chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm 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; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 21Oct2023 to 25Oct2023.  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-202300352197 same patient, different drug/event (Paxlovid Case);
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE  1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE  3 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergies. Paxlovid taken from 18Oct2023 to 23Oct2023.  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-202300352143 Same patient, different product, different event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 18Oct2023 to 23Oct2023. Clinical course: Patient didn't have any known allergies.  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-202300351934 Same reporter/patient, different drug, different AE.;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2023 at 08:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2023) Positive; (30Oct2023) Positive; (26Oct2023) Negative; (21Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (lot number: GJ7161) from 21Oct2023, the first day patient had symptoms and tested positive, Both PCR and antigen test, completed five day doses dosage 25Oct2023. Symptoms improved by day two and three. Tested negative on 26Oct2023. Symptoms resumed early in the morning of 30Oct2023, and antigen tested with a strong positive. Patient had no Known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Pain in extremity
Clinical narrative: Scratchy throat; Hacky cough; Still plugged up/Congestion nasal; Sore arm; Not body ache so much anything like that just it really tired; Headache; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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): "been tired", "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm"; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm". The following information was reported: THROAT IRRITATION (non-serious), outcome "unknown", described as "Scratchy throat"; COUGH (non-serious), outcome "unknown", described as "Hacky cough"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "Still plugged up/Congestion nasal"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Not body ache so much anything like that just it really tired"; HEADACHE (non-serious), outcome "unknown".   Additional information: Reporter stated that reporter had couples of questions and got Pfizer Vaccines, reporter had all vaccines, this was sixth one and all of them had been Pfizer and had no issues other than may be sore arm and been tired. But this last one (Clarified as Comirnaty) got on Monday and by Tuesday within 24 hours. Started having COVID like symptoms. Had this scratchy throat, the hacky cough. Still plugged up and headache, not body ache so much anything like that just it really tired but reporter question was, it was possible after having the vaccine to have COVID like symptoms afterwards. After 24 hours and actually even before that may be within, well do not know, about 12 hours started having, was not sick and it can be span of before the afterward started having like COVID like symptoms.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352643 same patient, different dose/event;US-PFIZER INC-202300352644 same patient, different dose/event;US-PFIZER INC-202300352647 same patient, different dose/event;US-PFIZER INC-202300352646 same patien, different dose/event;US-PFIZER INC-202300352645 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Scratchy throat; Hacky cough; Still plugged up/Congestion nasal; Sore arm; Not body ache so much anything like that just it really tired; Headache; 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 patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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): "been tired", "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm"; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "been tired", "Sore arm". The following information was reported: THROAT IRRITATION (non-serious), outcome "unknown", described as "Scratchy throat"; COUGH (non-serious), outcome "unknown", described as "Hacky cough"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "Still plugged up/Congestion nasal"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Not body ache so much anything like that just it really tired"; HEADACHE (non-serious), outcome "unknown".   Additional information: Reporter stated that reporter had couples of questions and got Pfizer Vaccines, reporter had all vaccines, this was sixth one and all of them had been Pfizer and had no issues other than may be sore arm and been tired. But this last one (Clarified as Comirnaty) got on Monday and by Tuesday within 24 hours. Started having COVID like symptoms. Had this scratchy throat, the hacky cough. Still plugged up and headache, not body ache so much anything like that just it really tired but reporter question was, it was possible after having the vaccine to have COVID like symptoms afterwards. After 24 hours and actually even before that may be within, well do not know, about 12 hours started having, was not sick and it can be span of before the afterward started having like COVID like symptoms.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352643 same patient, different dose/event;US-PFIZER INC-202300352644 same patient, different dose/event;US-PFIZER INC-202300352647 same patient, different dose/event;US-PFIZER INC-202300352646 same patien, different dose/event;US-PFIZER INC-202300352645 same patient, different dose/event;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Jul2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyper thyroid" (unspecified if ongoing), notes: other medical history: Hyper thyroid; "Allergy" (unspecified if ongoing), notes: other medical history: Allergy. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: Ibuprofen", notes: known allergies: Ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose #5: Moderna/ Dose #6: Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 72 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Moderna, start date: 07Aug2023, stop date: 07Aug2023, for Covid-19 Immunization, notes: DOSE 5, SINGLE, Vaccine administration date- 07Aug2023,, Vaccine administration time- 03:00 PM,, Vaccine lot number- AS7647B,, Vaccine location- Left arm; Covid-19 vaccine, start date: 07Aug2023, stop date: 07Aug2023, for Covid-19 Immunization, notes: DOSE 4, SINGLE; Manufacturer unknown; Covid-19 vaccine for Covid-19 Immunization, notes: DOSE 3, SINGLE; Manufacturer unknown; Covid-19 vaccine for Covid-19 Immunization, notes: DOSE 2, SINGLE; Manufacturer unknown; Covid-19 vaccine for Covid-19 Immunization, notes: DOSE 1, SINGLE; Manufacturer unknown. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #5: Moderna/ Dose #6: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received any other medication in 2week. Patient received treatment for COVID 19 with Paxlovid. Treatment start date was 21Oct2023 and Treatment stop date was 25Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (dose 3, Vaccine location=Left arm), administration date: 18May2023, for covid-19 immunisation; pfizer / biontech (dose 2, Vaccine location=Left arm), administration date: 28Sep2022, for covid-19 immunisation; pfizer / biontech (dose 1), administration date: 04Apr2022, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 20Oct2023 to 24Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program, reporting the same event under the same product for 6 patients. This is one of 6 reports.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown".  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-PV202300179111 same reporter/product/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), reporting the same event under the same product for 6 patients. This is one of 6 reports.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown".  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-PV202300179111 same reporter/product/event, different patient;
Sex: M
Vaccine: RSV
Symptoms: COVID-19, Malaise
Clinical narrative: ill; getting 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 male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 23Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (2023-2024 formula) (Dose Number Unknown, Single, The first 2 shots we got were Covid and Flu on 02Oct), administration date: 02Oct2023, for COVID-19 Immunization, reaction(s): "COVID-19"; flu shot (The first 2 shots we got were Covid and Flu on 02Oct), administration date: 02Oct2023, for Immunization. The following information was reported: COVID-19 (non-serious) with onset Oct2023, outcome "unknown", described as "getting Covid"; ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "ill".  Additional information: The patient had COVID vaccine and flu shot on 02Oct2023. Then had RSV vaccine on 23Oct2023 for which the patient felt ill and wound up getting COVID.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: feverish; flu-like symptoms; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 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: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "feverish"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2023, outcome "unknown", described as "flu-like symptoms".  Additional information: she and her husband had received the Pfizer COVID vaccine yesterday at (Facility name withheld), and everything was good. She said she had experienced flu-like symptoms last night and was feverish, and her husband was fine and golfing today, and he was good. She had a question about whether she can take Tylenol or Motrin and does not want to interfere with the vaccine if she takes a painkiller in case her fever goes up tonight with that. She wants to know if there was one better than the other: Motrin versus Tylenol. Creating an AE Form since the caller had experienced flu-like symptoms last night and feverishness after receiving the Pfizer COVID vaccine yesterday  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Scan, Thyroid disorder, Thyroid function test
Clinical narrative: feeling quite anxious; routine check of my thyroid and detected some anomalies.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), on 05May2021 as dose 1, single (Batch/Lot number: unknown), on 27May2021 as dose 2, single (Batch/Lot number: unknown), on 28Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Jul2022 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. The following information was reported: THYROID DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "routine check of my thyroid and detected some anomalies."; ANXIETY (non-serious), outcome "unknown", described as "feeling quite anxious". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient wrote as a concerned individual who had received the COVID-19 vaccine developed by Pfizer on multiple occasions (05May2021, 27May2021, 28Jan2022, 22Jul2022, 20Oct2022). Patient had a specific health concern related to thyroid condition. Last year (2022), Dr. (PRIVACY) conducted a routine check of patient's thyroid and detected some anomalies. She conducted blood tests, sampling, and scanning, and concluded that patient did not had cancer, but there were some minor issues with thyroid. This was something that was not a pre-existing condition. Patient had researched the impact of Covid Vaccine on the thyroid, and patient was feeling quite anxious.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5,BNT162B2] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), reporting the same event under the same product for 6 patients. This is one of 6 reports.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown".  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-202300354114 same reporter/product/event, different patient;US-PFIZER INC-202300355044 same reporter/product/event, different patient;US-PFIZER INC-202300355045 same reporter/product/event, different patient;US-PFIZER INC-202300355046 same reporter/product/event, different patient;US-PFIZER INC-202300355043 same reporter/product/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Body aches; chills; headache; nausea; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PAIN (non-serious), outcome "unknown", described as "Body aches"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352467 same reporter/AE, different drug/Patients;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Experience heart problems and still over year later she is still having problems with her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19-year-old female patient received bnt162b2 (BNT162B2 NOS), 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: CARDIAC DISORDER (non-serious), outcome "not recovered", described as "Experience heart problems and still over year later she is still having problems with her heart".  Additional information: Reporter stated that her 19 year old daughter was made to take the vaccine because of her college she was attending. Approximately a week after her shot. she started to experience heart problems and still over year later she was still having problems with her heart. They were not seeing specialist after specialist to help her. She will never get another Covid shot again especially a Pfizer.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Bladder pain, Headache, Hepatic pain, Malaise, Nasal congestion
Clinical narrative: Patient claims that the following adverse events occurred following vaccination and contributes them solely to the vaccine. 1) Headache 2) Swollen Throat 3) Nasal Congestion 4)Internal Liver Pain 5) Bladder Pain 6) Malaise 7) Nausea
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pharyngeal swelling
Clinical narrative: Patient claims that the following adverse events occurred following vaccination and contributes them solely to the vaccine. 1) Headache 2) Swollen Throat 3) Nasal Congestion 4)Internal Liver Pain 5) Bladder Pain 6) Malaise 7) Nausea
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Groin pain, Mobility decreased, Myalgia
Clinical narrative: Severe muscle pains in legs, groin, shoulders and arms.   Lasted two weeks. Difficult to walk and get in and out of the car and get up off the floor.  Muscle pains continue in week three but are more moderate than the first two weeks.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Severe muscle pains in legs, groin, shoulders and arms.   Lasted two weeks. Difficult to walk and get in and out of the car and get up off the floor.  Muscle pains continue in week three but are more moderate than the first two weeks.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Vertigo
Clinical narrative: I was feeling dizzy at 22:00. I woke up at 1:30 to breastfeed the baby and when lying down had a bout of 3-5 seconds of vertigo. It felt peripheral, like BPPV, triggered by moving my head sideways as I went down to lie on the bed again. I have been breastfeeding for 10 months and drink plenty of water. My Blood pressure is fine.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, large red patch on upper arm, congestion
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Impaired healing, Injection site cellulitis, Injection site inflammation, Injection site pain
Clinical narrative: Patient reports continuous inflammation and pain in left deltoid 4 weeks after vaccine was given. Also reports stiff neck and upper back pain. There is a small wound that patient says has not healed at all, from where the vaccine was given. I suspect cellulitis, even if no longer active infection.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Patient reports continuous inflammation and pain in left deltoid 4 weeks after vaccine was given. Also reports stiff neck and upper back pain. There is a small wound that patient says has not healed at all, from where the vaccine was given. I suspect cellulitis, even if no longer active infection.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ataxia, Brain oedema, Confusional state, Coordination abnormal, General physical health deterioration
Clinical narrative: Unable to type in above- but he received both COVID and RSV that day.   Following day the decline began - which by at 2 weeks led to hospitalization for what appears to be PRES- bilateral significant edema of parieto occipital lobes- with corresponding neurological decline (ie ataxia, neglect to the left, confusion, inabilty to see left or coordinate use of left hemibody).
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging head abnormal, Neurologic neglect syndrome, Neurological decompensation, Posterior reversible encephalopathy syndrome
Clinical narrative: Unable to type in above- but he received both COVID and RSV that day.   Following day the decline began - which by at 2 weeks led to hospitalization for what appears to be PRES- bilateral significant edema of parieto occipital lobes- with corresponding neurological decline (ie ataxia, neglect to the left, confusion, inabilty to see left or coordinate use of left hemibody).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Patient received COVID booster vaccine in our office without issue. He was sent home and approximately one hour after the vaccine, he developed a full body tonic-clonic seizure that lasted <5 minutes and self abated. Patient has never had a seizure before and has never had any similar effects with other seizures.
Age: 49.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: C-reactive protein increased, Condition aggravated, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive, Epstein-Barr virus infection reactivation
Clinical narrative: Within 18 hours, I developed a fever, fatigue, and severe body ache as expected from previous doses. Managed with Tylenol for two days. Inflammation and fatigue still continues three weeks later. Labs drawn a week after (10/17/23)  revealed elevated EBV early antigen D AB (IGG)  and hsCRP  levels, suggesting reactivation of EBV.
Age: 49.0
Sex: F
Vaccine: COVID19-2, FLUR4
Symptoms: Fatigue, Inflammation, Pain, Pyrexia
Clinical narrative: Within 18 hours, I developed a fever, fatigue, and severe body ache as expected from previous doses. Managed with Tylenol for two days. Inflammation and fatigue still continues three weeks later. Labs drawn a week after (10/17/23)  revealed elevated EBV early antigen D AB (IGG)  and hsCRP  levels, suggesting reactivation of EBV.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain in hand; headache
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: patient presented on 11/4/23 with an erythematous rash extending down upper right arm. warm to palpation, advised that pt should follow up with a prescribing healthcare provider to be evaluated for possible infection. At the time of writing result is unknown as professional recommendation was made within the last hour
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Foreign travel, Malaise, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: Patient traveled abroad and as she was getting on the plane to return, she noticed a tickling in her throat. Afterwards, she became sick with Covid. She tested herself for Covid and it was positive both times. She went to see the doctor and was prescribed a z-pak and benzonatate. However, she wasn't hospitalized. Called to pharmacy to confirm if she was given correct updated vaccine (she did) and complain that the vaccine didn't work. Was reminded that the vaccine helps to prevent hospitalization and death
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills with shaking, headache, dizziness, joint pain, fatigue.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills with shaking, headache, dizziness, joint pain, fatigue.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given a COVID 19 vaccination that was meant for 12 year old and above
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient was given adjuvant suspension only . It was not mixed with antigen. Patient was contacted and asked to return for correct mix.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Laboratory test
Clinical narrative: We had the COVID Moderna vaccine at Pharmacy. We do not know the series or lot number information.  Patient received only the Moderna. I received the Moderna & Flu.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain
Clinical narrative: Body aches, 100.8 temp, headache Stuffy nose
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: vertigo
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Bell's palsy, Chills, Ear pain, Erythema, Facial paralysis
Clinical narrative: Within 12 hours of receiving vaccine, experienced typical flu-like symptoms: shivering, fever, body ache.  Woke Thursday morning with extreme pain in left ear; went to ENT and Allergy Associates to see if ear was infected/negative.  Friday morning, face paralysis - Bell's Palsy - began and has persisted ever since.  Primary care physician referred her over -the-phone to neurologist.  Neurologist Dr. examined and confirmed Bell's Palsy.  Ordered an MRI to double-check for possible mild stroke due to age.  MRI performed 11/1, still awaiting results.  Mom cannot sleep; pain is extreme at night.  She cannot have steroids due to herpes in left eye, which she has had for decades, but is not currently flaring.  Mouth drooping, ear is red and hot and sore.  All of this is on the left side of face.  Jaw pain, ear pain, miserable.
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Feeling abnormal, Feeling hot, Influenza like illness, Magnetic resonance imaging head, Pain
Clinical narrative: Within 12 hours of receiving vaccine, experienced typical flu-like symptoms: shivering, fever, body ache.  Woke Thursday morning with extreme pain in left ear; went to ENT and Allergy Associates to see if ear was infected/negative.  Friday morning, face paralysis - Bell's Palsy - began and has persisted ever since.  Primary care physician referred her over -the-phone to neurologist.  Neurologist Dr. examined and confirmed Bell's Palsy.  Ordered an MRI to double-check for possible mild stroke due to age.  MRI performed 11/1, still awaiting results.  Mom cannot sleep; pain is extreme at night.  She cannot have steroids due to herpes in left eye, which she has had for decades, but is not currently flaring.  Mouth drooping, ear is red and hot and sore.  All of this is on the left side of face.  Jaw pain, ear pain, miserable.
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain in jaw, Pyrexia, Sleep disorder
Clinical narrative: Within 12 hours of receiving vaccine, experienced typical flu-like symptoms: shivering, fever, body ache.  Woke Thursday morning with extreme pain in left ear; went to ENT and Allergy Associates to see if ear was infected/negative.  Friday morning, face paralysis - Bell's Palsy - began and has persisted ever since.  Primary care physician referred her over -the-phone to neurologist.  Neurologist Dr. examined and confirmed Bell's Palsy.  Ordered an MRI to double-check for possible mild stroke due to age.  MRI performed 11/1, still awaiting results.  Mom cannot sleep; pain is extreme at night.  She cannot have steroids due to herpes in left eye, which she has had for decades, but is not currently flaring.  Mouth drooping, ear is red and hot and sore.  All of this is on the left side of face.  Jaw pain, ear pain, miserable.
Age: 84.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Brain scan normal, Chest X-ray normal, Chest pain, Computerised tomogram abdomen normal, Fall
Clinical narrative: 1.  10/20/2023 9:18 pm -- Checked into ER with chest pain and spiking high blood pressure (180/75).  Blood tests showed that there were no heard or kidney issues.  Chest x-ray was normal.  Was released from ER after blood pressure subsided some and chest pain lessened.  The following day, I noticed a mild f3ever that broke in the evening as which my blood pressure returned to normal (130 / 60 ) and I felt much better.  2.  10/24/2023 --  I awoke early and felt very dopy.  I fell and was unable to get myself up after which my wife managed to get me up and into the ER again.  Blood tests indicated liver issues and a number of other blood results that were out of normal range.  I was diagnosed with acute hepatitis.  Scans of the abdomen and head were normal.
Age: 84.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Feeling abnormal, Hepatitis acute, Hypertension, Liver disorder, Liver function test abnormal
Clinical narrative: 1.  10/20/2023 9:18 pm -- Checked into ER with chest pain and spiking high blood pressure (180/75).  Blood tests showed that there were no heard or kidney issues.  Chest x-ray was normal.  Was released from ER after blood pressure subsided some and chest pain lessened.  The following day, I noticed a mild f3ever that broke in the evening as which my blood pressure returned to normal (130 / 60 ) and I felt much better.  2.  10/24/2023 --  I awoke early and felt very dopy.  I fell and was unable to get myself up after which my wife managed to get me up and into the ER again.  Blood tests indicated liver issues and a number of other blood results that were out of normal range.  I was diagnosed with acute hepatitis.  Scans of the abdomen and head were normal.
Age: 84.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: 1.  10/20/2023 9:18 pm -- Checked into ER with chest pain and spiking high blood pressure (180/75).  Blood tests showed that there were no heard or kidney issues.  Chest x-ray was normal.  Was released from ER after blood pressure subsided some and chest pain lessened.  The following day, I noticed a mild f3ever that broke in the evening as which my blood pressure returned to normal (130 / 60 ) and I felt much better.  2.  10/24/2023 --  I awoke early and felt very dopy.  I fell and was unable to get myself up after which my wife managed to get me up and into the ER again.  Blood tests indicated liver issues and a number of other blood results that were out of normal range.  I was diagnosed with acute hepatitis.  Scans of the abdomen and head were normal.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, flushing experience 1 hour after vaccine administration
Age: 76.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching that traveled 3/4 around left arm and down to elbow. On this date still dealing with redness  and itching  inside of left arm to elbow area.
Age: 75.0
Sex: F
Vaccine: FLU4, FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in on 10/14 requesting a High Dose flu shot.  She was given Fluzone HD.  Patient came back in 10/29 and requested another flu shot.  She was given Fluad 65+.  She has not reported any adverse reaction, but wanted to document that patient received 2 flu shots.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Nausea, chills, diarrhea, elevated temperature (99 degrees F as opposed to normal basal body temp of 97 degrees F) developed overnight following the vaccine and resolved after 24 hours. Swollen and painful arm at injection site developed a few hours after vaccination and resolved after 3 days. Redness, pain, swelling of vulva developed the day after vaccination and got worse over the next few days. Am treating with prescribed hydrocortisone cream.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vulvovaginal erythema, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: Nausea, chills, diarrhea, elevated temperature (99 degrees F as opposed to normal basal body temp of 97 degrees F) developed overnight following the vaccine and resolved after 24 hours. Swollen and painful arm at injection site developed a few hours after vaccination and resolved after 3 days. Redness, pain, swelling of vulva developed the day after vaccination and got worse over the next few days. Am treating with prescribed hydrocortisone cream.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Infection, Pain in extremity
Clinical narrative: Patient received Arexvy on 10/18/23. Patient had no issues with immunization. Patient c/o arm pain and streaking and went to ER on 11/3/23. Patient was diagnosed with infection and given clindamycin and tramadol.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported to have developed redness and swelling at site of injection accompanied by intense itchiness. This can be a common reaction to the vaccine but the patient does not agree.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: Rash that began on trunk and spread to head, face, and extremities. Fever to 102 F axillary. Fussiness. Lack of appetite
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspepsia, Fatigue, Headache
Clinical narrative: Headache,  day-long heartburn, very tired, sore and achy joints
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid, Blindness unilateral, Computerised tomogram head normal, Magnetic resonance imaging head normal
Clinical narrative: PRESENTED WITH ACUTE ONSET LEFT EYE BLURRED VISION AND VISION LOSS.  CONCERN FOR CENTRAL RETINAL ARTERY OCCLUSION. RECEIVED TNK. SYMPTOMS IMPROVED AFTER TNK ADMINISTRATION.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: PRESENTED WITH ACUTE ONSET LEFT EYE BLURRED VISION AND VISION LOSS.  CONCERN FOR CENTRAL RETINAL ARTERY OCCLUSION. RECEIVED TNK. SYMPTOMS IMPROVED AFTER TNK ADMINISTRATION.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Soreness and limited range of motion 24 hours after injection
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Peripheral coldness, Syncope, Vision blurred
Clinical narrative: experienced fainting symptoms, cold hands, numb extremities, and  blurry vision
Age: 14.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chills, Eye movement disorder, Hyperhidrosis, Immediate post-injection reaction, Posture abnormal
Clinical narrative: Flucelvax was given first in the left deltoid,  the patient responded fine. Then approximately 30 seconds later the Spikevax was administered, also in the left arm, approximately 2 inches away from the administration site of the Flucelvax. The patient's head drooped forward immediately when the injection started going into the muscle. I then took the needle out to discontinue the administration. The patient had a full body rigor, head dropped back, her eyes rolled back in her head and she started shaking. The patients mother and I called her name and she was then alert, but drowsy and diaphoretic. 911 was called, blood pressure taken (86/64 ). I stayed with the patient and mom while we waited for emergency services to arrive. The patient was given some water and stayed alert until EMT's arrived. Patient and mother were transported to Hospital Emergency Department.
Age: 14.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Somnolence, Tremor
Clinical narrative: Flucelvax was given first in the left deltoid,  the patient responded fine. Then approximately 30 seconds later the Spikevax was administered, also in the left arm, approximately 2 inches away from the administration site of the Flucelvax. The patient's head drooped forward immediately when the injection started going into the muscle. I then took the needle out to discontinue the administration. The patient had a full body rigor, head dropped back, her eyes rolled back in her head and she started shaking. The patients mother and I called her name and she was then alert, but drowsy and diaphoretic. 911 was called, blood pressure taken (86/64 ). I stayed with the patient and mom while we waited for emergency services to arrive. The patient was given some water and stayed alert until EMT's arrived. Patient and mother were transported to Hospital Emergency Department.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: vaccinated 10/25/2023 -- immunizer states there was an immediate swelling and bruising reaction. minimal / normal external bleeding.  patient returned to the pharmacy on 11/02/2023, she showed her arm, which showed the evolution of a bruise, that was in the purple / yellow phase.  she said this has been going on since she was vaccinated. 7 out of 10 pain for a couple days, especially when sleeping. reduced to no pain upon follow up call 11/04.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Developed COVID symptoms 5 days after receiving both vaccinations and tested positive on home test