chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Fatigue, Gait inability, Influenza like illness
Clinical narrative: Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Muscles hurt like the flu after second dose.; Muscles hurt like the flu after second dose.; Sore arm, after  first and second dose; Tired after first and second doses; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received bnt162b2 (Pfizer BioNTech Covid 19 Vaccine), dose 2 via an unspecified route of administration on 07Oct2021 10:00 (Lot Number: FF2590) at the age of 64-year-old, as single dose at left arm for covid-19 immunisation. Medical history included knee replacement of her left knee back in May2021. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2(Lot Number: FC3183) on 16Sep2021 2PM at the age of 64-year-old at left arm for covid-19 immunisation and experienced sore arm and fatigue. No additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccinations (within 4 weeks). The patient experienced sore arm, after first and second dose on 07Oct2021 13:00 with outcome of recovered, tired after first and second doses on 07Oct2021 13:00 with outcome of recovered, muscles hurt like the flu after second dose on 08Oct2021 in the morning with outcome of recovered on 09Oct2021, pain in knee, down leg, couldn't walk, right leg, after second dose on 13Oct2021 in the morning with outcome of not recovered(she can't walk even now with a walker). Events resulted in emergency room and physician office visit on 05Nov2021. The patient underwent lab tests and procedures which included ultrasound right leg on 17Oct2021 and 03Nov2021: normal; CT Scan right leg on 03Nov2021: normal; X-ray of right leg on 03Nov2021 and 05Nov2021: normal. The clinical course was reported as follows: The patient was  having an adverse reaction to the vaccine. She had a sore arm, was tired, and muscles hurt like the flu after the second vaccine. She had a knee replacement of her left knee back in May2021. On 17Oct2021 she went to the emergency room, she couldn't walk and they did an ultrasound of her leg and it was normal. She was taken to the hospital by ambulance after that because she couldn't walk and had a CT can, Ultrasound, and X-ray which were all normal. The patient was going for an MRI on 09Nov2021. The patient couldn't walk, and it started with pain in her knee and down her leg. Patient thought this was a reaction from the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Muscles hurt like the flu after second dose.; Muscles hurt like the flu after second dose.; Sore arm, after  first and second dose; Tired after first and second doses; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received bnt162b2 (Pfizer BioNTech Covid 19 Vaccine), dose 2 via an unspecified route of administration on 07Oct2021 10:00 (Lot Number: FF2590) at the age of 64-year-old, as single dose at left arm for covid-19 immunisation. Medical history included knee replacement of her left knee back in May2021. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2(Lot Number: FC3183) on 16Sep2021 2PM at the age of 64-year-old at left arm for covid-19 immunisation and experienced sore arm and fatigue. No additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccinations (within 4 weeks). The patient experienced sore arm, after first and second dose on 07Oct2021 13:00 with outcome of recovered, tired after first and second doses on 07Oct2021 13:00 with outcome of recovered, muscles hurt like the flu after second dose on 08Oct2021 in the morning with outcome of recovered on 09Oct2021, pain in knee, down leg, couldn't walk, right leg, after second dose on 13Oct2021 in the morning with outcome of not recovered(she can't walk even now with a walker). Events resulted in emergency room and physician office visit on 05Nov2021. The patient underwent lab tests and procedures which included ultrasound right leg on 17Oct2021 and 03Nov2021: normal; CT Scan right leg on 03Nov2021: normal; X-ray of right leg on 03Nov2021 and 05Nov2021: normal. The clinical course was reported as follows: The patient was  having an adverse reaction to the vaccine. She had a sore arm, was tired, and muscles hurt like the flu after the second vaccine. She had a knee replacement of her left knee back in May2021. On 17Oct2021 she went to the emergency room, she couldn't walk and they did an ultrasound of her leg and it was normal. She was taken to the hospital by ambulance after that because she couldn't walk and had a CT can, Ultrasound, and X-ray which were all normal. The patient was going for an MRI on 09Nov2021. The patient couldn't walk, and it started with pain in her knee and down her leg. Patient thought this was a reaction from the vaccine.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Chest pain, Computerised tomogram abdomen, Computerised tomogram thorax, Dyspnoea
Clinical narrative: heart attack. Was air lifted out of state.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Full blood count, International normalised ratio, Metabolic function test, SARS-CoV-2 test
Clinical narrative: heart attack. Was air lifted out of state.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus tachycardia, Troponin increased
Clinical narrative: heart attack. Was air lifted out of state.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myocardial infarction
Clinical narrative: heart attack. Was air lifted out of state.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bradypnoea, Malaise, Nausea, Pallor, Syncope
Clinical narrative: Immediate negative reaction. Feeling of imminent death. Nausea, cold sweat, numbness, tingling, pass out.  Continuing joint / tendon pain, night sweats, weakness 2 weeks post vaccination. Pain inside of left leg.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Blood fibrinogen, Blood uric acid
Clinical narrative: Immediate negative reaction. Feeling of imminent death. Nausea, cold sweat, numbness, tingling, pass out.  Continuing joint / tendon pain, night sweats, weakness 2 weeks post vaccination. Pain inside of left leg.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Cold sweat, Fibrin D dimer, Full blood count, Hypoaesthesia
Clinical narrative: Immediate negative reaction. Feeling of imminent death. Nausea, cold sweat, numbness, tingling, pass out.  Continuing joint / tendon pain, night sweats, weakness 2 weeks post vaccination. Pain inside of left leg.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Laboratory test, Loss of consciousness, Nausea, Night sweats
Clinical narrative: Immediate negative reaction. Feeling of imminent death. Nausea, cold sweat, numbness, tingling, pass out.  Continuing joint / tendon pain, night sweats, weakness 2 weeks post vaccination. Pain inside of left leg.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Prothrombin time, Tendon pain
Clinical narrative: Immediate negative reaction. Feeling of imminent death. Nausea, cold sweat, numbness, tingling, pass out.  Continuing joint / tendon pain, night sweats, weakness 2 weeks post vaccination. Pain inside of left leg.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac ventricular disorder, Catheterisation cardiac, Echocardiogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: stated that she had a heart attack; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 60 years old, dose 1 via an unspecified route of administration on 21Sep2021 as 30 ug single dose for COVID-19 immunisation at a pharmacy. Medical history included rheumatoid arthritis from Sep2016 and ongoing (autoimmune disease). The patient said that she needed to taking COVID shot because she had rheumatoid arthritis; had an autoimmune disease. There were no concomitant medications. Patient had an adverse side effect of COVID shot. Stated that she had a heart attack on 26Oct2021 after the first shot. Stated that she wished that she never had the shot. Stated that she would refer nobody to take it. The patient was hospitalized for heart attack from 26Oct2021 to 28Oct2021. Patient was now on 5-6 different medications. Outcome of event was recovering.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Myocarditis
Clinical narrative: stated that she had a heart attack; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 60 years old, dose 1 via an unspecified route of administration on 21Sep2021 as 30 ug single dose for COVID-19 immunisation at a pharmacy. Medical history included rheumatoid arthritis from Sep2016 and ongoing (autoimmune disease). The patient said that she needed to taking COVID shot because she had rheumatoid arthritis; had an autoimmune disease. There were no concomitant medications. Patient had an adverse side effect of COVID shot. Stated that she had a heart attack on 26Oct2021 after the first shot. Stated that she wished that she never had the shot. Stated that she would refer nobody to take it. The patient was hospitalized for heart attack from 26Oct2021 to 28Oct2021. Patient was now on 5-6 different medications. Outcome of event was recovering.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: stated that she had a heart attack; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 60 years old, dose 1 via an unspecified route of administration on 21Sep2021 as 30 ug single dose for COVID-19 immunisation at a pharmacy. Medical history included rheumatoid arthritis from Sep2016 and ongoing (autoimmune disease). The patient said that she needed to taking COVID shot because she had rheumatoid arthritis; had an autoimmune disease. There were no concomitant medications. Patient had an adverse side effect of COVID shot. Stated that she had a heart attack on 26Oct2021 after the first shot. Stated that she wished that she never had the shot. Stated that she would refer nobody to take it. The patient was hospitalized for heart attack from 26Oct2021 to 28Oct2021. Patient was now on 5-6 different medications. Outcome of event was recovering.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bedridden, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath requiring oxygen; Shortness of breath requiring oxygen; chest (heart) heaviness and discomfort; chest (heart) heaviness and discomfort; zero energy; extreme fatigue (bedridden); extreme fatigue (bedridden); edema from toes up to abdomen; edema from toes up to abdomen; loss of appetite; a feeling of impending doom; This is a spontaneous report from a contactable Nurse. This 57-year-old female nurse reported for herself that: A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in left arm on 01Oct2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation at pharmacy or drugstore. Medical history Heart failure, hypertension, high cholesterol, fatty liver, psoriasis, diabetic retinopathy, history of basal cell carcinoma and known allergies of penicillin, diovan and acarbose. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 10Sep2021 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination (medications unspecified). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received the second Pfizer COVID vaccine on 01Oct2021. On 02Oct2021, patient experienced shortness of breath required oxygen, chest (heart) heaviness and discomfort, zero energy and extreme fatigue (bedridden), edema from toes up to abdomen (2+), loss of appetite and felt impending doom. The symptoms started on 02Oct2021 and never eased up until 19-20Oct2021. Patient was bedridden the entire event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. The patient underwent lab tests and procedures which included localised oedema: edema from toes up to abdomen (2+) on unspecified date. At the time of this report, the outcome of events was recovered up until 19-20Oct2021.  Follow-Up (16Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Oedema
Clinical narrative: Shortness of breath requiring oxygen; Shortness of breath requiring oxygen; chest (heart) heaviness and discomfort; chest (heart) heaviness and discomfort; zero energy; extreme fatigue (bedridden); extreme fatigue (bedridden); edema from toes up to abdomen; edema from toes up to abdomen; loss of appetite; a feeling of impending doom; This is a spontaneous report from a contactable Nurse. This 57-year-old female nurse reported for herself that: A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in left arm on 01Oct2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation at pharmacy or drugstore. Medical history Heart failure, hypertension, high cholesterol, fatty liver, psoriasis, diabetic retinopathy, history of basal cell carcinoma and known allergies of penicillin, diovan and acarbose. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 10Sep2021 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination (medications unspecified). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received the second Pfizer COVID vaccine on 01Oct2021. On 02Oct2021, patient experienced shortness of breath required oxygen, chest (heart) heaviness and discomfort, zero energy and extreme fatigue (bedridden), edema from toes up to abdomen (2+), loss of appetite and felt impending doom. The symptoms started on 02Oct2021 and never eased up until 19-20Oct2021. Patient was bedridden the entire event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. The patient underwent lab tests and procedures which included localised oedema: edema from toes up to abdomen (2+) on unspecified date. At the time of this report, the outcome of events was recovered up until 19-20Oct2021.  Follow-Up (16Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Asthenia, Bedridden, Chest discomfort, Decreased appetite
Clinical narrative: Shortness of breath requiring oxygen; Shortness of breath requiring oxygen; chest (heart) heaviness and discomfort; chest (heart) heaviness and discomfort; zero energy; extreme fatigue (bedridden); extreme fatigue (bedridden); edema from toes up to abdomen; edema from toes up to abdomen; loss of appetite; a feeling of impending doom; This is a spontaneous report from a contactable Nurse. This 57-year-old female nurse reported for herself that: A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in left arm on 01Oct2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation at pharmacy or drugstore. Medical history Heart failure, hypertension, high cholesterol, fatty liver, psoriasis, diabetic retinopathy, history of basal cell carcinoma and known allergies of penicillin, diovan and acarbose. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 10Sep2021 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination (medications unspecified). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received the second Pfizer COVID vaccine on 01Oct2021. On 02Oct2021, patient experienced shortness of breath required oxygen, chest (heart) heaviness and discomfort, zero energy and extreme fatigue (bedridden), edema from toes up to abdomen (2+), loss of appetite and felt impending doom. The symptoms started on 02Oct2021 and never eased up until 19-20Oct2021. Patient was bedridden the entire event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. The patient underwent lab tests and procedures which included localised oedema: edema from toes up to abdomen (2+) on unspecified date. At the time of this report, the outcome of events was recovered up until 19-20Oct2021.  Follow-Up (16Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Localised oedema, Oedema peripheral, Oxygen therapy
Clinical narrative: Shortness of breath requiring oxygen; Shortness of breath requiring oxygen; chest (heart) heaviness and discomfort; chest (heart) heaviness and discomfort; zero energy; extreme fatigue (bedridden); extreme fatigue (bedridden); edema from toes up to abdomen; edema from toes up to abdomen; loss of appetite; a feeling of impending doom; This is a spontaneous report from a contactable Nurse. This 57-year-old female nurse reported for herself that: A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in left arm on 01Oct2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation at pharmacy or drugstore. Medical history Heart failure, hypertension, high cholesterol, fatty liver, psoriasis, diabetic retinopathy, history of basal cell carcinoma and known allergies of penicillin, diovan and acarbose. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 10Sep2021 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination (medications unspecified). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received the second Pfizer COVID vaccine on 01Oct2021. On 02Oct2021, patient experienced shortness of breath required oxygen, chest (heart) heaviness and discomfort, zero energy and extreme fatigue (bedridden), edema from toes up to abdomen (2+), loss of appetite and felt impending doom. The symptoms started on 02Oct2021 and never eased up until 19-20Oct2021. Patient was bedridden the entire event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for adverse events. The patient underwent lab tests and procedures which included localised oedema: edema from toes up to abdomen (2+) on unspecified date. At the time of this report, the outcome of events was recovered up until 19-20Oct2021.  Follow-Up (16Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond the Best Used Date but before expiration date.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal
Clinical narrative: diagnosed with Guillain-Barre Syndrome; possible UTI; fever; abdominal pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Aug2021 12:00 (at the age of 78 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included Renal Cell Carcinoma/Right Nephrectomy; covid prior vaccination. Concomitant medications included prednisone; losartan; finasteride; atorvastatin. There was no other vaccine in four weeks. The patient previously received BNT162B2, first dose on 22Jan2021 12:00 (lot number: EL3249), second dose on 13Feb2021 12:00 (lot number: EL9269), both at the age of 78 years old for Covid-19 immunization; hydralazine (reported as Hydralaxine) and experienced allergies, cefalexin (CEPHALEXIN) and experienced allergies, metronidazole (FLAGYL) and experienced allergies. The patient experienced diagnosed with Guillain-Barre Syndrome on 01Sep2021 12:00, possible UTI on 01Sep2021 12:00, fever on 01Sep2021 12:00, abdominal pain on 01Sep2021 12:00. The patient was hospitalized from 03Sep2021. Clinical course: On 01Sep2021 patient was unable to get out of car/put weight on his legs so he crawled into his home and went to bed. On 02Sep2021, he could not put weight on legs and his daughter and son-in-law transported me to (withheld) ER. He presented with a fever, abdominal pain, leg weakness and was admitted on 03Sep2021. It was determined that his fever was related to possible UTI and antibiotics were given. He also had abdominal/lumbar scans and neurologist did not know what to attribute his leg weakness to. After one week, he was discharged to acute rehab facility. Ten days later, his family and he agreed that he was not getting better and after consultation with (withheld), it was recommended that he go to (withheld) ER for a neurological evaluation. Within four hours, he was diagnosed with Guillain-Barre Syndrome and received 3 IVIG (Immunoglobulin Therapy) treatments. Three days later, he was admitted to (withheld) where he received OT/PT for 20 days and currently use a walker at home. AEs resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient underwent lab tests and procedures which included Nasal swab: negative on 19Sep2021. The outcome of the events was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pyrexia, Scan with contrast abnormal, Walking aid user, Weight bearing difficulty
Clinical narrative: diagnosed with Guillain-Barre Syndrome; possible UTI; fever; abdominal pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Aug2021 12:00 (at the age of 78 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included Renal Cell Carcinoma/Right Nephrectomy; covid prior vaccination. Concomitant medications included prednisone; losartan; finasteride; atorvastatin. There was no other vaccine in four weeks. The patient previously received BNT162B2, first dose on 22Jan2021 12:00 (lot number: EL3249), second dose on 13Feb2021 12:00 (lot number: EL9269), both at the age of 78 years old for Covid-19 immunization; hydralazine (reported as Hydralaxine) and experienced allergies, cefalexin (CEPHALEXIN) and experienced allergies, metronidazole (FLAGYL) and experienced allergies. The patient experienced diagnosed with Guillain-Barre Syndrome on 01Sep2021 12:00, possible UTI on 01Sep2021 12:00, fever on 01Sep2021 12:00, abdominal pain on 01Sep2021 12:00. The patient was hospitalized from 03Sep2021. Clinical course: On 01Sep2021 patient was unable to get out of car/put weight on his legs so he crawled into his home and went to bed. On 02Sep2021, he could not put weight on legs and his daughter and son-in-law transported me to (withheld) ER. He presented with a fever, abdominal pain, leg weakness and was admitted on 03Sep2021. It was determined that his fever was related to possible UTI and antibiotics were given. He also had abdominal/lumbar scans and neurologist did not know what to attribute his leg weakness to. After one week, he was discharged to acute rehab facility. Ten days later, his family and he agreed that he was not getting better and after consultation with (withheld), it was recommended that he go to (withheld) ER for a neurological evaluation. Within four hours, he was diagnosed with Guillain-Barre Syndrome and received 3 IVIG (Immunoglobulin Therapy) treatments. Three days later, he was admitted to (withheld) where he received OT/PT for 20 days and currently use a walker at home. AEs resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient underwent lab tests and procedures which included Nasal swab: negative on 19Sep2021. The outcome of the events was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdomen scan, Abdominal pain, Guillain-Barre syndrome, Immunisation, Neurological examination
Clinical narrative: diagnosed with Guillain-Barre Syndrome; possible UTI; fever; abdominal pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Aug2021 12:00 (at the age of 78 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included Renal Cell Carcinoma/Right Nephrectomy; covid prior vaccination. Concomitant medications included prednisone; losartan; finasteride; atorvastatin. There was no other vaccine in four weeks. The patient previously received BNT162B2, first dose on 22Jan2021 12:00 (lot number: EL3249), second dose on 13Feb2021 12:00 (lot number: EL9269), both at the age of 78 years old for Covid-19 immunization; hydralazine (reported as Hydralaxine) and experienced allergies, cefalexin (CEPHALEXIN) and experienced allergies, metronidazole (FLAGYL) and experienced allergies. The patient experienced diagnosed with Guillain-Barre Syndrome on 01Sep2021 12:00, possible UTI on 01Sep2021 12:00, fever on 01Sep2021 12:00, abdominal pain on 01Sep2021 12:00. The patient was hospitalized from 03Sep2021. Clinical course: On 01Sep2021 patient was unable to get out of car/put weight on his legs so he crawled into his home and went to bed. On 02Sep2021, he could not put weight on legs and his daughter and son-in-law transported me to (withheld) ER. He presented with a fever, abdominal pain, leg weakness and was admitted on 03Sep2021. It was determined that his fever was related to possible UTI and antibiotics were given. He also had abdominal/lumbar scans and neurologist did not know what to attribute his leg weakness to. After one week, he was discharged to acute rehab facility. Ten days later, his family and he agreed that he was not getting better and after consultation with (withheld), it was recommended that he go to (withheld) ER for a neurological evaluation. Within four hours, he was diagnosed with Guillain-Barre Syndrome and received 3 IVIG (Immunoglobulin Therapy) treatments. Three days later, he was admitted to (withheld) where he received OT/PT for 20 days and currently use a walker at home. AEs resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient underwent lab tests and procedures which included Nasal swab: negative on 19Sep2021. The outcome of the events was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: diagnosed with Guillain-Barre Syndrome; possible UTI; fever; abdominal pain; Booster; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Aug2021 12:00 (at the age of 78 years old) (Lot Number: FC3180) as dose 3 (booster), single for COVID-19 immunisation. Medical history included Renal Cell Carcinoma/Right Nephrectomy; covid prior vaccination. Concomitant medications included prednisone; losartan; finasteride; atorvastatin. There was no other vaccine in four weeks. The patient previously received BNT162B2, first dose on 22Jan2021 12:00 (lot number: EL3249), second dose on 13Feb2021 12:00 (lot number: EL9269), both at the age of 78 years old for Covid-19 immunization; hydralazine (reported as Hydralaxine) and experienced allergies, cefalexin (CEPHALEXIN) and experienced allergies, metronidazole (FLAGYL) and experienced allergies. The patient experienced diagnosed with Guillain-Barre Syndrome on 01Sep2021 12:00, possible UTI on 01Sep2021 12:00, fever on 01Sep2021 12:00, abdominal pain on 01Sep2021 12:00. The patient was hospitalized from 03Sep2021. Clinical course: On 01Sep2021 patient was unable to get out of car/put weight on his legs so he crawled into his home and went to bed. On 02Sep2021, he could not put weight on legs and his daughter and son-in-law transported me to (withheld) ER. He presented with a fever, abdominal pain, leg weakness and was admitted on 03Sep2021. It was determined that his fever was related to possible UTI and antibiotics were given. He also had abdominal/lumbar scans and neurologist did not know what to attribute his leg weakness to. After one week, he was discharged to acute rehab facility. Ten days later, his family and he agreed that he was not getting better and after consultation with (withheld), it was recommended that he go to (withheld) ER for a neurological evaluation. Within four hours, he was diagnosed with Guillain-Barre Syndrome and received 3 IVIG (Immunoglobulin Therapy) treatments. Three days later, he was admitted to (withheld) where he received OT/PT for 20 days and currently use a walker at home. AEs resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient underwent lab tests and procedures which included Nasal swab: negative on 19Sep2021. The outcome of the events was not recovered.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure abnormal, Blood pressure measurement, Dyspnoea
Clinical narrative: mini stroke; loss of vision in one eye; blood pressure got out of balance; severe weakness in her legs; systemic edema; difficulty in breathing as she was laying flat in bed; subcutaneous bulge of fluid over her sternum; This is a spontaneous report from a contactable pharmacist. This pharmacist (patients son) reported for 90-year-old female patient that: A 90-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER) (at the age of 90-year-old), SINGLE for covid-19 immunization. Medical history included Cardiac failure congestive, Macular degeneration, Arthritis, Blood pressure abnormal (blood pressure was 145/75 or something around that). The patient previously took BNT162B2 (first and second dose) on unspecified dates for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced mini stroke, loss of vision, severe weakness in her legs, severe weakness in her legs, systemic edema, difficulty in breathing as she was laying flat in bed with outcome of unknown; subcutaneous bulge of fluid over her sternum with outcome of recovered after 8 hours on an unspecified date. Therapeutic medications were taken for mini stroke, loss of vision in one eye. Patient was on antiarrhythmics but no diuretic. The patient underwent lab tests and procedures included Blood pressure measurement showed 206/98 mmHg on 06Nov2021 and regular blood screening/scans with unknown results. Blood pressure got out of balance required an emergency room visit. Patient did the regular screening at the hospital. She didn't have any cardiac issues or manifestation of a myocardial infarction. The hospital didn't go very deep into anything, just creatinine clearance and that kind of stuff.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fluid retention, Immunisation, Insomnia, Oedema
Clinical narrative: mini stroke; loss of vision in one eye; blood pressure got out of balance; severe weakness in her legs; systemic edema; difficulty in breathing as she was laying flat in bed; subcutaneous bulge of fluid over her sternum; This is a spontaneous report from a contactable pharmacist. This pharmacist (patients son) reported for 90-year-old female patient that: A 90-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER) (at the age of 90-year-old), SINGLE for covid-19 immunization. Medical history included Cardiac failure congestive, Macular degeneration, Arthritis, Blood pressure abnormal (blood pressure was 145/75 or something around that). The patient previously took BNT162B2 (first and second dose) on unspecified dates for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced mini stroke, loss of vision, severe weakness in her legs, severe weakness in her legs, systemic edema, difficulty in breathing as she was laying flat in bed with outcome of unknown; subcutaneous bulge of fluid over her sternum with outcome of recovered after 8 hours on an unspecified date. Therapeutic medications were taken for mini stroke, loss of vision in one eye. Patient was on antiarrhythmics but no diuretic. The patient underwent lab tests and procedures included Blood pressure measurement showed 206/98 mmHg on 06Nov2021 and regular blood screening/scans with unknown results. Blood pressure got out of balance required an emergency room visit. Patient did the regular screening at the hospital. She didn't have any cardiac issues or manifestation of a myocardial infarction. The hospital didn't go very deep into anything, just creatinine clearance and that kind of stuff.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Blood pressure abnormal, Blood pressure measurement, Blood test, Cerebrovascular accident
Clinical narrative: mini stroke; loss of vision in one eye; blood pressure got out of balance; severe weakness in her legs; systemic edema; difficulty in breathing as she was laying flat in bed; subcutaneous bulge of fluid over her sternum; This is a spontaneous report from a contactable pharmacist. This pharmacist (patients son) reported for 90-year-old female patient that: A 90-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER) (at the age of 90-year-old), SINGLE for covid-19 immunization. Medical history included Cardiac failure congestive, Macular degeneration, Arthritis, Blood pressure abnormal (blood pressure was 145/75 or something around that). The patient previously took BNT162B2 (first and second dose) on unspecified dates for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced mini stroke, loss of vision, severe weakness in her legs, severe weakness in her legs, systemic edema, difficulty in breathing as she was laying flat in bed with outcome of unknown; subcutaneous bulge of fluid over her sternum with outcome of recovered after 8 hours on an unspecified date. Therapeutic medications were taken for mini stroke, loss of vision in one eye. Patient was on antiarrhythmics but no diuretic. The patient underwent lab tests and procedures included Blood pressure measurement showed 206/98 mmHg on 06Nov2021 and regular blood screening/scans with unknown results. Blood pressure got out of balance required an emergency room visit. Patient did the regular screening at the hospital. She didn't have any cardiac issues or manifestation of a myocardial infarction. The hospital didn't go very deep into anything, just creatinine clearance and that kind of stuff.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fluid retention, Muscular weakness, Oedema
Clinical narrative: mini stroke; loss of vision in one eye; blood pressure got out of balance; severe weakness in her legs; systemic edema; difficulty in breathing as she was laying flat in bed; subcutaneous bulge of fluid over her sternum; This is a spontaneous report from a contactable pharmacist. This pharmacist (patients son) reported for 90-year-old female patient that: A 90-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER) (at the age of 90-year-old), SINGLE for covid-19 immunization. Medical history included Cardiac failure congestive, Macular degeneration, Arthritis, Blood pressure abnormal (blood pressure was 145/75 or something around that). The patient previously took BNT162B2 (first and second dose) on unspecified dates for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced mini stroke, loss of vision, severe weakness in her legs, severe weakness in her legs, systemic edema, difficulty in breathing as she was laying flat in bed with outcome of unknown; subcutaneous bulge of fluid over her sternum with outcome of recovered after 8 hours on an unspecified date. Therapeutic medications were taken for mini stroke, loss of vision in one eye. Patient was on antiarrhythmics but no diuretic. The patient underwent lab tests and procedures included Blood pressure measurement showed 206/98 mmHg on 06Nov2021 and regular blood screening/scans with unknown results. Blood pressure got out of balance required an emergency room visit. Patient did the regular screening at the hospital. She didn't have any cardiac issues or manifestation of a myocardial infarction. The hospital didn't go very deep into anything, just creatinine clearance and that kind of stuff.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: My 12 year old was given the pediatric formulation without diluent added. He was given 0.3mls of the concentrated pediatric formulation, with no diluent.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Incorrect dose administered, Pain in extremity
Clinical narrative: Child's mother brought him to an adult vaccine clinic.  Child received Pfizer 0.3 ml.  Vaccinator reported to coordinator that she asked child's age after vaccine was administered.  Child's mother made aware that her son received an adult dose of Pfizer.  Child was observed for 15-20 minutes and did not experience an adverse reaction to adult dose.  Vaccine coordinator advised mother to report incident to child's pediatrician.  Understanding verbalized and child and mother left the clinic. HCP made aware.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Child's mother brought him to an adult vaccine clinic.  Child received Pfizer 0.3 ml.  Vaccinator reported to coordinator that she asked child's age after vaccine was administered.  Child's mother made aware that her son received an adult dose of Pfizer.  Child was observed for 15-20 minutes and did not experience an adverse reaction to adult dose.  Vaccine coordinator advised mother to report incident to child's pediatrician.  Understanding verbalized and child and mother left the clinic. HCP made aware.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse event; VARIVAX was administered after experiencing temperature excursion; This spontaneous report as received from a medical assistant refers to a 12 month old patient. On 19-OCT-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032932 exp date 28-SEP-2022) (dose and route not reported) after experiencing temperature excursion. The temperature of excursion was 6°F to 14°F (8.5F) for 0 hours 18 minutes 0 seconds; 6°F to 14 °F (11.9F) for 1 hour 0 minutes 0 seconds. Cumulative timeframe was 1 hour and 18 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; a dose of PROQU AD that was administered improperly stored during a temperature excursion; This spontaneous report has been received from a medical assistant, referring to patient of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinantHumanalbumin (rHA)) (PROQUAD) (lot # T034614 with expiration date: 10-APR-2022, dose: 0.5 milliliter, strength and route were unknown) for prophylaxis during a temperature excursion found supported (Product storage error). No further information given. No additional adverse events reported. Permission for correspondence given.  Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinantHumanalbumin (rHA)) (PROQUAD) experienced the temperature excursion under 6 degrees Fahrenheit (F) to 14F (8.5F) for 0 hours 18 minutes and 0 seconds; 6F to 14F (11.9F) for 1 hour 0 minutes and 0 seconds. The time frame was reported as cumulative timeframe: 1 hour and 18 minutes. The previous temperature excursions was not reported.