chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years 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 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 23Oct2023 to 28Oct2023.  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-202300357524 same reporter/patient, different drug/event;
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) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Allergy: Coconut" (unspecified if ongoing). 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 (start date24Oct2023, stop date28Oct2023).  The information on the batch/lot number for [Comirnaty (2023-2024 Formula] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357525 same reporter/patient, different drug/event;
Sex: M
Vaccine: COVID19, 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.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jul2015, stop date: 25Aug2022; LEVOTHYROXINE, start date: 03Jul2015, stop date: 25Aug2022; ALLOPURINOL, start date: 03Jul2015, stop date: 25Aug2022; FERROUS SULFATE, start date: 03Jul2015, stop date: 25Aug2022; SPIRONOLACTON, start date: 03Jul2015, stop date: 25Aug2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  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: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Insomnia, Nausea, Pain, Vaccination site pain
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.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jul2015, stop date: 25Aug2022; LEVOTHYROXINE, start date: 03Jul2015, stop date: 25Aug2022; ALLOPURINOL, start date: 03Jul2015, stop date: 25Aug2022; FERROUS SULFATE, start date: 03Jul2015, stop date: 25Aug2022; SPIRONOLACTON, start date: 03Jul2015, stop date: 25Aug2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid again on 04Nov2023 after negative test on 20Oct2023; Tested positive for Covid again on 04Nov2023 after negative test on 20Oct2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Environment allergies" (unspecified if ongoing). 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 "recovered" (20Oct2023) and all described as "Tested positive for Covid again on 04Nov2023 after negative test on 20Oct2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Oct2023 to 18Oct2023.  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-202300357547 same patient, different drug and event;
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 32-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 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 included: "Asthma" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE), administration date: 22Sep2022, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. 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". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 25Oct2023 to 30Oct2023.  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-202300356701 same patient, different drug/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills
Clinical narrative: she has been having continuous chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 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 (primary immunisation series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset Oct2023, outcome "not recovered", described as "she has been having continuous chills". The event "she has been having continuous chills" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said she took the Covid-19 booster and she had continuous chills for weeks non-stop. Caller took blood tests and the results came back negative. Caller would like to know if there were also records of people experiencing that. Upon providing response, Caller stated that she got all the Pfizer COVID vaccines and all and subsequent shots and she understands that chills was part of it but never lasted for a month. Caller stated that she had taken blood test as instructed by her primary care physician and nothing showed up at all  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: F
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: she has been having continuous chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 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 (primary immunisation series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset Oct2023, outcome "not recovered", described as "she has been having continuous chills". The event "she has been having continuous chills" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said she took the Covid-19 booster and she had continuous chills for weeks non-stop. Caller took blood tests and the results came back negative. Caller would like to know if there were also records of people experiencing that. Upon providing response, Caller stated that she got all the Pfizer COVID vaccines and all and subsequent shots and she understands that chills was part of it but never lasted for a month. Caller stated that she had taken blood test as instructed by her primary care physician and nothing showed up at all  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: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Her arm became very red, big, hot and really itchy for 4 days after receiving the shot.; Her arm became very red, big, hot and really itchy for 4 days after receiving the shot.; Her arm became very red, big, hot and really itchy for 4 days after receiving the shot/itchiness; Her arm became very red, big, hot and really itchy for 4 days after receiving the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 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 Number unknown , Manufacturer unknown), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2023, outcome "recovered" (2023), described as "Her arm became very red, big, hot and really itchy for 4 days after receiving the shot"; ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 2023, outcome "recovered" (2023) and all described as "Her arm became very red, big, hot and really itchy for 4 days after receiving the shot."; PRURITUS (non-serious) with onset 2023, outcome "recovered" (2023), described as "Her arm became very red, big, hot and really itchy for 4 days after receiving the shot/itchiness".  Additinal information: Patient had 2023-2024 vaccine on 18Oct2023. Her arm became very red, big, hot and really itchy for 4 days after receiving the shot. It was annoying for 4 days. It was reported that the itchiness felt like the worst mosquito bite. She read that it was 'COVID arm' and also read that it was rare. She didnt experienced this with the other COVID vaccines (unclear mfg for prior COVID vaccines).   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, 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: COVID-19 (non-serious), outcome "unknown", described as "COVID 19". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body height, Condition aggravated, Dizziness
Clinical narrative: he got strong dizziness, every thing is spinning/dizziness is so much stronger; he got strong dizziness, every thing is spinning/dizziness is so much stronger; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "brain tumor surgery" (unspecified if ongoing), notes: 15 years ago; "brain tumor" (unspecified if ongoing); "lost one and one half of my eyes" (unspecified if ongoing), notes: can't read anymore, anything looks sideways, upside down, or backwards; "dizziness" (unspecified if ongoing), notes: slight dizziness for many many years; "dyslexia" (unspecified if ongoing), notes: caller thinks; "trouble with short term memory" (unspecified if ongoing); "Caller has broken a bunch of bones" (unspecified if ongoing), notes: used to race motorcycles, so broke a bunch of bones; "lungs collapsed" (unspecified if ongoing), notes: a long time ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 5(BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4(BOOSTER), SINGLE), reaction(s): "COVID-19 immunization"; Bnt162b2 (DOSE 3(BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2023, outcome "not recovered" and all described as "he got strong dizziness, every thing is spinning/dizziness is so much stronger". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient stated he had the sixth shot, lately I've got real strong dizziness. Patient had a brain tumor surgery and they made some errors and I lost one and one half of his eyes and he could no longer read and write and he had a really slight dizziness for many years but after the vaccines all of a sudden his dizziness was so much stronger. He also did the flu shot first and then he waited about a week of two weeks and then he got the Pfizer shot. Probably one week later dizziness started and it was pretty strong. Caller mentions that he had the dizziness for two or three days before. Caller was going to call general doctor. Caller had a lot of different medicines but nothing changed.  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: Balance disorder, Nausea, Vomiting
Clinical narrative: This is the second time patient was getting VN after receiving the COVID vaccine; This is the second time patient was getting VN after receiving the COVID vaccine; Really messing with patient's like and equilibrium; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 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: NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "This is the second time patient was getting VN after receiving the COVID vaccine"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Really messing with patient's like and equilibrium". Additional information: This is the second time patient was getting VN after receiving the COVID vaccine. It happens within 2 days of the shot. Really messing with patient's like and equilibrium.  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-PV202300180437 same patient/different dose;
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Nausea, Vomiting
Clinical narrative: getting VN; getting VN; Really messing with my like and equilibrium.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 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: NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "getting VN"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Really messing with my like and equilibrium.".  Additional information: This is the second time I am getting VN after receiving the COVID vaccine. It happens within 2 days of the shot.  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-PV202300180436 same patient, event and product/different dose;
Sex: M
Vaccine: RSV
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  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.
Age: 48.0
Sex: F
Vaccine: COVID19, FLUX, UNK
Symptoms: Chills, Feeling hot, Hangover, Nausea, Product administered to patient of inappropriate age
Clinical narrative: nausea; Chills; Feeling hot; Feeling like she has a hangover; Pediatric formulation of Pfizer-BioNTech COVID-19 Vaccine OMICRON XBB.1.5 was given to an adult patient; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: UNT-2023-030632.  This case is a spontaneous report received on 20 Oct 2023, from a consumer via specialty pharmacy. This 48-year-old, 190-lb female patient began therapy with Orenitram (treprostinil diethanolamine), on 03 Nov 2022 for secondary pulmonary arterial hypertension. The patient was supplied with Orenitram 5 mg and the current dose was reported as 10 mg (2 tablets of 5 mg), oral (PO), three times daily (TID). On 18 Oct 2023, 11 months 16 days after initiating Orenitram, the patient had nausea (nausea), chills (chills), feeling hot (feeling hot) and was feeling like she had a hangover (hangover) after receiving flu vaccine and COVID vaccine. Co-suspect products included: flu (influenza) vaccine and PFIZER COVID-19 vaccine (EUA) (tozinameran). Concomitant medications included: ondansetron hydrochloride [HCL], Adempas (riociguat), lidocaine, fluoxetine HCL, furosemide, Imodium multi symptom relief (loperamide hydrochloride, simeticone), Pepcid (famotidine), tramadol HCL, Synthroid (levothyroxine sodium), Flonase allergy relief (fluticasone propionate), loratadine, gabapentin, lamotrigine, Tums (calcium carbonate), Tylenol (paracetamol), albuterol sulfate hfa, Opsumit (macitentan) and Benadryl (diphenhydramine hydrochloride). Relevant medical history included: secondary pulmonary arterial hypertension. Action taken with Orenitram dose was not reported for the events of nausea, chills, feeling hot and hangover. At the time of reporting, the outcome of the events of nausea, chills, feeling hot and hangover was unknown. The reporter did not provide causality for the events of nausea, chills, feeling hot and hangover with Orenitram. The reporter's causality for the events of nausea, chills, feeling hot and hangover with flu vaccine and PFIZER COVID-19 vaccine was considered to be possibly related.  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: Injury
Clinical narrative: they had multiple vaccine MRNA-injured people in her family; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 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: INJURY (non-serious), outcome "unknown", described as "they had multiple vaccine MRNA-injured people in her family".  Additional information: The caller said that they got an advertisement in the mail from (Withheld mail) from Pfizer. The caller would like to opt out of the advertisement that she got through mail. The caller refused to provide her email address and phone number. The caller stated that they had multiple vaccine MRNA injured people in her family. I created the manual AE form because the caller stated that they had multiple vaccine MRNA-injured people in her family including her husband.  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-PV202300182139 same drug /event different  patient;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Pain, Pain in extremity
Clinical narrative: Worsening sore arm, body aches, 101.1 temperature, increased fatigue
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 1 DAY BEYOND ADJUSTED USE DATE
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS BEYOND ADJUSTED USE DATE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS BEYOND ADJUSTED USE DATE
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS BEYOND ADJUSTED USE DATE
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS BEYOND ADJUSTED USE DATE
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS BEYOND ADJUSTED USE DATE
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired product used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   On 24-OCT-2023, the patient received the 1st dose of Shingrix. On 24-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired product used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacist reported his pharmacy sent out a Shingrix vaccine to a nursing facility who administered it to a patient and then realized that the vaccine was expired. This was the patient's first dose in the series.  At the time of reporting, dose had not been repeated.  The reporter consented to follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site urticaria
Clinical narrative: Broke out in hives over injection site and on the shoulder.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: States that a 41 year old received a pediatric dose of ENGERIX-B; States that a 41 year old received a pediatric dose of ENGERIX-B.; received Engerix-B by intercostal route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On 30-OCT-2023, the patient received Engerix B pediatric (intercostal, left deltoid). On 30-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: States that a 41 year old received a pediatric dose of ENGERIX-B), adult use of a child product (Verbatim: States that a 41 year old received a pediatric dose of ENGERIX-B) and intramuscular formulation administered by other route (Verbatim: received Engerix-B by intercostal route). The outcome of the underdose, adult use of a child product and intramuscular formulation administered by other route were unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The reporter reported that 41 year old patient received a pediatric dose of Engerix-B by intercostal route, which led to underdose, adult use of a child product and intramuscular formulation administered by other route.   The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry eye, Dyspnoea, Fatigue, Headache
Clinical narrative: dry eyes; lightheadedness; headache; fatigue; heavy breathing; This spontaneous case was reported by a patient and describes the occurrence of DRY EYE (dry eyes), DIZZINESS (lightheadedness), DYSPNOEA (heavy breathing), HEADACHE (headache) and FATIGUE (fatigue) in a 21-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced DYSPNOEA (heavy breathing). On 03-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DRY EYE (dry eyes), DIZZINESS (lightheadedness), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, DRY EYE (dry eyes), DIZZINESS (lightheadedness), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and DYSPNOEA (heavy breathing) outcome was unknown.            Concomitant medication was not reported.  Patient had headache, dry eyes, lightheadedness, fatigue, heavy breathing. It is unknown if the patient experienced any additional symptoms/events.  treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lymphedema.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up). At the time of the report, PERIPHERAL SWELLING (The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that the patient cannot find a vaccination provider that will administer a dose of Spikevax 2023 2024 in her thigh. The patient had lymphedema in her arms and must receive the vaccine in her thigh. The patient does not have a Physician and when she went to the Pharmacy to ask, they said that they only provide the Spikevax 2023 2024 vaccine in the deltoid muscle. The patient previously received the Moderna Covid-19 vaccine in her arms however because of her Lymphedema her arms swelled up and a previous provider recommended that the patient should receive her Covid-19 vaccine in her thigh. Previously the patient could find a provider who would administer the vaccine in her thigh however at that time she cannot find a provider. The patient said that she had been to several Pharmacies and discussed her situation with corporate headquarters of Pharmacies and that they will not administer the Spikevax 2023 2024 vaccine in her thigh. No treatment information was provided.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Wrong product administered
Clinical narrative: 4th dose - 12Apr2022, lot number 001M21A; He also had aching body; He has a cough and a runny nose; His breathing was a little worse than normal/it is his breathing that is concerning him; He has a cough and a runny nose; His temperature was slightly high; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (He also had aching body), COUGH (He has a cough and a runny nose), DYSPNOEA (His breathing was a little worse than normal/it is his breathing that is concerning him), RHINORRHOEA (He has a cough and a runny nose) and PYREXIA (His temperature was slightly high) in a 62-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:COPD.  The patient's past medical history included COPD. Previously administered products included for Drug use for unknown indication: Moderna (1st dose: lot number 025J20-2A) on 09-Jan-2021, Moderna (2nd dose -lot number 012M20A) on 11-Feb-2021, Moderna (3rd dose-Lot number 049E21A) on 04-Nov-2021, Spikevax (4th dose- Lot number 001M21A) on 12-Apr-2022, Moderna (5th dose-lot number was unknown) on 17-Nov-2022 and Flu vaccine. Past adverse reactions to the above products included No adverse reaction with Flu vaccine, Moderna, Moderna, Moderna, Moderna and Spikevax. Concomitant products included PREDNISONE for an unknown indication.    On 29-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced PAIN (He also had aching body). 02-Nov-2023, the patient experienced COUGH (He has a cough and a runny nose), DYSPNOEA (His breathing was a little worse than normal/it is his breathing that is concerning him), RHINORRHOEA (He has a cough and a runny nose) and PYREXIA (His temperature was slightly high). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (4th dose - 12Apr2022, lot number 001M21A). At the time of the report, PAIN (He also had aching body), COUGH (He has a cough and a runny nose), DYSPNOEA (His breathing was a little worse than normal/it is his breathing that is concerning him), RHINORRHOEA (He has a cough and a runny nose) and PYREXIA (His temperature was slightly high) was resolving and WRONG PRODUCT ADMINISTERED (4th dose - 12Apr2022, lot number 001M21A) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Slightly high (100 degrees)..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748628, US-MODERNATX, INC.-MOD-2023-748631, US-MODERNATX, INC.-MOD-2023-748624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748628:Wife Case (Monovalent) US-MODERNATX, INC.-MOD-2023-748631:Wife Case (Bivalent)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria
Clinical narrative: Chronic spontaneous urticaria on both arms from wrist to underarms, prescribed 4 Zyrtec a day, and given steroids through injection in my upper right butt check
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Parosmia, SARS-CoV-2 antibody test positive, Taste disorder
Clinical narrative: For the last 16+ months, I have had a significant change in both Taste and Smell.  There are many things I can not smell, more that have a distorted smell and with every food item that has a distorted smell, I also have a distorted tasted.  This was all reported to CDC (with followup via telephone interview).  Over the last 4 months or so, the condition had improved somewhat, although certainly not gone. After my recent Covid booster, the taste and smell issues have once again worsened. The negative, nauseating, distorted smells are worse and the taste of a very long list of food (same foods for last 16 months) has also become worse.  I am concerned the vaccine has caused this issue to reoccur/worsen.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash pruritic
Clinical narrative: Rash 1 day after injection. Red, tiny bumps approx. 3 inch diameter around injection area. Rash itched. No treatment. Resolved in 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: onset of cellulitis    11/7/23  , was painful the previous evening as well. was seen for redness swelling pain + treated with Keflex
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Limb discomfort
Clinical narrative: Patient received a flu vaccine and developed redness, swelling, tenderness, blisters, at injection site the next day. Legs feel heavy.
Sex: F
Vaccine: FLUA4
Symptoms: Feeling abnormal, Pain, Pain in extremity
Clinical narrative: The patient was given a flu shot, and she said it felt weird. Now over a month later it hurts to lift her arm, and she is in constant pain. She said it felt weird when the shot was given, but she thought it would go away. There's no knot, and her PCP said heat would help - and it does some. But the patient's mobility is severely limited.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Received the first dose of Shingrix vaccine (Lot 429MK, Exp 05/28/2024) in the left deltoid at 1800 on 11/3/2023. At approximately 2200 on 11/6/2023, noted rash along right cyatic nerve. Diagnosed with shingles on 11/7/2023. Prescribed valacyclovir 1 gm TID x 5 days, therapy initiated with 2 doses received on 11/7/2023.
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; Patient developed fever and chills for 3 days after receiving Tdap.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Vaccination failure; Herpes zoster; Pain; Information has been received from agency (agency #  AU-TGA-0000742743) On 30-OCT-2023.   This spontaneous report was received from patient via interactive digital media who was currently 73 years old with unknown gender via social media referring to him/herself. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On an unknown date (at patient's 70 years old), the patient was vaccinated with zoster vaccine live (manufacturer unknown) subcutaneous injection, administered for prophylaxis (strength, dose description, lot #, expiry date, anatomical site of administration and route of administration were not provided).  On an unknown date (after 1 year), the patient had shingles (herpes zoster). On an unknown date, the patient experienced excruciating pain lasted for ages. On an unknown date, more than a year after receiving zoster vaccine live (manufacturer unknown), the patient experienced vaccination failure. On an unknown date, the patient recovered from the event of shingles and pain. At the time of reporting, the outcome of the event vaccination failure was not known. The patient enquired about having different vaccination which would be costly. The patient hoped to never get shingles again. It was reported that this case described the occurrence of suspected vaccination failure, this case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting. The causal relationship between shingles, pain, vaccination failure and zoster vaccine live (manufacturer unknown) was unknown.  The reporting institution considered vaccination failure as medically significant.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: sore arm x 2 months post vaccination, pain with muscular movement doing normal daily activities requiring use of the arm. Patient not currently receiving treatment.  Patient states she will give her symptoms until the end of the month to seek medical advise.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: arm soreness began, mom tried rubbing alcohol at home. 11/7/23 pt's arm began to itch, it felt warm and was swollen, ice tried at home. Today mom received a call from school, pt was crying saying her arm was hurting and mom picked her up. Still itchy and warm today. Pt has been scratching arm.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arrhythmic storm, Arteriogram coronary normal, Cardiac arrest, Cardioversion, Echocardiogram
Clinical narrative: Aborted sudden cardiac arrest and VT/VF storm requiring 13 shocks and sedation/intubation.  Sinus rhythm was restored with each shock, but the patient would promptly go back into VT, with rapid degeneration to VF, such that ROSC was obtained only twice over the course of 10 shocks delivered.  The patient had no further VT/VF after sedation & intubation.  He suffered an encephalopathy and remained unresponsive for several days, but ultimately recovered and an ICD was placed.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Encephalopathy, Endotracheal intubation, Implantable defibrillator insertion
Clinical narrative: Aborted sudden cardiac arrest and VT/VF storm requiring 13 shocks and sedation/intubation.  Sinus rhythm was restored with each shock, but the patient would promptly go back into VT, with rapid degeneration to VF, such that ROSC was obtained only twice over the course of 10 shocks delivered.  The patient had no further VT/VF after sedation & intubation.  He suffered an encephalopathy and remained unresponsive for several days, but ultimately recovered and an ICD was placed.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinus rhythm, Unresponsive to stimuli, Ventricular fibrillation
Clinical narrative: Aborted sudden cardiac arrest and VT/VF storm requiring 13 shocks and sedation/intubation.  Sinus rhythm was restored with each shock, but the patient would promptly go back into VT, with rapid degeneration to VF, such that ROSC was obtained only twice over the course of 10 shocks delivered.  The patient had no further VT/VF after sedation & intubation.  He suffered an encephalopathy and remained unresponsive for several days, but ultimately recovered and an ICD was placed.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchospasm, Dyspnoea
Clinical narrative: Couldn't take a full breath for about an hour or two. Went to urgent care where they noted acute bronchospasm, administered Dexamethasone 10mg and Duo nebulizer treatment. Didn't have any other reactions after being discharged but was told to go to the ER if bronchospasm returns.
Age: 2.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: While doing inventory, noticed this patient received entire vial of Pfizer COVID vaccine.  Vial was suppose to be diluted and have 3 doses in each vial.  It was not diluted and patient given 0.3ml, which was all 3 doses.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Based on immunization history Pentacel was indicated. Pediarix was administered. Pt received Hep B dose early. After medication error identified, parent notification made to patient's mother. Per parent, at time of notification 11/8/2023 @ 1844, child was not exhibiting and adverse reactions. Follow up by parent with clinic.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: This was not supposed to be administered. The RSV shot was supposed to be administered.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Skin warm, Throat irritation
Clinical narrative: About 4 hours aftr receiving the vaccination pt reports whole arm became red and warm and he felt his throat become itchy and it was more difficult to breath. He states he did not receive any treatment or care because symptoms decreased over the next few hours and returned to normal by the next day
Age: 69.0
Sex: M
Vaccine: PNC20, RSV
Symptoms: Rash, Rash erythematous
Clinical narrative: back rash with red non-itchy patches
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix vaccine ordered by provider and given to a 2 yr. old.   Vaccine recommended for 4-6 yrs.  No reaction was had by the child.
Age: 77.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Skin discolouration
Clinical narrative: PT described arm as turning purple. Stated no pain, no issues, but arm with flu vaccine site turned slightly purple. She stated it went away after a few days but that she was concerned I may have hit a vein or something.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 5-11yr old dose given to a 14yr old, of updated 2023/2024 vaccine. Pt is under-dosed.   Pt guardian notified, will give 12+ dose in 3-4 months.
Age: 54.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects. Patient was under the age of 60 and received this vaccine which is only indicated for 60 and older.
Age: 77.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Extra dose administered
Clinical narrative: This was a duplicate vaccination- Patient received Fluzone High Dose on 10/3/2023 Patient also received duplicate COVID-19 vaccine -- received Spikevax on 10/3/2023
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Dyspnoea, Encephalopathy, Lung infiltration
Clinical narrative: Resident had been having sob, coughing with sputum, encephalopathy, over the weekend .
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Resident had been having sob, coughing with sputum, encephalopathy, over the weekend .
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: I had the shot in my right arm but my left arm got really really sore. The right arm did get sore eventually. In the middle of the night I could barely move my left arm at all from the soreness of it. It resolved after a day or 2.