chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: big lumps on both sides of his neck; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age (reported as 62, no unit provided, pending clarification) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Jan2021 (reported as two weeks ago), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he received the first dose two weeks ago (Jan2021) and the morning after, he experienced big lumps on both sides of his neck, in which he still has at the time of the report. The patient stated that he called his HCP, in which they want to perform a biopsy. The patient wanted to know if having big lumps on the sides of his neck was a common side effect after receiving the COVID vaccine. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). This male patient received first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection)at SINGLE DOSE for covid-19 immunisation .  His physician recommended him to not be administered with the second dose of the vaccine because he was going to start with a cancer treatment just before the administration of the second dose.Outcome of the events was unknown.. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test, Weight
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self. This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 29Dec2020 around 10AM at left arm at single dose for COVID-19 immunization. Medical history included allergic to penicillin. She also had an allergy to anesthesia but was told this was irrelevant to the shot, this allergy was over 20 years ago. Ongoing acid reflux, she had a problem with acid reflux for a year (it was controlled on medication) but they made changes to her medication and started to come back. She stated it was not real bad and that this wasn't a side effect because she has been dealing with it for a year. Concomitant medications were none. No other vaccinations within 4 weeks. The patient stated she received her first dose of the vaccine and didn't have any problem with it, just that her arm was sore and ached but by the next morning it was gone. The arm soreness happened maybe 12 hours later after she took the shot. She didn't experience it immediately after getting the injection. The soreness lasted overnight and by mid morning of 30Dec2020, she recovered completely. She stated this morning (18Jan2021) she woke up with a sore throat and her ear started to throb and she asked if it is safe for someone to receive the second dose if they are not feeling their very best? She is scheduled for her next dose tomorrow.  The events did not require a visit to emergency room or physician office. Patient stated she was not sure about her weight because she lost a lot of weight dealing with the acid reflux she had had lately. Lab data included she had two COVID tests because of work previously, but these were negative. The outcome of arm soreness was recovered on 30Dec2020, outcome of other events was unknown.    Information on the LOT/Batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Dysgeusia, Feeling abnormal
Clinical narrative: urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, SARS-CoV-2 test negative
Clinical narrative: Diagnosed with Bell's Palsy six days after receiving the vaccine; This is a spontaneous report from a contactable other HCP (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in the right arm on 06Jan2021 14:30 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 12Jan2021, the patient was diagnosed with bell's palsy six days after receiving the vaccine. COVID was tested post vaccination: Nasal Swab: negative on 13Jan2021. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Event treatment included oral steroids. Outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous report from a contactable pharmacist.   A 77-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730) via an unspecified route of administration on 13Jan2021 12:30 single dose for covid-19 immunisation. Vaccine location was left arm. Patient did not receive any other vaccines that day and none 4 weeks prior. Medical history was none. There were no concomitant medications. The patient experienced burning pain going down into the forearm on the same side vaccine given on 17Jan2021. She has never experienced anything like this before having that vaccine. The event was reported as medically significant. The outcome was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering he known safety profile of COVID-19 vaccine, BNT162B2, the Company considers there is a reasonable possibility that the reported "burning pain going down into the forearm on the same side vaccine given" is related to BNT162B2 administration.   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 RA, IEC, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hypertension, Hypoaesthesia, Lip swelling
Clinical narrative: swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient).  A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021.  Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pruritus, Rash
Clinical narrative: swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient).  A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021.  Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Exposure during pregnancy, Facial paresis, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).   A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test negative
Clinical narrative: Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).   A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram thorax normal, Fatigue, Gait inability, Guillain-Barre syndrome
Clinical narrative: Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).   A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotonia, Immunoglobulin therapy, Impaired work ability, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).   A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).   A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Exposure during pregnancy, Facial paresis, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient experiencing profound fatigue and muscle weakness since receiving the Pfizer covid-vaccine. Episodes of flaccid muscles and increasing weakness until patient was no longer able to walk and admitted to the hospital just over 3 weeks after receiving the vaccine. Patient was hospitalized for 6 days and received IVIG treatment for presumed Guillaine Barre/variant . Patient now 2 1/2 weeks post-hospitalization and almost 7 weeks since vaccination and has not returned to normal function although condition is improving. Patient currently able to ambulate short distances, unable to work or perform other activities of daily living.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test negative
Clinical narrative: Patient experiencing profound fatigue and muscle weakness since receiving the Pfizer covid-vaccine. Episodes of flaccid muscles and increasing weakness until patient was no longer able to walk and admitted to the hospital just over 3 weeks after receiving the vaccine. Patient was hospitalized for 6 days and received IVIG treatment for presumed Guillaine Barre/variant . Patient now 2 1/2 weeks post-hospitalization and almost 7 weeks since vaccination and has not returned to normal function although condition is improving. Patient currently able to ambulate short distances, unable to work or perform other activities of daily living.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram thorax normal, Fatigue, Gait inability, Guillain-Barre syndrome
Clinical narrative: Patient experiencing profound fatigue and muscle weakness since receiving the Pfizer covid-vaccine. Episodes of flaccid muscles and increasing weakness until patient was no longer able to walk and admitted to the hospital just over 3 weeks after receiving the vaccine. Patient was hospitalized for 6 days and received IVIG treatment for presumed Guillaine Barre/variant . Patient now 2 1/2 weeks post-hospitalization and almost 7 weeks since vaccination and has not returned to normal function although condition is improving. Patient currently able to ambulate short distances, unable to work or perform other activities of daily living.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotonia, Immunoglobulin therapy, Impaired work ability, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: Patient experiencing profound fatigue and muscle weakness since receiving the Pfizer covid-vaccine. Episodes of flaccid muscles and increasing weakness until patient was no longer able to walk and admitted to the hospital just over 3 weeks after receiving the vaccine. Patient was hospitalized for 6 days and received IVIG treatment for presumed Guillaine Barre/variant . Patient now 2 1/2 weeks post-hospitalization and almost 7 weeks since vaccination and has not returned to normal function although condition is improving. Patient currently able to ambulate short distances, unable to work or perform other activities of daily living.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: Patient experiencing profound fatigue and muscle weakness since receiving the Pfizer covid-vaccine. Episodes of flaccid muscles and increasing weakness until patient was no longer able to walk and admitted to the hospital just over 3 weeks after receiving the vaccine. Patient was hospitalized for 6 days and received IVIG treatment for presumed Guillaine Barre/variant . Patient now 2 1/2 weeks post-hospitalization and almost 7 weeks since vaccination and has not returned to normal function although condition is improving. Patient currently able to ambulate short distances, unable to work or perform other activities of daily living.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Ocular rosacea, Pruritus
Clinical narrative: Roscia-major flare occured in eyes/Continued to worsen over next 24 hours; severe itchiness; This is a spontaneous report from a contactable other Health Professional (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 18Jan2021 08:15 at single dose in left arm for COVID-19 immunization. Medical history included non allergic rhinitis and vestibular migraines. The patient had not known allergic, but very sensitive to SE. Concomitant medications included "sensimist", naproxen sodium (ALEVE), progesterone, estradiol. The patient had no covid prior vaccination and did not had covid tested post vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 28Dec2020 08:45 at single dose in left arm for COVID-19 immunization. No other vaccine was received in four weeks. The patient experienced roscia-major flare occurred in eyes within 2 hours of second vaccine on 18Jan2021 09:00. Continued to worsen over next 24 hours. Necessitated a trip to eye dr. Have never had a flare this serious. In addition, severe itchiness day vaccine given. Took antihistamine (Allegra) second day which solved issue. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received Neomycin & Polymyxin B Sulfates & Dexamethasone Op as treatment. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Condition aggravated, Echocardiogram, Fatigue, Headache
Clinical narrative: Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events  due to temporal relationship.  However,  the events may likely possibly  represent concurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging brain, Malaise, Orthostatic hypotension, SARS-CoV-2 test negative
Clinical narrative: Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events  due to temporal relationship.  However,  the events may likely possibly  represent concurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Ultrasound Doppler
Clinical narrative: Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events  due to temporal relationship.  However,  the events may likely possibly  represent concurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular in the left arm on 17Dec2020 16:15 at a single dose for COVID-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, Factor V Leiden, GERD (Gastroesophageal reflux disease), DVT (deep vein thrombosis), hypertension, neck pain on left side, rhinitis, and rhomboid muscle strain. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone nasal spray, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone, and sodium chloride nasal spray. The patient had no other vaccines in four weeks before covid vaccine. The patient had no prior vaccination and she had not been tested post vaccination. The patient noticed some numbness on the right side of face after receiving the first dose of vaccine on an unknown date. She was concerned for early Bell's Palsy on 15Jan2021 at 09:00 AM. She will be treated with valganciclovir and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events early Bell's Palsy and some numbness on the right side of face was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "concerned for early Bell's palsy". 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: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Tenderness
Clinical narrative: Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL0140) via an unspecified route of administration on left arm on an unspecified date at a single dose for covid-19 immunization. The patient had a heart condition and a stroke. The patient concomitant medications were not reported. The patient stated that she had a when I had the shot on the 13th (not clarified) and end up going to urgent care on Friday. She had a huge swelling around her eyes and redness and tenderness and her left eye was swollen shut. She went to urgent care and got some antibiotics and some cream to put on it. The patient had not any lab test. However, she did have microblading done to her eyebrows, three days before she had the shot. The patient wanted to know if it was because she had the microblading done and then she got the shot.  The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Jaundice, Joint swelling, Malaise, Pallor
Clinical narrative: Knee joint swelled 3 times the size; Bruising that is not at the injection site that just came up; Looks yellow, like jaundiced; does not feel well; he looks a little pale; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL3249, expiry date unknown) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, resident at the Nursing Home received the vaccine on 15Jan2021. On an unspecified date, his knee joint swelled 3 times the size. He has a bruising that is not at the injection site that just came up. Overall, he does not feel well and looks a little pale and jaundiced. He almost looks like yellow, like jaundiced. Should he go to the ER or should he wait? The reporter and the doctor did not know what to do. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Yellow skin
Clinical narrative: Knee joint swelled 3 times the size; Bruising that is not at the injection site that just came up; Looks yellow, like jaundiced; does not feel well; he looks a little pale; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL3249, expiry date unknown) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, resident at the Nursing Home received the vaccine on 15Jan2021. On an unspecified date, his knee joint swelled 3 times the size. He has a bruising that is not at the injection site that just came up. Overall, he does not feel well and looks a little pale and jaundiced. He almost looks like yellow, like jaundiced. Should he go to the ER or should he wait? The reporter and the doctor did not know what to do. The outcome of the events was unknown.