chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Tachycardia
Clinical narrative: neuropathy; tingling; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "tachycardia".  The caller is a patient/consumer requesting information about the side effects after the booster shot whether they are similar to those of the 1st and 2nd shots or are they worse. There is a small set of people that develop reaction of the vaccine such as tingling than persist and tachycardia. I got the 2 shots 8 months ago, I developed tingling, tachycardia and neuropathy. A couple of days they give me information a reaction i got. However i am in this hard decision should i get the booster, There is no enough information, are the side effects similar to those of the 1st and 2nd shots or they are worse. Agency: e-transmitting, potential AE, duplicated information. Response: Responded from attached document. The caller was wondering if is there any research to guide her. Is pfizer investigating what is happening, what is the cause of it, why is people experiencing these side effects, is expected that the patient is going to get worse with the booster. She wanted to know if there was any information about the reports of people, or studies related to the booster shot. Response: Referred to agency to look for information on the factsheets regarding the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Heart rate, Heart rate increased, Neuropathy peripheral, Paraesthesia
Clinical narrative: neuropathy; tingling; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "tachycardia".  The caller is a patient/consumer requesting information about the side effects after the booster shot whether they are similar to those of the 1st and 2nd shots or are they worse. There is a small set of people that develop reaction of the vaccine such as tingling than persist and tachycardia. I got the 2 shots 8 months ago, I developed tingling, tachycardia and neuropathy. A couple of days they give me information a reaction i got. However i am in this hard decision should i get the booster, There is no enough information, are the side effects similar to those of the 1st and 2nd shots or they are worse. Agency: e-transmitting, potential AE, duplicated information. Response: Responded from attached document. The caller was wondering if is there any research to guide her. Is pfizer investigating what is happening, what is the cause of it, why is people experiencing these side effects, is expected that the patient is going to get worse with the booster. She wanted to know if there was any information about the reports of people, or studies related to the booster shot. Response: Referred to agency to look for information on the factsheets regarding the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tachycardia
Clinical narrative: neuropathy; tingling; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "tachycardia".  The caller is a patient/consumer requesting information about the side effects after the booster shot whether they are similar to those of the 1st and 2nd shots or are they worse. There is a small set of people that develop reaction of the vaccine such as tingling than persist and tachycardia. I got the 2 shots 8 months ago, I developed tingling, tachycardia and neuropathy. A couple of days they give me information a reaction i got. However i am in this hard decision should i get the booster, There is no enough information, are the side effects similar to those of the 1st and 2nd shots or they are worse. Agency: e-transmitting, potential AE, duplicated information. Response: Responded from attached document. The caller was wondering if is there any research to guide her. Is pfizer investigating what is happening, what is the cause of it, why is people experiencing these side effects, is expected that the patient is going to get worse with the booster. She wanted to know if there was any information about the reports of people, or studies related to the booster shot. Response: Referred to agency to look for information on the factsheets regarding the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid 19; Covid 19; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Dec2021 14:00 (Lot number: FE3594) as dose 3, single, intramuscular, administered in arm left, administration date 23Mar2021 (Lot number: EL8982) as dose 2, single and intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: EL8982) as dose 1, single for COVID-19 immunization. Relevant medical history included: "asthma" (ongoing), notes: Onset date: Birth, Pertinent details: lifelong asthma; "Migraine" (unspecified if ongoing). Concomitant medications included: VENTOLIN [SALBUTAMOL SULFATE] taken for asthma (ongoing); VICODINE taken for migraine (ongoing). The following information was reported: IMMUNISATION (medically significant) with onset 13Dec2021 14:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "unknown" and all described as "Covid 19". The events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Dec2021) pos. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Sick 3rd shot 8 days and ER visit with pos- Covid-19 test. I am (87) 113 lbs and you are given a shot for to strong for small people. We need a 1/2 dose OOO (out of the office).  No follow-up attempts are possible. No further information is expected.  Follow-up (17Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate increased, Influenza virus test negative, Pain, Palpitations
Clinical narrative: Heart fluttering; resting heart rate increased; Sever body pain; fatigue; low grade fever upto 99.7; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 14:00 (Lot number: F31620) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: None, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 30Jun2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Dec2021 14:00, outcome "unknown", described as "booster shot"; CARDIAC FLUTTER (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "Heart fluttering"; HEART RATE INCREASED (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "resting heart rate increased"; PAIN (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "Sever body pain"; FATIGUE (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "fatigue"; PYREXIA (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "low grade fever upto 99.7". The events "booster shot", "heart fluttering", "resting heart rate increased", "sever body pain", "fatigue" and "low grade fever upto 99.7" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) 99.7.. Therapeutic measures were taken as a result of immunisation, cardiac flutter, heart rate increased, pain, fatigue, pyrexia.  Other vaccine same date details other vaccine same date product-None. If other vaccine in four weeks: No. Other medications in two weeks: No. AE treatment: Pain killer medicines and prednisone. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: None. Other medical history: None. Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Heart fluttering; resting heart rate increased; Sever body pain; fatigue; low grade fever upto 99.7; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 14:00 (Lot number: F31620) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: None, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 30Jun2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Dec2021 14:00, outcome "unknown", described as "booster shot"; CARDIAC FLUTTER (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "Heart fluttering"; HEART RATE INCREASED (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "resting heart rate increased"; PAIN (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "Sever body pain"; FATIGUE (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "fatigue"; PYREXIA (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "low grade fever upto 99.7". The events "booster shot", "heart fluttering", "resting heart rate increased", "sever body pain", "fatigue" and "low grade fever upto 99.7" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) 99.7.. Therapeutic measures were taken as a result of immunisation, cardiac flutter, heart rate increased, pain, fatigue, pyrexia.  Other vaccine same date details other vaccine same date product-None. If other vaccine in four weeks: No. Other medications in two weeks: No. AE treatment: Pain killer medicines and prednisone. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: None. Other medical history: None. Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cardiac flutter, Fatigue, Heart rate increased, Immunisation
Clinical narrative: Heart fluttering; resting heart rate increased; Sever body pain; fatigue; low grade fever upto 99.7; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 14:00 (Lot number: F31620) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: None, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 30Jun2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Dec2021 14:00, outcome "unknown", described as "booster shot"; CARDIAC FLUTTER (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "Heart fluttering"; HEART RATE INCREASED (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "resting heart rate increased"; PAIN (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "Sever body pain"; FATIGUE (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "fatigue"; PYREXIA (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "low grade fever upto 99.7". The events "booster shot", "heart fluttering", "resting heart rate increased", "sever body pain", "fatigue" and "low grade fever upto 99.7" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) 99.7.. Therapeutic measures were taken as a result of immunisation, cardiac flutter, heart rate increased, pain, fatigue, pyrexia.  Other vaccine same date details other vaccine same date product-None. If other vaccine in four weeks: No. Other medications in two weeks: No. AE treatment: Pain killer medicines and prednisone. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: None. Other medical history: None. Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Heart fluttering; resting heart rate increased; Sever body pain; fatigue; low grade fever upto 99.7; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 14:00 (Lot number: F31620) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: None, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 30Jun2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 05Dec2021 14:00, outcome "unknown", described as "booster shot"; CARDIAC FLUTTER (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "Heart fluttering"; HEART RATE INCREASED (medically significant) with onset 06Dec2021 14:00, outcome "not recovered", described as "resting heart rate increased"; PAIN (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "Sever body pain"; FATIGUE (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "fatigue"; PYREXIA (non-serious) with onset 06Dec2021 14:00, outcome "not recovered", described as "low grade fever upto 99.7". The events "booster shot", "heart fluttering", "resting heart rate increased", "sever body pain", "fatigue" and "low grade fever upto 99.7" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (06Dec2021) 99.7.. Therapeutic measures were taken as a result of immunisation, cardiac flutter, heart rate increased, pain, fatigue, pyrexia.  Other vaccine same date details other vaccine same date product-None. If other vaccine in four weeks: No. Other medications in two weeks: No. AE treatment: Pain killer medicines and prednisone. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: None. Other medical history: None. Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antiacetylcholine receptor antibody, Aphasia, Balance disorder, Dysphagia, Hypopnoea
Clinical narrative: Onset of Myasthenia Gravis symptoms, Slurred speech, muscle weak-ness, trouble swallowing; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 17Sep2021 13:00 (Lot number: 301308A) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 12:00PM), administration date: 19Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant, disability) with onset 17Sep2021 13:00, outcome "unknown", described as "dose_number=3"; MYASTHENIA GRAVIS (medically significant, disability) with onset 01Nov2021 12:00, outcome "not recovered", described as "Onset of Myasthenia Gravis symptoms, Slurred speech, muscle weak-ness, trouble swallowing ". The event "onset of myasthenia gravis symptoms, slurred speech, muscle weak-ness, trouble swallowing " was evaluated at the physician office visit. Therapeutic measures were taken as a result of myasthenia gravis which included Mestinon.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Onset of Myasthenia Gravis symptoms, Slurred speech, muscle weak-ness, trouble swallowing; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 17Sep2021 13:00 (Lot number: 301308A) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 12:00PM), administration date: 19Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant, disability) with onset 17Sep2021 13:00, outcome "unknown", described as "dose_number=3"; MYASTHENIA GRAVIS (medically significant, disability) with onset 01Nov2021 12:00, outcome "not recovered", described as "Onset of Myasthenia Gravis symptoms, Slurred speech, muscle weak-ness, trouble swallowing ". The event "onset of myasthenia gravis symptoms, slurred speech, muscle weak-ness, trouble swallowing " was evaluated at the physician office visit. Therapeutic measures were taken as a result of myasthenia gravis which included Mestinon.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Myasthenia gravis
Clinical narrative: Onset of Myasthenia Gravis symptoms, Slurred speech, muscle weak-ness, trouble swallowing; dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 17Sep2021 13:00 (Lot number: 301308A) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Mar2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 12:00PM), administration date: 19Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant, disability) with onset 17Sep2021 13:00, outcome "unknown", described as "dose_number=3"; MYASTHENIA GRAVIS (medically significant, disability) with onset 01Nov2021 12:00, outcome "not recovered", described as "Onset of Myasthenia Gravis symptoms, Slurred speech, muscle weak-ness, trouble swallowing ". The event "onset of myasthenia gravis symptoms, slurred speech, muscle weak-ness, trouble swallowing " was evaluated at the physician office visit. Therapeutic measures were taken as a result of myasthenia gravis which included Mestinon.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphonia, Borrelia test, Chest X-ray, Computerised tomogram, Computerised tomogram head
Clinical narrative: developed a rash on my legs; voice became very scratchy; feet also felt a little numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM; PREDNISONE; FOLIC ACID; TYLENOL. The following information was reported: RASH (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "developed a rash on my legs"; DYSPHONIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "voice became very scratchy"; HYPOAESTHESIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "feet also felt a little numb". The patient was hospitalized for rash, dysphonia, hypoaesthesia (hospitalization duration: 5 day(s)). The events "developed a rash on my legs", "voice became very scratchy" and "feet also felt a little numb" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of rash, dysphonia, hypoaesthesia. Patient was recently administered dose number 2 on 27Mar2021 at 11:00 AM, had Lot number=ER8727.Vaccine administered on Left arm .Patient was not administered any other vaccine in four weeks.: After the first one patient developed a rash on legs and voice became very scratchy, Patient feet also felt a little numb. Patient went on and got the second shot on 27Mar2021. Eventually rash went away, voice improved and feet are still numb, somewhat and patient was negative for Guillame-Barre. Patient was not Covid prior vaccination   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram neck, Diarrhoea, Dysphonia, Feeding disorder, Fluid intake reduced
Clinical narrative: developed a rash on my legs; voice became very scratchy; feet also felt a little numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM; PREDNISONE; FOLIC ACID; TYLENOL. The following information was reported: RASH (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "developed a rash on my legs"; DYSPHONIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "voice became very scratchy"; HYPOAESTHESIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "feet also felt a little numb". The patient was hospitalized for rash, dysphonia, hypoaesthesia (hospitalization duration: 5 day(s)). The events "developed a rash on my legs", "voice became very scratchy" and "feet also felt a little numb" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of rash, dysphonia, hypoaesthesia. Patient was recently administered dose number 2 on 27Mar2021 at 11:00 AM, had Lot number=ER8727.Vaccine administered on Left arm .Patient was not administered any other vaccine in four weeks.: After the first one patient developed a rash on legs and voice became very scratchy, Patient feet also felt a little numb. Patient went on and got the second shot on 27Mar2021. Eventually rash went away, voice improved and feet are still numb, somewhat and patient was negative for Guillame-Barre. Patient was not Covid prior vaccination   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Impaired work ability, Lumbar puncture, Lymphadenopathy
Clinical narrative: developed a rash on my legs; voice became very scratchy; feet also felt a little numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM; PREDNISONE; FOLIC ACID; TYLENOL. The following information was reported: RASH (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "developed a rash on my legs"; DYSPHONIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "voice became very scratchy"; HYPOAESTHESIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "feet also felt a little numb". The patient was hospitalized for rash, dysphonia, hypoaesthesia (hospitalization duration: 5 day(s)). The events "developed a rash on my legs", "voice became very scratchy" and "feet also felt a little numb" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of rash, dysphonia, hypoaesthesia. Patient was recently administered dose number 2 on 27Mar2021 at 11:00 AM, had Lot number=ER8727.Vaccine administered on Left arm .Patient was not administered any other vaccine in four weeks.: After the first one patient developed a rash on legs and voice became very scratchy, Patient feet also felt a little numb. Patient went on and got the second shot on 27Mar2021. Eventually rash went away, voice improved and feet are still numb, somewhat and patient was negative for Guillame-Barre. Patient was not Covid prior vaccination   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Malaise, Pain, Pain of skin, Rash
Clinical narrative: developed a rash on my legs; voice became very scratchy; feet also felt a little numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM; PREDNISONE; FOLIC ACID; TYLENOL. The following information was reported: RASH (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "developed a rash on my legs"; DYSPHONIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "voice became very scratchy"; HYPOAESTHESIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "feet also felt a little numb". The patient was hospitalized for rash, dysphonia, hypoaesthesia (hospitalization duration: 5 day(s)). The events "developed a rash on my legs", "voice became very scratchy" and "feet also felt a little numb" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of rash, dysphonia, hypoaesthesia. Patient was recently administered dose number 2 on 27Mar2021 at 11:00 AM, had Lot number=ER8727.Vaccine administered on Left arm .Patient was not administered any other vaccine in four weeks.: After the first one patient developed a rash on legs and voice became very scratchy, Patient feet also felt a little numb. Patient went on and got the second shot on 27Mar2021. Eventually rash went away, voice improved and feet are still numb, somewhat and patient was negative for Guillame-Barre. Patient was not Covid prior vaccination   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Speech disorder, Tuberculin test, Vomiting
Clinical narrative: developed a rash on my legs; voice became very scratchy; feet also felt a little numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM; PREDNISONE; FOLIC ACID; TYLENOL. The following information was reported: RASH (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "developed a rash on my legs"; DYSPHONIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "voice became very scratchy"; HYPOAESTHESIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "feet also felt a little numb". The patient was hospitalized for rash, dysphonia, hypoaesthesia (hospitalization duration: 5 day(s)). The events "developed a rash on my legs", "voice became very scratchy" and "feet also felt a little numb" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of rash, dysphonia, hypoaesthesia. Patient was recently administered dose number 2 on 27Mar2021 at 11:00 AM, had Lot number=ER8727.Vaccine administered on Left arm .Patient was not administered any other vaccine in four weeks.: After the first one patient developed a rash on legs and voice became very scratchy, Patient feet also felt a little numb. Patient went on and got the second shot on 27Mar2021. Eventually rash went away, voice improved and feet are still numb, somewhat and patient was negative for Guillame-Barre. Patient was not Covid prior vaccination   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphonia, Hypoaesthesia, Rash, SARS-CoV-2 test
Clinical narrative: developed a rash on my legs; voice became very scratchy; feet also felt a little numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6206) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE SODIUM; PREDNISONE; FOLIC ACID; TYLENOL. The following information was reported: RASH (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "developed a rash on my legs"; DYSPHONIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "voice became very scratchy"; HYPOAESTHESIA (hospitalization, disability) with onset 08Mar2021, outcome "not recovered", described as "feet also felt a little numb". The patient was hospitalized for rash, dysphonia, hypoaesthesia (hospitalization duration: 5 day(s)). The events "developed a rash on my legs", "voice became very scratchy" and "feet also felt a little numb" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of rash, dysphonia, hypoaesthesia. Patient was recently administered dose number 2 on 27Mar2021 at 11:00 AM, had Lot number=ER8727.Vaccine administered on Left arm .Patient was not administered any other vaccine in four weeks.: After the first one patient developed a rash on legs and voice became very scratchy, Patient feet also felt a little numb. Patient went on and got the second shot on 27Mar2021. Eventually rash went away, voice improved and feet are still numb, somewhat and patient was negative for Guillame-Barre. Patient was not Covid prior vaccination   Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Erythema, Flushing, Lip swelling
Clinical narrative: Consistent over 100 degree fever; facial swelling; flushed face; swollen lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 09:00 (Lot number: FL8094) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "Consistent over 100 degree fever"; SWELLING FACE (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "facial swelling"; FLUSHING (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "flushed face"; LIP SWELLING (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "swollen lips". The events "consistent over 100 degree fever", "facial swelling", "flushed face" and "swollen lips" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pyrexia, swelling face, flushing, lip swelling.  Additional Information: Patient has not been vaccinated prior to vaccination. Patient has been tested after COVID-19 vaccination. patient had IV treatment "Decadron, toradol and lactated ringers iv bolus".  No follow-up attempts are possible. No further information is expected.  Follow-Up (14Jan2022):Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling of eyelid
Clinical narrative: Consistent over 100 degree fever; facial swelling; flushed face; swollen lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 09:00 (Lot number: FL8094) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "Consistent over 100 degree fever"; SWELLING FACE (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "facial swelling"; FLUSHING (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "flushed face"; LIP SWELLING (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "swollen lips". The events "consistent over 100 degree fever", "facial swelling", "flushed face" and "swollen lips" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pyrexia, swelling face, flushing, lip swelling.  Additional Information: Patient has not been vaccinated prior to vaccination. Patient has been tested after COVID-19 vaccination. patient had IV treatment "Decadron, toradol and lactated ringers iv bolus".  No follow-up attempts are possible. No further information is expected.  Follow-Up (14Jan2022):Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Lip swelling, Pyrexia, SARS-CoV-2 test, Swelling face
Clinical narrative: Consistent over 100 degree fever; facial swelling; flushed face; swollen lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 09:00 (Lot number: FL8094) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "Consistent over 100 degree fever"; SWELLING FACE (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "facial swelling"; FLUSHING (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "flushed face"; LIP SWELLING (medically significant) with onset 05Jan2022 08:00, outcome "recovering", described as "swollen lips". The events "consistent over 100 degree fever", "facial swelling", "flushed face" and "swollen lips" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pyrexia, swelling face, flushing, lip swelling.  Additional Information: Patient has not been vaccinated prior to vaccination. Patient has been tested after COVID-19 vaccination. patient had IV treatment "Decadron, toradol and lactated ringers iv bolus".  No follow-up attempts are possible. No further information is expected.  Follow-Up (14Jan2022):Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Blood test, Erythema, Hypersensitivity, Immunisation
Clinical narrative: ON NOVEMBER 16, 2021 I WAS VACCINATED WITH THE THIRD DOSE FOR COVID 19 WITH PFIZER, ON DAY 16 I STARTED A RASH AND ITCHING ON THE LOWER BACK WHICH BY DECEMBER 6 WAS ALL OVER THE BODY IN THE FORM OF WEALS AND WITH A LOT OF ITCHING, THAT DAY I STARTED MY LONG JOURNEY THROUGH THE MEDICAL OFFICES, CHANGING MEDICATIONS, CREAMS AND SLEEPING PILLS AT EACH APPOINTMENT. THE DOCTORS DID NOT WORK UNTIL THEY PRESCRIBED ME TREATMENT WITH CORTIZONE, AFTER BLOOD TESTS AND A BIOPSY, WITH THE CORTIZONE UNDER THE INFLAMMATION BUT NOT THE ITCHING BECAUSE OF A CHANGE IN INSURANCE I COULD NOT GO BACK TO THE DERMATOLOGIST AND ON JANUARY 10 I RETURNED TO MY PRIMARY DOCTOR, THEY INJECTED ME AT THE CLINIC AND THEY CHANGED THE MEDICATION. I HAVE BEEN WITH THE ALLERGY FOR MORE THAN 2 MONTHS AND I WAS DISABLED FOR THREE WEEKS, I COULD NOT STAND HAVING CLOTHES ON 12/16/2021 BLOOD TESTS DIAGNOSTICS 12/16/2021 DR 12/21/2021; DR DERMATOLOGY 05/01/2021; DR; I COULD NOT RETURN TO A CONSULTATION WITH HER BECAUSE MY NEW INSURANCE DOES NOT COVER HER. I RETURNED TO MY PRIMARY DOCTOR 10/01/2021 DR. BECAUSE I CAME OUT POSITIVE FOR COVID I HAVE NOT BEEN ABLE TO RETURN TO A CONSULTATION. MODERNA'S VACCINES WERE APPLIED IN THE DOCTOR'S OFFICE BECAUSE DOCTOR WORKS THERE AT THAT TIME.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Inflammation, Interchange of vaccine products, Pruritus, Rash
Clinical narrative: ON NOVEMBER 16, 2021 I WAS VACCINATED WITH THE THIRD DOSE FOR COVID 19 WITH PFIZER, ON DAY 16 I STARTED A RASH AND ITCHING ON THE LOWER BACK WHICH BY DECEMBER 6 WAS ALL OVER THE BODY IN THE FORM OF WEALS AND WITH A LOT OF ITCHING, THAT DAY I STARTED MY LONG JOURNEY THROUGH THE MEDICAL OFFICES, CHANGING MEDICATIONS, CREAMS AND SLEEPING PILLS AT EACH APPOINTMENT. THE DOCTORS DID NOT WORK UNTIL THEY PRESCRIBED ME TREATMENT WITH CORTIZONE, AFTER BLOOD TESTS AND A BIOPSY, WITH THE CORTIZONE UNDER THE INFLAMMATION BUT NOT THE ITCHING BECAUSE OF A CHANGE IN INSURANCE I COULD NOT GO BACK TO THE DERMATOLOGIST AND ON JANUARY 10 I RETURNED TO MY PRIMARY DOCTOR, THEY INJECTED ME AT THE CLINIC AND THEY CHANGED THE MEDICATION. I HAVE BEEN WITH THE ALLERGY FOR MORE THAN 2 MONTHS AND I WAS DISABLED FOR THREE WEEKS, I COULD NOT STAND HAVING CLOTHES ON 12/16/2021 BLOOD TESTS DIAGNOSTICS 12/16/2021 DR 12/21/2021; DR DERMATOLOGY 05/01/2021; DR; I COULD NOT RETURN TO A CONSULTATION WITH HER BECAUSE MY NEW INSURANCE DOES NOT COVER HER. I RETURNED TO MY PRIMARY DOCTOR 10/01/2021 DR. BECAUSE I CAME OUT POSITIVE FOR COVID I HAVE NOT BEEN ABLE TO RETURN TO A CONSULTATION. MODERNA'S VACCINES WERE APPLIED IN THE DOCTOR'S OFFICE BECAUSE DOCTOR WORKS THERE AT THAT TIME.