chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL, MMRV, VARCEL
Symptoms: Vaccination error
Clinical narrative: No additional AEs reported; Caller reported VARIVAX and PROQUAD were administered at the same visit.; This solicited report has been received from a registered nurse, regarding a 12-months old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JAN-2023, the patient was administered a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection (lot number: W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) and also a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number: W021741, which was determined to be valid, with an expiration date on 10-JUL-2024), both on the same visit at a dos of 0.5 milliliter subcutaneously as prophylaxis (strengths, schemes and anatomical locations of administration were not reported) (overdose). No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Accidental overdose
Clinical narrative: Adverse event: none; Nurse calling to report that she administered PROQUAD and VARIVAX at the same time. No PQC. No additional information.; MMR Proquad route of administration: IM; This spontaneous report was received from a nurse and refers to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 09-JAN-2023, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), intramuscularly, lot # FN5556, expiration date: 30-AUG-2024 (strength, dose and anatomical location were not provided), hib vaccine (HIB), intramuscularly, lot # YH44IU, expiration date 13-DEC-2023 (strength, dose and anatomical location were not provided), varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (mL), subcutaneously, # W017552, expiration date: 01-JUN-2024 (strength and anatomical location were not provided) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) 0.5 mL, intramuscularly (incorrect route of product administration), lot # W019629, expiration date: 19-DEC-2023 (strength and anatomical location were not provided). All suspect vaccine were given for prophylaxis.   On 09-JAN-2023, the nurse "grabbed vaccines for the patient. She thought she grabbed a single MMR and did not realize it had varicella in it. She gave additional single varicella vaccine". The nurse called the mother of the patient and made her aware that "the patient received 2 doses of the varicella vaccine" (accidental overdose). The patient's response was provided as "no issue". Suspect vaccines were used according to the instruction leaflet. No temperature excursion occurred as a result of a reading from a data logger. No adverse events following a prior vaccination (no adverse event), no illness at the time of vaccination and no pre-existing physician-diagnosed allergies, birth defects and medical conditions was reported. The outcome of the event of accidental overdose was provided as recovered. The outcome of remained events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product confusion, Product selection error, Wrong product administered
Clinical narrative: she then inadvertently administered the PROQUAD to the patient instead of the MMR II; she confused the PROQUAD for the MMR II as they were stored in the same exact spot; 23-DEC-1985,  PROQUAD was inadvertently administered to a patient; confused the PROQUAD for the MMR II as they were stored in the same exact spot; No additional AE reported; This spontaneous report was received from a health care professional and referred to a currently 37-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On an unknown date, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (anatomical location, strength, dose, route, lot number, and expiration date were not reported; for prophylaxis) was scheduled to be administered, but the reporter confused the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as they were stored in the same exact spot (Product confusion, Product selection error). The caller said she then inadvertently administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA), 0.5 milliliter, lot #U024508, expiration date: 02-FEB-2023, administered for prophylaxis; strength, and route of administration were not provided) to the patient instead of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong product administered, Product administered to patient of inappropriate age). There was no adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; SRP Voicemail received on 16JAN2023 at 8:56am reporting that PNEUMOVAX 23 expired on 08JAN2023 and was administered on 16JAN2023. Company awareness date reflects the date the voicemail was received. Filing today as it was outside of business hours. N; This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 16-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe, lot number U018309, for prophylaxis (route of administration was unknown).  The dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) that was administered to the patient had expired on 08-JAN-2023. There was no temperature excursions. No adverse event  were reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE details or PQC; Inbound call from HCP stating that an MMR-II was inadvertently administered intramuscularly in and adult instead of subcutaneously. No symptomatic side effects reported. No additional AE details or PQC.; This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender. The patient's concomitant medication included sterile diluent (lot # T030955, expiration date: 23-APR-2023, dose was not reported). Medical history, concurrent conditions and drug reaction/allergies were not reported.  On 23-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status recombinant Human albumin) (rHA) (M-M-R II) subcutaneous injection (0.5 milliliter [ml], lot # U022174, expiration date: 14-JUL-2023, strength and anatomical site of administration were not provided) inadvertently administered intramuscularly instead of subcutaneously for prophylaxis (incorrect route of product administration). No symptomatic side effects were reported (no adverse event).
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M decreased, Diarrhoea, Electrolyte imbalance, Hypogammaglobulinaemia
Clinical narrative: This literature marketed report was received from the authors of a published article, titled as stated above, and concerns to a 3-months-old female patient.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) orally, (strength, dose, frequency, dose number, lot number and expiration date were not reported), for prophylaxis.  On an unknown date, the 3-months-old patient,female, presented with worsening diarrhea beginning one-week post rotavirus vaccination; she was meeting age-appropriate milestones, had a negative newborn screen (NBS), including Severe Combined Immunodeficiency (SCID) screen, and no pertinent family history; she was admitted for un-resolving diarrhea, electrolyte abnormalities, lymphopenia and hypogammaglobulinemia; Stool rotavirus Protein C Reaction (PCR) was positive (vaccine breakthrough infection and rotavirus infection), 8 weeks after vaccination, on an unknown date, and Total immunoglobulin G (IgG) and IgM were low; the presence of a thymus was confirmed on ultrasound, and esophagogastroduodenoscopy (EGD) and flexible sigmoidoscopywere grossly normal. She received palivizumab, Intravenous immune globulin (IVIG), and Trimethoprim / Sulfamethoxazol (BACTRIM) and fluconazole prophylaxis; the diarrhea resolved one week after hospitalization.  At the time of reporting, the outcome of the events was not reported. The authors considered the events to be related with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) as they stated: "The temporal relationship of vaccine administration with onset of clinical findings, the persistently positive stool rotavirus PCR, and the absence of other clear etiology suggested rotavirus vaccine as the inciting factor for this patient's presentation. This case highlighted a potentially rare subset of immunocompetent patients who could contract rotavirus infection from the rotavirus vaccine."  The authors considered lymphopenia and hypogammaglobulinemia as life-threatening events.   Upon internal review hypogammaglobulinemia was determined to be medically significant event.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Immunoglobulin therapy, Lymphopenia, Oesophagogastroduodenoscopy normal, Rotavirus infection, Rotavirus test positive
Clinical narrative: This literature marketed report was received from the authors of a published article, titled as stated above, and concerns to a 3-months-old female patient.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) orally, (strength, dose, frequency, dose number, lot number and expiration date were not reported), for prophylaxis.  On an unknown date, the 3-months-old patient,female, presented with worsening diarrhea beginning one-week post rotavirus vaccination; she was meeting age-appropriate milestones, had a negative newborn screen (NBS), including Severe Combined Immunodeficiency (SCID) screen, and no pertinent family history; she was admitted for un-resolving diarrhea, electrolyte abnormalities, lymphopenia and hypogammaglobulinemia; Stool rotavirus Protein C Reaction (PCR) was positive (vaccine breakthrough infection and rotavirus infection), 8 weeks after vaccination, on an unknown date, and Total immunoglobulin G (IgG) and IgM were low; the presence of a thymus was confirmed on ultrasound, and esophagogastroduodenoscopy (EGD) and flexible sigmoidoscopywere grossly normal. She received palivizumab, Intravenous immune globulin (IVIG), and Trimethoprim / Sulfamethoxazol (BACTRIM) and fluconazole prophylaxis; the diarrhea resolved one week after hospitalization.  At the time of reporting, the outcome of the events was not reported. The authors considered the events to be related with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) as they stated: "The temporal relationship of vaccine administration with onset of clinical findings, the persistently positive stool rotavirus PCR, and the absence of other clear etiology suggested rotavirus vaccine as the inciting factor for this patient's presentation. This case highlighted a potentially rare subset of immunocompetent patients who could contract rotavirus infection from the rotavirus vaccine."  The authors considered lymphopenia and hypogammaglobulinemia as life-threatening events.   Upon internal review hypogammaglobulinemia was determined to be medically significant event.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Sigmoidoscopy normal, Ultrasound scan, Ultrasound scan abnormal, Vaccine breakthrough infection
Clinical narrative: This literature marketed report was received from the authors of a published article, titled as stated above, and concerns to a 3-months-old female patient.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) orally, (strength, dose, frequency, dose number, lot number and expiration date were not reported), for prophylaxis.  On an unknown date, the 3-months-old patient,female, presented with worsening diarrhea beginning one-week post rotavirus vaccination; she was meeting age-appropriate milestones, had a negative newborn screen (NBS), including Severe Combined Immunodeficiency (SCID) screen, and no pertinent family history; she was admitted for un-resolving diarrhea, electrolyte abnormalities, lymphopenia and hypogammaglobulinemia; Stool rotavirus Protein C Reaction (PCR) was positive (vaccine breakthrough infection and rotavirus infection), 8 weeks after vaccination, on an unknown date, and Total immunoglobulin G (IgG) and IgM were low; the presence of a thymus was confirmed on ultrasound, and esophagogastroduodenoscopy (EGD) and flexible sigmoidoscopywere grossly normal. She received palivizumab, Intravenous immune globulin (IVIG), and Trimethoprim / Sulfamethoxazol (BACTRIM) and fluconazole prophylaxis; the diarrhea resolved one week after hospitalization.  At the time of reporting, the outcome of the events was not reported. The authors considered the events to be related with rotavirus vaccine, live, oral, pentavalent(manufacturer unknown) as they stated: "The temporal relationship of vaccine administration with onset of clinical findings, the persistently positive stool rotavirus PCR, and the absence of other clear etiology suggested rotavirus vaccine as the inciting factor for this patient's presentation. This case highlighted a potentially rare subset of immunocompetent patients who could contract rotavirus infection from the rotavirus vaccine."  The authors considered lymphopenia and hypogammaglobulinemia as life-threatening events.   Upon internal review hypogammaglobulinemia was determined to be medically significant event.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 1.25
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse event was reported; The vaccine had temperature excursion of 47.9°F on 01-DEC-2022 and then was administered to the patient; This spontaneous report was received from a certified medical assistant and refers to a 15-month-old female patient with not concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies reported.      On 01-DEC-2022, hepatitis a vaccine, inactivated (VAQTA), lot # reported as W006596, expiration date 11-OCT-2024 had temperature excursion of 47.9 Fahrenheit degrees (°F) for 47 minutes.  On 15-DEC-2022, the patient was vaccinated with an  improper store third dose of hepatitis a vaccine, inactivated (VAQTA), intramuscularly in the right thigh , lot # reported as W006596, expiration date 11-OCT-2024 for prophylaxis (quantity dose was not reported) ((improper storage of product in use).  No additional adverse event and not product quality complain were reported.  Lot number W006596 is an invalid lot number for hepatitis a vaccine, inactivated (VAQTA).
Age: 0.17
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMP EXCURSION; No additional AE reported; This spontaneous report was received from a Medical Assistant referring to a 2-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date after the vaccines temperature excursion of 47.9 degree Fahrenheit (F) for 47 minutes on 01-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023 orally; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, intramuscularly (IM) at left thigh (LT), both administered for prophylaxis (strength and dose were not provided) (product storage error). No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; Pharmacist reports administration of MMR II on 01FEB2023 via the intramuscular route instead of the subcutaneous route; This spontaneous report has been received from a pharmacist, concerning a male patient of unknown age.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 01-FEB-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, dose frequency: 1, administered via the intramuscular route instead of the subcutaneous route as prophylaxis (exact dose, lot number, and expiration date were not provided) (Incorrect route of product administration).  No additional information provided. No additional adverse event (AE) was reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: PNEUMONIA; The spontaneous report was received from a pharmacist, referring to a 68-year-old female patient, via PFIZER. The patient's concurrent conditions, medical history, concomitant therapies and allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, route, lot number, expiration date and anatomical location were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (dose, route, lot number, expiration date and anatomical location were not reported) for prophylaxis.  On an unknown date in September 2022 (reported as 5 months ago), the patient the patient was hospitalized due to pneumonia and was in the hospital "quite awhile" due to the pneumonia. The patient did not have been administered pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). The patient was wondering if there was a time fame from having pneumonia before they can go with the pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). The patient was wondering if she received a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) shot in their 50's be eligible to get a shot of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). The outcome of pneumonia was not provided. The causality between all suspect therapies and pneumonia was not provided.  Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; Arm pain; Rash; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies (the patient had allergies but could not find out what the active and inactive ingredients for this product).   On 27th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced pain in arm and rash. On 27th January 2023, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were not recovered/not resolved and the outcome of the pain in arm and rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, upset stomach, pain in arm and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Jan-2023 Reporter's Comments: This case was self-reported by the patient. The patient experienced pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach was ongoing. The patient also experienced arm pain and rash. The unspecified expiry date of Shingrix was unknown. The patient tried to find out the ingredients that had an allergies but could not find out what the active and inactive ingredients for this product. The symptoms were not treated.  The reporter had gave the permission to contact you.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; Arm pain; Rash; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies (the patient had allergies but could not find out what the active and inactive ingredients for this product).   On 27th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced pain in arm and rash. On 27th January 2023, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were not recovered/not resolved and the outcome of the pain in arm and rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, upset stomach, pain in arm and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Jan-2023 Reporter's Comments: This case was self-reported by the patient. The patient experienced pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach was ongoing. The patient also experienced arm pain and rash. The unspecified expiry date of Shingrix was unknown. The patient tried to find out the ingredients that had an allergies but could not find out what the active and inactive ingredients for this product. The symptoms were not treated.  The reporter had gave the permission to contact you.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pain at the injection site; Redness at the injection site; Swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; Arm pain; Rash; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies (the patient had allergies but could not find out what the active and inactive ingredients for this product).   On 27th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced pain in arm and rash. On 27th January 2023, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were not recovered/not resolved and the outcome of the pain in arm and rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever, upset stomach, pain in arm and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Jan-2023 Reporter's Comments: This case was self-reported by the patient. The patient experienced pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach was ongoing. The patient also experienced arm pain and rash. The unspecified expiry date of Shingrix was unknown. The patient tried to find out the ingredients that had an allergies but could not find out what the active and inactive ingredients for this product. The symptoms were not treated.  The reporter had gave the permission to contact you.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Product administered at inappropriate site
Clinical narrative: small rash at site of injection; site of injection-red ring- rash / Shot was given in buttocks; Shot was given in buttocks; This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site rash and injection site erythema were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingrix.     Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The reporter reported that the patient had small rash at site of injection red ring rash which was resolved. The shot was given in buttocks because other vaccines were given that day. Additional supportive information: As patient received vaccine on buttocks, which led to vaccine administered at inappropriate site.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots, he/she was sick a few days but hopefully he/she would not got shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.
Age: 80.0
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 80-year-old patient who received HAB (Twinrix) (batch number unknown, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 1-Feb-2023 Reporter's comment: The reporter reported that one of their medical offices administered an expired Twinrix vaccine to a patient.  They were looking to see if there were any recommendations in regards to revaccinating the patient. That was reporter's office location address, the previous address might had been from one of their locations. They had 15 locations. That was the address for the corporate building. Additional supportive information: The patient received a dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 5Dec2022, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 31st January 2022, the patient received the 2nd dose of Shingrix. On 31st January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: Medical assistant (MA) reported the potential administration of Shingrix less than 2 months following the initial dose in an immunocompetent patient.  The patient was administered 1st dose of Shingrix on 5th December 2022 and was in office on the day of reporting for 2nd dose, which was 5 days prior to dose being due.  It was unknown if dose would be administered or not at time of call. The reporter did not consent to follow-up. HCP disconnected phone call prior to collecting patient demographics.  2nd dose of Shingrix had not been administered at time of the call.  It was unknown whether Shingrix was administered at the patient's visit.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck, can't move neck; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30th May 2024) for prophylaxis.   On 30th January 2023, the patient received Shingrix. On 31st January 2023, 1 days after receiving Shingrix, the patient experienced stiff neck. On an unknown date, the outcome of the stiff neck was unknown.   It was unknown if the reporter considered the stiff neck to be related to Shingrix.     Additional Information: GSK Receipt date: 31-Jan-2023. Reporter's Comment: The reporter stated that the patient could not move her neck. The reporter consented to follow-up via email.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administered to a 4 months-old; Kinrix administered instead of Pentacel; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 31-Jan-2023 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix instead of Pentacel at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old received Boostrix in error; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 3rd June 2023) for prophylaxis.   On 31st January 2023, the patient received Boostrix. On 31st January 2023, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The reporter called to get instructions on how to care for 2 years old recipient of Boostrix vaccine administered in error. No symptoms was reported. Provided medical information telephone number, transferred to medical information. Emergency room visit required. The reporter consented to follow-up via email. Additional supportive information: The patient received a dose of Boostrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2023015024:same reporter
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose early given /no documentation of vaccine given; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult  (received first dose on 26th July 2022) and Engerix B adult (received second dose 26th August 2022).   On 10th January 2023, the patient received the 3rd dose of Engerix B adult. On 10th January 2023, unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The nurse reported the patient received dose 3 of Engerix (early dose) but there was no record of it at the health care professional office.  The nurse stated that the nurse who gave the vaccines to the patient no longer works there.  The vaccine log did not have this vaccine logged in for Engerix given on 10th January 2023. Medical information, phone numbr and warm transfer were provided. The reporter consented to follow-up. Additional supportive information: The patient received 3rd dose of Engerix-B adult earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 11Oct2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 11th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 31-Jan-2023 Reporter's comment: A pharmacist called to ask for information regarding the patient who did not receive the second dose after 1 month of first dose. The reporter asked if they could administer the second dose or if the patient had to start over with vaccination. The reporter did not shared Twinrix first dose lot number and expiration date. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Age: 0.33
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given not at age 4-6, given at 4 and 6 months old; Kinrix given at 4 and 6 month age; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered 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: 31-JAN-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Kinrix vaccine at the age of 4 month and 6 month. The reporter wanted to know If the patient was given Kinrix vaccine earlier in the vaccination series and not at age 4 between 6 years, can you provide data if that was ok or the office need to repeat the doses using Pediarix vaccine. This patient was from another health system that joined their practice that was administered Kinrix in this way. The reporter did not provided lot number, expiration date and patient identifier. The reporter did consent to follow up. Additional Supportive Information: The patient received Kinrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received extra dose of Kinrix in error, which led to extra dose administered. This case had been linked with US2023015601 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023015601:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Intercepted product prescribing error, Limb injury
Clinical narrative: Hand injury; cellulitis; pharmacist told him to get his second Shingrix dose one month after the first dose; This case was reported by a consumer via call center representative and described the occurrence of hand injury in a adult male 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 1st dose of Shingrix (intramuscular) and did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hand injury (serious criteria hospitalization), cellulitis (serious criteria hospitalization and GSK medically significant) and intercepted product prescribing error. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the hand injury and intercepted product prescribing error were unknown and the outcome of the cellulitis was recovered/resolved.   It was unknown if the reporter considered the hand injury to be related to Shingrix. The reporter considered the cellulitis to be unrelated to Shingrix.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The reporter was the patient.  The patient received his first Shingrix dose about 1 month ago from reporting. The patient recently injured his hand and developed cellulitis.  The patient was hospitalized and treated with antibiotics. The patient mentioned that his pharmacist told him to get his second Shingrix dose one month after the first dose, but he had not yet received it and nothing else was reported. The reporter did not consent to follow up. Additional supportive information: Pharmacist told the patient to get his second Shingrix dose one month after the first dose, but he had not yet received it, which led to intercepted product prescribing error.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Nightmare
Clinical narrative: Felt weird; Headache; Did not sleep well; Shivering; Had Nightmares; Legs hurt/Arm hurts; Whole body hurts; Does not feel well; This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023 10:30, the patient received the 1st dose of Shingrix. On 1st February 2023, less than a day after receiving Shingrix, the patient experienced weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell. On an unknown date, the outcome of the weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell were unknown.   It was unknown if the reporter considered the weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: The patient self-reported this case. The patient received Shingrix vaccine on left arm at about 10:30 am. The patient stated that she was okay all the day after received Shingrix vaccine, but on the same night when she was laid down to go to sleep, she felt weird, headache, did not sleep well, shivering, nightmares, her legs, arms and whole body hurts, she did not felt well. The reporter did consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Felt weird; Headache; Did not sleep well; Shivering; Had Nightmares; Legs hurt/Arm hurts; Whole body hurts; Does not feel well; This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023 10:30, the patient received the 1st dose of Shingrix. On 1st February 2023, less than a day after receiving Shingrix, the patient experienced weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell. On an unknown date, the outcome of the weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell were unknown.   It was unknown if the reporter considered the weird feeling, headache, poor sleep, shivering, nightmare, pain in extremity, general body pain and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: The patient self-reported this case. The patient received Shingrix vaccine on left arm at about 10:30 am. The patient stated that she was okay all the day after received Shingrix vaccine, but on the same night when she was laid down to go to sleep, she felt weird, headache, did not sleep well, shivering, nightmares, her legs, arms and whole body hurts, she did not felt well. The reporter did consent to follow up.
Age: 0.92
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA657A, expiry date 31st January 2023) for prophylaxis.   On 3rd February 2023, the patient received Menveo. On 3rd February 2023, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter stated that a patient was administered an expired dose of Menveo at the time of reporting.  The reporter did not consent to follow-up from safety team . Additional Supportive Information: The patient was administered with expired dose of Menveo, which led to expired vaccine used.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included: pancreatectomy, and urinary tract infection, and concurrent conditions included: type 1 diabetes, pancreatic insufficiency, ra (Rheumatoid arthritis), hypothyroidism, hyperparathyroidism, depression, and hypercholesterolemia (Increased cholesterol), and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no pre-existing acute illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UKNOWN) dose was not reported, administered on 09-FEB-2022 for covid-19 prophylaxis. Age at time of vaccination 62 years old. Concomitant medications included sertraline for depression, levothyroxine for hypothyroidism, ergocalciferol for pancreatectomy, omeprazole for pancreatectomy, pancrelipase for pancreatectomy, insulin aspart for type 1 diabetes, vaccinium macrocarpon for urinary tract infection, and atorvastatin. On 12-FEB-2022, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This case, involving the same patient is linked to 20230107357.