chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations
Clinical narrative: heart palpitations; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; She is not feeling well; she has fatigue; Shortness of breath; having problem sleeping at night; This is a spontaneous report received from a contactable consumer. This 45-year-old female consumer(patient) reported for herself.  A 45-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in Deltoid Left on 04Mar2021 as dose 2, single for covid-19 immunisation. The patient Medical history and concomitant medications were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number: EN6201) in Afternoon, via an unspecified route of administration on 12Feb2021 as dose 1, single for covid-19 immunisation and patient was perfectly fine after getting vaccination, she got second one. On an unspecified date on 2021, the patient experienced heart palpitations, it just progressively got worse; wakes up with chest pain; feels like heart coming out her chest, She is not feeling well, she had fatigue, shortness of breath, had problem sleeping at night. The patient stated to through out the course after she received it having heart palpitations, blood pressure her heart was (incomplete sentence), had chest pain and didn't really thought any thing other in beginning and it just progressively got worse. The Secondary Reporter stated, "she has been seeing a cardiologist, she was having a heart monitor and she was placed on several heart medications. (Further clarifications unknown). She was not feeling well and she was very upset. she was little frustrated and little concern it was going. The reporter stated that she had fatigue, she had shortness of breath, she had such things she is having problem sleeping at night she wakes up with chest pain after taking rest it feels like heart coming out her chest. She is on a beta blocker (Treatment), and they put her on the statin (Treatment) as well because of the heart issue. The events heart palpitations, it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest, Shortness of breath required physician office visit. On an unspecified date on 2021, the patient underwent lab tests and procedures which included blood test: unknown results, cardiac stress test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, magnetic resonance imaging heart: unknown result. The outcome of event it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest was Not recovered and other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: the patient tested positive with covid-19 and vaccination failure on 30jul2021; the patient tested positive with covid-19 and vaccination failure on 30jul2021; This is a spontaneous report from a Pfizer sponsored Program (Patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration on 09Feb2021 (at the age of 54-year-old) as DOSE 2, SINGLE, first dose via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. On 30Jul2021, patient tested positive with covid-19 and vaccination failure. Clinical course: Patient symptoms of COVID-19 began Sunday, 30Jul2021, as a sore throat, then by Monday 01Aug2021 she had no taste and smell. Patient had a fever that got up to 101 degrees Fahrenheit, for four to five days, it would stop and then went up, 99 degrees Fahrenheit raised to 101. Patient clarified that fever began 30Jul2021. Therapeutic measures taken as a result of covid-19 (symptoms) included vitamins and Tylenol, patient drank a lot of Gatorade and Pedialyte. Patient stated that Tylenol she took was regular Extra Strength Tylenol. Patient said, for 10 days stayed in the house and recovered, with no lasting effects, she was okay. The patient underwent lab tests and procedures which included body temperature: 101 degree fahrenheit on she had that for four to five days, body temperature: 99 degrees fahrenheit raised to 101 fahrenheit on then went up, 99 degrees Fahrenheit raised to 101, sars-cov-2 test: positive on 30Jul2021, sars-cov-2 test: positive on 30Jul2021 one that she did at home, both came back positive. The clinical outcome of the event tested positive with covid-19 was recovered on an unspecified date in 2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lipoma
Clinical narrative: got a lypoma on my shoulder left  blade after my 1st shot; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient) reported in response to Non-health care professional letter sent to consumer via follow letter (in the cross-referenced case). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0176), via intramuscularly, in upper Left arm on 24Aug2021 11:00 AM (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D) taken for hypersensitivity from Apr2021 and ongoing. On 2021, The patient experienced got a lypoma on patient shoulder left blade after her 1st shot. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urticaria
Clinical narrative: Booster; she has a few (hives) on her lower back; hives from elbow to inside of forearm to the top of her wrist of right arm; she has a few (hives) on the other hand (left); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 22Oct2021 (Batch/Lot number was not reported) (age at vaccination 57-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on 11Mar2021 (Lot number: EN6208) (age at vaccination 56-year-old) as dose 1, single, dose 2 via an unspecified route of administration, administered on 01Apr2021 (Batch/Lot number: ER8737) (age at vaccination 56-year-old) as dose 2, single for covid-19 immunization. The patient experienced hives from elbow to inside of forearm to the top of her wrist of right arm on 24Oct2021, she has a few (hives) on the other hand (left) on an unspecified date of 2021 and she has a few (hives) on her lower back on 27Oct2021. Seriousness criteria of the events was not reported. The adverse events resulted to visit physician office. Therapeutic measures included she was given a prescription for Benadryl at night and Cetirizine HCL 10mg as needed during the day were taken for all the events. The outcome of the event hives from elbow to inside of forearm to the top of her wrist of right arm and she has a few (hives) on her lower back were not recovered, she has a few (hives) on the other hand (left) was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Balance disorder, Chills
Clinical narrative: had every one of the typical Covid symptoms; had every one of the typical Covid symptoms; extreme fatigue/ fatigue and weakness; Muscle weakness/ leg weakness; sort of dizziness that made her feel off balance; sort of dizziness that made her feel off balance; Stomach ache; Chills; can't lift like she did before this; lost 3 pounds through this; Upset stomach; was miserable for almost 3 weeks; it triggered IBS symptoms as well; freezing; felt like she had a fever but she didn't have a thermometer to check her temperature; weakness/ still feeling weak; sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for himself and another patient. This report is 2nd of 2 reports.  A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she had a friend that had typical covid symptoms which she also had, and these symptoms only lasted at most 3 or 4 days. Typical covid symptoms experienced are extreme fatigue/ fatigue and weakness, muscle weakness/ leg weakness, sort of dizziness that made patient felt off balance, stomach ache, chills, shortness of breath, can't lift like the patient did before this, lost 3 pounds through this, upset stomach, was miserable for almost 3 weeks, it triggered IBS (irritable bowel syndrome) symptoms as well, freezing, felt like had a fever but didn't have a thermometer to check temperature, weakness/ still feeling weak, sore arm. Event typical covid symptoms was medically significant. The outcome of the events were recovered on an unknown date.  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-202101507250 Same reporter/vaccine/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Drug ineffective, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: had every one of the typical Covid symptoms; had every one of the typical Covid symptoms; extreme fatigue/ fatigue and weakness; Muscle weakness/ leg weakness; sort of dizziness that made her feel off balance; sort of dizziness that made her feel off balance; Stomach ache; Chills; can't lift like she did before this; lost 3 pounds through this; Upset stomach; was miserable for almost 3 weeks; it triggered IBS symptoms as well; freezing; felt like she had a fever but she didn't have a thermometer to check her temperature; weakness/ still feeling weak; sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for himself and another patient. This report is 2nd of 2 reports.  A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she had a friend that had typical covid symptoms which she also had, and these symptoms only lasted at most 3 or 4 days. Typical covid symptoms experienced are extreme fatigue/ fatigue and weakness, muscle weakness/ leg weakness, sort of dizziness that made patient felt off balance, stomach ache, chills, shortness of breath, can't lift like the patient did before this, lost 3 pounds through this, upset stomach, was miserable for almost 3 weeks, it triggered IBS (irritable bowel syndrome) symptoms as well, freezing, felt like had a fever but didn't have a thermometer to check temperature, weakness/ still feeling weak, sore arm. Event typical covid symptoms was medically significant. The outcome of the events were recovered on an unknown date.  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-202101507250 Same reporter/vaccine/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Irritable bowel syndrome, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: had every one of the typical Covid symptoms; had every one of the typical Covid symptoms; extreme fatigue/ fatigue and weakness; Muscle weakness/ leg weakness; sort of dizziness that made her feel off balance; sort of dizziness that made her feel off balance; Stomach ache; Chills; can't lift like she did before this; lost 3 pounds through this; Upset stomach; was miserable for almost 3 weeks; it triggered IBS symptoms as well; freezing; felt like she had a fever but she didn't have a thermometer to check her temperature; weakness/ still feeling weak; sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for himself and another patient. This report is 2nd of 2 reports.  A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she had a friend that had typical covid symptoms which she also had, and these symptoms only lasted at most 3 or 4 days. Typical covid symptoms experienced are extreme fatigue/ fatigue and weakness, muscle weakness/ leg weakness, sort of dizziness that made patient felt off balance, stomach ache, chills, shortness of breath, can't lift like the patient did before this, lost 3 pounds through this, upset stomach, was miserable for almost 3 weeks, it triggered IBS (irritable bowel syndrome) symptoms as well, freezing, felt like had a fever but didn't have a thermometer to check temperature, weakness/ still feeling weak, sore arm. Event typical covid symptoms was medically significant. The outcome of the events were recovered on an unknown date.  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-202101507250 Same reporter/vaccine/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19, Weight decreased
Clinical narrative: had every one of the typical Covid symptoms; had every one of the typical Covid symptoms; extreme fatigue/ fatigue and weakness; Muscle weakness/ leg weakness; sort of dizziness that made her feel off balance; sort of dizziness that made her feel off balance; Stomach ache; Chills; can't lift like she did before this; lost 3 pounds through this; Upset stomach; was miserable for almost 3 weeks; it triggered IBS symptoms as well; freezing; felt like she had a fever but she didn't have a thermometer to check her temperature; weakness/ still feeling weak; sore arm; Shortness of breath; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for himself and another patient. This report is 2nd of 2 reports.  A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she had a friend that had typical covid symptoms which she also had, and these symptoms only lasted at most 3 or 4 days. Typical covid symptoms experienced are extreme fatigue/ fatigue and weakness, muscle weakness/ leg weakness, sort of dizziness that made patient felt off balance, stomach ache, chills, shortness of breath, can't lift like the patient did before this, lost 3 pounds through this, upset stomach, was miserable for almost 3 weeks, it triggered IBS (irritable bowel syndrome) symptoms as well, freezing, felt like had a fever but didn't have a thermometer to check temperature, weakness/ still feeling weak, sore arm. Event typical covid symptoms was medically significant. The outcome of the events were recovered on an unknown date.  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-202101507250 Same reporter/vaccine/event, different patients
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tooth abscess, Vaccination site bruising, Vaccination site pain, Vaccination site reaction
Clinical narrative: The soreness is the same as a bruise; The soreness is the same as a bruise; Again, the white circle appeared at the injection site; fatigue; abscessed tooth; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in Left Arm on 17Apr2021 11:30 (at the age of 63-years-old) as dose 2, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. Concomitant medications included TYLENOL taken for an unspecified indication, start and stop date were not reported; Z-PAK taken for an unspecified indication, start and stop date were not reported in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported) ), via an unspecified route of administration, administered in Left Arm on an unspecified date as dose1, single for covid-19 immunisation and experienced a white circle appeared around the injection site, The soreness is the same as a bruise, dizziness, and fatigue. The patient had allergy to penicillin. The patient previously received albuterol, duricef, steroids, and experienced allergy. On an unspecified date in 2021, experienced the soreness is the same as a bruise, again, the white circle appeared at the injection, fatigue, and abscessed tooth. After all, three vaccinations, a white circle appeared around the injection site. There is no pigment in her arm in that 1/2" diameter circle. The soreness is the same as a bruise.The patient was on azithromycin due to an abscessed tooth. The patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in Left Arm on02Nov2021 11:00 as dose 3, single for covid-19 immunisation The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; This is a spontaneous report from a contactable consumer or other non HCP. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date the patient experienced Guillain-Barre. The outcome of the event was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (09Nov2021): This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Severe bilateral hip pain/along with other joint pains such as knees and ankles.; This is a spontaneous report from a contactable other hcp (patient). A 24-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection in pre-filled syringe Batch/Lot Number: FF2588), dose 2 intramuscular, administered in Arm Left on 01Sep2021 (At the age of 24 years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included anxiety, depression and covid-19 from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, unspecified date; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, unspecified date; lorazepam (ATIVAN) taken for an unspecified indication, unspecified date. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection in pre-filled syringe Batch/Lot Number: FC3180), dose 1 intramuscular, administered in Arm Left on 11Aug2021 (At the age of 24 years old) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant during vaccination. The patient did not take other vaccine in four weeks. Other medications in two weeks: Prescribed Wellbutrin SR 150 mg every morning, Zoloft 75 mg every morning and Ativan 0.5 mg two times per day. On 01Sep2021 patient experienced severe bilateral hip pain, along with other joint pains such as knees and ankles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Sep2021 covid test type post vaccination was Nasal Swab covid test name post vaccination, Cephid covid test date on 10Sep2021 and covid test result was Negative. The outcome of the events was not recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID; got COVID; This is a spontaneous report from a Pfizer-sponsored program. This non-contactable consumer reported for patient (reporter's relative). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE; and received dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date were not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got COVID. The reporter wanted to know how it was possible that his relative after getting both doses of the COVID-19 vaccine still got COVID. The clinical 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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: This is a spontaneous report from a contactable other health-care professional.  A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FD8448), via intramuscularly, in Left arm on 19Aug2021 13:00 PM (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FC3182), intramuscular, administered in Arm Left on 09Sep2021 11:00 AM (age at vaccination 54years) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Aug2021, the patient test (+) for covid/ he tested positive for COVID. On 23Sep2021, the patient underwent lab tests and procedures which included computerized tomogram resulted as negative, electrocardiogram resulted as possible enlarged, full blood count resulted as negative, Left Atrium, metabolic function test resulted as negative and on 21Aug2021 sars-cov-2 test was positive. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other health-care professional.  A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FD8448), via intramuscularly, in Left arm on 19Aug2021 13:00 PM (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number FC3182), intramuscular, administered in Arm Left on 09Sep2021 11:00 AM (age at vaccination 54years) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Aug2021, the patient test (+) for covid/ he tested positive for COVID. On 23Sep2021, the patient underwent lab tests and procedures which included computerized tomogram resulted as negative, electrocardiogram resulted as possible enlarged, full blood count resulted as negative, Left Atrium, metabolic function test resulted as negative and on 21Aug2021 sars-cov-2 test was positive. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: L shoulder pain; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0171, Expiry Date: not reported) via an intramuscular route of administration in deltoid left on 06Apr2021 (at the age of 56-years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously did not receive any vaccinations. The patient experienced left shoulder pain on an unspecified date in Apr2021. The event seriousness criteria was persistent/ significant / disability / incapacity. Ae required to visit physician office. Therapeutic measures were taken as a result of left shoulder pain with PT naproxen. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Gait inability, Hypoaesthesia, Neck pain
Clinical narrative: my nerves flared up; "I" was unable to stand or walk for 12 hours; "I" was unable to stand or walk for 12 hours; My nerves flared up and went numb/ My left foot, left ankle, left knee, spine and neck stayed feeling of numbness; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 15Oct2021 at 16:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 24Sep2021 at 17:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 16Oct2021 at 02:30, 10 hours post second dose of vaccine, the patient's nerves flared up and went numb. The patient was unable to stand or walk for 12 hours. The patient's left foot, left ankle, left knee, spine and neck had feeling of numbness and pain for the next 12 days which started to slowly decrease at day 5 until majority was gone at day 12. 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 unable to stand or walk for 12 hours was resolved on 16Oct2021 at 14:30 and of nerves flared up and went numb, left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain was resolving at the time of this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Neuritis, Pain in extremity, Spinal pain
Clinical narrative: my nerves flared up; "I" was unable to stand or walk for 12 hours; "I" was unable to stand or walk for 12 hours; My nerves flared up and went numb/ My left foot, left ankle, left knee, spine and neck stayed feeling of numbness; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; My left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 15Oct2021 at 16:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 24Sep2021 at 17:30 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. On 16Oct2021 at 02:30, 10 hours post second dose of vaccine, the patient's nerves flared up and went numb. The patient was unable to stand or walk for 12 hours. The patient's left foot, left ankle, left knee, spine and neck had feeling of numbness and pain for the next 12 days which started to slowly decrease at day 5 until majority was gone at day 12. 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 unable to stand or walk for 12 hours was resolved on 16Oct2021 at 14:30 and of nerves flared up and went numb, left foot, left ankle, left knee, spine and neck stayed feeling of numbness and pain was resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: who was also fully vaccinated - also tested positive for Covid; who was also fully vaccinated - also tested positive for Covid; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot numbers were not reported) via an unspecified route of administration on an unspecified dates as dose 1, single and received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot numbers were not reported) via an unspecified route of administration on an unspecified dates as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The reporter stated patient who was also fully vaccinated - also tested positive for covid on an unspecified date. The outcome of the event patient who was also fully vaccinated - also tested positive for covid was unknown. The patient underwent lab test and procedures on an unknown date which included SARS-VoV-2 test: Positive tested positive for Covid with symptoms lasting for more than a week. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Cerebrovascular accident, Chest X-ray, Computerised tomogram, Electrocardiogram
Clinical narrative: They were thinking this was a possible a brain aneurysm; Stroke; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8735; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in left arm on 27Apr2021 given around 8-9AM as dose 2, single for COVID-19 immunization (at the age of 54-year-old). Medical history included kidney cancer from 2020 and ongoing and medical device she has implanted, a Medtronic stimulator device, it couldn't be done (She confirms she had this device for years, about 8-9 years. It is described as like a pace maker but not for her heart but for other things). Cocnomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 06Apr2021 (around 8-9 am) (Lot Number: EP7533; Expiration Date: 31Jul2021) as dose 1, single for COVID-19 immunization (at the age of 54-year-old) and experienced felt really drugged up, dizziness, nausea, headache, loss of vision, and vomiting. No prior vaccinations within 4 weeks. On an unspecified date in 2021, the patient experienced stroke and they were thinking this was a possible a brain aneurysm. The patient was hospitalized for stroke and they were thinking this was a possible a brain aneurysm from 28Apr2021 to 30Apr2021.She was referred to a neurologist. On an unspecified date in 2021, the patient underwent lab tests and procedures which included chest x-ray: normal, CT scan: normal, EKG: normal, EEG: normal and MRI: results unknown. Therapeutic measures were taken as a result of stroke. The patient visited emergency room and no visits of physician office. The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Magnetic resonance imaging
Clinical narrative: They were thinking this was a possible a brain aneurysm; Stroke; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8735; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in left arm on 27Apr2021 given around 8-9AM as dose 2, single for COVID-19 immunization (at the age of 54-year-old). Medical history included kidney cancer from 2020 and ongoing and medical device she has implanted, a Medtronic stimulator device, it couldn't be done (She confirms she had this device for years, about 8-9 years. It is described as like a pace maker but not for her heart but for other things). Cocnomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 06Apr2021 (around 8-9 am) (Lot Number: EP7533; Expiration Date: 31Jul2021) as dose 1, single for COVID-19 immunization (at the age of 54-year-old) and experienced felt really drugged up, dizziness, nausea, headache, loss of vision, and vomiting. No prior vaccinations within 4 weeks. On an unspecified date in 2021, the patient experienced stroke and they were thinking this was a possible a brain aneurysm. The patient was hospitalized for stroke and they were thinking this was a possible a brain aneurysm from 28Apr2021 to 30Apr2021.She was referred to a neurologist. On an unspecified date in 2021, the patient underwent lab tests and procedures which included chest x-ray: normal, CT scan: normal, EKG: normal, EEG: normal and MRI: results unknown. Therapeutic measures were taken as a result of stroke. The patient visited emergency room and no visits of physician office. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Pyrexia
Clinical narrative: Headaches; Fever; Joints aching; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable other healthcare professional. A 51-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an intramuscular route of administration in the right arm on 03Nov2021 at 15:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma. The patient had 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. The concomitant medication included unspecified multivitamin 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: EP6955) via an unspecified route of administration on 24Mar2021 (at the age of 50-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 14Apr2021 (at the age of 50-years-old), both as a single dose for COVID-19 immunisation. On 04Nov2021, the patient experienced headaches, fever and joints aching. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, fever and joints aching were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain, Pain in extremity
Clinical narrative: The patient received the third/booster dose of BNT162b2.; Chills; Aches; Fever; Sore arm; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 04Nov2021 as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 24Feb2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunisation. On 04Nov2021, the patient experienced chills, aches, fever, sore arm and fatigue. 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 chills, aches, fever, sore arm and fatigue were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The patient received the third/booster dose of BNT162b2.; Chills; Aches; Fever; Sore arm; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received third/booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 04Nov2021 as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 24Feb2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunisation. On 04Nov2021, the patient experienced chills, aches, fever, sore arm and fatigue. 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 chills, aches, fever, sore arm and fatigue were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy. I have tested positive for COVID-19 on 03NOV2021, despite having been fully vaccinated.; Lack of efficacy. I have tested positive for COVID-19 on 03NOV2021, despite having been fully vaccinated.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 28Jan2021 (at the age of 42 years old) as dose 1, single and second dose on BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an an unspecified route of administration on 17Feb2021 (at the age of 42 years old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient had known allergies that was food intolerances (wheat, eggs). Concomitant medications included Claritine (LORATADINE) from an unspecified date for an unknown indication while SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) from an unspecified date for seasonal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 01Nov2021 the patient experienced lack of efficacy. I have tested positive for COVID-19 on 03NOV2021, despite having been fully vaccinated. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab, PCR) resulted in positive on 02Nov2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Flatulence, Insomnia, Nausea, Night sweats
Clinical narrative: Then about 6 hours later I started to get burning feet and terrible gas pains; Then about 6 hours later I started to get burning feet and terrible gas pains; That night I woke up in a sweat; Then Nausea came back Tuesday; I could not stop vomiting; I am still having tingling sensations so I have started on electrolytes.; But other then some insomnia last nigh; janssen covid-19 vaccine was administered on the same date; janssen covid-19 vaccine was administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 58-Year-old female patient (no pregnant) received the second dose of bnt162b2 on 15May2021 (at the age of 57-year-old) (lot number: FG3527) via unknown route of administration in arm right at dose 2, single for COVID-19 immunization; janssen covid-19 vaccine on 15May2021 at 02:30 (lot number: 205A21A) via unknown route of administration at dose 1, single in arm right for unknown indication. Medical history was reported as none. Concomitant medications were reported as none. Patient previously took Codeine and experienced Allergies. On 29Oct2021 at 08:00 PM, patient felt fine when she left the store. Then about 6 hours later she started to get burning feet and terrible gas pains. That night she woke up in a sweat, then the next night and the next night also. Then she woke up Monday and felt really good. Then Nausea came back Tuesday and by then she could not stop vomiting and was admitted by ambulance to the hospital. She was still having tingling sensations so had started on electrolytes.  But other then some insomnia last night she was almost back to normal. Treatment included zofran and fluids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. The events resulted in Emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The events did not result in Disability, Congenital anomaly, death and did not prolong Hospitalization.