chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Respiratory syncytial virus test negative, Rhinorrhoea, SARS-CoV-2 test negative, Sneezing
Clinical narrative: This started in the morning of the 12/21/2022, with a real sore throat. It felt like I had a golf ball in my throat. Severe cold symptoms: running nose, coughing, lethargy, fatigue, sneezing, headache, and body aches. sleeplessness. I tested 3 times for COVID-19 and they all came back negative every time.  I tested for RSV, the results were negative. I tested for the Flu A and B and the results were negative.  I tested at the Hospital for the RSV and the Flu A and B because I am in a study. December 26, 2022, I had a telehealth visit on January 16, 2023 because I was not feeling better. The first visit. I was prescribed Doxycycline for 7 days. I did not get better. January 16, 2023, I had an in person visit, they did a chest X-ray, and they gave me methylprednisolone tablet.  I never fully recovered. On March 27, 2023, I got sick again. It regrouped and I went through the same symptoms again.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose before the recommended age; A HCP called to report that she inadvertently administered a dose of PROQUAD to a 2 year old patient. The caller said the patient had received "MMR and Varicella vaccines at their 12 month doctor appointment." The caller did not provide brand names f; This spontaneous report was received from an other Health Professional and refers to a 2-year-old male patient.  The patient's medical history, concurrent conditions were not reported. The patient had received measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR) and Varicella vaccines (unspecified) at their 12 month doctor appointment.   On an unspecified date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, lot #, expiration date, route of administration were not reported). On 28-MAR-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot #W034209, expiration date: 24-APR-2024), administered intramuscularly (left deltoid) for prophylaxis (dose and strength were not reported) (Product administered to patient of inappropriate age) and sterile diluent was used to reconstitute the vaccine (lot#and expiration were not provided). The patient also was vaccinated with diphteria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (VERO) (+) tetanus vaccine toxoid (KINRIX) (lot number 69N2M intramuscular (right deltoid).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Pain, Pruritus, Rash
Clinical narrative: shingles; unable to sleep; This spontaneous report was received from a consumer who was reporting on herself as a 86-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included  sulfonamide allergy, and penicillin allergy. Concomitant therapies included unspecified vitamins. Since an unknown date, the patient was vaccinated with a total of 3 unspecified zoster vaccine live (manufacturer unknwn) with her last vaccine being 5 years ago (approximately 2018) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date (reported as "about 3 to 4 months ago"), the patient was diagnosed with shingles and has been dealing with the pain and itching from the shingles rash since. The patient sought medical attention and her doctor prescribed her suvorexant (BELSOMRA) to help her sleep after she was diagnosed with shingles because the itching was so bad that she was unable to sleep. She reported rhat she has had no issues or side effects from the suvorexant (BELSOMRA) and that it was working well for her and she reported no adverse experience with this product. At the time of reporting, the patient was recovering from the event of shingles and from the event of unable to sleep. The causal relationship between shingles and zoster vaccine live (manufacturer unknwn) was unknown. The causal relationship between unable to sleep and zoster vaccine live (manufacturer unknwn) was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired dose of PNEUMOVAX 23 was inadvertently administered to a patient; This spontaneous report was received from a 56 year old patient of unknown gender referring to himself/herself. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-APR-2023, the patient was inadvertently vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml injection, lot # U027357, expiration date: 25-MAR-2023) for prophylaxis (expired product administered). No additional adverse event (AE) was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W019628, expiration date: 19-DEC-2023, albumin status has been verified as recombinant human albumin (rHA), administered intramuscularly in right thigh for prophylaxis (strength and dose was not provided). The vaccine had undergone temperature excursion (product storage error). No additional adverse event (AE) reported.; Sender's Comments:  US-009507513-2303USA002114:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 16-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot #W019628, expiration date: 19-DEC-2023, administered intramuscularly into right thigh (exact dose was not provided) for prophylaxis. On 10-DEC-2023, the vaccine experienced the temperature excursion between negative 14 and negative 10 Celsius degrees for 1 hour (product storage error). No additional adverse event (AE) details were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007931:
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; GARDASIL 9 was inadvertently administered to 4 month old patient; This spontaneous report was received from a pharmacist and refers to a 4-month-old female patient. There was no information regarding the patient's medical history, concurrent condition and concomitant therapies details reported.  On 20-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775808, expiration date: 20-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age).
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Neoplasm malignant
Clinical narrative: Is Cancer Yes; tested positive for HPV since vaccination; unspecified HPV vaccine; This spontaneous report has been received from a physician assistant (also reported as physician, conflicting information) referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were unknown.   On unknown dates, the patient was vaccinated with a complete series of an unspecified human papillomavirus (HPV) vaccine injection (route reported as injection; strength, dose, lot number and expiration date were not known) as protection against HPV (product origin unknown).  On an unknown date since vaccination, the patient was tested positive for HPV. It was also reported as a cancer event (neoplasm malignant). The patient sought medical attention and was requesting additional vaccinations with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was unknown if any treatment was given. At time of reporting, the outcome of the event was unknown. The causality between unspecified HPV vaccine and the event was not reported. The reporter stated that their electronic medical record (EMR) was down at this time, so she was unable to provide exact vaccine name, patient's age and all additional information. No product quality complaint (PQC).   Upon internal review, the event of neoplasm malignant was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided. On an unknown date, VARIVAX was improperly stored (product storage error). Temperature was 1.1 Celsius degree (C). Time frame was 1 hour and 49 minutes. Previous temperature excursion did not occur. On 25-APR-2023, the patient was vaccinated with VARIVAX (0.5 milliliter (ml), lot# W024335 has been verified to be a valid lot number, expiration date was reported as 31-JUL-2024, but upon internal validation established as 01-AUG-2024, anatomical location was not provided) subcutaneously for prophylaxis after temperature excursion. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Vaccine was administered after data logger discrepancy; This spontaneous report was received from an other reporter and referred to a patient with unknown age and gender. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was improperly stored and occurred data logger discrepancy. Temperature, time frame and previous temperature excursion were unknown. On 25-APR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (1 dosage form, lot # W034211 has been verified to be a valid lot number, expiration date was reported as 24-APR-2024, anatomical location and route were not provided) for prophylaxis after data logger discrepancy (product storage error). No additional adverse event (AE) reported (no adverse event).
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further information provided, no additional AEs, no PQCs.; one dose of PEDVAXHIB from expired lot on 15APR2023 was administered on 26APR2023.; This spontaneous report was received from a certified medical assistant and refers to a 15-month-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 26-APR-2023, the patient was vaccinated with expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, once, lot # U003873 was confirmed to be valid, expiration date 15-APR-2023 for prophylaxis (route and site of administration were not reported). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot but still got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot but still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-APR-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she know few patients who received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and had them/Suspected Vaccination Failure; had them; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and had them/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2023 The case  was received from the patient' sister/brother via interactive digital media. The patient got the shot and had them really bad a few years ago. The reporter stated that they say vaccine was different now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, got shingles/Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-APR-2023 The case  was received from the patient via interactive digital media. The patient got the Shingles shot and got shingles. No contact details were provided. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles shots and having a mild case of shingles/Suspected Vaccination Failure; mild case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles shots and having a mild case of shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: mild case of shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-APR-2023 The case  was received from the patient wife via interactive digital media. The patient got Shingles shots 6 years ago did not prevent from having a mild case of shingles recently.  The reporter enquired that could COVID had interrupted the protection that they should have had from the shots? The reporter stated that it was stopped from being terrible probably from the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: the poison jabbies gave my mother shingles/suspected vaccination failure; shingles; 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: the poison jabbies gave my mother shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-APR-2023 The case  was received from the patient via interactive digital media. The patient stated that true he/she got it again after the shot but pain was no where was the level of pain before the shot. The patient stated that the shot definitely helped him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Hepatitis B surface antibody, Therapeutic response decreased
Clinical narrative: less than 10 mIU/mL for patient who completed series; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of therapeutic response decreased in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 03-NOV-2005, the patient received the 3rd dose of Pediarix .5 ml. On an unknown date, the patient received the 2nd dose of Pediarix .5 ml and the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, Pediarix and Pediarix, the patient experienced therapeutic response decreased (Verbatim: less than 10 mIU/mL for patient who completed series). The outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter called to request information for revaccination of Hepatitis B after post-vaccination test showed anti-HBs antibody concentrations less than 10 mIU/mL for patient who completed Pediarix series.  No further information provided, no additional adverse events, no PQC (product quality complaint). The reporter called to request information for revaccination of Hepatitis B after post-vaccination test showed anti-HBs antibody concentrations less than 10 mIU/mL for patient who completed Pediarix series, which led to therapeutic response decreased.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine adjuvant without active component; Patient received vaccine adjuvant without active component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Patient received vaccine adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter reported that there was multiple patients received Shingrix vaccine adjuvant without active component. The reporter did consent to follow up. The reporter gave by error Shingrix adjuvant portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered; Sender's Comments:  US-GSK-US2023058298:Same reporter/Batch case US-GSK-US2023058300:Same reporter/Batch case
Sex: M
Vaccine: MENB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: doctor prescribed it to me anyway; older male; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a elderly male patient who received Men B NVS (Bexsero) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Bexsero. On 20-MAR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: older male). On an unknown date, the patient experienced off label use (Verbatim: doctor prescribed it to me anyway). The outcome of the off label use and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:21-APR-2023 The reporter reported that he was an older male but he would be in an immersive language school and live confined on campus and share a small room with another student. He had his first dose of Bexsero on and wanted to know when do he need to have second dose. The reporter was aware that that vaccine was mainly for younger ages. But his doctor prescribed it to him as he was living in a strict campus life for more than two months and after that doctor went away for a month but never mentioned when the second dose was recommended. The reporter for some reason could not find any straight forward guidelines for dose interval between 2 bexsero dose some said 2 month, some said six and 1 so it was confusing to him. The agent advised to contact another doctor for further direction as she did not want him to get a vaccine which he may not need. The reporter realized that was not medical advice and he will just follow what was recommended there. Follow-up would not be possible as no contact details were available. The vaccine was prescribed by doctor at wrong age which led to Inappropriate age at vaccine administration and off label use.
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 13-APR-2023, the patient received Rotarix lyophilized formulation. On 13-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060516:Same reporter
Age: 0.42
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 13-APR-2023, the patient received Rotarix lyophilized formulation. On 13-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059808:Same Reporter US-GSK-US2023AMR059807:Same Reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 12-APR-2023, the patient received Rotarix lyophilized formulation. On 12-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 18-APR-2023, the patient received Rotarix lyophilized formulation. On 18-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 21-APR-2023, the patient received Rotarix lyophilized formulation. On 21-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication, accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Dysgeusia, Product complaint, Regurgitation
Clinical narrative: Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 14-APR-2023, the patient received Rotarix lyophilized formulation. On 14-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: BABY NOT ABLE TO SWALLOW FULL DOSE DUE TO SPITTING OUT; Not able to swallow full dose; Tasted very bad, appeared oily; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and product complaint (Verbatim: Tasted very bad, appeared oily). On an unknown date, the patient experienced regurgitation of medication (Verbatim: BABY NOT ABLE TO SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 8-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 and 25-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter