chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Diarrhoea, Dysstasia, Eustachian tube dysfunction, Feeling abnormal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP), Program ID: Unknown. A 48-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I was going to die"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological side effects"; NEURITIS (non-serious), outcome "unknown", described as "nerve inflammation"; EUSTACHIAN TUBE DYSFUNCTION (non-serious), outcome "unknown", described as "ETD"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss"; HYPERACUSIS (non-serious), outcome "unknown", described as "Painful hyperacusis"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost 30 pounds in less than 3 months"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Excessive sweating"; INSOMNIA (non-serious), outcome "unknown", described as "Barely got 3 hours of sleep a night"; HEADACHE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Head and neck pain"; DYSSTASIA (non-serious), outcome "unknown", described as "Inability to stand"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog and parenthesis"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "vision changes". The patient underwent the following laboratory tests and procedures: Weight: 30 lbs., notes: I lost 30 pounds in less than 3 months. Clinical information: Patient still suffering from neurological side effects after vaccine. Patient have suffered from side effects ever since. Patient has had 3 doctors told not to get another Covid vaccine. Patient is currently suffering from nerve inflammation and ETD. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperacusis, Hyperhidrosis, Insomnia, Near death experience
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP), Program ID: Unknown. A 48-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I was going to die"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological side effects"; NEURITIS (non-serious), outcome "unknown", described as "nerve inflammation"; EUSTACHIAN TUBE DYSFUNCTION (non-serious), outcome "unknown", described as "ETD"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss"; HYPERACUSIS (non-serious), outcome "unknown", described as "Painful hyperacusis"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost 30 pounds in less than 3 months"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Excessive sweating"; INSOMNIA (non-serious), outcome "unknown", described as "Barely got 3 hours of sleep a night"; HEADACHE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Head and neck pain"; DYSSTASIA (non-serious), outcome "unknown", described as "Inability to stand"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog and parenthesis"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "vision changes". The patient underwent the following laboratory tests and procedures: Weight: 30 lbs., notes: I lost 30 pounds in less than 3 months. Clinical information: Patient still suffering from neurological side effects after vaccine. Patient have suffered from side effects ever since. Patient has had 3 doctors told not to get another Covid vaccine. Patient is currently suffering from nerve inflammation and ETD. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Nervous system disorder, Neuritis, Visual impairment, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP), Program ID: Unknown. A 48-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I was going to die"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological side effects"; NEURITIS (non-serious), outcome "unknown", described as "nerve inflammation"; EUSTACHIAN TUBE DYSFUNCTION (non-serious), outcome "unknown", described as "ETD"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss"; HYPERACUSIS (non-serious), outcome "unknown", described as "Painful hyperacusis"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost 30 pounds in less than 3 months"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Excessive sweating"; INSOMNIA (non-serious), outcome "unknown", described as "Barely got 3 hours of sleep a night"; HEADACHE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Head and neck pain"; DYSSTASIA (non-serious), outcome "unknown", described as "Inability to stand"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog and parenthesis"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "vision changes". The patient underwent the following laboratory tests and procedures: Weight: 30 lbs., notes: I lost 30 pounds in less than 3 months. Clinical information: Patient still suffering from neurological side effects after vaccine. Patient have suffered from side effects ever since. Patient has had 3 doctors told not to get another Covid vaccine. Patient is currently suffering from nerve inflammation and ETD. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP), Program ID: Unknown. A 48-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2021 as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I was going to die"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological side effects"; NEURITIS (non-serious), outcome "unknown", described as "nerve inflammation"; EUSTACHIAN TUBE DYSFUNCTION (non-serious), outcome "unknown", described as "ETD"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss"; HYPERACUSIS (non-serious), outcome "unknown", described as "Painful hyperacusis"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost 30 pounds in less than 3 months"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Excessive sweating"; INSOMNIA (non-serious), outcome "unknown", described as "Barely got 3 hours of sleep a night"; HEADACHE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Head and neck pain"; DYSSTASIA (non-serious), outcome "unknown", described as "Inability to stand"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog and parenthesis"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "vision changes". The patient underwent the following laboratory tests and procedures: Weight: 30 lbs., notes: I lost 30 pounds in less than 3 months. Clinical information: Patient still suffering from neurological side effects after vaccine. Patient have suffered from side effects ever since. Patient has had 3 doctors told not to get another Covid vaccine. Patient is currently suffering from nerve inflammation and ETD. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Bone densitometry, Cognitive disorder, Dementia
Clinical narrative: COVID tested positive; COVID tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing), notes: was found 2-years-ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Apr2022, outcome "unknown" and all described as "COVID tested positive". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Jan2022) Emphysema; SARS-CoV-2 test: (04Apr2022) Positive. This year CT scan (Jan2022) found no change and remains with small mass. Therapeutic measures were taken as a result of covid-19.  Doctor prescribed (and still on) Pfizer Paxlovid tablets, Nirmatrelvir and Ritonavir. Have to date: Lost smell and taste.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypothyroidism, Investigation, Memory impairment, Mental impairment
Clinical narrative: COVID tested positive; COVID tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing), notes: was found 2-years-ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Apr2022, outcome "unknown" and all described as "COVID tested positive". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Jan2022) Emphysema; SARS-CoV-2 test: (04Apr2022) Positive. This year CT scan (Jan2022) found no change and remains with small mass. Therapeutic measures were taken as a result of covid-19.  Doctor prescribed (and still on) Pfizer Paxlovid tablets, Nirmatrelvir and Ritonavir. Have to date: Lost smell and taste.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Sluggishness, Weight
Clinical narrative: COVID tested positive; COVID tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing), notes: was found 2-years-ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Apr2022, outcome "unknown" and all described as "COVID tested positive". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Jan2022) Emphysema; SARS-CoV-2 test: (04Apr2022) Positive. This year CT scan (Jan2022) found no change and remains with small mass. Therapeutic measures were taken as a result of covid-19.  Doctor prescribed (and still on) Pfizer Paxlovid tablets, Nirmatrelvir and Ritonavir. Have to date: Lost smell and taste.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight increased
Clinical narrative: COVID tested positive; COVID tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing), notes: was found 2-years-ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Apr2022, outcome "unknown" and all described as "COVID tested positive". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Jan2022) Emphysema; SARS-CoV-2 test: (04Apr2022) Positive. This year CT scan (Jan2022) found no change and remains with small mass. Therapeutic measures were taken as a result of covid-19.  Doctor prescribed (and still on) Pfizer Paxlovid tablets, Nirmatrelvir and Ritonavir. Have to date: Lost smell and taste.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID tested positive; COVID tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing), notes: was found 2-years-ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Apr2022, outcome "unknown" and all described as "COVID tested positive". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Jan2022) Emphysema; SARS-CoV-2 test: (04Apr2022) Positive. This year CT scan (Jan2022) found no change and remains with small mass. Therapeutic measures were taken as a result of covid-19.  Doctor prescribed (and still on) Pfizer Paxlovid tablets, Nirmatrelvir and Ritonavir. Have to date: Lost smell and taste.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: patient had total hip replacement on 15Oct2021; mild headache; Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1;  Anatomical location: Upper arm; Route: Intramuscular; Batch/Lot number:  EN6206), administration date: 11Mar2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Mild headache", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Second dose: Had a sore arm"; HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "patient had total hip replacement on 15Oct2021"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2021) Negative, notes: Tested Negative cleared for surgery. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine. Patient  received her 1st dose and 2nd dose of covid vaccine as the dates reflect. Side effects were not serious expect for a sore arm and a mild headache for a day. She then received the booster (3rd dose) on 28Dec2021. Her son reported she just felt "out of it" and just generally did not felt well. She had a post-Christmas gathering planned for family on the 30Dec but cancelled it because she wasn't feeling up to it. On the morning of new year's Day, she complained of her left leg hurting as if someone "hit her with a bat". Hours later, she was found, face down, in her home, deceased. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: patient had total hip replacement on 15Oct2021; mild headache; Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1;  Anatomical location: Upper arm; Route: Intramuscular; Batch/Lot number:  EN6206), administration date: 11Mar2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Mild headache", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Second dose: Had a sore arm"; HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "patient had total hip replacement on 15Oct2021"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2021) Negative, notes: Tested Negative cleared for surgery. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine. Patient  received her 1st dose and 2nd dose of covid vaccine as the dates reflect. Side effects were not serious expect for a sore arm and a mild headache for a day. She then received the booster (3rd dose) on 28Dec2021. Her son reported she just felt "out of it" and just generally did not felt well. She had a post-Christmas gathering planned for family on the 30Dec but cancelled it because she wasn't feeling up to it. On the morning of new year's Day, she complained of her left leg hurting as if someone "hit her with a bat". Hours later, she was found, face down, in her home, deceased. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Pulmonary embolism
Clinical narrative: patient had total hip replacement on 15Oct2021; mild headache; Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1;  Anatomical location: Upper arm; Route: Intramuscular; Batch/Lot number:  EN6206), administration date: 11Mar2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Mild headache", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Second dose: Had a sore arm"; HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "patient had total hip replacement on 15Oct2021"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2021) Negative, notes: Tested Negative cleared for surgery. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine. Patient  received her 1st dose and 2nd dose of covid vaccine as the dates reflect. Side effects were not serious expect for a sore arm and a mild headache for a day. She then received the booster (3rd dose) on 28Dec2021. Her son reported she just felt "out of it" and just generally did not felt well. She had a post-Christmas gathering planned for family on the 30Dec but cancelled it because she wasn't feeling up to it. On the morning of new year's Day, she complained of her left leg hurting as if someone "hit her with a bat". Hours later, she was found, face down, in her home, deceased. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: patient had total hip replacement on 15Oct2021; mild headache; Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1;  Anatomical location: Upper arm; Route: Intramuscular; Batch/Lot number:  EN6206), administration date: 11Mar2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Mild headache", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Second dose: Had a sore arm"; HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "patient had total hip replacement on 15Oct2021"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2021) Negative, notes: Tested Negative cleared for surgery. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine. Patient  received her 1st dose and 2nd dose of covid vaccine as the dates reflect. Side effects were not serious expect for a sore arm and a mild headache for a day. She then received the booster (3rd dose) on 28Dec2021. Her son reported she just felt "out of it" and just generally did not felt well. She had a post-Christmas gathering planned for family on the 30Dec but cancelled it because she wasn't feeling up to it. On the morning of new year's Day, she complained of her left leg hurting as if someone "hit her with a bat". Hours later, she was found, face down, in her home, deceased. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hip arthroplasty, Pain in extremity, SARS-CoV-2 test
Clinical narrative: patient had total hip replacement on 15Oct2021; mild headache; Second dose: Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years intramuscular, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1;  Anatomical location: Upper arm; Route: Intramuscular; Batch/Lot number:  EN6206), administration date: 11Mar2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Mild headache", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Second dose: Had a sore arm"; HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "patient had total hip replacement on 15Oct2021"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2021) Negative, notes: Tested Negative cleared for surgery. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: Had a sore arm: The patient had a sore arm after receiving the first and second dose Adult Pfizer Covid Vaccine. Caller states the patients sore arm believes began shortly thereafter receiving the first and second dose Adult Pfizer Covid Vaccine. Patient  received her 1st dose and 2nd dose of covid vaccine as the dates reflect. Side effects were not serious expect for a sore arm and a mild headache for a day. She then received the booster (3rd dose) on 28Dec2021. Her son reported she just felt "out of it" and just generally did not felt well. She had a post-Christmas gathering planned for family on the 30Dec but cancelled it because she wasn't feeling up to it. On the morning of new year's Day, she complained of her left leg hurting as if someone "hit her with a bat". Hours later, she was found, face down, in her home, deceased. The caller does not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller states the cause of death was Pulmonary Embolism.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Headaches; Decline in mental health; Shortness of breath; Ankle swelling (daily); Nausea; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left), administration date: 21Aug2021, when the patient was 29-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Ankle swelling (daily)"; MENTAL IMPAIRMENT (medically significant) with onset 15Mar2022, outcome "not recovered", described as "Decline in mental health"; NAUSEA (non-serious) with onset 15Mar2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Shortness of breath"; FATIGUE (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Tiredness"; VOMITING (non-serious) with onset 15Mar2022, outcome "not recovered"; HEADACHE (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Headaches". The events "decline in mental health", "shortness of breath", "ankle swelling (daily)", "nausea", "tiredness", "vomiting" and "headaches" required physician office visit.  Clinical course: No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Multiples vitamins within 2 weeks of vaccination. I continue to have shortness of breath, ankle swelling (daily), nausea, tiredness, vomiting, decline in mental health, headaches 20 days after receiving the booster. No Prior to vaccination, was the patient diagnosed with COVID-19. No Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Joint swelling, Lymphadenopathy, Mental impairment
Clinical narrative: Headaches; Decline in mental health; Shortness of breath; Ankle swelling (daily); Nausea; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left), administration date: 21Aug2021, when the patient was 29-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Ankle swelling (daily)"; MENTAL IMPAIRMENT (medically significant) with onset 15Mar2022, outcome "not recovered", described as "Decline in mental health"; NAUSEA (non-serious) with onset 15Mar2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Shortness of breath"; FATIGUE (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Tiredness"; VOMITING (non-serious) with onset 15Mar2022, outcome "not recovered"; HEADACHE (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Headaches". The events "decline in mental health", "shortness of breath", "ankle swelling (daily)", "nausea", "tiredness", "vomiting" and "headaches" required physician office visit.  Clinical course: No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Multiples vitamins within 2 weeks of vaccination. I continue to have shortness of breath, ankle swelling (daily), nausea, tiredness, vomiting, decline in mental health, headaches 20 days after receiving the booster. No Prior to vaccination, was the patient diagnosed with COVID-19. No Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Night sweats, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Headaches; Decline in mental health; Shortness of breath; Ankle swelling (daily); Nausea; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left), administration date: 21Aug2021, when the patient was 29-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Ankle swelling (daily)"; MENTAL IMPAIRMENT (medically significant) with onset 15Mar2022, outcome "not recovered", described as "Decline in mental health"; NAUSEA (non-serious) with onset 15Mar2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Shortness of breath"; FATIGUE (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Tiredness"; VOMITING (non-serious) with onset 15Mar2022, outcome "not recovered"; HEADACHE (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Headaches". The events "decline in mental health", "shortness of breath", "ankle swelling (daily)", "nausea", "tiredness", "vomiting" and "headaches" required physician office visit.  Clinical course: No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Multiples vitamins within 2 weeks of vaccination. I continue to have shortness of breath, ankle swelling (daily), nausea, tiredness, vomiting, decline in mental health, headaches 20 days after receiving the booster. No Prior to vaccination, was the patient diagnosed with COVID-19. No Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Joint swelling, Mental impairment
Clinical narrative: Headaches; Decline in mental health; Shortness of breath; Ankle swelling (daily); Nausea; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left), administration date: 21Aug2021, when the patient was 29-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Ankle swelling (daily)"; MENTAL IMPAIRMENT (medically significant) with onset 15Mar2022, outcome "not recovered", described as "Decline in mental health"; NAUSEA (non-serious) with onset 15Mar2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Shortness of breath"; FATIGUE (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Tiredness"; VOMITING (non-serious) with onset 15Mar2022, outcome "not recovered"; HEADACHE (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Headaches". The events "decline in mental health", "shortness of breath", "ankle swelling (daily)", "nausea", "tiredness", "vomiting" and "headaches" required physician office visit.  Clinical course: No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Multiples vitamins within 2 weeks of vaccination. I continue to have shortness of breath, ankle swelling (daily), nausea, tiredness, vomiting, decline in mental health, headaches 20 days after receiving the booster. No Prior to vaccination, was the patient diagnosed with COVID-19. No Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headaches; Decline in mental health; Shortness of breath; Ankle swelling (daily); Nausea; Tiredness; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left), administration date: 21Aug2021, when the patient was 29-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: 301308A, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Ankle swelling (daily)"; MENTAL IMPAIRMENT (medically significant) with onset 15Mar2022, outcome "not recovered", described as "Decline in mental health"; NAUSEA (non-serious) with onset 15Mar2022, outcome "not recovered"; DYSPNOEA (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Shortness of breath"; FATIGUE (non-serious) with onset 15Mar2022, outcome "not recovered", described as "Tiredness"; VOMITING (non-serious) with onset 15Mar2022, outcome "not recovered"; HEADACHE (non-serious) with onset 03Apr2022, outcome "not recovered", described as "Headaches". The events "decline in mental health", "shortness of breath", "ankle swelling (daily)", "nausea", "tiredness", "vomiting" and "headaches" required physician office visit.  Clinical course: No patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Multiples vitamins within 2 weeks of vaccination. I continue to have shortness of breath, ankle swelling (daily), nausea, tiredness, vomiting, decline in mental health, headaches 20 days after receiving the booster. No Prior to vaccination, was the patient diagnosed with COVID-19. No Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Facial pain, Furuncle, Gingival pain, Headache
Clinical narrative: Shingles; Cold sores; Splotches on face/left side of his face that is affected by splotches; Headache, ice pick, temple "electric pulses"; Boils on nose; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date unknown) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st April 2022, less than a day after receiving Shingrix, the patient experienced blotchy, headache, boil and pain. On 4th April 2022, the patient experienced shingles and cold sores. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blotchy, headache, boil, pain and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blotchy, headache, boil, pain and cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix dose on right arm at approximately at 11:45 am. Around 6 pm on the same day, he noticed splotches on his face and experienced a headache (which he described as an ice pick headache), at his left temple which emanates electric pulses.  The splotches on his face continued to grow over the weekend, as well as the headache at his temple.  He stated that it was his left side of his face that was affected by splotches which also include boils on his nose. He was also experiencing pain. The patient noticed cold sores on his lip, and then went to the doctor and was diagnosed with Shingles.  He was started on Valacyclovir for treatment.  At time of reporting, the patient stated his condition (boils, splotches, cold sores, pain) had stabilized and his headaches were not as frequent. The reporter gave consent to follow up with healthcare professional.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Oral herpes, Oral pain, Rash macular, Seizure
Clinical narrative: Shingles; Cold sores; Splotches on face/left side of his face that is affected by splotches; Headache, ice pick, temple "electric pulses"; Boils on nose; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date unknown) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st April 2022, less than a day after receiving Shingrix, the patient experienced blotchy, headache, boil and pain. On 4th April 2022, the patient experienced shingles and cold sores. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blotchy, headache, boil, pain and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blotchy, headache, boil, pain and cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix dose on right arm at approximately at 11:45 am. Around 6 pm on the same day, he noticed splotches on his face and experienced a headache (which he described as an ice pick headache), at his left temple which emanates electric pulses.  The splotches on his face continued to grow over the weekend, as well as the headache at his temple.  He stated that it was his left side of his face that was affected by splotches which also include boils on his nose. He was also experiencing pain. The patient noticed cold sores on his lip, and then went to the doctor and was diagnosed with Shingles.  He was started on Valacyclovir for treatment.  At time of reporting, the patient stated his condition (boils, splotches, cold sores, pain) had stabilized and his headaches were not as frequent. The reporter gave consent to follow up with healthcare professional.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Sensitive skin, Skin infection
Clinical narrative: Shingles; Cold sores; Splotches on face/left side of his face that is affected by splotches; Headache, ice pick, temple "electric pulses"; Boils on nose; Pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date unknown) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 1st April 2022, less than a day after receiving Shingrix, the patient experienced blotchy, headache, boil and pain. On 4th April 2022, the patient experienced shingles and cold sores. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blotchy, headache, boil, pain and cold sores were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blotchy, headache, boil, pain and cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix dose on right arm at approximately at 11:45 am. Around 6 pm on the same day, he noticed splotches on his face and experienced a headache (which he described as an ice pick headache), at his left temple which emanates electric pulses.  The splotches on his face continued to grow over the weekend, as well as the headache at his temple.  He stated that it was his left side of his face that was affected by splotches which also include boils on his nose. He was also experiencing pain. The patient noticed cold sores on his lip, and then went to the doctor and was diagnosed with Shingles.  He was started on Valacyclovir for treatment.  At time of reporting, the patient stated his condition (boils, splotches, cold sores, pain) had stabilized and his headaches were not as frequent. The reporter gave consent to follow up with healthcare professional.