chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Dyspnoea, Heat exhaustion, Mental disorder, SARS-CoV-2 test
Clinical narrative: Mental health issues; breathing issues; over heating during exertion; getting me angry at this point; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Lot number: Ewol76) at the age of 28 years for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1; Lot Number: Er8730), administration date: 29Mar2021, when the patient was 28-year-old, for COVID-19 Immunization. The following information was reported: MENTAL DISORDER (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "Mental health issues"; DYSPNOEA (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "breathing issues"; ANGER (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "getting me angry at this point"; HEAT EXHAUSTION (hospitalization, life threatening) with onset 13Oct2021, outcome "recovering", described as "over heating during exertion". The patient was hospitalized for mental disorder, dyspnoea, heat exhaustion, anger (hospitalization duration: 2 days). The events "mental health issues", "breathing issues", "over heating during exertion" and "getting me angry at this point" required physician office visit and emergency room visit.  Clinical course: The events were assessed as life threatening due to "immediate risk of death from the event." The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks prior to the COVID vaccine: "no nothing no toxins until this." Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: post vaccination=Nasal Swab. Therapeutic measures were taken as a result of mental disorder, dyspnoea, heat exhaustion, anger.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "three friends die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. For the query of the caller, Can you tell me where I can get Comirnaty vaccine, not the biotech labeled product', it was answered that my daughter is being forced to take a vaccine they say is Comirnaty but I don't get that because the labeled product is not available'. According to the CDC website that she last looked at this past Friday they specifically state that the Comirnaty would not be available until all EUA products not available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835906 same reporter/drug/event for different patients.;US-PFIZER INC-202200835907 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: three friends die
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 19Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 03Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: vaginal suppositories" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2010; PEPCID [FAMOTIDINE], start date: Apr2021; FLUTICASONE, start date: Oct2013, stop date: 04Jun2022; FLOVENT, start date: Jan2010, stop date: 04Jun2022; ALBUTEROL [SALBUTAMOL], start date: Jan1980; LEVOXYL, start date: Oct2001. Past drug history included: Nifedipine, reaction(s): "known allergy:Nifedipine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Therapeutic measures for covid-19 included Paxlovid with start date 04Jun2022 and stop date 08Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got COVID May2022; Got COVID May2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Lot number: EL3247), in Feb2021 as dose 2, single (Lot number: EL3247) and in Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Patient did not received any other vaccine in four weeks and did not have COVID prior to the COVID-19 vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "recovered" (2022) and all described as "Got COVID May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08May2021 at 15:15 as dose 2, single (Batch/Lot number: unknown), in right arm, on 11Nov2021 at 16:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 26Apr2022 at 18:15 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "seizure disorder" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Doxazosin, reaction(s): "Known allergies: Doxazosin"; Hydantoins, reaction(s): "Known allergies: Hydantoins"; Tadalafil, reaction(s): "Known allergies: Tadalafil"; Phenytoin sodium extended, reaction(s): "Known allergies: Phenytoin Sodium Extended". The following information was reported: VACCINATION FAILURE (congenital anomaly, medically significant), COVID-19 (congenital anomaly, medically significant) all with onset 28May2022 at 08:00, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical information: Treatment drug included Paxlovid from 28May2022 to 01Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "three friends die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. It was reported that after assisting caller with her questions, prior to disconnection, the caller states we had "three friends die, 39-year-old, die. Yea."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835907 same reporter/drug/event for different patients.;US-PFIZER INC-202200835754 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: three friends die
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Three friends die". The patient date of death was unknown. Reported cause of death: "Three friends die". It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835754 same reporter/drug/event for different patients.;US-PFIZER INC-202200835906 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: Three friends die
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Muscular weakness, Oropharyngeal pain
Clinical narrative: Fever; Chills; Joint pain; Headache; Sore throat; Muscle weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril", notes: Known allergies: lisinopril. Vaccination history included: BNT162b2 (Dose:3, Lot number: 30135BA, Location: Right Arm), administration date: 15Oct2021, when the patient was 75-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022); PYREXIA (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Fever"; HEADACHE (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022); ARTHRALGIA (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Joint pain"; MUSCULAR WEAKNESS (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Muscle weakness"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Sore throat".  Additional information: Patient did not have Covid prior vaccination. Patient did not receive other vaccine in four weeks. Patient received other medication, Pirtobrutinib, in four weeks. 12 hours after shot, fever, chills, joint pain, muscle weakness sore throat, headache lasting almost two days. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Joint pain; Headache; Sore throat; Muscle weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jun2022 at 11:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril", notes: Known allergies: lisinopril. Vaccination history included: BNT162b2 (Dose:3, Lot number: 30135BA, Location: Right Arm), administration date: 15Oct2021, when the patient was 75-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022); PYREXIA (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Fever"; HEADACHE (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022); ARTHRALGIA (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Joint pain"; MUSCULAR WEAKNESS (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Muscle weakness"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jun2022 at 23:00, outcome "recovered" (Jun2022), described as "Sore throat".  Additional information: Patient did not have Covid prior vaccination. Patient did not receive other vaccine in four weeks. Patient received other medication, Pirtobrutinib, in four weeks. 12 hours after shot, fever, chills, joint pain, muscle weakness sore throat, headache lasting almost two days. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 at 10:00 as dose 1, single (Lot number: EK9231), in left arm, on 05Feb2021 at 10:00 as dose 2, single (Lot number: EL8982), in left arm and on 29Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 58 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin's Lymphoma" (unspecified if ongoing); "Invasive Ductal Carcinoma Right Breast" (unspecified if ongoing), notes: Invasive Ductal Carcinoma Right Breast. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Paxlovid Treatment start date-01Jun2022, Treatment stop date-06Jun2022, Lot number=GA2279. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "htn" (unspecified if ongoing). Concomitant medication(s) included: COLD RELIEF, start date: 02Jun2022, stop date: 04Jun2022, also reported as, other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti viral Paxlovid started on 03Jun2022 and stopped on 07Jun2022. Clinical course reported as, patient symptoms went away after about day 4 of paxlovid and returned again on about a week later still testing positive on COVID test now day ten. Patient received no treatment for symptoms and not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Movement disorder, Pyrexia, Tremor
Clinical narrative: high fever; shaking; chills; fatigue; couldn't move; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN5318) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EN5318, Expiry: unknown , NDC: unknown, had a bad taste which started immediately with the first dose), administration date: 03Feb2021, for Covid-19 Immunization, reaction(s): "Bad taste". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "couldn't move"; FATIGUE (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "shaking".  Additional information: Vaccination Facility Type: Caller state that the 3rd and 4th dose were given at withhled and the 1st and 2nd were given at a hospital, withhled , Additional Vaccines Administered on Same Date: not for the last 2 doses, caller states it is hard to remember she had so many immunizations this year. She dosen't think so but she is not 100% certain. Adds that on 30Sep2021 she could have gotten the flu shot that day but she doesn't know for sure. Prior Vaccinations (within 4 weeks): not that she is aware of. AE(s) following prior vaccinations: Caller then states that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. States she had a localized reaction as well, attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Patient's Medical History: unknown, can't think of anything. Family Medical History: caller states the only thing she can think of is that her half brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So it wouldn't affect her she doesn't have the markers for that. Relevant Tests: Caller then asks if this information or does she need to report all of this as well. She feels strongly that information like this should be shared so Pfizer can keep track of this and for recommendations. Caller states she got worse but she is grateful she is alive. Is there a product complaint to report? Yes Description of Product Complaint: Description of complaint: Pfizer COVID Vaccine (not suspect Product): tested positive for COVID after having all 4 doses.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Movement disorder, Pyrexia
Clinical narrative: High Fever; Shaking; extreme chills; extreme fatigue; Couldn't move; she had swelling; redness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, Lot: EN5318, Expiry: unknown , NDC: unknown, Dose: unknown), administration date: 03Feb2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose:2, LOT EN5318, Expiry: unknown , NDC: unknown, Dose: unknown), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "high fever", "shaking", "chills", "fatigue", "couldn't move"; Shingles vaccine, for immunization, reaction(s): "localized reaction". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "High Fever"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; CHILLS (non-serious), outcome "unknown", described as "extreme chills"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "Couldn't move"; SWELLING (non-serious), outcome "unknown", described as "she had swelling"; INJECTION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at the injection site".  Additional Information: Caller stated that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. Stated she had a localized reaction as well; attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Caller stated the only thing she can think of is that her half-brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So it wouldn't affect her she doesn't have the markers for that.   No follow up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tremor
Clinical narrative: High Fever; Shaking; extreme chills; extreme fatigue; Couldn't move; she had swelling; redness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, Lot: EN5318, Expiry: unknown , NDC: unknown, Dose: unknown), administration date: 03Feb2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (Dose:2, LOT EN5318, Expiry: unknown , NDC: unknown, Dose: unknown), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "high fever", "shaking", "chills", "fatigue", "couldn't move"; Shingles vaccine, for immunization, reaction(s): "localized reaction". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "High Fever"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; CHILLS (non-serious), outcome "unknown", described as "extreme chills"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "Couldn't move"; SWELLING (non-serious), outcome "unknown", described as "she had swelling"; INJECTION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at the injection site".  Additional Information: Caller stated that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. Stated she had a localized reaction as well; attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Caller stated the only thing she can think of is that her half-brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So it wouldn't affect her she doesn't have the markers for that.   No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling and redness at the injection site; swelling and redness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EN5318), administration date: 03Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2, Lot: EN5318), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "high fever", "shaking", "extreme chills", "extreme fatigue", "she couldn't move", "COVID-19"; BNT162b2 (Dose: 3, Lot: 30130BA), administration date: 30Sep2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "swelling and redness at the injection site", "swelling and redness at the injection site", "COVID-19"; Shingles vaccine (shingles vaccine), for Immunization, reaction(s): "localized reaction". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2022, outcome "unknown" and all described as "swelling and redness at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The NDC number was unknown for all doses unknown. Additional Vaccines Administered on Same Date were not for the last 2 doses, reported stated it is hard to remember she had so many immunizations this year. She doesnt think so but she is not 100% certain. On 30Sep2021 she could have gotten the flu shot that day, but she doesn't know for sure. Adverse Event (AE) Details was Not Provided. She was not Prior aware of Vaccinations within 4 weeks. Reporter then stated that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. States she had a localized reaction as well, attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Patient's Medical History was unknown, can't think of anything. About Family Medical History reporter stated that the only thing she can think is that her half-brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So, it wouldn't affect her she doesn't have the markers for that. The patient tested positive for COVID after having all 4 doses.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: swelling and redness at the injection site; swelling and redness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EN5318), administration date: 03Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2, Lot: EN5318), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "high fever", "shaking", "extreme chills", "extreme fatigue", "she couldn't move", "COVID-19"; BNT162b2 (Dose: 3, Lot: 30130BA), administration date: 30Sep2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "swelling and redness at the injection site", "swelling and redness at the injection site", "COVID-19"; Shingles vaccine (shingles vaccine), for Immunization, reaction(s): "localized reaction". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2022, outcome "unknown" and all described as "swelling and redness at the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The NDC number was unknown for all doses unknown. Additional Vaccines Administered on Same Date were not for the last 2 doses, reported stated it is hard to remember she had so many immunizations this year. She doesnt think so but she is not 100% certain. On 30Sep2021 she could have gotten the flu shot that day, but she doesn't know for sure. Adverse Event (AE) Details was Not Provided. She was not Prior aware of Vaccinations within 4 weeks. Reporter then stated that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. States she had a localized reaction as well, attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Patient's Medical History was unknown, can't think of anything. About Family Medical History reporter stated that the only thing she can think is that her half-brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So, it wouldn't affect her she doesn't have the markers for that. The patient tested positive for COVID after having all 4 doses.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 49-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 1, single (Lot number: FC3180) at the age of 48 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "has just fallen apart, his body has fallen apart"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "he did get sick but it was not too bad". Additional information included: This report was not related to a study or program. PRODUCT DETAILS: NDC, Expiration date unknown. Unknown which arms he got them in. Second dose administered on 07Sep2021, LOT- FC3181. Caller says his first dose he did get sick but it was not too bad. He says the second dose he got really sick and had the issues to his whole body which he continues to have problems.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: rapid heartbeat; tiredness; headache; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 56-year-old female patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 25Jan2021, for Covid-19 immunization; BNT162b2 (Dose 2), administration date: 17Feb2021, for Covid-19 immunization; BNT162b2 (Dose 3), administration date: 03Dec2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 10Jun2022, outcome "unknown"; FATIGUE (non-serious) with onset 10Jun2022, outcome "unknown", described as "tiredness"; HEART RATE INCREASED (non-serious) with onset 12Jun2022, outcome "unknown", described as "rapid heartbeat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient was tested positive on COVID-19 rapid antigen test today (12Jun2022). Her symptoms were tiredness and headache over the last two days and rapid heartbeat today (12Jun2022). No other respiratory symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "got COVID". clinical course: Is there a primary COVID vaccine in development for the fall? I haven't gotten my 2nd Pfizer booster yet because I got COVID in Mar. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Somnolence
Clinical narrative: Headache; Fever of 103.2/fever went up again to 101.0; Tired; Sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 09Jun2022, outcome "unknown", described as "Sleepy"; FATIGUE (non-serious) with onset 09Jun2022, outcome "unknown", described as "Tired"; PYREXIA (non-serious) with onset 09Jun2022 at 19:00, outcome "recovered" (Jun2022), described as "Fever of 103.2/fever went up again to 101.0"; HEADACHE (non-serious) with onset 10Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: "My Son # is 12-year-old. He received his first booster shot on Wednesday 08Jun2022. On Thursday 09Jun2022 at 7 pm he had a fever of 103.2. He was fine all day but by evening he got tired and sleepy and took a nap. When I got home from work, I noticed his high fever. I gave him 2 Advil and he was fine for the rest of the night and Friday morning. Later today, Friday the 10Jun2022 his fever went up again to 101.0. Again, he was tired and had a headache. So, I gave him Advil and the fever has subsided. Event took place after use of product".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Lymphatic disorder, Swelling
Clinical narrative: my chest and arm pits swelled up horribly with lymphatic fluid; my chest and arm pits swelled up horribly with lymphatic fluid; painful lymphatic swelling; painful lymphatic swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "breast cancer survivor" (unspecified if ongoing), notes: I am a breast cancer survivor and also have Truncal Lymphadema.; "Truncal Lymphadema" (unspecified if ongoing), notes: I am a breast cancer survivor and also have Truncal Lymphadema. The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), LYMPHATIC DISORDER (non-serious), outcome "unknown" and all described as "my chest and arm pits swelled up horribly with lymphatic fluid"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "painful lymphatic swelling".  Additional Information: I am a breast cancer survivor and also have Truncal Lymphadema. I received three of the Pfizer Covid shots (mandatory because I drive a school bus). After my 1st shot my chest and arm pits swelled up horribly with lymphatic fluid!! I called all my physicians and no one could give me any answers (including the CDC). I had to receive the other 2 shots as required. I now have horrible, painful lymphatic swelling where I hadn't had it before your shots! Why wasn't I warned of this?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after receiving two doses and booster of Pfizer COVID-19 vaccine.; Tested positive for COVID-19 after receiving two doses and booster of Pfizer COVID-19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19 after receiving two doses and booster of Pfizer COVID-19 vaccine.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19 after receiving two doses and booster of Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (13Jun2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive with Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: was tested positive with Covid-19. Therapeutic measures were taken as a result of covid-19. Patient tested positive with Covid-19 on her second day of symptoms and was able to staff Paxlovid on Monday 06Jun and Paxlovid works properly for her. Patient had finished with all the covid-19 vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I had the original 2 shots plus one booster/ thank fully my symptoms were small -sorethroat, headache, chills and lasted only 2 days; I had the original 2 shots plus one booster/ thank fully my symptoms were small -sore throat, headache, chills and lasted only 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I had the original 2 shots plus one booster/ thank fully my symptoms were small -sore throat, headache, chills and lasted only 2 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid -19 positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 months after second dose of COVID vaccine tested positive for COVID; 6 months after second dose of COVID vaccine tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 months after second dose of COVID vaccine tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: 8-year-old, 6 months after second dose of COVID vaccine tested positive for COVID. Name of Product: COVID-19 vaccine. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, Feeling abnormal
Clinical narrative: Positive rapid antigen test for Covid-19; Positive rapid antigen test for Covid-19; feeling bad; Headache; cough; chest congestion; fatigue; dose 4 (booster); dose 4 (booster); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 20May2022, outcome "unknown" and all described as "dose 4 (booster)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022, outcome "not recovered" and all described as "Positive rapid antigen test for Covid-19"; FEELING ABNORMAL (non-serious) with onset 11Jun2022, outcome "not recovered", described as "feeling bad"; HEADACHE (non-serious) with onset Jun2022, outcome "not recovered"; RESPIRATORY TRACT CONGESTION (non-serious) with onset Jun2022, outcome "not recovered", described as "chest congestion"; COUGH (non-serious) with onset Jun2022, outcome "not recovered"; FATIGUE (non-serious) with onset Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Negative; (11Jun2022) Positive. Positive rapid antigen test for Covid-19 despite receiving 2nd booster shot of Pfizer vaccine on 20May2022. Mild symptoms so far included headache, cough, chest congestion and fatigue. The patient travelled last week for vacation and tested negative on 09Jun2022 (last Thursday) before leaving on 10Jun2022 (on Friday) to return home, but the patient began feeling bad on 11Jun2022 and took an at home test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.