chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Unresponsive to stimuli, Vital signs measurement
Clinical narrative: patient died; BP 83/55; no respiration noted; patient unresponsive; blood glucose level of 193; This is a spontaneous report received from a contactable nurse.  A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581, expiry date: unknown), via an unspecified route of administration in the right arm, on 01Mar2021 13:50, as single dose, for covid-19 immunization, at a public health department. Medical history included diabetes, obesity, hypertension (HTN), myocardial infarction (MI) in 2011, gastroparesis, home oxygen use, motorize scooter use, pulmonary embolism (PE) in Oct2020, and iodine allergy. Concomitant medications included insulin for diabetes and fentanyl patch. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown) received at age 68 years, on 08Feb2021, for COVID-19 immunization and experienced breathing difficulty. The patient's doctor stopped "Zarello" (as reported) subsequent to the first dose of BNT162B2 vaccine due to breathing difficulty. It was reported that the patient did not have an adverse event following any previous vaccine. On 01Mar2021 at 13:50, the patient received the second dose of the Pfizer COVID-19 vaccine. At 14:18, a nurse was called to the parking lot and observed the patient having difficulties (unspecified). The nurse called for emergency medical services (EMS) and for a crash cart. The patient's vitals were taken and the patient had pressure (BP) 83/55, no respiration noted and the patient was unresponsive. The EMS arrived as 14:22 and look over care. The patient was transported to the hospital at 14:40. Per the EMS, the patient had a blood glucose level of 193. It was reported that the patient died on 01Mar2021. It was not reported if an autopsy was performed. The outcome of the event "patient died" was fatal; and the outcome of the events "BP 83/55", "no respiration noted", "patient unresponsive" and "blood glucose level of 193" was unknown.; Sender's Comments: Based on temporal association and limited information, the causal relationship between BNT162B2 and the events death, hypotension, apnea, unresponsive to stimuli and blood glucose increased cannot be excluded. The contributory role of other pre-existing diseases cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.; Reported Cause(s) of Death: patient died
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Gastrointestinal disorder, Haematochezia
Clinical narrative: bloody stool; diarrhea; nausea; bloating; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 18:00 (at the age of 42 years-old), as single dose for covid-19 immunization.  Medical history included diabetes, hypothyroidism, palindrome rheumatoid and known allergies with seafood. Patient is not pregnant at the time of report and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was taking several daily prescription medications. On 25Feb2021 18:30, patient experienced severe GI issues: bloody stool, diarrhea, nausea, bloating and stomach cramping. Symptoms have continued for 8 days now. Patient stated, "It took me this long to figure out it may have been the vaccine". The outcome of events was not recovered. Patient did not receive any treatment for the events.   Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: bloody stool; diarrhea; nausea; bloating; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 18:00 (at the age of 42 years-old), as single dose for covid-19 immunization.  Medical history included diabetes, hypothyroidism, palindrome rheumatoid and known allergies with seafood. Patient is not pregnant at the time of report and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was taking several daily prescription medications. On 25Feb2021 18:30, patient experienced severe GI issues: bloody stool, diarrhea, nausea, bloating and stomach cramping. Symptoms have continued for 8 days now. Patient stated, "It took me this long to figure out it may have been the vaccine". The outcome of events was not recovered. Patient did not receive any treatment for the events.   Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Haematochezia, Nausea
Clinical narrative: bloody stool; diarrhea; nausea; bloating; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 18:00 (at the age of 42 years-old), as single dose for covid-19 immunization.  Medical history included diabetes, hypothyroidism, palindrome rheumatoid and known allergies with seafood. Patient is not pregnant at the time of report and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was taking several daily prescription medications. On 25Feb2021 18:30, patient experienced severe GI issues: bloody stool, diarrhea, nausea, bloating and stomach cramping. Symptoms have continued for 8 days now. Patient stated, "It took me this long to figure out it may have been the vaccine". The outcome of events was not recovered. Patient did not receive any treatment for the events.   Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tinnitus
Clinical narrative: Lost hearing on my right ear, same side the shot I had; Tinnitus and still I have ringing in my right ear; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration in right arm on 03Mar2021 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. Concomitant medications included amlodipine besilate/ valsartan for blood pressure high, hydrochlorothiazide, atorvastatin for cholesterol, and alprazolam. The patient stated "I had a really bad side effect from my 1st (dose) Pfizer vaccine for Covid shot. I probably got it 16 days ago on Wednesday, the date I got it, I received it on Wednesday 03Mar2021 of this year. It was the Wednesday, this Saturday I was feeling great, feeling fine and I became, I lost my hearing on my right ear, my right ear at the same side as the shot and I still have tinnitus then I have taken steroids (prednisone) for it (treatment). Four days later, I experienced low hearing in my right ear, low hearing, I lost my hearing in my right ear. I have tinnitus, still I have ringing in my (right) ear. Yes, I want them to follow up because I don't know if I should take the 2nd shot. I am not sure if I am going to take the 2nd shot because I will just the "affect" (not clarified), I don't want to get deaf. I got, my hearing, my hearing is back. I don't know what extend, I am going to the doctor next week to get a hearing test. I have been taking prednisone, a steroid for my hearing; 10 mg tablet, I started off of it's 6 tablets 3 times a day and decreased to 5 tablets 3 times a day, 60 mg for 3 days in a row then 50 mg for 3 days in a row and then 40 mg for 3 days in a row, I got a table at time, so I was getting a bad reaction to the prednisone, So my doctor told me to stop it. (Dosage further not clarified) I was getting super anxiety, I couldn't, I can't sleep at night and can't sleep at all. I am on antibiotics and steroid (treatment), I am on steroid to regain my hearing and now next weekend I am supposed to do for my second shot and I don't to take it but I "still" (not clarified) have tinnitus and I lost my hearing in my right ear, I don't know what to do, so I just waited at home let's see what happened this. Are those side adverse effects or what, I don't know?" Outcome of lost hearing was recovered and of tinnitus was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Lost hearing on my right ear, same side the shot I had; Tinnitus and still I have ringing in my right ear; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration in right arm on 03Mar2021 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. Concomitant medications included amlodipine besilate/ valsartan for blood pressure high, hydrochlorothiazide, atorvastatin for cholesterol, and alprazolam. The patient stated "I had a really bad side effect from my 1st (dose) Pfizer vaccine for Covid shot. I probably got it 16 days ago on Wednesday, the date I got it, I received it on Wednesday 03Mar2021 of this year. It was the Wednesday, this Saturday I was feeling great, feeling fine and I became, I lost my hearing on my right ear, my right ear at the same side as the shot and I still have tinnitus then I have taken steroids (prednisone) for it (treatment). Four days later, I experienced low hearing in my right ear, low hearing, I lost my hearing in my right ear. I have tinnitus, still I have ringing in my (right) ear. Yes, I want them to follow up because I don't know if I should take the 2nd shot. I am not sure if I am going to take the 2nd shot because I will just the "affect" (not clarified), I don't want to get deaf. I got, my hearing, my hearing is back. I don't know what extend, I am going to the doctor next week to get a hearing test. I have been taking prednisone, a steroid for my hearing; 10 mg tablet, I started off of it's 6 tablets 3 times a day and decreased to 5 tablets 3 times a day, 60 mg for 3 days in a row then 50 mg for 3 days in a row and then 40 mg for 3 days in a row, I got a table at time, so I was getting a bad reaction to the prednisone, So my doctor told me to stop it. (Dosage further not clarified) I was getting super anxiety, I couldn't, I can't sleep at night and can't sleep at all. I am on antibiotics and steroid (treatment), I am on steroid to regain my hearing and now next weekend I am supposed to do for my second shot and I don't to take it but I "still" (not clarified) have tinnitus and I lost my hearing in my right ear, I don't know what to do, so I just waited at home let's see what happened this. Are those side adverse effects or what, I don't know?" Outcome of lost hearing was recovered and of tinnitus was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Loss of consciousness, Malaise
Clinical narrative: passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very weak and sick; feeling very weak and sick; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 11Mar2021 at 15:45 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, known allergies to red food dye and sulfa; all from unspecified dates. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEXA), lorazepam (ATIVAN), VITAMIN D NOS (VITAMIN D), cyanocobalamin (VITAMIN B12), curcuma longa (TURMERIC); all taken for unspecified indications, start and stop date were not reported. The patient previously took gabapentin, escitalopram (LEXAPRO), and promethazine and experienced known allergies to all drugs. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. It was unknown if the patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. After receiving the first shot, the patient felt the expected side effects (low fever, arm pain, fatigue and chills) but they worsened over the next several days. After feeling very weak and sick all day, she passed out for approx 30+ minutes, she was alone but was found on the floor by her mother after she attempted to call her multiple times and she didn't respond. She experienced seizure like activity and was advised by her primary care doctor to go to the emergency room, and was seen there. Start date for the adverse events reported as 15Mar2021 at 16:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. There was no treatment received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Seizure
Clinical narrative: passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very weak and sick; feeling very weak and sick; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 11Mar2021 at 15:45 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, known allergies to red food dye and sulfa; all from unspecified dates. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEXA), lorazepam (ATIVAN), VITAMIN D NOS (VITAMIN D), cyanocobalamin (VITAMIN B12), curcuma longa (TURMERIC); all taken for unspecified indications, start and stop date were not reported. The patient previously took gabapentin, escitalopram (LEXAPRO), and promethazine and experienced known allergies to all drugs. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. It was unknown if the patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. After receiving the first shot, the patient felt the expected side effects (low fever, arm pain, fatigue and chills) but they worsened over the next several days. After feeling very weak and sick all day, she passed out for approx 30+ minutes, she was alone but was found on the floor by her mother after she attempted to call her multiple times and she didn't respond. She experienced seizure like activity and was advised by her primary care doctor to go to the emergency room, and was seen there. Start date for the adverse events reported as 15Mar2021 at 16:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. There was no treatment received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Loss of consciousness, Malaise
Clinical narrative: passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very weak and sick; feeling very weak and sick; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 11Mar2021 at 15:45 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, known allergies to red food dye and sulfa; all from unspecified dates. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEXA), lorazepam (ATIVAN), VITAMIN D NOS (VITAMIN D), cyanocobalamin (VITAMIN B12), curcuma longa (TURMERIC); all taken for unspecified indications, start and stop date were not reported. The patient previously took gabapentin, escitalopram (LEXAPRO), and promethazine and experienced known allergies to all drugs. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. It was unknown if the patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. After receiving the first shot, the patient felt the expected side effects (low fever, arm pain, fatigue and chills) but they worsened over the next several days. After feeling very weak and sick all day, she passed out for approx 30+ minutes, she was alone but was found on the floor by her mother after she attempted to call her multiple times and she didn't respond. She experienced seizure like activity and was advised by her primary care doctor to go to the emergency room, and was seen there. Start date for the adverse events reported as 15Mar2021 at 16:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. There was no treatment received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Seizure like phenomena
Clinical narrative: passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very weak and sick; feeling very weak and sick; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 11Mar2021 at 15:45 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, known allergies to red food dye and sulfa; all from unspecified dates. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEXA), lorazepam (ATIVAN), VITAMIN D NOS (VITAMIN D), cyanocobalamin (VITAMIN B12), curcuma longa (TURMERIC); all taken for unspecified indications, start and stop date were not reported. The patient previously took gabapentin, escitalopram (LEXAPRO), and promethazine and experienced known allergies to all drugs. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. It was unknown if the patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. After receiving the first shot, the patient felt the expected side effects (low fever, arm pain, fatigue and chills) but they worsened over the next several days. After feeling very weak and sick all day, she passed out for approx 30+ minutes, she was alone but was found on the floor by her mother after she attempted to call her multiple times and she didn't respond. She experienced seizure like activity and was advised by her primary care doctor to go to the emergency room, and was seen there. Start date for the adverse events reported as 15Mar2021 at 16:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. There was no treatment received for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Chills, Dehydration, Dysarthria, Dysphagia
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eating disorder, Electric shock sensation, Fatigue, Gait disturbance
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immobile, Increased upper airway secretion, Lethargy, Mastication disorder
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pyrexia, Retching
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chills, Dehydration, Dysphagia, Dyspnoea
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Fatigue, Headache, Immobile, Increased upper airway secretion
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Mastication disorder, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; difficulty swallowing,chewing and speaking; had a lot of mucus in my throat; difficulty breathing; asthma acting up; lethargic; dehydrated; headaches; immobility; fever; chills; muscle aches; stiffness; electrical shocks up and down my body; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6202), at the age of 53-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, multiple sclerosis, seasonal allergies, dust, animals. The patient did not have COVID prior vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included glatiramer acetate (COPAXONE); lamotrigine (LAMICTAL); risperidone (RISPERDAL); alprazolam (XANAX); salbutamol (ALBUTEROL HFA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took dilaudid and experienced allergies. On 04Mar2021 17:00, the patient got fever, chills, headaches, muscle aches and stiffness. The patient treated the symptoms with ibuprofen and ice packs. The next day, on 05Mar2021, the patient had difficulty swallowing, chewing and speaking. The patient had a lot of mucus in my throat and difficulty breathing from asthma acting up. The patient was very lethargic and dehydrated. The patient had to use inhalers, benedryl and musinex to treat symptoms. The patient had the chills, headaches, fever and aches through Tuesday, 09Mar2021. The patient touched base with her general practitioner's and neurologists' offices on March 5 & 6 and left messages. They suggested she go to the ER. (She didn't go out of fear of getting COVID), she was too fatigued and weak to walk. No balance. She had electrical shocks up and down her body. The patient was still experiencing immobility and fatigue. The outcome of the events chills, headaches, fever and aches was recovered on 09Mar2021; the other events were not recovered. The patient was not tested for COVID post vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Fatigue, Feeling jittery, Impaired driving ability, Loss of consciousness
Clinical narrative: started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization  .  There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Loss of consciousness, Road traffic accident
Clinical narrative: started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization  .  There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test normal, Cardiac telemetry normal, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: face swollen/ facial swelling; rash; chest pain; tongue/ mouth started to go numb; rash tongue; rash mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) on 16Mar2021 03:45 PM in left arm at single dose for COVID-19 immunisation. Medical history included Fabry's disease, kidney disease, known allergies: penicillin. No covid prior vaccination. Concomitant medications in two weeks included clopidogrel, agalsidase beta (FABRAZYME), atorvastatin, nortriptyline hydrochloride (NORTRIPTYLIN). The patient did not receive other vaccine in four weeks. No covid tested post vaccination. The patient experienced face swollen, rash 30 minutes after injection at 04:30 PM on 16Mar2021, two diphenhydramine hydrochloride (BENADRYL) were taken at home before heading to ER (emergency room), arrived to ER with chest pain, facial swelling and rash tongue/ mouth started to go numb around 2 hrs past injection. The events resulted in emergency room/department or urgent care, hospitalization, the patient was hospitalization for two days. The patient received treatment as Albuterol (salbutamol) nebulizer, famotidine (PEPCID), solumedrol nitroglyce for the events. Outcome of the events was recovered.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Rash, Swelling face, Swollen tongue
Clinical narrative: face swollen/ facial swelling; rash; chest pain; tongue/ mouth started to go numb; rash tongue; rash mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) on 16Mar2021 03:45 PM in left arm at single dose for COVID-19 immunisation. Medical history included Fabry's disease, kidney disease, known allergies: penicillin. No covid prior vaccination. Concomitant medications in two weeks included clopidogrel, agalsidase beta (FABRAZYME), atorvastatin, nortriptyline hydrochloride (NORTRIPTYLIN). The patient did not receive other vaccine in four weeks. No covid tested post vaccination. The patient experienced face swollen, rash 30 minutes after injection at 04:30 PM on 16Mar2021, two diphenhydramine hydrochloride (BENADRYL) were taken at home before heading to ER (emergency room), arrived to ER with chest pain, facial swelling and rash tongue/ mouth started to go numb around 2 hrs past injection. The events resulted in emergency room/department or urgent care, hospitalization, the patient was hospitalization for two days. The patient received treatment as Albuterol (salbutamol) nebulizer, famotidine (PEPCID), solumedrol nitroglyce for the events. Outcome of the events was recovered.