chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymph node pain, Lymphadenopathy, Myalgia, Osteoarthritis
Clinical narrative: osteoarthritis flare is severe pain, generalized in joints and soft tissue.; brain fog to date; dry sinuses; Joint pain; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; Taste the chemical ingratiates; 100 temp/temp 99.9; muscles/body aches; muscles/body aches; diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration, administered in Arm Left on 02Aug2021 at 10:30 (age at vaccination was 53 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included osteoarthritis (OA) and allergies: several. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Aug2021, the patient experienced immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node, taste the chemical ingratiates, 100 temp/temp 99.9, muscles/body aches and diarrhea. On 03Aug2021, the patient experienced brain fog to date, dry sinuses, joint pain and increasing (L) lymph node swelling and pain. On 04Aug2021, the patient experienced osteoarthritis flare is severe pain, generalized in joints and soft tissue. The events resulted in doctor or other healthcare professional office/clinic visit on an unspecified date. The patient underwent lab tests and procedures which included temperature was 100 on 02Aug2021 and 99.9 on 03Aug2021. Therapeutic measures were taken as a result of events Voltaren for 5 days, Tylenol fore fever, penetrex for muscles aches, an unspecified supplements and pushed fluids 8/7 at outstanding SEs: for brain fog and (L) lymph node swelling. PCP was notified. Forced to call out from work. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sinus disorder
Clinical narrative: osteoarthritis flare is severe pain, generalized in joints and soft tissue.; brain fog to date; dry sinuses; Joint pain; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; Taste the chemical ingratiates; 100 temp/temp 99.9; muscles/body aches; muscles/body aches; diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration, administered in Arm Left on 02Aug2021 at 10:30 (age at vaccination was 53 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included osteoarthritis (OA) and allergies: several. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Aug2021, the patient experienced immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node, taste the chemical ingratiates, 100 temp/temp 99.9, muscles/body aches and diarrhea. On 03Aug2021, the patient experienced brain fog to date, dry sinuses, joint pain and increasing (L) lymph node swelling and pain. On 04Aug2021, the patient experienced osteoarthritis flare is severe pain, generalized in joints and soft tissue. The events resulted in doctor or other healthcare professional office/clinic visit on an unspecified date. The patient underwent lab tests and procedures which included temperature was 100 on 02Aug2021 and 99.9 on 03Aug2021. Therapeutic measures were taken as a result of events Voltaren for 5 days, Tylenol fore fever, penetrex for muscles aches, an unspecified supplements and pushed fluids 8/7 at outstanding SEs: for brain fog and (L) lymph node swelling. PCP was notified. Forced to call out from work. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Metal poisoning
Clinical narrative: cesium toxicity; This spontaneous case was reported by a pharmacist and describes the occurrence of METAL POISONING (cesium toxicity) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0448A21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced METAL POISONING (cesium toxicity) (seriousness criterion medically significant). At the time of the report, METAL POISONING (cesium toxicity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.  The patient was diagnosed to have cesium toxicity 2 weeks ago and results was unknown.  Company Comment : This case concerns a 40-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of METAL POISONING (cesium toxicity). The event occurred approximately 6 months after the second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event happened after the second dose and no additional dosing is expected. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 40-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of METAL POISONING (cesium toxicity). The event occurred approximately 6 months after the second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event happened after the second dose and no additional dosing is expected. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 vaccine) is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Heavy menstrual bleeding, Menstrual disorder, Therapeutic response unexpected, Ultrasound scan
Clinical narrative: Period schedule on and off the chart; Increased period bleeding; She experienced was headache which was resolved day after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Period schedule on and off the chart), HEAVY MENSTRUAL BLEEDING (Increased period bleeding) and THERAPEUTIC RESPONSE UNEXPECTED (She experienced was headache which was resolved day after getting vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Period schedule on and off the chart), HEAVY MENSTRUAL BLEEDING (Increased period bleeding) and THERAPEUTIC RESPONSE UNEXPECTED (She experienced was headache which was resolved day after getting vaccine). At the time of the report, MENSTRUAL DISORDER (Period schedule on and off the chart) and HEAVY MENSTRUAL BLEEDING (Increased period bleeding) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (She experienced was headache which was resolved day after getting vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab test included Pelvic test : normal   No Concomitant and Treatment medication were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Mass, Vaccination site swelling
Clinical narrative: size of half baseball; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of MASS (size of half baseball) and VACCINATION SITE SWELLING (swollen injection site) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced MASS (size of half baseball) and VACCINATION SITE SWELLING (swollen injection site). At the time of the report, MASS (size of half baseball) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not provided. Treatment was not given. Patient had recently been diagnosed that her kidney is not filtering properly.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25-Oct-2021, this lot number has an expiration date of 24-Oct-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received on 29-Oct-2021 contains No new information.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: now vomiting; very sick throughout the night; Fourth day fever/Fifth day fever of 106 throughout the night; weak; chills; Headache; tired; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 16Sep2021 10:00 (at the age of 17-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19. Patient did not have known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Patient was not pregnant at the time of vaccination. The patient experienced headache, tired on 17Sep2021, fourth day fever/fifth day fever of 106 throughout the night, weak, chills on 20Sep2021, very sick throughout the night on 22Sep2021, now vomiting on 23Sep2021. The patient underwent lab tests and procedures which included body temperature: fever on 20Sep2021 Fourth day fever, body temperature: 106 on 21Sep2021 Fifth day fever of 106 throughout the night, sars-cov-2 test: negative on 22Sep2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient has covid prior vaccination and covid was tested post vaccination. The patient did not receive any treatment for adverse events. The outcome of all events was not recovered.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: now vomiting; very sick throughout the night; Fourth day fever/Fifth day fever of 106 throughout the night; weak; chills; Headache; tired; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 16Sep2021 10:00 (at the age of 17-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19. Patient did not have known allergies. There were no concomitant medications. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. Patient was not pregnant at the time of vaccination. The patient experienced headache, tired on 17Sep2021, fourth day fever/fifth day fever of 106 throughout the night, weak, chills on 20Sep2021, very sick throughout the night on 22Sep2021, now vomiting on 23Sep2021. The patient underwent lab tests and procedures which included body temperature: fever on 20Sep2021 Fourth day fever, body temperature: 106 on 21Sep2021 Fifth day fever of 106 throughout the night, sars-cov-2 test: negative on 22Sep2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient has covid prior vaccination and covid was tested post vaccination. The patient did not receive any treatment for adverse events. The outcome of all events was not recovered.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm pain; fever (101-102); headache; myalgias; chills; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2589), via an unspecified route of administration, administered in Arm Left on 27Sep2021 14:30 (at the age of 72-year-old) as dose number unknown, single for covid-19 immunisation. Medical history of patient was not reported. Concomitant medication(s) included omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient experienced arm pain, fever (101-102), headache, myalgias, chills on 28Sep2021 04:00. The patient underwent lab tests and procedures which included body temperature: 101-102 on 28Sep2021. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient did not receive any treatment for the adverse events. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm pain; fever (101-102); headache; myalgias; chills; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2589), via an unspecified route of administration, administered in Arm Left on 27Sep2021 14:30 (at the age of 72-year-old) as dose number unknown, single for covid-19 immunisation. Medical history of patient was not reported. Concomitant medication(s) included omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. The patient experienced arm pain, fever (101-102), headache, myalgias, chills on 28Sep2021 04:00. The patient underwent lab tests and procedures which included body temperature: 101-102 on 28Sep2021. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient did not receive any treatment for the adverse events. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash by her collar bone; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 301358A), via an unspecified route of administration, administered in Arm Right on 29Sep2021 14:00 (at the age of 85-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included arthritis, breast cancer female (The caller is immunocompromised with breast and bone cancer), blood pressure, bone cancer, immunocompromised. Concomitant medication(s) included atenolol 50 mg taken for blood pressure, start and stop date were not reported; letrozole 2.5 mg taken for breast cancer, start and stop date were not reported; lovastatin 10 mg taken for blood cholesterol, start and stop date were not reported; calcium carbonate (TUMS [CALCIUM CARBONATE]) taken for mineral supplementation, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; gummy vitamins. The patient previously took amoxicillin and experienced rash, bnt162b2 dose 1 on 22Feb2021 (Lot number and Expiration date: Unknown) and dose 2 on 15Mar2021 (Lot number: EM9809, Expiration date: 30Jun2021) for covid-19 immunisation (received both doses at the age of 84-year-old), received flu vaccine on 13Sep2021. The caller is immunocompromised with breast and bone cancer. Prior Vaccinations (within 4 weeks) includes Flu vaccine, the high dose for seniors received on 13Sep2021.The patient experienced rash by her collar bone on 30Sep2021. The rash was on the right side of the caller's body. The outcome of event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood oestrogen, C-reactive protein, Chest discomfort, Full blood count, Haemoglobin
Clinical narrative: I have pain in lower left leg, back side feels like somebody kicks me. It''s a real localize pain about 5-6 Inches up from the ankle.; I am a little tightened the chest for breathing, It is not extreme or anything but I do notice it breathing.; Off-label use; booster; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at the age of 60-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) taken for an unspecified indication from 29Sep2021 to 29Sep2021. Medical history included Lyme disease, chronic pain. Concomitant medication(s) included hydrocodone and morphine. The patient previously received bnt162b2 dose 1 and dose 2 on an unspecified date for covid-19 immunisation and the patient reported having swollen testicles and the couple other issues (Further not clarified) after dose 2. The consumer stated that his left leg lower cap from back side feels like somebody kicks him in his sleep and little tightened the chest for breathing. It was not extreme or anything, but he did notice that breathing. He was having pain in lower left leg, back side felt like somebody kicks him. It was a real small localize pain about 5-6 Inches left from the ankle. The patient underwent lab tests and procedures which included blood oestrogen: unknown results, c-reactive protein: unknown results, full blood count(Hemogram): unknown results, haemoglobin: unknown results, immunology test (western blot line test): unknown result, investigation (Lyme test ): unknown results, lipids panel: unknown results, metabolic function test: unknown results, polymerase chain reaction: unknown results, red blood cell sedimentation rate (ESR): unknown results, sars-cov-2 test: unknown results, thyroid function test: unknown results, all tests on 29Sep2021. The patient did not receive any treatment for adverse events, he stated he has not taken anything since his 4 O clock morphine dose. He takes a bunch of supplements for his Lyme disease but did not take any supplement today (Further clarifications unknown). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101308580 same patient/drug, different dose/event
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Immunology test, Investigation, Lipids, Metabolic function test
Clinical narrative: I have pain in lower left leg, back side feels like somebody kicks me. It''s a real localize pain about 5-6 Inches up from the ankle.; I am a little tightened the chest for breathing, It is not extreme or anything but I do notice it breathing.; Off-label use; booster; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at the age of 60-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) taken for an unspecified indication from 29Sep2021 to 29Sep2021. Medical history included Lyme disease, chronic pain. Concomitant medication(s) included hydrocodone and morphine. The patient previously received bnt162b2 dose 1 and dose 2 on an unspecified date for covid-19 immunisation and the patient reported having swollen testicles and the couple other issues (Further not clarified) after dose 2. The consumer stated that his left leg lower cap from back side feels like somebody kicks him in his sleep and little tightened the chest for breathing. It was not extreme or anything, but he did notice that breathing. He was having pain in lower left leg, back side felt like somebody kicks him. It was a real small localize pain about 5-6 Inches left from the ankle. The patient underwent lab tests and procedures which included blood oestrogen: unknown results, c-reactive protein: unknown results, full blood count(Hemogram): unknown results, haemoglobin: unknown results, immunology test (western blot line test): unknown result, investigation (Lyme test ): unknown results, lipids panel: unknown results, metabolic function test: unknown results, polymerase chain reaction: unknown results, red blood cell sedimentation rate (ESR): unknown results, sars-cov-2 test: unknown results, thyroid function test: unknown results, all tests on 29Sep2021. The patient did not receive any treatment for adverse events, he stated he has not taken anything since his 4 O clock morphine dose. He takes a bunch of supplements for his Lyme disease but did not take any supplement today (Further clarifications unknown). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101308580 same patient/drug, different dose/event
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Polymerase chain reaction, Red blood cell sedimentation rate, SARS-CoV-2 test, Thyroid function test
Clinical narrative: I have pain in lower left leg, back side feels like somebody kicks me. It''s a real localize pain about 5-6 Inches up from the ankle.; I am a little tightened the chest for breathing, It is not extreme or anything but I do notice it breathing.; Off-label use; booster; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at the age of 60-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) taken for an unspecified indication from 29Sep2021 to 29Sep2021. Medical history included Lyme disease, chronic pain. Concomitant medication(s) included hydrocodone and morphine. The patient previously received bnt162b2 dose 1 and dose 2 on an unspecified date for covid-19 immunisation and the patient reported having swollen testicles and the couple other issues (Further not clarified) after dose 2. The consumer stated that his left leg lower cap from back side feels like somebody kicks him in his sleep and little tightened the chest for breathing. It was not extreme or anything, but he did notice that breathing. He was having pain in lower left leg, back side felt like somebody kicks him. It was a real small localize pain about 5-6 Inches left from the ankle. The patient underwent lab tests and procedures which included blood oestrogen: unknown results, c-reactive protein: unknown results, full blood count(Hemogram): unknown results, haemoglobin: unknown results, immunology test (western blot line test): unknown result, investigation (Lyme test ): unknown results, lipids panel: unknown results, metabolic function test: unknown results, polymerase chain reaction: unknown results, red blood cell sedimentation rate (ESR): unknown results, sars-cov-2 test: unknown results, thyroid function test: unknown results, all tests on 29Sep2021. The patient did not receive any treatment for adverse events, he stated he has not taken anything since his 4 O clock morphine dose. He takes a bunch of supplements for his Lyme disease but did not take any supplement today (Further clarifications unknown). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101308580 same patient/drug, different dose/event
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Headache, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A patient, of unspecified age and gender, received the second dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 29, 2021, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included patient taking 10 medications. The historical vaccine included the first dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 8, 2021, single dose, for COVID-19 immunisation. On an unspecified date Sep 2021, patient had a fever, body ache, red injection area, aching, lumps in armpit area, cold and headache. Patient had the second dose of the vaccine 3 days ago, and still having symptoms. Yesterday, patient had a fever, body ache, red injection area and aching. Patient also patient had lumps in the armpit area, and needed medical attention. The outcome of the events: not recovered. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A patient, of unspecified age and gender, received the second dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 29, 2021, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medications included patient taking 10 medications. The historical vaccine included the first dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 8, 2021, single dose, for COVID-19 immunisation. On an unspecified date Sep 2021, patient had a fever, body ache, red injection area, aching, lumps in armpit area, cold and headache. Patient had the second dose of the vaccine 3 days ago, and still having symptoms. Yesterday, patient had a fever, body ache, red injection area and aching. Patient also patient had lumps in the armpit area, and needed medical attention. The outcome of the events: not recovered. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Diarrhoea, Immunisation, Lip dry
Clinical narrative: booster dose of the vaccine; booster dose of the vaccine; diarrhea; tongue and lips feeling very dry and sticky; tongue and lips feeling very dry and sticky; he checked his fever and it was 97.5; he can't pronounce words; This is a spontaneous report from a contactable consumer. A 73-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Oct2021 (Age at Vaccination 73-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced booster dose of the vaccine (off label use) and booster dose of the vaccine (immunization) and diarrhea on 04Oct2021, on 2021 patient experienced tongue and lips feeling very dry and sticky, he checked his fever, and it was 97.5, he can't pronounce words. It was reported that Caller reports that he received his third booster dose of the Pfizer Biontech covid 19 vaccines yesterday. On Sunday he ate a bad plum and was experiencing diarrhea, however he is still experiencing this side effect. He states normally when he experiences diarrhea it only last 1-2 days, but this is day 3. Caller report he had it all day yesterday, he went to the clinic at 9:15 AM to get his booster dose, ran some errands and then was home at 2:30-3, then he didn't go to the bathroom until after eating lunch at 3-3:30 when he had diarrhea/ loose stool for a second time. He then took two immodium at 10 PM and one a 1 AM. Today he reports he only had one episode after his breakfast of kashi cereal, milk and oatmeal. Caller reports side effect of tongue and lips feeling very dry and sticky. Caller would like to ask, as he is talking all of a sudden, his mouth is dry and he can't pronounce words, was that part of it, his lips and tongue are dry. States he likes to speak. Caller states he knows he will be strong as a rock in a few days. Caller states he checked his fever, and it was 97.5. States he wanted to make sure his diarrhea goes away soon.The patient underwent lab tests and procedures which included body temperature: 97.5 Fahrenheit in 2021. Therapeutic measures were taken as a result of diarrhea. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Tongue dry
Clinical narrative: booster dose of the vaccine; booster dose of the vaccine; diarrhea; tongue and lips feeling very dry and sticky; tongue and lips feeling very dry and sticky; he checked his fever and it was 97.5; he can't pronounce words; This is a spontaneous report from a contactable consumer. A 73-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Oct2021 (Age at Vaccination 73-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced booster dose of the vaccine (off label use) and booster dose of the vaccine (immunization) and diarrhea on 04Oct2021, on 2021 patient experienced tongue and lips feeling very dry and sticky, he checked his fever, and it was 97.5, he can't pronounce words. It was reported that Caller reports that he received his third booster dose of the Pfizer Biontech covid 19 vaccines yesterday. On Sunday he ate a bad plum and was experiencing diarrhea, however he is still experiencing this side effect. He states normally when he experiences diarrhea it only last 1-2 days, but this is day 3. Caller report he had it all day yesterday, he went to the clinic at 9:15 AM to get his booster dose, ran some errands and then was home at 2:30-3, then he didn't go to the bathroom until after eating lunch at 3-3:30 when he had diarrhea/ loose stool for a second time. He then took two immodium at 10 PM and one a 1 AM. Today he reports he only had one episode after his breakfast of kashi cereal, milk and oatmeal. Caller reports side effect of tongue and lips feeling very dry and sticky. Caller would like to ask, as he is talking all of a sudden, his mouth is dry and he can't pronounce words, was that part of it, his lips and tongue are dry. States he likes to speak. Caller states he knows he will be strong as a rock in a few days. Caller states he checked his fever, and it was 97.5. States he wanted to make sure his diarrhea goes away soon.The patient underwent lab tests and procedures which included body temperature: 97.5 Fahrenheit in 2021. Therapeutic measures were taken as a result of diarrhea. 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: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nerve injury, Off label use
Clinical narrative: he has a friend who got two doses of Moderna Covid-19 Vaccine and then seven months later got a dose of the Pfizer BioNTech Covid-19 Vaccine; he has a friend who got two doses of Moderna Covid-19 Vaccine and then seven months later got a dose of the Pfizer BioNTech Covid-19 Vaccine; Reported states he believes he may have been injected with too large of a needle that may have hit a nerve; This is a spontaneous report from Medical Information Team. A contactable consumer reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter told a long story about being shorted cholesterol pills at PRIVACY pharmacy. Historical vaccine included two doses of moderna vaccine via unspecified route of administration on an unspecified date for COVID-19 immunisation. After receiving first booster dose of vaccine the patient experienced he has a friend who got two doses of moderna covid-19 vaccine and then seven months later got a dose of the pfizer biontech covid-19 vaccine reporter states he believes he may have been injected with too large of a needle that may have hit a nerve on an unspecified date. Reporter states he believes it is better to get a dose of Pfizer BioNTech Covid-19 Vaccine and also a dose of Moderna Covid-19 Vaccine instead of getting two doses of the same vaccine. He reports that he has heard of many people doing this. He also reports he has a friend who got two doses of Moderna Covid-19 Vaccine and then seven months later got a dose of the Pfizer BioNTech Covid-19 Vaccine. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Nervous system disorder, Pain in extremity, Pulse abnormal
Clinical narrative: felt like an injury; pulsing in her chest and arms and legs; felt like an injury; pulsing in her chest and arms and legs; she experienced some nervous system side effects/What she feels like is her nervous system overly responding to something; right arm which she got the injection in was sore; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 67-years-old female patient (Consumer) received bnt162b2 (COMIRNATY ; Solution for injection, Lot Number: FD0809), dose 1 via an unspecified route of administration, administered in Arm Right on 02Sep2021 12:30 as DOSE 1, SINGLE for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported. On 2Sep2021 at 22:00 in the evening right arm which she got the injection in was sore , the event ended on 03Sep2021. On 03Sep2021 she felt like her nervous system overly responding to something (Nervous System Disorder). On 03Sep2021 she had a little bit of something going on in her body; felt like an injury; pulsing in her chest and arms and legs for a bit that seemed to have gone away but when she woke up in the morning there was some other energy that feels like her nervous system is overly responding to something. This event went away in the day but is still happening in the morning. She still had a little bit of strange nerve impulses that she felt are getting through. The patient reported that the feelings kind of shifted from the individual body areas to a more general internal pulsing that is experienced strongest in the mornings but is a little better now. Patient reported she has only contacted her Naturopathic provider and inquired with her Internist because she was thinking about getting a second shot of Covid Vaccine by a different manufacturer than Pfizer, like of the J&J Covid Vaccine but they don't have any information on that to provide. The outcome of nervous system overly responding to something (Nervous System Disorder) is not recovered . The outcome of event right arm sore was recovered on 03Sep2021. The outcome of the events pulse abnormal and Nerve injury(chest and arms and legs) was Recovered in 2021. She asked if there was information on getting a different manufacturer's vaccine for the second dose of Covid Vaccine, like the J&J Covid Vaccine. She has not been administered any additional doses of Pfizer Covid Vaccine or any other manufacturer's Covid Vaccine.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Neuralgia, Pain, Palpitations
Clinical narrative: Muscle/body aches from the bottom of my ribcage to the base of my neck; Muscle/body aches from the bottom of my ribcage to the base of my neck; Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest; My nerves felt like they were on fire in my entire upper body; Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest; This is a spontaneous report from a contactable other hcp (patient).  A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ff2588), dose 1 via an unspecified route of administration, administered in the right arm on 17Sep2021 at 08:30 (at the age of 29 years old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy or drug store. Medical history included obesity and known allergies: sodium benzoate, raw fruits and vegetables. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE) er 20 mg/ as needed taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccines in 4 weeks. Patient did not have COVID prior vaccination. Patient did not tested COVID post vaccination. On 18Sep2021, at 02:00, patient experienced muscle/body aches from the bottom of her ribcage to the base of her neck. Chest pain- her heart was pounding hard against her chest like it was about to beat out of her chest. Her nerves felt like they were on fire in her entire upper body where she was experiencing the muscle/body aches. This lasted from about 2:00 am until 6:00 am- ibuprofen was taken to help alleviate the symptoms which for the most part subsided next day. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the right arm on 08Oct2021 at 08:30 (at the age of 29 years old) (Batch/Lot Number: ff2589) as DOSE 2, SINGLE for covid-19 immunization. Therapeutic measures were taken as a result of all the events (ibuprofen). The outcome of all the events was recovered/resolved with sequel with the stop date reported as 18Sep2021 at 06:00.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: swollen lymph nodes; elevated or rapid heart beat; muscle pain; fever; swelling at the injection site; This is a spontaneous report from a non-contactable consumer(patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration, on unknown date, at the age of 65-year-old, at dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no concomitant medications. On 30Sep2021, the patient experienced swollen lymph nodes, elevated or rapid heart beat, muscle pain, fever and swelling at the injection site. The outcome of the events was unknown. The patient also received BNT162b2 (COMIRNATY; Lot Number and expiry date were  not reported) via an unspecified route of administration on 07Oct2021, dose 2, single COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen lymph nodes; elevated or rapid heart beat; muscle pain; fever; swelling at the injection site; This is a spontaneous report from a non-contactable consumer(patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration, on unknown date, at the age of 65-year-old, at dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no concomitant medications. On 30Sep2021, the patient experienced swollen lymph nodes, elevated or rapid heart beat, muscle pain, fever and swelling at the injection site. The outcome of the events was unknown. The patient also received BNT162b2 (COMIRNATY; Lot Number and expiry date were  not reported) via an unspecified route of administration on 07Oct2021, dose 2, single COVID-19 immunization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.