chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Dec 7, approximately 7:30 pm, injection site hard, inflamed, red, and hot to the touch. Neck and Left arm pain. Swollen Lymph node in left axilla.  Dec 8-  approximately 6-7 am sluggish and short of breath at work. approximately 10:30 am sent to ER with shortness of breath and chest pain. Diagnosed with left sided costochondritis. Treatments Dec 8-14 Tylenol/Ibuprofen, Ice, rest, stretching. Dec 14 Diagnosed with costochondritis and intercostal neuritis new medications: Methylprednisolone DosePack, lyrica 25mg capsule. Seven Ortholazer treatments throughout December, Intercostal nerve blocks to T8, T9, T10 on Jan 29th 2024.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given high dose flu when patient should have had regular Flulaval (patient 62)
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Injection site nodule
Clinical narrative: Patient reports feeling a "knot" after vaccine was administered.
Age: 11.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product supply issue, Wrong product administered
Clinical narrative: Patient was given a Dtap although she is 11 years old.  She should have received a Td or, in the alternative, a Tdap due to the limited supply of Td.  The patient did not have an adverse reaction.  She received the wrong vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with covid
Age: 80.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Confusional state, Malaise, Pyrexia
Clinical narrative: Patient received Spikevax Moderna and Fluzone High dose quadrivalent on same day. Patient stated about 6 hours later he began to not feel well. He developed a fever and stated he was "out of it" (had confusion). Paramedics was called and patient was taken to hospital. Patient states hospital never gave him a definitive diagnosis of what was wrong with him, but recommended for him not to get 2 vaccines at once in the future.  Patient thinks he recovered within 24 to 36 hours, but his caregiver thinks it could have been up to 3 days. Patient believes it was less than 3 days in hospital.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given unnecessary 3rd flu vaccine. Patient stayed in office for 15 minutes no symptoms or side effects. Consulted with provider and  informed parent.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Mom states patient had redness, swelling, and hot to the touch on left arm. was concerned and was seen at urgent care. Mother states she was prescribed prednisolone and cream.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient given Meningococcal B instead of MenQuadfi. No treatment needed.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: 3 days after vaccine; burning pain on right and left arm
Age: 27.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: none that we are aware of
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received to covid vaccines, one in primary care and another at the outpatient pharmacy. (patient was supposed to receive a RSV vaccine at the pharmacy)
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received adult covid vaccine for 12+ at 9 years old
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Myositis
Clinical narrative: Inflamed Intramuscular area.
Age: 11.0
Sex: M
Vaccine: COVID19-2, FLU4, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave a covid 12+ instead of 5-11 years. Per guardian, no adverse reactions or symptoms. Doing well after vaccine. Advised to contact office if any reactions occur.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given.  Vaccine expired 01/25/2024
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-related death
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Full blood count, Metabolic function test, Neurological examination, Thyroid function test
Clinical narrative: bilateral hand tremors started post COVID-19 vaccines (Moderna 3/29/2021, 4/2021, 12/2021) and eventually resolved. However,    bilateral hand tremors reoccurred again at a worsened level after COVID-19 infection on 15Dec2023.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: bilateral hand tremors started post COVID-19 vaccines (Moderna 3/29/2021, 4/2021, 12/2021) and eventually resolved. However,    bilateral hand tremors reoccurred again at a worsened level after COVID-19 infection on 15Dec2023.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient marked on form they wanted to receive yearly flu shot at clinic. After returning to store to process billing it was discovered the patient had already received a flu shot in the prior year.
Age: 66.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Asthenia, Chills, Influenza like illness, Pulmonary congestion, Pyrexia
Clinical narrative: flu like symptoms, chills, excessive post nasal drip, lung congestion, mild fever, weakness
Age: 66.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: SARS-CoV-2 test negative, Upper-airway cough syndrome
Clinical narrative: flu like symptoms, chills, excessive post nasal drip, lung congestion, mild fever, weakness
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient did not have any adverse reaction to vaccine but after administering, staff noted that vaccine was outside the 10-week refrigeration time by 48 hours.  Expired 1/24/24 an given 1/26/24.  Provider notified.  Patient notified.  Declines additional COVID vaccine.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No side effects were reported/No additional AE; HCP reports a patient received VARIVAX on 29DEC2023, but was notified after the administration that the patient received MMRII on 28DEC2023.; This spontaneous report was received from a pharmacist and referred to a patient of unknow age and gender. The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On 28-DEC-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type not specified) (M-M-R II) injection (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided); On 29-DEC-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #x020151, expiration date: 01-AUG-2025, strength, anatomical site of administration and route of administration were not provided) both administered for prophylaxis (inappropriate schedule of product administration), and was notified after the administration that the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type not specified) (M-M-R II) on 28-DEC-2023. Operator of device was a healthcare professional. No additional adverse event (AE) (no AE).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report that a single dose of PEDVAX HIB that was in a not supported TE was administered to a patient. HCP gives permission to contact. No further AE details available. No PQC.       ?    Names of vaccines involved (including lot/exp); This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 04-JAN-2024, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X003656, expiration date: 06-NOV-2025, 0.5 milliliter (once) (route of administration and anatomical location were not provided) for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of -13.21 degrees Celsius for 6 minutes and 44 seconds. The previous temperature excursion had occurred: 8.07 degrees Celsius for 29 minutes, and 8.08 degrees Celsius for 14 minutes and 15 seconds (product storage error). There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV, RAB, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; HCP reported AE related to RABAVERT and PROQUAD. Reported patient received RABAVERT on 07/07/2023 and 07/12/2023 and received PROQUAD on 08/03/2023.; HCP reported AE related to RABAVERT and PROQUAD. Reported patient received RABAVERT on 07/07/2023 and 07/12/2023 and received PROQUAD on 08/03/2023.; This spontaneous report was received from a medical assistant, referring to a child patient of unknown age and gender.  The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 07-JUL-2023 and 12-JUL-2023 respectively, the patient was vaccinated with rabies vaccine inact (chick embryo) (RABAVERT), lot # ARBA971A, expiration date: 01-FEB-2025 (strength, formulation, and route of administration were not provided), 1 dose, administered for prophylaxis. On 03-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X005167, expiration date: 15-AUG-2024 (strength, and route of administration were not provided), 1 dose, administered for prophylaxis (Labelled drug-drug interaction issue, Inappropriate schedule of product administration). On an unknown date, the patient also received immunoglobulin human anti-rabies (HYPERRAB) lot # R02G060213, expiration date: 31-JUL-2025 (strength, formulation, and route of administration were not provided), 1 dose, administered for prophylaxis. Health care professional (HCP) stated the patient's school was "flagging" this patient's vaccines as these two vaccines were not administered in the "correct order". No additional adverse event (AE) was reported (no adverse event).
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report was received from a nurse refers to a 6-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 04-JAN-2024, the patient was vaccinated with an improperly stored third doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral, lot # 1947634, expiration date: 05-MAY-2024, oral (exact dose and anatomical location were not provided); pneumococcal vaccine conj 7v (crm197)(PREVENAR)(Pfizer), lot # was reported as: GW7964, expiration date was reported as: 31-DEC-2024, intramuscular in the right thigh (formulation and exact dose were not provided); diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX)(GSK), lot # was reported as: 39KS9, expiration date was reported as: 07-SEP-2025, intramuscular in the left thigh (formulation and exact dose were not provided) for prophylaxis.   It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 04-JAN-2024. Administered doses of vaccines were exposed to the previous temperature excursion on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; and on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes; on 30-DEC-2023 of 1.8 (units not provided) for 3 hours and 21 minutes; on 31-DEC-2023 of 1.8 (units not provided) for 3 hours and 19 minutes; on 01-JAN-2024 of 1.8 (units not provided) for 3 hours and 11 minutes; on 02-JAN-2024 of 1.6 (units not provided) for 3 hours and 3 minutes and on 03-JAN-2024 of 1.5 (units not provided) for 2 hours and 57 minutes. Administered doses of vaccines were exposed to the current temperature excursion on 04-JAN-2024 of 1.9 (units not provided) for 34 minutes (product storage error). No additional adverse event reported (no adverse event).
Age: 70.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse Event; Pharmacist called report administration of one dose of GARDASIL 9 to a 70-year-old patient on 18DEC2023. Patient is scheduled to receive a second dose of GARDASIL 9 on 19JAN2024 but has not received it yet at time of call. Limited patient demographic; This spontaneous report was received from a pharmacist refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-DEC-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: injection, 0.5 milliliter (once) (lot #, expiation date, route of administration and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age).  On 19-JAN-2024, the patient was scheduled to receive a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) but has not received it yet (at the time of call). No additional adverse event reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; dose of VAQTA was administered to a patient on 01/15/2024 after te; This spontaneous report was received from nurse and refers to 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-JAN-2024, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 milliliter, lot #X017083 was valid with formulation pre-filled syringe, expiration date: 13-DEC-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursions of 9.4 degrees Celsius (C) for 2 minutes, 8.2 C for 1 minute and 10.3 for 10 minutes were reported. No prior excursions. The patient did not report any adverse issues or side effects. No additional adverse event (AE) information was provided during the call (No adverse event). No product quality complaint (PQC). ; Sender's Comments:  US-009507513-2401USA014344:MSD
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Systemic inflammatory response syndrome
Clinical narrative: he had an adult patient that experienced a systemic inflammatory response; This spontaneous report was received from physician via company representative and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (also reported as years ago), the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  Later, on an unknown date after receiving the vaccine, the patient experienced a systemic inflammatory response and therefore did not continue the series after the first dose. No other side effects or adverse issues were reported in association to the vaccine. At the reporting time, the outcome of the event was unknown.  The causal relationship between the event and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two reports from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration; A HCP called to report a TE for ROTATEQ in which the vaccines had also been administered to a patient on 01/19/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be provi; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Temperature excursions were reported on 04-DEC-2023: 54.3F for 9 hours and 32 minutes, 05-DEC-2023: 57.7F for 15 hours and 30 minutes, 06-DEC-2023: 50.2F for 5 hours and 43 minutes, 07-DEC-2023: 30.6F for 1 hour and 55 minutes and 52.7F for 11 hours and 3 minutes,  and 11-DEC-2023: 48.4F for 1 hour and 47 minutes. No other reported current or previous temperature excursions were reported. On 19-JAN-2024, the patient was vaccinated with an improperly storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 vial, valid lot #1965644, expiration date: 02-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). The patient did not report any adverse issues or side effects from the administration.; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015463: US-009507513-2401USA015432:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: did not report any adverse issues or side effects; GARDASIL 9 in which the vaccines had also been administered to a patient with temperature excursions; This spontaneous report was received from a medical assistant referring to a 11-year-old patient of unknown gender.    the patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-DEC-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml once (route was not reported) lot # X019196, expiration date on 25-APR-2024 for prophylaxis, after temperature excursions (on 04-DEC-2023 of 54.3F for 9 hours 32 minutes 0 seconds, on 05-DEC-2023 of 57.7F for 15 hours 30 minutes 0 seconds, on 06-DEC-2023 of 50.2F for 5 hours 43 minutes 0 seconds, on 07-DEC-2023 of 30.6F for 1 hour 55 minutes 0 seconds, on 07-DEC-2023 of 52.7F for 11 hours 3 minutes 0 seconds). No other reported current or previous temperature excursions. The patient did not report any adverse issues or side effects from the administration.  No other adverse event information was able to be provided during the call.  This is one of several report from the same reporter. ; Sender's Comments:  US-009507513-2401USA015463: US-009507513-2401USA015454: US-009507513-2401USA015432:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration. No other AE information was able to be provided during the call.; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 01/17/2024.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be pr; This spontaneous report was received from medical assistant and refers to a 12-year-old.  The patient's medical history , concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #X019196, expiration date: 25-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion on 04-DEC-2023 in 54.3 Farenheit for 9 hours 32 minutes, on 05-DEC-2023 in 57.7 Farenheit for 15 hours 30 minutes, on 06-DEC-2023 in 50.2 Farenheit for 5 hours 43 minutes, on 07-DEC-2023 Iin 30.6 Farenheit for 1 hour 55 minutes, on 07-DEC-2023 in 52.7 Farenheit for 11 hours 3 minutes and in 11-DEC-2023 in 48.4 Farenheit for 1 hour 47 minutes (Product storage error). No additional adverse event was reported. ; Sender's Comments:  US-009507513-2401USA015454: US-009507513-2401USA015463: US-009507513-2401USA015432:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration. No other AE information was able to be provided during the call.; A HCP called to report a TE for GARDASIL 9 in which the vaccines had also been administered to a patient on 12/13/2023.  The patient did not report any adverse issues or side effects from the administration.  No other AE information was able to be pr; This spontaneous report was received from medical assistant and refers to a 15-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-DEC-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #X019196, expiration date: 25-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion on 04-DEC-2023 in 54.3 Farenheit for 9 hours 32 minutes, on 05-DEC-2023 in 57.7 Farenheit for 15 hours 30 minutes, on 06-DEC-2023 in 50.2 Farenheit for 5 hours 43 minutes, on 07-DEC-2023 in 30.6 Farenheit for 1 hours 55 minutes, on 07-DEC-2023 in 52.7 Farenheit for 11 hours 3 minutes and on 11-DEC-2023 in 48.4 Farenheit for 1 hour 47 minutes (Inappropriate schedule of product administration). No additional adverse event was reported. ; Sender's Comments:  US-009507513-2401USA015432: US-009507513-2401USA015454: US-009507513-2401USA015463:
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; HCP calling to report AE for 5 y/o female that received additional dose of VAQTA inadvertently.  MA "prepped vaccines for patient and sibling and grabbed the wrong pile".; This spontaneous report was received from a medical assistant and refers to a 5-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-JAN-2024, the patient was inadvertently vaccinated with an extra dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, single dose, lot #X015720, expiration date: 05-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided) (Extra dose administered). Reporter said, "prepped vaccines for patient and sibling, and grabbed the wrong pile". No adverse effects reported.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Pertussis; This serious case was reported by a medical representative via call center representative and described the occurrence of vaccination failure in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number N2YY25) for prophylaxis.   On 21-JUL-2018, the patient received Boostrix. On 25-NOV-2023, 1953 days after receiving Boostrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: Pertussis) (serious criteria GSK medically significant). The outcome of the vaccination failure was unknown and the outcome of the pertussis was not reported.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.     It was unknown if the company considered the vaccination failure and pertussis to be related to Boostrix.   Additional Information: GSK receipt date: 24-JAN-2024 This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule pertussis were unknown at the time of reporting. The reporter was requested for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2024009488:same reporter US-GLAXOSMITHKLINE-US2024009489: US-GSK-US2024AMR011535: US-GLAXOSMITHKLINE-US2024009486:
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: got RSV; Suspected vaccination failure; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got RSV) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK receipt date: 24-JAN-2024 The provider had a patient the received Arexvy 3 weeks prior and still got RSV and was hospitalized for 2 days. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming RSV were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pediatric Dose given 3 times; This non-serious case was reported by a consumer via patient support programs and described the occurrence of extra dose administered in a female patient who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis.   Previously administered products included Flulaval (1st dose received on an unknown date) and Flulaval (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Flulaval. On an unknown date, an unknown time after receiving Flulaval, the patient experienced extra dose administered (Verbatim: Pediatric Dose given 3 times). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The patient received pediatric dose 3 times, which led to extra dose administered. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral sensory neuropathy
Clinical narrative: Sensory neuropathy in my feet; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of peripheral sensory neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine (Flu vaccine VII) for prophylaxis.   In NOV-2019, the patient received Shingrix and Flu vaccine VII. On an unknown date, an unknown time after receiving Shingrix, the patient experienced peripheral sensory neuropathy (Verbatim: Sensory neuropathy in my feet). The outcome of the peripheral sensory neuropathy was not reported.   It was unknown if the reporter considered the peripheral sensory neuropathy to be related to Shingrix.     It was unknown if the company considered the peripheral sensory neuropathy to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-Jan-2024 The reporter reported that the patient received Shingrix and Flu vaccine VII at the same time on late November 2019 and experienced sensory neuropathy in his or her feet. It was unknown if the reporter considered the peripheral sensory neuropathy to be related to Flu vaccine VII. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Influenza
Clinical narrative: Flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza 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 influenza (Verbatim: Flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to Arexvy.     It was unknown if the company considered the influenza to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-JAN-2024. This case was reported by a patient via interactive digital media. The patient seeks to had two of the symptoms and patient felt last. The patient had the flu. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Vaccination failure; believed to be infected with RSV during vaccination; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: believed to be infected with RSV during vaccination). The outcome of the vaccination failure and respiratory syncytial virus infection were unknown.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.     It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-JAN-2024 The reported that the 60 and above year adult patient received Arevxy vaccine. The reported that patient to be infected with RSV during vaccination. The reported that do the patient need to revaccinated booster or follow any other recommendations. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV were unknown at the time of reporting.
Age: 57.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy given to patient under 60 years of age; 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 57-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LL942, expiry date 23-MAR-2025) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy. On 31-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy given to patient under 60 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The pharmacist stated a fellow pharmacist mistakenly thought that Arexvy was indicated for patients under 60 if they had certain medical conditions (not further specified), so the vaccine was given to a patient under 60 years of age, which led to an inappropriate age at vaccine administration. No further details were provided. The reporter consented to follow up. This was 1 of the 4 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024010100:Same reporter US-GSK-US2024010097:Same reporter US-GSK-US2024010099:Same reporter
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given to patient younger than 60 years of age; 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 56-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LL942, expiry date 23-MAR-2025) for prophylaxis.   On 08-NOV-2023, the patient received Arexvy (intramuscular). On 08-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Given to patient younger than 60 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The pharmacist stated a fellow pharmacist mistakenly thought that Arexvy was indicated for patients under 60 if they had certain medical conditions (not further specified), so the vaccine was given to a patient under 60 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2024010099:Same reporter US-GSK-US2024010098:Same reporter US-GSK-US2024010097:Same reporter
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the vaccine was given to four patients under 60; 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 59-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2CY74, expiry date 30-MAR-2025) for prophylaxis.   On 14-NOV-2023, the patient received Arexvy. On 14-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: the vaccine was given to four patients under 60). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 22-JAN-2024 The pharmacist stated a fellow pharmacist mistakenly thought that Arexvy was indicated for patients under 60 if they had certain medical conditions (not further specified), so the vaccine was given to four patients under 60, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This is one of the link case among 4 cases.; Sender's Comments:  US-GSK-US2024010100:Same reporter US-GSK-US2024010097:Same reporter US-GSK-US2024010098:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Covid-19 Infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-AUG-2023, the patient received the 1st dose of Shingrix. On 04-JAN-2024, 138 days after receiving Shingrix, the patient experienced covid-19 (Verbatim: Covid-19 Infection). The outcome of the covid-19 was resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt date: 22-JAN-2024 The patient self reported this case. The patient received fist dose of Shingrix and got Covid-19. The patient was scheduled to received second dose on 20-FEB-2024. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Shingrix on 4/15/2022 but the patient did not return for the 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th April 2022).   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: patient received the first dose of Shingrix on 4/15/2022 but the patient did not return for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2024 The office manager stated that a patient received the first dose of Shingrix but he did not return for the 2nd dose.  The reporter asked if the patient could get the 2nd dose or did he needed to restart.  It was appeared that the patient had not receive the dose at the time of the call. The vaccine administration facility was the same as primary reporter and it was reported for the 1st dose of Shingrix. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination. The reporter consented to follow up via postal.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: RN states Hiberix was mixed with another/different diluent and was administered to a patient; RN states Hiberix was mixed with another/different diluent and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old male patient who received Hib (Hiberix) (batch number 9D2PN, expiry date 14-DEC-2024) for prophylaxis.   On 24-JAN-2024, the patient received the 2nd dose of Hiberix. On 24-JAN-2024, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: RN states Hiberix was mixed with another/different diluent and was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: RN states Hiberix was mixed with another/different diluent and was administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2024 The reporter stated that Hiberix was mixed with another/different diluent and was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients; Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number y7pp4, expiry date 07-MAY-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients) and inappropriate dose of vaccine administered (Verbatim: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2024 The nurse reported that the Shingrix powder was reconstituted with with non GlaxoSmithKline diluent and administered to 3 patients which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter enquired if they needed revaccinate. The reporter consented to follow up. No dates patient details available.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: My arm looks I was hit by a baseball ball; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (My arm looks I was hit by a baseball ball) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced IMMUNISATION REACTION (My arm looks I was hit by a baseball ball). At the time of the report, IMMUNISATION REACTION (My arm looks I was hit by a baseball ball) had not resolved.            Concomitant medication and treatment details were not reported.  It was unknown if the patient experienced any additional symptoms/events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Injection site erythema, Lymphadenopathy, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Injection site became painful, swollen, red and hot to the touch; Injection site became painful, swollen, red and hot to the touch; swelling in the lymph nodes in the jaw/neck area; Injection site became painful; Injection site became painful, swollen, red and hot to the touch; sore throat; earache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), EAR PAIN (earache), VACCINATION SITE WARMTH (Injection site became painful, swollen, red and hot to the touch), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became painful, swollen, red and hot to the touch) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Jan-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), EAR PAIN (earache), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became painful, swollen, red and hot to the touch). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site became painful, swollen, red and hot to the touch), INJECTION SITE ERYTHEMA (Injection site became painful, swollen, red and hot to the touch) and LYMPHADENOPATHY (swelling in the lymph nodes in the jaw/neck area). At the time of the report, OROPHARYNGEAL PAIN (sore throat), EAR PAIN (earache), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became painful, swollen, red and hot to the touch) was resolving and VACCINATION SITE WARMTH (Injection site became painful, swollen, red and hot to the touch), INJECTION SITE ERYTHEMA (Injection site became painful, swollen, red and hot to the touch) and LYMPHADENOPATHY (swelling in the lymph nodes in the jaw/neck area) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were provided.  Area involved was approximately 4 inches in diameter around injection site. It is unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site became painful, swollen, red and hot to the touch; Injection site became painful, swollen, red and hot to the touch; swelling in the lymph nodes in the jaw/neck area; Injection site became painful; Injection site became painful, swollen, red and hot to the touch; sore throat; earache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), EAR PAIN (earache), VACCINATION SITE WARMTH (Injection site became painful, swollen, red and hot to the touch), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became painful, swollen, red and hot to the touch) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Jan-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), EAR PAIN (earache), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became painful, swollen, red and hot to the touch). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site became painful, swollen, red and hot to the touch), INJECTION SITE ERYTHEMA (Injection site became painful, swollen, red and hot to the touch) and LYMPHADENOPATHY (swelling in the lymph nodes in the jaw/neck area). At the time of the report, OROPHARYNGEAL PAIN (sore throat), EAR PAIN (earache), VACCINATION SITE PAIN (Injection site became painful) and VACCINATION SITE SWELLING (Injection site became painful, swollen, red and hot to the touch) was resolving and VACCINATION SITE WARMTH (Injection site became painful, swollen, red and hot to the touch), INJECTION SITE ERYTHEMA (Injection site became painful, swollen, red and hot to the touch) and LYMPHADENOPATHY (swelling in the lymph nodes in the jaw/neck area) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were provided.  Area involved was approximately 4 inches in diameter around injection site. It is unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   Reporter did not allow further contact