chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Facial discomfort, Pain in extremity, Pruritus
Clinical narrative: 10 minutes following vaccination, itchiness, "fullness in face and chest" She took benadryl and cetirizine due to known adverse reaction to H1N1 vaccine Overall resolved in 30 min   no worsening Arm achiness x2 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: 12/18: First hour after vaccine: increased heart rate, felt flush and jittery - like I had drank a lot of espresso. Not debilitating but unpleasant. Then mostly went away, felt drained 12/19: headache and nausea started along with fatigue. Nausea would come in waves 12/20: Fatigued, headache 12/21: Headache, Nausea, waves of feeling flush (never had fever) and increased Heart rate. Worked all day but felt lousy 12/22: Continued symptoms from day before - feeling drained especially after episode of nausea/increased HR. Worked all day 12/23: Heached, Nausea - stayed home from work because they wanted a covid test to rule out that I had not contracted. Slept on and off all day. Cough started PM 12/24: Just headache, no nausea but no appetite, low energy 12/25: started feeling normal. still no appetite.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Flushing, Headache, Heart rate increased, Nausea
Clinical narrative: 12/18: First hour after vaccine: increased heart rate, felt flush and jittery - like I had drank a lot of espresso. Not debilitating but unpleasant. Then mostly went away, felt drained 12/19: headache and nausea started along with fatigue. Nausea would come in waves 12/20: Fatigued, headache 12/21: Headache, Nausea, waves of feeling flush (never had fever) and increased Heart rate. Worked all day but felt lousy 12/22: Continued symptoms from day before - feeling drained especially after episode of nausea/increased HR. Worked all day 12/23: Heached, Nausea - stayed home from work because they wanted a covid test to rule out that I had not contracted. Slept on and off all day. Cough started PM 12/24: Just headache, no nausea but no appetite, low energy 12/25: started feeling normal. still no appetite.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: 12/18: First hour after vaccine: increased heart rate, felt flush and jittery - like I had drank a lot of espresso. Not debilitating but unpleasant. Then mostly went away, felt drained 12/19: headache and nausea started along with fatigue. Nausea would come in waves 12/20: Fatigued, headache 12/21: Headache, Nausea, waves of feeling flush (never had fever) and increased Heart rate. Worked all day but felt lousy 12/22: Continued symptoms from day before - feeling drained especially after episode of nausea/increased HR. Worked all day 12/23: Heached, Nausea - stayed home from work because they wanted a covid test to rule out that I had not contracted. Slept on and off all day. Cough started PM 12/24: Just headache, no nausea but no appetite, low energy 12/25: started feeling normal. still no appetite.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness on side vaccine was given
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Pain and generalized swelling to  left arm for 3 days post injection.  One day after injection fatigue and myalgia, Tylenol taken twice that day. Day 8 post injection a hot and painful red circle at injection site, approximately size of a quarter.  Day 9 circle is size of half dollar and still hot and painful.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain and generalized swelling to  left arm for 3 days post injection.  One day after injection fatigue and myalgia, Tylenol taken twice that day. Day 8 post injection a hot and painful red circle at injection site, approximately size of a quarter.  Day 9 circle is size of half dollar and still hot and painful.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Feeling hot, Hypertension, Nausea, Paraesthesia
Clinical narrative: nausea, entire body tingling, hypertensive (197/103) at highest, feeling very hot. laid down on cool bench for 25 minutes while BP was taken, left facility went BP was 149/88. slept for about a hour and felt better  returned to normal at the 2 hour post shot mark
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Weakness/ chills and fever.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid sensory disorder, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Tongue went numb on right side. My face then went numb on the right side and spread to my ear. It then progressed up to my right eye lid. I took a dose of Benadryl and Flonase. Numbness stopped spreading. It lasted about 35 hours. No facial drooping noted. I was able to close my eyelid then entire time.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Nausea, Swollen tongue, Syncope
Clinical narrative: syncope, anxiety, nausea, vomiting, diarrhea, perceived tongue swelling although no visible swelling
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: syncope, anxiety, nausea, vomiting, diarrhea, perceived tongue swelling although no visible swelling
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 100.4 deg F, took tylenol
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Significant fatigue ~24 hours after vaccination. Muscle aches, joint pain, fatigue ~48 hours after vaccine. No fever noticed.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Cough, Dizziness, Dyspnoea
Clinical narrative: I took the shot at 11:45. By 3ish my shoulders and neck began to become stiff with slight pain which progressed throughout the evening until I developed a severe headache. By 6pm I had difficulty turning my head due to neck stiffness with a resting HR:98 SpO2:99%. I then developed a cough, SOB, dizziness, and balance deficit. Around 9pm my lips went numb with tingling when touched. I then developed small blisters around my lips. I was awake till around 4am with a severe headache. By 9am all these symptoms subsided except for the tachycardia and lips tingling with paresthesia which resolved by the next morning. 48hrs later I was back to normal.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Lip blister, Musculoskeletal stiffness, Neck pain
Clinical narrative: I took the shot at 11:45. By 3ish my shoulders and neck began to become stiff with slight pain which progressed throughout the evening until I developed a severe headache. By 6pm I had difficulty turning my head due to neck stiffness with a resting HR:98 SpO2:99%. I then developed a cough, SOB, dizziness, and balance deficit. Around 9pm my lips went numb with tingling when touched. I then developed small blisters around my lips. I was awake till around 4am with a severe headache. By 9am all these symptoms subsided except for the tachycardia and lips tingling with paresthesia which resolved by the next morning. 48hrs later I was back to normal.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tachycardia
Clinical narrative: I took the shot at 11:45. By 3ish my shoulders and neck began to become stiff with slight pain which progressed throughout the evening until I developed a severe headache. By 6pm I had difficulty turning my head due to neck stiffness with a resting HR:98 SpO2:99%. I then developed a cough, SOB, dizziness, and balance deficit. Around 9pm my lips went numb with tingling when touched. I then developed small blisters around my lips. I was awake till around 4am with a severe headache. By 9am all these symptoms subsided except for the tachycardia and lips tingling with paresthesia which resolved by the next morning. 48hrs later I was back to normal.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left sided facial numbness
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Significant pain at injection site that lasted about 36 hours and prevented any touching of the site. Also had mild headache and some generalized myalgias. These also resolved after 36 hours.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: Injection site pain, low-grade fever, bodyaches, sore throat, headache, tiredness - lasted from around 10 am to 9 pm, when I went to bed. I had a confirmed negative antibody test 11/24/20
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Injection site pain, low-grade fever, bodyaches, sore throat, headache, tiredness - lasted from around 10 am to 9 pm, when I went to bed. I had a confirmed negative antibody test 11/24/20
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness of the tongue
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Moderna COVID-19 Vaccine EUA  Excessive shoulder pain with limits on range of motion. Has diminished in the past 36 hours but pain still persists and range of motion is not back to normal.  Only took Tylenol, aleve, and albuterol.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymph node palpable, Lymphadenopathy
Clinical narrative: Enlarged left cervical lymph nodes. Two palpable nodes that are hard and tender.  Measuring about  3 cm in diameter today.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Electroencephalogram, Laboratory test, Magnetic resonance imaging, Seizure
Clinical narrative: # 2 Shingrix vaccine (no adverse reaction from #1) 10:30 on 11-11-20 after received Shingrix on 11-10-20 pt slumped over, pale, diaphrotic observed eyes rolled back & hand contracted 10 min period in & out with unresponsiveness very agitated at office went to ED had old brain injury 2007. ER Dr. concluded seizures adm to hospital MRI done. No more seizures.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Agitation, Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram
Clinical narrative: # 2 Shingrix vaccine (no adverse reaction from #1) 10:30 on 11-11-20 after received Shingrix on 11-10-20 pt slumped over, pale, diaphrotic observed eyes rolled back & hand contracted 10 min period in & out with unresponsiveness very agitated at office went to ED had old brain injury 2007. ER Dr. concluded seizures adm to hospital MRI done. No more seizures.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gaze palsy, Hyperhidrosis, Magnetic resonance imaging, Muscle contractions involuntary, Pallor
Clinical narrative: # 2 Shingrix vaccine (no adverse reaction from #1) 10:30 on 11-11-20 after received Shingrix on 11-10-20 pt slumped over, pale, diaphrotic observed eyes rolled back & hand contracted 10 min period in & out with unresponsiveness very agitated at office went to ED had old brain injury 2007. ER Dr. concluded seizures adm to hospital MRI done. No more seizures.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Posture abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: # 2 Shingrix vaccine (no adverse reaction from #1) 10:30 on 11-11-20 after received Shingrix on 11-10-20 pt slumped over, pale, diaphrotic observed eyes rolled back & hand contracted 10 min period in & out with unresponsiveness very agitated at office went to ED had old brain injury 2007. ER Dr. concluded seizures adm to hospital MRI done. No more seizures.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Hypotension, Laboratory test, Pain
Clinical narrative: 11 AM BP decreased + fever on 11-11-20. received Shingrix on 11-10-20. "felt like I was to faint" gave fluids, UA + bloodwork. dx with dehydration in ED. No reaction first vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 11 AM BP decreased + fever on 11-11-20. received Shingrix on 11-10-20. "felt like I was to faint" gave fluids, UA + bloodwork. dx with dehydration in ED. No reaction first vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Dehydration, Dizziness, Laboratory test, Pyrexia
Clinical narrative: 11 AM BP decreased + fever on 11-11-20. received Shingrix on 11-10-20. "felt like I was to faint" gave fluids, UA + bloodwork. dx with dehydration in ED. No reaction first vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urine analysis
Clinical narrative: 11 AM BP decreased + fever on 11-11-20. received Shingrix on 11-10-20. "felt like I was to faint" gave fluids, UA + bloodwork. dx with dehydration in ED. No reaction first vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Pruritus, Tachycardia, Urticaria
Clinical narrative: felt like I was going to pass out; lightheaded/Dizzy; 9 minutes after administration heart rate up to 154; leg shakes; started having chest itchiness; neck rash; facial hives; Injection site sore; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 08:00 at a single dose for covid-19 immunisation. Medical history included allergies to cephalosphorins. Concomitant medication include unspecified multivitamins. On 17Dec2020 08:09, the patient's heart rate went up to 154 after vaccine administration. On 17Dec2020 08:15, she felt like she was going to pass out, she was lightheaded and dizzy. The patient also experienced leg shakes, started having chest itchiness, neck rash, facial hives and injection site sore on 17Dec2020. The patient was treated with diphenhydramine (BENADRYL) 50mg intramuscularly (IM) for the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy", "leg shakes", "started having chest itchiness", "neck rash" and "facial hives". The patient's heart rate came down to 130s then down to 90s and the hives subsided. The patient underwent lab tests and procedures which included heart rate: 154, heart rate: 130 and heart rate: 90; all on 17Dec2020. Outcome of the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy" and "facial hives" recovered on an unspecified date while the outcome of events "leg shakes", "started having chest itchiness", "neck rash" and "injection site sore" was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Injection site pain, Pruritus, Rash
Clinical narrative: felt like I was going to pass out; lightheaded/Dizzy; 9 minutes after administration heart rate up to 154; leg shakes; started having chest itchiness; neck rash; facial hives; Injection site sore; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 08:00 at a single dose for covid-19 immunisation. Medical history included allergies to cephalosphorins. Concomitant medication include unspecified multivitamins. On 17Dec2020 08:09, the patient's heart rate went up to 154 after vaccine administration. On 17Dec2020 08:15, she felt like she was going to pass out, she was lightheaded and dizzy. The patient also experienced leg shakes, started having chest itchiness, neck rash, facial hives and injection site sore on 17Dec2020. The patient was treated with diphenhydramine (BENADRYL) 50mg intramuscularly (IM) for the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy", "leg shakes", "started having chest itchiness", "neck rash" and "facial hives". The patient's heart rate came down to 130s then down to 90s and the hives subsided. The patient underwent lab tests and procedures which included heart rate: 154, heart rate: 130 and heart rate: 90; all on 17Dec2020. Outcome of the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy" and "facial hives" recovered on an unspecified date while the outcome of events "leg shakes", "started having chest itchiness", "neck rash" and "injection site sore" was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor, Urticaria
Clinical narrative: felt like I was going to pass out; lightheaded/Dizzy; 9 minutes after administration heart rate up to 154; leg shakes; started having chest itchiness; neck rash; facial hives; Injection site sore; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 08:00 at a single dose for covid-19 immunisation. Medical history included allergies to cephalosphorins. Concomitant medication include unspecified multivitamins. On 17Dec2020 08:09, the patient's heart rate went up to 154 after vaccine administration. On 17Dec2020 08:15, she felt like she was going to pass out, she was lightheaded and dizzy. The patient also experienced leg shakes, started having chest itchiness, neck rash, facial hives and injection site sore on 17Dec2020. The patient was treated with diphenhydramine (BENADRYL) 50mg intramuscularly (IM) for the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy", "leg shakes", "started having chest itchiness", "neck rash" and "facial hives". The patient's heart rate came down to 130s then down to 90s and the hives subsided. The patient underwent lab tests and procedures which included heart rate: 154, heart rate: 130 and heart rate: 90; all on 17Dec2020. Outcome of the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy" and "facial hives" recovered on an unspecified date while the outcome of events "leg shakes", "started having chest itchiness", "neck rash" and "injection site sore" was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Myalgia
Clinical narrative: felt like I was going to pass out; lightheaded/Dizzy; 9 minutes after administration heart rate up to 154; leg shakes; started having chest itchiness; neck rash; facial hives; Injection site sore; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 08:00 at a single dose for covid-19 immunisation. Medical history included allergies to cephalosphorins. Concomitant medication include unspecified multivitamins. On 17Dec2020 08:09, the patient's heart rate went up to 154 after vaccine administration. On 17Dec2020 08:15, she felt like she was going to pass out, she was lightheaded and dizzy. The patient also experienced leg shakes, started having chest itchiness, neck rash, facial hives and injection site sore on 17Dec2020. The patient was treated with diphenhydramine (BENADRYL) 50mg intramuscularly (IM) for the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy", "leg shakes", "started having chest itchiness", "neck rash" and "facial hives". The patient's heart rate came down to 130s then down to 90s and the hives subsided. The patient underwent lab tests and procedures which included heart rate: 154, heart rate: 130 and heart rate: 90; all on 17Dec2020. Outcome of the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy" and "facial hives" recovered on an unspecified date while the outcome of events "leg shakes", "started having chest itchiness", "neck rash" and "injection site sore" was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Pruritus, Rash, Urticaria
Clinical narrative: felt like I was going to pass out; lightheaded/Dizzy; 9 minutes after administration heart rate up to 154; leg shakes; started having chest itchiness; neck rash; facial hives; Injection site sore; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 08:00 at a single dose for covid-19 immunisation. Medical history included allergies to cephalosphorins. Concomitant medication include unspecified multivitamins. On 17Dec2020 08:09, the patient's heart rate went up to 154 after vaccine administration. On 17Dec2020 08:15, she felt like she was going to pass out, she was lightheaded and dizzy. The patient also experienced leg shakes, started having chest itchiness, neck rash, facial hives and injection site sore on 17Dec2020. The patient was treated with diphenhydramine (BENADRYL) 50mg intramuscularly (IM) for the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy", "leg shakes", "started having chest itchiness", "neck rash" and "facial hives". The patient's heart rate came down to 130s then down to 90s and the hives subsided. The patient underwent lab tests and procedures which included heart rate: 154, heart rate: 130 and heart rate: 90; all on 17Dec2020. Outcome of the events "9 minutes after administration heart rate up to 154", "felt like I was going to pass out", "lightheaded/Dizzy" and "facial hives" recovered on an unspecified date while the outcome of events "leg shakes", "started having chest itchiness", "neck rash" and "injection site sore" was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood urea increased, C-reactive protein increased, Full blood count normal, International normalised ratio normal
Clinical narrative: anaphylaxis; nausea; This is a spontaneous report from a contactable physician.  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left arm on 17Dec2020 at single dose for COVID-19 immunisation. Facility type vaccine: Public Health Clinic/facility. Relevant medical history included diabetes mellitus, hypertension, pulmonary embolus, protein C deficiency, lumbosacral radiculopathy and iodine contrast media allergy. Concomitant medications included apixaban, metformin, chlortalidone, metoprolol, clonidine, atorvastatin, magnesium oxide, tramadol and diphenhydramine as needed. About 13 minutes after vaccination, while under observation, the patient experienced anaphylaxis and developed hives, facial swelling, throat swelling/itching and nausea. She was taken to the ED. Corrective treatments taken as a result of the events included IM epinephrine and IV methylprednisolone sodium succinate (SOLU MEDROL), IV diphenhydramine hydrochloride (BENADRYL), normal saline and IV famotidine. The patient was hemodynamically stable during the entire ED visit. The anaphylaxis resolved and she was discharged. The patient recovered from the events in Dec2020.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis and nausea due to temporal association.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Nausea, Pharyngeal swelling, Swelling face, Throat irritation
Clinical narrative: anaphylaxis; nausea; This is a spontaneous report from a contactable physician.  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left arm on 17Dec2020 at single dose for COVID-19 immunisation. Facility type vaccine: Public Health Clinic/facility. Relevant medical history included diabetes mellitus, hypertension, pulmonary embolus, protein C deficiency, lumbosacral radiculopathy and iodine contrast media allergy. Concomitant medications included apixaban, metformin, chlortalidone, metoprolol, clonidine, atorvastatin, magnesium oxide, tramadol and diphenhydramine as needed. About 13 minutes after vaccination, while under observation, the patient experienced anaphylaxis and developed hives, facial swelling, throat swelling/itching and nausea. She was taken to the ED. Corrective treatments taken as a result of the events included IM epinephrine and IV methylprednisolone sodium succinate (SOLU MEDROL), IV diphenhydramine hydrochloride (BENADRYL), normal saline and IV famotidine. The patient was hemodynamically stable during the entire ED visit. The anaphylaxis resolved and she was discharged. The patient recovered from the events in Dec2020.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis and nausea due to temporal association.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: anaphylaxis; nausea; This is a spontaneous report from a contactable physician.  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left arm on 17Dec2020 at single dose for COVID-19 immunisation. Facility type vaccine: Public Health Clinic/facility. Relevant medical history included diabetes mellitus, hypertension, pulmonary embolus, protein C deficiency, lumbosacral radiculopathy and iodine contrast media allergy. Concomitant medications included apixaban, metformin, chlortalidone, metoprolol, clonidine, atorvastatin, magnesium oxide, tramadol and diphenhydramine as needed. About 13 minutes after vaccination, while under observation, the patient experienced anaphylaxis and developed hives, facial swelling, throat swelling/itching and nausea. She was taken to the ED. Corrective treatments taken as a result of the events included IM epinephrine and IV methylprednisolone sodium succinate (SOLU MEDROL), IV diphenhydramine hydrochloride (BENADRYL), normal saline and IV famotidine. The patient was hemodynamically stable during the entire ED visit. The anaphylaxis resolved and she was discharged. The patient recovered from the events in Dec2020.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis and nausea due to temporal association.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Nausea, Pharyngeal swelling, Swelling face, Throat irritation
Clinical narrative: anaphylaxis; nausea; This is a spontaneous report from a contactable physician.  A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left arm on 17Dec2020 at single dose for COVID-19 immunisation. Facility type vaccine: Public Health Clinic/facility. Relevant medical history included diabetes mellitus, hypertension, pulmonary embolus, protein C deficiency, lumbosacral radiculopathy and iodine contrast media allergy. Concomitant medications included apixaban, metformin, chlortalidone, metoprolol, clonidine, atorvastatin, magnesium oxide, tramadol and diphenhydramine as needed. About 13 minutes after vaccination, while under observation, the patient experienced anaphylaxis and developed hives, facial swelling, throat swelling/itching and nausea. She was taken to the ED. Corrective treatments taken as a result of the events included IM epinephrine and IV methylprednisolone sodium succinate (SOLU MEDROL), IV diphenhydramine hydrochloride (BENADRYL), normal saline and IV famotidine. The patient was hemodynamically stable during the entire ED visit. The anaphylaxis resolved and she was discharged. The patient recovered from the events in Dec2020.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis and nausea due to temporal association.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Facial paralysis, Laboratory test, Magnetic resonance imaging, Oral discomfort
Clinical narrative: I had right facial drooping 3 hours after the vaccine/Facial drooping only on right cheek and left side uneveness on smile; At ER they confirmed bells palsy; fatigue; Pain at injection site; This is a spontaneous report from a contactable Nurse reporting for herself.  A 35-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Injection, Batch/Lot # EH9899) intramuscular at single dose to left upper arm on 17Dec2020 10:00 for immunization, prescribed by a doctor at work and administered at hospital.  Medical history included allergy to animal: sea urchin. No other prior medical history, not relevant drug history, not drug or alcohol abuse. No family history. The patient previously took C-cor and experienced drug allergies. Concomitant medications includes OTC Vitamins. On 17Dec2020 the patient experienced right facial drooping 3 hours after the vaccine/facial drooping only on right cheek and left side uneveness on smile, at ER they confirmed bells palsy, fatigue, pain at injection site. She noticed symptoms 3 hours later 1 O' clock in the afternoon. She was seen in an emergency room but not admitted to hospital for the events and she received treatment. The patient underwent lab tests and procedures which included CT, MRI, lab work, ECG, all with unknown results. She was sent home with steroids and Valtrex.  No treatment for pain at injection site. Events have improved after medication. The outcome of events was recovering. The reporter stated there was a reasonable possibility that the events were related to suspect product.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Facial paralysis, Fatigue, Injection site pain
Clinical narrative: I had right facial drooping 3 hours after the vaccine/Facial drooping only on right cheek and left side uneveness on smile; At ER they confirmed bells palsy; fatigue; Pain at injection site; This is a spontaneous report from a contactable Nurse reporting for herself.  A 35-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Injection, Batch/Lot # EH9899) intramuscular at single dose to left upper arm on 17Dec2020 10:00 for immunization, prescribed by a doctor at work and administered at hospital.  Medical history included allergy to animal: sea urchin. No other prior medical history, not relevant drug history, not drug or alcohol abuse. No family history. The patient previously took C-cor and experienced drug allergies. Concomitant medications includes OTC Vitamins. On 17Dec2020 the patient experienced right facial drooping 3 hours after the vaccine/facial drooping only on right cheek and left side uneveness on smile, at ER they confirmed bells palsy, fatigue, pain at injection site. She noticed symptoms 3 hours later 1 O' clock in the afternoon. She was seen in an emergency room but not admitted to hospital for the events and she received treatment. The patient underwent lab tests and procedures which included CT, MRI, lab work, ECG, all with unknown results. She was sent home with steroids and Valtrex.  No treatment for pain at injection site. Events have improved after medication. The outcome of events was recovering. The reporter stated there was a reasonable possibility that the events were related to suspect product.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging
Clinical narrative: I had right facial drooping 3 hours after the vaccine/Facial drooping only on right cheek and left side uneveness on smile; At ER they confirmed bells palsy; fatigue; Pain at injection site; This is a spontaneous report from a contactable Nurse reporting for herself.  A 35-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Injection, Batch/Lot # EH9899) intramuscular at single dose to left upper arm on 17Dec2020 10:00 for immunization, prescribed by a doctor at work and administered at hospital.  Medical history included allergy to animal: sea urchin. No other prior medical history, not relevant drug history, not drug or alcohol abuse. No family history. The patient previously took C-cor and experienced drug allergies. Concomitant medications includes OTC Vitamins. On 17Dec2020 the patient experienced right facial drooping 3 hours after the vaccine/facial drooping only on right cheek and left side uneveness on smile, at ER they confirmed bells palsy, fatigue, pain at injection site. She noticed symptoms 3 hours later 1 O' clock in the afternoon. She was seen in an emergency room but not admitted to hospital for the events and she received treatment. The patient underwent lab tests and procedures which included CT, MRI, lab work, ECG, all with unknown results. She was sent home with steroids and Valtrex.  No treatment for pain at injection site. Events have improved after medication. The outcome of events was recovering. The reporter stated there was a reasonable possibility that the events were related to suspect product.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dyspepsia, Fatigue, Headache
Clinical narrative: Arm soreness; fever max of 101.9; cough; heart burn; fatigue; chills; headache; This is a spontaneous report from a contactable consumer (patient himself). A 35-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 17Dec2020 10:30 AM at single dose (left arm) for immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MI with Stent and diabetes type 2. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously took amoxicilin and experienced allergies. On 17Dec2020 at 07:00 PM, the patient experienced arm soreness, Fever max of 101.9, cough, heart burn, fatigue, chills and headache. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included Tylenol and Motrin. The events recovered on unspecified date in De2020.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Arm soreness; fever max of 101.9; cough; heart burn; fatigue; chills; headache; This is a spontaneous report from a contactable consumer (patient himself). A 35-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 17Dec2020 10:30 AM at single dose (left arm) for immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MI with Stent and diabetes type 2. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously took amoxicilin and experienced allergies. On 17Dec2020 at 07:00 PM, the patient experienced arm soreness, Fever max of 101.9, cough, heart burn, fatigue, chills and headache. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included Tylenol and Motrin. The events recovered on unspecified date in De2020.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; fever max of 101.9; cough; heart burn; fatigue; chills; headache; This is a spontaneous report from a contactable consumer (patient himself). A 35-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 17Dec2020 10:30 AM at single dose (left arm) for immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MI with Stent and diabetes type 2. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously took amoxicilin and experienced allergies. On 17Dec2020 at 07:00 PM, the patient experienced arm soreness, Fever max of 101.9, cough, heart burn, fatigue, chills and headache. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included Tylenol and Motrin. The events recovered on unspecified date in De2020.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dysgeusia
Clinical narrative: had absolutely no appetite; developed a strange metallic taste; This is a spontaneous report from a contactable nurse reported for herself.    A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, Expiration Date Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization.  Medical history included type 2 diabetes.  Concomitant medication included metformin, empagliflozin, linagliptin (GLYXAMBI) both ongoing for diabetes. The patient experienced had absolutely no appetite (medically significant) on 17Dec2020, developed a strange metallic taste (non-serious) on 17Dec2020. The vaccine was received first dose 17Dec2020 in the morning. About an hour and one half later she developed a strange metallic taste and nothing has tasted right since then. The reporter reported she also had absolutely no appetite. She worked nights and her sleep pattern was different and she woke up in the day and she was starving, and got off work she was starving but she had to force herself to eat last night in the middle of the night for her normal break. Added she really couldn't finish her meal as she had no appetite. The outcome of event had absolutely no appetite was not recovered while for developed a strange metallic taste was recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, decreased appetite and dysgeusia, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dysgeusia, Taste disorder
Clinical narrative: had absolutely no appetite; developed a strange metallic taste; This is a spontaneous report from a contactable nurse reported for herself.    A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, Expiration Date Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization.  Medical history included type 2 diabetes.  Concomitant medication included metformin, empagliflozin, linagliptin (GLYXAMBI) both ongoing for diabetes. The patient experienced had absolutely no appetite (medically significant) on 17Dec2020, developed a strange metallic taste (non-serious) on 17Dec2020. The vaccine was received first dose 17Dec2020 in the morning. About an hour and one half later she developed a strange metallic taste and nothing has tasted right since then. The reporter reported she also had absolutely no appetite. She worked nights and her sleep pattern was different and she woke up in the day and she was starving, and got off work she was starving but she had to force herself to eat last night in the middle of the night for her normal break. Added she really couldn't finish her meal as she had no appetite. The outcome of event had absolutely no appetite was not recovered while for developed a strange metallic taste was recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, decreased appetite and dysgeusia, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Pain in extremity, Vision blurred
Clinical narrative: felt warm; blurred vision; light headed; arm pain; This is a spontaneous report from a contactable pharmacist. A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on the left arm on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation (a fib). Concomitant medication included flecainide and apixaban (ELIQUIS). The patient previously took pantoprazole sodium sesquihydrate (PROTONIX) and experienced allergies to pantoprazole sodium sesquihydrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Dec2020, 5 minutes after injection, the patient felt warm, blurred vision, light headed, and arm pain. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on 18Dec2020. The events were considered non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Chest pain, Condition aggravated
Clinical narrative: 10 min after the vaccine had sudden cold hands; palpit; dizziness; BP 150/90 - high for patient; a sensation of chest awareness (not pain, but a bit of tension); anxiety; a clear sensation of chest warmth; presyncopal episodes; chest tightness; Still with waves of chest warmth/heat/burning sensation and chest awareness; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 15:00 at single dose at left arm for immunization. Medical history included hypothyroidism, migraine from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT). There's no other vaccine in four weeks. 10 min after the vaccine patient had sudden cold hands (the kind of inside cold like Propofol gives you), with palpit and dizziness, self-limited in a few mins. BP 150/90 - high for patient. Similar episode but shorter and less intense within next half an hour. Also a sensation of chest awareness (not pain, but a bit of tension, which patient had experienced before with anxiety and put it on anxiety). Decided to go home and while walking patient noticed a clear sensation of chest warmth. Patient decided to stick around the hospital a bit more, pondering about going into the ER. Drank 2 bottles of orange juice and headed home. Then on the way home patient had 2 presyncopal episodes. The fact that patient had not eaten all day and wasn't well hydrated might have contributed. Patient didn't go to the ER. Patient ate, drank juice, took diphenhydramine hydrochloride (BENADRYL) 25 mg. The chest tightness got better. Still with waves of chest warmth/heat/burning sensation and chest awareness. Never had such sxs 2/2 anxiety. Patient received acetylsalicylic acid (ASPIRIN), diphenhydramine hydrochloride, clonazepam as treatment. Outcome of all events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination, and no COVID tested post vaccination. Events were reported as non-serious.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Injection site pain, Palpitations
Clinical narrative: 10 min after the vaccine had sudden cold hands; palpit; dizziness; BP 150/90 - high for patient; a sensation of chest awareness (not pain, but a bit of tension); anxiety; a clear sensation of chest warmth; presyncopal episodes; chest tightness; Still with waves of chest warmth/heat/burning sensation and chest awareness; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 15:00 at single dose at left arm for immunization. Medical history included hypothyroidism, migraine from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT). There's no other vaccine in four weeks. 10 min after the vaccine patient had sudden cold hands (the kind of inside cold like Propofol gives you), with palpit and dizziness, self-limited in a few mins. BP 150/90 - high for patient. Similar episode but shorter and less intense within next half an hour. Also a sensation of chest awareness (not pain, but a bit of tension, which patient had experienced before with anxiety and put it on anxiety). Decided to go home and while walking patient noticed a clear sensation of chest warmth. Patient decided to stick around the hospital a bit more, pondering about going into the ER. Drank 2 bottles of orange juice and headed home. Then on the way home patient had 2 presyncopal episodes. The fact that patient had not eaten all day and wasn't well hydrated might have contributed. Patient didn't go to the ER. Patient ate, drank juice, took diphenhydramine hydrochloride (BENADRYL) 25 mg. The chest tightness got better. Still with waves of chest warmth/heat/burning sensation and chest awareness. Never had such sxs 2/2 anxiety. Patient received acetylsalicylic acid (ASPIRIN), diphenhydramine hydrochloride, clonazepam as treatment. Outcome of all events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination, and no COVID tested post vaccination. Events were reported as non-serious.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.