chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose administered on 20-JUN-2008 (when the pt was 56 days old); This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000365), concerning a 8-week-old (exact 56-days-old) female patient (pt). The pt's historical vaccine included hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HBV) administered on 26-APR-2008. The pt's concomitant medications included diphtheria, tetanus, acellular pertussis, hepatitis b, polio (dTAP-HBV-POL) administered on 20-JUN-2008. No information regarding pt's medical history or concurrent conditions was reported.  On 20-JUN-2008, when the pt was 56 days old, she was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis, which was considered an inappropriate age at vaccine administration.  The pt's vaccines also included hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HBV) administered on 31-OCT-2008; diphtheria, tetanus, acellular pertussis, hepatitis b, polio (dTAP-HBV-POL) administered on 29-AUG-2008; 30-JAN-2009 and 06-AUG-2009; diphtheria, tetanus, pertussis (DTaP) vaccine administered on 29-APR-2009; measles, mumps, rubella (MMR) vaccine administered on 29-APR-2009 and 09-AUG-2012; hepatitis A vaccine (HAV) administered on 29-APR-2009 and 06-NOV-2009; pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered on 30-APR-2010; influenza (INF) vaccine administered on 17-OCT-2011, 22-SEP-2012, 21-DEC-2013 and 15-NOV-2014; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered on 09-AUG-2012; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT) administered on 11-OCT-2015; influenza vaccine inact sag 3v (FLUVIRIN) administered on 11-NOV-2016; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered on 25-JUL-2017 and 25-JAN-2018; meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) administered on 28-NOV-2017 and influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) administered on 27-OCT-2017 and 26-OCT-2018.  This is one of the three reports concerning the same patient..; Sender's Comments:  US-009507513-2303USA000365: US-009507513-2307USA001583:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from nurse prescriber who reports improperly stored VARIVAX was administered to 1 patient. Excursion occurred 7/7/2023 and product was administered 7/8/2023.    ?    Names of vaccines involved (including lot/exp) VARIVAX X002101 1/19/2; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent(MERCK STERILE DILUENT).        On 08-JUL-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # X002101with expiration date 19-JAN-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). The temperature excursion occurred on 07-JUL-2023. The vaccines was exposed to a temperature of 47°F to 77 °F for 45 minutes and 5 seconds. There was not a previous temperature excursion. No additional adverse event (AE) was reported. It was reported that sterile diluent(MERCK STERILE DILUENT) was not involved in the temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Nurse reports patient was accidently administered an expired dose of VARIVAX on Jul 17, 2023. Product expired on Jun 28, 2023. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC reported.; 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 reported.  On 17-JUL-2023, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot #U020238, expiration date: 28-JUN-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  The reporter informed that the was accidently administered an expired dose of vaccine (expired product administered). No prior temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; products that experienced temperature excursion were administered; 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.  On 14-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) doses of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, intramuscular injection, lot # reported and confirmed as: X004813, expiration date reported and confirmed as: 28-JUL-2024; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, lot # reported and confirmed as: W017556, expiration date reported and confirmed as: 07-JAN-2024 (exact doses, strengths, sites and and routes of administration were not provided) for prophylaxis. Temperature excursion details: occurred on 11-JUL-2023; temperature above 47 degree Fahrenheit (46.7 degree Fahrenheit) for 25 minutes; no previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; HCP calling to report an AE regarding the VAQTA and RECOMBIVAX HB vaccines. HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB. The operator of the devices are unknown. Permission was provided to cont; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #X004814, expiration date: 10-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, lot #W008704, expiration date: 18-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced No additional AE/PQC reported. On 10-JUL-2023, the patient experienced HCP calling to report an AE regarding the VAQTA and RECOMBIVAX HB vaccines. HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB. The operator of the devices are unknown. Permission was provided to contact the HCP. Case 02430905 filed. AE cases 02430937 and 02430938 filed. No additional AE/PQC reported.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report an AE regarding the VAQTA and RECOMBIVAX HB vaccines. HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB. The operator of the devices are unknown. Permission was provided to cont; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 13-JUL-2023 the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # X004814 and expiration date 10-OCT-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided). On that same day the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# W008704 and expiration date 18-NOV-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. See original AE case 02429442 which did not include un; This spontaneous report was received from Other and refers to a patien of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JUL-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1968385, expiration date: 22-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 12-JUL-2023, the patient experienced Inbound call from customer to provide updated temperature excursion information. She also provided names and administration dates of improperly stored administered ROTATEQ that was not supported. Temperature excursion: 20-JUN-2023 - 34.9F for 6 hours 34 minutes 0 seconds, 03-JUL-2023 - 51.4 F for 7 hours 33 minutes 0 seconds, 04-JUL-2023 - 51.1F for 24 hours 0 minutes 0 seconds and 05-JUL-2023 - 50.7F for 9 hours 27 minutes 0 seconds.See original AE case 02429442 which did not include unique patient identifiers. Company awareness date reflects the date was originally made aware. Additional AE cases were created for all patients involved: 02430210 02430211 02430254 02430255 02430256 02430257 02430258 02430259 02430261 02430267 02430578 02430599 02430623 02430642 02430682 02430683 02430684 02430686 02430687 02430690 02430691 02430699 02430701. No PQC. No additional information.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported AE related to improperly stored and administered PROQUAD.         ?; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 17-JUL-2023 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X002292 and expiration date 21-JUL-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was 6.93 degrees Fahrenheit and lasted for 1 Hour 13 Minutes 0 Seconds. There was previous excursion 52.01 degrees Fahrenheit that lasted for 2 hours 6 minutes 0 seconds and 9.74 degrees Fahrenheit  that lasted for 4 hours 34 minutes 0 seconds.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report an expired dose of MMR-II that was inadvertently administered to a patient.; This spontaneous report was received from a medical assistance and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, expiration date: 15-JUL-2023, administered for prophylaxis (strength, lot #, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Age: 0.17
Sex: F
Vaccine: RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Product storage error
Clinical narrative: No adverse effects; Temperature excursion- vaccine not viable according to manufacturer; This spontaneous report has been received from a physician, regarding a 9-weeks-old female patient. The patient's pertinent medical history included hepatitis B vaccine as historical drug, previous drug reactions or allergies were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (PREVENAR 13).  On 26-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, orally as prophylaxis (lot number: 1968386, which was determined to be valid, with an expiration date on 23-MAY-2024) (strength, dose and scheme were not reported) (Product storage error). The vaccine was bought with public funds and was administered at a private doctor's office.  The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion reported during unreported amount of time on unreported temperature as well. No adverse effect was reported.  No additional information was reported.
Age: 0.17
Sex: F
Vaccine: RV5, DTAPIPVHIB, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Temperature excursion- vaccine not viable according to manufacturer; This spontaneous report has been received from a physician, regarding a 9-weeks-old female patient. The patient's pertinent medical history included hepatitis B vaccine as historical drug, previous drug reactions or allergies were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (PREVENAR 13).  On 26-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, orally as prophylaxis (lot number: 1968386, which was determined to be valid, with an expiration date on 23-MAY-2024) (strength, dose and scheme were not reported) (Product storage error). The vaccine was bought with public funds and was administered at a private doctor's office.  The administered dose underwent a temperature excursion during unreported amount of time on unreported temperature. It was reported the alarm was believed to be due to sensory issues and the temperatures were monitored with back up logger, which was by the time of the report was replaced with a new one and temperature was then in range. There was a previous temperature excursion reported during unreported amount of time on unreported temperature as well. No adverse effect was reported.  No additional information was reported.
Age: 0.33
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE/PQC; inadvertent administration of VAXELIS and ROTATEQ after TE; This spontaneous report has been received from a consumer referring to a 4-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 01-MAY-2023, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) via unspecified route for prophylaxis (both strength, exact dose, dose number, lot number and expiration date were not known) after temperature excursion (TE) (product storage error). The storage temperature and time frame were not provided. No symptoms were reported. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Injury associated with device
Clinical narrative: Negative Hepatitis B Antibodies; Hepatitis B Antigen of 41; Initial Report Received on 10-May-2023  A registered nurse reported that a 28-year-old female patient (race and ethnicity unknown) had a needle stick, then received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization per protocol, and had a positive hepatitis B antigen titer the next day.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had an allergy to amoxicillin (throat swelling and vomiting).  On 06-May-2023, the patient had a needlestick. Per protocol, on 07-May-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 941584; expiration date 31-Jan-2025, NDC # unknown) intramuscularly in the left deltoid. On 08-May-2023, the patient had a hepatitis B titer that showed a hepatitis B antigen of 41, and negative for Hepatitis B antibodies. No adverse effects were reported by the patient.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received Expired Dose; Initial Report Received on 10-May-2023  A registered nurse reported that a male patient (age, race, and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On an unknown date, the patient received an expired dose of HEPLISAV-B vaccine (Lot # T035865, expiration date and NDC # unknown) intramuscularly in the left deltoid. The reporter insisted it was HEPLISAV-B given to the patient. No adverse effects to the patient were reported.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got a terrible case/suspected vaccination failure; shingles/got a terrible; Residual pain; This serious case was reported by a consumer via interactive digital media 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.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced residual pain (Verbatim: Residual pain). On an unknown date, the patient experienced vaccination failure (Verbatim: got a terrible case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/got a terrible). The outcome of the vaccination failure, shingles and residual pain were unknown.   The reporter considered the vaccination failure, shingles and residual pain to be possibly related to Shingrix and Shingrix.   The company considered the vaccination failure, shingles and residual pain to be possibly related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2023 This case was reported by a patient via interactive digital media. The patient had all the shots of shingles and got a terrible case of shingles. The patient had residual pain since February. The reporter stated that shots were no help at all. The reporter thought that the event might had been related to drug. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Erythema, Feeling abnormal, Hyperaesthesia, Oral discomfort
Clinical narrative: Burning pain/Stabbing pain; Tenderness; Tingling; redness under my left breast and left side; skin is so sensitive to touch; Stress; Anxiety; Burning even in my mouth, lips, and tongue; she felt like her body was raw; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain burning (Verbatim: Burning pain/Stabbing pain), tenderness (Verbatim: Tenderness), tingling (Verbatim: Tingling), redness in breast (Verbatim: redness under my left breast and left side), touch sensitivity increased (Verbatim: skin is so sensitive to touch), stress (Verbatim: Stress), anxiety (Verbatim: Anxiety), burning mouth (Verbatim: Burning even in my mouth, lips, and tongue) and feeling abnormal (Verbatim: she felt like her body was raw ). The patient was treated with diclofenac (Voltaren) and steroids nos (Steroid (Not Specified)). The outcome of the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal were not resolved.   It was unknown if the reporter considered the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that she had both shots at age 60 and had burning pain, stabbing pain, tenderness, tingling, and redness under her left breast and left side. The skin was so sensitive to touch, wearing a bra was difficult, she thinks it all started with severe stress, anxiety, and getting into a chlorinated pool. This was going on six weeks of misery. The patient states that she had been on a steroid pack, volterian gel, and meds for pain and she felt like her body was raw and burning even in her mouth, lips, and tongue. Follow up was not possible, as no contact details were available.
Age: 60.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Paraesthesia, Stress, Tenderness
Clinical narrative: Burning pain/Stabbing pain; Tenderness; Tingling; redness under my left breast and left side; skin is so sensitive to touch; Stress; Anxiety; Burning even in my mouth, lips, and tongue; she felt like her body was raw; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain burning (Verbatim: Burning pain/Stabbing pain), tenderness (Verbatim: Tenderness), tingling (Verbatim: Tingling), redness in breast (Verbatim: redness under my left breast and left side), touch sensitivity increased (Verbatim: skin is so sensitive to touch), stress (Verbatim: Stress), anxiety (Verbatim: Anxiety), burning mouth (Verbatim: Burning even in my mouth, lips, and tongue) and feeling abnormal (Verbatim: she felt like her body was raw ). The patient was treated with diclofenac (Voltaren) and steroids nos (Steroid (Not Specified)). The outcome of the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal were not resolved.   It was unknown if the reporter considered the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain burning, tenderness, tingling, redness in breast, touch sensitivity increased, stress, anxiety, burning mouth and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that she had both shots at age 60 and had burning pain, stabbing pain, tenderness, tingling, and redness under her left breast and left side. The skin was so sensitive to touch, wearing a bra was difficult, she thinks it all started with severe stress, anxiety, and getting into a chlorinated pool. This was going on six weeks of misery. The patient states that she had been on a steroid pack, volterian gel, and meds for pain and she felt like her body was raw and burning even in her mouth, lips, and tongue. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: had open sores in mouth and pain associated; had open sores in mouth and pain associated; This non-serious case was reported by a physician via sales rep and described the occurrence of sores mouth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sores mouth (Verbatim: had open sores in mouth and pain associated) and oral pain (Verbatim: had open sores in mouth and pain associated). The patient was treated with valaciclovir (Valacyclovir) and mouthwash, nos (Mouth Rinse). The outcome of the sores mouth and oral pain were not resolved.   It was unknown if the reporter considered the sores mouth and oral pain to be related to Shingrix.     It was unknown if the company considered the sores mouth and oral pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUL-2023 The doctor stated patient administered first dose of Shingrix in 2019. The patient had open sores in mouth and associated with pain. Apparently, since 2019 patient has been going through this. The patient has been treated with Valacyclovir and a mouth rinse. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue). The outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt date: 17-JUL-2023 The physician reported that some patients had systemic adverse reactions/fatigue within 24 hours of receiving shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Kinrix that was stored outside of the guidelines within the package insert; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Kinrix that was stored outside of the guidelines within the package insert). The outcome of the incorrect storage of drug 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: 18-Jul-2023 The health care professional called to state that a patient was administered a dose of Kinrix that was stored outside of the guidelines within the package insert.  The reporter stated that the dose reached a maximum temperature of 10.8 celsius.  The entire excursion lasted was 1 hour 3 minutes 0 seconds. The patient demographics were unavailable at this time.  The reporter noted that no other adverse events were occurred.  No additional adverse event or product quality complaint. The patient received a dose of Kinrix after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: fever; diarrhea; nausea; bad pain in the arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: fever), diarrhea (Verbatim: diarrhea), nausea (Verbatim: nausea) and pain in arm (Verbatim: bad pain in the arm). The outcome of the fever, diarrhea, nausea and pain in arm were not reported.   It was unknown if the reporter considered the fever, diarrhea, nausea and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever, diarrhea, nausea and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUL-2023 On first couple of days after administration of first dose of Shingrix patient experienced fever. On day 4 and day 5 later, she had nausea and diarrhea. She also experienced bad pain in the arm. She said she will not administer the second dose of Shingrix due to side effect she experienced on the first dose of Shingrix. The reporter did not consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix; It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix; This non-serious case was reported by a consumer and described the occurrence of wrong vaccine administered in a adult patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-JUL-2023 It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter had everything but the expiration date for the Infanrix but cannot view the details as could not find the case.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site discolouration
Clinical narrative: small grey spot at the injection sites that are not fading or going away; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site discoloration in a 1-year-old male patient who received DTPa (Infanrix) (batch number 9R2D7) for prophylaxis.   Co-suspect products included Hib (Hiberix) (batch number 7F257) for prophylaxis and MMR (Priorix) (batch number 75593) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received on 27th May 2022, for tolerance of Pediarix, refer case US2022AMR149561) and Hiberix with an associated reaction of skin discolouration (received on 27th May 2022, for tolerance of Hiberix, refer case US2022AMR149561).   On 30-JUN-2023, the patient received Infanrix .5 ml, Hiberix .5 ml and Priorix .5 ml. On an unknown date, an unknown time after receiving Infanrix, Hiberix and Priorix, the patient experienced injection site discoloration (Verbatim: small grey spot at the injection sites that are not fading or going away). The outcome of the injection site discoloration was not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Infanrix, Infanrix Pre-Filled Syringe Device, Hiberix, Priorix and Priorix Pre-Filled Syringe Device.   It was unknown if the company considered the injection site discoloration to be related to Infanrix, Infanrix Pre-Filled Syringe Device, Hiberix, Priorix and Priorix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2022AMR149561   Additional Information: GSK Receipt Date: 13-JUL-2023 The Infanrix, Hiberix and Priorix vaccines were leaving a small grey spot at the injection sites that were not fading or going away.  This patient had multiple spots while their sibling had zero. The reporter agreed to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR149561:Same patient/diffrent vaccine
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: nodule at the injection; Nodule was tender; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site nodule in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On 11-JUL-2023, the patient received the 1st dose of Menveo (injection, left deltoid). On 12-JUL-2023, 1 days after receiving Menveo, the patient experienced injection site nodule (Verbatim: nodule at the injection) and injection site tenderness (Verbatim: Nodule was tender). The patient was treated with ibuprofen. The outcome of the injection site nodule and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site nodule and injection site tenderness to be related to Menveo.     It was unknown if the company considered the injection site nodule and injection site tenderness to be related to Menveo.   Additional Information: GSK receipt date: 13-Jul-2023 The patient age was reported as 11 years. The medical assistant called for a minor child. The next day the child's parents called doctor's office to report a nodule at the injection site the size of a half lemon.   The nodule was tender to the touch, not warm, and not red.   Treatment recommended by office physician was cool compresses and Ibuprofen as needed. The reporter consented to follow up. This case is linked with US2023096266, by same reporter.; Sender's Comments:  US-GSK-US2023096266:Same reporter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Chills, Computerised tomogram normal, Fibrin D dimer increased, Injection site irritation
Clinical narrative: minor irritation at injection site; chills; fever/febrile; chest pain; Heart Rate 120; Abnormal Laboratory Results; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site irritation in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number EN939, expiry date 31-OCT-2024) for prophylaxis.   On 13-JUL-2023 10:30, the patient received Bexsero (injection, left deltoid). On 13-JUL-2023, 3 hrs after receiving Bexsero, the patient experienced chills (Verbatim: chills), fever (Verbatim: fever/febrile), chest pain (Verbatim: chest pain), tachycardia (Verbatim: Heart Rate 120) and lab test abnormal (Verbatim: Abnormal Laboratory Results). On 14-JUL-2023, the patient experienced injection site irritation (Verbatim: minor irritation at injection site). The patient was treated with ibuprofen and paracetamol (Tylenol). The outcome of the injection site irritation and lab test abnormal were unknown and the outcome of the chills, fever, chest pain and tachycardia were resolved.   It was unknown if the reporter considered the injection site irritation, chills, fever, chest pain, tachycardia and lab test abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site irritation, chills, fever, chest pain, tachycardia and lab test abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 14-JUL-2023 At approximately 1:00 pm patient's mother called at doctor's office and reported about chills, fever and chest pain, then gave patient Ibuprofen. Patient's mother was instructed to bring patient to office for assessment. Abnormal value reported by Physician Assistant as D-Dimer more than 5000. Patient given Tylenol at doctor's office. Symptoms resolved and patient was sent home in Mothers care.  On the reporting day, the patient complained of minor irritation at injection site during follow up call. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test abnormal, Pyrexia, Tachycardia
Clinical narrative: minor irritation at injection site; chills; fever/febrile; chest pain; Heart Rate 120; Abnormal Laboratory Results; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site irritation in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number EN939, expiry date 31-OCT-2024) for prophylaxis.   On 13-JUL-2023 10:30, the patient received Bexsero (injection, left deltoid). On 13-JUL-2023, 3 hrs after receiving Bexsero, the patient experienced chills (Verbatim: chills), fever (Verbatim: fever/febrile), chest pain (Verbatim: chest pain), tachycardia (Verbatim: Heart Rate 120) and lab test abnormal (Verbatim: Abnormal Laboratory Results). On 14-JUL-2023, the patient experienced injection site irritation (Verbatim: minor irritation at injection site). The patient was treated with ibuprofen and paracetamol (Tylenol). The outcome of the injection site irritation and lab test abnormal were unknown and the outcome of the chills, fever, chest pain and tachycardia were resolved.   It was unknown if the reporter considered the injection site irritation, chills, fever, chest pain, tachycardia and lab test abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site irritation, chills, fever, chest pain, tachycardia and lab test abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 14-JUL-2023 At approximately 1:00 pm patient's mother called at doctor's office and reported about chills, fever and chest pain, then gave patient Ibuprofen. Patient's mother was instructed to bring patient to office for assessment. Abnormal value reported by Physician Assistant as D-Dimer more than 5000. Patient given Tylenol at doctor's office. Symptoms resolved and patient was sent home in Mothers care.  On the reporting day, the patient complained of minor irritation at injection site during follow up call. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Immunodeficiency, Serology negative, Therapy non-responder, Viral titre decreased
Clinical narrative: low immunity; received the Hepatitis B series and had negative titers; This serious case was reported by a other health professional via call center representative and described the occurrence of immunodeficiency in an unspecified number of patients who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced immunodeficiency (Verbatim: low immunity) (serious criteria GSK medically significant) and therapy non-responder (Verbatim: received the Hepatitis B series and had negative titers). The outcome of the immunodeficiency and therapy non-responder were unknown.   It was unknown if the reporter considered the immunodeficiency to be related to Hepatitis B vaccine.     It was unknown if the company considered the immunodeficiency to be related to Hepatitis B vaccine.   Additional Information: GSK Receipt date: 17-JUL-2023 The reporter was a medical assistant. The reporter reported that other patients that received the Hepatitis B series and had negative titers/low immunity where they had to repeat series or a booster. The reporter did not know the brand name/manufacturer of the Hepatitis vaccines received. Their office uses 0.5 ml dose. The reporter consented to follow up. This case was linked with case US2023098115, reported by same reporter.; Sender's Comments:  US-GSK-US2023098115:Same reporter
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: administered adult dose of Engerix-B vaccines to a 16 year old; administered adult dose of Engerix-B vaccines to a 16 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 08-AUG-2023) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Engerix B adult. On 17-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administered adult dose of Engerix-B vaccines to a 16 year old) and inappropriate age at vaccine administration (Verbatim: administered adult dose of Engerix-B vaccines to a 16 year old). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 Nurse reported that a Medical Assistant administered adult dose of Engerix-B vaccines to a 16-year-old, which led to overdose and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been linked with US2023099076, reported by same reporter.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Engerix-B vaccines to a 14 year old female; Engerix-B vaccines to a 14 year old female; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HBV (Engerix B adult) (batch number AC397, expiry date 08-AUG-2023) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Engerix B adult. On 17-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Engerix-B vaccines to a 14 year old female) and inappropriate age at vaccine administration (Verbatim: Engerix-B vaccines to a 14 year old female). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter reported that the medical assistant administered adult dose of Engerix-B vaccine to the 14 years old patient. The vaccine administration facility was the same as primary reporter. This case had been linked with US2023099074 by same reporter for different patient. The Adolescent patient was administered a adult dose of Engerix B, which led to overdose and inappropriate age at vaccine administration. The reporter did consent to follow up.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: accidently administered an expired dose of ENGERIX B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HBV (Engerix B) (batch number f73dg, expiry date 03-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Engerix B. On 14-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: accidently administered an expired dose of ENGERIX B). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 18 Jul 2023. The pharmacist stated that a patient was accidently administered an expired dose of ENGERIX B which was expired on 03-JUL-2023. The reporter consented to follow up. The patient accidently administered an expired dose of ENGERIX B which led to expired vaccine used.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient was accidently administered an expired dose of ENGERIX B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number f73dg, expiry date 03-JUL-2023) for prophylaxis.   On 16-JUL-2023, the patient received Engerix B. On 16-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient was accidently administered an expired dose of ENGERIX B). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Jul-2023 The reporter consented to follow-up. The patient was accidently administered an expired dose of Engerix-B, which led to expired vaccine used.