chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; GARDASIL 9 was inadvertently administered today (10/09/2024) after it's labeled expiration date; This spontaneous report was received from office manager and refers to a 22-year-old patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-OCT-2024, the patient was inadvertently vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (0.5ml / once, lot #U031056 was valid for formulation pre-filled syringe, expiration date: 16-JUN-2024, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). The patient did not report any adverse issues or side effects from the administered dose and the product had not undergone any prior temperature excursions. No additional AE (No adverse event). No PQC.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient administered GARDASIL 9 after product experienced a temperature excursion.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-OCT-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 #Y000205, expiration date: 23-SEP-2026 (dose number, route of administration and anatomical location were not provided), for prophylaxis, after a temperature excursion of 31.7 Fahrenheit degrees for 18 minutes (Product storage error). There was no previous temperature excursion. No symptoms or additional adverse event were reported. ; Sender's Comments:  US-009507513-2410USA003805:
Age: 6.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/No PQC.; Patient's father calling in reporting an AE for GARDASIL and GARDASIL 9. Patient's father reported that a nurse administered the GARDASIL or GARDASIL 9 vaccine to the patient who is only six years old. Patient's father is unsure if the vaccine was; This spontaneous report was received from a consumer and refers to a 6-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.    On 11-OCT-2024 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter for prophylaxis (dose number, route and site of administration, lot number and expiration date were not provided) or with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 0.5 milliliter for prophylaxis (dose number, route and site of administration, lot number and expiration date were not provided). Patient's father reported that a nurse administered the GARDASIL or GARDASIL 9 vaccine to the patient who was only six years old (product administered to patient of inappropriate age). Patient's father is unsure if the vaccine was GARDASIL or GARDASIL 9 as the nurse informed him it was the GARDASIL vaccine but did not specify which it was. Patient's father reported that the patient did not experience any symptoms or side effects following vaccination (no adverse event).
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event reported; Patient got 2 doses of Gardasil 9 at 15 years of age, but did not received the 3rd dose until 27-SEP-2024 (when she had 21 years old); This spontaneous report was received from Pharmacist and refers to a 21-year-old female. The patient's medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date between 2018 and 2019 (reported as when the patient was 15 years old), the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection 0.5 mL for prophylaxis (strength, route of administration, anatomical location, lot number, and expiration date were not provided). The patient got the 2 doses, but never got the third dose as recommended by package insert. After calling the manufacturer, the vaccine did not need to be restarted and could be proceed with the third dose to complete the series.  On 27-SEP-2024, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot # Y011500 has been verified to be a valid lot number, expiration date: 29-MAY-2026) administered intramuscularly in the left deltoid for prophylaxis (strength was not provided) (inappropriate schedule of product administration). No additional adverse event (AE)/ no adverse event to report.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event was reported; HCP called to report that PROQUAD was inadvertently administered to an adult. HCP refused to provide any further information, including demographics, date of administration, and patient information.  Consent to contact is no. No additional AE/No PQC.; This spontaneous report was received from consumer and refers to a 28-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-SEP-2024, the adult patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: PNC15
Symptoms: Scratch, Syringe issue
Clinical narrative: receive a "tiny scratch on right thumb".; RN had tiny scratch on right thumb from broken glass; HCP reported VAXNEUVANCE PFS broke during administration.  HCP states consumer was not injured due to PFS breakage but HCP did receive a "tiny scratch on right thumb".  Additional AE/PQC filed.  No additional PQC reported.  Caller is HCP who; This spontaneous report was received from a registered nurse who is also the patient referring to herself, a 29-year-old non-pregnant female patient. Her concurrent conditions, concomitant medications, drug reactions/allergies and concomitant medications were not reported.      On 14-OCT-2024, during the administration of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL "1DS x 10 syringes" injection, lot # X027947 with expiration date 12-JAN-2026, for prophylaxis (dose, route of administration and anatomical location were not reported), the pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) prefilled syringe broke (syringe issue) during administration and the patient received a "tiny scratch on right thumb" (Injury associated with device and Scratch). It was stated that the syringe breakage occurred at the finger flange. No treatment was given to the patient and she did not sought medical attention. At the time of reporting, the outcome of injury associated with device and scratch was not resolved.   The causality assessment between injury associated with device and scratch with the suspect vaccine was not provided.  This is one of two reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; HCP reports 12-month-old patient received VARIVAX and PROQUAD instead of VARIVAX and MMR II.; HCP reports 12-month-old patient received VARIVAX and PROQUAD instead of VARIVAX and MMR II.; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-OCT-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella recombinant human albumin (rHA) (Oka-Merck) Virus Vaccine Live (PROQUAD) single dose, lot # X026599, expiration date 11-MAY-2025 (exact dose, route of administration and anatomical location were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX) single dose, lot # X023717, expiration date 26-SEP-2025 (exact dose, route of administration and anatomical location were not reported) (overdose) instead of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered). Both vaccines were administered for prophylaxis. No additional adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Malaise, Paraplegia
Clinical narrative: Paralyzed to waist; guilluan Barre; Ill; This serious case was reported by a consumer via interactive digital media and described the occurrence of paraplegia in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced paraplegia (Verbatim: Paralyzed to waist) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: guilluan Barre) (serious criteria GSK medically significant) and illness (Verbatim: Ill). The outcome of the paraplegia and guillain barre syndrome were not reported and the outcome of the illness was resolved (duration 7 years).   It was unknown if the reporter considered the paraplegia and illness to be related to Shingles vaccine. The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the paraplegia and guillain barre syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-OCT-2024 This case was reported by a patient's wife via interactive digital media. The patient got guilluan Barre from a shingles shot. The reporter reported, the patient was ill for seven years and paralyzed to waist.; Sender's Comments: Paraplegia and Guillain-Barre syndrome are unlisted events which are considered unrelated to GSK vaccine Shingles.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: I signed up and verbally consented to receive a Covid vaccine. The pharmacist mistakenly administered Shingrix; This non-serious case was reported by a consumer via sales rep and described the occurrence of wrong vaccine administered in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On 08-OCT-2024, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, the patient did not receive COVID-19 vaccine. On 08-OCT-2024, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: I signed up and verbally consented to receive a Covid vaccine. The pharmacist mistakenly administered Shingrix). The outcome of the wrong vaccine administered was unknown.  Additional Information: GSK Receipt Date: 08-OCT-2024 The patient self-reported this case. The patient stated, as a patient she signed up and verbally consented to receive a Covid vaccine. The pharmacist mistakenly administered Shingrix, which led to wrong vaccine administered. The patient signed up online to receive a Covid vaccine at a local pharmacy and she reported at the assigned time and verbally discussed that she was to receive Covid. The pharmacy provided a printout of additional vaccines that they advised were due as well. The patient explained that she just had her annual physical with her primary care physician (PCP) and all she wanted to receive was a Covid vaccine. The pharmacist agreed and she sat down for the administration. The pharmacist asked patient if she was aware that she would need to return for the second series. The patient was confused, thinking he was confused but nodded her head in agreement. The pharmacist administered the vaccine and asked patient about the pending vaccines due on the printout and she stated that she only came in for Covid. The pharmacist then said that he had administered Shingrix not Covid. The pharmacist stated that he would report to patient's PCP but the printout produced by the pharmacy was a listing from a national registry and he said that patient was due to receive Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure, Viral infection
Clinical narrative: Suspected vaccination failure; Shingles; post herpetic neuralgia; Viral infection; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) (serious criteria other: Serious as per reporter), post herpetic neuralgia (Verbatim: post herpetic neuralgia) (serious criteria other: Serious as per reporter) and viral infection (Verbatim: Viral infection). The outcome of the vaccination failure and viral infection were not reported and the outcome of the shingles and post herpetic neuralgia were resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and viral infection to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles and post herpetic neuralgia to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the viral infection to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2024 The nurse reported that a patient received Shingrix vaccine and experienced severe case of shingles which led to post herpetic neuralgia. The patient had an autoimmune condition as psoriatic arthritis and she had completed second dose of shingles vaccine. Within the month of completing the second dose, the patient got sick with viral infection. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(dose 1 and 2).  Herpes zoster and Post herpetic neuralgia are unlisted events which are considered unrelated to GSK vaccine Shingrix(dose 1 and 2).
Sex: M
Vaccine: RV5, RVX
Symptoms: Interchange of vaccine products
Clinical narrative: Circumstance or information capable of leading to medication error/Interchangeability; Interchangeability; This non-serious case was reported by a nurse via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a infant male patient who received Rotavirus vaccine for prophylaxis.   Co-suspect products included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine and ROTATEQ. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error/Interchangeability) and interchange of vaccine products (Verbatim: Interchangeability). The outcome of the circumstance or information capable of leading to medication error and interchange of vaccine products 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: 18-SEP-2024 The reporter reported that a 10 week and a half-old patient came to the office to receive a dose of Rotarix and the patient had already received a dose of Rotateq, which led to circumstance or information capable of leading to medication error and interchange of vaccine products. The reporter mentioned that it was the intention to give the patient one dose of Rotarix to continue the Rotavirus series.
Age: 0.5
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who travel recently, is a 6  month old patient, and during the travel, they did start the Meningococco B vaccine,; 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 6-month-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 10-JUL-2024, the patient received the 1st dose of Bexsero. On 10-JUL-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: patient who travel recently, is a 6  month old patient, and during the travel, they did start the Meningococco B vaccine,). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2024 The reporter calling with an inquiry on the Bexsero vaccine from GlaxoSmithKline, had a patient who travel international recently, was a 6-month-old patient, and during the travel, they did start the Meningococcal B vaccine which led inappropriate age at vaccine administration. The reporter consented to follow.
Age: 74.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis C antibody positive, Underdose
Clinical narrative: 74 years patient received a pediatric dose of Engerix-B; 74 years patient received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 74-year-old male patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 17-SEP-2024, the patient received Engerix B pediatric. On 17-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 74 years patient received a pediatric dose of Engerix-B) and underdose (Verbatim: 74 years patient received a pediatric dose of Engerix-B). The outcome of the adult use of a child product and underdose 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: 19-SEP-2024 The nurse reported that they administered a pediatric dose of Engerix-B to a 74 years old male patient, which led adult use of a child product and underdose. The patient who received improper vaccine dose, the physician felt he had a reactive Hepatitis C antibody. Now this patient received all his shots a long time ago and was up to date with all his shots. He received Engerix-B, not because he was not immune at all, but I guess as a precaution because of the Hepatitis C antibody reactive bloodwork that came back. The reporter consented to follow up
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: received approximately half of the volume of the complete dose due to an issue with the syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number NJ374, expiry date 16-JUN-2026) for prophylaxis.   On 21-SEP-2024, the patient received Shingrix. On 21-SEP-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: received approximately half of the volume of the complete dose due to an issue with the syringe). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2024 The HCP (health care professional) reported that during the administration of Shingrix, a patient received approximately half of the volume of the complete dose due to an issue with the syringe, which led to an accidental underdose. The HCP asked for recommendations on this situation.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: a patient were administered twice doses in the last month; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis.   Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On 30-SEP-2024, the patient received the 2nd dose of Menveo. On 30-SEP-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: a patient were administered twice doses in the last month). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 A nurse reported a Menveo one vial presentation was administered to a patient twice in the last month. The patient was administered two doses which led to extra dose administered. The patient also had an initial dose when she was eleven years of age. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: she thinks she had AREXVY administered last year and again this year, but is not certain; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received first dose of Arexvy last year).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: she thinks she had AREXVY administered last year and again this year, but is not certain). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The patient self-reported this case for herself. The reporter thought she had Arexvy administered last year and again this year, but was not certain (possible extra dose) which led to extra dose administered. No further information available. The reporter declined to provide demographics or any further information until she was able to verify if she had received two doses of Arexvy.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient that received a first dose in October twenty-twenty three; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 16th October 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient that received a first dose in October twenty-twenty three). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The pharmacist reported that female patient that received a first dose in October twenty-twenty three.  The pharmacist asked which would be the advise for this patient, whether to the restart schedule or what to do. No further information was provided from the pharmacist´s end. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a male patient had come into the office who had received two shots of AREXVY; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose of Arexvy vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a male patient had come into the office who had received two shots of AREXVY). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2024 The GlaxoSmithKline sales representative called GlaxoSmithKline response center (GRC) to report that she had just left a medical center on the day of reporting where she had a conversation with a medical assistant. The medical assistant indicated that a patient had come into the office who had received two shots of Arexvy which led to extra dose administered. The reporter said that they made him get it twice. The medical assistant did not say how far apart the two shots were given. The medical assistant also did not provide the age of the patient. No further details were provided to the GlaxoSmithKline response center by the sales representative.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient can get the second dose of Shingrix if the first dose was on 12 August 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th August 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: a patient can get the second dose of Shingrix if the first dose was on 12 August 2022). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-OCT-2024 The pharmacist called and asked if a patient can get the second dose of Shingrix if the first dose was given on 12th August 2022. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received his first dose of SHINGRIX on 10/12/2022 but never received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02nd October 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 his first dose of SHINGRIX on 10/12/2022 but never received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter was the pharmacist who stated that a patient received his first dose of Shingrix but never received a second dose which led to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Pruritus, Rash
Clinical narrative: rash on the back of left leg; shingle-like symptoms; she felt tingling coming from the left leg; itchiness left leg; burning coming from the left leg; This non-serious case was reported by a other health professional via call center representative and described the occurrence of tingling of extremity in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol), lidocaine and naproxen.   On 21-SEP-2024, the patient received the 1st dose of Shingrix (left arm). In SEP-2024, 5 days after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: she felt tingling coming from the left leg), itchy legs (Verbatim: itchiness left leg) and burning leg (Verbatim: burning coming from the left leg). On an unknown date, the patient experienced rash (Verbatim: rash on the back of left leg) and shingles (Verbatim: shingle-like symptoms). The outcome of the tingling of extremity, itchy legs, burning leg, rash and shingles were not resolved.   It was unknown if the reporter considered the tingling of extremity, itchy legs, burning leg, rash and shingles to be related to Shingrix.     It was unknown if the company considered the tingling of extremity, itchy legs, burning leg, rash and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2024 The health care professional reported that a patient receive d Shingrix vaccine and states that 5 days after she felt tingling, itchiness and burning coming from the left leg. She states on 5th October 2024 her husband noticed that she had a rash on the back of left leg.   The patient also experienced shingle-like symptoms. She had been taking Naproxen, Tylenol and Lidocaine spray, she states it was not resolved.
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: patient developed atrial fibrillation after receiving Arexvy in February 2024; This serious case was reported by a physician via sales rep and described the occurrence of atrial fibrillation in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In FEB-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: patient developed atrial fibrillation after receiving Arexvy in February 2024) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     The company considered the atrial fibrillation to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 11-OCT-2024 The patient developed atrial fibrillation after receiving Arexvy. The reporter consented to follow up.; Sender's Comments: Atrial fibrillation is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 96.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Chills, Dizziness, Influenza, Myalgia
Clinical narrative: she had a bad flu or cold; feeling as she had a bad cold; weakness; dizziness; muscle pain; fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (she had a bad flu or cold), NASOPHARYNGITIS (feeling as she had a bad cold), ASTHENIA (weakness), DIZZINESS (dizziness) and MYALGIA (muscle pain) in a 97-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.   On 08-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2024, the patient experienced INFLUENZA (she had a bad flu or cold), NASOPHARYNGITIS (feeling as she had a bad cold), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (muscle pain), PYREXIA (fever) and CHILLS (Chills). At the time of the report, INFLUENZA (she had a bad flu or cold), NASOPHARYNGITIS (feeling as she had a bad cold), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (muscle pain), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.  She also mentioned she would be very cautious in future in taking Moderna shots because she never had this "bad reaction before".  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775283 (E2B Linked Report). This case was linked to MOD-2024-775282 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775283:Case for many friends
Age: 96.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: she had a bad flu or cold; feeling as she had a bad cold; weakness; dizziness; muscle pain; fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (she had a bad flu or cold), NASOPHARYNGITIS (feeling as she had a bad cold), ASTHENIA (weakness), DIZZINESS (dizziness) and MYALGIA (muscle pain) in a 97-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine.   On 08-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. In October 2024, the patient experienced INFLUENZA (she had a bad flu or cold), NASOPHARYNGITIS (feeling as she had a bad cold), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (muscle pain), PYREXIA (fever) and CHILLS (Chills). At the time of the report, INFLUENZA (she had a bad flu or cold), NASOPHARYNGITIS (feeling as she had a bad cold), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (muscle pain), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.  She also mentioned she would be very cautious in future in taking Moderna shots because she never had this "bad reaction before".  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775283 (E2B Linked Report). This case was linked to MOD-2024-775282 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775283:Case for many friends
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: aggravated my sciatica; This spontaneous case was reported by a patient and describes the occurrence of SCIATICA (aggravated my sciatica) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Sciatica.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced SCIATICA (aggravated my sciatica). At the time of the report, SCIATICA (aggravated my sciatica) outcome was unknown.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   No concomitant medications were reported.  It was reported that, the first rounds of Covid vaccine shots aggravated the patient's sciatica, such a level that he could barely walk. The patient had spent over a year in physical therapy.   This case was linked to US-MODERNATX, INC.-MOD-2024-775292 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775292:one case created for people
Sex: M
Vaccine: COVID19
Symptoms: Infertility male
Clinical narrative: received the vaccine, now is unable to get his wife pregnant, requiring in-vitro fertilization; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFERTILITY MALE (received the vaccine, now is unable to get his wife pregnant, requiring in-vitro fertilization) in a male 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. On an unknown date, the patient experienced INFERTILITY MALE (received the vaccine, now is unable to get his wife pregnant, requiring in-vitro fertilization). At the time of the report, INFERTILITY MALE (received the vaccine, now is unable to get his wife pregnant, requiring in-vitro fertilization) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  Patient's age was less than 30 years. Patient was unable to get his wife pregnant, requiring in-vitro fertilization.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: high fever; extreme fatigue; headaches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (high fever), FATIGUE (extreme fatigue) and HEADACHE (headaches) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 027l208, 02582a2, 022ct1a and 202823) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever), FATIGUE (extreme fatigue) and HEADACHE (headaches). At the time of the report, PYREXIA (high fever), FATIGUE (extreme fatigue) and HEADACHE (headaches) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had taken 6 doses of the Spikevax COVID-19 vaccine but experienced side effects like high fever, extreme fatigue, and headaches lasting 2-4 days after each dose.  No treatment information was provided.   This case was linked to MOD-2024-775056, MOD-2024-775070 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2024: Live Follow-up received contains significant information included dosage regimen added and lot number added. On 10-Oct-2024: Live Follow-up received contains significant information included dosage regimen added and lot number added. On 10-Oct-2024: Live Follow-up received contains significant information included dosage regimen added and lot number added.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Vaccination site pain
Clinical narrative: injection quite painful; they received a 5 mL dose of Moderna Spikevax rather than a 0.5 mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (injection quite painful) and OVERDOSE (they received a 5 mL dose of Moderna Spikevax rather than a 0.5 mL dose) 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) 5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection quite painful) and OVERDOSE (they received a 5 mL dose of Moderna Spikevax rather than a 0.5 mL dose). At the time of the report, VACCINATION SITE PAIN (injection quite painful) and OVERDOSE (they received a 5 mL dose of Moderna Spikevax rather than a 0.5 mL dose) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that We are confident that it was a 5 mL dose as the syringe used was much larger than usual, and the injection quite painful.  Treatment information was not provided.  Reporter causality was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: aggravated his sciatica; This spontaneous case was reported by a patient and describes the occurrence of SCIATICA (aggravated his sciatica) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Sciatica.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced SCIATICA (aggravated his sciatica). At the time of the report, SCIATICA (aggravated his sciatica) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The patient stated that he spent over a year in physical therapy because of the way the COVID-19 vaccine 1st round of shots had aggravated his sciatica, to such a level that he could barely walk. Reporter causality was not reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given 12+ year old COVID vaccine. No adverse events noted, family notified.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Throat irritation
Clinical narrative: Patient began to feel light headedness, throat irritation and itching and overall dizziness
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: About 5 minutes after receiving immunizations, patient had syncopal episode. Patient regained consciousness after about 5 seconds and was alert, when he reported nausea and vomited. Patient then reported feeling better and denied any further symptoms. EMS were called to evaluate the patient, and found normal vitals. Patient's father denied transport to hosptial and opted to continue to monitor child at home and follow up with pediatrician.
Age: 8.0
Sex: U
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving vaccine.  He struggled to regain consciousness, so paramedics were called.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Pulmonary mass
Clinical narrative: Patient was administered duplicate dose of Boostrix
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was seen in Clinic 10/18/24  scheduled for a Influenza Vaccination, brought pt back and verbally asked if they were here for a influenza vaccine , mother stated yes and also covid, Covid Vaccine not indicated in note, asked mother and confirmed and then stated they were just here for the Influenza vaccine , proceeded  took temperature which was 96.9 F axillary, no fevers not symptoms before vaccination, asked mother if allergic to any medication or taking any medication, denied both,  vaccine was given  10/18/24 at 4:00 p.m. no reaction , no symptoms , advised like normally to give tylenol or mortin for any fevers or pain. to give us a call if any or worsening symptoms and  had left afterwards. when documenting Vaccine, stated pt was not indicated to have a influenza vaccine at the time , went into her chart and stated she had received vaccine on the 10/10/24 for an appt she had For her 18month.  I then spoke to supervisor and  also Provider over the situation , and advised to report incident and call parents to notify. Provider Had acknowledge and Called parents so they been made aware, the parents stated they did have an appt in a month but some how it had been scheduled sooner.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the 12+ vaccine dose. No adverse reaction. Patient's guardian notified.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse events reported. patient received a comirnaty but patient is only 8 and was supposed to received a pediatric covid shot.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Incident involving a patient who experienced dizziness and difficulty breathing approximately 15 to 20 minutes post vaccination. Oxygen was administered promptly and vital signs were checked. BP-179/69 mmhg HR84/min SPO2-100%. MAR(medical alert response) was announced, MAR arrived to assess the patient. Subsequently, 911 was contacted for further medical evaluation and assistance
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient fainted and fell out of the chair within 15 seconds after receiving second vaccination and hit her head, woke back up within 10 seconds. Paramedics were called and responded, patient did not go to er. Patient was provided hydration.
Age: 11.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event at this time but bexsero given my mistake