chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: using syringe adapters to transfer the full contents of the vial into a larger syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (using syringe adapters to transfer the full contents of the vial into a larger syringe) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (using syringe adapters to transfer the full contents of the vial into a larger syringe). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (using syringe adapters to transfer the full contents of the vial into a larger syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Discomfort, Headache, Nausea
Clinical narrative: she reported having the pain and discomfort come back quickly once she held her xeljanz; she reported having the pain and discomfort come back quickly once she held her xeljanz; headaches; pain in her joints; upset stomach and nausea; upset stomach and nausea; This is a spontaneous report from a contactable other HCP. A 49-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID -19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID -19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported having the pain and discomfort come back quickly once she held her Xeljanz, headaches, pain in her joints, upset stomach and nausea. Patient reported her MD instructed to hold Xeljanz for 1 week after each COVID vaccine shot. She just got her second vaccine and is on day 3 of holding her Xeljanz. She reported having the pain and discomfort come back quickly once she held her Xeljanz. The symptoms included headaches as well as pain in her joints. She said when she got the first covid vaccine she was off for 1 week with her Xeljanz. She said she had the same headache and pains when she got back on her Xeljanz, she had the same adverse effects as when she started Xeljanz which included an upset stomach and nausea. MD was not aware of her symptoms and adverse effects this time, but her MD was aware of the nausea and upset stomach when she originally started Xeljanz and will follow-up with MD during next visit. 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: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she reported having the pain and discomfort come back quickly once she held her xeljanz; she reported having the pain and discomfort come back quickly once she held her xeljanz; headaches; pain in her joints; upset stomach and nausea; upset stomach and nausea; This is a spontaneous report from a contactable other HCP. A 49-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID -19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID -19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported having the pain and discomfort come back quickly once she held her Xeljanz, headaches, pain in her joints, upset stomach and nausea. Patient reported her MD instructed to hold Xeljanz for 1 week after each COVID vaccine shot. She just got her second vaccine and is on day 3 of holding her Xeljanz. She reported having the pain and discomfort come back quickly once she held her Xeljanz. The symptoms included headaches as well as pain in her joints. She said when she got the first covid vaccine she was off for 1 week with her Xeljanz. She said she had the same headache and pains when she got back on her Xeljanz, she had the same adverse effects as when she started Xeljanz which included an upset stomach and nausea. MD was not aware of her symptoms and adverse effects this time, but her MD was aware of the nausea and upset stomach when she originally started Xeljanz and will follow-up with MD during next visit. 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: Ear discomfort, Headache, Hypoacusis, Hypoaesthesia, Paraesthesia
Clinical narrative: Headache; left ear has been clogged; he's experiencing tinnitus; My ear there is 20% hearing now; I've had sinus problems; There is numbness and tingling in my head; There is numbness and tingling in my head; I did have a fever the first week; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer of unspecified age and gender reported that:  A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, left ear has been clogged, he's experiencing tinnitus, my ear there is 20% hearing now, I've had sinus problems, there is numbness and tingling in my head and i did have a fever the first week. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinus disorder, Tinnitus
Clinical narrative: Headache; left ear has been clogged; he's experiencing tinnitus; My ear there is 20% hearing now; I've had sinus problems; There is numbness and tingling in my head; There is numbness and tingling in my head; I did have a fever the first week; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer of unspecified age and gender reported that:  A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, left ear has been clogged, he's experiencing tinnitus, my ear there is 20% hearing now, I've had sinus problems, there is numbness and tingling in my head and i did have a fever the first week. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Palpitations
Clinical narrative: Racing heart; elevated blood pressure; tingling in arm, neck and face; Light headed; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FC3184), via an unspecified route of administration, administered in Arm Left on 11Sep2021 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); thyroid (ARMOUR THYROID); hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA); multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone) CEFTIN, (pseudoephedrine hydrochloride) SUDAFED and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 11Sep2021, day of shot, the patient started experiencing racing heart, elevated blood pressure, tingling in arm, neck and face and light headed and it got progressively worse. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included additional medications to lower bp and pulse. Reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Racing heart; elevated blood pressure; tingling in arm, neck and face; Light headed; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FC3184), via an unspecified route of administration, administered in Arm Left on 11Sep2021 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); thyroid (ARMOUR THYROID); hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA); multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone) CEFTIN, (pseudoephedrine hydrochloride) SUDAFED and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 11Sep2021, day of shot, the patient started experiencing racing heart, elevated blood pressure, tingling in arm, neck and face and light headed and it got progressively worse. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included additional medications to lower bp and pulse. Reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Bedridden, Body temperature
Clinical narrative: headache; chills; nausea; not able to get out of bed the first day after each vaccines.; had the flu after each dose; no appetite; Fever 100.5; injection site pain; severe lower back ache; muscle pain; joint pain; feeling so ill / I felt so ill; dizzy; swollen lymph nodes under right arm; tired/fatigue; body aches; weakness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 60-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via an intramuscular route of administration, administered in Arm Right on 05Mar2021 15:50 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history none. Concomitant medications included calcium. Other medications the patient received within 2 weeks of vaccination included One-A-Day Multivitamin and Calcium 600. The patient did not received 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 had not been tested for COVID-19. On 05Mar2021 Friday night-5 pm patient experienced with a headache, chills and nausea. On Saturday - Fever 100.5, injection site pain, tiredness, severe headache and lower back ache, muscle pain, chills, joint pain, nausea, feeling so ill and dizzy remained in bed all day, no appetite, swollen lymph nodes under right arm - took Tylenol at 5 pm. On Sunday - Woke up at 4 am with severe headache. Took Tylenol. Headache has not returned, but still tired, have no appetite and lymph node is still swollen. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understand that all these are possible side effects after receiving the vaccine. I felt like I had the flu after each dose. Symptoms began at night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. The patient underwent lab tests and procedures which included body temperature: 100.5 on unspecified date in 2021. The clinical outcome of the events was recovered for headache in 2021; recovering for chills, nausea, pyrexia, vaccination site pain, back pain, myalgia, arthralgia, illness, dizziness; not recovered for lymphadenopathy, fatigue; unknown for pain, asthenia, influenza like illness, bedridden, decreased appeptite.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101303445 same reporter/product, different patient / event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: headache; chills; nausea; not able to get out of bed the first day after each vaccines.; had the flu after each dose; no appetite; Fever 100.5; injection site pain; severe lower back ache; muscle pain; joint pain; feeling so ill / I felt so ill; dizzy; swollen lymph nodes under right arm; tired/fatigue; body aches; weakness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 60-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via an intramuscular route of administration, administered in Arm Right on 05Mar2021 15:50 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history none. Concomitant medications included calcium. Other medications the patient received within 2 weeks of vaccination included One-A-Day Multivitamin and Calcium 600. The patient did not received 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 had not been tested for COVID-19. On 05Mar2021 Friday night-5 pm patient experienced with a headache, chills and nausea. On Saturday - Fever 100.5, injection site pain, tiredness, severe headache and lower back ache, muscle pain, chills, joint pain, nausea, feeling so ill and dizzy remained in bed all day, no appetite, swollen lymph nodes under right arm - took Tylenol at 5 pm. On Sunday - Woke up at 4 am with severe headache. Took Tylenol. Headache has not returned, but still tired, have no appetite and lymph node is still swollen. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understand that all these are possible side effects after receiving the vaccine. I felt like I had the flu after each dose. Symptoms began at night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. The patient underwent lab tests and procedures which included body temperature: 100.5 on unspecified date in 2021. The clinical outcome of the events was recovered for headache in 2021; recovering for chills, nausea, pyrexia, vaccination site pain, back pain, myalgia, arthralgia, illness, dizziness; not recovered for lymphadenopathy, fatigue; unknown for pain, asthenia, influenza like illness, bedridden, decreased appeptite.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101303445 same reporter/product, different patient / event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: headache; chills; nausea; not able to get out of bed the first day after each vaccines.; had the flu after each dose; no appetite; Fever 100.5; injection site pain; severe lower back ache; muscle pain; joint pain; feeling so ill / I felt so ill; dizzy; swollen lymph nodes under right arm; tired/fatigue; body aches; weakness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 60-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via an intramuscular route of administration, administered in Arm Right on 05Mar2021 15:50 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history none. Concomitant medications included calcium. Other medications the patient received within 2 weeks of vaccination included One-A-Day Multivitamin and Calcium 600. The patient did not received 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 had not been tested for COVID-19. On 05Mar2021 Friday night-5 pm patient experienced with a headache, chills and nausea. On Saturday - Fever 100.5, injection site pain, tiredness, severe headache and lower back ache, muscle pain, chills, joint pain, nausea, feeling so ill and dizzy remained in bed all day, no appetite, swollen lymph nodes under right arm - took Tylenol at 5 pm. On Sunday - Woke up at 4 am with severe headache. Took Tylenol. Headache has not returned, but still tired, have no appetite and lymph node is still swollen. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understand that all these are possible side effects after receiving the vaccine. I felt like I had the flu after each dose. Symptoms began at night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. The patient underwent lab tests and procedures which included body temperature: 100.5 on unspecified date in 2021. The clinical outcome of the events was recovered for headache in 2021; recovering for chills, nausea, pyrexia, vaccination site pain, back pain, myalgia, arthralgia, illness, dizziness; not recovered for lymphadenopathy, fatigue; unknown for pain, asthenia, influenza like illness, bedridden, decreased appeptite.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101303445 same reporter/product, different patient / event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: headache; chills; nausea; not able to get out of bed the first day after each vaccines.; had the flu after each dose; no appetite; Fever 100.5; injection site pain; severe lower back ache; muscle pain; joint pain; feeling so ill / I felt so ill; dizzy; swollen lymph nodes under right arm; tired/fatigue; body aches; weakness; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 60-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via an intramuscular route of administration, administered in Arm Right on 05Mar2021 15:50 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 60 years). Medical history none. Concomitant medications included calcium. Other medications the patient received within 2 weeks of vaccination included One-A-Day Multivitamin and Calcium 600. The patient did not received 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 had not been tested for COVID-19. On 05Mar2021 Friday night-5 pm patient experienced with a headache, chills and nausea. On Saturday - Fever 100.5, injection site pain, tiredness, severe headache and lower back ache, muscle pain, chills, joint pain, nausea, feeling so ill and dizzy remained in bed all day, no appetite, swollen lymph nodes under right arm - took Tylenol at 5 pm. On Sunday - Woke up at 4 am with severe headache. Took Tylenol. Headache has not returned, but still tired, have no appetite and lymph node is still swollen. She mentioned to her physician what she experienced after receiving the 1st and 2nd vaccine: headache, fever, body aches, weakness, fatigue, severe lower back pain, she understand that all these are possible side effects after receiving the vaccine. I felt like I had the flu after each dose. Symptoms began at night. She received each vaccine and continued on the next day she felt so ill that she was not able to get out of bed the first day after each vaccines. The patient underwent lab tests and procedures which included body temperature: 100.5 on unspecified date in 2021. The clinical outcome of the events was recovered for headache in 2021; recovering for chills, nausea, pyrexia, vaccination site pain, back pain, myalgia, arthralgia, illness, dizziness; not recovered for lymphadenopathy, fatigue; unknown for pain, asthenia, influenza like illness, bedridden, decreased appeptite.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101303445 same reporter/product, different patient / event.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Blood pressure diastolic increased
Clinical narrative: Diastolic blood pressure spiked from usual 55-60 to 95.; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). An 86-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 30Sep2021 at 13:15 (at the age of 86-years-old) as dose 3, single for COVID-19 immunization. Medical history included prostate cancer, arrhythmia, myasthenia gravis, pacemaker, a fib, Sulfa allergy. Patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported) administered in left arm on 05Feb2021 12:00 AM (at the age of 86-years-old) and First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported) administered in left arm on 18Jan2021 12:00 AM (at the age of 86-years-old) for COVID-19 Immunization Batch/Lot No: Not available/provided to reporter at the time of report completion. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXIN); acetylsalicylic acid (BABY ASPIRIN); apixaban (ELIQUIS); sotalol (SOTALOL); retinol (VITA A. Patient didn't received vaccine within 4 weeks prior to the COVID vaccine. Prior and since vaccination patient was not tested and diagnosed for COVID-19. Patient didn't had prolong hospitalization. On 03Oct2021 at 04:00 AM the patient experienced diastolic blood pressure spiked from usual 55-60 to 95. The patient underwent lab tests and procedures which included Diastolic blood pressure: 95 on 03Oct2021 spiked from usual 55-60 to 95. Patient received the treatment for event. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Hypotension, Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: Migraine headache; unable to raise my arm and dress myself; unable to raise my arm and dress myself; low blood pressure; low body temperature; nausea; dose 1 administered on 03Aug2021 and dose 2 administered on 30Sep2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 48-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration in arm left on 30Sep2021 at 08:00 AM (at the age of 48-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergies: Sulfa, NutraSweet. Past drug event included doxycycline, experienced known allergies: doxycycline and Keflex, experienced known allergies: Keflex. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration in arm left on 03Aug2021 at 08:00 AM (at the age of 48-years-old) as a dose 1, single for COVID-19 immunization and experienced blood pressure dropped to 78/52, body temp 92, debilitating headache. It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 01Oct2021 at 05:00 AM, the patient experienced migraine headache, the worst headache she ever had in her life, even worse than the first house which she did not think was possible, unable to raise her arm and dress herself, nausea, low blood pressure, low body temperature. On 30Sep2021, the patient had dose 1 administered on 03Aug2021 and dose 2 administered on 30Sep2021. The adverse events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature. On 01Oct2021, the patient underwent lab tests and procedures which included low body temperature (body temperature), resulted as decreased. The device date was on 01Oct2021. The outcome of the events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature was not recovered, while for the other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Migraine, Nausea
Clinical narrative: Migraine headache; unable to raise my arm and dress myself; unable to raise my arm and dress myself; low blood pressure; low body temperature; nausea; dose 1 administered on 03Aug2021 and dose 2 administered on 30Sep2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 48-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration in arm left on 30Sep2021 at 08:00 AM (at the age of 48-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergies: Sulfa, NutraSweet. Past drug event included doxycycline, experienced known allergies: doxycycline and Keflex, experienced known allergies: Keflex. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration in arm left on 03Aug2021 at 08:00 AM (at the age of 48-years-old) as a dose 1, single for COVID-19 immunization and experienced blood pressure dropped to 78/52, body temp 92, debilitating headache. It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 01Oct2021 at 05:00 AM, the patient experienced migraine headache, the worst headache she ever had in her life, even worse than the first house which she did not think was possible, unable to raise her arm and dress herself, nausea, low blood pressure, low body temperature. On 30Sep2021, the patient had dose 1 administered on 03Aug2021 and dose 2 administered on 30Sep2021. The adverse events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature. On 01Oct2021, the patient underwent lab tests and procedures which included low body temperature (body temperature), resulted as decreased. The device date was on 01Oct2021. The outcome of the events migraine headache, unable to raise my arm and dress myself, nausea, low blood pressure, low body temperature was not recovered, while for the other event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: possible chest pain; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as UNKNOWN DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced possible chest pain on an unspecified date in 2021. The patient reported having gotten what was believed to have been reported as the Pfizer shot on Saturday and was at the ER (Emergency Room). Patient possibly reported chest pain, but unable to clarify if that was captured correctly as patient declined to clarify information provided on call, she had to go, was in the ER, and disconnected the call. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Immunisation, Overdose, Product preparation error
Clinical narrative: she lost her sense of taste and smell; she lost her sense of taste and smell; It was her Booster dose; Pharmacist seeking guidance for a dose of the Pfizer Covid-19 Vaccine administered to a patient undiluted.; Pfizer Covid-19 Vaccine administered to a patient undiluted.; Pharmacist seeking guidance for a dose of the Pfizer Covid-19 Vaccine administered to a patient undiluted.; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration on 05Oct2021 (at the age of 69-year-old) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 as DOSE 1, SINGLE (Batch/Lot Number: EN6205) and received second dose of bnt162b2 on 01Apr2021 (Batch/Lot Number: ER2613) for covid-19 immunisation. The pharmacist reported that the female patient received a 0.3 mL undiluted Pfizer Covid-19 Vaccine on 05Oct2021 (Between 11:30-12:00) by a co-worker. It was her Booster dose. The patient lost her sense of taste and smell on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: she lost her sense of taste and smell; she lost her sense of taste and smell; It was her Booster dose; Pharmacist seeking guidance for a dose of the Pfizer Covid-19 Vaccine administered to a patient undiluted.; Pfizer Covid-19 Vaccine administered to a patient undiluted.; Pharmacist seeking guidance for a dose of the Pfizer Covid-19 Vaccine administered to a patient undiluted.; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration on 05Oct2021 (at the age of 69-year-old) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 as DOSE 1, SINGLE (Batch/Lot Number: EN6205) and received second dose of bnt162b2 on 01Apr2021 (Batch/Lot Number: ER2613) for covid-19 immunisation. The pharmacist reported that the female patient received a 0.3 mL undiluted Pfizer Covid-19 Vaccine on 05Oct2021 (Between 11:30-12:00) by a co-worker. It was her Booster dose. The patient lost her sense of taste and smell on an unspecified date. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: headache; Blood pressure was measured to be 160/90mmHg; This is a spontaneous report from a non-contactable/contactable Pharmacist. A 39-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0187, unspecified expiration date) dose 2, single through intramuscular, administered in left arm on 24Sep2021 10:00am for COVID-19 immunization (Age at vaccination: 39-year-old). The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0187, unspecified expiration date) on 03Sep2021 10:00am for COVID-19 immunization with events vials was diluted with 0.18 ml of diluent and slight pain in left arm. The patient had no prior vaccinations. The patient medical history was unknown. Concomitant medications were unknown. On unspecified date, the patient experienced headache and blood pressure was measured to be 160/90 mmHg. The laboratorial test included blood pressure was measured to be 160/90 mmHg. Outcome of all the events was unknown.    No follow up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: after the 1st dose I just felt a headache; joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 22Feb2021 at 10:00 (Batch/Lot Number: EN6200) (age at vaccination 69-year-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Medical history included high cholesterol and atrial fibrillation from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received any other medications within 2 weeks of vaccination included lovastatin, metoprolol and aspirin (acetylsalicylic acid). Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced on an unspecified date, after the 1st dose i just felt a headache and joint pain. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Big swollen red lump; like I have a injection site reaction; Big swollen red lump; like I have a injection site reaction; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) (PREVNAR 13, Solution for injection in pre-filled syringe Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 06Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient Medical history none. Concomitant medication included buspirone taken for an unspecified indication. It was reported that a big swollen red, had the Prevnar vaccine on 06Oct and yesterday noticed mp like had a injection site reaction, have no pain had nice big lump. Therapeutic measures were taken as a result of events vaccination site mass and vaccination site erythema included took Benadryl. The outcome of the events was unknown.  The information about Lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Infection, Investigation, Oxygen saturation
Clinical narrative: infection; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 25Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the Pfizer- Sponsored Program. A 80-year-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm, in the morning of 05Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (received at the age of 80-years-old) for COVID-19 immunisation. Medical history included chronic myeloid leukaemia (CML) from 2011 to an unknown date; his cancer (CML) was almost undetectable at time of injection. Cancer count in Feb2021 was 0.01. Concomitant medication(s) included bosutinib (BOSULIF) taken for an unspecified indication, start and stop date were not reported; dasatinib monohydrate (SPRYCEL) taken for CML from 2011 to 2021. The patient had no prior vaccinations. The patient experienced infection on 10Feb2021. The patient stated he had the Pfizer Covid shot and it put him under oxygen. He was on ventilator for 8 days and almost died. Now he is not as strong as he was before Pfizer Covid shot. The patient stated that the doctor and nurse said his temperature and blood pressure were normal. He was told he is in great shape and to take the Pfizer covid shot. When he got the Pfizer covid shot on 05Feb2021, he was 80 Ups and could do 50 push up without stopping. He was in great condition at the time of his first and only Covid-19 injection. Five days later (10Feb2021), he had infection. The patient stated, "Five days later, I was infection". He was in the hospital bed for 9 days on a Ventilator for much of the time. His son drove him to the hospital as he could not drive at the time. The Doctors told him that if his son took him to the hospital 2 minutes later, they could never have woken him up and he surely would have died. He further stated, "I am so Dammed mad that no one warned me about the Danger of the Covid shot!! and that my Doctor urged me to get it." Outcome of the event infection was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: sour arm; fatigue; fever; chill; shortness of breath; coughed; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8839), via an unspecified route of administration, administered in Arm Left on 13Oct2021 at 12:00 (age at the time of vaccination was 44 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at workplace clinic. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 28Sep2021 to an unspecified stop date. Other vaccine 4 weeks included Flu shot. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (age at the time of vaccination was 44 years) as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Jan2021 (age at the time of vaccination was 44 years) as DOSE 1, SINGLE for both covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Oct2021 at 20:00, the patient experienced sour arm, fatigue, fever, chill, shortness of breath and coughed. It was reported that, in addition to the usual and most common reactions (sour arm, fatigue,) the patient started to develop a fever and chill later at night. The patient woke up with fever around 2:30 am and then started to experience shortness of breath and coughed. He took an Advil and the fever started to alleviate. Shortness of breath was also gone after about 1 to 2 hours. During the next day he still had chills and fever and tried to control them with Advil. No shortness of breath was experienced the next day. No prolonged hospitalization was reported. Therapeutic measures were taken as a result of fatigue, fever, chill, shortness of breath and coughed. On 13Oct2021, the patient underwent lab tests and procedures which included fever: unknown result. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient has not been diagnosed with COVID-19. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sour arm; fatigue; fever; chill; shortness of breath; coughed; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8839), via an unspecified route of administration, administered in Arm Left on 13Oct2021 at 12:00 (age at the time of vaccination was 44 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at workplace clinic. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 28Sep2021 to an unspecified stop date. Other vaccine 4 weeks included Flu shot. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (age at the time of vaccination was 44 years) as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Jan2021 (age at the time of vaccination was 44 years) as DOSE 1, SINGLE for both covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Oct2021 at 20:00, the patient experienced sour arm, fatigue, fever, chill, shortness of breath and coughed. It was reported that, in addition to the usual and most common reactions (sour arm, fatigue,) the patient started to develop a fever and chill later at night. The patient woke up with fever around 2:30 am and then started to experience shortness of breath and coughed. He took an Advil and the fever started to alleviate. Shortness of breath was also gone after about 1 to 2 hours. During the next day he still had chills and fever and tried to control them with Advil. No shortness of breath was experienced the next day. No prolonged hospitalization was reported. Therapeutic measures were taken as a result of fatigue, fever, chill, shortness of breath and coughed. On 13Oct2021, the patient underwent lab tests and procedures which included fever: unknown result. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient has not been diagnosed with COVID-19. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure abnormal, Blood pressure measurement, Condition aggravated, Heart rate
Clinical narrative: heart rate over 100 beats per minute; panic, anxiety attack lasting 1/2-1 hour; panic, anxiety attack lasting 1/2-1 hour; Blood pressure reading 142 over 100; Panic/Anxiety attack lasting 1/2-1 hour with elevated heart rate over 100 beats per minute, reaching 144 beats per minutes at it's worse; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER COVID) via an unspecified route of administration on the left arm on 20Oct2021 at 11:00 AM (Lot Number: FF2590) at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included atrial fibrillation and high blood pressure. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergy was none. Concomitant medications included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), amlodipine, olmesartan medoxomil (OLMESAR) and atorvastatin. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 26Feb2021 at 11:00 AM (Batch/Lot Number: EN6203), the first dose on 05Feb2021 at 11:00 AM (Batch/Lot Number: EL9265), both via an unspecified route of administration on the left arm at the age of 77-year-old as single dose for COVID-19 immunization. On 23Oct2021 at 19:30, the patient experienced panic, anxiety attack lasting 1/2-1 hour with elevated heart rate over 100 beats per minute, reaching 144 beats per minutes at it's worse, blood pressure reading 142 over 100. Hospitalization prolonged was none. Treatment was received included Clonazepam 0.5 mg & Amlodipine Besylate 2.5mg. The outcome of events was recovering.