chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: she had an allergic reaction to first dose; could not get warm; Facial swelling; lips got hard; nose got firm; tingling of both feet/tingling of both hands; lips were tingling/severe vaccine reaction; This is a spontaneous report from a contactable Physician (patient). A 65-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 17:00 at single dose in left arm for COVID-19 immunisation at the age of 65-year-old. Lot number was EL3247. Relevant medical history included ongoing Psoriatic arthritis since fall 2018. Concomitant medications included APREMILAST (OTEZLA) from 2018 and ongoing for Psoriatic arthritis. On 21Jan2021, the patient experienced Tingling lips (at 17:30), lips got hard (at 19:00), nose got firm (at 19:00), tingling of both feet (at 19:00), tingling of both hands (at 19:00), Facial swelling (at 19:00), could not get warm (at 21:00). Tingling lips were considered an important medical event. It was reported that on unknown date the patient had an allergic reaction to first dose. On unknown date, full blood count, chem 20 and temperature measurement were performed but results were unknown. The patient was treated for the event with benadryl. The patient was recovering from Tingling lips, the patient recovered from lips got hard on 24Jan2021, from nose got firm on 21Jan2021, from tingling of both feet/both hands on 21Jan2021, from facial swelling on 21Jan2021, could not get warm on 21Jan2021, the outcome of allergic reaction was unknown.; Sender's Comments: Based on a compatible temporal association and known product safety profile a causal relationship between events "lips were tingling/severe vaccine reaction", "facial swelling" and "allergic reaction to first dose" 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Hypersensitivity, Nasal discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: she had an allergic reaction to first dose; could not get warm; Facial swelling; lips got hard; nose got firm; tingling of both feet/tingling of both hands; lips were tingling/severe vaccine reaction; This is a spontaneous report from a contactable Physician (patient). A 65-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 17:00 at single dose in left arm for COVID-19 immunisation at the age of 65-year-old. Lot number was EL3247. Relevant medical history included ongoing Psoriatic arthritis since fall 2018. Concomitant medications included APREMILAST (OTEZLA) from 2018 and ongoing for Psoriatic arthritis. On 21Jan2021, the patient experienced Tingling lips (at 17:30), lips got hard (at 19:00), nose got firm (at 19:00), tingling of both feet (at 19:00), tingling of both hands (at 19:00), Facial swelling (at 19:00), could not get warm (at 21:00). Tingling lips were considered an important medical event. It was reported that on unknown date the patient had an allergic reaction to first dose. On unknown date, full blood count, chem 20 and temperature measurement were performed but results were unknown. The patient was treated for the event with benadryl. The patient was recovering from Tingling lips, the patient recovered from lips got hard on 24Jan2021, from nose got firm on 21Jan2021, from tingling of both feet/both hands on 21Jan2021, from facial swelling on 21Jan2021, could not get warm on 21Jan2021, the outcome of allergic reaction was unknown.; Sender's Comments: Based on a compatible temporal association and known product safety profile a causal relationship between events "lips were tingling/severe vaccine reaction", "facial swelling" and "allergic reaction to first dose" 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: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast.  On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure.  Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam).  Symptoms appear to be improved.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Eructation, Palpitations
Clinical narrative: Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast.  On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure.  Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam).  Symptoms appear to be improved.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast.  On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure.  Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam).  Symptoms appear to be improved.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Ophthalmoplegia
Clinical narrative: Left eye 6 nerve palsy and could not move my eye laterally; This is a spontaneous report from a contactable physician (patient)  A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 27Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 01Feb2021, patient started to notice, left eye 6 oculomotor nerve ("abduscens") palsy and could not move his eye laterally. Patient also asked information about 6 oculomotor nerve and possible interaction with vaccine. At the time of the reporting event outcome was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship.  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: M
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: Left eye 6 nerve palsy and could not move my eye laterally; This is a spontaneous report from a contactable physician (patient)  A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 27Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 01Feb2021, patient started to notice, left eye 6 oculomotor nerve ("abduscens") palsy and could not move his eye laterally. Patient also asked information about 6 oculomotor nerve and possible interaction with vaccine. At the time of the reporting event outcome was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship.  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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: 2-4 days after vaccination: wheezing, cough, sore throat, headache, chills, extreme exhaustion, and sweating last up to 4 days post-vaccination
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Wheezing
Clinical narrative: 2-4 days after vaccination: wheezing, cough, sore throat, headache, chills, extreme exhaustion, and sweating last up to 4 days post-vaccination
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 2-4 days after vaccination: wheezing, cough, sore throat, headache, chills, extreme exhaustion, and sweating last up to 4 days post-vaccination
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Wheezing
Clinical narrative: 2-4 days after vaccination: wheezing, cough, sore throat, headache, chills, extreme exhaustion, and sweating last up to 4 days post-vaccination
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Dry skin, Headache
Clinical narrative: He tested positive for Covid 19; He tested positive for Covid 19; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got the first shot last 08Jan2021 and second vaccine was due on 29Jan2021, Friday however, he tested positive for Covid 19 on 25Jan2021. The patient was asking if it's okay to take a second dose and if there will be any effect on the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: He tested positive for Covid 19; He tested positive for Covid 19; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got the first shot last 08Jan2021 and second vaccine was due on 29Jan2021, Friday however, he tested positive for Covid 19 on 25Jan2021. The patient was asking if it's okay to take a second dose and if there will be any effect on the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He tested positive for Covid 19; He tested positive for Covid 19; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got the first shot last 08Jan2021 and second vaccine was due on 29Jan2021, Friday however, he tested positive for Covid 19 on 25Jan2021. The patient was asking if it's okay to take a second dose and if there will be any effect on the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Body temperature increased, Diarrhoea, Feeling cold, Headache
Clinical narrative: Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flatulence, Gastrooesophageal reflux disease, Influenza like illness, Myalgia, Nausea
Clinical narrative: Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram head, Computerised tomogram head normal, Eye movement disorder, Eyelid ptosis
Clinical narrative: left side of face drooping, could not smile, could not close left eye; feeling numbness/tingling lower lip; feeling numbness/tingling lower lip; This is a spontaneous report from a contactable consumer reporting for herself.    A 84-years-old female patient received the second dose of  bnt162b2 (BNT162B2;Lot # EL9269) vaccine , via an unspecified route of administration in the left arm on 08Feb2021 19:30 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation, allergy to sulpha.  The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 15Jan2021. The patient experienced left side of face drooping, could not smile, could not close left eye  on 09Feb2021 12:00 with outcome of recovering , feeling numbness/tingling lower lip  on 09Feb2021 12:00 with outcome of recovering. Therapeutic measures included: Prednisone, Valacyclovir  Follow up information has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Paraesthesia oral
Clinical narrative: left side of face drooping, could not smile, could not close left eye; feeling numbness/tingling lower lip; feeling numbness/tingling lower lip; This is a spontaneous report from a contactable consumer reporting for herself.    A 84-years-old female patient received the second dose of  bnt162b2 (BNT162B2;Lot # EL9269) vaccine , via an unspecified route of administration in the left arm on 08Feb2021 19:30 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation, allergy to sulpha.  The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 15Jan2021. The patient experienced left side of face drooping, could not smile, could not close left eye  on 09Feb2021 12:00 with outcome of recovering , feeling numbness/tingling lower lip  on 09Feb2021 12:00 with outcome of recovering. Therapeutic measures included: Prednisone, Valacyclovir  Follow up information has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: left side of face drooping, could not smile, could not close left eye; feeling numbness/tingling lower lip; feeling numbness/tingling lower lip; This is a spontaneous report from a contactable consumer reporting for herself.    A 84-years-old female patient received the second dose of  bnt162b2 (BNT162B2;Lot # EL9269) vaccine , via an unspecified route of administration in the left arm on 08Feb2021 19:30 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation, allergy to sulpha.  The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 15Jan2021. The patient experienced left side of face drooping, could not smile, could not close left eye  on 09Feb2021 12:00 with outcome of recovering , feeling numbness/tingling lower lip  on 09Feb2021 12:00 with outcome of recovering. Therapeutic measures included: Prednisone, Valacyclovir  Follow up information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: shot site was red and swollen; shot site was red and swollen; Area felt warm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 72-year-old) on 03Feb2021 at 03:15 PM as a single dose for COVID-19 immunisation, lot number: EN5318. Medical history included breast cancer from Dec1995. Patient previously received prochlorperazine (COMPAZINE) and experienced allergy. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Concomitant medications in two weeks prior to the vaccination included sumatriptan nasal spray and Vitamin D NOS. Prior to vaccination the patient was not diagnosed with COVID-19. On 11Feb2021 (also reported as on day 8) at 05:00 PM after vaccine shot site was red and swollen. Area felt warm, no previous discomfort. Symptoms have continued for 48 hours. No treatment was received for the events. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the events, at the time of the report.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: shot site was red and swollen; shot site was red and swollen; Area felt warm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 72-year-old) on 03Feb2021 at 03:15 PM as a single dose for COVID-19 immunisation, lot number: EN5318. Medical history included breast cancer from Dec1995. Patient previously received prochlorperazine (COMPAZINE) and experienced allergy. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Concomitant medications in two weeks prior to the vaccination included sumatriptan nasal spray and Vitamin D NOS. Prior to vaccination the patient was not diagnosed with COVID-19. On 11Feb2021 (also reported as on day 8) at 05:00 PM after vaccine shot site was red and swollen. Area felt warm, no previous discomfort. Symptoms have continued for 48 hours. No treatment was received for the events. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the events, at the time of the report.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Face numb and tingly for several hours; Face numb and tingly for several hours; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), via an unspecified route of administration at the right arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included carbamazepine and quetiapine. On 01Feb2021 16:00, the patient experienced face numb and tingly for several hours. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date in Feb2021.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Injection site pain, Injection site rash
Clinical narrative: pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Pain, Vaccination site pain
Clinical narrative: pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash
Clinical narrative: pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Muscular weakness, Throat tightness
Clinical narrative: history of MS, feels bilateral upper extremity weakness, throat tightness and a feeling of shortness of breath. Fortunately her O2 sat is 100% on room air, she is not tachypneic. Her lungs demonstrate no wheezing, her oropharynx is widely patent. She was observed for 3 hours after given Benadryl, Pepcid and Solu-Medrol, was able to ambulate to the bathroom. Still with some remaining symptomatology but appears more comfortable. Will discharge with close outpatient follow-up with PCP and neurologist. Recommended patient follow-up with her neurologist and her PCP regarding guidance regarding second vaccination dose as this did not truly represent an anaphylactic reaction but still symptoms could worsen with second vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Contusion, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: bleeding through bandage (ceased quickly); pain at needle insertion; cold/chill sensation at injection site; very large bruise at injection site; residual discomfort at injection site; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 15Jan2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; administered at a Nursing Home/Senior Living Facility. The patient's medical history was reported as none.  Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]); all taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the vaccine. On 15Jan2021 at 13:00, the patient experienced: bleeding through bandage (ceased quickly) (medically significant), pain at needle insertion (non-serious), cold/chill sensation at injection site (non-serious), very large bruise at injection site (non-serious), residual discomfort at injection site (non-serious); with no treatment received . The clinical course was reported as follows: The patient's concern was whether these issues affect the efficacy of the injection. The patient wanted to know if the vaccine was administered incorrectly. The patient wanted to know if he should be concerned about the continuing discomfort. The patient reported that he received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the right arm from 05Feb2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; and there was no reaction whatsoever to the second injection (other than slight arm discomfort; none of the above-described issues). The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative   on 19Jan2021, negative on 26Jan2021, negative on 02Feb2021, unknown results-pending on 09Feb2021. The clinical outcome of the events was recovered with sequelae ("recovered with lasting effects") on an unspecified date.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site coldness, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: bleeding through bandage (ceased quickly); pain at needle insertion; cold/chill sensation at injection site; very large bruise at injection site; residual discomfort at injection site; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 15Jan2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; administered at a Nursing Home/Senior Living Facility. The patient's medical history was reported as none.  Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]); all taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the vaccine. On 15Jan2021 at 13:00, the patient experienced: bleeding through bandage (ceased quickly) (medically significant), pain at needle insertion (non-serious), cold/chill sensation at injection site (non-serious), very large bruise at injection site (non-serious), residual discomfort at injection site (non-serious); with no treatment received . The clinical course was reported as follows: The patient's concern was whether these issues affect the efficacy of the injection. The patient wanted to know if the vaccine was administered incorrectly. The patient wanted to know if he should be concerned about the continuing discomfort. The patient reported that he received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the right arm from 05Feb2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; and there was no reaction whatsoever to the second injection (other than slight arm discomfort; none of the above-described issues). The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative   on 19Jan2021, negative on 26Jan2021, negative on 02Feb2021, unknown results-pending on 09Feb2021. The clinical outcome of the events was recovered with sequelae ("recovered with lasting effects") on an unspecified date.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, SARS-CoV-2 test, Vaccination site bruising, Vaccination site coldness, Vaccination site discomfort
Clinical narrative: bleeding through bandage (ceased quickly); pain at needle insertion; cold/chill sensation at injection site; very large bruise at injection site; residual discomfort at injection site; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 15Jan2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; administered at a Nursing Home/Senior Living Facility. The patient's medical history was reported as none.  Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]); all taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the vaccine. On 15Jan2021 at 13:00, the patient experienced: bleeding through bandage (ceased quickly) (medically significant), pain at needle insertion (non-serious), cold/chill sensation at injection site (non-serious), very large bruise at injection site (non-serious), residual discomfort at injection site (non-serious); with no treatment received . The clinical course was reported as follows: The patient's concern was whether these issues affect the efficacy of the injection. The patient wanted to know if the vaccine was administered incorrectly. The patient wanted to know if he should be concerned about the continuing discomfort. The patient reported that he received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the right arm from 05Feb2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; and there was no reaction whatsoever to the second injection (other than slight arm discomfort; none of the above-described issues). The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative   on 19Jan2021, negative on 26Jan2021, negative on 02Feb2021, unknown results-pending on 09Feb2021. The clinical outcome of the events was recovered with sequelae ("recovered with lasting effects") on an unspecified date.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: bleeding through bandage (ceased quickly); pain at needle insertion; cold/chill sensation at injection site; very large bruise at injection site; residual discomfort at injection site; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 15Jan2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; administered at a Nursing Home/Senior Living Facility. The patient's medical history was reported as none.  Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]); all taken for an unspecified indication from an unspecified date to an unspecified date; received within two weeks of the vaccine. On 15Jan2021 at 13:00, the patient experienced: bleeding through bandage (ceased quickly) (medically significant), pain at needle insertion (non-serious), cold/chill sensation at injection site (non-serious), very large bruise at injection site (non-serious), residual discomfort at injection site (non-serious); with no treatment received . The clinical course was reported as follows: The patient's concern was whether these issues affect the efficacy of the injection. The patient wanted to know if the vaccine was administered incorrectly. The patient wanted to know if he should be concerned about the continuing discomfort. The patient reported that he received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the right arm from 05Feb2021 at 13:00 at 71-years-old at a single dose for COVID-19 immunization; and there was no reaction whatsoever to the second injection (other than slight arm discomfort; none of the above-described issues). The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative   on 19Jan2021, negative on 26Jan2021, negative on 02Feb2021, unknown results-pending on 09Feb2021. The clinical outcome of the events was recovered with sequelae ("recovered with lasting effects") on an unspecified date.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: The day after patient received the vaccination (Tuesday), she spiked a low temp (Wednesday), felt very sick on Thursday, on Friday a pneumonia development found, and admitted to hospice, died the following Monday. She had survived Covid-19 five weeks before the vaccine given,
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Death, Malaise, Pneumonia, Pyrexia
Clinical narrative: The day after patient received the vaccination (Tuesday), she spiked a low temp (Wednesday), felt very sick on Thursday, on Friday a pneumonia development found, and admitted to hospice, died the following Monday. She had survived Covid-19 five weeks before the vaccine given,
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Headache, Impaired work ability, Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe intractable headache with pain into neck
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Headache, Musculoskeletal stiffness, Urine analysis
Clinical narrative: Severe intractable headache with pain into neck
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Severe intractable headache with pain into neck
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Headache, Neck pain
Clinical narrative: Severe intractable headache with pain into neck
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Glossodynia, Oropharyngeal pain, Swollen tongue
Clinical narrative: I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support.  A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D).  The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support.  A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D).  The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Hypersensitivity, Pain, Productive cough
Clinical narrative: I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support.  A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D).  The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.