chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Dehydration, Delirium, Pyrexia, Syncope
Clinical narrative: Delirium; Syncope; Altered state of consciousness; Dehydration; Pyrexia; This case was received via VAERS (Reference number: 1358559) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirium), SYNCOPE (Syncope) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized for 8-10 (No vent).) in February 2021.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion medically significant), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia). At the time of the report, DELIRIUM (Delirium), SYNCOPE (Syncope), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness), DEHYDRATION (Dehydration) and PYREXIA (Pyrexia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with  IV fluid and condition improved after that.  Physician did not recommend dose 2.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Deep vein thrombosis; Pulmonary embolism; This case was received via VAERS (Reference number: 1358680) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease and Latex allergy. Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), TAMSULOSIN, DROXIDOPA (NORTHERA), MELATONIN, CYANOCOBALAMIN (B-12), FINASTERIDE, POTASSIUM, CITALOPRAM and ROSUVASTATIN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information was not provided.  Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Swelling, Tenderness
Clinical narrative: Muscular weakness; Swelling; Tenderness; This case was received via VAERS (Reference number: 1358802) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (Muscular weakness), SWELLING (Swelling) and TENDERNESS (Tenderness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Muscular weakness) (seriousness criterion hospitalization), SWELLING (Swelling) (seriousness criterion hospitalization) and TENDERNESS (Tenderness) (seriousness criterion hospitalization). At the time of the report, MUSCULAR WEAKNESS (Muscular weakness), SWELLING (Swelling) and TENDERNESS (Tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment information was provided.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: I got the shots /felt alittle tinged across my lower back; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient felt a little tinged across lower back for a few days. The case is linked with US2021AMR135364 for second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've got shingles after the 2 dose vaccination.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient reported that he/she received 2nd dose of Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. No other information was provided.
Sex: F
Vaccine: MEN
Symptoms: Rheumatoid arthritis
Clinical narrative: my daughter / developed RA after getting this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis was unknown.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. Age at vaccination was not reported. Parents reported that patient had experienced rheumatoid arthritis after taking this Meningococcal B vaccine. No further information was reported. Follow up was not possible as no contact details were provided.
Sex: U
Vaccine: HPVX
Symptoms: Injury
Clinical narrative: Got seriously injured by that vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced injury (serious criteria other: Serious as per reporter.). On an unknown date, the outcome of the injury was unknown.   The reporter considered the injury to be related to HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she knew someone got seriously injured by the HPV vaccine.
Sex: U
Vaccine: MENB, PNC13, VARZOS
Symptoms: Product storage error
Clinical narrative: temp excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and pneumococcal 13 valent conjugate vaccine (Prevenar13) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Shingrix and Prevenar13 at an unknown dose and frequency. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the Shingrix and Bexsero were stored other than recommended temperature, which led to incorrect storage of drug. Also temperature excursion was reported for Prevenar13. Over the phone call there was no mention that the medication was given to any patients after the temperature excursion. No other information was provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got my shot. I year later I had a mild case.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and 1 year later patient experienced shingles. The patient stated that it was mild case and patient had all the systems described above. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had the shot and got shingles, but was very mild; got shingles, but was very mild; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) ( to mother ) and pain (Family History) ( to mother ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient's mother had shingles twice and worst pain ever. The patient received Shingles vaccine and experienced shingles, but was very mild. The reporter stated that get the shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got it again AFTER the vax / Got the shot, still get it; Got it. Got the shot, still get it; Hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles again after vaccination and hurts. This case was considered as suspected vaccination failure, since completeion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: Enlargement of lymph nodes on both sides / in his chest also; Lymph nodes turned fire red; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 56-year-old patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis.   On 19th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and localized erythema. On an unknown date, the outcome of the enlargement of lymph nodes and localized erythema were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm intramuscularly and approximately seven days after experienced an enlargement of lymph nodes on both sides and lymph nodes turned fire red.  Also the patient experienced swollen lymph node in his chest. The reaction got subsided after about a week. The reporter consented permission to follow up with health care professional.
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory tract irritation
Clinical narrative: felt like his lungs were burning; This case was reported by a physician via sales rep and described the occurrence of lung irritation in a 54-year-old male 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 lung irritation. On an unknown date, the outcome of the lung irritation was unknown.   It was unknown if the reporter considered the lung irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and he felt like his lungs was burning. No other information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR136715:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Feeling tired; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows:  The patient reported the case for himself/herself. The age at vaccination was not reported. On the day before reporting date, the patient had received first dose of Shingrix and was feeling tired. The patient inquired that was this normal. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave the diluent for Shingrix rather than the mixed dose; Gave the diluent for Shingrix rather than the mixed dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter mentioned that, someone in his/her office gave the diluent for Shingrix rather than the mixed dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter mentioned that, the patient had to return to the office to get the full dose of Shingrix. No other information was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shinghles is i got that from shinghles shots; shinghles is i got that; Pain; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, got shingles shots and experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had the shingles and after I got the shot they came back with a vengeance; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had the shingles and after he/she got the shot, shingles came back with a vengeance This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Shingrix on 2018 / have not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-years-old male patient who received Herpes zoster (Shingrix)(batch number 3PD3E, Expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix on 2018 and came back on the day of reporting to receive the second one.  Till the time of reporting, the patient did not receive 2nd dose, which led to in incomplete course of vaccination. This case has been linked with case US2020254931, reported by same reporter. The reporter consented to follow up.   Follow up information received from pharmacist on 23rd June 2021: On 23rd December 2020, the patient received 2nd dose of Shingrix (0.5 ml) intramuscularly, which led to lengthening of vaccination schedule. Te batch number and expiry date was updated. The VAERS details were updated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254931:same reporter
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Product preparation issue, Underdose
Clinical narrative: reconstitution was mix in the same syringe with the Pfizer covid vaccines; reconstitution was mix in the same syringe with the Pfizer covid vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER for prophylaxis.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and underdose. On an unknown date, the outcome of the inappropriate reconstitution technique and underdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that Shingrix final reconstitution was mix in the same syringe with the Pfizer covid vaccines, which led to inappropriate reconstitution technique. It was stated that the pharmacist realized that, they leak 0.3ml of the vaccine and administrated to the patient, which led to underdose. No adverse event was reported. The reporter consented to follow up. No vaccination date provided.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect dosage administered
Clinical narrative: accidentally gave a pediatric dose of Hep B to an adult; accidentally gave a pediatric dose of Hep B to an adult; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric and the 2nd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric and not applicable after receiving Engerix B pediatric, the patient experienced adult use of a child product and adult use of a child product. On an unknown date, the outcome of the adult use of a child product and adult use of a child product were unknown.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that clinical medical assistant (CMA) accidentally gave a pediatric dose of Hep B to an adult, which led to adult use of a child product. The Nurse PR actioner ended up ordering a second dose of the pediatric Hep B to equal the adult dosage.  The reporter asked was there any considerations or any additional doses the patient would need. No additional information available at this time. Outbound call made in attempts to gather information for adverse event, but health care professional was not available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient immunocompromised had Shingrix first dose 3 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient received first dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The patient was immunocompromised and the pharmacist inquired if she needs to restart the series. The patient was taking steroids medication. The reporter consented to follow up by fax.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 1st dose / on 04/20/2021 / 2nd dose / on 06/02/2021; 23y/o adult - administered 1st dose of 10mcg dose; 23y/o adult - administered 1st dose of 10mcg dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 2nd dose of Engerix B adult 20 ug. On 20th April 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 20th April 2021, not applicable after receiving Engerix B adult and unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On 2nd June 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the adult use of a child product, underdose and drug dose administration interval too long 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 details were provided as follows: The pharmacist reported that 23 years old patient administered 1st dose of Engerix B 10 mcg, which led to adult use of child product and underdose. The patient received 2nd dose of Engerix B 20 mcg more than the recommended interval, which led to lengthening of vaccine schedule. The reporter consent to follow up. This case has been linked with case US2021134489, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134489:same reporter
Age: 2.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: on Jun 18th 2021 / received Pediarix /with expiration date on Jun 14th 20; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Pediarix and Pediarix 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 details were provided as follows: The patient received the Pediarix vaccine after its expiry date which led to the event expired vaccine used. The reporter consented to contact via email. The batch number was updated from D93BA to D93B4 as per sales data sheet. The case is linked to case US2021134507 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134507:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Antiallergic therapy, Hypersensitivity
Clinical narrative: Patient takes allergy shots 3 times a week and she wants to received Shingrix second dose./ first dose was on April 19th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of allergy in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced allergy. The patient was treated with allergens (nos) (Allergy Shots). On an unknown date, the outcome of the allergy was not recovered/not resolved.   It was unknown if the reporter considered the allergy to be related to Shingrix.  Additional details were provided as follows: The age of the patient was over 50 years old. The age at vaccination was not reported. Pharmacist was looking for information about Shinrgix second dose for the patient who took allergy shots 3 times a week and she wanted to receive Shingrix second dose.  No information was provided about allergy product type or brand name.  The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose: 4/10/2018 / Second dose: 3/4/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10h April 2018).   On 4th March 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended schedule, which led to lengthening of vaccination schedule.  The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapeutic response decreased
Clinical narrative: Fully vaccinated with Engerix B / Titers were low; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   Additional details were reported as follows: This case was reported by a pharmacist. No patient's identifiers other than age and gender were provided. No lot number or expiration date provided. The reporter reported that the patient was fully vaccinated with Engerix B and to get into nursing school titers were measured. The titers were low and it was recommended to proceed with revaccination. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose /on November 9th 2019 /not received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th October 2019, batch number 3425X, expiry date 18th December 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose / administered on 23Oct2019 / second dose on the same day as reported it; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number PK5B9, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2019).   On 22nd June 2021, the patient received the 2nd dose of Shingrix. On 22nd June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: On the day of reporting, the patient received 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: received 1st dose / in Nov. or Dec. 2019 / not received 2nd dose/ due to the Covid19  Pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November or December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient was not sure which arm the 1st dose was administered in and the patient did not have any product details such as lot number and expiration date. Due to Covid 19 Pandemic, the patient did not receive 2nd dose of Shingrix. The patient wanted to know if he had to start over with the 1st shot due to the time frame of missing the 2nd shot. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: varied from 13 to 18 months since their first dose / Second dose had not been given at time of report.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, no patient or vaccine /vaccination information was available since it was not received since it was not given at reporter's location. The reporter consented to follow up. This case was 1 of the 3 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021136326:Same reporter US-GLAXOSMITHKLINE-US2021136324:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: varied from 13 to 18 months since their first dose/ Second dose had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, no patient or vaccine/vaccination information was available.  The reporter also mentioned that, patient information could be retrieved but vaccination data is not available since it was not given at the reporter's location.  The reporter consented to follow up. This case was 1 of the 3 cases, reported by same reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021136324:Same reporter US-GLAXOSMITHKLINE-US2021136325:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the Shingles vaccine/ has had 6 bouts of Shingles since / suspected vaccination failure; had 6 bouts of Shingles since then.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported that, she received the Shingles vaccine (Shingrix) some time ago and had 6 bouts of shingles since then. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on August 24, 2020/ received the second dose 10 months later; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th August 2020).   On 14th June 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The patient received the 2nd dose of Shingrix, 10 months later, which led to lengthening of vaccination schedule. The patient stated, she did not read the paper the pharmacy gave her on Shingrix and was not aware the second dose had to be administered 2-6 months after first dose. The reporter enquired if she needs to receive 3rd dose. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: POSSIBLE INCORRECT ROUTE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced possible incorrect route. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible incorrect route was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache
Clinical narrative: DIARRHEA; HEADACHE; MILD ABDOMINAL PAIN AND IT HAS GOTTEN A  WHOLE LOT WORSE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included steel plate left hip (accident), and concurrent conditions included non-smoker, and non alcohol user, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient was previously treated with gabapentin for steel plate left hip (accident). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A,  expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 11:00 for prophylactic vaccination. Concomitant medications included atorvastatin for heart condition, and lisinopril for heart condition. On 12-JUN-2021, the subject experienced mild abdominal pain and it has gotten a whole lot worse. On 13-JUN-2021, the subject experienced diarrhea. On 13-JUN-2021, the subject experienced headache. Treatment medications included: paracetamol/methocarbamol. Additional treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-JUN-2021, and had not recovered from diarrhea, and mild abdominal pain and it has gotten a whole lot worse. This report was non-serious. This case, involving the same patient is linked to 20210648123.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Joint stiffness, Myalgia
Clinical narrative: STIFFNESS IN THE JOINTS; LOWER BACK HURTS; MUSCLE ACHES, MUSCLE SORENESS; HEADACHES; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included arm hurting from a vaccine, and concurrent conditions included arthritis, headaches, penicillin allergy, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 18-JUN-2021 09:30:00 for prophylactic vaccination. Concomitant medications included paracetamol. On 18-JUN-2021, the subject experienced stiffness in the joints. On 18-JUN-2021, the subject experienced lower back hurts. On 18-JUN-2021, the subject experienced muscle aches, muscle soreness. On 18-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, muscle soreness, headaches, stiffness in the joints, and lower back hurts. This report was non-serious.