chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Chills; Injection site pain; Myalgia; Pyrexia; This case was received via FDA VAERS (Reference number: 0917261) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), MYALGIA (Myalgia) and PYREXIA (Pyrexia) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Jan-2021, the patient experienced CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), MYALGIA (Myalgia) and PYREXIA (Pyrexia). At the time of the report, CHILLS (Chills), INJECTION SITE PAIN (Injection site pain), MYALGIA (Myalgia) and PYREXIA (Pyrexia) had not 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.   Other Meds : Novolog (insulin pump) levothyroxine, atorvastatin Symptom Text : Pain at injection site, myalgia, chills, fever,   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 year old). On 14-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Palpitations
Clinical narrative: I couldn't breathe; My heart was racing; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing 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, less than a day after receiving Shingles vaccine, the patient experienced difficulty breathing and heart racing. On an unknown date, the outcome of the difficulty breathing and heart racing were unknown.   It was unknown if the reporter considered the difficulty breathing and heart racing to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received first shingles vaccine during a check up with doctor later in the day the patient ended up in the emergency room with a reaction to the vaccine. The patient experienced felt like patient was dying, patient couldn't breathe and patient's heart was racing. The patient needless to said he/she was not getting another one. No further information reported.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: has an elevated temperature of 99.8; This case was reported by a consumer via call center representative and described the occurrence of body temperature increased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 10th June 2021 and felt achy refer case US2021169796). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)), acetylsalicylic acid (Aspirin) and paracetamol (Tylenol).   On 10th August 2021, the patient received the 2nd dose of Shingrix. On 11th August 2021, 1 days after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Aditional details were provided as follows: The patient reported this case for himself. The patient stated he had taken Tylenol and also takes a low dose aspirin every morning. The patient also stated that he received the COVID vaccine in the winter. The patient received Shingrix and experienced elevated temperature of 99.8 degree F. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169796:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: got "shingles"/ Small patch but uncomfortable; Small patch; Small patch but uncomfortable; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (first dose of shingles vaccine received seven years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced shingles, patchy rash and discomfort. On an unknown date, the outcome of the shingles, patchy rash and discomfort were unknown.   It was unknown if the reporter considered the shingles, patchy rash and discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received first dose of shingles vaccine seven years ago and was fine. Then patient received dose of Shingrix vaccine and got shingles 24 hours later small patch but uncomfortable.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had the shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. Patient had the Shingles shot and 3 days later got shingles. The patient reported to stop lying to the people
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: GAVE MENVEO AS A 3RD DOSE INSTEAD OF BEXSERO FIRST DOSE; First dose at 11 / booster / prior to / incident / gave the patient a / (third dose); This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AXMA44A, expiry date 1st March 2022) for prophylaxis.   Previously administered products included Menveo (1st dose received on an unknown date at the age of 11 year old) and Menveo (2nd dose received on an unknown date at a visit prior to the date of the incident, was the booster dose,when they were in high school for the school rule compliance.).   On 3rd August 2021, the patient received the 3rd dose of Menveo .5 ml. On 3rd August 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.  Additional details were provided as follows: The patient received 3rd dose of Menveo instead of Bexsero 1st dose, which led to wrong vaccine administered. The patient returned to get a dose of Menningococcal B at a later visit, but the nurse gave the patient a Menveo (would be their third dose) when she should have given the patient a dose of Bexsero, which led to extra dose administered. The reporter consent for follow up was unknown.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given twice in 3 mos; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: This case was reported by the registered nurse. The age at vaccination was not reported. The patient received Menveo vaccine twice in 3 months, which led to shortening of vaccination schedule. The formulation, dose, frequency, lot, start/stop date and the duration dates were not known. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: 2nd dose in December 2020. Got shingles in July 2021; Got shingles; rash; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received the 1st dose of Shingrix. In July 2021, between 6 and 8 months after receiving Shingrix and between 8 and 10 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional case details were provided as follows: The reporter was physician assistant. The age at vaccination was not reported. The patient was vaccinated with 1st dose and 2nd dose of Shingrix and got shingles. The patient noticed rash and after three days contacted with physician who treated her with regular shingles medication and symptoms diminished after 5 days. less than 9 months after receiving 1st dose of Shingrix and less than a year after receiving 2nd dose of Shingrix the patient experienced vaccination rash. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; administered / liquid conjugate portion only / not reconstituted with the lyophilized / portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 nurse reported that the patient was administered MenCYW liquid conjugate portion only of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Vaccine was not reconstituted with the lyophilized MenA portion. The nurse did not have any patient details or vaccine lot number and expiration date. The reporter consented to follow up. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169160:Same reporter US-GLAXOSMITHKLINE-US2021AMR170397:Same reporter US-GLAXOSMITHKLINE-US2021AMR170398:Same reporter US-GLAXOSMITHKLINE-US2021AMR170399:Same reporter US-GLAXOSMITHKLINE-US2021AMR170400:Same reporter US-GLAXOSMITHKLINE-US2021AMR170401:Same reporter US-GLAXOSMITHKLINE-US2021AMR170403:Same reporter
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third vaccine; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 18th December) and Shingrix (received 1st dose on 18th June).   On 12th August 2021, the patient received the 3rd dose of Shingrix. On 12th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The patient received third dose of Shingrix, which led to extra dose administered. The patient enquired if there were any problems after receiving this third dose.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder with a diluent solution. Not the one that goes with menveo; powder with a diluent solution. Not the one that goes with menveo; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Menveo powder with a diluent solution. Not the one that goes with Menveo which led to wrong solution used during drug reconstitution and inappropriate dose of vaccine administered. This case is linked to the case US2021AMR170516, reported by the same reporter for different patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170516:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: get vaccine / got shingles 6 days later; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient never had shingles doctor insisted to get vaccine. The patient received Shingles vaccine and got shingles 6 days later. The patient get them yearly in the same spot on his/her back on the side. The follow up would not be possible as no contact details were available. The case has been linked with case US2021AMR170524 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170524:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received the first dose / on 8/30/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of shingrix received on 30th August 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 provide are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter preferred not to disclose any information regarding the patients but clarified that there were two patients involved. The reporter had no further information but agreed to contacted for follow-up. The reporter consented to follow-up. This case is linked to the case US2021169814, reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169814:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Flushing, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever; headache; face feels flushed; arm in which I received the vaccine is slightly sore; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2021, the patient received the 1st dose of Shingrix. In August 2021, 19 hrs after receiving Shingrix, the patient experienced fever, headache, facial flushing and pain in arm. On an unknown date, the outcome of the fever, headache, facial flushing and pain in arm were unknown.   It was unknown if the reporter considered the fever, headache, facial flushing and pain in arm to be related to Shingrix.  Additional details were provide are as follows: The case reported by patient himself/herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix in an unknown arm in evening, just before 20:00 pm and about 19 hours later he/she developed a fever, headache, his/her face felt flushed and arm in which he/she received the vaccine was slightly sore. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative 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 quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered Shingrix Diluent only; administered Shingrix Diluent only; This case was reported by a other health professional via call center representative 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 quality assurance specialist called to report that, the patient inadvertently administered shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The specialist was unable to provide any patient or vaccines details. The specialist also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 41 linked cases, reported by same reporter for different patients..; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170619:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR171145:
Sex: M
Vaccine: VARZOS
Symptoms: Death, Hypersensitivity
Clinical narrative: Has passed away; Severe allergic reaction; This case was reported by a nurse via sales rep and described the occurrence of death in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant) and allergic reaction. On an unknown date, the outcome of the death was fatal and the outcome of the allergic reaction was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed a severe allergic reaction and was categorized as a contraindication to get second dose. The patient passed away since this information was given to the reporter. The reporter consented to follow up. This case has been linked to US2021AMR171275, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR171275:Same reporter.; Reported Cause(s) of Death: Death NOS
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Intercepted medication error
Clinical narrative: Intercepted early dose; Drug dose administration interval too short; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted medication error in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced intercepted medication error and drug dose administration interval too short. On an unknown date, the outcome of the intercepted medication error and drug dose administration interval too short were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that it was less than 2 months since 1st dose of Shingrix but the patient would like to get the 2nd dose of Shingrix on the day of reporting, which led to intercepted medication error for shortening of the schedule.
Sex: F
Vaccine: MNQ
Symptoms: Muscular weakness, Paralysis
Clinical narrative: paralysis; muscle weakness; This case was reported by a physician via call center representative and described the occurrence of paralysis in a child female patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal ACWY Vaccine (potential Menveo). On an unknown date, less than a day after receiving Meningococcal ACWY Vaccine (potential Menveo), the patient experienced paralysis (serious criteria GSK medically significant) and muscle weakness. On an unknown date, the outcome of the paralysis and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the paralysis and muscle weakness to be related to Meningococcal ACWY Vaccine (potential Menveo).  Additional details were provided as follows: The age at vaccination was unknown. The patient was 18 years old at the time of reporting. The vaccine was administered by patient's pediatrician. The patient received the dose of Meningococcal ACWY vaccine (manufacturer unknown) in 2013 or 2014 and within 24 hours after the vaccination, the patient experienced muscle weakness and paralysis. The patient evaluated by neurology and told she did not have Guillain Barre Syndrome (GBS). The symptoms persisted for 1 year. The reporting allergist stated he/she had a question about any published data regarding potential/additional adverse effects of Bexsero, particularly if a patient developed adverse effect after receiving the Meningococcal A (Men ACWY per call back-manufacturer unknown) vaccine. The reporter had no further details regarding event. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of the / vaccine 9 months ago; 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 9 months ago from the date of reporting, 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 did not have information about the patient at the time of the report. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix. The case was linked with case US2021168359, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168359:Same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bone swelling, Burning sensation, Chills, Erythema
Clinical narrative: Neck / it felt like it was on fire / still feel the burning every once in a while; Chills; Fever; Upset stomach; red itchy neck; Itchy neck / neck was itching; Collar bone was swollen; swollen on left side which traveled up her left arm; Neck was puffy and swollen on left side which traveled up her left arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included The patient did not have breathing problems..   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2021, 2 days after receiving Shingrix, the patient experienced chills, fever and upset stomach. On 23rd July 2021, the patient experienced red neck, pruritus, bone swelling, swelling arm and neck swelling. On 24th July 2021, the patient experienced burning sensation. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On 19th July 2021, the outcome of the chills, fever and upset stomach were recovered/resolved. On an unknown date, the outcome of the red neck, pruritus, bone swelling, swelling arm and neck swelling were recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, upset stomach, red neck, pruritus, bone swelling, swelling arm, neck swelling and burning sensation to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received shingrix vaccine and two days later she developed, chills, fever, and upset stomach, which had resolved on the 3rd day.  7 days later she developed a red itchy neck and her collar bone was swollen on left side which traveled up her left arm and had lasted for 10 days.  On July 22nd and 23rd her neck was itching, and by the weekend it felt like it was on fire.  She went to the ER and was discharged home with cortisone.  Patient did not have breathing problems.  Her neck was puffy and swollen on the front left side, and she can still feel the burning every once in a while. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Swelling
Clinical narrative: Neck / it felt like it was on fire / still feel the burning every once in a while; Chills; Fever; Upset stomach; red itchy neck; Itchy neck / neck was itching; Collar bone was swollen; swollen on left side which traveled up her left arm; Neck was puffy and swollen on left side which traveled up her left arm; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included The patient did not have breathing problems..   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th July 2021, 2 days after receiving Shingrix, the patient experienced chills, fever and upset stomach. On 23rd July 2021, the patient experienced red neck, pruritus, bone swelling, swelling arm and neck swelling. On 24th July 2021, the patient experienced burning sensation. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On 19th July 2021, the outcome of the chills, fever and upset stomach were recovered/resolved. On an unknown date, the outcome of the red neck, pruritus, bone swelling, swelling arm and neck swelling were recovered/resolved and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, upset stomach, red neck, pruritus, bone swelling, swelling arm, neck swelling and burning sensation to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient had received shingrix vaccine and two days later she developed, chills, fever, and upset stomach, which had resolved on the 3rd day.  7 days later she developed a red itchy neck and her collar bone was swollen on left side which traveled up her left arm and had lasted for 10 days.  On July 22nd and 23rd her neck was itching, and by the weekend it felt like it was on fire.  She went to the ER and was discharged home with cortisone.  Patient did not have breathing problems.  Her neck was puffy and swollen on the front left side, and she can still feel the burning every once in a while. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first / shot in March of 2020 / never got the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st March 2020).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the tme 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. This case was linked with case US2021168380, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168380:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received his first / shot in March of 2020 and never got the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5 ml) received on 31st March 2020).   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 detals were provided as follows: The reporter was the patient's wife. 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 did not consent to follow up. This case was linked with case US2021168378, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168378:Same reporter
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose / (expired on 8/8/2021) was given to a patient on 8/9/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number ht479, expiry date 8th August 2021) for prophylaxis.   On 9th August 2021, the patient received the 1st dose of Boostrix. On 9th August 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received expired dose of Boostrix, which led to expired vaccine used. The reporter wanted to know what to do. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated on 12/09/2019 with first dose / didn´t receive the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th 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 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 stated that, the 1st dose was administered in another facility (did not have information) and because the patient was not present, he did not want to share demographic information. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 12 month old / received the adult dose; 12 month old / received the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-month-old female patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The 12 month old patient received the adult dose of the Havrix vaccine inadvertently,which led to adult product administered to the child and accidental overdose. The reporter consented to follow up. This case was linked with US2021129066 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129066:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: prescription was written for patient intentionally even though she is under age 50; This case was reported by a consumer via call center representative and described the occurrence of off label use in a 35-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient herself reported the case. The patient had shingles in past. It was stated that Shingrix prescription was written for patient intentionally even though patient was under age 50 and pharmacy refused to administered it,which led to off lable use. The patient stated that her primary care doctor and her rheumatologist both want her to get the vaccine and patient did not know the date the prescription was written. The patient stated that Shingrix was originally only for age 50 years and older but the package insert has been updated recently and it was now approved in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy and patient stated that she fall into that category. The patient did not go into any specific details as to why she was seeing a rheumatologist or if she was currently taking a medication which causes immunosuppression or if she has an immunodeficiency. The patient's doctor wrote patient's script but pharmacy won't fill it and insurance won't cover it. It was stated that the script was written (over 2 months ago) prior to the package insert indication change and patient stated that she already had shingles and She was out of work for 2 months because her shingles case was so severe.  The patient had 3 eye doctor appointments, 8 primary care appointments and 1 emergency room visit and because if that Doctors were really worried about her getting another outbreak and for that Shingrix was prescribed.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: after the patient had received the complete schedule for Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on December 2020), Twinrix (received 2nd dose on January 2021) and Engerix B (had received the complete schedule for Engerix-B on unknown dates).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not applicable for this report. Pharmacist reported that, the patient received 2 doses of Twinrix and did not receive 3rd dose till the time of reporting, which led to incomplete course of vaccination. Twinrix was started after patient had received the complete schedule for Engerix-B. The reporter did not consented to follow-up. The VAERS details pertains to previous doses.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received / first dose / on Nov 12, 2020 / dose received today count as the 2nd dose?; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on 12th November 2020).   On 9th August 2021, the patient received the 2nd dose of Shingrix. On 9th August 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 stated that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. The reporter follow up via an email. This case was linked with case US2021168421, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168421:Same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received / first dose / on Nov 9, 2020 / does the dose received today count as the 2nd dose?; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2020).   On 9th August 2021, the patient received the 2nd dose of Shingrix. On 9th August 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 stated that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. The reporter follow up via an email. This case was linked with case US2021168420, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168420:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Incorrect dose administered
Clinical narrative: about 0.1cc of the vaccine leaked out; during administration/vaccine leaked out of patient's arm; vaccine leaked out of patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2021, the patient received Shingrix. On 9th August 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the Shingrix needle leaked during administration of vaccine and the reporter estimated about 0.1cc of the vaccine leaked out of patient's arm, creating a potential underdose, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose / 29Oct2020 / not received a 2nd dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th october 2020).   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 consented to follow up. The VAERS details were reported for 1st dose of Shingrix.