chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillain-Barré syndrome; This serious case was reported by a nurse via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain-Barré syndrome) (serious criteria GSK medically significant).The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.   It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 21-AUG-2023 A nurse practitioner reported that a patient developed Guillain-Barrre syndrome after receiving Shingrix.  The patient developed the syndrome after unspecified period after receiving Shingrix. This case had been linked with the case US2023AMR115224 reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR115224:1st dose, different patient, same reporter
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Endoscopy, Magnetic resonance imaging, Migraine
Clinical narrative: positive on Dec2021; positive on Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 16Jul2021 as dose 1, single (Lot number: EW0198), in left arm and on 06Aug2021 as dose 2, single (Lot number: EW0198) at the age of 15 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Crohns", start date: Jan2021 (ongoing). Concomitant medication(s) included: PENTASA oral taken for crohn's disease, start date: Jul2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "positive on Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2021) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient; different dose/ events;US-PFIZER INC-202300272469 same patient, same event, different dose;
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive on Dec2021; positive on Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 16Jul2021 as dose 1, single (Lot number: EW0198), in left arm and on 06Aug2021 as dose 2, single (Lot number: EW0198) at the age of 15 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Crohns", start date: Jan2021 (ongoing). Concomitant medication(s) included: PENTASA oral taken for crohn's disease, start date: Jul2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021, outcome "unknown" and all described as "positive on Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2021) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272460 same patient; different dose/ events;US-PFIZER INC-202300272469 same patient, same event, different dose;
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Accidental underdose, No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: No additional AE/; one of her very experienced was administering the vaccine into the deltoid of a 17 year old patient when she was sprayed with the dose.; it seems like the hub wasn't on like it normally is, the hub looks crooked; This spontaneous report was received from a nurse, concerning a 17-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were unknown by the reporter.  On 01-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe injection, product quantity: 1, lot #1775808, expiration date: 20-AUG-2023, administered intramuscularly for prophylaxis (dose was not provided). The reporter stated that while her "very experienced" was administering the vaccine into the deltoid of the patient, she was sprayed with the dose (occupational exposure to product, captured in MARRS#2308USA004789). She stated that "it seemed like the hub wasn't on like it normally was, the hub looked crooked" (syringe issue) (accidental underdose).  The gauge and size needle and syringe used were 25 gauge, 1 inch. The reporter stated that it did not spray from the insertion site where the needle was within patient arm, it came from the defective prefilled syringe.  No injuries and no adverse event were reported. ; Sender's Comments:  US-009507513-2308USA004789:
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP called to report that an expired dose of MMR II was given to a patient.; No further AE details; This spontaneous report was received from other health professional and refers to a 2-year-old female.  The patient's medical history, concurrent conditions and concomitant medications were not provided.   On 02-AUG-2023, the patient was vaccinated with an expired (expired product administered) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter, [Lot No. U023829 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)], expiration date reported as 30-JUL-2023, and confirmed upon internal validation], administered for prophylaxis (strength, and route of administration were not provided). The user of the device (conflicting information as product is not a device) was a repeat user/Health Care Professional, also, it had not been under temperature excursion (TE). The lot number and expiration date for sterile diluent were not provided. No further adverse event (AE) details were provided.
Sex: F
Vaccine: HPV9
Symptoms: Accidental underdose, Occupational exposure to product, Syringe issue
Clinical narrative: No additional AE/; one of her very experienced was administering the vaccine into the deltoid of a 17 year old patient when she was sprayed with the dose.; This spontaneous report was received from a nurse, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.  On 01-AUG-2023, while a very experienced nurse was administering hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe injection, product quantity: 1, lot #1775808, expiration date: 20-AUG-2023, into the deltoid of a patient (dose was not provided), she was sprayed with the dose (occupational exposure to product). She stated that "it seemed like the hub wasn't on like it normally was, the hub looked crooked" (syringe issue and accidental underdose, captured in MARRS#2308USA001096).  The gauge and size needle and syringe used were 25 gauge, 1 inch. The reporter stated that it did not spray from the insertion site where the needle was within patient arm, it came from the defective prefilled syringe.  No injuries and no adverse event were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA001096:
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE; MMR II expired vaccine given to a patient; This spontaneous report has been received from an administrator regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 21-AUG-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-RVAXPRO) injection, one time (valid lot number U024229 [expiration date 04-AUG-2023]) (dose, dose number, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (expired product administered). No side effects.   No further adverse event (AE).
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No further AE.; Medical assistant calls to report RECOMBIVAX pediatric dose given to a 28 year old. 8/24/2023.  No further AE.  No PQC.; This spontaneous report has been received from a medical assistant, regarding a 28-years-old female patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 24-AUG-2023, the patient was vaccinated with a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection, as prophylaxis (lot number: W025817, which was determined to be valid as syringe formulation, with an expiration date on 21-AMY-2025) (strength, dose, route and anatomical location of administration were not reported) (Inappropriate dose of vaccine administered).   No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE/PQC; Inbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX.  TE case filed under 02458467. AE details were provided by medical assistant. No symptoms reported. No additional AE/PQC.  ?    Names of vaccines invo; This spontaneous report has been received form a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 02-AUG-2023, the patient was vaccinated with an improperly storage first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, subcutaneously as prophylaxis (lot number: X006983, which was determined to be valid, with an expiration date on 07-MAR-2025) (strength, dose and anatomical location of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of -12.48 degrees Celsius for 1 hour and 30 minutes. There was a no previous temperature excursion reported.   No additional adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for patient that received VARIVAX during TE.  No additional AE.  No PQC.; HCP calling to report AE for patient that received VARIVAX during TE.  No additional AE.  No PQC.; This spontaneous report was received from a registered nurse referring to a 34-year-old female patient. The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On 10-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # W022293, expiry date: 13-JUN-2024, 1 dose for prophylaxis (route of administration was not provided) during temperature excursion (TE) (experienced product storage error). No additional adverse event reported.  Lot No. W022293 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 13-JUN-2024, but upon internal validation established as 13-JUL-2024.
Sex: U
Vaccine: UNK
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells Palsy) 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 20-May-2023, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) was resolving.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Months after covid shot on 20-May-2023 patient was presented with Bell's Palsy. For past 3 months patient was recovering from Bell's Palsy. Treatment medication was not reported. Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant) expected, AESI event of Bell's palsy, which occurred with unknown exact latency after a dose of Spikevax NOS (unknown COVID-19 vaccination schedule). The outcome of the event was reported as recovering. It was reported that months after covid shot, patient had Bell's Palsy. Patient was recovering from Bell's Palsy during approximately 3 months. The benefit-risk relationship of Spikevax NOS vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Somnolence
Clinical narrative: sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy"; Bnt162b2 (Dose 2, single), for Covid-19 immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy/feeling sleepy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like thing/flu like symptoms". Additional information: Patient was kind of sleepy and with a flu like thing for a little while which is pretty typical, he had that before with some of earlier Pfizer vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: severe involuntary movement in my hands, sometimes up my arms to include my shoulder and neck muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: before my first two immunizations. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DYSKINESIA (non-serious), outcome "unknown", described as "severe involuntary movement in my hands, sometimes up my arms to include my shoulder and neck muscles".  Additional information: the patient took the third (as) booster in Oct2021 and the patient's life hadn't been the same since. The patient had severe involuntary movement in the patient's hands, sometimes up to the patient's arms to include the patient's shoulder and neck muscles. The patient tried to report the vaccination injury, but it fell on deaf ears. The patient's quality of life had significantly decreased.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300144572 same reporter/patient/suspect product; different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear (tinnitus); This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Ringing in the ear (tinnitus)". It was unknown if therapeutic measures were taken as a result of tinnitus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 1, single (Lot number: FE3590) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300075974 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300285293 same reporter/patient/product, different dose/AE;
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 2, single (Lot number: PE3590) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Pfizer LOT number FE3590), administration date: 28Oct2021, when the patient was 63-year-old, for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300284611 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300075974 same reporter/patient/product, different dose/AE;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had Covid before my first two immunizations and once after; I had Covid before my first two immunizations and once after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: before the first two immunizations. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had Covid before my first two immunizations and once after". Additional information: Patient had Covid before the first two immunizations and once after. Patient stated "Covid was NOTHING to go through. Less than a cold."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypoaesthesia, Nerve injury, Pain
Clinical narrative: patient's arm went numb; pain; nerve damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), in 2016 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "patient's arm went numb"; PAIN (non-serious), outcome "unknown"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage".  Additional information: Co administration of flu and pneumonia vaccine, patient's arm went numb. Respondent described pain and nerve damage. He further indicated that there was a settlement between him and vaccine manufacturer (it sounds like he said SERVA).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: Death
Clinical narrative: Your vaccine caused my mother's death.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Your vaccine caused my mother's death.) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  Company Comment This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria events of death unknown days after a dose of mRNA-1273.  Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2023: Follow-up received and added reference number.; Reported Cause(s) of Death: Unknown cause of death
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was administered the ACTHIB 2 days ago but it was diluted with another diluent and not the one that came with the ACTHIB with no reported adverse event; Initial information received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient who was administered the vaccine HIB (PRP/T) vaccine [ACT-HIB] 2 days ago but it was diluted with another diluent and not the one that came with the ACTHIB with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar), Varicella Zoster Vaccine (Varicella Vaccine), Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) And Hepatitis A Vaccine (Hepatitis A Vaccine), all for Immunisation.  On 21-Aug-2023, the patient received a dose of 0.5 ml (Frequency = once) of suspect HIB (PRP/T) vaccine of standard strength powder and solvent for solution for injection (lot: UJ801AA, Expiry date: 05-OCT-2023) via intramuscular route in the right thigh for Prophylactic Vaccination (Immunisation), patient was administered the vaccine but it was diluted with another diluent and not the one that came with the ACTHIB with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: she accidentally administered an expired dose of ACT-HIB to one of their patients, with no reported adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient who experienced she accidentally administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2023, the patient received accidently an expired dose of 0.5 ml dose 4 of suspect standard strength HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: UJ739ABA, Expiry date: 10-Aug-2023) via intramuscular route in unknown administration site for Immunisation with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 guidelines. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Hyponatraemia, Malaise
Clinical narrative: Dx with COVID 1 week PTA, arrived with worsening symptoms and failed OP treatment (medrol zofran, cefdinir). Admitted for hyponatremia and AKI w/ COVID infection. Received O2, singulair, zinc. DC home on RA.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-MAY-2023, the patient started was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 14-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 17-MAY-2023, the patient started was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 12-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, administered for prophylaxis (strength, and route of administration were not provided), lot #U039722, expiration date: 15-DEC-2023 (discrepancy: lot# reported also as U0397722 and this lot# is not valid for varicella virus vaccine live [oka/merck] [VARIVAX]) (product storage error). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes. There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HBP called for AE regarding MMR II. Expired MMR II (expiry 08/13/2023) was administered to a patient on 08/17/2023. Patient is not reporting signs/symptoms of adverse effects. Permission to contact HCP was given. No additional AE/no PQC.; This spontaneous report was received from  an other reporter and refers to a patient of unknown age and gender..  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-AUG-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 2nd dose, lot #u025199, expiration date: 13-AUG-2023 (Expired vaccine used), albumin status rHA administered for prophylaxis (strength, dose and route of administration were not provided). The patient did not report signs/symptoms of adverse effects. No additional adverse event (AE) was reporter (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; received improperly stored vaccine.; This spontaneous report was received from a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 17-AUG-2023, the patient received one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection (lot #was reported as x009733, but established as X009733 per company guidelines, expiration date: 02-SEP-2024; strength and route were unknown) administered for prophylaxis.  Temperature excursion of this vaccine was 29 Fahrenheit degrees for 4 hours and 30 minutes. There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient has not reported signs/symptoms of adverse effects; Expired PROQUAD (08/02/2023) was administered on 08/21/2023; PROQUAD had undergone prior TE on 08/08/2023; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 21-AUG-2023, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection that had also undergone a temperature excursion (expired product administered, product storage error). (lot number w004028 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 02-AUG-2023), administered for prophylaxis (strength, and anatomical site of administration were not provided).
Age: 14.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: This agent reporting this administration as a misuse due to prescribing information age; No additional AE; Nurse calling to report misuse administration of MMR II to a patient over the age of 6 years old.  Nurse reporting that the patient in question is a new patient to their practice and reports that the patient has a history of MMR II being administered; This spontaneous report was received from a nurse referring to a 14-year-old patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.    In approximately 2015, when the patient was 6-year-old, he/she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).           On 09-MAR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 mL/two dose series, for prophylaxis (strength, route of administration, lot # and expiration date were not reported) (product administered to patient of inappropriate). Nurse stated that the patient was not in the care of their practice at the time of the administration of the  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine. Nurse stated that they were unaware of the patient's previous healthcare professional (HCP) information, or if the patient experienced any symptoms related to the off label use of the  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).The nurse reported this as a misuse due to prescribing information age recommendations for first and second dose administration ( product prescribing issue ). No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Pruritus, Vaccination failure
Clinical narrative: last year I got vaccinated against shingles and I still have the same problem/suspected vaccination failure; Last year I got vaccinated against shingles and I still have the same problem; I'm 3 years old and I still have the itch; I'm 3 years old/last year I got vaccinated against shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 3-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: last year I got vaccinated against shingles and I still have the same problem/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Last year I got vaccinated against shingles and I still have the same problem), pruritus (Verbatim: I'm 3 years old and I still have the itch) and inappropriate age at vaccine administration (Verbatim: I'm 3 years old/last year I got vaccinated against shingles).  The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles and pruritus were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 23-Aug-2023 The case was received from the patient via interactive digital media. The patient stated that good afternoon, he or she want to contact us and he or she need a phone number.  The patient stated that you treat the shingles problem.  Last year the patient got vaccinated against shingles and still had the same problem. The patient still had the itch.  The patient asked that how could he or she get rid of this problem. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: never got her 2nd dose due to Covid; This non-serious case was reported by a consumer and described the occurrence of social problem in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2021, in right arm).   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 social problem (Verbatim: I got my first shingles shot but didn't get back for my second within time, do I start over/she received her 1st dose of Shingrix around October 2021 (no specific date provided), and never got her 2nd dose due to Covid).  The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 19-Aug-2023 and 21-Aug-2023 The patient was not sure who administered the vaccine. The patient did not have any lot and expiry date. The patient received 1st dose and never get 2nd dose due to Covid, which led to social problem.  The patient was not asked for the follow up with the health care professional (HCP).
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was given to a 2-month-old patient instead of Dtap; Kinrix was given to a 2-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 21-AUG-2023, the patient received Kinrix. On 21-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was given to a 2-month-old patient instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Kinrix was given to a 2-month-old patient).  The outcome of the wrong vaccine administered 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: 21-AUG-2023 The reporter reported that the 2 months old patient received Kinrix vaccine instead of Dtap, which led to wrong vaccine administered and  inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter was unsure if patient was supposed to be given infanrix or pediarix. The reporter mentioned that patient did not had any prior doses of Dtap or IPV. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site vesicles, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: a 6-inch circular red rash around the injection site that is blistering; a 6-inch circular red rash around the injection site that is blistering; about 7 hours after receiving the Shingrix vaccine she developed a high fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, 7 hrs after receiving Shingrix, the patient experienced fever (Verbatim: about 7 hours after receiving the Shingrix vaccine she developed a high fever). On 19-AUG-2023, the patient experienced injection site rash (Verbatim: a 6-inch circular red rash around the injection site that is blistering) and injection site blisters (Verbatim: a 6-inch circular red rash around the injection site that is blistering). The outcome of the injection site rash, injection site blisters and fever were not resolved.   It was unknown if the reporter considered the injection site rash, injection site blisters and fever to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site blisters and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-AUG-2023 The patient self-reported this case. The patient reported about 7 hours after receiving the Shingrix vaccine she developed a high fever.  The patient still had a fever (on the day of reporting), but it was about 100 degrees.  The patient also reported, a day after the Shingrix vaccine, a 6-inch circular red rash around the injection site that was blistering.  The reporter consented to follow up and gave permission to contact health care professional (HCP).
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration of Bexsero second dose less than 1 month apart form the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Administration of Bexsero second dose less than 1 month apart form the first dose).  The outcome of the drug dose administration interval too short 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: 21-Aug-2023 Pharmacist administered Bexsero second dose less than 1 month apart. The reporter were on the car with no access to information regarding this adverse event.  The reporter accepted follow up email to her personal email. The patient received second dose earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: a 17-year-old patient received a dose of Infanrix on 29/Mar/2023; a 17-year-old patient received a dose of Infanrix on 29/Mar/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 29-MAR-2023, the patient received Infanrix. On 29-MAR-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 17-year-old patient received a dose of Infanrix on 29/Mar/2023) and inappropriate schedule of vaccine administered (Verbatim: a 17-year-old patient received a dose of Infanrix on 29/Mar/2023).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 22-Aug-2023 The pharmacist called to informed that the patient received a dose of Infanrix as 3rd dose of the series at an inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.  The reporter consented to follow-up.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 year old patient inadvertently received a dose of Boostrix; 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 8-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2LG35, expiry date 09-MAY-2025) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 year old patient inadvertently received a dose of Boostrix).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: Receipt Date: 22-AUG-2023 The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Encephalopathy, Hypertensive urgency, SARS-CoV-2 test positive
Clinical narrative: Admit for hypertensive urgency and encephalopathy in setting of COVID infection; tested + in ER. Did not require O2. Received vit-d, vit-b, singulair, zinc. Husband signed pt out.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state
Clinical narrative: Admitted for confusion 2/2 COVID infection. Did not require any specific therapy. Remained on RA. DC home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea, Faeces discoloured, SARS-CoV-2 test positive
Clinical narrative: Arrived for SOB, N, weakness and black stools. Dx with COVID 9 days PTA. Tested positive on arrival. Given O2 intermittently but did not require other target therapies. Treated for upper GIB. DC home.