chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects; Nurse calling to report an adverse event regarding PROQUAD.  Nurse states that a patient in their care who is being seen today (7/31/2024) at their clinic for a follow up vaccination appointment has a documented administration of PROQUAD on 11/6/2023; This spontaneous report was received from a nurse, concerning a 16-year-old patient of unknown gender.   The patient's medical, concurrent conditions and concomitant therapies were not reported.   On 16-NOV-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter/ two dose series, (lot #X019554, expiration date: 19-JAN-2025) (albumin status: recombinant human albumin (rHa)), administered for prophylaxis (strength, and route of administration were not provided). The patient was 16-year-old when vaccinated, below the recommended age of administration (Inappropriate age at vaccine administration).   The nurse stated that the patient had a documented administration of the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD from another physician's practice, and confirmed that the patient has not reported any medical concerns or symptoms after the administration. Nurse stated that the patient has not received  any other measles, mumps, rubella or varicella containing vaccines in their history.   On 31-JUL-2024 (also reported as "today"), the patient went to the clinic for a follow up vaccination appointment and reported the above information.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; MMR II inadvertently was administered on 8/1/2024 after its labeled expiry date; This spontaneous report was received from a Medical assistant referring to a 14 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 01-AUG-2024, the patient was vaccinated with an expired dose of (expired product administered) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, lot # W023508, expiration date: 25-JUL-2024, albumin status: rHA (strength, route and anatomical location were not provided) for prophylaxis.    The primary reporter confirmed no temperature excursion has occurred. No adverse event event reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster infection neurological, Vaccination failure
Clinical narrative: Suspected vaccination failure; it has returned; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster infection neurological (chronic shingles in a nerve distribution in her neck).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster infection neurological (Verbatim: it has returned) (serious criteria GSK medically significant). The outcome of the vaccination failure and herpes zoster infection neurological were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster infection neurological to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the herpes zoster infection neurological to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-JUL-2024 The patient self-reported this case for herself. The patient was healthy active. The patient had the two shot vaccine in 2019 and was free of breakouts until the time of reporting.  The patient stated that, it had returned.  The patient asked should she get another set of vaccines. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix (1st dose)and Shingrix(2nd dose)
Sex: U
Vaccine: COVID19, FLUX, RVX
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; This serious case was reported by a physician via call center representative and described the occurrence of polymyalgia rheumatica in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine (unknown arm), Influenza vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced polymyalgia rheumatica (Verbatim: polymyalgia rheumatica) (serious criteria GSK medically significant). The outcome of the polymyalgia rheumatica was not reported.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to RSV vaccine.     The company considered the polymyalgia rheumatica to be unrelated to RSV vaccine.   Additional Information: GSK Receipt date: 31-JUL-2024  A reporter reported that a patient was given a prescription for Shingrix, patient took prescription to Publix and was given RSV vaccine, Flu and Covid vaccines at the same visit in separate arms and sites. Patient was diagnosed with polymyalgia rheumatica post administration by prescribing physician. It was unknown if the reporter considered the polymyalgia rheumatica to be related to Flu and Covid vaccine.; Sender's Comments: Polymyalgia rheumatica  is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 30-JUL-2024 The reporter reported that among 28 reports of Guillain-Barre syndrome, 11 occurred following receipt of the Axrevy vaccine and 17 occurred following receipt of the Abrysvo vaccine. The case is linked with US2024AMR096100 and US2024AMR096242, same reporter.; Sender's Comments: Guillain barre syndrome  is an unlisted event which is considered unrelated to GSK vaccine Arexvy US-GSK-US2024AMR096242: US-GSK-US2024AMR096100:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills and fever; Chills and fever; This non-serious case was reported by a consumer and described the occurrence of fever in a 76-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease and clot blood. Concomitant products included apixaban (Eliquis) and empagliflozin, linagliptin (Elipta).   On 25-JUL-2024, the patient received Shingles vaccine. On 25-JUL-2024, less than a day after receiving Shingles vaccine, the patient experienced fever (Verbatim: Chills and fever) and chills (Verbatim: Chills and fever). The outcome of the fever and chills were not resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     It was unknown if the company considered the fever and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 26-JUL-2024  The patient self-reported. The symptoms were not treated.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: the vial and SHINGRIX splashed onto the nurse face and chest; Exposure via skin contact; Stopper at the neck of the vial; Pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: the vial and SHINGRIX splashed onto the nurse face and chest), exposure via skin contact (Verbatim: Exposure via skin contact), product container leak (Verbatim: Stopper at the neck of the vial) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, exposure via skin contact, product container leak and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2024 and 23-JUL-2024 The reporter states that when she went to reconstitute the Shingrix the vial was leaking around the stopper. Also, the nurse stated that when she went to withdraw the reconstituted Shingrix there was so much force that the syringe pushed out of the vial and Shingrix splashed onto the nurse face and chest, which led to occupational exposure via skin contact with product and exposure via skin contact. The customer removes only the plastic flip-off before handling. During preparation the defect was discovered. The leak was coming from the stopper at the neck of the vial. Reported defect was classified as vial stopper integrity issue.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: patient received 2 Tdap (Boostrix) vaccines during pregnancy; patient received 2 Tdap (Boostrix) vaccines during pregnancy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Boostrix and the 1st dose of Boostrix. On an unknown date, not applicable after receiving Boostrix and an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient received 2 Tdap (Boostrix) vaccines during pregnancy) and vaccine exposure during pregnancy (Verbatim: patient received 2 Tdap (Boostrix) vaccines during pregnancy). The outcome of the extra dose administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 23-JUL-2024 The pharmacist reported patient received 2 Tdap (Boostrix) vaccines during pregnancy, which led to extra dose administered nd vaccine exposure during pregnancy. Did not consent to follow-up. .
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: underdose; Patient received Tdap instead of DTaP for 4th dose of series./a patient received a dose of Boostrix instead of the programmed Dtap vaccine; This non-serious case was reported by a pharmacist and described the occurrence of underdose in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HA9CH, expiry date 13-JUL-2024) for prophylaxis.   On 22-JUL-2024, the patient received the 1st dose of Boostrix .5 ml. On 22-JUL-2024, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: underdose) and inappropriate age at vaccine administration (Verbatim: Patient received Tdap instead of DTaP for 4th dose of series./a patient received a dose of Boostrix instead of the programmed Dtap vaccine). The outcome of the underdose and inappropriate age at vaccine administration were 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: 23-JUL-2024 The patient received Tdap instead of DTaP for 4th dose of series. The dose was given to a 3 year old patient, which led to underdose and inappropriate age at vaccine administration.
Age: 0.92
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotarix vaccine, to an 11 months old today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received Rota (Rotarix liquid formulation) (batch number GG2YF, expiry date 18-OCT-2025) for prophylaxis.   On 24-JUL-2024, the patient received the 2nd dose of Rotarix liquid formulation. On 24-JUL-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: Rotarix vaccine, to an 11 months old today). The outcome of the inappropriate age at vaccine administration 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: 24-JUL-2024 A Rotarix vaccine administered to an 11 months old patient, which led inappropriate age at vaccine administration. The reporter reported they just wondering what to do because it was not recommended to an 11 months old. The reporter consented to follow up.
Age: 31.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix); Infanrix administered at 31 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 31-year-old patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration of DTAP (Infanrix) instead of TDAP (Boostrix)) and inappropriate age at vaccine administration (Verbatim: Infanrix administered at 31 years of age). The outcome of the wrong vaccine administered was unknown and the outcome of the inappropriate age at vaccine administration was not reported.   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: 24-JUL-2024 The pharmacist reports that a patient has been administered with an Infanrix vaccine instead of a Boostrix by mistake, which led wrong vaccine administered. The Infanrix was administered at not as per recommended age, which led inappropriate age at vaccine administration. The reporter asks for their best course of action since the centers for disease control and prevention did not have any guidance about this situation, so he wanted to double check with us for any information available. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose 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 18-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 25-JUL-2024, the patient received the 1st dose of Bexsero. On 25-JUL-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired dose 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: 25-JUL-2024 Caller reported that he gave a Bexsero vaccine and noticed that was expired which led to expired vaccine used. So, what I wanted to know was did this vaccine still account or was going to be less effective or was not consider account at all.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site oedema, Pyrexia
Clinical narrative: Edema at injection site; Inability to lift left arm or use left hand/could not lift her left arm or use her left hand; fever; headache; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site edema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included splenectomy.   In MAY-2023, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. In MAY-2023, immediately after receiving Shingrix, the patient experienced injection site edema (Verbatim: Edema at injection site), injected limb mobility decreased (Verbatim: Inability to lift left arm or use left hand/could not lift her left arm or use her left hand), fever (Verbatim: fever), headache (Verbatim: headache) and chills (Verbatim: chills). The outcome of the injection site edema, injected limb mobility decreased, fever, headache and chills were resolved (duration 6 days).   It was unknown if the reporter considered the injection site edema, injected limb mobility decreased, fever, headache and chills to be related to Shingrix.     It was unknown if the company considered the injection site edema, injected limb mobility decreased, fever, headache and chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR094516   Additional Information: GSK Receipt date: 26-JUL-2024  The patient self-reported. She received first dose of suspect vaccine in May of 2023 and immediately after first dose she could not lift her left arm or use her left hand.  Also, after first dose she immediately had edema in her left injection site, chills, headache, and fever.  Symptoms after first dose of suspect vaccine resolved in 6 days.  Patient reported she had no spleen since 2008 due to complications during a colonoscopy.; Sender's Comments:  US-GSK-US2024AMR094516:same reporter 2nd dose
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: delayed her second dose because she did not want to get off methotrexate; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 08-NOV-2023). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: delayed her second dose because she did not want to get off methotrexate). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-JUL-2024 The reporter report that patient who  got  1st dose of Shingrix had been on oral Methotrexate.   The pharmacist shared that the patient started methotrexate 2 weeks after she got the first dose of Shingrix. Pharmacist reported patient delayed her second dose because she did not want to get off Methotrexate. Pharmacist believed she was taking it for Rheumatoid Arthritis. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she forgot to have her second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12-MAR-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she forgot to have her second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2024 The patient self-reported this case. The patient received her first dose of Shingrix and had forgot to have her second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired dose of Shingrix on July 29th 2024. Dose expired on May 21th 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF, expiry date 21-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received on 02-OCT-2013).   On 29-JUL-2024, the patient received Shingrix. On 29-JUL-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired dose of Shingrix on July 29th 2024. Dose expired on May 21th 2024.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2024 Pharmacist stated they accidentally administered an expired dose of Shingrix, which led expired vaccine used. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: woke up this morning with the shivers and shakes; woke up this morning with the shivers and shakes; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivers in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-JUL-2024, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 31-JUL-2024, 1 days after receiving Shingrix, the patient experienced shivers (Verbatim: woke up this morning with the shivers and shakes) and tremor (Verbatim: woke up this morning with the shivers and shakes). The outcome of the shivers and tremor were not resolved.   It was unknown if the reporter considered the shivers and tremor to be related to Shingrix.     It was unknown if the company considered the shivers and tremor to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2024 The reporter was the patient's mother. The patient received her 2nd dose of the shingles vaccine yesterday (day before reporting). The reporter could not verify product with a lot number and did not know the site of administration. The reporter stated her daughter told her that she woke up this morning (on the day of reporting) with the shivers and shakes. The symptoms had not resolved.
Age: 6.0
Sex: U
Vaccine: COVID19, DTAPIPV, HEPA, PNC15, VARCEL
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml; the patient developed after vaccine no  noticeable side effects besides achy shot site; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml) and VACCINATION SITE PAIN (the patient developed after vaccine no  noticeable side effects besides achy shot site) in a 6-year-old patient of an unknown gender who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. AU5558B) for COVID-19 prophylaxis.    Co-suspect products included non-company products QUADRACEL for Prophylactic vaccination, HEPATITIS A VACCINE INACT (VAQTA) for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Prophylactic vaccination.    No Medical History information was reported.   On 26-Oct-2023, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use) .5 milliliter, fifth dose of QUADRACEL (Intramuscular use) 1 dosage form, first dose of HEPATITIS A VACCINE INACT (VAQTA) (Intramuscular use) 1 dosage form, first dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and second dose of VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) (Subcutaneous use) 1 dosage form. On 26-Oct-2023, the patient experienced ACCIDENTAL OVERDOSE (the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml) and VACCINATION SITE PAIN (the patient developed after vaccine no  noticeable side effects besides achy shot site). At the time of the report, ACCIDENTAL OVERDOSE (the vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/ was given 0.5 ml when it should have been 0.25 ml) and VACCINATION SITE PAIN (the patient developed after vaccine no  noticeable side effects besides achy shot site) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability
Clinical narrative: fussy that night after vaccines; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of IRRITABILITY (fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for Prophylactic vaccination.    Co-suspect products included non-company products PENTACEL for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.    Concurrent medical conditions included Plagiocephaly ((Improving) since 12-Jan-2023), Teething and Cough (at the time of vaccination and up to one month before). Concomitant products included IBUPROFEN for Teething, VITAMINS NOS for an unknown indication.   On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of PENTACEL (unknown route) 1 dosage form, third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (unknown route) 1 dosage form. On 09-Jun-2023, the patient experienced IRRITABILITY (fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, IRRITABILITY (fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that post puncture vial was initially stored in the refrigerator on 01-Jun-2023 and it was also reported that twelve hours post puncture vial was initially stored in the refrigerator, first punctured date was on 08-Jun-2023 and vial was administered on 09-Jun-2023. Patient experienced fussy that night after vaccines. It was not reported if the patient received a corrective treatment for the event fussy that night after vaccines.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: lung disease; This is a spontaneous report received from a Physician, Program ID:.  A female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21May2023 as dose number unknown, single (Lot number: GJ3270) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), 5 weeks after the suspect product(s) administration, outcome "unknown", described as "lung disease".  Additional information  The patient received on 21May2023 and five and half weeks got very sick. The patient inquired if there were other reports of lung disease following the vaccination.    No follow-up attempts are possible.
Sex: U
Vaccine: MEN
Symptoms: No adverse event, Underdose
Clinical narrative: partial dose of menquadfi administered with no reported adverse event; Initial information received on 30-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and reporter stated partial dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site as Prophylactic Vaccination (immunization) and partial dose of menquadfi administered with no reported adverse event (incorrect dose administered) (latency: same day).  Information regarding batch number and expiration date corresponding to the one at time of event was requested.  Reportedly, Caller reporting during administration of MENQUADFI, a safety vanish syringe was being used and the provider administering popped the plunger down at the end causing the needle to retract prior to patient receiving full dose of medication. Caller reporting some of the liquid stayed in the syringe and some may have leaked out, reporting unknown as to how much of the product was received.   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: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: could happen if the diluent (lyophilized vaccine component ACTHIB vaccine) was the only one given and not the powder with no adverse event; Initial information received on 01-Aug-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown gender child for whom it could happen if the diluent (lyophilized vaccine component acthib vaccine) was the only one given and not the powder with no adverse event with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Powder and suspension for suspension for injection via unknown route in unknown administration site for Immunization (strength, dose, batch number and expiry date unknown) could happen if the diluent (lyophilized vaccine component acthib vaccine) was the only one given and not the powder with no adverse event (single component of a two-component product administered) (latency same day).  Information on batch number corresponding to the one at time of event occurrence 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: M
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information received on 01-Aug-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 11 years old male patient who experienced allergic reaction after receiving vaccine Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel].  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 dose of suspect DIPHTHERIA-Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date the patient developed a allergic reaction (hypersensitivity) (unknown latency) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report as received from Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 29-JUL-2024, the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, lot # y002062, expiration date: 09-JAN-2026 (strength, dose number, route and anatomical location were not provided) for prophylaxis.      The temperature excursión was -12.13°C and time frame was: 19 minutes and there was no previous temperature excursión. No adverse event reported.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient was administered the initial dose of GARDASIL 9 in 2019 at 11 years old (exact date unknown by reporter) and returned to clinic 5 years later inquiring about the second dose they had never received; No symptoms reported/No AE/PQC; This spontaneous report was received from a pharmacist regarding to a 16-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date in 2019 (exact date unknown by reporter), the patient was vaccinated with the first dose of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (mL) (strength, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis.   It was stated that the patient returned to clinic 5 years later inquiring about the second dose they had never received (inappropriate schedule of product administration). No symptoms reported. No AE/PQC (no adverse event). No further information provided.  Lot number is being requested and will be submitted if received.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex, Pain, Pruritus, Swelling face
Clinical narrative: stabbing pain right side forehead; itching on forehead; bump on forehead; Herpes simplex migrated to the opposite side of his body; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2024). Concurrent medical conditions included herpes simplex.   On 08-APR-2024, the patient received the 2nd dose of Shingrix. On 19-JUL-2024, 102 days after receiving Shingrix, the patient experienced herpes virus infection (Verbatim: Herpes simplex migrated to the opposite side of his body). On an unknown date, the patient experienced forehead headache (Verbatim: stabbing pain right side forehead), pruritus facial (Verbatim: itching on forehead) and local swelling (Verbatim: bump on forehead). The outcome of the herpes virus infection, forehead headache and pruritus facial were unknown and the outcome of the local swelling was not reported.   It was unknown if the reporter considered the herpes virus infection, forehead headache, pruritus facial and local swelling to be related to Shingrix.     It was unknown if the company considered the herpes virus infection, forehead headache, pruritus facial and local swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2024 The patient reported that he had a 35 year history of herpes simplex (per his doctor) outbreaks frequently occurring on the right side of his forehead. The patient received his first dose of Shingrix on 8th January 2024, 2nd dose on 8th April 2024. He stated that he had experienced stabbing pain on the right side of his head with itching for the past 3 to 4 months. These episodes are short in duration, approximately 15 seconds. It was happening intermittently about two times per week. In June, 2024 the pain began on the right side of his head as per usual, then moved to the middle and finally to the left side of his head. On July 19 he noticed a bump on the left side of his forehead in the exact opposite location from the previous lesions on the other side of his forehead. It then turned into an identical outbreak as the one usually seen on the other side of his forehead. He stated that this most recent outbreak of simplex was significantly weaker than those he has experienced for the past 35 years. His questions was whether Shingrix could cause those type lesions to migrate to the opposite side. The patient was a former employee of GlaxoSmithKline. He stated that he was always willing to speak with Safety or any other personnel to help GlaxoSmithKline understand this issue if needed. He had not recently seen his doctor, but does give consent to contact him. He will see him in 5 months.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Crying, Loss of consciousness, Syncope, Tremor
Clinical narrative: The patient fainted and started shaking for about 3 to 5 seconds about 1 to 2 minutes after receiving both vaccinations. She regained consciousness less than a minute after and started crying. The patient was really scared and nervous prior to receiving the vaccinations. Paramedics arrived in less than 10 minutes and checked all her vitals; everything was normal. The paramedics asked the mother if they want to go to the ER for further tests but the mother refused and said it was fine.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis, Blood test, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: 12 days after vaccination she had a seizure (never had one before this). 19 days later she was diagnosed with ADEM autoimmune disease. This was diagnosed after having a fever that persisted for over 9 days. Multiple blood tests, an x-ray, 2 lumbar punctures, and 3 MRIs were performed to confirm diagnosis.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, X-ray
Clinical narrative: 12 days after vaccination she had a seizure (never had one before this). 19 days later she was diagnosed with ADEM autoimmune disease. This was diagnosed after having a fever that persisted for over 9 days. Multiple blood tests, an x-ray, 2 lumbar punctures, and 3 MRIs were performed to confirm diagnosis.
Age: 5.0
Sex: M
Vaccine: HEP, HEPA, IPV, VARCEL
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Hyperhidrosis, Oxygen saturation decreased
Clinical narrative: about twenty minutes after vaccines were given patient became pale, sweaty, dizzy, and faint. Dad notified staff Dr. was alerted and instructed me (MA) to get vitals and check glucose. BP and o2 were low . Patient did not have breakfast that morning Dr. gave Gatorade and vitals were taken every 5 minutes. They improved and patients color became normal.  Vitals were taken 3 times at 5 minute intervals until Dr. determined patient was able to leave.  Dr. instructed parents on how to monitor patient and when to seek medical attention .
Age: 5.0
Sex: M
Vaccine: HEP, HEPA, IPV, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: about twenty minutes after vaccines were given patient became pale, sweaty, dizzy, and faint. Dad notified staff Dr. was alerted and instructed me (MA) to get vitals and check glucose. BP and o2 were low . Patient did not have breakfast that morning Dr. gave Gatorade and vitals were taken every 5 minutes. They improved and patients color became normal.  Vitals were taken 3 times at 5 minute intervals until Dr. determined patient was able to leave.  Dr. instructed parents on how to monitor patient and when to seek medical attention .
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Rash erythematous, Skin warm, Swelling face, Urticaria
Clinical narrative: Patient came into our Clinic after getting the MMRV vaccine at the local Health Department. He had face swelling with red rash and white spots that kept popping up during the visit had welts all over body that were red and hot to the touch
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Amblyopia, Asthenia, Blood test, Fine motor skill dysfunction, Gait inability
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Gastrointestinal tube insertion, Guillain-Barre syndrome, Hypotonia, Immunoglobulin therapy, Inability to crawl
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Intensive care, Lumbar puncture, Magnetic resonance imaging, Malaise, Mobility decreased
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Muscular weakness, Musculoskeletal disorder, Nasopharyngitis, Rhinorrhoea, Social avoidant behaviour
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again