chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment /Drug ineffective; COVID 19 Treatment / COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 20Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Dairy sensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment /Drug ineffective". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (Apr2023) negative, notes: negative test; (Apr2023) positive, notes: positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Apr2023 to 24Apr2023).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175804 same reporter/patient, different drug/event;
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years, in left arm 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 included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 21Apr2023 to 26Apr2023.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Tremor
Clinical narrative: Hands shook like had Parkinson's, was hard to hold a glass of water/shaking; 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 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills"; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills"; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills"; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "chills".  The following information was reported: TREMOR (non-serious), outcome "recovered", described as "Hands shook like had Parkinson's, was hard to hold a glass of water/shaking". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The caller was calling about the Pfizer vaccine, clarified and confirmed the newest one, the Pfizer bivalent vaccine. Caller has had 5 shots, the 2 original vaccines, no specific product name provided, which caller thinks were 21 days apart, then 2 parts of the monovalent, no specific product name provided, then 6 months ago had the first bivalent. The caller knew he was eligible for the 2nd bivalent because the caller was 76 years old, which caller thinks was the latest booster even in existence right now. The first 4 shots the caller had no reaction other than chills one or two times, which caller thought was common, and one time maybe had a temperature of about 100 which was no big deal. The last bivalent, which was the only bivalent caller has had, that evening after caller got home for about an hour and a half, caller's hands shook like had Parkinson's, was hard to hold a glass of water, then went away, had no more symptoms like that. The caller understands that was a neurological response to the bivalent, from what caller was able to understand maybe such a thing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance test, Blood test, Dizziness, Magnetic resonance imaging, Tinnitus
Clinical narrative: ringing sound in both of his ears; constant dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Balance therapy" (unspecified if ongoing), notes: balance therapy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First primary series dose in Oct2020), administration date: Oct2020, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2020, outcome "not recovered", described as "constant dizziness"; TINNITUS (non-serious) with onset 2020, outcome "not recovered", described as "ringing sound in both of his ears". The events "ringing sound in both of his ears" and "constant dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, dizziness.  Additional information: The report was not related to a study or programme. Reporter mentioned that she was calling on behalf of her friend who had been suffering from symptoms for a year and a half. Her friend had consulted a Neurologist, an ENT for some symptoms and reactions to original covid vaccine which her friend received. Reporter stated "He had constant dizziness, when he moves along with ringing in the ear, those are getting worse. He had all kind of ear tests, he had an MRI on his brain, he had blood work, and balance therapy, He had taken Meclizine, and nothing had helped, actually the Meclizine made it worse. It made him feel worse because he was very drowsy. The patient mentioned that the patient received the first primary series dose in Oct2020 and two weeks after he received the second Primary dose, Symptoms started to appear.  Patient received first dose Pfizer BioNTech Covid-19 vaccine Monovalent Oct2020. 2 weeks after patient received second dose Covid-19 vaccine, the symptoms started to appear. Clarified that reporter had only mentioned the date of the first dose of the vaccine and experienced symptoms after second dose of Covid-19 vaccine. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Blood test, Culture urine, Dizziness exertional
Clinical narrative: ringing sound in both of his ears; constant dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Balance therapy" (unspecified if ongoing), notes: balance therapy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First primary series dose in Oct2020), administration date: Oct2020, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2020, outcome "not recovered", described as "constant dizziness"; TINNITUS (non-serious) with onset 2020, outcome "not recovered", described as "ringing sound in both of his ears". The events "ringing sound in both of his ears" and "constant dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, dizziness.  Additional information: The report was not related to a study or programme. Reporter mentioned that she was calling on behalf of her friend who had been suffering from symptoms for a year and a half. Her friend had consulted a Neurologist, an ENT for some symptoms and reactions to original covid vaccine which her friend received. Reporter stated "He had constant dizziness, when he moves along with ringing in the ear, those are getting worse. He had all kind of ear tests, he had an MRI on his brain, he had blood work, and balance therapy, He had taken Meclizine, and nothing had helped, actually the Meclizine made it worse. It made him feel worse because he was very drowsy. The patient mentioned that the patient received the first primary series dose in Oct2020 and two weeks after he received the second Primary dose, Symptoms started to appear.  Patient received first dose Pfizer BioNTech Covid-19 vaccine Monovalent Oct2020. 2 weeks after patient received second dose Covid-19 vaccine, the symptoms started to appear. Clarified that reporter had only mentioned the date of the first dose of the vaccine and experienced symptoms after second dose of Covid-19 vaccine. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Ophthalmological examination, Tinnitus
Clinical narrative: ringing sound in both of his ears; constant dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Balance therapy" (unspecified if ongoing), notes: balance therapy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First primary series dose in Oct2020), administration date: Oct2020, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2020, outcome "not recovered", described as "constant dizziness"; TINNITUS (non-serious) with onset 2020, outcome "not recovered", described as "ringing sound in both of his ears". The events "ringing sound in both of his ears" and "constant dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, dizziness.  Additional information: The report was not related to a study or programme. Reporter mentioned that she was calling on behalf of her friend who had been suffering from symptoms for a year and a half. Her friend had consulted a Neurologist, an ENT for some symptoms and reactions to original covid vaccine which her friend received. Reporter stated "He had constant dizziness, when he moves along with ringing in the ear, those are getting worse. He had all kind of ear tests, he had an MRI on his brain, he had blood work, and balance therapy, He had taken Meclizine, and nothing had helped, actually the Meclizine made it worse. It made him feel worse because he was very drowsy. The patient mentioned that the patient received the first primary series dose in Oct2020 and two weeks after he received the second Primary dose, Symptoms started to appear.  Patient received first dose Pfizer BioNTech Covid-19 vaccine Monovalent Oct2020. 2 weeks after patient received second dose Covid-19 vaccine, the symptoms started to appear. Clarified that reporter had only mentioned the date of the first dose of the vaccine and experienced symptoms after second dose of Covid-19 vaccine. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: diagnosed with COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient wanted to confirm for his 2nd booster dose after completing the Paxlovid treatment. He was told to wait 90 days after being diagnosed with COVID. He was travelling therefore wants to be protected.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300176517 Same patient, different event/drug;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid, 2months after 2nd vaccine May2021; covid, 2months after 2nd vaccine May2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 14:00 as dose 1, single (Lot number: EZ9266), in left arm and on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "OSA", start date: 01Jan2012, stop date: 01Jan2020, notes: Illness/AE: OSA Mild with CPAP occasional use, Pertinent Details: Borderline; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Illness/AE: Urethral Fascia sling repeat removal, Pertinent Details: Sling Broken in muscle; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019; "CPAP", start date: 01Jan2012, stop date: 01Jan2020; "vaginal atrophy" (ongoing); "Asthma" (ongoing); "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "covid, 2months after 2nd vaccine May2021". Clinical course: The patient had Covids, 2 months after 2nd vaccine May2021 the approximately every 6 month from May2021 until Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dizziness, Dyspnoea, Full blood count, Haematocrit
Clinical narrative: covid, 2months after 2nd vaccine May2021; covid, 2months after 2nd vaccine May2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 14:00 as dose 1, single (Lot number: EZ9266), in left arm and on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "OSA", start date: 01Jan2012, stop date: 01Jan2020, notes: Illness/AE: OSA Mild with CPAP occasional use, Pertinent Details: Borderline; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Illness/AE: Urethral Fascia sling repeat removal, Pertinent Details: Sling Broken in muscle; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019; "CPAP", start date: 01Jan2012, stop date: 01Jan2020; "vaginal atrophy" (ongoing); "Asthma" (ongoing); "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "covid, 2months after 2nd vaccine May2021". Clinical course: The patient had Covids, 2 months after 2nd vaccine May2021 the approximately every 6 month from May2021 until Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit abnormal, Haemoglobin, Haemoglobin abnormal, Metabolic function test, Red blood cell abnormality
Clinical narrative: covid, 2months after 2nd vaccine May2021; covid, 2months after 2nd vaccine May2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 14:00 as dose 1, single (Lot number: EZ9266), in left arm and on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "OSA", start date: 01Jan2012, stop date: 01Jan2020, notes: Illness/AE: OSA Mild with CPAP occasional use, Pertinent Details: Borderline; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Illness/AE: Urethral Fascia sling repeat removal, Pertinent Details: Sling Broken in muscle; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019; "CPAP", start date: 01Jan2012, stop date: 01Jan2020; "vaginal atrophy" (ongoing); "Asthma" (ongoing); "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "covid, 2months after 2nd vaccine May2021". Clinical course: The patient had Covids, 2 months after 2nd vaccine May2021 the approximately every 6 month from May2021 until Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red cell distribution width abnormal, Visual field tests
Clinical narrative: covid, 2months after 2nd vaccine May2021; covid, 2months after 2nd vaccine May2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 14:00 as dose 1, single (Lot number: EZ9266), in left arm and on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "OSA", start date: 01Jan2012, stop date: 01Jan2020, notes: Illness/AE: OSA Mild with CPAP occasional use, Pertinent Details: Borderline; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Illness/AE: Urethral Fascia sling repeat removal, Pertinent Details: Sling Broken in muscle; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019; "CPAP", start date: 01Jan2012, stop date: 01Jan2020; "vaginal atrophy" (ongoing); "Asthma" (ongoing); "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRADIOL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2021, outcome "unknown" and all described as "covid, 2months after 2nd vaccine May2021". Clinical course: The patient had Covids, 2 months after 2nd vaccine May2021 the approximately every 6 month from May2021 until Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: with covid Dx (during) Dec2021; with covid Dx (during) Dec2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 19:00 as dose 1, single (Lot number: EZ9266), in left arm, on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm and on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Seasonal asthma" (ongoing); "Vaginal atrophy" (ongoing); "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: Sling Broken in muscle; "Sling Broken in muscle", start date: 22Oct2019, stop date: 22Oct2019; "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "with covid Dx (during) Dec2021". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I also had a booster in Oct2021; with covid Dx (during) Dec2021; The episode 27Dec2022 lasted until 07Jan2023 with paxlovid; (1st dose, 2nd dose and 3rd dose) Vaccine administered at private location was reported as No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cataract, Glomerular filtration rate, Glomerular filtration rate decreased, Metabolic function test, Visual acuity tests
Clinical narrative: with covid Dx (during) Dec2021; with covid Dx (during) Dec2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 19:00 as dose 1, single (Lot number: EZ9266), in left arm, on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm and on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Seasonal asthma" (ongoing); "Vaginal atrophy" (ongoing); "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: Sling Broken in muscle; "Sling Broken in muscle", start date: 22Oct2019, stop date: 22Oct2019; "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "with covid Dx (during) Dec2021". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I also had a booster in Oct2021; with covid Dx (during) Dec2021; The episode 27Dec2022 lasted until 07Jan2023 with paxlovid; (1st dose, 2nd dose and 3rd dose) Vaccine administered at private location was reported as No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: with covid Dx (during) Dec2021; with covid Dx (during) Dec2021; 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 female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 19:00 as dose 1, single (Lot number: EZ9266), in left arm, on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm and on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Seasonal asthma" (ongoing); "Vaginal atrophy" (ongoing); "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: Sling Broken in muscle; "Sling Broken in muscle", start date: 22Oct2019, stop date: 22Oct2019; "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "with covid Dx (during) Dec2021". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I also had a booster in Oct2021; with covid Dx (during) Dec2021; The episode 27Dec2022 lasted until 07Jan2023 with paxlovid; (1st dose, 2nd dose and 3rd dose) Vaccine administered at private location was reported as No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hepatic enzyme abnormal
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 7/22/2021 ABNL LIVER ENZYMES
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram abnormal
Clinical narrative: Original Covid Moderna Vaccine: 5/4/21.  Second Dose: 6/2/21. Three boosters given in the Hospital system by doctors associated with Hospital. Noticed an enlarged lymph node on left side of breast. It was administered in the left arm three weeks prior to the mammogram.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Anticoagulant therapy, Echocardiogram abnormal, Electrocardiogram abnormal, Pericardial effusion, Pericardial rub
Clinical narrative: Pericarditis presenting one week after shot was taken; patient was hospitalized x3 and failed first line therapy with aspirin and colchicine. Was then titrated up to using aspirin, colchicine, prednisone before feeling any relief. Thereafter, was discharged on a long term taper of all the medications. Yet to follow up with outpatient cardiologists.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pericarditis
Clinical narrative: Pericarditis presenting one week after shot was taken; patient was hospitalized x3 and failed first line therapy with aspirin and colchicine. Was then titrated up to using aspirin, colchicine, prednisone before feeling any relief. Thereafter, was discharged on a long term taper of all the medications. Yet to follow up with outpatient cardiologists.
Age: 57.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Chills, Condition aggravated, Cough, Fatigue
Clinical narrative: On 4/29/2022, I got my second Moderna COVID-19 booster and a flu shot. On 5/2/2022, I took a home antigen test and got a positive result. On 5/3/2022, I woke up and felt like I was getting chest congestion. I had a productive cough and coughed up some phlegm. I called my PA, and he prescribed me PAXLOVID, which I began taking that day. I had just the congestion, cough, and a bit of a chill for the rest of the day. On the morning of 5/4/2022, I woke with a productive cough. By that evening, the cough was pretty much gone, though. I had fatigue for a few days. I then finished my isolation and then returned to my normal life afterwards. I have been dealing with fatigue for the past couple of years, but it became even more pronounced in September 2022. I don't blame the vaccine or the COVID-19. I have osteoarthritis, psoriatic arthritis, and arteriosclerosis, so I think it may tie in with those conditions.
Age: 57.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Productive cough, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: On 4/29/2022, I got my second Moderna COVID-19 booster and a flu shot. On 5/2/2022, I took a home antigen test and got a positive result. On 5/3/2022, I woke up and felt like I was getting chest congestion. I had a productive cough and coughed up some phlegm. I called my PA, and he prescribed me PAXLOVID, which I began taking that day. I had just the congestion, cough, and a bit of a chill for the rest of the day. On the morning of 5/4/2022, I woke with a productive cough. By that evening, the cough was pretty much gone, though. I had fatigue for a few days. I then finished my isolation and then returned to my normal life afterwards. I have been dealing with fatigue for the past couple of years, but it became even more pronounced in September 2022. I don't blame the vaccine or the COVID-19. I have osteoarthritis, psoriatic arthritis, and arteriosclerosis, so I think it may tie in with those conditions.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Blood test normal, Gait inability, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: In February on night, I went to bed and when I woke up, I could not walk. It was the burning pain from my back all the way down my left leg to my foot. My foot was numb and stayed numb for about a week. I felt it mostly numb in my outside 3 toes. It was sharp pain and burning in my back and leg and buttock. It did not improve over time. I consulted with my doctor and received a steroid and TYLENOL. My pain got a little better but did not go away completely. As of today, I am not longer feeling pain from the sciatic nerve.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity
Clinical narrative: In February on night, I went to bed and when I woke up, I could not walk. It was the burning pain from my back all the way down my left leg to my foot. My foot was numb and stayed numb for about a week. I felt it mostly numb in my outside 3 toes. It was sharp pain and burning in my back and leg and buttock. It did not improve over time. I consulted with my doctor and received a steroid and TYLENOL. My pain got a little better but did not go away completely. As of today, I am not longer feeling pain from the sciatic nerve.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINATION ADMINISTERED AFTER BUD
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINATION ADMINISTERED AFTER BUD
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINATION ADMINISTERED AFTER BUD
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Tinnitus
Clinical narrative: Tinnitus constantly
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM; LOSARTAN; NEBIVOLOL. Vaccination history included: moderna coviD-19 vaccine (Moderna (1st Dose) (Moderna COVID-19 Vaccine), Date of administration: 14Jan2021, LOT#: 028L20A (Captured in tab)), administration date: 14Jan2021, when the patient was 62-year-old, for Covid-19 immunization; moderna coviD-19 vaccine (Moderna (2nd Dose) , Date of administration: 12Feb2021, LOT#: 013M20A), administration date: 12Feb2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Pfizer (3rd Dose) , Date of administration: 17Nov2021, LOT#: FH8027), administration date: 17Nov2021, when the patient was 63-year-old, for Covid-19 immunization, reaction(s): "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick", "I had Moderna, moderna, Pfizer, Pfizer, Pfizer", "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick".  Additional information: It was reported that patient got these reaction every time; had gotten COVID Vaccine; gotten sick.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300177316 same patient/vaccine, diff dose/event;US-PFIZER INC-202300177412 same patient/vaccine, diff dose/event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products
Clinical narrative: I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick; I had Moderna, moderna, Pfizer, Pfizer, Pfizer; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM; LOSARTAN; NEBIVOLOL. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE, LOT#: 028L20A), administration date: 14Jan2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sick"; moderna coviD-19 vaccine (DOSE 2, SINGLE, LOT#: 013M20A), administration date: 12Feb2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sick". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 17Nov2021, outcome "unknown", described as "I had Moderna, moderna, Pfizer, Pfizer, Pfizer"; ILLNESS (non-serious), outcome "unknown", described as "I got these reaction every time, every time I have gotten COVID Vaccine I have gotten sick".  Additional information: Additional information: Investigation was none. No Prior vaccinations within 4 weeks. Patient stated, "she had 5th COVID (Pfizer COVID-19 Vaccine) shot Saturday and just like all the other time, she got sick from Saturday night all day yesterday, she was almost back to normal on the day of reporting. The person exactly encourages people to get these vaccines 'then' you have fever, chills and burn ache. So, that's why the patient was calling. She further stated, "she got these reactions every time, every time she has gotten COVID Vaccine she has gotten sick. Sender's Comments: Linked Report(s): US-PFIZER INC-202300177411 same patient/vaccine, diff dose/event; US-PFIZER INC-202300177316 same patient/vaccine, diff dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: is not good at walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2), as dose 2, 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, SINGLE), for COVID-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "is not good at walking".  Addition Information: Patient wife reporting that her husband was a senior who is not good at walking around and he was homebound too. Her husband managed to get himself a shot to a supermarket where they did covid shots and she had a home visit for her shot. The second time they had shots was a home visit and that was in August. She wants to know if they can arrange another home visit for the bivalent vaccine. Also the caller mentioned that when she had those two vaccines she said it's like not feeling so great but she's fine. Also she said her husband is a senior who is not good at walking around and got the two doses of the 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: Feeling abnormal
Clinical narrative: not feeling so great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 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: FEELING ABNORMAL (non-serious), outcome "recovered", described as "not feeling so great".  Additional information: A caller is calling on behalf of her husband and herself. She said that her husband is a senior who is not good at walking around and he is homebound too. Her husband managed to get himself a shot to a supermarket where they did covid shots and she had a home visit for her shot. The second time they had shots was a home visit and that was in August. She wants to know if they can arrange another home visit for the bivalent vaccine. Provided the information about the vaccination appointment. Also the caller mentioned that when she had those two vaccines she said it's like not feeling so great but she's fine.  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-PV202300079136 same reporter/drug, different patient/AE;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: not feeling so great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, 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, SINGLE), for COVID-19 immunization, reaction(s): "not feeling so great". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovering", described as "not feeling so great".  Additional information: Reporter was calling on behalf of her husband and herself. She said that her husband is a senior who is not good at walking around and he is homebound too. Her husband managed to get himself a shot to a supermarket where they did covid shots and she had a home visit for her shot. The second time they had shots was a home visit and that was in August. She wants to know if they can arrange another home visit for the bivalent vaccine. Also, she mentioned that when she had those two vaccines, she said it's like not feeling so great but she's fine.  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-PV202300079136 same reporter/drug, different patient/AE;
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive on 01May2023 with a home test.; I tested positive on 01May2023 with a home test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: gj6742) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: el3247), on 25Mar2021 as dose 2, single (Lot number: ep6955), in right arm, on 29Oct2021 as dose 3 (booster), single (Lot number: fe3509), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: fl3197), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMBIEN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01May2023, outcome "not recovered", COVID-19 (medically significant) with onset 01May2023, outcome "not recovered" and all described as "I tested positive on 1May2023 with a home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2023) Positive, notes: I tested positive on 01May2023 with a home test. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: Facility type vaccine was  clinic. No other other vaccine in four weeks. Other medications in two weeks: ambien. Patient tested positive on 1May2023 with a home test. No covid prior vaccination. If covid tested post vaccination was Unknown
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: broke out in hives all over body.  called dr and was advised to take zyrtec and dr called in a topical steroid to another pharmacy
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Lymphadenopathy, Rash
Clinical narrative: Patient came into the pharmacy on Wednesday (2 days after vaccine). Patient has a rash that has grown over the past 2 days. The rash has fever in it and the patient also experienced a headache and chills. The patient has a swollen lymph node under the arm . We advised patient to see doctor if rash gets worse. As of right now, patient hasn't seen the doctor but the doctor is aware.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Maternal exposure before pregnancy, Menstruation irregular, Ovarian cyst ruptured
Clinical narrative: 3 miscarriages in one year - March 2022 - pregnant when received booster  D&C -March 2022  Diagnosed with PCOS May 2023  Rupture ovarian cysts -May 2022  Missed ovulation  Irregular period-heavy bleeding  Severe pelvic pain  No know cysts or reproductive issues/pain prior to vaccine .
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ovulation disorder, Pelvic pain, Polycystic ovaries, Pregnancy, Ultrasound scan
Clinical narrative: 3 miscarriages in one year - March 2022 - pregnant when received booster  D&C -March 2022  Diagnosed with PCOS May 2023  Rupture ovarian cysts -May 2022  Missed ovulation  Irregular period-heavy bleeding  Severe pelvic pain  No know cysts or reproductive issues/pain prior to vaccine .
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Malaise, SARS-CoV-2 test positive
Clinical narrative: Developed Covid 19 symptoms on Dec 28, 2022 at 7AM after having been exposed to two Covid positive individuals for a lengthly period on Tuesday Dec 27, 2022
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Posture abnormal
Clinical narrative: Patient was given vaccine and 10 minutes after , while patient was waiting for her form, she started to feel dizzy , lost consciousness , and slumped down to the floor.