chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose of Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 03-APR-2024, the patient received Bexsero (intramuscular). On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired dose of Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-APR-2024 The health care professional reported that the patient received the Bexsero vaccine which was expired one, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: a dose of Kinrix expired on 3/22 and was administered to a patient today 05April2024.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 05-APR-2024, the patient received Kinrix. On 05-APR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: a dose of Kinrix expired on 3/22 and was administered to a patient today 05April2024.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-APR-2024 The reporter was a medical assistant. The reporter reported that a dose of Kinrix expired was administered to a patient, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient was injected on the right deltoid an expired Bexsero vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 02-APR-2024, the patient received Bexsero (intramuscular, right deltoid). On 02-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: patient was injected on the right deltoid an expired Bexsero vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-APR-2024 The reporter stated that the patient was injected on the right deltoid an expired Bexsero vaccine, which led to expired vaccine used. No additional event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: HAD SLIGHT HEARING LOSS IN MY RIGHT EAR; RINGING IN MY EARS; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. Patient very healthy, with no prior history of bad health. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced had slight hearing loss in my right ear and ringing in my ears (dose series 1).  After receiving the vaccine, less than 2 weeks later patient noticed ringing in her ears. Now, almost 2 years and 7 months later, she still had ringing in her ears. It never went away. Patient goes for checkups yearly, and always up to date with all her preventative care. Looking back from when she received the vaccine, she was told to email this email address.  She had since seen multiple doctors, all which tell me there was no cure for tinnitus. She did not expose herself to loud music (concert etc), She was not diagnosed with anxiety or depression. She went to an ENT who had given her steroids within 6 weeks of onset of the tinnitus which did not work. She was checked for hearing loss, and it was reported that she had slight hearing loss in her right ear which to my knowledge. She was unaware as she can hear perfectly fine. She attributes her tinnitus to receiving the covid vaccine, and she would like to know next steps on what she can do to go about finding help to find a cure to reverse this awful side effect. The fact sheet was changed shortly after to add this side effect which to my knowledge at the time of receiving the vaccine, she did not know this side effect was even a long-term possibility. Now that it has been almost 2 years and 7 months since having received the vaccine, she had accepted that this was a part of my life now which was very unfortunate and she regret every day receiving this vaccine. If she could go back knowing this was going to happen to me, I would have never gotten it. I don't know what writing this email will accomplish, as all she could do to help her situation was write an email to this email address. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in my ears and had slight hearing loss in my right ear was not reported. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Completed suicide, Death, Gun shot wound
Clinical narrative: committed suicide, shot himself in the head and died; Gunshot wound; Information has been received from a physician concerning a 14-year-old male patient with no pertinent medical history and no drug allergies who was vaccinated intramuscularly with the first and second 0.5ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not reported) respectively on 02-APR-2012 and 04-JUN-2012. There was no concomitant medication.   On 07-JUN-2012 the patient committed suicide. He shot himself in head. Physician stated this young male was happy go lucky, healthy, and never had any psychiatric issues in the past. It was not known if the patient sought for medical attention. On 07-JUN-2012 the patient died of suicide.  The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, lot number and hospital name.  Additional information has been requested.  Follow-up information has been received from a physician via social media via a vendor on 03-APR-2024. On 04-JUN-2012, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection 0.5 ml, lot #1224AA (is an invalid lot number for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine), administered intramuscularly at left arm (LA) as prophylaxis (strength and expiry date not provided). On 07-JUN-2012, the patient died of suicide and gunshot wound.  This is one of several reports received from the same reporter.; Sender's Comments: , MERCK1206USA02932:Mfr number; Reported Cause(s) of Death: committed suicide, shot himself in the head and died; Gun shot wound
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Positive for Covid; Not feeling good and feels terrible; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for Covid) and FEELING ABNORMAL (Not feeling good and feels terrible) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive for Covid) and FEELING ABNORMAL (Not feeling good and feels terrible). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive for Covid) and FEELING ABNORMAL (Not feeling good and feels terrible) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medication not reported.  The patient had covid earlier but did not remember when it was and took Paxlovid at that time. It was reported that was vaccinated and had all of boosters. The patient was currently not feeling good and felt terrible. was thinking it was covid. The patient was notified that needs a valid prescription for to be enrolled and was referred to physician by the transferring agent. The patient verified the information provided by the transferring agent but clarified that tested twice and it was positive for Covid. The patient clarified that had Covid a few years ago and took Paxlovid at that time. It was shortly after we advertise for Paxlovid, it was that long ago. The patient had the Moderna Covid-19 vaccines, not Pfizer.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced pain in the arm and even after 3 years they still have the pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient experienced pain in the arm and even after 3 years they still have the pain in the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for an unknown indication.     No Medical History information was reported.   In 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced pain in the arm and even after 3 years they still have the pain in the arm). At the time of the report, PAIN IN EXTREMITY (Patient experienced pain in the arm and even after 3 years they still have the pain in the arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had a significant pain in arm with each shot and expected it was known side effect. After 2 to 3 years also patient still experiencing pain in arm. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2024: Live non-significant follow-up received: reference number was added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reported an injection site reaction and recovered from the injection site reaction before their next dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reported an injection site reaction and recovered from the injection site reaction before their next dose.) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reported an injection site reaction and recovered from the injection site reaction before their next dose.). At the time of the report, VACCINATION SITE REACTION (reported an injection site reaction and recovered from the injection site reaction before their next dose.) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.     No concomitant medications were reported. The patient reported injection site reaction was recovered before the next dose. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got Covid in October last year; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got Covid in October last year) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (got Covid in October last year). At the time of the report, COVID-19 (got Covid in October last year) outcome was unknown.            It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain that runs from the hand to the shoulder; This is a spontaneous report received from a Pharmacist from medical information team.  A 91-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain that runs from the hand to the shoulder". Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400083918 same product/event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain that runs from the hand to the shoulder; This is a spontaneous report received from a Pharmacist from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2022, outcome "not recovered", described as "pain that runs from the hand to the shoulder". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400083595 same product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: body hurt; felt lethargic; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US057135.  A 33-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (unknown manufacturer, dose 1), for COVID-19 immunization, reaction(s): "felt lethargic", "body hurt". The following information was reported: PAIN (non-serious), outcome "unknown", described as "body hurt"; LETHARGY (non-serious), outcome "unknown", described as "felt lethargic". Additional information: The day after injection, the patient felt lethargic and body hurt. she felt similar to what she felt after receiving her first COVID vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Peripheral swelling
Clinical narrative: hand, fingers and forearm are still a little swollen; This is a spontaneous report received from a Physician.  An adult male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Nov2023, outcome "not recovered", described as "hand, fingers and forearm are still a little swollen". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  Additional information: The physician stated received RSV vaccine 6 months ago (note his health system only uses "arexvy") so believe this adverse event pertains to a non-Pfizer vaccine. He said his hand, fingers and forearm are still a little swollen  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Moderna, dose number: 6; Vaccine brand: Pfizer /BioNTech, dose number: 5/Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: Git9694) at the age of 42 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 20Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Oct2023 as dose 6 (booster), single (Lot number: 3031280), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulphur" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2023, outcome "recovered", described as "Vaccine brand: Moderna, dose number: 6; Vaccine brand: Pfizer /BioNTech, dose number: 5/Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "recovered" (Apr2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 01Apr2024 to 05Apr2024. Clinical course: Patient was Tested negative for COVID once the Paxlovid course was completed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 43.0
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 Consumer or other non HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 28Mar2024 to 02Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
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 Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing) and no known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6203, Anatomical location: Arm Right), administration date: 08Mar2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER2613, Anatomical location: Arm Right), administration date: 29Mar2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: FF2593, Anatomical location: Arm Right), administration date: 21Oct2021, when the patient was 43-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: GH9694, Anatomical location: Arm Right), administration date: 15Sep2022, when the patient was 44-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered" (03Apr2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2024) Negative, notes: Tested Negative on the last day of taking Paxlovid; (Apr2024) Negative, notes: Tested negative again 2 days after completing Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 30Mar2024 to 03Apr2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: given her a shot above the area where it should be given it hurt so much; has given a shot above  the area that should have been given; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "given her a shot above the area where it should be given it hurt so much"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "has given a shot above  the area that should have been given".  Additional information: Patient mentioned covid vaccines and nurses responding to them with rashes. Patient was talking about Moderna and Pfizer vaccines not clarified during the call with one she was referring to when she mentioned rashes. Patient mentioned another incident with another pharmacist that they did not have a booster for 8 month so they decided to get it at (withheld) pharmacy because they had a little medical clinic, the pharmacist was in hurry and had given her a shot above the area where it should be given it hurt so much immediately then she checked online and find out that there is a specific spot where the shot should be given, he (pharmacist) had given a shot above the area that should have been given per caller mistakes had been made on her and her children because of know it all pharmacist.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: he had to "take it easy" or rest the next day; This is a spontaneous report received from a Consumer or other non HCP.  A male patient in his 40's 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 included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacture unknown), for covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "he had to "take it easy" or rest the next day". It was unknown if therapeutic measures were taken as a result of fatigue. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin disorder, Swelling
Clinical narrative: She got covered in rash on her entire body; it was very painful; Balls around her body; not just the regular rashes; it has been getting worse; Her skin also apply pressure through her arteries; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly patient received BNT162b2 (BNT162B2), on 11Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "She got covered in rash on her entire body; it was very painful"; SWELLING (non-serious), outcome "unknown", described as "Balls around her body; not just the regular rashes; it has been getting worse"; SKIN DISORDER (non-serious), outcome "unknown", described as "Her skin also apply pressure through her arteries".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: body hurt; felt lethargic; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US057135.  A 33-year-old female patient 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 hurt"; LETHARGY (non-serious), outcome "unknown", described as "felt lethargic". Batch/lot number is not provided, and it cannot be obtained.  Additional information: The day after injection she felt lethargic and her body hurt. She felt similar to what she felt after receiving her first Covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400083959 same patient and AE, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy in feet going up the legs; This is a solicited report received from a Consumer or other non HCP. Other Case identifier(s): 2024BI01259146.  A 71-year-old female patient 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy in feet going up the legs".  The reporter's assessment of the causal relationship of "neuropathy in feet going up the legs" with the suspect product(s) BNT162b2 omi xbb.1.5 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The reasonable possibility that the event neuropathy peripheral is related to BNT162B2 OMI XBB.1.5 administration cannot be excluded completely. However, information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Skin itching throughout my body; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 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: PRURITUS (non-serious) with onset 2023, outcome "unknown", described as "Skin itching throughout my body". Additional information: The patient reported he/she had under skin itching throughout the body since shortly after he/she received the "omnicron booster" in 22Sep. They need to speak with someone regarding the booster side effects as soon as possible.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered Typhim Vi to a patient 3 days after the expiration date, with no reported adverse event; Initial information received on 03-Apr-2024 regarding an unsolicited valid  non-serious case received from a Physician.  This case involves female patient (age unknown) who was administered Typhoid VI Polysaccharide Vaccine [Typhim VI] 3 days after the expiration date, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Mar-2024, the patient was administered Typhoid VI Polysaccharide Vaccine (Solution for injection) (expiry date: 26-Mar-2024, lot number, strength, route, administration site: not reported) for Prophylactic vaccination after the expiration date, with no reported adverse event (expired product administered) (latency: same day).  Information regarding batch number will be requested in this case.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering expired pentacel to a pediatric patient with no reported adverse event; Initial information received on 05-Apr-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a child patient of an unknown age and gender who had administered expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] to a pediatric patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a expired unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization (expired product administered) (same day latency).  Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: one of the staff members had given an 11-year-old patient daptacel instead of adacel with no reported adverse event; Initial information received on 10-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient and one of the staff members had given patient Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization) (wrong product administered) (same day latency). Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Hypoaesthesia, Muscle swelling, Paraesthesia
Clinical narrative: Swealing of the muscle area for 6 plus months with numbness and tingling.
Age: 71.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric/Adolescent dose administered to an adult.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test abnormal, Visual impairment
Clinical narrative: Per patient, visual abnormalities began to be experienced approximately 1 week after receiving the vaccine. Patient stated that since receiving the vaccine he has experienced an increase in visual abnormalities. In addition, patient states that blood coagulation abnormalities appeared on subsequent bloodwork done. Patient states that he is positive for GD1b antibodies as well as GQ1b antibodies from bloodwork performed around March of 2024. Patient states his symptoms align with those associated with miller fisher syndrome (GBS). Patient states his visual disturbances experienced align with those associated with ophthalmoplegia and believes that the Novavax vaccine received in Nov 2023. He is in the process of seeking a formal medical diagnosis from his primary care physician and ophthalmologist.
Age: 51.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine before indicated.  Patient is only 51 years old.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye oedema, Eye swelling, Mouth swelling, Swelling face
Clinical narrative: Routine 4 y.o. vaccines were given around 10:40 a.m. Mom called around 3:45 p.m. stating that pt's eyes were swelling. Pt came back in the clinic with bilateral edema of the eyes. He also presented with slight swelling of the right side of the face and mouth. No sire reaction, breathing issues or other reactions noted. No sure if this reaction was from the vaccines or some other external factors. BP upon re-arrival to the clinic was 94/52. Pt was given 6.5 mL of oral Benadryl from parent before returning to the clinic. In clinic, pt received 1 tsp of prednisone (15mg/5mL) and was kept for observation for an additional hours. Pt was sent home with a prescription for oral steroids to take for the next 3 days and an epipen. Parents aware that if symptoms progressed through the night to take to Hospital ED. An Infection Disease referral was also placed with Dr. at Allergy and Asthma and pt was followed up by phone call the next day.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Apnoea, Cyanosis, Electroencephalogram normal, Magnetic resonance imaging head abnormal, Oxygen saturation decreased
Clinical narrative: Cyanosis, apnea admit to local hospital, transfer to higher level of care after ongoing desaturation and apnea events
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Subdural effusion
Clinical narrative: Cyanosis, apnea admit to local hospital, transfer to higher level of care after ongoing desaturation and apnea events
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Perioral dermatitis, Rash, Rash pruritic, Skin exfoliation
Clinical narrative: Dry Ichy, scaling skin Rash Around mouth & Forehead (check area).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Did Not Show Immunity After Anti-HBs Serologic Testing; Initial report received on 19-Mar-2024.  A nurse in the reported that an immunocompromised adult patient (age, gender, race, and ethnicity not provided) received ENGERIX-B and HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not show immunity after hepatitis B surface antibody serologic testing.  The patient was immunocompromised.  The patient was not on pre-dialysis or dialysis. concomitant medications were not reported.   On an unknown date,  the patient received ENGERIX-B (lot number, expiration date, NDC number, injection site, and route of administration unknown).  On an unknown date, the patient received HEPLISAV-B (lot number, expiration date, NDC number, injection site, and route of administration unknown ).   On an unknown date, the patient did not show immunity after hepatitis B surface antibody serologic testing.  The reporter declined to provide further information.  Company Comment: The company assessed the event as non-serious and not immunologically confirmed since dosing schedule and time to serological titer were not specified.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed since dosing schedule and time to serological titer were not specified.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adnexa uteri pain
Clinical narrative: It [HPV vaccine] affects my ovaries/my ovary feels like it's on fire; It [HPV vaccine] affects my ovaries/my ovary feels like it's on fire; product origin unknown; This Literature marketed report was received from the authors in a published literature article titled as stated below, concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) intramuscular injection (strength, lot #, expiry date, and route of administration were not provided); or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection strength, lot #, expiry date, and route of administration were not provided) (reported as an unspecified human papillomavirus (HPV) vaccine), both administered as prophylaxis (Product origin unknown).   On an unspecified date, the patient experienced an adverse reaction. It was reported that the unspecified HPV vaccine affected her ovaries, every month when she ovulated, she could tell which one was ovulating, and for about a week every month, her ovary felt like it was on fire. (Ovarian disorder; Adnexa uteri pain). At the time of reporting, the patient had not recovered from the events.   The reporter considered the events of ovarian disorder and adnexa uteri pain to be related to the vaccination with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 Month Old Received Heplisav-B; Initial report received on 14-Feb-2024.  A physician in the reported that a 4-month-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 14-Feb2024, the patient received the first dose of HEPLISAV-B (lot #, expiration date, site, route, and NDC # not reported) from a physician.  The patient was 4 months old when she received the dose. There were no side effects reported.  No additional information was reported.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Pregnancy; Inappropriate schedule of vaccine administered; Initial report received on 14-Feb-2024.  A patient reported to the HEPLISAV-B pregnancy registry that she, a female, (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.   No relevant medical history was reported.     No relevant concomitant medications were reported.     In Nov-2023, the patient received the first dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported). On 14-Feb-2024, the patient received the second dose of HEPLISAV-B (lot #, expiration date, NDC #, route, and site not reported). The patient is currently pregnant. The registry was closed to all new enrollments.   No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: 15 Weeks Pregnant and Received Heplisav-B; Initial report received on 19-Feb-2024.  A pharmacist in the reported that a 30-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 15 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 20-Jan-2024, the patient received the first dose of HEPLISAV-B (lot # 945139, expiration date 22-Jan-2026, and NDC # 43528-003-01) intramuscularly in the left deltoid from a pharmacist.  The patient was 15 weeks pregnant.    No additional information was reported.    Company Comment The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient Received First Dose On 02/05/2024, and The Second Dose Two Weeks Later; Initial report received on 22-Feb-2024.  A registered nurse in the reported that a 28-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization then received the second dose 15 days after the first.  No relevant medical history was reported.  The patient has no known allergies.  No relevant concomitant medications were reported.    On 05-Feb-2024, the patient received the first dose of HEPLISAV-B (lot # 945139, expiration date 22-Jan-2026, and NDC # 43528-003-01) intramuscularly in the left deltoid from a nurse.   On 20-Feb-2024, 15 days after the first dose, the patient received the second dose of HEPLISAV-B (lot # 945139, expiration date 22-Jan-2026, and NDC # 43528-003-01) intramuscularly in the right deltoid from a nurse.  No adverse reactions were reported.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received First Dose on September 18, 2023 and The Second Dose On January 24, 2024; Initial report received on 26-Feb-2024.  A pharmacist in the reported that a 31-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 18-Sep-2023 and the second dose approximately four months later on 24-Jan-2024.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 18-Sep-2023, the patient received the first dose of HEPLISAV-B (lot # 943011, expiration date 31-Oct-2025, and NDC # 43528-003-05; route and site not specified) from a pharmacist.   On 24-Jan-2024, 128 days after receiving the first dose, the patient received the second dose of HEPLISAV-B (lot # 943010, expiration date 31-Oct-2025, and NDC # 43528-003-05; route and site not specified) from a pharmacist.   No additional information was reported.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Received Series With Heplisav-B, and The Second Dose of Engerix-B; Initial report received on 13-Mar-2024.  A nurse in the reported that a 25-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B for the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 06-Nov-2023, the patient received the first dose of hepatitis B vaccine, HEPLISAV-B (lot # 943241, expiration date 07-Sep-2025, and NDC # 43528-002-01) intramuscularly in the left deltoid.   On 30-Jan-2024, 86 days after having been vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (lot #, expiration date, and NDC # not reported) intramuscularly in the left deltoid. No adverse events were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.