chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nervousness, Oropharyngeal discomfort, Sleep disorder
Clinical narrative: trouble sleeping; lump in her throat; high blood pressures; feeling very shaky and very weak; feeling very shaky and very weak; feeling unwell; alternating slow heartbeat and fast heartbeat; a weird feeling in her head like pressure but not a headache/pressure feeling in my head; they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction.; This is a spontaneous report from a contactable consumer.   A 65 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 31Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included allergic to shrimp, lupus anticoagulant syndrome, chronic kidney disease and antiphospholipid syndrome. Concomitant medications included amlodipine, HCTZ, losartan, acetylsalicylic acid (ASPIRIN (E.C.) and atorvastatin calcium (LIPITOR ORIFARM). The patient informed that immediately after receiving the injection she felt a lump in her throat and could not swallow, still present now. Patient also informed that after vaccination she was having a very high blood pressures, feeling very shaky and very weak, a weird feeling in her head like pressure but not a headache, trouble sleeping because of the pressure feeling in my head, feeling unwell and alternating slow heartbeat and fast heartbeat.  Patient also reported she had scheduled an allergist appointment and they are going to check me for all the ingredients in the Pfizer vaccine that could give me an allergic reaction. At the time of the reporting event outcome was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Joint swelling
Clinical narrative: Fatigue; Swelling in the joint of my left thumb; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration at the left arm on 16Jan2021 16:45 at a single dose for COVID-19 immunization. The vaccine was administered at the Public Health Department. The patient's medical history includes asthma, allergic rhinitis, migraine, fibromyalgia, gluten intolerance, GERD and Allergies: NSAIDS, gluten. The patient is not pregnant. Concomitant medication includes unspecified medications. On 17Jan2021 07:00 AM, the patient experienced fatigue lasting 6 days, swelling in the joint of her left thumb. The swelling has not gone down yet. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Oral discomfort, Pruritus
Clinical narrative: Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date was not reported) given at 64 years of age, via an unspecified route of administration in the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included known allergies. Concomitant medication included thyroid (ARMOUR THYROID), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), and metronidazole. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 since the vaccination. It was reported that less than one hour after receiving the vaccine on 25Jan2021 at 04:00 PM, the patient developed itching inside her mouth and throat, and on her hands and legs. The itching stopped with BENADRYL. Four days later on 29Jan2021 14:30, she developed swollen and blistered lips. The outcome of the events was recovering and were reported non-serious. Treatment received for the events included steroid injection five days after the vaccine. The events resulted to doctor or other healthcare professional office/clinic visit then emergency room/department or urgent care.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip blister, Lip swelling, Oral pruritus, Pruritus, Throat irritation
Clinical narrative: Swollen and blistered lips; Swollen and blistered lips; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; Itching inside my mouth and throat, and on my hands and legs; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date was not reported) given at 64 years of age, via an unspecified route of administration in the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history included known allergies. Concomitant medication included thyroid (ARMOUR THYROID), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), and metronidazole. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested for COVID-19 since the vaccination. It was reported that less than one hour after receiving the vaccine on 25Jan2021 at 04:00 PM, the patient developed itching inside her mouth and throat, and on her hands and legs. The itching stopped with BENADRYL. Four days later on 29Jan2021 14:30, she developed swollen and blistered lips. The outcome of the events was recovering and were reported non-serious. Treatment received for the events included steroid injection five days after the vaccine. The events resulted to doctor or other healthcare professional office/clinic visit then emergency room/department or urgent care.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Full blood count
Clinical narrative: my blood pressure went up uncomfortably. 178/82; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 11:00 at a single dose for covid-19 immunisation. Medical history included hypertension and high cholesterol. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), acetylsalicylic acid (BABY ASPIRIN), bumetanide and rosuvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day of the vaccination around 5 pm (26Jan2021 05:30 PM), the patient reported that her blood pressure went up uncomfortably to 178/82 [unit unspecified]. The patient did not received treatment for the adverse event. The event was considered as non-serious, but the event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: my blood pressure went up uncomfortably. 178/82; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 11:00 at a single dose for covid-19 immunisation. Medical history included hypertension and high cholesterol. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), acetylsalicylic acid (BABY ASPIRIN), bumetanide and rosuvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day of the vaccination around 5 pm (26Jan2021 05:30 PM), the patient reported that her blood pressure went up uncomfortably to 178/82 [unit unspecified]. The patient did not received treatment for the adverse event. The event was considered as non-serious, but the event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Full blood count, Hypertension
Clinical narrative: my blood pressure went up uncomfortably. 178/82; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 11:00 at a single dose for covid-19 immunisation. Medical history included hypertension and high cholesterol. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), acetylsalicylic acid (BABY ASPIRIN), bumetanide and rosuvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day of the vaccination around 5 pm (26Jan2021 05:30 PM), the patient reported that her blood pressure went up uncomfortably to 178/82 [unit unspecified]. The patient did not received treatment for the adverse event. The event was considered as non-serious, but the event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood pressure increased, Chest pain, Dizziness, Electrocardiogram abnormal
Clinical narrative: Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On  02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm  and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. 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.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Injection site paraesthesia, Laboratory test, Palpitations, Paraesthesia
Clinical narrative: Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On  02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm  and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. 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.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Dizziness, Heart rate
Clinical narrative: Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On  02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm  and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. 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.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Paraesthesia
Clinical narrative: Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On  02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm  and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number and expiry date: unknown) via an unspecified route of administration in the left arm, on 23Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. The patient has no known medical history and no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (LOESTRIN), and thyroid (NATURE THROID). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 24Jan2021, the patient experienced headache lasting for more than one week (ongoing). The event was considered as non-serious. The event resulted to a doctor or other healthcare professional office/clinic visit. The patient received Tylenol and Sudafed as treatment for the event. Outcome of the event was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Ear pain, Eyelid function disorder, Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypertension, Hypoaesthesia, Magnetic resonance imaging brain, Magnetic resonance imaging neck
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain in jaw, Pyrexia
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Eyelid function disorder, Facial pain, Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Muscle spasms, Neck pain
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in jaw
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. 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.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration right arm on 03Feb2021 10:30 at a single dose for covid-19 immunization. The patient medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D), probiotics, chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN), thyroid (ARMOUR THYROID), magnesium glycinate, progesterone and melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in her workplace clinic. On 04Feb2021 04:30 AM, the patient reported that she woke the morning after the vaccine, and she was unable to walk without assistance due to dizziness. The adverse event result in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The following information on the batch/lot number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration right arm on 03Feb2021 10:30 at a single dose for covid-19 immunization. The patient medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D), probiotics, chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN), thyroid (ARMOUR THYROID), magnesium glycinate, progesterone and melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in her workplace clinic. On 04Feb2021 04:30 AM, the patient reported that she woke the morning after the vaccine, and she was unable to walk without assistance due to dizziness. The adverse event result in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered. The following information on the batch/lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Oversensing, Photophobia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (right arm) first dose on 29Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history included LBP (herniated disc and sciatica), GERD, IBS, PTSD, and allergies: Sulfa drugs. The patient was not pregnant at time of vaccination. The patient's concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), esomeprazole magnesium (NEXIUM), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC), and "Multi-vitamin". The patient previously took Ceclor and experienced allergies. On 29Jan2021 17:45, the patient noticed a slight headache, which I do not get often, and thought I might be slightly dehydrated, so the patient increased my water intake and drank 8 ounces of Gatorade.  The headache got worse and when she was preparing to leave work, the patient was so much pain on the right, front side of my head lights, "noise", and walking hurt. The patient never had a migraine before, but I think this is what it was. The patient went home and took 2 Tylenol tablets, and went to bed.  The patient woke up and in the morning with slight headache and took 2 more Tylenol tablets, and the headache subsided and did not return. The outcome of the events was recovered. The reporter assess the events as non-serious.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Headache, Migraine, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (right arm) first dose on 29Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history included LBP (herniated disc and sciatica), GERD, IBS, PTSD, and allergies: Sulfa drugs. The patient was not pregnant at time of vaccination. The patient's concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), esomeprazole magnesium (NEXIUM), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC), and "Multi-vitamin". The patient previously took Ceclor and experienced allergies. On 29Jan2021 17:45, the patient noticed a slight headache, which I do not get often, and thought I might be slightly dehydrated, so the patient increased my water intake and drank 8 ounces of Gatorade.  The headache got worse and when she was preparing to leave work, the patient was so much pain on the right, front side of my head lights, "noise", and walking hurt. The patient never had a migraine before, but I think this is what it was. The patient went home and took 2 Tylenol tablets, and went to bed.  The patient woke up and in the morning with slight headache and took 2 more Tylenol tablets, and the headache subsided and did not return. The outcome of the events was recovered. The reporter assess the events as non-serious.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematochezia
Clinical narrative: Blood in stools the next day after getting vaccine.; This is spontaneous case from a contactable consumer reported for himself. A 65-year-old male patient received 1st dose of BNT162B2 (lot# EN5318) on 04Feb2021 00:00 (reported as 03Feb2021 12:00 PM) at single dose on Right arm for covid-19 immunization. Medical history was diabetes from Aug2018. Concomitant drug was Insulin lispro (HUMALOG) for Diabetic. Patient experienced Blood in stools the next day after getting vaccine (04Feb2021 08:15 PM). Never had this problem before. Have had colonoscopy in last 5 years with no diagnosed problems. No treatment received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Haematochezia
Clinical narrative: Blood in stools the next day after getting vaccine.; This is spontaneous case from a contactable consumer reported for himself. A 65-year-old male patient received 1st dose of BNT162B2 (lot# EN5318) on 04Feb2021 00:00 (reported as 03Feb2021 12:00 PM) at single dose on Right arm for covid-19 immunization. Medical history was diabetes from Aug2018. Concomitant drug was Insulin lispro (HUMALOG) for Diabetic. Patient experienced Blood in stools the next day after getting vaccine (04Feb2021 08:15 PM). Never had this problem before. Have had colonoscopy in last 5 years with no diagnosed problems. No treatment received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test, Fatigue, Malaise
Clinical narrative: activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus; day 5-8 was intense GI distress with stabbing stomach pain; day 5-8 was intense GI distress with stabbing stomach pain; general malaise; Day 1-4 was significant fatigue and headache; Day 1-4 was significant fatigue and headache; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 14Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included high cholesterol, blood pressure abnormal, degenerative arthritis and allergies to penicillin and NSAIDS. Concomitant medications included gabapentin, lisinopril, levothyroxine and atorvastatin. On days 1-4, the patient experienced significant fatigue and headache on 15Jan2021. On days 5-8, there was intense GI distress with stabbing stomach pain, following these events has been continued with fatigue and general malaise. Most problematic was activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus, which attacks soft tissue areas on the body with blisters and sloughing skin. This is a very uncomfortable experience to go through. The patient's healthcare provider is aware and treating him for such. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of day 1-4 was significant fatigue and headache, day 5-8 was intense gi distress with stabbing stomach pain and general malaise. The outcome of the events was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus; day 5-8 was intense GI distress with stabbing stomach pain; day 5-8 was intense GI distress with stabbing stomach pain; general malaise; Day 1-4 was significant fatigue and headache; Day 1-4 was significant fatigue and headache; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 14Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included high cholesterol, blood pressure abnormal, degenerative arthritis and allergies to penicillin and NSAIDS. Concomitant medications included gabapentin, lisinopril, levothyroxine and atorvastatin. On days 1-4, the patient experienced significant fatigue and headache on 15Jan2021. On days 5-8, there was intense GI distress with stabbing stomach pain, following these events has been continued with fatigue and general malaise. Most problematic was activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus, which attacks soft tissue areas on the body with blisters and sloughing skin. This is a very uncomfortable experience to go through. The patient's healthcare provider is aware and treating him for such. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of day 1-4 was significant fatigue and headache, day 5-8 was intense gi distress with stabbing stomach pain and general malaise. The outcome of the events was not recovered.