chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed periods (already 2 months) after vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient had missed periods (already 2 months) after vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event missed periods (already 2 months) after vaccination was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in armpit of injected arm; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 13Oct2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Oct2021, the patient had swollen lymph node in armpit of injected arm. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node in armpit of injected arm was resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced reactogenicity of leg pain in both calves during exercise when walking; This is a spontaneous report from a contactable other hcp (Patient). A 44-years-old non-pregnant female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 30Sep2021 17:00 (at the age of 44 years), as a single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received second dose of BNT162B2 vaccine (Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 43 years), as single dose and first dose of BNT162B2 vaccine (Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 43 years), as single dose for COVID-19 immunization and after first set of vaccines had reactogenicity of leg pain in both calves during exercise when walking past 7 days. Known allergies not reported. No other vaccine received in four weeks. No COVID prior vaccination. Not COVID tested post vaccination. On 30Sep2021, the patient experienced reactogenicity of leg pain in both calves during exercise when walking. Patient stated, after first set of vaccines had reactogenicity of leg pain in both calves during exercise when walking past 7 days (last over 30days and slowly disappeared. received 3rd injection on 30sep2021 and same issue appeared when walking during exercise. No treatment was received. The clinical outcome of the event was not recovered.  Follow-up (26Oct2021): This is a follow-up spontaneous report from a contactable other-HCP. This other-HCP reported in response to HCP letter sent via telephonic follow-up activity.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Menstrual cycle disrupted for 4 months after vaccination; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and also the patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced menstrual cycle disrupted for 4 months after vaccination. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event menstrual cycle disrupted for 4 months after vaccination was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Myalgia, Nausea
Clinical narrative: Myalgia; Headache; Nausea; The patient administered with third booster dose; The patient administered with third booster dose; This is a spontaneous report from a non-contactable physician. A 66-year-old non-pregnant female patient received dose 3 ( booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 15Oct2021 at 14:30(at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) from 08Oct2021 for immunisation and amlodipine (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of (BNT162B2) PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the right arm on 23Jan2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN624) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 16Oct2021 at 02:30, 12 hours after vaccination, the patient experienced myalgia, headache and nausea. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events myalgia, headache and nausea were recovered on 16Oct2021 at 14.30, after12 hours of onset.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Rash, Urticaria
Clinical narrative: Rash on waist, chest, arms and head, similar to bug bites; Rash on waist, chest, arms and head. Similar to bug bites. Hives??; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Oct2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The medical history included immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. The concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on 15Sep2021 for immunization. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 11:00 (at the age of 68-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 02:00, the patient experienced rash on waist, chest, arms and head which was similar to bug bites and hives. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash on waist, chest, arms and head which was similar to bug bites and hives were unknown at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood creatinine increased, Condition aggravated, Extra dose administered, Off label use
Clinical narrative: I took the booster shot now; I took the booster shot now; the creatinine level of the Kidney number got increased by 25% got worse; got worse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported, number, Expiration date: unknown), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (booster), single and dose 2 via an unspecified route of administration on an unspecified date (, Lot number was not reported, UPC, NDC number, Expiration date: unknown) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported, Expiration date was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient took the Pfizer shot first and second shot and after the second shot the creatinine level of the Kidney number got increased by 25% got worse and then it got better after a month or two. Patient took the booster shot and the booster shot brought up the creatinine number 25% again. On an unspecified date, the patient underwent lab tests and procedures which included creatinine: 25 % (Increased). The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Very long and painful periods; spotting 3  months after the vaccine.; Very long and painful periods; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, 3 months after the vaccine, the patient had a very long and painful periods and spotting. She had never had this before. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event very long and painful periods and spotting were not resolved at the time of this report   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Diarrhoea, Lymphadenopathy
Clinical narrative: Slight fever; chills; diarrhea; swollen lymph nodes (left arm pit); low back pain; This is a spontaneous report from a contactable Consumer (patient) reported for herself. A 65-year-old non pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: 301358A) via unknown route of administration in left arm on 14Oct2021 at 14:30 (at the age of 65 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included Kidney disease, Stage 1. The patient did not have allergies. The concomitant medication included rizatriptan for an unknown indication from an unknown date ( reported as other medication in two weeks). The patient historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6199) via unknown route in left arm on 08Mar2021 at 09:00 AM (at the age of 65 years old) as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ER8737) via unknown route in left arm on 30Mar2021 at 08:30 AM (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. Patient did not receive other vaccine in 4 weeks. On 14Oct2021 at 21:00, the patient experienced slight fever, chills, diarrhea, swollen lymph nodes (left arm pit) and low back pain. It was reported that Fever, chills lasted 24 hours, but lymph nodes still swollen and back pain was persistent. Patient did not have covid prior vaccination and not tested for covid post vaccination. The lab data included body temperature was slight fever on 14Oct2021. It was also reported that the events were non-serious. Patient did not receive the treatment. The outcome of the events Fever and chills were recovered on 15Oct2021 and other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever; chills; diarrhea; swollen lymph nodes (left arm pit); low back pain; This is a spontaneous report from a contactable Consumer (patient) reported for herself. A 65-year-old non pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: 301358A) via unknown route of administration in left arm on 14Oct2021 at 14:30 (at the age of 65 years old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included Kidney disease, Stage 1. The patient did not have allergies. The concomitant medication included rizatriptan for an unknown indication from an unknown date ( reported as other medication in two weeks). The patient historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6199) via unknown route in left arm on 08Mar2021 at 09:00 AM (at the age of 65 years old) as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: ER8737) via unknown route in left arm on 30Mar2021 at 08:30 AM (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. Patient did not receive other vaccine in 4 weeks. On 14Oct2021 at 21:00, the patient experienced slight fever, chills, diarrhea, swollen lymph nodes (left arm pit) and low back pain. It was reported that Fever, chills lasted 24 hours, but lymph nodes still swollen and back pain was persistent. Patient did not have covid prior vaccination and not tested for covid post vaccination. The lab data included body temperature was slight fever on 14Oct2021. It was also reported that the events were non-serious. Patient did not receive the treatment. The outcome of the events Fever and chills were recovered on 15Oct2021 and other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, SARS-CoV-2 antibody test
Clinical narrative: Shot # 1 one week after shot I had my first bout of gout. in my left ankle; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Feb2021 at 08:15 (Age at vaccination: 71 years) as dose 1, single for covid-19 immunisation. Medical history were none. The patient did not have any known allergy. Patient was right handed. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021 one week after shot the patient had his first bout of gout in his left ankle. The event was reported as non-serious. The patient was not hospitalized. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The adverse event resulted in emergency room or department or urgent care. In Jun2021 the patient underwent lab tests and procedures which included Nasal Swab test with result negative. The patient received Cocicine as therapeutic measure for the event. The patient was recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Epicondylitis
Clinical narrative: his first case of tennis elbow in his right elbow; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 (Age at vaccination 71-years-old), as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021, 08:15 AM (Age at vaccination 71-years-old) as dose 1, single for COVID-19 immunization and had first bout of gout in his left ankle. On an unspecified day of Mar2021, one week after shot patient experienced his first case of tennis elbow in his right elbow. On an unspecified day of Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative, Nasal Swab. The clinical outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Mild body aches from the waist down; Fatigue; Dose 3; Off label use; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an intramuscular route of administration in the left arm on 15Oct2021 at 09:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included nocturnal epileptic, hypothyroidism and known allergies to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) from 04Oct2021, levothyroxine (MANUFACTURER UNKNOWN), lamotrigine (LAMICTAL), naproxen sodium (ALEVE), paracetamol (TYLENOL), fluticasone propionate (FLONASE), pseudoephedrine hydrochloride (SUDAFED), oxymetazoline hydrochloride (AFRIN), cetirizine hydrochloride (ZYRTEC), glucosamine (MANUFACTURER UNKNOWN) and chondroitin (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication and unknown if going. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 26Jan2021 (at the age of 41-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 16Feb2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 16Oct2021, the patient experienced mild body aches from the waist down and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild body aches from the waist down and fatigue was resolving at the time of this report.  No follow-up attempts are required. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: Pain, a little redness, itching at injection site; Pain, a little redness, itching at injection site; Pain, a little redness, itching at injection site; Fatigue; Slight, intermittent headache; Mild chills; feeling cold from the inside; Moderate flu-like muscle pains in the back muscles; Mild nausea; loss of appetite; Bed rest with elevated head; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in right arm on 14Oct2021 10:30 (at the age of 63-years) as dose 3 (booster), single for COVID-19 immunization. Patient relevant medical history includes mild hypertension, and allergy to cats, some dogs, dust, some pollen, and allergy to ibuprofen, allergy to sumatriptan, allergy to bactrim DS, allergy to pamabrom, allergy to meloxicam. The patient concomitant medication includes losartan 50mg, hydrochlorothiazide 12.5mg, tylen, and flu vaccine VII (INFLUENZA VACCINE), administered in right arm on 04Oct2021 for Immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL3247), administered in left arm on 02Mar2021 (at the age of 63-years), as a single dose, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL3247), administered in left arm on 25Mar2021 (at the age of 63-years), as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Oct2021, the patient experienced Pain, a little redness, itching at injection site; Fatigue; Slight, intermittent headache; Mild chills; feeling cold from the inside out; Moderate flu-like muscle pains in the back muscles; Mild nausea; loss of appetite; and Bed rest with elevated head. The patient received tylenol 650mg 4x over 48 hrs as a treatment for the adverse events. The outcome of events was recovering, and event fatigue was recovered on 17Oct2021.  Follow-Up (20Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain, a little redness, itching at injection site; Pain, a little redness, itching at injection site; Pain, a little redness, itching at injection site; Fatigue; Slight, intermittent headache; Mild chills; feeling cold from the inside; Moderate flu-like muscle pains in the back muscles; Mild nausea; loss of appetite; Bed rest with elevated head; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in right arm on 14Oct2021 10:30 (at the age of 63-years) as dose 3 (booster), single for COVID-19 immunization. Patient relevant medical history includes mild hypertension, and allergy to cats, some dogs, dust, some pollen, and allergy to ibuprofen, allergy to sumatriptan, allergy to bactrim DS, allergy to pamabrom, allergy to meloxicam. The patient concomitant medication includes losartan 50mg, hydrochlorothiazide 12.5mg, tylen, and flu vaccine VII (INFLUENZA VACCINE), administered in right arm on 04Oct2021 for Immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL3247), administered in left arm on 02Mar2021 (at the age of 63-years), as a single dose, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL3247), administered in left arm on 25Mar2021 (at the age of 63-years), as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Oct2021, the patient experienced Pain, a little redness, itching at injection site; Fatigue; Slight, intermittent headache; Mild chills; feeling cold from the inside out; Moderate flu-like muscle pains in the back muscles; Mild nausea; loss of appetite; and Bed rest with elevated head. The patient received tylenol 650mg 4x over 48 hrs as a treatment for the adverse events. The outcome of events was recovering, and event fatigue was recovered on 17Oct2021.  Follow-Up (20Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Pain, a little redness, itching at injection site; Pain, a little redness, itching at injection site; Pain, a little redness, itching at injection site; Fatigue; Slight, intermittent headache; Mild chills; feeling cold from the inside; Moderate flu-like muscle pains in the back muscles; Mild nausea; loss of appetite; Bed rest with elevated head; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in right arm on 14Oct2021 10:30 (at the age of 63-years) as dose 3 (booster), single for COVID-19 immunization. Patient relevant medical history includes mild hypertension, and allergy to cats, some dogs, dust, some pollen, and allergy to ibuprofen, allergy to sumatriptan, allergy to bactrim DS, allergy to pamabrom, allergy to meloxicam. The patient concomitant medication includes losartan 50mg, hydrochlorothiazide 12.5mg, tylen, and flu vaccine VII (INFLUENZA VACCINE), administered in right arm on 04Oct2021 for Immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL3247), administered in left arm on 02Mar2021 (at the age of 63-years), as a single dose, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL3247), administered in left arm on 25Mar2021 (at the age of 63-years), as a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Oct2021, the patient experienced Pain, a little redness, itching at injection site; Fatigue; Slight, intermittent headache; Mild chills; feeling cold from the inside out; Moderate flu-like muscle pains in the back muscles; Mild nausea; loss of appetite; and Bed rest with elevated head. The patient received tylenol 650mg 4x over 48 hrs as a treatment for the adverse events. The outcome of events was recovering, and event fatigue was recovered on 17Oct2021.  Follow-Up (20Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, SARS-CoV-2 test
Clinical narrative: Muscle pinching pain in right deltoid muscle, similar to a rotator cuff injury; Muscle weakness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Oct2021 at 12:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included unspecified daily inhaler from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Oct2021, the patient experienced muscle pinching pain in right deltoid muscle, similar to a rotator cuff injury. Muscle weakness accompanied the pain. Arm movements and weight lifting aggravated the pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 12Oct2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events muscle pinching pain in right deltoid muscle, similar to a rotator cuff injury and muscle weakness accompanied the pain; arm movements and weight lifting aggravated the pain was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Immunisation, Off label use
Clinical narrative: Complete numbness of right leg (below knee) and foot.; I also had some pain in back of right knee; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 13Oct2021 at 16:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, controlled high blood pressure and cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glipizide/metformin hydrochloride (GLIPIZIDE/METFORMIN), carvedilol (MANUFACTURER UNKNOWN), amlodipine besilate (AMLODIPINE) and olmesartan medoxomil (OLMESAN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the right arm on 03Feb2021 at 12:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 24Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient received other unspecified vaccines within four weeks prior to the COVID-19 vaccine. On 15Oct2021 at 10:15, the patient experienced complete numbness of right leg (below knee) and foot and also had some pain in back of right knee. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events complete numbness of right leg (below knee) and foot and also had some pain in back of right knee was resolved on an unknown date in Oct2021.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Usual soreness at injection site; Then a few days of itchy, red area on left arm; Then a few days of itchy, red area on left arm; Administered date 13Oct2021 at 11:00, dose number=3; This is a spontaneous report from a contactable consumer, the patient. An elder female patient of unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 13Oct2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included osteoarthritis. The patient had unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included first dose of the influenza vaccine inact sag 4v (FLUAD QUAD) in left arm on 15Sep2021 for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 as a single dose for COVID-19 immunisation. On 13Oct2021 at 11:00, the patient had "administration date 13Oct2021 at 11:00, dose number=3". On 14Oct2021, the patient experienced usual soreness at injection site, then a few days of itchy, red area on left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events usual soreness at injection site, then a few days of itchy, red area on left arm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events usual soreness at injection site, then a few days of itchy, red area on left arm was recovering at the time of this report. The clinical outcome of the event "administration date 13Oct2021 at 11:00, dose number=3" was unknown at the time of this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: experiencing a heavy cough, he did not have prior; he is coughing consistently; This is a spontaneous report from a Contactable consumer (mother reported for son). A 17-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration in arm left (at the age of 17 years old) on an unspecified date in Oct2021 as dose 1, single for COVID-19 immunization. Medical history included migraine. Concomitant medications included Amitriptyline for migraine. On 18Oct2021, the patient experienced a heavy cough, he did not have prior, he was coughing consistently. The patient received Mucinex as a treatment. The outcome of the event was unknown. This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: "I" have rash with swelling all over "my" face and neck; "I" have rash with swelling all over "my" face and neck; "I" have rash with swelling all over "my" face and neck; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 16Oct2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lactobacillus nos (CULTURELLE) (reported as culturelle probiotic) and multivitamin (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. On 17Oct2021 at 01:00, the patient experienced rash with swelling all over her face and neck and the patient never had facial filers. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she had rash with swelling all over face and neck was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo positional
Clinical narrative: Positional benign vertigo; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 13Aug2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 13Jul2021 at 13:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 23Aug2021, the patient experienced positional benign vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 30Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 22Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event positional benign vertigo was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Cold sweat, Immunisation, Pain
Clinical narrative: Bone and joint pains; Bone and joint pains,; Body aches; cold calmly while sweating.; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A male patient of 50-years-old received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the arm left on an unknown date in 2021 at 11:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were reported as not applicable. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 24Feb2021(at the age of 49-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient also took previously sulfur(MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 16Oct2021 at 06:00, the patient experienced bone and joint pains, body aches and cold calmly while sweating. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bone and joint pains, body aches and cold calmly while sweating were resolving at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the COVID ten days ago; tested positive for the COVID ten days ago; This is a spontaneous report from a contactable consumer. A patent of unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for the COVID ten days ago. It was reported that the reporter (an x-ray technician) called to report a patient who received the first dose of the Pfizer Biontech COVID19 (Comirnaty) vaccine and tested positive for COVID ten days ago. The patient received a "COVID infusion" or the convalescent plasma. The reporter wanted to know if there was a time period the patient needed to follow before the patient got the second dose of the vaccine. The clinical outcome of the event tested positive for the COVID ten days ago was unknown.   The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Headache
Clinical narrative: blood clot in the brain; still suffering with headaches; This is a spontaneous report from a contactable consumer. A "young" female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called with questions regarding COMIRNATY and the reporter stated a young girl at their church who received the shot ended up with a blood clot in the brain and was still suffering with headaches. The clinical outcome of blood clot in the brain was unknown, the outcome of still suffering with headaches was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Night sweats, Pain, Suspected COVID-19
Clinical narrative: experiencing "baby covid"; body aches/sore; tired; night sweats; nauseated; This is a spontaneous report from a non-contactable consumer (patient). A 59-years-old female patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Oct2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Oct2021, patient experienced baby COVID, had body aches, sore, tired, night sweats and nauseated. Patient stated that she was not running a fever. Patient asked how long these side effects should last and how long can she wait to get the second dose of Pfizer COVID-19 vaccine if she is still experiencing these side effects. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Immunisation, Pyrexia
Clinical narrative: Temperature peaked to 101 about 19 hours later. By 48 hours there were no symptoms.; Headache within a hour.; Dose 3 administered; This is a spontaneous report from a contactable consumer. A male patient of age 41-year-old received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 14Oct2021 at 08:45 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 28Sep2021 for immunization within 4 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 13Jan2021(at the age of 40-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 02Feb2021 (at the age of 41-year-old); both as a single dose for COVID-19 immunisation. On 14Oct2021 at 09:30, the patient experienced headache within an hour and temperature peaked to 101 (units unspecified) about 19 hours later. By 48 hours there were no symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of headache within an hour and temperature peaked to 101 was resolved on an unknown date in Oct2021.