chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Left arm rash  Narrative:  Patient reports having "COVID arm" (red, hot, itchy at injection site) on 2/6/21 after vaccination on 1/22/21. Reports this has been going on for about 1  week and also involves itching on her head, neck, and shoulders. Reports the rash has not gotten smaller and is still itchy. PCP entered consult for allergist and  recommended Benadryl (unclear dosing) at night if needed for itching. Patient  reports rubbing "medicated lotion" on itches, but unclear what is being used.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Left arm rash  Narrative:  Patient reports having "COVID arm" (red, hot, itchy at injection site) on 2/6/21 after vaccination on 1/22/21. Reports this has been going on for about 1  week and also involves itching on her head, neck, and shoulders. Reports the rash has not gotten smaller and is still itchy. PCP entered consult for allergist and  recommended Benadryl (unclear dosing) at night if needed for itching. Patient  reports rubbing "medicated lotion" on itches, but unclear what is being used.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS INJECTION SITE SORENESS <24 HOURS
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: left arm sore at injection site and left arm "puffy" from elbow down to end of left arm Narrative:  Other Relevant History:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Injection site pain and swelling Narrative:  Pt called COVID-19 Vaccine ADR hotline reporting L arm swelling and soreness on 2/8/21 after receiving his second dose of the Moderna Vaccine. Denies any other swelling, SOB, or rash/hives. Pt reports taking acetaminophen, applying ice and Bengay cream to the area and has noticed much improvement now on 2/9/21. Pt instructed to inform PCP, and if he experiences any severe sx to seek immediate medical attention.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: Headache, Arthralgia, Fever, Localized pain Narrative:  Other Relevant History:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Fever, Fatigue, chills Narrative:  Other Relevant History:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH UPPER ABDOMIN RESOLVED IN 6  HOURS Narrative:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, Fatigue
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash two to three weeks post covid vaccine. Was treated with hydrocortisone
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: injection site reaction Narrative:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheaded  Narrative:  apple juice given, pt states he is back to normal. No lightheadedness, dizziness, or sweaty. Pt states he believes it was low blood sugar. Pt felt better after drinking apple juice, VSS when pt left. BP 102/60, HR 100, T 97.9F, 97% RA
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling jittery, Flushing, Paraesthesia oral, Throat tightness
Clinical narrative: Lip tingling, throat tight, cough, flushing, jittery sensation
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Two hours post vaccine while working as Resp. Therapist in patient room suddenly felt nauseous, dizzy, diaphoretic, headache & near syncope event . Exited room, sat down.  ED response called. Was seen at ED, admitted over night for observation. Had full cardiac work up.  Had #2 Pfizer vaccine without symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Two hours post vaccine while working as Resp. Therapist in patient room suddenly felt nauseous, dizzy, diaphoretic, headache & near syncope event . Exited room, sat down.  ED response called. Was seen at ED, admitted over night for observation. Had full cardiac work up.  Had #2 Pfizer vaccine without symptoms.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram head, Fatigue, Full blood count, Headache
Clinical narrative: On the 1/3 - felt feverish, achy, and weak. I had a headache. It was bad. It got worse throughout the day. I was nearly calling 911 that night - My wife ended up taking me to urgent care to be seen for headache. CAT SCAN and blood work to rule out aneurisms. I was given: Injection of Toradol -a steroidal anti-inflammatory. Viral inflammation in the brain caused by the vaccine - their diagnosis. Out of work for a week. I experienced symptoms on and off for three weeks - headaches; somedays I feel good and some days I don't feel good - with low energy and weakness and body aches. I have been taking (alternating) ibuprofen and Tylenol - the first week nothing could help but after that the alternating doses did start helping. I haven't had a headache for about a week now.  The body aches and low energy is still not resolved - comes and goes.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Tremor
Clinical narrative: On the 1/3 - felt feverish, achy, and weak. I had a headache. It was bad. It got worse throughout the day. I was nearly calling 911 that night - My wife ended up taking me to urgent care to be seen for headache. CAT SCAN and blood work to rule out aneurisms. I was given: Injection of Toradol -a steroidal anti-inflammatory. Viral inflammation in the brain caused by the vaccine - their diagnosis. Out of work for a week. I experienced symptoms on and off for three weeks - headaches; somedays I feel good and some days I don't feel good - with low energy and weakness and body aches. I have been taking (alternating) ibuprofen and Tylenol - the first week nothing could help but after that the alternating doses did start helping. I haven't had a headache for about a week now.  The body aches and low energy is still not resolved - comes and goes.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Feeling abnormal, Headache
Clinical narrative: On the 1/3 - felt feverish, achy, and weak. I had a headache. It was bad. It got worse throughout the day. I was nearly calling 911 that night - My wife ended up taking me to urgent care to be seen for headache. CAT SCAN and blood work to rule out aneurisms. I was given: Injection of Toradol -a steroidal anti-inflammatory. Viral inflammation in the brain caused by the vaccine - their diagnosis. Out of work for a week. I experienced symptoms on and off for three weeks - headaches; somedays I feel good and some days I don't feel good - with low energy and weakness and body aches. I have been taking (alternating) ibuprofen and Tylenol - the first week nothing could help but after that the alternating doses did start helping. I haven't had a headache for about a week now.  The body aches and low energy is still not resolved - comes and goes.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Noninfective encephalitis, Pain, Physical examination, Pyrexia
Clinical narrative: On the 1/3 - felt feverish, achy, and weak. I had a headache. It was bad. It got worse throughout the day. I was nearly calling 911 that night - My wife ended up taking me to urgent care to be seen for headache. CAT SCAN and blood work to rule out aneurisms. I was given: Injection of Toradol -a steroidal anti-inflammatory. Viral inflammation in the brain caused by the vaccine - their diagnosis. Out of work for a week. I experienced symptoms on and off for three weeks - headaches; somedays I feel good and some days I don't feel good - with low energy and weakness and body aches. I have been taking (alternating) ibuprofen and Tylenol - the first week nothing could help but after that the alternating doses did start helping. I haven't had a headache for about a week now.  The body aches and low energy is still not resolved - comes and goes.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Fatigue, Headache, Pain
Clinical narrative: Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue.  Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue.  Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue.  Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Tremor, Vomiting
Clinical narrative: Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue.  Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Flushing, Tachycardia
Clinical narrative: Day of vaccine pt had tachycardia (HR 150s) that lasted a few hours. Then had progressive fatigue sleeping 16hrs per day on weekends. Then on  1/27/21 pt had syncopal episode. Recovered, but continued with HA and dizziness and palpitations. Then had another syncopal episode on 1/28/21. Pt slept a lot for new few days. Continued with dizziness and fatigue. Then on 2/1/21 pt had another syncopal episode at work. Was evaluated with labs, vitals signs. Then the next day had Holter monitor placed and found to have what was thought to be SVT (HR 174). Referred to cardiologist and see on 2/5/21. However pt was unable to stand and was then admitted to the hospital. Holter monitor was further reviewed and decided that symptoms were all attributed to POTS/dysautonomia/MCAS. She was treated with metoprolol, florinef, prednisone, zyrtec, pepcid. She is still recovering.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone normal, Cardiac monitoring abnormal, Cortisol normal
Clinical narrative: Day of vaccine pt had tachycardia (HR 150s) that lasted a few hours. Then had progressive fatigue sleeping 16hrs per day on weekends. Then on  1/27/21 pt had syncopal episode. Recovered, but continued with HA and dizziness and palpitations. Then had another syncopal episode on 1/28/21. Pt slept a lot for new few days. Continued with dizziness and fatigue. Then on 2/1/21 pt had another syncopal episode at work. Was evaluated with labs, vitals signs. Then the next day had Holter monitor placed and found to have what was thought to be SVT (HR 174). Referred to cardiologist and see on 2/5/21. However pt was unable to stand and was then admitted to the hospital. Holter monitor was further reviewed and decided that symptoms were all attributed to POTS/dysautonomia/MCAS. She was treated with metoprolol, florinef, prednisone, zyrtec, pepcid. She is still recovering.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Echocardiogram normal, Electrocardiogram ambulatory abnormal, Fatigue
Clinical narrative: Day of vaccine pt had tachycardia (HR 150s) that lasted a few hours. Then had progressive fatigue sleeping 16hrs per day on weekends. Then on  1/27/21 pt had syncopal episode. Recovered, but continued with HA and dizziness and palpitations. Then had another syncopal episode on 1/28/21. Pt slept a lot for new few days. Continued with dizziness and fatigue. Then on 2/1/21 pt had another syncopal episode at work. Was evaluated with labs, vitals signs. Then the next day had Holter monitor placed and found to have what was thought to be SVT (HR 174). Referred to cardiologist and see on 2/5/21. However pt was unable to stand and was then admitted to the hospital. Holter monitor was further reviewed and decided that symptoms were all attributed to POTS/dysautonomia/MCAS. She was treated with metoprolol, florinef, prednisone, zyrtec, pepcid. She is still recovering.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Headache, Hypersomnia, Mast cell activation syndrome, Metabolic function test
Clinical narrative: Day of vaccine pt had tachycardia (HR 150s) that lasted a few hours. Then had progressive fatigue sleeping 16hrs per day on weekends. Then on  1/27/21 pt had syncopal episode. Recovered, but continued with HA and dizziness and palpitations. Then had another syncopal episode on 1/28/21. Pt slept a lot for new few days. Continued with dizziness and fatigue. Then on 2/1/21 pt had another syncopal episode at work. Was evaluated with labs, vitals signs. Then the next day had Holter monitor placed and found to have what was thought to be SVT (HR 174). Referred to cardiologist and see on 2/5/21. However pt was unable to stand and was then admitted to the hospital. Holter monitor was further reviewed and decided that symptoms were all attributed to POTS/dysautonomia/MCAS. She was treated with metoprolol, florinef, prednisone, zyrtec, pepcid. She is still recovering.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Postural orthostatic tachycardia syndrome, SARS-CoV-2 antibody test negative, Supraventricular tachycardia, Syncope
Clinical narrative: Day of vaccine pt had tachycardia (HR 150s) that lasted a few hours. Then had progressive fatigue sleeping 16hrs per day on weekends. Then on  1/27/21 pt had syncopal episode. Recovered, but continued with HA and dizziness and palpitations. Then had another syncopal episode on 1/28/21. Pt slept a lot for new few days. Continued with dizziness and fatigue. Then on 2/1/21 pt had another syncopal episode at work. Was evaluated with labs, vitals signs. Then the next day had Holter monitor placed and found to have what was thought to be SVT (HR 174). Referred to cardiologist and see on 2/5/21. However pt was unable to stand and was then admitted to the hospital. Holter monitor was further reviewed and decided that symptoms were all attributed to POTS/dysautonomia/MCAS. She was treated with metoprolol, florinef, prednisone, zyrtec, pepcid. She is still recovering.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Day of vaccine pt had tachycardia (HR 150s) that lasted a few hours. Then had progressive fatigue sleeping 16hrs per day on weekends. Then on  1/27/21 pt had syncopal episode. Recovered, but continued with HA and dizziness and palpitations. Then had another syncopal episode on 1/28/21. Pt slept a lot for new few days. Continued with dizziness and fatigue. Then on 2/1/21 pt had another syncopal episode at work. Was evaluated with labs, vitals signs. Then the next day had Holter monitor placed and found to have what was thought to be SVT (HR 174). Referred to cardiologist and see on 2/5/21. However pt was unable to stand and was then admitted to the hospital. Holter monitor was further reviewed and decided that symptoms were all attributed to POTS/dysautonomia/MCAS. She was treated with metoprolol, florinef, prednisone, zyrtec, pepcid. She is still recovering.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip blister
Clinical narrative: Patient notes that approximately 22 1/2 hours post vaccination she began to feel tingling in her upper lip. Next noticed swelling of left upper lip and then spread to right upper lip, continuing to spread up her right cheek and under her nose. No erythema or itching noticed. She took Benadryl 25mg PO and also iced the area. Iced area about 30 minutes . Today 02/10/2021 patient notes that she continues to have swelling of the underside of the upper lip, none noted in cheek, does note swelling somewhat improved on outside of upper lip. She denies any itching, swelling of tongue or redness. She will use benadryl after work if not improved ,as this causes her drowsiness.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Swelling face
Clinical narrative: Patient notes that approximately 22 1/2 hours post vaccination she began to feel tingling in her upper lip. Next noticed swelling of left upper lip and then spread to right upper lip, continuing to spread up her right cheek and under her nose. No erythema or itching noticed. She took Benadryl 25mg PO and also iced the area. Iced area about 30 minutes . Today 02/10/2021 patient notes that she continues to have swelling of the underside of the upper lip, none noted in cheek, does note swelling somewhat improved on outside of upper lip. She denies any itching, swelling of tongue or redness. She will use benadryl after work if not improved ,as this causes her drowsiness.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Palpitations
Clinical narrative: Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Choking sensation, Dysphagia, Dyspnoea, Pharyngeal oedema
Clinical narrative: Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 test negative
Clinical narrative: Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I am facing Severe Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient faced Severe Headache after second dose vaccination.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: I am facing Severe Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient faced Severe Headache after second dose vaccination.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: I am facing Severe Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient faced Severe Headache after second dose vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Oropharyngeal discomfort, Pain, Pain in extremity
Clinical narrative: tested positive; tested positive; bronchitis; she has a problem with chest and coughing; she has a problem with chest and coughing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.   A female patient of an unspecified age received the 1st dose of dbnt162b2 (BNT162B2) at single dose on 08Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive on 12Jan2021. In Jan2021 after taking the vaccine she experienced bronchitis and she has a problem with chest and coughing. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 12Jan2021. However, she was unsure if the virus is already in her system before taking the 1st dose of the vaccine. The patient claimed that she was now COVID free but her doctor told her that she was not recommended to take the 2nd shot of the vaccine after 21 days, but only after 90 days because she has a problem with chest and coughing. She confirmed that she experienced a bronchitis after taking the vaccine. The caller also mentioned taking Tessalon for cough and steroid pills as her doctor's recommendation. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: tested positive; tested positive; bronchitis; she has a problem with chest and coughing; she has a problem with chest and coughing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.   A female patient of an unspecified age received the 1st dose of dbnt162b2 (BNT162B2) at single dose on 08Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive on 12Jan2021. In Jan2021 after taking the vaccine she experienced bronchitis and she has a problem with chest and coughing. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 12Jan2021. However, she was unsure if the virus is already in her system before taking the 1st dose of the vaccine. The patient claimed that she was now COVID free but her doctor told her that she was not recommended to take the 2nd shot of the vaccine after 21 days, but only after 90 days because she has a problem with chest and coughing. She confirmed that she experienced a bronchitis after taking the vaccine. The caller also mentioned taking Tessalon for cough and steroid pills as her doctor's recommendation. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, COVID-19, Chest discomfort, Cough, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; bronchitis; she has a problem with chest and coughing; she has a problem with chest and coughing; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.   A female patient of an unspecified age received the 1st dose of dbnt162b2 (BNT162B2) at single dose on 08Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive on 12Jan2021. In Jan2021 after taking the vaccine she experienced bronchitis and she has a problem with chest and coughing. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 12Jan2021. However, she was unsure if the virus is already in her system before taking the 1st dose of the vaccine. The patient claimed that she was now COVID free but her doctor told her that she was not recommended to take the 2nd shot of the vaccine after 21 days, but only after 90 days because she has a problem with chest and coughing. She confirmed that she experienced a bronchitis after taking the vaccine. The caller also mentioned taking Tessalon for cough and steroid pills as her doctor's recommendation. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Decreased appetite, Electrocardiogram, Fluid intake reduced
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersomnia, Unresponsive to stimuli, Urine analysis
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Cognitive disorder, Computerised tomogram abdomen, Computerised tomogram head, Electrocardiogram
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer, Food refusal, Full blood count, General physical health deterioration, Loss of personal independence in daily activities
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, SARS-CoV-2 test, Urine analysis
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Death, Decreased appetite, Depressed level of consciousness, Diarrhoea
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fluid intake reduced, General physical health deterioration, Headache, Hypersomnia, Incontinence
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Viral test negative
Clinical narrative: 2 days after the injection, this patient suffered rapid cognitive decline over the course of 2-3 days. She began refusing food, was unable to perform activities of daily living, and rapidly declined in functional status.  Her husband was unable to care for her at home. He took her to the local ER several times with no definitive answers as to the cause of her rapid decline, and placed her in the long term care facility where I took over care. She was placed on palliative care and supportive measures were provided for comfort.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: headache, fatigue, no energy and gets tired easily; headache, fatigue, no energy and gets tired easily; headache, fatigue, no energy and gets tired easily; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer. An 81-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient said he had headache, fatigue, no energy and got tired easily after the first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: headache, fatigue, no energy and gets tired easily; headache, fatigue, no energy and gets tired easily; headache, fatigue, no energy and gets tired easily; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer. An 81-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient said he had headache, fatigue, no energy and got tired easily after the first dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: tingling sensation in throat and lips; tingling sensation in throat and lips; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL0142, via an unspecified route of administration on 12Jan2021 09:30 at single dose at left arm for covid-19 immunisation.  Medical history included Grave's Disease, Lobular carcinoma of breast (LCIS), allergies: sometimes reddened skin from tape/bandaid.  Concomitant medications included levothyroxine sodium (SYNTHROID), tamoxifen and vitamin D3.  The patient experienced tingling sensation in throat and lips on 12Jan2021 09:45 AM. It was also reported that tingling sensation in throat and lips approximately 25 minutes after vaccine given, lasted approximately 40 minutes and resolved completely on 12Jan2021 with no medications to treat it.The patient was not pregnant. No other vaccine received in four weeks. If COVID prior vaccination: No. If COVID tested post vaccination: No.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bradyphrenia, Feeling drunk, Injection site pain, Nausea
Clinical narrative: diarrhea; I still don't feel quite well; i felt almost like a mild fever; light headed; little nauseated; quite chilled; had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3246/expiration date: unknown), via unknown route of administration, on 19Jan2021 03:30 PM (at the age of 56 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a hospital. Relevant medical history included hypothyroid, hypertension, celiac, chronic dermatitis. The patient allergic to statins, gluten-intolerant (celiac). The patient was not pregnant at time of vaccination. Relevant concomitant medications included Levothyroxine, Irbesartin, Vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that on 19Jan2021 10:30 PM, about 7 hours after the shot and for the next 12 hours, she was quite chilled, had nausea that worsened when lying down and felt like she was drunk (balance/coordination, clarity of thought). After 12 hours of those symptoms, the drunk feeling and nausea were gone but she has since then struggled with diarrhea if she eats anything not completely bland, including today (4 days later). She stated "I still don't feel quite well and if I am very active (like she was packing boxes last night), I felt almost like a mild fever, light headed and a little nauseated." The outcome of the events chills, nausea, feeling drunk was recovered after 12 hrs later. The outcome of events diarrhea, don't feel quite well, fever, light headed and nauseated was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Feeling drunk, Malaise
Clinical narrative: diarrhea; I still don't feel quite well; i felt almost like a mild fever; light headed; little nauseated; quite chilled; had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3246/expiration date: unknown), via unknown route of administration, on 19Jan2021 03:30 PM (at the age of 56 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a hospital. Relevant medical history included hypothyroid, hypertension, celiac, chronic dermatitis. The patient allergic to statins, gluten-intolerant (celiac). The patient was not pregnant at time of vaccination. Relevant concomitant medications included Levothyroxine, Irbesartin, Vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that on 19Jan2021 10:30 PM, about 7 hours after the shot and for the next 12 hours, she was quite chilled, had nausea that worsened when lying down and felt like she was drunk (balance/coordination, clarity of thought). After 12 hours of those symptoms, the drunk feeling and nausea were gone but she has since then struggled with diarrhea if she eats anything not completely bland, including today (4 days later). She stated "I still don't feel quite well and if I am very active (like she was packing boxes last night), I felt almost like a mild fever, light headed and a little nauseated." The outcome of the events chills, nausea, feeling drunk was recovered after 12 hrs later. The outcome of events diarrhea, don't feel quite well, fever, light headed and nauseated was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.