chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: arm was sore and had no bullseye in it but was red and a little swollen; arm was sore and had no bullseye in it but was red and a little swollen; arm was sore and had no bullseye in it but was red and a little swollen; Caller states she had the booster on Sunday; rash; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on 03Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not reported) as dose 1, single and second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not reported) as dose 2, single both for COVID-19 immunization. On 03Oct2021, patient experienced caller stated she had the booster. On 05Oct2021, patient experienced arm was sore and had no bullseye in it but was red and a little swollen. On Oct2021, patient experienced rash. It was reported that she was calling about her follow up visit to the doctor and they thought it was a rash she got from the booster shot that says it looks like it could be Lyme's. She stated she had the booster on Sunday and on Tuesday her arm was sore and had no bullseye in it but was red and a little swollen and very mild and was almost gone now; She asked if that was seen or was a normal type of thing at the injection site. Reporter stated she was read a whole big thing about the vaccine, and they put her on with another nurse and they said she would have to talk to another medical person to get an answer to her question; stated the reason she was reporting about her follow up visit to the doctor and they thought it was a rash she got from the booster shot that says it looks like it could be Lyme's. Adverse event rash resulted in physician office visit. The outcome of the event arm was sore and had no bullseye in it but was red and a little swollen was recovering and other event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use
Clinical narrative: Coworker had his third pfizer vaccine dose; Coworker had his third pfizer vaccine dose; fatigued enough to miss work; This is a spontaneous report from a non-contactable Other HCP via sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 3 (booster), Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, Single via an unspecified route of administration on an unspecified date as Dose 2, Single for COVID-19 immunization. It was stated that, event took place after use of product. On an unspecified date (after booster dose administration), the patient had experienced fatigued enough to miss work. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever of 102.5; chills; body aches; headache; fatigue; nausea; lightheaded; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable other Health Care Professional (patient). A 39-year-old non-pregnant female patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF2590, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 04Oct2021 17:30 (at the age of 39 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included colitis ulcerative and gastrooesophageal reflux disease. The patient was allergic to Penicillin and sulfa. Concomitant medication(s) included: Other vaccine 4weeks details was diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 16Sep2021 as dose 1 in left deltoid. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 13Jan2021 07:30 (at the age of 38 years old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 01Feb2021 07:30 (at the age of 39 years old) for COVID-19 immunization. The patient was non-pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID post vaccination. On 05Oct2021 14:00, the patient experienced fever of 102.5, chills, body aches, headache, fatigue, nausea, lightheaded. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 102.5 on 05Oct2021, sars-cov-2 test: negative on 06Oct2021 Nasal Swab. The outcome of the events was recovered on unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Off label use, Pain, Pyrexia
Clinical narrative: Fever of 102.5; chills; body aches; headache; fatigue; nausea; lightheaded; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable other Health Care Professional (patient). A 39-year-old non-pregnant female patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF2590, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 04Oct2021 17:30 (at the age of 39 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included colitis ulcerative and gastrooesophageal reflux disease. The patient was allergic to Penicillin and sulfa. Concomitant medication(s) included: Other vaccine 4weeks details was diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 16Sep2021 as dose 1 in left deltoid. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 13Jan2021 07:30 (at the age of 38 years old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 01Feb2021 07:30 (at the age of 39 years old) for COVID-19 immunization. The patient was non-pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID post vaccination. On 05Oct2021 14:00, the patient experienced fever of 102.5, chills, body aches, headache, fatigue, nausea, lightheaded. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 102.5 on 05Oct2021, sars-cov-2 test: negative on 06Oct2021 Nasal Swab. The outcome of the events was recovered on unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever of 102.5; chills; body aches; headache; fatigue; nausea; lightheaded; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable other Health Care Professional (patient). A 39-year-old non-pregnant female patient received third booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FF2590, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 04Oct2021 17:30 (at the age of 39 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included colitis ulcerative and gastrooesophageal reflux disease. The patient was allergic to Penicillin and sulfa. Concomitant medication(s) included: Other vaccine 4weeks details was diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 16Sep2021 as dose 1 in left deltoid. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 13Jan2021 07:30 (at the age of 38 years old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264, Expiry date: not reported) via an unspecified route of administration, administered in left arm on 01Feb2021 07:30 (at the age of 39 years old) for COVID-19 immunization. The patient was non-pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID post vaccination. On 05Oct2021 14:00, the patient experienced fever of 102.5, chills, body aches, headache, fatigue, nausea, lightheaded. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 102.5 on 05Oct2021, sars-cov-2 test: negative on 06Oct2021 Nasal Swab. The outcome of the events was recovered on unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Currently on titrated steroid regimen for asthma; This is a spontaneous report received from contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient experienced currently on titrated steroid regimen for asthma on 07Oct2021. Therapeutic measures were taken as a result of currently on titrated steroid regimen for asthma. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341987 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain, Pyrexia
Clinical narrative: headache; low fever/low grade fever; body ache; mild chills; Symptoms began about 18 hours after administration of the 3rd dose/booster; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified dates as DOSE 1, SINGLE and DOSE 2, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced headache, low fever/low grade fever, body ache, mild chills, symptoms began about 18 hours after administration of the 3rd dose/booster. The outcome of the events 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: Arthralgia, Erythema, Immunisation, Joint swelling, Rash papular
Clinical narrative: left wrist with swelling erythema; left wrist with swelling erythema; raised rash over painful joint; Joint pain through out body but worse in left wrist the following day/raised rash over painful joint; dose number=3; This is a spontaneous report from a contactable other health care professional.  A 41-years-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8839, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 06Oct2021 (Age at vaccination: 41 years old) as dose 3 (booster), single for covid-19 immunization at a hospital. Patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1685, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 05Jan2021 (Age at vaccination: 40 years old) as dose 1, single for covid-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 26Jan2021 (Age at vaccination: 40 years old) as dose 2, single for covid-19 immunization. Patient did not take any vaccine in four weeks and any other medications in two weeks, patient did not get covid prior vaccination and did not get covid tested post vaccination and there no known allergies. On 06Oct2021, patient took dose number 3 (booster). On 07Oct2021, following day of vaccination, patient experienced joint pain throughout body but worse in left wrist. By 08Oct2021 am left wrist with swelling erythema and raised rash over painful joint. Patient did not take any treatment for adverse events. Outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Immunisation
Clinical narrative: chills; Lymph node swelling; pain under left arm; fatigue; low grade fever (100.3 F) for 2 days; muscle aches; dose_number=3; dose_number=3; headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 55-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Left on 04Oct2021 09:30 (Batch/Lot Number: 301558A) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, drug hypersensitivity known allergy: SULFA from an unknown date and unknown if ongoing, the patient was allergic to Cephalexin. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 19Feb2021, (at the age of 55 years) (Batch/Lot No: EL9264; Location of injection: Arm Left; Vaccine Administration Time: 09:30 AM) for covid-19 immunization, and the second dose of bnt162b2 on 12Mar2021 (Batch/Lot No: EN6203; Location of injection: Arm Left; Vaccine Administration Time: 08:30 AM) for covid-19 immunization. On 04Oct2021, at 09:30, the patient experienced dose number=3 (off label use), dose number=3 (immunization). On 04Oct2021, at 13:00 the patient developed chills (chills), lymph node swelling (lymphadenopathy), pain under left arm (pain), fatigue (fatigue), low grade fever (100.3 f) for 2 days (pyrexia), muscle aches (myalgia), headache (headache). The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit 100.3 F on 04Oct2021. Therapeutic measures were taken as a result of chills (chills), lymph node swelling (lymphadenopathy), pain under left arm (pain) , fatigue (fatigue), low grade fever (100.3 f) for 2 days (pyrexia), muscle aches (myalgia), headache (headache). The clinical outcome for the events chills, Lymph node swelling, pain under left arm, fatigue, low grade fever (100.3 F) for 2 days and muscle aches was recovering. The outcome for the other events was unknown.  Follow-Up (25Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: chills; Lymph node swelling; pain under left arm; fatigue; low grade fever (100.3 F) for 2 days; muscle aches; dose_number=3; dose_number=3; headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 55-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Left on 04Oct2021 09:30 (Batch/Lot Number: 301558A) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, drug hypersensitivity known allergy: SULFA from an unknown date and unknown if ongoing, the patient was allergic to Cephalexin. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 19Feb2021, (at the age of 55 years) (Batch/Lot No: EL9264; Location of injection: Arm Left; Vaccine Administration Time: 09:30 AM) for covid-19 immunization, and the second dose of bnt162b2 on 12Mar2021 (Batch/Lot No: EN6203; Location of injection: Arm Left; Vaccine Administration Time: 08:30 AM) for covid-19 immunization. On 04Oct2021, at 09:30, the patient experienced dose number=3 (off label use), dose number=3 (immunization). On 04Oct2021, at 13:00 the patient developed chills (chills), lymph node swelling (lymphadenopathy), pain under left arm (pain), fatigue (fatigue), low grade fever (100.3 f) for 2 days (pyrexia), muscle aches (myalgia), headache (headache). The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit 100.3 F on 04Oct2021. Therapeutic measures were taken as a result of chills (chills), lymph node swelling (lymphadenopathy), pain under left arm (pain) , fatigue (fatigue), low grade fever (100.3 f) for 2 days (pyrexia), muscle aches (myalgia), headache (headache). The clinical outcome for the events chills, Lymph node swelling, pain under left arm, fatigue, low grade fever (100.3 F) for 2 days and muscle aches was recovering. The outcome for the other events was unknown.  Follow-Up (25Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Oropharyngeal pain, Pyrexia
Clinical narrative: Booster; Fever of 100.4 degree Fahrenheit; Little sore throat; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient reported for herself). A 72-years-old female patient received third booster dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 07Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration on an unspecified date (Both at the age of 72-yers-old) as dose 2, single for COVID-19 immunisation. The patient experienced fever of 100.4 degree Fahrenheit and little sore throat on an unspecified date in 2021. Patient was asking if it was okay to be around her friends and family and can she get in the pool with her complaints. Patient stated that Pfizer should be the ones who know what she should or cannot do post-vaccination of the Pfizer Covid vaccine. She was also unhappy with information provided to her and stated that she was like she has lost an hour of her life. The patient underwent lab tests and procedures which included pyrexia (fever): 100.4 fahrenheit on an unspecified date in 2021. The clinical outcome fever of 100.4 degree Fahrenheit and little sore throat 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: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain, swelling, warmth and redness at injection site; pain, swelling, warmth and redness at injection site; warmth; redness at injection site; This is a spontaneous report from a contactable consumer (patient).   A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm left on 05Oct2021 19:15 PM (Lot number: FF8841; Expiration Date was not reported, at the age of 41-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history included migraine headaches; activity induced asthma. Concomitant medications included unspecified medications in two weeks. The patient did not receive any other vaccine in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via unknown route of administration in arm left on 10Feb2021 (Lot number: EL9269 and Expiration Date was not reported) and dose 2 via unknown route of administration in arm left on 03Mar2021 07:15 PM (Lot number: EN6201and Expiration Date was not reported), both at the age of 40-year-old for COVID-19 immunisation. The patient also took acetylsalicylic acid (ASA) in high doses before and experienced allergy. The patient had no Covid prior vaccination and had not tested Covid post vaccination. The patient experienced pain, swelling, warmth and redness at injection site several days after Injection on 07Oct2021. She had no fever. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood thrombin increased, Fatigue, Hypoaesthesia, Investigation
Clinical narrative: I also feel the fatigue in the past few months; finger joint and left arm became numb and swollen.; finger joint and left arm became numb and swollen.; The rib and back also aches; The rib and back also aches; The thrombus level elevated to 4.6.  After taking antibiotics, it dropped to 0.6; the left  wrist joint and left face joint became swollen; This is a spontaneous report from a contactable consumer, the patient:   A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown and expiry date was not provided) via an unspecified route of administration in the left arm on 17Mar2021 at 12:30 (at the age of 69-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Blood pressure high from an unknown date and Unknown if ongoing. Concomitant medications were not reported. The patient did not have known allergies. 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. The events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation; Solution for Injection; Lot Number: Unknown and expiry date was Not provided) via an unspecified route of administration in the left arm on 24Feb2021 at 13:15 (at the age of 69-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. On 17Mar2021 at 16:30, after four hours of the 2nd dose of vaccination, the patient experienced the left wrist joint and left face joint became swollen. On 07Apr2021, the patient's thrombus level elevated to 4.6 and after taking antibiotics, it dropped to 0.6, on 09Apr2021, the patient's finger joint and left arm became numb and swollen which spread to the right side and even the rib and back also had ached, the patient felt fatigued in the past few months. It was reported that her doctor prescribed Lyrica in May but the patient stopped taking it in July since it did not alleviate the pain. The events were assessed as Non serious. Therapeutic measures were taken as a result of swollen joints, thrombin increase, numbness, ache and fatigue included treatment with unspecified medications and pregabalin (LYRICA). The patient underwent lab tests and procedures which included Thrombus level on 07Apr2021 as 4.6 and 0.6 on 07Apr2021, on 03Apr2021, the patient underwent a SARS-CoV-2 test (PCR) and the result was negative. The clinical outcome of the events thrombus level elevated to 4.6 was resolved on 09Apr2021 while that of the events the left wrist joint and left face joint became swollen, finger joint and left arm became numb and swollen, rib and back also aches and fatigue 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Musculoskeletal chest pain, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: I also feel the fatigue in the past few months; finger joint and left arm became numb and swollen.; finger joint and left arm became numb and swollen.; The rib and back also aches; The rib and back also aches; The thrombus level elevated to 4.6.  After taking antibiotics, it dropped to 0.6; the left  wrist joint and left face joint became swollen; This is a spontaneous report from a contactable consumer, the patient:   A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown and expiry date was not provided) via an unspecified route of administration in the left arm on 17Mar2021 at 12:30 (at the age of 69-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Blood pressure high from an unknown date and Unknown if ongoing. Concomitant medications were not reported. The patient did not have known allergies. 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. The events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation; Solution for Injection; Lot Number: Unknown and expiry date was Not provided) via an unspecified route of administration in the left arm on 24Feb2021 at 13:15 (at the age of 69-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. On 17Mar2021 at 16:30, after four hours of the 2nd dose of vaccination, the patient experienced the left wrist joint and left face joint became swollen. On 07Apr2021, the patient's thrombus level elevated to 4.6 and after taking antibiotics, it dropped to 0.6, on 09Apr2021, the patient's finger joint and left arm became numb and swollen which spread to the right side and even the rib and back also had ached, the patient felt fatigued in the past few months. It was reported that her doctor prescribed Lyrica in May but the patient stopped taking it in July since it did not alleviate the pain. The events were assessed as Non serious. Therapeutic measures were taken as a result of swollen joints, thrombin increase, numbness, ache and fatigue included treatment with unspecified medications and pregabalin (LYRICA). The patient underwent lab tests and procedures which included Thrombus level on 07Apr2021 as 4.6 and 0.6 on 07Apr2021, on 03Apr2021, the patient underwent a SARS-CoV-2 test (PCR) and the result was negative. The clinical outcome of the events thrombus level elevated to 4.6 was resolved on 09Apr2021 while that of the events the left wrist joint and left face joint became swollen, finger joint and left arm became numb and swollen, rib and back also aches and fatigue 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: 78.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Colonoscopy, Erythema, Immunisation, Peripheral swelling, Rash
Clinical narrative: My arms swelled up and it's red; My arms swelled up and it's red; I had a rash; I had the Pfizer booster shot; This is a spontaneous report from a contactable consumer(patient). A 78-year-old female patient received a third dose of BNT162B2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number FE3590 and Expiry date 01Nov2021) via intramuscular route of administration, administered in left arm on 07Oct2021 (at the age of 78-year-old) as dose 3 (booster), single for COVID-19 immunization. On 07Oct2021 patient received Flu (INFLUENZA VACCINE) for immunization. The patient had no medical history. The patient concomitant medication included metoprolol for blood pressure and cholesterol. The patient previously received first dose of BNT162B2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EL9261 and Expiry date 31May2021) via intramuscular route of administration in left arm on 26Jan2021 as dose 1 and second dose of BNT162B2 (BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EN6201 and Expiry date 20Jun2021) via intramuscular route of administration in left arm on 17Feb2021 as dose 2, single for COVID-19 immunization (at the age of 78-year-old). On an unspecified date, the patient experienced my arms swelled up and it's red and I had a rash. On an unspecified date patient reported that I had the colonoscopy last week (no further details provided). Patient reported that no treatment was taken for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing their hair/lost hair; This spontaneous report from two contactable consumers reporting same event under the same suspect product for 7 patients. This is one of 7 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Reporter stated seven patients off the top of head that were losing their hair since they had the vaccine, also reported these seven patients were having hair changing or falling out right after Pfizer vaccination, 7 patient who have lost hair. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up attempts completed. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529886 same drug/event, different patient;US-PFIZER INC-202101530873 same drug/event, different patient;US-PFIZER INC-202101530874 same drug/event, different patient;US-PFIZER INC-202101530876 same drug/event, different patient;US-PFIZER INC-202101530872 same drug/event, different patient;US-PFIZER INC-202101530875 same drug/event, different patient
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Dizziness, Rash, Swelling
Clinical narrative: Lump was size of tennis ball in axilla area with pain; Rash-welts; Dizziness; Axilla Lump; axils swelling; red welts streaking arm and breast; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).   A 47-year-old non-pregnant female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch No. Not available/Lot Number: FF8841; Expiration Date: 31Mar2022), via intramuscular route, administered in right deltoid on 07Oct2021 at 15:30 (at the age of 47-year-old) as dose 2, single for covid-19 immunization. Medical history included , ongoing Subclinical hyperthyroid from 04Feb2013, ongoing anxiety from 07Oct2019, ongoing prediabetes from 30May2019, ongoing gastro oesophageal reflux disease from 21May2020, ongoing DUB from 16Mar2020. Family medical history relevant to AE was none. Relevant past drug history reported for an unknown drug and reaction experienced was allergy. Concomitant medications received within 2 weeks of vaccination included metformin, clarithromycin (CLARITIN [CLARITHROMYCIN]), famotidine (PEPCID [FAMOTIDINE]), oral contraceptives taken for an unspecified indication, start and stop date were not reported. The historical vaccine included, received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch No. Not available/Lot Number: FC3183; Expiration date: 31Oct2021) via intramuscular route, administered in right deltoid on 16Sep2021 at 15:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Prior vaccinations was none. On 08Oct2021 at 21:00, the patient experienced axils swelling and red welts streaking arm and breast. On 09Oct2021, patient experienced axilla lump. On 10Oct2021, patient experienced rash-welts, dizziness. On an unspecified date, patient experienced, lump was size of tennis ball in axilla area with pain. Patient was not received treatment for events. No hospitalization prolonged. The seriousness was reported as non serious. No therapeutic measures were taken for the events. The outcome of the events axils swelling and red welts streaking arm and breast, rash-welts, dizziness was not recovered and rash was still present as of 15Oct2021, event axilla lump was recovered on an unknown date in 2021, outcome of event Lump was size of tennis ball in axilla area with pain was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Lump was size of tennis ball in axilla area with pain; Rash-welts; Dizziness; Axilla Lump; axils swelling; red welts streaking arm and breast; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).   A 47-year-old non-pregnant female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch No. Not available/Lot Number: FF8841; Expiration Date: 31Mar2022), via intramuscular route, administered in right deltoid on 07Oct2021 at 15:30 (at the age of 47-year-old) as dose 2, single for covid-19 immunization. Medical history included , ongoing Subclinical hyperthyroid from 04Feb2013, ongoing anxiety from 07Oct2019, ongoing prediabetes from 30May2019, ongoing gastro oesophageal reflux disease from 21May2020, ongoing DUB from 16Mar2020. Family medical history relevant to AE was none. Relevant past drug history reported for an unknown drug and reaction experienced was allergy. Concomitant medications received within 2 weeks of vaccination included metformin, clarithromycin (CLARITIN [CLARITHROMYCIN]), famotidine (PEPCID [FAMOTIDINE]), oral contraceptives taken for an unspecified indication, start and stop date were not reported. The historical vaccine included, received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch No. Not available/Lot Number: FC3183; Expiration date: 31Oct2021) via intramuscular route, administered in right deltoid on 16Sep2021 at 15:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Prior vaccinations was none. On 08Oct2021 at 21:00, the patient experienced axils swelling and red welts streaking arm and breast. On 09Oct2021, patient experienced axilla lump. On 10Oct2021, patient experienced rash-welts, dizziness. On an unspecified date, patient experienced, lump was size of tennis ball in axilla area with pain. Patient was not received treatment for events. No hospitalization prolonged. The seriousness was reported as non serious. No therapeutic measures were taken for the events. The outcome of the events axils swelling and red welts streaking arm and breast, rash-welts, dizziness was not recovered and rash was still present as of 15Oct2021, event axilla lump was recovered on an unknown date in 2021, outcome of event Lump was size of tennis ball in axilla area with pain was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Feeling abnormal, Feeling cold, Headache
Clinical narrative: I woke up with headache; pain in left arm; nauseous; all my major joints hurt; Could not eat all day; Then, my legs (from the knees down became cold even with 2 blankets).; Today, I still feel awful; Booster; This is a spontaneous report from a contactable Other HCP (patient). A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 301358A), via an unspecified route of administration in arm left on 08Oct2021 12:30 (at the age of 71 years old) as dose 3 (booster) single for covid-19 immunisation. Medical history included arthritis. Concomitant medications included ezetimibe (ZETIA). The patient previously took Statins, strawberries, Codeine, Sulfa and experienced allergy. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El9263) via an unspecified route of administration, administered in arm left on 30Jan2021 09:30 as dose 1, single for covid-19 immunisation and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19265) via an unspecified route of administration, administered in arm left on 20Feb2021 09:00 as dose 2, single for covid-19 immunisation, influenza vaccine (FLU) taken for immunisation from 27Sep2021 to an unspecified stop date. The patient was not pregnant at the time of vaccination. The patient receive Flu vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 08Oct2021 12:30, administered booster. On 09Oct2021 07:00, the patient reported that I woke up with headache, pain in left arm, nauseous, all my major joints hurt, could not eat all day, then, my legs (from the knees down became cold even with 2 blankets) and today, i still feel awful. The treatment of the event was unknown and not reported. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pain in extremity
Clinical narrative: I woke up with headache; pain in left arm; nauseous; all my major joints hurt; Could not eat all day; Then, my legs (from the knees down became cold even with 2 blankets).; Today, I still feel awful; Booster; This is a spontaneous report from a contactable Other HCP (patient). A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 301358A), via an unspecified route of administration in arm left on 08Oct2021 12:30 (at the age of 71 years old) as dose 3 (booster) single for covid-19 immunisation. Medical history included arthritis. Concomitant medications included ezetimibe (ZETIA). The patient previously took Statins, strawberries, Codeine, Sulfa and experienced allergy. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El9263) via an unspecified route of administration, administered in arm left on 30Jan2021 09:30 as dose 1, single for covid-19 immunisation and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19265) via an unspecified route of administration, administered in arm left on 20Feb2021 09:00 as dose 2, single for covid-19 immunisation, influenza vaccine (FLU) taken for immunisation from 27Sep2021 to an unspecified stop date. The patient was not pregnant at the time of vaccination. The patient receive Flu vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 08Oct2021 12:30, administered booster. On 09Oct2021 07:00, the patient reported that I woke up with headache, pain in left arm, nauseous, all my major joints hurt, could not eat all day, then, my legs (from the knees down became cold even with 2 blankets) and today, i still feel awful. The treatment of the event was unknown and not reported. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Immunisation, Pain
Clinical narrative: moderate body aches; severe diarhhea; severe lower back pain; patient received third dose of BNT162B2; patient received third dose of BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 60-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 11Oct2021 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included influenza vaccine (FLU) taken for immunisation; ibuprofen (ADVIL); probiotics (MANUFACTURER UNKNOWN); acetylsalicylic acid (ASPIRIN); and metoprolol (MANUFACTURER UNKNOWN). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), first dose on an unspecified date at 17:00 and second dose on 11May2021 at 17:00 (at the age of 60-years-old), both intramuscularly in the left arm for COVID-19 immunization. The patient experienced moderate body aches, severe diarrhea, and severe lower back pain on 11Oct2021 19:00. The patient received third dose of BNT162B2 on 11Oct2021 12:00. Therapeutic measures were taken as a result of the events, which included treatment with ibuprofen (ADVIL). The clinical outcome of moderate body aches, severe diarrhea, and severe lower back pain was not recovered and of patient received third dose of BNT162B2 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Glycosylated haemoglobin, Immunisation, Malaise, Nausea
Clinical narrative: dizzy; I have a rash on the site; Just feeling very unwell; vomiting; Nauseated; I had the booster vaccine on Thursday; I had the booster vaccine on Thursday; This initial case was previously invalid due to no adverse event. Upon receipt of follow-up information on 11Oct2021, this case now contains all required information to be considered valid  This is a spontaneous report from a contactable Consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 30135BA), via an unspecified route of administration, administered in arm left on 07Oct2021 (at the age of 70 years old) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from 01Oct2021 (Batch/Lot number was not reported) to 01Oct2021, at unspecified dose for an unspecified indication. Medical history included diabetes mellitus. Concomitant medications included metformin (METFORMIN), insulin glargine (BASAGLAR) and dulaglutide (TRULICITY) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 1, single for covid-19 immunisation and the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) on an unspecified date as dose 2, single for covid-19 immunisation. She had any vaccination 4 weeks prior to COVID 19 Vaccine (Booster), it was reported She received the Flu Shot (Unspecified flu shot) on 01Oct2021. On 07Oct2021, the patient had the booster vaccine on Thursday. On 10Oct2021, the patient experienced dizzy, had  a rash on the site, just feeling very unwell, vomiting and nauseated. the patient took I just took Advil and Tylenol, as treatment medication,it was reported 300 and 75mg, was a combination and  took 2, it's a dual action, took 4 pills, yeah but not all at once, took them earlier in the afternoon and then before bed. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 9.5 on 28Sep2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.