rhinorrhoea
Clinical narrative: Flu like symptoms; cough; runny nose; This spontaneous case was retrieved on 27-Oct-2021 from Vaccine Adverse Event Reporting System (reference number: 1774817-1), reported by other non-healthcare professional and concerned an adult, female patient of unreported age.   The patient had no relevant medical history and was not taking any concomitant medications.  On unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location: not reported). The batch number was not reported.  On unknown date, an unspecified amount of time after receiving influenza virus vaccine polyvalent, the patient developed non-serious events flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea). It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of unreported age developed flu like symptoms, rhinorrhea and cough after receiving influenza virus vaccine polyvalent. Due to lack of information regarding chronology, causality for the reported events is unassessable.; Sender's Comments: A female patient of unreported age developed flu like symptoms, rhinorrhea and cough after receiving influenza virus vaccine polyvalent. Due to the lack of information regarding chronology, causality for the reported events is unassessable.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Insomnia, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 31-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Sep2021 13:00 (Lot number: 30155BA) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (prev dose product=COVID 19, prev dose brand=Comirnaty, prev dose brand unknown=False, prev dose lot number=FF2587, prev dose lot unknown=False, prev dose administration date=07Sep2021, prev dose administration time=01:15PM, prev dose number=1, prev dose vaccine location=Left arm), administration date: 07Sep2021, when the patient was 31 years old, for COVID-19 IMMUNIZATION. The following information was reported: ARTHRALGIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Moderate to severe joint pain, primarily located in wrists, elbows, ankles, and knees."; PAIN (non-serious) with onset 30Sep2021, outcome "not recovered", described as "pain"; INSOMNIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "inability to sleep through the night". The events "moderate to severe joint pain, primarily located in wrists, elbows, ankles, and knees.", "pain" and "inability to sleep through the night" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia, pain, insomnia. Additional Information: Facility type Vaccine was Hospital. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Insomnia, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 31-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Sep2021 13:00 (Lot number: 30155BA) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (prev dose product=COVID 19, prev dose brand=Comirnaty, prev dose brand unknown=False, prev dose lot number=FF2587, prev dose lot unknown=False, prev dose administration date=07Sep2021, prev dose administration time=01:15PM, prev dose number=1, prev dose vaccine location=Left arm), administration date: 07Sep2021, when the patient was 31 years old, for COVID-19 IMMUNIZATION. The following information was reported: ARTHRALGIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "Moderate to severe joint pain, primarily located in wrists, elbows, ankles, and knees."; PAIN (non-serious) with onset 30Sep2021, outcome "not recovered", described as "pain"; INSOMNIA (non-serious) with onset 30Sep2021, outcome "not recovered", described as "inability to sleep through the night". The events "moderate to severe joint pain, primarily located in wrists, elbows, ankles, and knees.", "pain" and "inability to sleep through the night" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia, pain, insomnia. Additional Information: Facility type Vaccine was Hospital. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Joint stiffness, Myalgia
Clinical narrative: STIFFNESS; JOINT PAIN; MAJOR HEADACHE; LOW GRADE FEVER; MUSCLE SORENESS  AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old of unspecified sex.  The patient's height, and weight were not reported. The patient's past medical history included: temporomandibular joint (TMJ) disorder, and concurrent conditions included: premenstrual dysphoric disorder (PMDD), penicillin allergy (PCN),drug allergy (sudafed), and season allergies.  The patient received covid-19 vaccine ad26.cov2.s (Dose Number in Series: 1, batch number: 202A21A, expiry: 21-SEP-2021) for prophylactic vaccination in 28-APR-2021 and experienced hair loss that began on 15-MAY-2021 where patient notice a more than normal amount and longer duration of hair loss.(Dose Number in Series: 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, (Dose Number in Series: 2), 1 total administered on 04-NOV-2021 11:45 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 04-NOV-2021, after 1 hour, the patient began to experienced muscle soreness at injection site. On 05-NOV-2021, morning, the patient experienced joint pain, stiffness, major headache and low grade fever. (Dose Number in Series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the joint pain, stiffness, major headache, low grade fever and muscle soreness at injection site was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211127938 (Dose Number in Series: 1).
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: STIFFNESS; JOINT PAIN; MAJOR HEADACHE; LOW GRADE FEVER; MUSCLE SORENESS  AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old of unspecified sex.  The patient's height, and weight were not reported. The patient's past medical history included: temporomandibular joint (TMJ) disorder, and concurrent conditions included: premenstrual dysphoric disorder (PMDD), penicillin allergy (PCN),drug allergy (sudafed), and season allergies.  The patient received covid-19 vaccine ad26.cov2.s (Dose Number in Series: 1, batch number: 202A21A, expiry: 21-SEP-2021) for prophylactic vaccination in 28-APR-2021 and experienced hair loss that began on 15-MAY-2021 where patient notice a more than normal amount and longer duration of hair loss.(Dose Number in Series: 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, (Dose Number in Series: 2), 1 total administered on 04-NOV-2021 11:45 to left arm for prophylactic vaccination. No concomitant medications were reported.   On 04-NOV-2021, after 1 hour, the patient began to experienced muscle soreness at injection site. On 05-NOV-2021, morning, the patient experienced joint pain, stiffness, major headache and low grade fever. (Dose Number in Series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the joint pain, stiffness, major headache, low grade fever and muscle soreness at injection site was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211127938 (Dose Number in Series: 1).
Age: 83.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient came into office and received first dose of Pfizer/BioNTech Covid vaccine. The MA administering vaccine noticed at the end of the day the vaccine was give 1.5 hours after the vaccine expiration time. Our Clinical Manager reached out to our pharmacy director for guidance and obtained direction confirming time expiration of 6 hours once drawn into vials and stored at room temperature. Provider and staff notified the patient called to advise them to return for repeat dose. Patient returned on 11/9/2021 for new dose - Lot #FG3527. New vaccine was given in same right arm/deltoid.
Age: 83.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Expired product administered, Immunisation
Clinical narrative: Patient came into office and received first dose of Pfizer/BioNTech Covid vaccine. The MA administering vaccine noticed at the end of the day the vaccine was give 1.5 hours after the vaccine expiration time. Our Clinical Manager reached out to our pharmacy director for guidance and obtained direction confirming time expiration of 6 hours once drawn into vials and stored at room temperature. Provider and staff notified the patient called to advise them to return for repeat dose. Patient returned on 11/9/2021 for new dose - Lot #FG3527. New vaccine was given in same right arm/deltoid.
Age: 83.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Back pain, Expired product administered, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came into office and received first dose of Pfizer/BioNTech Covid vaccine. The MA administering vaccine noticed at the end of the day the vaccine was give 1.5 hours after the vaccine expiration time. Our Clinical Manager reached out to our pharmacy director for guidance and obtained direction confirming time expiration of 6 hours once drawn into vials and stored at room temperature. Provider and staff notified the patient called to advise them to return for repeat dose. Patient returned on 11/9/2021 for new dose - Lot #FG3527. New vaccine was given in same right arm/deltoid.
Age: 83.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Poor quality product administered, Vascular test
Clinical narrative: Patient came into office and received first dose of Pfizer/BioNTech Covid vaccine. The MA administering vaccine noticed at the end of the day the vaccine was give 1.5 hours after the vaccine expiration time. Our Clinical Manager reached out to our pharmacy director for guidance and obtained direction confirming time expiration of 6 hours once drawn into vials and stored at room temperature. Provider and staff notified the patient called to advise them to return for repeat dose. Patient returned on 11/9/2021 for new dose - Lot #FG3527. New vaccine was given in same right arm/deltoid.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cardio-respiratory arrest, Hypoaesthesia, Movement disorder, Oxygen saturation decreased, Paraesthesia
Clinical narrative: Allergic reaction - major. Shortness of breath; Temperature Tympanic [36-38 Deg C] 36.4 Deg C (1/9/20 1:04 PM); Peripheral Pulse Rate [60-100 bpm] 69 bpm (1/9/20 1:04 PM); 72 bpm (10/17/19 1:56 PM); Peripheral Pulse Rate [50-100 bpm] 82 bpm (10/7/19 12:59 PM); Respiratory Rate [12-20 br/min]; 18 br/min (1/9/20 1:04 PM) 18 br/min (10/17/19 1:56 PM) 22 br/min *HI*  (10/7/19 12:59 PM); Mean Arterial Pressure, Cuff 83 mmHg (10/17/19 1:56 PM) 94 mmHg; (10/7/19 12:59 PM) Blood Pressure Manual Automatic  (10/17/19 1:56 PM) Automatic (10/7/19 12:59 PM); Temperature Temporal [36.6-38.1 Deg C] 37.0 Deg C (10/7/19 12:59 PM)   Blood Pressure [90-160/50-90 mmHg] 158/92 mmHg  (1/9/20 1:04 PM) 113/68 mmHg  (10/17/19 1:56 PM)  Blood Pressure [110-130/64-83 mmHg] 132/75 mmHg  *HI*   (10/7/19 12:59 PM); Epi-Pen administered on scene. Ambulance gave second dose of Epinephrine, IV fluid, Benedryl and Prednisone; Ambulance called.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Peripheral coldness
Clinical narrative: Allergic reaction - major. Shortness of breath; Temperature Tympanic [36-38 Deg C] 36.4 Deg C (1/9/20 1:04 PM); Peripheral Pulse Rate [60-100 bpm] 69 bpm (1/9/20 1:04 PM); 72 bpm (10/17/19 1:56 PM); Peripheral Pulse Rate [50-100 bpm] 82 bpm (10/7/19 12:59 PM); Respiratory Rate [12-20 br/min]; 18 br/min (1/9/20 1:04 PM) 18 br/min (10/17/19 1:56 PM) 22 br/min *HI*  (10/7/19 12:59 PM); Mean Arterial Pressure, Cuff 83 mmHg (10/17/19 1:56 PM) 94 mmHg; (10/7/19 12:59 PM) Blood Pressure Manual Automatic  (10/17/19 1:56 PM) Automatic (10/7/19 12:59 PM); Temperature Temporal [36.6-38.1 Deg C] 37.0 Deg C (10/7/19 12:59 PM)   Blood Pressure [90-160/50-90 mmHg] 158/92 mmHg  (1/9/20 1:04 PM) 113/68 mmHg  (10/17/19 1:56 PM)  Blood Pressure [110-130/64-83 mmHg] 132/75 mmHg  *HI*   (10/7/19 12:59 PM); Epi-Pen administered on scene. Ambulance gave second dose of Epinephrine, IV fluid, Benedryl and Prednisone; Ambulance called.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Hypersensitivity, Hypertension, Mean arterial pressure
Clinical narrative: Allergic reaction - major. Shortness of breath; Temperature Tympanic [36-38 Deg C] 36.4 Deg C (1/9/20 1:04 PM); Peripheral Pulse Rate [60-100 bpm] 69 bpm (1/9/20 1:04 PM); 72 bpm (10/17/19 1:56 PM); Peripheral Pulse Rate [50-100 bpm] 82 bpm (10/7/19 12:59 PM); Respiratory Rate [12-20 br/min]; 18 br/min (1/9/20 1:04 PM) 18 br/min (10/17/19 1:56 PM) 22 br/min *HI*  (10/7/19 12:59 PM); Mean Arterial Pressure, Cuff 83 mmHg (10/17/19 1:56 PM) 94 mmHg; (10/7/19 12:59 PM) Blood Pressure Manual Automatic  (10/17/19 1:56 PM) Automatic (10/7/19 12:59 PM); Temperature Temporal [36.6-38.1 Deg C] 37.0 Deg C (10/7/19 12:59 PM)   Blood Pressure [90-160/50-90 mmHg] 158/92 mmHg  (1/9/20 1:04 PM) 113/68 mmHg  (10/17/19 1:56 PM)  Blood Pressure [110-130/64-83 mmHg] 132/75 mmHg  *HI*   (10/7/19 12:59 PM); Epi-Pen administered on scene. Ambulance gave second dose of Epinephrine, IV fluid, Benedryl and Prednisone; Ambulance called.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Needle issue
Clinical narrative: The hypodermic needle disconnected from the syringe when pressure was applied to the plunger.   It appeared that the majority of the 0.5 ml dose was splattered on the skin of the upper arm.   This was a first dose; the client received very little if any of the intended dosage.   She refused any further treatment at that time.         Note: this was mobile mass-vaccination clinic held at the local fairgrounds on a Saturday.  We had problems at least 4 times with needles disconnecting from syringes and may have been a production problem.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: The hypodermic needle disconnected from the syringe when pressure was applied to the plunger.   It appeared that the majority of the 0.5 ml dose was splattered on the skin of the upper arm.   This was a first dose; the client received very little if any of the intended dosage.   She refused any further treatment at that time.         Note: this was mobile mass-vaccination clinic held at the local fairgrounds on a Saturday.  We had problems at least 4 times with needles disconnecting from syringes and may have been a production problem.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram, Dyspnoea, Pain
Clinical narrative: Fever; shortness of breath; chest tightening; This is a spontaneous report received from contactable consumer (patient).  A 38-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)), administered in the left arm, administration date 13Nov2021 at 10:00 (Lot number: FC-3527) at the age of 38 years as dose 1, single dose for COVID-19 immunisation at a pharmacy or drug store. Relevant medical history included: "chronic asthma" (unspecified if ongoing). The patient did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. Prior to the vaccination the patient did not receive any other vaccine within four weeks. The following information was reported: PYREXIA (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "Fever"; DYSPNOEA (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "shortness of breath"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "chest tightening". The patient was hospitalized for pyrexia, dyspnoea, chest discomfort in Nov2021 for 5 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (nasal swab) on 15Nov2021 was negative. Therapeutic measures taken as a result of pyrexia, dyspnoea, chest discomfort included steroids taken intravenously and breathing treatments, etc.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; shortness of breath; chest tightening; This is a spontaneous report received from contactable consumer (patient).  A 38-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)), administered in the left arm, administration date 13Nov2021 at 10:00 (Lot number: FC-3527) at the age of 38 years as dose 1, single dose for COVID-19 immunisation at a pharmacy or drug store. Relevant medical history included: "chronic asthma" (unspecified if ongoing). The patient did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. Prior to the vaccination the patient did not receive any other vaccine within four weeks. The following information was reported: PYREXIA (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "Fever"; DYSPNOEA (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "shortness of breath"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "chest tightening". The patient was hospitalized for pyrexia, dyspnoea, chest discomfort in Nov2021 for 5 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (nasal swab) on 15Nov2021 was negative. Therapeutic measures taken as a result of pyrexia, dyspnoea, chest discomfort included steroids taken intravenously and breathing treatments, etc.
Age: 38.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Chest discomfort, Dyspnoea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; shortness of breath; chest tightening; This is a spontaneous report received from contactable consumer (patient).  A 38-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)), administered in the left arm, administration date 13Nov2021 at 10:00 (Lot number: FC-3527) at the age of 38 years as dose 1, single dose for COVID-19 immunisation at a pharmacy or drug store. Relevant medical history included: "chronic asthma" (unspecified if ongoing). The patient did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. Prior to the vaccination the patient did not receive any other vaccine within four weeks. The following information was reported: PYREXIA (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "Fever"; DYSPNOEA (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "shortness of breath"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 14Nov2021, outcome "recovering", described as "chest tightening". The patient was hospitalized for pyrexia, dyspnoea, chest discomfort in Nov2021 for 5 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (nasal swab) on 15Nov2021 was negative. Therapeutic measures taken as a result of pyrexia, dyspnoea, chest discomfort included steroids taken intravenously and breathing treatments, etc.